Magistrates Court : 2009 TASADT 03 Cain -v- The Australian Red Cross Society

Anti-Discrimination Decisions

[2009] TASADT 03

Parties:	CAIN, Michael v The AUSTRALIAN RED CROSS SOCIETY
File No/s:	100-0607003
Inquiry dates:	Inquiry dates: 7, 12, 13, 15, 18, 19, 25, 28 August; 29, 30 September; 28, 31 October; 7, 17 November 2008 - Delivered on: 27 May 2009
Decision of:	H Wood, Chairperson & C Rheinberger & M Otlowski, Tribunal Members

Catchwords:

Representation:

Counsel:
Complainant:	P W Tree SC, K Walker, W Morgan
Respondent:	J Ruskin QC, A Ryan

Solicitors:
Complainant:	Hobart Community Legal Service Inc.
Respondent:	Allens Arthur Robinson

Decision Number:	[2009] TASADT 03
Number of paragraphs:	563

Reasons For Decision

THE TRIBUNAL's DECISION

1. This decision relates to an Inquiry held under the Anti-Discrimination Act 1998 (Tas) with respect to a complaint brought by Mr Michael Cain against the Australian Red Cross Society. Mr Cain alleges he was discriminated against by the Red Cross when his offer to donate blood was declined. The Tribunal’s decision is that Mr Cain’s complaint is not substantiated and that the conduct of the Red Cross does not amount to direct or indirect discrimination. In any event, the conduct of the Red Cross was required by law and so even if he had been subjected to discrimination the conduct of the Red Cross could not be unlawful.

OVERVIEW

2. On the 25 October 2004 Mr Cain entered the premises of the Red Cross in Launceston and offered to donate his blood. The Red Cross Guidelines for the selection of blood donors were followed. He was handed a standard form questionnaire that all potential blood donors must fill out. He completed the questionnaire. One of the questions, question 8, was whether in the last 12 months “He had male-to-male sex”. He answered the question honestly and responded “yes”. Mr Cain is homosexual. Mr Cain was not permitted to donate his blood because of that answer. This decision was made in accordance with the Guidelines. The Guidelines explain to management that“male-to-male sex carries a deferral for 12 months. In this context, the use of condoms or number of partners does not alter the deferral period”.

3. The reason why male-to-male sex in the last 12 months is a ground for deferral under the Red Cross Guidelines is the risk of an undiagnosed HIV infected donation made by a homosexually active donor, and which may not be picked up with routine testing of the blood during the early stages of infection.

4. The Red Cross’ position in relation to the donor deferral policy is that it is one of a number of essential screening measures protecting the blood supply from transmission of disease. One of the essential screening measures is that all blood is scientifically tested for infection and the testing is accurate and sensitive. However, there is a very early stage of the HIV infection when it may not be detected. Another screening measure is the questioning of potential donors which addresses the risk of contaminated blood entering the blood supply at this early stage of infection.

5. Mr Cain alleges that the Red Cross discriminated against him as a homosexual and in relation to his lawful sexual activity. His case is that altruistically minded homosexuals in stable, monogamous relationships posing no realistic risk of HIV infection ought to be permitted to donate blood. He has argued that the risk of HIV transmission lies not with men who have sex with men per se, but with those who engage in unsafe sexual practices. He has urged the Tribunal to consider his alternative proposal that homosexual men who are in stable, monogamous relationships and practice safe sex, should be permitted to donate blood as this would not put the blood supply at risk. Instead, on the positive side, it would provide a new source of blood, and facilitate the altruistic motivations of those donors and do away with unwarranted discrimination.

6. Australia’s blood supply is one of the safest in the world and Mr Cain’s case is that if his approach is adopted that will remain the situation. It is important to note that Mr Cain has made it clear that he does not wish to press any outcome that would imperil the blood supply.

7. It was argued for Mr Cain that the Red Cross’ deferral policy should be modified to allow such donation and that it would be practically straightforward to implement. It was argued that it is possible to craft a few simple, direct questions with regard to safe sex practices and monogamous relationships that would be able to identify low risk homosexual men who should be eligible for blood donation.

8. The claim of discrimination has been rejected by the Red Cross which has strenuously sought to defend its deferral policy. At the outset it is noted that the events of 25 October 2004, set out in paragraph 2 above, are agreed.

9. During the Inquiry, the Tribunal has been provided with a vast volume of evidence. A significant number of expert witnesses have given evidence from a range of disciplines covering an extensive list of considerations such as the nature of HIV, its prevalence within groups of the community, particularly sexually active homosexuals, and evaluation of the risk potentially posed to the blood supply if the low risk segment of that group were permitted to donate blood. This has involved looking very carefully at the Australian system of blood collection and supply and also evaluating this in the context of international practice, including reference to Spain and Italy which Mr Cain relied upon in support of a more inclusive policy.

10. It would be remiss of the Tribunal not to mention that it has been enormously assisted by Counsel for both Mr Cain and the Red Cross in the clear, comprehensible and comprehensive presentation of their cases.

11. The case has also raised some important legal issues including whether the Anti-Discrimination Act applies to the conduct of the Red Cross and whether in its dealings with Mr Cain it was providing a ‘service’, whether the reason for the Red Cross’ deferral of Mr Cain was because of his homosexuality or his sexual activity of male-to-male sex and the issue of whether the Red Cross’ conduct, even if amounting to discrimination, is legally excused by s24 which refers to conduct that is required by a law of the State or Commonwealth. This issue is particularly complex. Regardless of the outcome of the decision on this point and other threshold points the Tribunal has been urged to consider the substantive issue of whether the policy is discriminatory. The Tribunal has acceded to that request because of the fundamental and important nature of this issue and the careful and extensive consideration given to it in the case.

12. As noted, the Tribunal’s decision is that Mr Cain’s complaint of discrimination is not substantiated. The reasons follow – but first, an outline of the structure of the decision and reference to some preliminary matters.

The Structure of the Decision

13. The Tribunal will deal first with the issue of whether the Act applies to the area of activity engaged in by the Red Cross. Unless there is an area of activity covered by the Act in s22, the Act has no application to a complaint concerning direct or indirect discrimination. Noting the threshold nature of this issue regarding s22, the Tribunal will deal with this at the outset of the decision together with other issues of general application.

14. The Tribunal will then proceed to consider indirect discrimination. Indirect discrimination gives rise to the question of the reasonableness of the deferral policy in light of all the circumstances and almost all of the contentious factual issues relate to the issue of reasonableness. The issue of reasonableness has been the focus of the vast amount of evidence in this case. It is noted that direct discrimination is pressed just as strenuously, with Mr Tree S.C. submitting that this case is a textbook example of direct discrimination, but factually, it does not traverse the vast array of evidence mentioned. Noting the prominence of the reasonableness issue in this case, it is convenient to deal with indirect discrimination before direct discrimination.

15. Having dealt with indirect and direct discrimination the Tribunal will consider finally the question of whether the conduct of the Red Cross falls within s24 and s25 of the Act as a statutory exception.

16. Due to the length of the decision and the overlap of some issues, a Table of Contents is provided.

Table of Contents

THE TRIBUNAL’S DECISION

1

OVERVIEW

2

The Structure of the Decision
13

Table of Contents
16

Some Preliminary Matters

17

Terminology
17

Onus of proof
22

A COMPLAINT OF DIRECT AND INDIRECT DISCRIMINATION
25

Provision of Services
29

INDIRECT DISCRIMINATION
56

Imposition of Condition, Requirement or Practice
58

Unreasonable in all the Circumstances
67

Legal principles
67

The issues in relation to unreasonableness in all the circumstances

75

Witness and Evidence
88

The witnesses and their roles in assisting the Tribunal in determining this case
88

The categories of evidence and the value of the evidence provided
93

General observations of the witnesses
103

The Precautionary Principle and other Ethical Principles associated with Blood Banking
110

Risk Management Issues
131

Public Confidence and Perceptions of Blood Safety

143

The Perspective of the Blood Banker
147

Epidemiology and Science
151

The hierarchy of risk
157

Mathematical modelling
186

Prevalence and incidence
209

Epidemiology and sexually transmitted diseases (STIs) and MRSA

240

Social research
250

Comparison with other tolerated risks
260

History of Blood Transfusion and HIV/AIDS in Australia
270

History of the Deferral Policy
294

Background to the Current Donor Questionnaire
300

Current Situation with HIV and the Blood Supply in Australia
310

New England Journal of Medicine Article
316

The Harm Arising from the Current Deferral Policy and Benefits of Change
334

International Situation
341

Italy and Spain
348

Efficacy of the Donor Questionnaire

355

Oral Sex: non-epidemiological considerations
367

Condoms and Monogamy
374

Condoms
375

Monogamy
376

Statutory Obligations
377

Conclusion in Relation to Unreasonableness
379

Whether the Policy had the Effect of Disadvantaging Mr Cain
398

Whether Mr Cain was Disadvantaged as a Member of a Group sharing an Attribute more than a person who is not a Member of that Group
399

DIRECT DISCRIMINATION
403

Whether the Reason for the Treatment is on the Basis of the Prescribed Attributes of Lawful Sexual Activity or Sexual Orientation or a Characteristic Imputed to Attribute
406

Whether the Treatment of the Complainant was Less Favourable or Rather, Equal Treatment
431

Comparator

435

Detriment
442

STATUTORY EXCEPTION
450

Section 24 Exception of 'Statutory Authority'
452

1. Blood Transfusion (Limitation of Liability) Act 1986 (Tas)
457

2. Therapeutic Goods Legislation
504

3. Workplace Health and Safety Act 1995 (Tas)

533

Section 25
540

CONCLUSIONS
549

ORDER
562

Some Preliminary Matters

Terminology
17. The respondent to these proceedings is the Australian Red Cross Society. The Society is an incorporated body established by Royal Charter and has an operating division known as the Australian Red Cross Blood Service which is responsible for the blood collection and distribution activities of the Society throughout Australia. Importantly, at all relevant times the Australian Red Cross Society conducted the Blood Service (see Agreed Statement of Facts C1). The Australian Red Cross Blood Service can be treated as an aspect of the Australian Red Cross Society and in this decision there is no need to distinguish between the Society and the Service. The Tribunal refers to the Australian Red Cross Service as the Red Cross.

18. During the Inquiry, the acronym ‘MSM’ was used by Counsel and witnesses to refer to the group of men who have sex with men, meaning the same as homosexually-active men. The Tribunal has adopted that acronym in this decision.

19. We note the concerns put on behalf of Mr Cain (Submissions in Reply, para 1.1.1 and following) that there has been some confusion and at times the Red Cross’ submissions and its witnesses have referred to MSM meaning the activity of male-to-male sex.

20. To avoid any confusion and to distinguish the group from the activity the Tribunal will refer to MSM as the MSM group.

21. Another matter concerns the reference to the Red Cross’ current policy as a ‘deferral’ policy. In this decision, the Tribunal refers to the policy as a deferral policy but does so noting the following. The reference is strictly correct, because if the interval of 12 months since the last incident of male-to-male sex lapses then the individual, previously deferred, may have the opportunity to donate blood. However, the Tribunal accepts that for most sexually active homosexuals this policy represents a permanent exclusion.

Onus of proof
22. In establishing both forms of discrimination under the Act, direct and indirect discrimination, Mr Cain bears the onus of proof, according to the civil standard, on the balance of probabilities. The approach to be followed by the Tribunal is established in Briginshaw v Briginshaw 1939 60 CLR 336 at 362:

“The seriousness of an allegation made, the inherent unlikelihood of an occurrence of a given description, or the gravity of the consequences flowing from a particular finding are considerations which must affect the answer to the question whether the issue has been proved.”

23. A more detailed discussion about the onus of proof in the context of the Act may be found in Rogers v Hanusiewicz Medical Pty Ltd (2004) TASADT 14.

24. In relation to the statutory exceptions the burden shifts to respondents so that the Red Cross has the onus of establishing the application of the exception: s101 of the Act. The standard of proof is the balance of probabilities.

A COMPLAINT OF DIRECT AND INDIRECT DISCRIMINATION

25. Mr Cain’s complaint is that the conduct of the Red Cross has contravened the Act and that the conduct amounts to either direct discrimination (s14) or indirect discrimination (s15). The attributes relevant to both forms of discrimination are lawful sexual activity and sexual orientation.

26. In relation to direct discrimination, it is Mr Cain’s case that the rejection of his blood by the Red Cross constituted direct discrimination within the meaning of s14 of the Act in that Mr Cain was treated less favourably than another person on the basis of the lawful sexual activity in which he had engaged being sex with another man, or alternatively, his sexual orientation as homosexual. Both of these attributes are covered by s16 of the Act. Section 16 provides the grounds of discrimination that are covered by the Act and includes lawful sexual activity (s16(d)) and sexual orientation (s16(c)).

27. Alternatively, it is Mr Cain’s case that the conduct of the Red Cross in rejecting his blood constituted indirect discrimination within the meaning of s15 of the Act. In particular, that the male-to-male sex deferral policy had the effect of causing disadvantage to Mr Cain, as a potential blood donor, by reason of his membership of two groups of people who share, or were believed to share, a prescribed attribute or a characteristic imputed to that attribute, being homosexual men or men who engage in the lawful sexual activity of male-to-male sex.

28. A threshold requirement before either form of discrimination can be established is that s22 of the Act applies and that Mr Cain was “a person engaged in, or undertaking any, activity in connection with” any of the areas of activity listed in s22 (1)(a)-(g). In this case the applicable activity is the “provision of facilities, goods and services”. Unless that provision applies the Act does not apply.

Provision of Services

29. A threshold issue for the Tribunal is whether Mr Cain was engaged in an activity of the kind specified in s22 of the Act or in connection with such an area of activity at the time of the alleged discrimination. The Act only applies to discriminatory conduct in the areas of activities prescribed by s22 of the Act.

30. The relevant part of s22 is set out below. It is noted that there has been a subsequent amendment to s22 (No. 44 of 2004), but that amendment took effect on the 16 November 2004, after the date of the alleged breach in this case. The terms of the section at the time of the alleged breach were as follows:

“s22(1) Subject to the exceptions and exemptions specified in Part 5, this Act applies to discrimination and prohibited conduct, other than inciting hatred, against a person engaged in, or undertaking any, activity in connection with any of the following:

(a) employment;
(b) education and training;
(c) provision of facilities, goods and services;
(d) accommodation;
(e) membership and activities of clubs;
(f) administration of any law of the State or any State program on any ground specified in section 16(e), (f), (fa), (g), (h), (i) or (j);
(g) awards, enterprise agreements and industrial agreements on any ground specified in section 16(e), (f), (fa), (g), (h), (i) or (j).”

31. The term ‘services’ is defined at s3 of the Act, which provides:

“‘services’ includes services -

(a) relating to access to, and the use of, any place that members of the public are permitted to enter; or

(b) relating to banking, insurance, superannuation or the provision of grants, loans, credit or finance; or

(c) relating to entertainment, refreshment or recreation; or

(d) relating to transportation and travel; or

(e) relating to any profession, trade or business; or

(f) provided by a State authority or a council; or

(g) relating to selling, buying, leasing, assigning or disposing of an interest in land.”

32. Mr Cain accepted in his submissions that there was not a direct correlation between the provisions of s3 and the facts of this case. It was submitted that subsections (a) and (e) had application to the facts of this case and subsection (e) had the closest correlation.

33. The submissions on behalf of Mr Cain and the Red Cross were in agreement that the definition was inclusive and not exhaustive and that ‘services’ should be attributed a wide interpretation.

34. In IW v City of Perth (1997) 191 CLR 1 at p11 and p69 the Macquarie Dictionary definition of ‘service’ was accepted by Brennan CJ, McHugh J and Kirby J. The definition is as follows:

“an act of helpful activity; the supplying or supplier of articles, commodities, activities etc required or demanded; the providing or a provider of some accommodation required by the public; the supplying or supplier of water, gas or the like to the public.”

35. The High Court in Waters v Public Transport Corporation (1991) 173 CLR 349 held that when construing legislation designed to protect basic human rights and dignity, the courts “have a special responsibility to take into account of and give effect to its purpose”. This approach is consistent with s8A of the Acts Interpretation Act 1931 (Tas), providing for an interpretation which promotes the objects of an Act whether the objects are specified, or not, in the Act.

36. The objects of the Act are not specifically stated. The Tribunal is of the view that it is clear that the Act is intended to be beneficial and remedial: see Waters v Public Transport Corporation (1991) 173 CLR 349 at 359 and IW v City of Perth (1997) 191 CLR 1 at p12.

37. Their Honours Brennan CJ and McHugh J in IW v City of Perth at p12 stated:

“…if the term ‘service’, read in the context of the Act and its object, is capable of applying to an activity, a court or Tribunal, exercising jurisdiction under the Act, should hold that that activity is a “service” for the purpose of the Act.”

38. His Honour Gummow J at p41 stated:

“The term ‘service’ and its variants are of wide and varied meaning. One speaks of the duties or work of a public servant, being a person serving the state or the community in a particular capacity, Service may also be rendered to an individual by conduct tending to welfare or advantage of that person.”

39. Consistent with the approach of the High Court, ‘services’ should be attributed a wide and ordinary meaning. It is noted that s22 of the Tasmanian Act is restricted to the ‘provision’ of services and so “…there must be discrimination not only in relation to a service but also in relation to the provision of a service”: see R v Anti-Discrimination Commissioner; Ex parte McDermott (2000) TASSC 113 at para 9.

40. Accepting that ‘service’ is interpreted widely, it also has to be considered in light of s22 of the Act. Section 22 focuses on the activity of a complainant as giving rise to the application of the Act rather than the activity of the discriminator. In Lindisfarne R & SLA Sub-Branch and Citizen’s Club Inc & Anor v Buchanan (2004) TASSC 73 Evans J said the following in relation to s22 of the Act:

“Section 22(1) is a somewhat curious provision insofar as its primary focus is on the activities of the person discriminated against, rather than those of the discriminator. Nevertheless, the determination of whether the victim was engaged in an activity in connection with any of the specified matters, almost inevitably, involves a consideration of the activities of the discriminator. The Tribunal held that Mr Buchanan was engaged in the activity of applying for membership of the appellant organisations and that this activity was in connection with the provision of services by both organisations to members.” (para18)

41. See also in relation to this point Underwood J at paragraph 43 of The Secretary of the Department of Justice and Industrial Relations v The Anti-Discrimination Commissioner (2003) TASSC 27.

42. Unlike other anti-discrimination legislation, the Tasmanian provision goes beyond the activities of the service to any activity ‘in connection with’ the provision of services. This is much broader than the legislation in other jurisdictions and was considered by Evans J in Buchanan. Mr Buchanan’s case is analogous to the case under consideration. Counsel for Mr Buchanan submitted that the RSL was not providing any services to Mr Buchanan as he had merely applied to be a member of the RSL and at that stage neither the state nor the national body of the RSL were providing any services to Mr Buchanan. Likewise, in this case it was submitted for the Red Cross that the Red Cross was not providing a service or services to Mr Cain or blood donors in general. Mr Cain’s submissions did not accept that proposition. A crucial issue for consideration in the case of Buchanan was whether the Mr Buchanan’s activity was ‘in connection with’ the provision of a service.

43. His Honour, Evans J, considered the phrase, ‘in connection with’, in Buchanan v RSL and at paragraph 20 provided useful guidance as to meaning of this phrase:

“Whilst the phrase ‘in connection with’ has a wide operation, it must be considered within the confines of s22(1). In Minister for Immigration and Multicultural Affairs v Singh & Ors (2000) 175 ALR 503, the court considered the phrase ‘in connection with’ as it appears in the Migration Act 1958 (Cth), s476(i)(a). Black CJ, Sundberg, Katz and Hely JJ said in their joint judgment at 509:

“The case law on the phrase ‘in connection with’ indicates that it is an expression of wide connotation that merely requires a relation between one thing and another: eg Perrett v Commissioner for Superannuation (1991) 29 FCR 581; Burswood Management Ltd v Attorney-General (Cth) (1990) 23 FCR 144; Collector of Customs v Pozzolanic Enterprises Pty Ltd (1993) FCA 456; (1993) 43 FCR 280. But in Burswood at 146 the Full Court quoted with approval a statement made by Davies J as follows:

“Expressions such as ‘relating to’, ‘in relation to’, ‘in connection with’ and ‘in respect of’ are commonly found in legislation but invariably raise problems of statutory interpretation. They are terms which fluctuate in operation from statute to statute … The terms may have a very wide operation but they do not usually carry the widest possible ambit, for they are subject to the context in which they are used, to the words with which they are associated and to the object or purpose of the statutory provision in which they appear.”

The phrase ‘in connection with’ does not necessarily require a causal relationship between the matters said to be connected: Perrett (supra), and phrases such as ‘having to do with’ are sometimes referred to as a useful synonym: re Nanaimo v Community Hotel Ltd (1944) 4 DLR 638. But so too are phrases such as ‘in the course of’, or ‘forming part of’: Dawson v Hoffman Brick and Potteries Ltd (1924) VLR 208. As the Full Court emphasised in Burswood (supra) at 146 reference to reported cases is of little assistance, because the nature of the relationship between one thing and another which is encompassed by the phrase ‘in connection with’ depends so much upon the statutory context in which the words appear.”

44. Evans J concluded, “…plainly, Mr Buchanan, in applying for membership of the League and the Sub-Branch was engaged in activity in connection with the provision of the services provided by these bodies. There is nothing remote about the connection between Mr Buchanan’s application for membership and the receipt of services. There is a direct link between membership and the receipt of services” (para 26).

45. The evidence establishes that the Red Cross has been involved in the collection, processing, screening and distribution of blood and blood products since 1929, when the Society established a blood service in Australia (see Dr Wylie R47, para 15). The activities of the Red Cross involve the collection of blood from voluntary donors, storage of blood, testing of blood, separation of blood into component parts (where appropriate) and distribution of blood to health care providers including hospitals (Agreed Statement of Facts, paragraph 3 and for a more detailed description see Dr Wylie Statement R47, para 37).

46. The Tribunal concludes that an offer to donate blood is an integral part of the activity of collecting blood. The Red Cross cannot provide their services of the distribution of blood to recipients in the community at large without the acceptance of donations of blood. In considering the link between blood donations and provision of services it is useful to draw from the terminology of Evans J in RSL v Buchanan at paragraph 26 when he considered that there was ‘nothing remote’ about the link between Mr Buchanan’s application for membership and the provision of services. In this case, the Tribunal concludes that the donation of blood is closely linked to the provision of services and that the donation of blood must be regarded as an activity in connection with the provision of services.

47. An additional limb of the submissions for Mr Cain that s22 applies to this case is that the activity that the Red Cross engages in includes the provision of services to blood donors such as Mr Cain. It was submitted for the Red Cross that it provides no service to Mr Cain or to any other blood donor. It was submitted that the Red Cross provides the facilities and the opportunity for a blood donor to be able to give blood to recipients and through the collection of blood, scientific testing of blood occurs for the benefit of donors (see Submissions para 2.20 and following). This argument draws on reasons of the Victorian Civil and Administrative Tribunal in Re Norman v Australian Red Cross Society (1998) 14 VAR 243. The complaint in that case is factually very similar to this case and came to the Tribunal as an application to strike out a complaint because it was misconceived. Deputy President McKenzie made comments as to whether the application of the Red Cross to strike out the complaint should succeed based on an argument that the Red Cross was not providing a service to blood donors:

“In my view, to say that the Red Cross blood bank only provides a service to those who ultimately are administered the blood it collects is to define what it does too narrowly. It conducts a blood bank. That includes a number of operations. It includes the collection of blood from donors, its storage, its separation … For those who wish to donate blood, the Red Cross provides them with the means and opportunity to do so, including premises at which, and facilities and equipment with which the blood can be collected, and the staff to carry out that procedure. It provides a centralised, co-ordinated and organised facility where people who wish to may attend and donate blood. It cannot be said that it is impossible to characterise this arrangement as a service, both to those who wish to donate blood and to those who ultimately receive those donations.”

48. Submissions for Mr Cain also relied on a decision of the Netherlands Equal Treatment Commission in The Dutch Case the Netherlands Equal Treatment Commission, File Number 2007-0085 that the provision of goods and services would be broad enough to encapsulate the provision of facilities to allow donors to donate blood (para 3.7 and 3.8).

49. While these authorities provide support for Mr Cain’s argument that the Red Cross was providing a service to him at the time his offer to donate blood was declined, it is not necessary for the Tribunal to consider the application of those cases here. As already noted, the legislation in Tasmania is broader than in other jurisdictions and, to succeed, it is not necessary for the complaint to be characterised as a case of provision of services to Mr Cain. The section clearly applies because of the extended terms of the section and its application to activity that it is ‘in connection with’ the provision of services.

50. It was submitted on behalf of the Red Cross that by not accepting Mr Cain’s offer to donate blood, the Red Cross were not refusing a service but rather, exercising a discretion whether to accept or reject an offer to donate blood. The Red Cross relied on IW v City of Perth in support of this argument. In that case, the local Council refused to grant planning approval for a drop in centre for persons affected with HIV. The group made a claim against the local Council alleging discrimination. The refusal was held to be an exercise of the Council’s statutory discretion and did not equate to a failure to provide a service.

51. Their Honours, Brennan CJ and McHugh J, held at p17 that the Council did not provide a service of giving planning approvals as that term is not capable of including a refusal to exercise a statutory discretion. Therefore, the Council had not refused to provide a service. Their Honours, Dawson and Gaudron JJ at pp23-24, held that the relevant service for the purposes of the act was the exercise of a discretion whether to grant or withhold planning approval. Discrimination was not established simply by showing refusal; it is necessary to show a refusal to consider whether approval should be granted or withheld. Gummow J at pp44-45 held that the Council provided services in dealing with applications for approval but it had not refused to provide those services.

52. It was submitted on behalf of the Red Cross that the ‘service’ in this case is the exercise of the Red Cross’ discretion to accept or reject blood donations. The Red Cross has merely exercised its discretion and determined to reject Mr Cain’s offer to donate blood. It was further submitted that the relevant service was provided, being the consideration of Mr Cain’s offer to donate blood.

53. It was submitted for Mr Cain that the Red Cross’ analogy to IW v City of Perth is flawed and that to characterise the Red Cross’ services as an assessment of the offer of a donation of blood is not correct. It was further submitted for Mr Cain that whether to accept the offer for blood is only part of the services provided to donors.

54. The Tribunal considers that it is artificial to consider the Red Cross’ services as merely accepting or rejecting offers of donations of blood. The Tribunal considers that the submission for Mr Cain that the Red Cross provides a service to donors that is more extensive than merely accepting or rejecting offers of donations of blood has merit. However, as noted above the Tribunal does not need to decide the question of whether services are provided to donors in addition to the services provided to the community at large as blood recipients. The Tribunal considers that the proper description of the relevant service or services for the purpose of the Act must relate to and include the collection, processing, screening and distribution of blood products. Further, Mr Cains’ conduct in offering to donate blood is ‘in connection with’ the service that the Red Cross provides to blood recipients. It may be noted that the provision considered by the High Court in IW v City of Perth, Equal Opportunity Act 1984 (WA) s66K, is in different terms to s22 and is confined to services vis a vis complainants and the sub-section relied on in that case (s66(1)(a)) required a refusal to provide a service to a complainant. The Tribunal rejects the Red Cross’ argument relating to IW v City of Perth.

55. The Red Cross also raised for consideration (Submissions, p9) that an offer to donate blood did not fall within s3 of the Act and relied on the case of E v The Australian Red Cross Society & Ors (1990-1991) 99 ALR 601. That case dealt with (amongst other matters) a consideration of whether the supply of blood to hospitals by the Red Cross was an activity in ‘trade or commerce’. It was held that the supply of blood to the hospitals was not an activity in ‘trade or commerce’. This concerned a narrow issue relating to s52 of the Trade Practices Act 1974 (Cth) and the Tribunal is not concerned with that issue in this case and in determining whether the supply of blood is a ‘service’ is not constrained by the terms ‘trade or commerce’. In the Tribunal’s view, the case does not apply and does not detract from the determinations that have been made in relation to the issue of services.

INDIRECT DISCRIMINATION

56. The elements of indirect discrimination are set out in s15 in the following terms:

“(1) Indirect discrimination takes place if a person imposes a condition, requirement or practice which is unreasonable in the circumstances and has the effect of disadvantaging a member of a group of people who -

(a) share, or are believed to share, a prescribed attribute; or

(b) share, or are believed to share, any of the characteristics imputed to that attribute-

more than a person who is not a member of that group.

(2) For indirect discrimination to take place, it is not necessary that the person who discriminates is aware that the condition, requirement or practice disadvantages the group of people.”

57. The elements of s15 are as follows:

1. Imposition of ‘condition, requirement or practice’.

2. The condition, requirement or practice is unreasonable in all the circumstances.

3. It has the effect of disadvantaging a complainant.

4. The complainant is disadvantaged as a member of a group of people who share or are believed to share a prescribed attribute more than a person who is not a member of that group.

Imposition of Condition, Requirement or Practice

58. The words ‘condition, requirement or practice’ have a broad meaning. In the employment context it has been considered that the words cover any form of qualification or prerequisite demanded by an employer of his employees: Australian Iron & Steel Pty Ltd v Banovic (1989) 168 CLR 165 per Dawson J at p185.

59. The first step is to identify with precision the actual condition, requirement or practice (see Australian Iron & Steel Pty. Ltd. v Banovic at p185). Mr Cain alleges that the Red Cross has imposed a condition, requirement or practice that a man who responds affirmatively to the question whether he had engaged in male-to-male sex within the previous 12 months was not to donate blood. It seems clear to the Tribunal that a ‘condition’ of giving blood is that a potential donor has not had male-to-male sex within the previous 12 months.

60. The question of whether a requirement was ‘imposed’ by a respondent was considered by the High Court in New South Wales v Amery (2006) HCA 14. The case involved a number of casual teachers who claimed indirect discrimination due to differences in their pay compared to permanent teachers. Most of the casual teachers had applied to be permanent teachers but placed a geographical caveat on their placement mainly due to family reasons. The majority of the judges found that there was no requirement or condition imposed by the Department on the casual teachers (see joint judgment Gummow, Hayne and Crennan JJ at paras 63-82 and Callinan J at paras 205-208).

61. The Red Cross rely on a passage from Callinan J in Amery at paragraph 207 where he noted:

“The appellant (the Dept) relevantly required nothing of the respondents (the teachers). It was the respondents who stipulated a condition, or, to put it another way, sought to impose a condition in respect of their employment, that their employment as teachers be confined to particular locations. It was from that, their stipulation, and no condition imposed by the appellant, that the differential remuneration flowed.”

62. Callinan J’s comments emphasise that, in this case, the mere existence of the male-to-male sex policy is not enough; Mr Cain must establish that the male-to-male sex policy is imposed on him by the Red Cross. The Red Cross denies that its male-to-male sex policy amounts to the ‘imposition’ of a requirement or condition. The argument is that just because the Red Cross has a policy of deferral, does not equate to the imposition of a requirement or condition upon Mr Cain.

63. The Tasmanian Anti-Discrimination Tribunal in Rosten v Clubhouse Tasmania Inc (2002) TASADT 01 considered the legal requirement of whether a condition, requirement or practice was imposed on a complainant. The Clubhouse provided rehabilitation services for people with mental illness. The complainant in that case alleged indirect discrimination on the basis that the practice of allowing alcohol at social occasions disadvantaged her as a person with mental illness. The Tribunal determined that on the evidence, the practice of allowing alcohol had not been imposed on the members but rather, it was a decision made by the members when it was agreed that the Clubhouse would not supply alcohol but members could bring in their own alcohol. The complainant failed to establish there was a practice imposed on members (see para 49 of the decision).

64. Mr Cain submits that neither Rosten nor Amery assist the Tribunal because of the factual differences. In Rosten the members imposed the condition about alcohol and in Amery there was a condition imposed by the teachers in relation to their placement. By contrast, Mr Cain does not impose any condition on the acceptance of his blood; it is the Red Cross which has imposed a condition on the acceptance of his offer to donate blood, that is, that they will not accept his blood if he has had male-to-male sex in the previous 12 months.

65. It was also submitted for the Red Cross that because Mr Cain’s offer to donate blood was voluntary, that is a bar to him claiming that a condition has been imposed on him (Closing Submissions, para 15). It was submitted for Mr Cain that this does not follow using the analogy of a person applying for a job in response to an advertisement in the newspaper, and that such a case would not fail because of the voluntary nature of the application. The Tribunal considers that the distinction drawn on behalf of the Red Cross is not valid and that voluntary engagement by a complainant with the alleged discriminator’s activity does not preclude a finding that the condition or requirement was ‘imposed’ by the alleged discriminator.

66. The Tribunal concludes that the Red Cross by asking the question about whether a potential donor has had male-to-male sex in the preceding 12 months is clearly imposing a condition, requirement or practice. Donors attending Red Cross to donate blood and who respond affirmatively to that question are not permitted to donate blood.

Unreasonable in all the Circumstances

Legal principles
67. The principles relating to unreasonableness are well settled and there is no dispute about those principles and the correct approach to be taken by the Tribunal in assessing whether the deferral policy applied to Mr Cain by the Red Cross was unreasonable (see Mr Cain’s Submissions in Reply, para 5.4).

68. The central principles are conveniently summarised in the Full Court Federal Court decision of Catholic Education v Clarke (2004) 138 FCR 121 per Sackville and Stone JJ at pp145-146:

“(i) The person aggrieved bears the onus of establishing that the condition or requirement was not reasonable in the circumstances; Commonwealth Bank of Australia v Human Rights and Equal Opportunity Commission (1997) 80 FCR 78 at 111, per Sackville J (with whom Davies and Beaumont JJ agreed), and the authorities cited there;

(ii) The test of reasonableness is an objective one, which requires the Court to weigh the nature and extent of the discriminatory effect, on the one hand, against the reasons advanced in favour of the condition or requirement, on the other: Secretary, Department of Foreign Affairs and Trade v Styles (1989) 23 FCR 251 at 263, per Bowen CJ and Gummow J; Walters v Public Transport Commission at 395-396, per Dawson and Toohey JJ; at 383, per Deane J. Since the test is objective, the subjective preferences of the aggrieved person are not determinative, but may be relevant in assessing whether the requirement or condition is unreasonable: Commonwealth v Human Rights and Equal Opportunity Commission (1995) 63 FCR 74 at 82-83, per Lockhart J;

(iii) The test of reasonableness is less demanding than one of necessity, but more demanding than a test of convenience: Styles at 263. It follows that the question is not whether the decision to impose the requirement or condition was correct, but whether it has been shown not to be objectively reasonable having regard to the circumstances of the case: Australian Medical Council v Wilson (1996) 68 FCR 46 at 61-62, per Heerey J; Commonwealth Bank v HREOC at 112-113, per Sackville J; and

(iv) The Court must weigh all relevant factors. While these may differ according to the circumstances of each case, they will usually include the reasons advanced in favour of the requirement or condition, the nature and effect of the requirement or condition, the financial burden on the alleged discriminator of accommodating the needs of the aggrieved person and the availability of alternative methods of achieving the alleged discriminator’s objectives without recourse to the requirement condition: Waters v Public Transport Corporation at 395, per Dawson and Toohey JJ (with whom Deane J agreed on this point, at 383-384). However, the fact that there is a reasonable alternative that might accommodate the interests of the aggrieved person does not of itself establish that a requirement or condition is unreasonable: Commonwealth Bank v HREOC at 88, per Beaumont J; Victoria v Schou (2004) 8 VR 120 at [26], per Phillips JA.”

69. It is useful to consider in more detail the legal principles that have particular relevance in this case. Before doing that, it is important to note that a broad range of circumstances are referred to as relevant to the deferral policy and many of these focus on the type of activity that the Red Cross is involved in as a blood banker. This is a case where Mr Cain presents an alternative deferral policy, arguing that in the circumstances of this case, the failure to adopt that approach is unreasonable. The current policy and the alternative approach are to be scrutinised by the Tribunal. With this in mind, the Tribunal refers to the following principles.

70. The question of whether the imposition of a condition is unreasonable ‘must be determined with reference to the activity in which the putative discriminator is engaged’. Reasonableness “….must be determined by reference to the activity or transaction in which the putative discriminator is engaged. Provided the purpose of the activity or transaction is not to discriminate on impermissible grounds, the reasonableness of a requirement or condition depends on whether it is reasonable to impose the requirement or condition in order to perform the activity or complete the transaction”: per Brennan J in Waters at p378.

71. When assessing all the circumstances of the case, the factors to be taken into account will depend on the case in question. It is worth noting the breadth of factors identified by the High Court in Waters:

“The cost of not imposing the discriminatory requirement in financial and efficiency terms (per McHugh J at pp409-410 and Brennan J at p378), effectiveness, efficiency and convenience (per Brennan J at p378), financial or economic circumstances of the Respondents, maintenance of good industrial relations, observance of health and safety requirements and the existence of competitors.” (Dawson and Toohey JJ at p395)

72. When assessing reasonableness and alternative measures it may be that a less discriminatory option is available. In Waters Brennan J stated:

“whether the activity could be performed … without imposing a requirement or condition that is discriminatory … or that is as discriminatory as the requirement or condition imposed: per Brennan J in Waters at p378.”

73. As to this matter, Brennan J said at page 379: “But even where the imposition of the particular requirement or condition is appropriate and adapted to the performance of the relevant activity or the completion of the relevant transaction, it is necessary to consider whether performance or completion might reasonably have been achieved without imposing so discriminatory a requirement or condition”. This factor of the availability of alternative methods was referred to in the joint judgment of Dawson and Toohey JJ in Waters at page 395.

74. If the condition under scrutiny is appropriate and adapted to the activity being pursued but an alternative is proposed that is viable, the existence of that viable alternative does not necessarily render the condition or requirement unreasonable. The availability of a viable alternative is a factor to be taken into account but not necessarily determinative of the question of whether the condition is unreasonable: State of Victoria v Schou (2004) 8 VR Phillips JA at paragraph 25. In Schou the condition imposed was held to be appropriate and well suited to the activity being pursued and in that context Phillips JA stated that “the alternatives must be as efficacious if the mere existence of an alternative is to bear upon the reasonableness of the condition or requirement under attack”: (para 39).

The issues in relation to unreasonableness in all the circumstances
75. The broad issue arising from s15 is whether the current deferral policy to disallow donors to donate blood if they have had male-to-male sex in the last 12 months is unreasonable in all the circumstances.

76. The Red Cross’ position is that the policy is reasonable because of the risk to recipients if donors who have had male-to-male sex in the last 12 months were permitted to donate.

77. As will be seen from the analysis that follows, the major risk of concern to the Red Cross, which drives the current deferral policy in relation to the MSM group, is the risk of a donor who is HIV positive donating blood in the window period when the virus is infectious and transmissible to blood transfusion recipients but not detectable by the NAT test (a maximum period of 3 months). The principle issue in this case, and the focus of the evidence, is whether, in view of that risk, the policy of the Red Cross is unreasonable in all the circumstances.

78. The position of Mr Cain is that if the deferral policy identified and excluded donors because of unsafe sexual practices and not because donors belonged to the MSM group, the blood supply would be as safe if not safer than currently is the situation in Australia and such a policy would have the advantages of not being one that discriminated against people on the basis of their sexual orientation and lawful sexual activity.

79. In assessing reasonableness, the considerations that arise in this case involve:

• the nature and extent of the risk or risks of concern to the Red Cross;
• a comparison with the risk to the blood supply if the alternative approach urged by Mr Cain was taken;
• whether the donor questionnaire is well adapted to address the risk of concern and does so effectively;
• the history of the 12 month deferral policy by the Red Cross;
• the history of HIV and blood transfusion in Australia;
• recent developments relating to blood transfusion and the current situation regarding the blood supply in Australia;
• current trends of the HIV disease;
• the approach taken by blood banks in other countries and a comparative assessment of the safety of the blood supply in those countries;
• the harm the policy causes to homosexuals in the Australian community and the benefits arising from a policy which does not exclude on the basis of membership of the MSM group;
• whether the alternative approach can be effectively implemented;
• the values and ethical principles that should guide the Red Cross in making policy decisions regarding donor exclusion or deferral given the activity that the Red Cross engages in as a blood banker;
• risk management principles that should guide the Red Cross; and
• the broad picture of other donors deferred and included and risks that are tolerated.

Issues that were resolved as the case progressed
80. There were various issues that arose at particular stages of the Inquiry that were explored and seemed contentious but were then later resolved. It is appropriate to briefly mention these.

The window period
81. The ‘window period’ is the period following infection, in which the donor’s blood carries a virus which is infectious and transmissible to a blood transfusion recipient but the virus will not be detected by the screening agent, NAT test, nucleic acid based test (Dr Wylie, Statement R47, para 67). While there is no agreement about the length of the window period for the HIV/AIDS virus, (see Mr Cain’s Submissions in Reply, para 6.7), in reality, there was a consensus from the witnesses. The average period for detection of the HIV virus by NAT testing is a period of 11 days following infection but depending on the individual, it could be as long as 3 months (Dr Wylie, Statement R47, para 68 and Professor Kaldor T966 who was not challenged on this evidence). When the Tribunal refers to the window period it is referring to a period of up to 3 months.

False negatives
82. There was some reference in the evidence to the very low risk that NAT testing could produce a false negative result (Dr Wylie T579, para 64). While there is scant evidence about this risk, there is evidence that tends to suggest that false negative results in relation to the window period are extraordinarily rare (Dr Halpern T24 and Dr Wylie T580). Professor Kaldor dismissed this issue as an issue of no concern and the evidence did not suggest that it was a risk that influenced the Red Cross in policy decision making. The Tribunal concludes that it should be disregarded as a relevant consideration in this case.

The option of shortening the deferral period
83. As the evidence about the window period unfolded, the Tribunal explored whether there was justification for deferring the MSM group for a shorter time frame, reducing it from 12 months to a time closer to 3 months, being the outer limit of the window period. Various reasons were advanced and these were explored with the witnesses. This evidence centred on considerations about the format of donor questionnaires and methods for extracting reliable information from donors. Considerations were advanced such as the risk of inaccurately remembering an event so that while it occurred in the window period it is remembered as occurring longer ago and consistency with other time frames in the donor questionnaire. Another concern was that people can be less likely to acknowledge an event if it occurred recently.

84. Mr Tree has made it clear that this approach of shortening the time frame for deferral is not an acceptable alternative. In reality, it results in indefinite deferral for sexually active members of the MSM group and sends the same objectionable and discriminatory messages as the 12 month deferral namely, that the MSM group are inherently a high risk group when the reality is that it is unsafe practices that pose a risk to the blood supply not the MSM group. It is Mr Cain’s case that the higher risk cohort can be identified and subject to deferral leaving the majority of the MSM group able to donate.

85. In light of Mr Cain’s attitude to this option and in particular, his position that it is, in principle and reality, just as discriminatory as the 12 month period, the Tribunal does not proceed to analyse and consider the option of reducing the deferral period.

Self-deferral
86. Some witnesses called by the Red Cross were critical of an approach to donor deferral known as ‘self-deferral’. An example of self-deferral is referred to in the section dealing with “History of Blood Transfusion and HIV/AIDS in Australia” and involved potential donors assessing and judging whether they had had ‘many or multiple partners’. Red Cross witnesses were critical of a system which involved potential donors exercising judgement about whether they fell within criteria which were open to interpretation. The witnesses were at cross purposes with Mr Cain’s position because it was contrary to the position he was advocating. In evaluating Mr Cain’s proposal for a deferral, the Tribunal does not equate his approach to a self-deferral approach.

Experimenting with the blood supply
87. Some of the witnesses called by the Red Cross were critical of Mr Cain’s case and spoke about it being inappropriate to experiment with the blood supply and that it was not an option to change the system to the one put forward by Mr Cain and then see if there was an increase in the transmission of HIV by blood transfusion and if there was, to then change back again. This notion was at odds with Mr Cain’s case that change should not be made in the first place unless it can be shown that his approach poses no greater risk to the blood supply than the risk that currently exists (Mr Cain’s Submissions in Reply, p40). During the case, some consideration was given to a pilot study in relation to the impact of changing the deferral policy on the blood supply to assess increased risk that would result from adopting an alternative approach but once Professor Kaldor gave evidence this notion was abandoned. He gave evidence that the risks are so low that it would be impossible to measure the increase in a pilot study.

Witnesses and Evidence

The witnesses and their roles in assisting the Tribunal in determining this case
88. Blood banking is a public health activity and development of blood donor policy draws on expert knowledge from a range of disciplines and fields: epidemiology, mathematical modelling, clinical research, social research, ethics, public policy and risk analysis. The witnesses who gave evidence reflected this range of disciplines and expertise.

89. For Mr Cain, the expert witnesses called were as follows: Associate Professor Anne Mitchell, social researcher, Director of the Gay and Lesbian Health, Victoria working in HIV/AIDS prevention education and research for over 20 years; Dr Scott Halpern, a practicing physician with expertise in public health policy and bioethics, Senior Scholar in the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, gave evidence regarding epidemiology and ethical issues relating to the selection of blood donor criteria; Dr Leslie Cannold, academic philosopher specialising in bioethics; Dr Travis Porco, mathematical epidemiologist providing commentary on mathematical modelling and epidemiology; Mr William Bowtell, with experience in the development and application of public health policy regarding HIV/AIDS as Director, HIV/AIDS Project, Lowy Institute for International Policy, Sydney and with past experience as Senior Advisor to the Commonwealth Minister for Health during the emergence of the AIDS epidemic (1984-87) provided evidence on public health policy.

90. The expert witnesses called by the Red Cross were as follows: Professor Paul Holland, consultant on blood banking and transfusion medicine and Clinical Professor of Medicine and Pathology, University of California, past Medical Director of a major blood bank in California; Dr Brenton Wylie, Clinical Haematologist, Gosford Hospital, New South Wales, and consultant in blood banking and transfusion medicine; Dr William Leiss from Canada, risk analyst in the field of environmental and public health.

Professor Kaldor
91. The Tribunal also called a witness, Professor Kaldor. It emerged during the evidence of Red Cross witness, Dr Wylie, that Professor Kaldor was an important witness and the Tribunal determined that he should give evidence in the case. Professor Kaldor is the leading epidemiologist in Australia, (Dr Wylie referred to him as the “number one” epidemiologist in Australia T582), Director of the National Centre in HIV Epidemiology and Clinical Research, Chief of the Advisory Committee of the Annual Surveillance Reports on HIV/AIDS, Viral Hepatitis and Sexually Transmissible Infections in Australia (data source on HIV epidemic and other sexually transmitted diseases envied by the rest of the world (T582, T522)). Professor Kaldor had regularly advised the Red Cross about its donor deferral policy and in 2001 had provided advice to the Red Cross regarding the deferral policy including the question of whether the deferral of potential donors who had engaged in male-to-male sex in the last 12 months was appropriate (Annexure 41, Dr Wylie R47B). Moreover, it emerged after research by Mr Cain’s lawyers that he was a key author of a paper recently published “Estimating the risk of blood donation associated with HIV risk behaviours” J.A. Musto et al, Transfusion Medicine, 2008, 18, 49-54, that developed a method of assessing the risk posed to the blood supply by selected HIV risk behaviours. Previously, the lack of such a study had been highlighted in the evidence (Dr Wylie “gap in world literature”, T581). In view of the position of Mr Cain and the Red Cross that they would not call Professor Kaldor as a witness, the Tribunal took the step of doing so.

92. Once called, Professor Kaldor gave evidence regarding current epidemiology. He also gave evidence about the Musto article and in response to questions about the limitations of that article and the data that the method was based on, he offered to prepare a mathematical model for the Tribunal with current data analysing the risk posed by selected HIV risk behaviours and compare that to heterosexual risk behaviours. He prepared that analysis with the assistance of colleagues (these colleagues featured in other research presented to the Tribunal) and provided that analysis to the Tribunal (Exhibit T6) and he was cross-examined about that and responded to a critique by Dr Halpern. Previously, such a comparative analysis had not been available in Australia and perhaps overseas either.

The categories of evidence and the value of the evidence provided
93. The expert witnesses have provided the Tribunal with evidence on various subjects from a range of perspectives and disciplines. The categories of evidence are set out below with a brief description of the way in which the evidence has assisted the Tribunal in this case.

The epidemiological evidence
94. The epidemiology and science of HIV and donor deferral is a critical aspect of the Red Cross’ case in that it is central to the rationale for the current policy in deferring the MSM group for 12 months. It is the evidence that identifies the risks to the Australian blood supply if the MSM group were permitted to donate. Professor Kaldor described this evidence as a major pillar of the Red Cross’ policy. However, the Tribunal is also conscious that it is not the only pillar and there are other considerations for the Blood Service beyond the science of risk.

95. It is important to note that the epidemiology is also of central significance to Mr Cain’s case. He relies on the epidemiology to establish that deferral of the MSM group is not justified and instead, it establishes that it is unsafe sexual practices rather than belonging to the MSM group which pose a risk to the blood supply. Further, that the epidemiology can provide the necessary information for identifying the higher risk members of the group and enabling the donor deferral on the basis of unsafe sexual practices.

Bioethics
96. The evidence in relation to ethics in the context of blood banking was helpful in setting a framework of values and ethical principles that should guide the Red Cross in the implementation and revision of donor screening policy. This framework of values and principles is to be taken into account as a critical aspect of the analysis undertaken by the Tribunal in assessing whether the exclusion of a group of potential donors is reasonable. The evidence relating to ethics also identified harm to individuals and society of a policy of exclusion of the MSM group and benefits of a policy that is instead based on risky behaviour.

97. Dr Cannold’s evidence and the logic and reasoning she employed in assessing Dr Leiss’ statements was useful to the Tribunal in a general way emphasising the importance of logical reasoning and rational analysis; in a sense, a reminder of the ‘logic lens’ to be employed by the Tribunal through which to consider the evidence given and critically assess the way questions have been framed, noting the way that is done can then frame the debate. Further, Dr Cannold’s evidence was useful to heighten our awareness of any inconsistencies and illogicalities in the reasoning of witnesses and the submissions advanced on behalf of both parties.

Risk analysis
98. There was evidence regarding risk management principles referred to as key principles of policy making in the blood banking industry, the application of those factors to decision making about blood donor selection, ethical and moral obligations in matters of health policy and the ‘burden of proof’ when change to blood donor policy is being considered. Risk management principles and ethical and moral obligations guide consideration of the blood donor deferral policy. As can be seen, there was an overlap with this evidence and the evidence concerning bioethics.

Public policy
99. Evidence given in relation to public policy provides insight into how considerations from different fields of expertise and the perspectives of different sectors of the community are balanced in order to develop an appropriate policy.

Social research
100. It will be seen from the analysis of the epidemiology that social research is part of the data relied on by epidemiologists. A key consideration for epidemiologists and risk analysts is knowledge about how people behave. The evidence about social research before the Tribunal is the data collected by social researchers relevant to the donor policy under consideration and also evidence of witnesses with expertise in this area who analyse and explain the data assisting the Tribunal with matters such as limitations of the research undertaken and whether the sample is representative of the population.

Mathematical modelling
101. Evidence of mathematical modelling was presented to the Tribunal to provide assessments of risk. Empirical data alone does not provide this information and cannot test assertions about level of risk; the mathematical structure is required to provide this analysis.

The perspectives of stakeholders affected by the policy
102. The Tribunal heard evidence from individuals affected by the donor deferral policy. In particular, the experience of potential donors, such as Mr Cain, excluded by the policy (addressed in the expert evidence of Associate Professor Mitchell, Mr Bowtell, Dr Halpern and Dr Cannold) and Mr Finklestein representing people with haemophilia.

General observations of the witnesses
103. All witnesses who gave evidence or provided a statement to the Tribunal assisted the Tribunal in reaching a determination in this case. The Tribunal made no adverse findings about the credibility of any of the witnesses or the veracity of their evidence. This is a case where the areas of dispute were about the inferences that ought to be drawn from data and the interpretation of studies and research and the weight to be given to facts. All of the witnesses were eminent in their field and well qualified to assist the Tribunal in relation to factual issues relating to their field of expertise.

104. There were various respects in which the weight to be allocated to aspects of the evidence of witnesses was diminished. While the witnesses gave evidence from the perspective of their field of expertise, at times, due to the multi-disciplinary issues in the case, they ventured into other areas. At other times, they were at cross purposes with the issue to be considered. For example, with regard to the evidence that change to the donor deferral policy was not appropriate because self-deferral had not worked in the past. There were examples of witnesses being at cross purposes with each other, for example, the debate in the statements provided by Dr Cannold and Dr Leiss.

105. In allocating weight to be given to the opinions provided by the witnesses, the Tribunal notes that some witnesses relied on a premise about a state of facts drawn from another field of expertise. Some witnesses were conscientious about spelling out that premise. For example, Dr Cannold in her statement (C6) concluded “If supported by the empirical evidence, the adoption of a policy that focuses on the safety of the sex engaged in by the prospective donor, rather than the sex of a man’s partner would end such discrimination, support the Safe Sex message and protect the reputation of the ARCBS”. Obviously, the conclusion that the change to the policy is desirable for the reasons given, stands or falls on the empirical evidence provided to the Tribunal from other sources. On other occasions, the factual premise was less apparent in the evidence given by the witnesses.

106. There were clear examples when the informed and valid perspectives of the witnesses impinged on their stance in relation to the Red Cross’ policy. For example, Dr Wylie was adverse to change to the policy. There were good reasons for that perspective given his experiences with blood transfusion patients being infected with HIV, his role working with Red Cross and his role as a witness for the Red Cross in litigation brought by blood transfusion patients infected with HIV. Associate Professor Mitchell’s perspective was quite different as an expert working with the gay and lesbian community and seeing the tragic impact of the HIV epidemic upon individuals in that community, the responsible and co-operative approach of that same community in seeking solutions and their attachment to those solutions and as a consequence seeing the dramatic pegging back of the epidemic. Also informing Associate Professor Mitchell’s perspective is an understanding of the broad gay and lesbian community and the lack of representativeness of social research that focuses on the segment of that community ‘at risk’ and an understanding of the impact of stigmatisation and false stereotypes on individuals within the community.

107. This does not mean that one witness with his/her valid perspective is to be preferred over another witness with a different, but equally valid, perspective.

108. The evidence of Professor Kaldor requires some specific mention. The Tribunal found his evidence to be of valuable assistance to the Tribunal. If in deciding not to call Professor Kaldor, the Red Cross was concerned that his evidence may be taken by the Tribunal as providing the answers to the ultimate issues in this case and obviating the perspectives of other disciplines and fields of expertise then that was a mistaken view. The Tribunal, mindful that he provided a perspective as an epidemiologist called him in that capacity. Furthermore, Professor Kaldor carefully highlighted the limits of epidemiology and science in developing donor deferral policy and drew the Tribunal’s attention to other considerations that the Red Cross needed to take into account as a blood banker noting that the epidemiology did not provide all the answers to the Red Cross in the development of its policy.

109. Having made these general observations, it will be apparent that the assistance given by the witnesses depends on the issue under consideration and the nature of the evidence given. Specific observations about the evidence the Tribunal accepted or found helpful will be made in the context of each specific issue set out below.

The Precautionary Principle and other Ethical Principles associated with Blood Banking

110. The evidence established that the Red Cross is bound by ethical principles and values arising from its activity as a blood banker. These principles provide the ethical framework in which the Red Cross operates and guide the Red Cross in determining its donor deferral policy and they must be taken into account by the Tribunal when assessing whether the policy is reasonable.

111. The activity of the Red Cross being the collection of blood in Australia, as work conducted in the public health setting is consistent with the International Red Cross Society’s primary objects of:

“The furnishing of aid to the sick and wounded irrespective of Nationality, the rendering of assistance in the case of any great public disaster, calamity or need and the improvement of health, the prevention of disease and the mitigation of suffering in Australia and elsewhere.” (Dr Wylie R47, para 34)

112. The ethical and moral principles to be discussed are not disputed by Mr Cain. It is the application of these principles that gives rise to the dispute.

113. The precautionary principle relates to the situation where there is scientific uncertainty about the risk to public health or safety but there is a possibility of harm flowing to the public from the situation. The principle is that policy decisions should be made that err on the side of caution with respect to the health of the public and definitive proof of threat to public health is not required. This reflects the notion that the safety of the public is paramount and in the blood banking setting, means that the safety of the blood supply is paramount. The Krever Inquiry, Commission of Inquiry on the Blood System in Canada (Annexure 4, Dr Wylie R47, pp1048-1049) highlighted these matters and stated as follows:

“The principle of safety must transcend other principles and policies…The costs of promoting safety may well be high…The safety of the blood supply system must be governed by the public health philosophy, which rejects the view that complete knowledge of a potential health hazard is a prerequisite for action.” (Dr Wylie R47, para 158)

114. Mr Cain’s case did not challenge the proposition that the interests of blood recipients is paramount.

115. Another aspect of the precautionary principle is that “if harm can occur, it should be assumed that it will occur” (Krever Inquiry, p1049). Dr Wylie advanced the opinion that:

“In light of the above, based on my review of relevant materials and experience as a blood banker, I consider that if a known risk of serious harm exists, it is clear that a blood bank must take all practicable measures to avoid transmission of infection to blood recipients and users of blood products.” (Statement R47, para 162)

116. That opinion is accepted by the Tribunal as a correct statement of principle.

117. The Tribunal considers that the precautionary principle is simply a key part of public health philosophy that every care must be taken with people’s lives and a pre-emptive and cautious approach guides responses to risks as they arise.

118. For a more general statement of ethical principles applying to health care and medical practice see the World Health Organization, in its World Health Report 2002 which identifies four ethical principles of primary importance in matters of health policy:

• Autonomy: protecting the rights of the individual and informed choice;
• Non-maleficence: do no harm or injury;
• Beneficence: produce benefits that far outweigh risks;
• Justice: achieve an equitable distribution of risks and benefits (this is also sometimes referred to as the principle of fairness).”, (Dr Leiss’s Statement R49, para 32)

119. The witnesses called by the Red Cross invoked these principles in assessing the proposed changes to the donor deferral policy. The Tribunal proceeds on the basis that the correct application of these principles does not accord the status quo a position of privilege (see Dr Halpern T13). The principles apply with equal force to an assessment of whether the blood supply could be rendered safer and in deciding whether to retain the current deferral policy.

120. The witnesses for the Red Cross and Mr Cain also are in agreement that another value or ethical principle binding the Red Cross is the principle of equity. It is noted that the overarching principles by which the international Red Cross organisation (the League of Red Cross and Red Crescent Societies) conducts all its business include principles of impartiality and neutrality and these principles refer to action that should be avoided as including action that would discriminate against individuals on the basis of their race or nationality or to cause controversy about a group of people (see the Krever Inquiry, pp51-52). Dr Halpern referred to equitable access to opportunities among free citizens – the opportunity enabling the satisfaction of altruistic motives. The altruism of blood donors is fundamental to the blood system – the Krever Inquiry (Forward) referred to the beneficence of blood donors “who are the heart of the blood system” and as a basic principle that “a fundamental value that must guide the blood supply system is that blood is a public resource, given altruistically by persons … for the benefit of other persons” (p1047). Dr Leiss acknowledged the interests of donors when considering the ethical principle of equity (Statement R49, paras 25, 32 and 33,).

121. Dr Halpern, in his analysis of the ethical issues relating to the selection of blood donor criteria, set out to provide a framework within which data elements can be incorporated so as to assess the current policy of the Red Cross. He noted in particular, the framework was designed to assist address the specific question of “whether the current policy of the Australian Red Cross Blood Service represents an undue violation of the rights of men who have had sex with men” (Statement C5, p1). He identified equitable access as mentioned and the consequences of restrictions for the rights and well-being of excluded individuals. He also identified as a key consideration the level of scarcity of blood to meet the needs of the community. He opined that any effort to bar a specific group of citizens from donating must have sound reasoning behind it and the ‘burden of proof’ must rest with those who wish to bar a particular group from donating.

122. The Tribunal accepts the notion of a framework of values and that a factual consideration to take into account is the degree of scarcity of blood as a medical resource and we return to the situation in Australia later regarding the adequacy of the blood supply. The Tribunal notes the evidence regarding the harm caused to members of the community from the existing policy and the Tribunal is of the view that that consideration must be taken into account by the Tribunal and it is also dealt with later.

123. A dispute between Mr Cain and the Red Cross exists as to who bears the ‘burden of proof’ when considering change to the policy (for the Red Cross see Dr Leiss, Statement R49, para 45 and Dr Wylie, Statement R47, para 155 and for Mr Cain, Dr Halpern, as mentioned). It is noted, as an aside, that it seems to the Tribunal that the conclusion reached by the witnesses as to whether change is appropriate is influenced by the way the question is framed by them. It is also noted that the discussion about burden of proof tends to skew the application of the values in favour of a particular outcome or conclusion.

124. In discussing ‘burden of proof’, the witnesses engaged in a process of qualitatively assessing and attributing weight to certain values and considerations. The Tribunal found the evidence about the ‘burden of proof’ and balancing the value of fairness and equity against other values and ethical principles to be unhelpful and unnecessary. Dr Halpern referred to the fact that a particular group in society ought not be barred unless certain threshold tests are met and he spoke of the need for a “preponderance of evidence”, “sound reasoning”, “great rationality”, “compelling evidence” (Statement C5) for excluding a group from donating, all of which tend to suggest that other values are less important.

125. It seemed to the Tribunal that Dr Halpern’s evidence regarding ‘burden of proof’ arose as a response to the Red Cross’ contention that Mr Cain had a ‘burden of proof’ to justify change. As Dr Halpern stated in his evidence:

“…there’s nothing particularly privileged about the status quo that gives it acceptance in the face of no data. So the burden of proof to change a policy need not be any stronger than the burden of proof to maintain a policy, and in cases where a particular group is being infringed upon in terms of the opportunities available to them, one could credibly argue that the burden of proof to change the current policy is actually substantially lower. The threshold will be lower.

…There’s nothing - just because a position exists does not make it the proper default. So the evidence required to maintain that position and the evidence required to change that position are certainly comparable.” (T13)

126. Consistent with an earlier statement made above, the Tribunal accepts the aspect of Dr Halpern’s evidence where he explains that the principles to be applied are the same and the approach is comparable whether the decision to maintain the status quo is under consideration or the decision to change the policy.

127. The Tribunal notes that this approach of placing an onus on the Red Cross tends to undermine the precautionary principle. The Tribunal accepts Dr Halpern’s contention that values of fairness and equity have to be considered when developing a donor policy. Donors should not be dealt with arbitrarily and should not be excluded on the basis of belonging to a group without good reason. However, applying the precautionary principle, a ‘good’ reason may be the possibility of harm to recipients.

128. The Tribunal also found the discussion about ‘burden of proof’ confusing because the discussion is occurring before the Tribunal in a legal setting in circumstances in which there is a legal onus of proof borne by Mr Cain to prove that the deferral is ‘unreasonable in all the circumstances’. It is noted that the witnesses for Mr Cain, at times, seemed to hold views about whether the deferral policy was discriminatory that seemed to involve an opinion about the unlawfulness of that conduct. Of course, an assessment about the lawfulness of the Red Cross’ conduct is a matter for the Tribunal and any such views do not influence the Tribunal in any way.

129. In summary, the Tribunal finds it inappropriate to attribute a ‘burden of proof’ to either Mr Cain or the Red Cross as part of the consideration of the donor deferral criterion in question. The ethical principles of equity and precaution guide the Red Cross and therefore, the Tribunal in the assessment of the policy. The notion of a ‘burden of proof’ distracts attention from the core values and ethical principles and does not advance the proper application of these values and principles.

130. In the context of evidence regarding ethical principles and values there was evidence about the goal of transfusion medicine. The Tribunal found that defining the goal of transfusion medicine was not of practical consequence in this case. Whether the goal is defined broadly, (Dr Halpern) to include meeting the altruistic needs of donors or more narrowly to focus on the needs of recipients (Professor Holland) is really of theoretical interest in this case. On either view, the Red Cross is obliged to take into account the interests of donors and acknowledges this obligation and, of course, without meeting the needs of donors the effective collection of blood is compromised. A community perception that the donor selection criteria are arbitrary will impact on community confidence in the Red Cross.

Risk Management Issues

131. Dr Leiss considered risk management principles and the general thrust of ethical and moral principles and derived two fundamental principles relating to donor deferral:

“(a) The primary basis for donor referral rests on the assessment and estimation of the various types of risks to health associated with donated blood;

(b) Any changes to existing policies on donor deferral must result in an improved or equivalent level of safety by comparison to what now exists.” (R49, para 35)

132. It is noted at the outset that these principles are not disputed and are in accordance with Mr Cain’s stance that the change advocated by him will result in, at least, an equivalent level of safety in comparison to what now exists.

133. It is also noted that the key principles of risk management are not contentious. These provide as follows:

“(a) Evidence-Based Decision Making: Choices about strategies to control the possibility of transfusion-transmitted infection in blood donation should be made on the basis of what is known, as reported in the scientific literature, about the sources and severity of infection risks, including relevant uncertainties in the risk estimations;

(b) Risk Assessment: The well-established techniques of assessment of risk, which investigate the probability and consequences of one’s exposure to substances or activities that may be harmful, should be used to estimate the likelihood of all risks that may be present in any specific sample of donated blood;

(c) Risk Management (Risk Control): The purpose of risk management is to anticipate and prevent or mitigate harms that may be avoidable. (Dr Leiss’ emphasis). The means that one is not justified in waiting until some new hazard actually causes harm or damage before taking reasonable risk control measures.

(d) ALARA: The objective of controlling risk to a level that is as low as can reasonable be achieved means that, in sensitive areas such as blood safety, a risk manager is obliged to seek to reduce the level of risk on an ongoing basis, so long as new measures that are cost-effective are available, rather than specifying a predetermined level of acceptable risk.

(e) Precaution: In many cases of risk management, especially where novel types of hazards (such as pathogens) are likely to be encountered, a risk manager is obliged to take risk control measures even where substantial uncertainties about the likelihood of harm are present.” (Dr Leiss’ Statement R49, para 5)

134. It can be seen that the ALARA and precaution principles are closely aligned with ethical and moral principles binding the Red Cross and are binding on the Red Cross in the same way. The other principles set out above are put forward as the appropriate response to risk and the approach to be taken by organisations in identifying and responding to risk. There seems nothing contentious about these principles of risk assessment and management.

135. There was also discussion in Dr Leiss’ evidence about various concepts regarding risk that do not qualify as principles and seem to arise from research or study of people’s perception of risk and tolerance for risk. There was discussion about the very low public tolerance for involuntary risks and the zero or almost zero tolerance for risk associated with blood safety. There does not seem to be any suggestion by Dr Leiss that these concepts govern risk policy decisions. Rather, they are merely considerations that organisations should be aware of in managing risk. In fact, the ALARA principle corrects any notion that public tolerance for risk should be determinative of the response to risk. In any event, these observations do not have significance in this case bearing in mind Mr Cain’s concession that he is only advocating change if there is no increase in risk.

136. Dr Leiss also examined concepts of distribution of risk and excess risk, risk-benefit trade-offs and trade-off in the context of relative risk. These concepts were noted but ultimately, did not advance the Tribunal’s consideration of the issues in this case other than broadly highlighting that change to policy and creating benefits for one group may result in disadvantages to another group for example, a more inclusive approach to donors may potentially have health implications for recipients.

137. More relevant and contentious is the notion of involuntary risk and the qualitative difference in the positions of the blood recipient and donor. Dr Leiss noted that “receiving blood for health reasons is an involuntary risk, in that the need is imposed on individuals as a result of medical necessity” (para 41). Later, Dr Leiss examined the situation where the benefit to the MSM group by altering the donor criteria results in an increase in risk to recipients. Dr Leiss stated as follows:

“Moreover, the benefit in question is of a qualitatively different kind from that of the risk; the two are incommensurable. It would be a violation of very important ethical principles to create such a benefit for one group by imposing a cost of this kind on an entirely different group. (There is another, entirely different group which would be an elevated risk under this policy change, namely, blood services employees [risks of needle-stick injuries and blood splashes]. Thus there would be a second type of covert risk transfer).” (R49, para 59)

138. The Tribunal notes that the assumption in this paragraph is that there will be an increase in risk to recipients. That is not in line with the contention underpinning Mr Cain’s case before this Tribunal.

139. In any event, the qualitative difference between the benefit and risk discussed is reflected in the precautionary principle and the paramountcy of public health and the interests of blood recipients. The Tribunal considers that the paramountcy of interests of health care recipients is implicit in the duty of health care professionals to those in their care as patients. In effect, the Tribunal concludes that this consideration of the qualitative difference between benefit and risk is already catered for in the proper application of the precautionary principle. Indeed, the debate regarding balancing benefits to blood donors and risk to blood recipients is not relevant given the concession made by Mr Cain that he is not seeking to jeopardise the safety of the blood supply to any extent and it is his contention that change should only occur if it is shown that the approach advocated by him is at least as safe or even safer than the current approach.

140. The Tribunal considers that the equity principle will weigh in favour of change if there is to be no increase in risk – as Dr Cannold has said, “all things being equal”.

141. An issue in the context of risk management principles is the debate that emerged in the evidence between Dr Leiss and Dr Cannold. Dr Cannold’s evidence provided a critique of Dr Leiss’ statement regarding concepts of risk and ‘burden of proof’ from a philosophical perspective and the debate that arose between Dr Cannold and Dr Leiss was really at cross purposes. Dr Cannold identified flaws in an argument as if Dr Leiss’ statement was a self-contained exercise in logical reasoning with a need for all factual matters to justify the claims made in the sense of compelling the conclusions drawn by Dr Leiss. Rather, Dr Leiss’ statement was a discussion of considerations relevant to the issues with some of the support for conclusions derived from other source material. The Tribunal did not need to resolve or make findings about the debate that arose and simply found that it sprang from a clash of different disciplines and perspectives.

142. Having made these observations, the Tribunal has found the evidence regarding ethical principles and risk management principles helpful in assessing the duties of the Red Cross to blood recipients and donors. These principles and values spring from the nature of the activity that the Red Cross is engaged in as a blood banker operating in the broad context of a public health provider. The application of the ethical principles, as discussed, ensures the priority of blood safety and the protection of the interests of recipients. It also ensures that blood donors are dealt with fairly and in an even-handed fashion.

Public Confidence and Perceptions of Blood Safety

143. The Tribunal draws from the principles set out above that there must be a rational basis for donor selection. If a group in society is to be excluded, then there must be a public health justification for it. A question arises as to the factor of public perception and the community level of tolerance for certain groups being excluded. This factor crept into some of the justifications advanced by witnesses for the Red Cross (Dr Leiss referred to public perception, the community’s tolerance for risk and political realities: T324, and the legacy of the past: T326). The Tribunal accepts that these are valid considerations if what is being judged is the public’s tolerance for some increment of risk.

144. The Tribunal finds that this factor of public perception and tolerance for particular groups being excluded should only be a consideration if it is justified from an informed perspective and if there are current and valid grounds for that perception. To state the obvious, it would not be reasonable for the Red Cross to exclude the MSM group merely because of baseless fear and misconception existing in the community about the risks associated with permitting members of the MSM group to donate and a concern about a consequential impact on the confidence in the blood supply. While public confidence in the safety of the blood supply is undoubtedly very important (Mr Bowtell T445) it cannot be permitted to drive the agenda if it is based on misinformation and false assumptions.

145. Obviously, there are historical reasons why the MSM group and AIDS and tragedy for blood transfusion patients are linked in the minds of people in the community. However, the Tribunal considers that if there are no longer valid scientific or rational reasons to justify excluding the MSM group then a community education program would be the appropriate response to counter these perceptions. This conclusion can be tested by asking the question how would the community respond if there was a baseless deferral of all Aboriginal citizens or women. The MSM group should be treated no differently given the same circumstances.

146. There was evidence regarding the perspective of people with haemophilia and like conditions and their sense of betrayal if change in deferral resulted in an avoidable increment of risk (Dr Leiss Statement, para 42). Their position of vulnerability in terms of any risk in the blood supply is clear (Mr Finkelstein Statement R53, para 4). The historical impact of HIV/AIDS upon them and other blood transfusion patients is a stark example of a failing with respect to the ‘do no harm’ principle and a terrible lesson from history that must always be borne in mind. However, that should not be used as an argument for not scrutinising the policy. There may be improvements in the level of risk to recipients that can be effected. In fact, the experience of the past reinforces the obligation to apply the ALARA standard and the precautionary principle so that the blood supply is as safe as possible and reinforces the importance of applying these principles to the current policy and the consideration of alternatives. If it is revealed that there is a means by which the safety of the blood supply may be improved then this should be assessed.

The Perspective of the Blood Banker

147. Applying the ethical principles discussed, the Tribunal regards Mr Cain’s approach that for any alternative policy to be adopted by the Red Cross the policy must not compromise the safety of the blood supply, as the only valid position for a blood bank to adopt when considering changes to the deferral policy.

148. However, misinformation and groundless community perception about increased risks should not be taken into account as valid considerations. As stated by Mr Bowtell, the precautionary principle should be applied without prejudice (T448).

149. Furthermore, the precautionary principle should be applied consistently. A practical consideration is that all risk cannot be eliminated and the current deferral policy tolerates a degree of risk (Dr Wylie, para 153). The precautionary principle applies so that measures that can be taken to minimise risk and, where practicable, should be taken to minimise risk. This principle should be applied consistently to all groups of donors. It would be inequitable to impose a zero risk requirement for a certain group and to tolerate a particular percentage risk from another group.

150. It is accepted too that the Red Cross must adopt a cautious approach to change. Equally though, the Red Cross must not be complacent about the status quo. If there are concerns that may be valid about the sufficiency of the blood supply then that should be considered. If there is a prospect that the blood supply can be rendered safer than it currently is or the supply enhanced then that should explored too. This concern was articulated by some of the witnesses for Mr Cain: they spoke about the dangers of the Australian community being complacent about the risk of HIV being limited to male-to-male sex (Mr Bowtell T467-468 and Dr Porco, Second Statement). Public confidence will be shattered if there is just one infection that could have been avoided when the Red Cross was alerted to the risk, regardless of the source of infection.

Epidemiology and Science

151. As identified at the outset, the key risk of concern to the Red Cross is the risk of a donor who is HIV positive donating blood in the window period when the current testing might not detect the virus. As Mr Cain has challenged the Red Cross’ current deferral policy of the MSM group who have had male-to-male sex within the last 12 months, a considerable amount of evidence in this case was epidemiological in nature and focused on the association between HIV and the MSM group and the risk of HIV transmission through the blood supply.

152. Mr Cain’s case is that it is unreasonable to defer from blood donation the entire MSM group in order to ensure blood recipients are at no greater risk of infection through transfusion than is currently the case. Further, it is argued that it is reasonable to defer potential donors who have engaged in risky sexual activity, regardless of the gender of their sexual partner. Again, if this approach is taken there will be no increased risk of infection (Closing Submissions, p22). Mr Cain relies on the epidemiology to establish:

“(i) among homosexually-active men there is a scale of risk from the high to the very low, and that admitting those at low risk poses no greater-than-currently-tolerated risk of disease infection through blood transfusion;

(ii) among heterosexually-active men and women there is also a range of risk that means some people in this category are at greater risk of contracting and passing on blood borne infection than some homosexually-active men; and

(iii) that is it possible to identify low and high risk within these population, at least as easily and reliably as homosexually-active men are currently identified.”

153. Relying on these propositions, a key aspect of Mr Cain’s argument was that there should be disaggregation of risk based on sexual activity such that homosexual men who practice safe sex, that is, within a monogamous relationship and using condoms, should be eligible to donate blood. It was argued that such disaggregation of risk poses no greater risk to the blood supply than already tolerated risk of infection.

154. There was evidence before the Tribunal from a number of witnesses, including Dr Wylie (First Statement R47, paras 167 and 173), Professor Kaldor (T744) and Associate Professor Mitchell (T11) that the most frequently reported route of HIV exposure in Australia is male-to-male sex. Whilst there have been fluctuations in statistics over time, the Tribunal heard evidence that HIV has continued to be transmitted primarily through male-to-male sex which has been reported in more than 86% of newly acquired HIV cases diagnosed in 2000-2004. Although these figures were well substantiated by various experts, and the epidemiology unequivocally establishes that the association of HIV is with male-to-male sex and that looking to the group as a whole, the MSM group are at demonstrably higher risk than those engaging in heterosexual activities, Mr Cain sought to challenge how this epidemiological data should be interpreted. Indeed, the proposition that “the most frequently reported route of HIV exposure in Australia is MSM” was challenged on the basis that it confuses a group with an activity (Submissions in Reply, p20). Furthermore, Mr Cain contested the repeated reference to the “the association between HIV and MSM” on the basis that it is a misleading representation of this association because the majority of homosexually active men do not have HIV. It was said to be an unsophisticated and crude analysis, and was likened to the approach of deferring men because there is an association between men and HIV. Also, it was argued to obscure the truer and more relevant association between HIV transmission and unprotected anal intercourse (Submissions in Reply, p23). Reliance was placed on the evidence of Associate Professor Mitchell that “the vast majority of MSM are never likely to become infected with HIV” (Closing Submissions, p30).

155. The evidence clearly establishes that there is a scale of risk in the MSM group and that some sexual practices may be characterised as very high risk and some are very low risk. Furthermore, while male-to-male sexual contact is the major route of transmission of HIV in Australia, it is only some of the sexual practices of some of that group that give rise to the risk. The most common means of HIV transmission is unprotected anal intercourse. Indeed, as was made clear from the evidence of Associate Professor Mitchell, the implementation of safe sex practices is the reason why infection rates reduced in the 1990’s and more recently, a higher level of unprotected anal intercourse explains an increase in HIV incidence (Guy et al, “HIV Diagnoses in Australia” Dr Wylie R47, Annexure 55).

156. These facts are not disputed by the Red Cross witnesses (Professor Holland, T421) and they were supported by Professor Kaldor (T744). The dispute between the Red Cross and Mr Cain relates to the extent of the risk posed by some of the sexual practices and whether those men having sex with men engaging in low risk practices pose no greater than an already tolerated risk of infection. It is therefore necessary to examine the range of male-to-male sex activities and their relative risk.

The hierarchy of risk
Kissing and mutual masturbation
157. There is no dispute that male-to-male kissing and mutual masturbation are not risky enough to be deferred. The policy of the Red Cross as it presently stands does not exclude donors if they engage in these activities. This is clear from the Australian Red Cross Blood Service, Guidelines for the Selection of Blood Donors (2004) (Annexure 13, Dr Wylie R47) which, by way, of explanatory commentary for the benefit of those who administer the guidelines, explain that persons engaging in kissing or mutual masturbation do not need to be deferred. While Professor Holland’s opinion is that these are sexual activities which ought to be deferred (T421) this opinion is not endorsed by the Red Cross.

Oral sex
158. It was Mr Cain’s case that exclusion of potential donors on the basis of male-to-male oral sex within the last 12 months was unreasonable and unjustifiable and that this, in itself, demonstrates indirect discrimination. Further, it was argued that as a result of advice provided to the Red Cross by Professor Kaldor in 2001 which had not supported the continuation of the deferral on grounds of male-to-male oral sex, the Red Cross knew and had advice that there was no justification for the continuation of the policy.

159. The Red Cross deferral policy simply excludes male-to-male sex. It is the position of the Red Cross that the phrase is clear and it covers oral sex as it is intended to. While this may be criticised for being ambiguous and that it is not clear as to whether it covers oral sex between males, the policy does not explicitly state that oral sex falls outside the term male-to-male sex. As noted, the Australian Red Cross Blood Service Guidelines for the Selection of Blood Donors (2004), (Annexure 13, Dr Wylie R47), contain some explanatory commentary which make clear that persons engaging in kissing or mutual masturbation do not need to be deferred. So, by implication at least, males who have engaged in oral sex (only) are to be deferred.

160. The position of the Red Cross is that male-to-male oral sex ought to be deferred. In support of this contention, it relied on the evidence of Dr Wylie (in particular, his First Statement R47, para 312) which reported that the UK’s Expert Advisory Group on AIDS had in March 2005 issued a statement warning the public of the risk of HIV transmission through oral sex, reporting studies undertaken in the United Kingdom and the United States suggesting that approximately 6-8% of HIV infection may have been acquired through oral sex. The Tribunal notes that this reported data only indicates the possibility of this means of transmission (‘may’). Dr Wylie’s statement also refers to an earlier document published in 2000 which also warned of the risks associated with oral sex and kissing. According to Dr Wylie, these reports also indicate that infectivity through activities such as oral sex is also associated with the type of activity, the position of partners, whether ejaculation occurred, if any inflammations or ulcerations were present and potentially the use of dental hygiene products.

161. Other evidence before the Tribunal (aside from Professor Holland, T356 and T357), was largely dismissive of male-to-male oral sex as being a relevant risk for HIV transmission. Professor Kaldor was of the opinion that for practical purposes it is reasonable to act as if it is not a route of transmission: (T759). He gave evidence that whilst there are no positive studies that fully exclude the risk of transmission of HIV through oral sex, there are no reliable studies that show a risk of HIV transmission resulting from oral sex. Within the ‘hierarchy of risk’, he stated that oral sex was not the safest thing you could do as “masturbation which involves hand genital contact is certainly safer than oral sex because as soon as you get near mucus membranes, there’s a higher susceptibility to transmission”: (T864).

162. Professor Kaldor noted that when something does not cause much risk it is hard to measure it: (T719-720, 759). Furthermore, a study has not been done and, from a practical point of view, cannot be done to positively establish that oral sex does not transmit HIV: (T759). This was because of the very low risk associated with this activity and the fact that it would be necessary to study many thousands of people who are only having oral sex and prove that they do not acquire the infection. Professor Kaldor was asked about the UK Expert Advisory Group on AIDS 2005 statement; Professor Kaldor referred to the source and essentially disagreed with it noting that there are virtually no HIV cases in the world literature that can demonstrably be shown to be due to oral sex. While acknowledging that there are cases reported, he was of the view that there are weaknesses in the supporting evidence precluding a definitive statement. It is plain that if there is a risk of transmission from oral sex it is a much lower rate than the rate of transmission via other tolerated forms of intercourse: (T888).

163. He noted that while he might disagree with this source of evidence, the Red Cross has a different perspective to his own and they are looking to potential risk: (T760-761). In response to one question he replied that he thought that the Red Cross has sometime taken positions that are overly conservative for reasons that he thought were justified in the context of which they operate: (T761). When questioned by the Tribunal, Professor Kaldor noted that given that there was a biological plausibility to the potential for transmission of HIV between men having oral sex, and from the perspective of the Red Cross adopting a position of conservatism, taking into consideration information beyond the purely epidemiological may not be an unreasonable step for them to take in this context: (T887-888).

164. Associate Professor Mitchell gave evidence that the risk of HIV transmission through male-to-male oral sex was a theoretical possibility: (T38). She also acknowledged that there are no studies which demonstrate that it is of no or negligible risk and she referred to the practical problems of being able to conclusively prove that as there are not very many people who only have oral sex, it is difficult to isolate this as a cause of HIV transmission. When the statement of the UK Expert Advisory Group was put to her Associate Professor Mitchell did not dismiss the risk outright, acknowledging “As gay men, it would be better to be well acquainted with the principles of safe sex, which is not to let anybody’s body fluids to get into your blood stream and therefore be mindful of the integrity of your mouth if you were going to have oral sex” (T67).

165. Dr Porco’s Second Statement (C7A (p3)) states that oral sex is believed to confer substantially less risk than unprotected receptive anal intercourse, though non-zero risk.

166. The Tribunal accepts that the epidemiology does not demonstrate that male-to-male oral sex poses a tangible risk of HIV transmission. So, if regard were had solely to the epidemiology in relation to male-to-male oral sex with regard to HIV, there appears to be no justification for excluding from blood donation males who have engaged in this practice. The risk is in the realm of a potential risk where current knowledge supports the biological plausibility of it as a route of transmission of HIV. It can be inferred from the evidence that the risk arising from male-to-male oral sex is below that posed by other risks that are tolerated by the Red Cross. Any justification for excluding donors on the basis of male-to-male oral sex must therefore be on a basis other than just the epidemiology.

Protected and unprotected anal sex
167. There was uncontested evidence that in the hierarchy of risk of male-to-male sexual activity, unprotected anal sex poses the highest risk of HIV infection. Broad agreement was acknowledged on this point by Counsel for Mr Cain (T1011) in circumstances where unprotected receptive anal intercourse involves ejaculation in the rectum. In discussion of different possible routes of transmission of HIV, Dr Porco in his Second Statement C7A (p3) stated that unprotected RAI (receptive anal intercourse) is particularly important because semen contains HIV and rectal trauma occurring during RAI may permit direct contact between semen and blood.

168. Professor Kaldor noted that the single riskiest practice and the one that is responsible for the greatest number of infections is unprotected receptive anal intercourse. The insertive partner is also at risk of HIV infection but to a lesser extent (reduction of risk approximately 5-10 fold in comparison with the receptive partner) (T718). It was clear both from Professor Kaldor’s evidence and that of Associate Professor Mitchell, that efficacy of safe sex including condom use has seen a dramatic decrease in HIV infection since the early years of the epidemic, although in more recent years, there has been some resurgence of risky sexual behaviour within the broader MSM group. Associate Professor Mitchell gave evidence that the very fact that the figures can go up and down is indicative of the efficacy of safe sex (T16).

Efficacy of condoms in reducing risk of HIV transmission
169. Associate Professor Mitchell gave evidence that it is clear that use of a condom in male-to-male anal intercourse reduces the risk very substantially (T720). As a general proposition, she was prepared to accept that condom use is approximately 80% effective, although she suggested that condom failure problems were more associated outside the MSM group.

170. There is, unquestionably, a residual risk of HIV infection when condoms are used in male-to-male anal sex. Professor Kaldor referred to reports from people in the Health in Men (HIM) cohort (Mao et al, Health in Men: Baseline Data, National Centre in HIV Social Research [2002] Annexure 3, Dr Wylie R47) who claim to use condoms consistently but who acquired HIV infection (T720). He has, however, acknowledged that the Health in Men cohort is not representative of all homosexually active men (T714-715). As noted in the evidence, consistent condom use is not entirely successful for heterosexual couples and sometimes fails to prevent pregnancy.

171. There are other studies which support the failure rate of between 10 although a review of studies internationally indicates a wide range of estimates. The Cochrane Library study by Weller and Davis-Beaty, “Condom Effectiveness in Reducing Heterosexual HIV Transmission (review)” published as part of the Cochrane collaboration, estimated best and worse case scenarios for condom effectiveness and concluded that it was approximately 80.2% but may be as low as 35.4% or as high as 94.2%. That study found that user incompetence and condom quality are relevant factors in the rate of condom failure. The Australian study by Grulich et al “Sex in Australia: Experience of Condom Failure Among A Representative Sample of Men” 27 Australian and New Zealand Journal of Public Health [2003] (Annexure 111, Dr Wylie R47) which involved a survey of almost 20,000 Australians via telephone found that condom slippage or breakage had been experienced by 38.7% of male respondents in the year prior to interview. It also reported that condom failure is related to certain characteristics of individuals (for example, younger age), and is not randomly distributed across all condom users.

172. Associate Professor Mitchell gave evidence that studies with regard to condom use amongst young heterosexuals are not helpful in this context. She argued that rates of slippage and breakage are lower amongst homosexually active men than amongst other groups such as young heterosexually active men as homosexuals are more expert in using condoms, particularly in light of education campaigns targeting this, as well as the importance of condom quality (T38). She stated “They have had so much ongoing education in both correct usage and strategies to test condom quality that they are the least likely to contribute to statistics on condom failure” (Second Statement C4A, p3).

173. Specifically with regard to the issue of HIV transmission, the study by Steiner et al “Condoms and Sexually Transmitted Infections” (2006) 354 New England Journal of Medicine 2642 reported that experts estimate the risk of HIV transmission being reduced by about 80 by consistent condom usage.

174. In the context of evaluating the relevant survey data, it was noted that such data relies on self-reporting and there are also limitations as the person’s awareness that there may have been some failure in the condoms effectiveness: see Professor Kaldor T722. These variables are presumably factored into the estimates of condom efficacy. It also emerged from his evidence that condom failure is considered to be more frequent in anal sex that in vaginal sex (T721-722).

175. There was a clear concession by Mr Cain that condom use in male-to-male anal sex reduces but does not eliminate the risk and that some allowance had to be made for slippage and breakage. The appropriate allowance to make was argued by Mr Cain to be approximately 5% (T1012). It was also argued, however, that the minimal residual risk associated with condoms due to slippage and breakage is further reduced if sex only occurs within a monogamous relationship (Complainant’s Closing Submissions, p31).

176. It can be seen from these studies that whilst there is a relatively broad range, the estimates with regard to condom efficacy generally fall into the category of no less than 80% effectiveness, and from consideration of these studies, this would seem a conservative estimate. Professor Kaldor’s opinion was that the using of condoms achieved 90% reduction in risk. The Tribunal considers that Professor Kaldor is well placed to assess the material regarding the effectiveness of condoms and that his opinion is sound. However, in view of the Red Cross’ responsibility to protect the blood supply it would be reasonable for it to take a more cautious approach and in assessing risk, to factor in a more conservative range of 10-20%, thus producing a reduction of risk in the range of 80-90%.

Number of partners
177. It is clear from the evidence that the number of partners correlates with risk and this was uncontested in the evidence before the Tribunal. Monogamy, referring to partnerships in which partners do not have sex outside the relationship, is regarded by all the witnesses as very low risk. Dr Porco’s Second Statement (C7A para 3)) described uninfected men who have sex with men who are in an exclusive monogamous relationship with an uninfected partner as being at very low or even zero risk. This was because individuals in exclusively monogamous relationships cannot acquire a sexually transmitted infection such as HIV. The logical force of this proposition in light of the mode of transmission of HIV is unassailable.

178. It was not contested by the Red Cross that a truly monogamous relationship between HIV negative men poses a low risk of HIV transmission. Rather, it was the Red Cross’ position that there is a concern about whether or not the relationship is in fact a monogamous one. Dr Porco had acknowledged in his Statement that identifying long-term exclusively monogamous individuals may be difficult because individuals may not always be aware of their partners’ sexual activities (para 5). Similarly, it was said by Dr Wylie and Professor Holland that while a donor may honestly speak about their own activity, it would be impossible for them to speak with any certainty as to the accuracy of their sexual partner’s risk (Dr Wylie First Statement R47, paras 276 -281; Professor Holland First Statement, paras 63-68). It was Dr Wylie’s opinion that utilising the criteria of monogamy as an exception for donor deferral of men who have sex with men would not be sufficiently safe for the blood supply (First Statement R47, para 278).

179. The inherent unreliability of relying on purportedly monogamous relationships is obviously a valid concern for the Red Cross, and was acknowledged by Professor Kaldor in his letter to the Red Cross (letter from Professor Kaldor to the Red Cross dated 19 April 2001, Annexure 41, Dr Wylie R47) in which he stated “Given that it is impossible for a person to make a declaration regarding a partner’s sexual behaviour, it would seem prudent to defer donors who have had male-to-male sex without a condom within the exclusion period”. Further, Associate Professor Mitchell stated in her evidence (T62) that “nobody would be able – no blood donor in the world would be able to give an absolutely reliable answer about the sexual activities of their partner”.

180. For Mr Cain this concern is countered by suggesting that this risk would be significantly reduced by the use of condoms within monogamous relationships. It was acknowledged in submissions that it was not possible to exactly quantity the risk these participants face (Closing Submissions, p33), but it was argued that “it is reasonable to infer that the level of risk associated with safe sex within monogamous relationships is so low as to be insignificant” (Closing Submissions, p33). It was argued that men who have sex with men and who practice safe sex within a monogamous relationship do not represent a particularly different risk to heterosexual men who only practice unsafe sex (T1017).

181. It was said that this same risk exists for monogamous heterosexual women who run the risk of having unfaithful homosexually active partners and being infected themselves (Associate Professor Mitchell, Second Statement C4A, p2).

182. The Red Cross presented evidence in support of the claim that in the MSM group, relationships that are ostensibly monogamous are less reliable than heterosexual monogamous relationships. Social research was presented indicating that the MSM group are more promiscuous and less reliable in key areas. The Tribunal deals with this below under the heading Social Research, but irrespective of what conclusions can be drawn from that data, it can be noted that the difficulty of a person in a ostensibly monogamous relationship being able to guarantee that their partner was not having sex outside the relationship applies with regard to both homosexual as well as heterosexual relationships.

183. However, critical to the Red Cross’ position is that due to the higher prevalence of HIV in the MSM group, the risk of sex outside monogamous relationships poses a greater risk than in relation to heterosexual couples.

184. It is Mr Cain’s position that men who practise safe sex within monogamous relationships should be admitted to donate blood and that they will be at the lowest risk of HIV infection and transmission within the MSM group. Further, it was argued that the risk associated with this low risk group is not significant and is less than risks associated with other groups that are tolerated by the Red Cross and who are accepted as donors.

185. This argument necessarily entails that it is possible to disaggregate the risk of different sexual acts of the MSM group for the purposes of donor deferral; a question which is dealt with in more detail below. Assuming, for the purposes of argument, that such disaggregation of risk is possible, it is necessary to determine what level of risk, if any, allowing donation from men who practise safe sex within monogamous relationships, would create to the blood supply. Whilst Mr Cain has argued that due to the very low risk associated with men who practise safe sex within monogamous relationships, there would be no relevant risk to the blood supply, this was, however, contested by other witnesses: Professor Kaldor (T748) gave evidence that the risk associated with a monogamous safe sex male homosexual couple is still higher than the risk of infection currently found in the donor pool. It was his view that it would introduce an unacceptable level of new risk to the current level of risk. The argument with regard to disaggregation calls for a closer analysis of identifying the risk associated with high and low risk activities and the Tribunal turns to consideration of mathematical modelling which provides such consideration.

Mathematical modelling
186. Mathematical modelling uses available empirical data within a mathematical structure that is then used to translate empirical findings of data to provide predictions or estimates. The Tribunal was referred to mathematical models which were designed to test the rationale for permanent exclusion of the MSM group in M. Germain, R. Remis, and G. Delage, “The Risks and Benefits of Accepting Men Who Have Had Sex With Men as Blood Donors” (2003) 43 Transfusion 25 and K. Soldan and K Sinka, “Evaluation of the De-Selection of Men Who Have Had Sex With Men From Blood Donation in England” (2003) 84 Vox Sanguinis 265-273 (Annexures 102 and 103 respectively in Dr Wylie R47). These papers examined the permanent exclusion of the MSM group in the United States and Canada and the United Kingdom and the risk increment of accepting 12 month abstinent men who have male-to-male sex and the benefit of obtaining additional donations were estimated. Both papers concluded that there would be an increase in the risk of introducing contaminated blood.

187. It is noted that the estimates of increased risk did not come to pass in Australia when the 12 month policy was introduced. Many assumptions were required to base the estimates of risk. These assumptions have been explored by the witnesses. In Dr Porco’s evidence (Statement C7) the underlying equations (implicit and explicit) are analysed. It is not necessary for the Tribunal to deal with the detail of the commentary and criticism of these studies. Significantly, the studies view the MSM group as a whole and did not distinguish between risk behaviours. For example, the studies do not distinguish between protected and unprotected sex or monogamous relationships. The studies do not assist the Tribunal in this case because as noted by Dr Porco, they do not address the policy question in this case. It was suggested by Dr Porco that if mathematical risk analysis is to be taken into account in this case, a risk analysis based on the population in Australia, and the specific policy under consideration, and based on current standards and tests be conducted.

188. At the commencement of this Inquiry, there were no studies, local or international, available to the Tribunal that had attempted to assess the risk posed by various risk behaviours within the MSM group and compare the risk with tolerated risks posed by other groups such as heterosexual donors. The Musto article was the first attempt to do so. It is noted in the article that “This study presents a new method of assessing the risk posed to the blood supply by selected HIV risk behaviours. A model was developed to estimate the probability of blood donation during the window period for HIV infection. Various scenarios were considered including male-to-male sex and the MSM group and heterosexuals and high risk groups such as women who have sex with men from countries of higher HIV prevalence and in each case whether there was condom use” (p49).

189. This evidence was contested by Associate Professor Mitchell. In her Third Statement, (C4B) responding to Professor Kaldor’s evidence, she expressed her disagreement with the proposition that safe sex between men is always riskier than unsafe sex between a man and a woman. In her view, that calculation is clearly based on an epidemiological calculation rather than a more practical look at the reality of people’s lives. She also raised concern that the Musto study had assumed that heterosexual sex inevitably entails vaginal intercourse, when in fact heterosexual behaviours are not limited to that, and that data from de Visser et al indicate one in five heterosexual people have engaged in anal intercourse.

190. In response, Professor Kaldor had made clear in his evidence to the Tribunal that he had never purported to suggest that all men who have sex with men represent a greater risk than heterosexual couples (T977). Professor Kaldor stated “I wouldn’t for a moment question that there are people who are heterosexual who are at a much higher risk than some gay men, there’s no question of that at all”. Professor Kaldor went on to say that the process of categorising people is for the purpose of protecting the blood supply and it is not about trying to say that everybody in this category is the same or even similar and that in a practical sense for the purpose of blood safety and for the purpose of donor deferral it is necessary to come up with broad categories because that is how the donor deferral system is going to be pragmatically applied (T977).

191. The evidence from Professor Kaldor highlighted the different perspectives of Associate Professor Mitchell and himself with Associate Professor Mitchell looking at the situation from the perspective that the “vast majority of gay men are not infected with HIV… and the kinds of sexual practices they are engaging in are those which prevent the spread of HIV infection” (Statement C4A). Professor Kaldor is viewing the matter from the perspective of the risk to the blood supply of permitting categories of people to donate and the risk associated with those categories. This is the perspective that the blood banker must adopt.

192. The risk estimates for the various scenarios were set out in the Musto paper and with the exception of the group women who have sex with a man from South Africa (scenario 3 - also a deferred group), the group at highest risk of becoming infected with HIV and donating in the window period is the MSM group.

193. The evidence of witnesses referred to the paper and Professor Kaldor was cross-examined about the assumptions in the paper and the accuracy of data relied upon. A criticism was made relating to the use of relatively old data from 1996 transmission rates (T804) assuming partners are not receiving treatment. Professor Kaldor explained that the paper was not an attempt to model the whole range of encounters that potential donors might experience and then integrate the results into an estimate of risk for the whole blood supply. The purpose of the model was to look at specific scenarios and describe how you might use a modelling approach to get a rational basis for establishing a hierarchy of risk. In other words, the purpose of the paper is not to provide definitive information about absolute risks but rather develop a new method (T822), a model for consideration of different exclusion criteria. Professor Kaldor explained that this is the first occasion in Australia or internationally when such a systematic approach had been undertaken and that the model could be further developed, updated and refined if it was to be used as a basis for decision making in risk assessment for blood banking (T807, 810-11).

194. This purpose is evident from the paper itself that emphasises that the paper provides a method and the potential application of the method to assess all components of the donor deferral system. The Tribunal accepted that the purpose of the paper was the development of a method that could be applied to assess the question of policy regarding deferral of the MSM group in this case. The results of the analysis are only helpful as a broad assessment of risk.

195. Viewed in that context, Professor Kaldor pointed out that the paper made a broad statement that the two scenarios in scenario 2 of the table; male having heterosexual contact, no condoms compared with scenario 1, male having homosexual contact with condoms, produce a substantial differential in risk. It is noted that the table shows that the proportion of HIV positive donation in the window period is 0.06-0.18 for heterosexuals in the scenario of no condoms and 0.25 -7.33 for homosexual contact with condoms.

196. Exhibit T6 was prepared by Professor Kaldor and his colleagues to provide the Tribunal with estimates of relative risk of HIV infected donors providing a donation in the window period. The categories of donors considered in the analysis were selected in response to questions posed by the Tribunal and Counsel and compared estimated HIV incidence in a year and relative risk.

Category

Estimated HIV incidence
per year

Relative risk

Heterosexual men who always use condoms (partners not from high prevalence countries)

0.0015%

1 (reference)

Heterosexual men in general

0.0086%

5.75

Heterosexual men who never use condoms (partners not from high prevalence countries)

0.0300%

19.98

MSM in monogamous partnership
where condom use is 100%
(partner has risk of 0.5% p.a.)

0.05%

34.99

MSM who always use condoms

5% prevalence in
MSM

0.09%

62.40

10% prevalence in MSM

0.19%

124.79

MSM in monogamous partnership: 5% condom use (partner has risk of 0.5% p.a.)

5% prevalence in MSM

0.16%

105.49

10% prevalence in MSM

0.32%

210.98

MSM in general

5% prevalence in MSM

0.52%

348.25

10% prevalence in MSM

1.04%

696.51

197. It is noted the categories included heterosexual men who always use condoms (partners not from high prevalence countries) and MSM in monogamous partnership where condom use is 100% (partner has risk of .5% p.a.).

198. The assumptions on which the analysis was based were set out and included that all men engage in an average of 100 penetrative sexual acts per year; condoms have 95% effectiveness in reducing HIV transmission per exposure; in a monogamous MSM partnership the other member of the partnership may be at risk of HIV acquisition from outside the relationship and the risk is 0.05% per year. The prevalence of HIV is 5% in MSM. A prevalence of 10% was also assumed as an additional estimate provided in relation to MSM who always use condoms, MSM in monogamous partnership with 5% condom use and MSM in general. While it would be apparent from the evidence that some of these assumptions may be open to question such as condoms 95% effectiveness, it does not undermine the analysis because the assumptions were applied across the board to homosexual and heterosexual men.

199. The analysis in Exhibit T6 was critiqued by Dr Halpern. Dr Halpern commended Professor Kaldor for attempting the analysis noting that such evidence is sorely needed. However, Dr Halpen was critical of Professor Kaldor’s approach in a number of respects. The essence of Dr Halpern’s critique is that adequate sensitivity analyses were not performed, several of the assumptions Professor Kaldor made were false and highly anti-conservative and that as a result of these flaws, it is likely (though difficult to prove) that there are certain groups of heterosexual men whose risk of transmitting HIV via blood donation is at least as high as, if not higher than, the risk among certain groups of men who have sex with men.

200. Criticisms were made regarding prevalence of HIV in the MSM group of 5% or 10% and also underpinning this assumption, the proportion of the adult male population that belong to the MSM group. These criticisms are dealt with later in the context of prevalence and related to this, estimates of the proportion of the MSM group. The Tribunal’s view is that the criticisms do not undermine the weight to be allocated to this analysis. The Tribunal deals here with the other criticisms of the analysis to ascertain whether they undermine the analysis.

201. There was criticism made of the assumption of frequency of sexual contact of 100 times per year. The assumption is that this sexual contact is with 100 different people and the assumption of 100 different partners results in a much higher risk than the total of 100 sexual contacts involving a few partners and that this model of sexual behaviour inevitably and certainly results in an overestimate of risk.

202. It is noted this assumption applies to the other categories of donors (see T964) and so the analysis is reliable in the assessment of relative risk as between homosexual and heterosexual donors. However Dr Halpern’s point is the model of sexual behaviour adopted by Professor Kaldor substantially overestimates the absolute risk of MSM donating blood. Professor Kaldor does not agree that the absolute risk factor is in fact lower.

203. The Red Cross must be concerned with both forms of risk – attributable or absolute risk and also relative risk. The difference in the risk posed by the MSM group who fall within the low risk category of that MSM group in monogamous partnerships and where condoms are used is 34.99 to 1 while a high risk heterosexual group – men who never use condoms - have a relative risk of 19.98 to 1 (the reference of 1 being heterosexual men who always use condoms with partners not from high prevalence countries). Applying the ALARA principle, as the Red Cross must, if a very low risk exists and the decision the Red Cross had to make was, all things being equal, whether to deliberately expose the blood supply to that risk or maintain current risk levels, then their obligation is to avoid that increase in risk, even if the increment, i.e. the new risk as an absolute risk, is nominal. The Red Cross must adopt the approach that if the risk can occur it will occur.

204. According to Dr Halpern, another difficulty with the frequency of sexual contact assumption is that it fails to take into account each of the 100 sexual contacts is not with an individual whose risk of HIV is exactly equal to the prevalence of HIV among members of the MSM group and that it can be demonstrated that this is erroneous. Dr Halpern referred to various phenomena that work to lower the risk below that proposed by Dr Kaldor. He referred to the effect of ‘self-selection’ that some of the MSM group who are HIV infected will choose not to have sex or not to have unprotected sex. He also referred to the ‘healthy participant effect’ which is that some HIV infected persons will be too ill to be participating in sex, further reducing the risk among the sexually active pool. Dr Halpern acknowledged that neither self-selection not the healthy participant effect reduced the risk to zero or even close to zero, but he argued that they are real phenomena that both work to lower the risk below that proposed by Professor Kaldor.

205. It is noted that it is not suggested by Dr Halpern that there is reliable data that can quantify the impact of these phenomena to enable a reliable adjustment to the figures. Professor Kaldor conceded that the model does involve a simplification as pointed out by Dr Halpern and that these are valid criticism from a purely theoretical perspective but that there is not the data to make a more complex model to produce a more accurate estimate any differently (T962). In this context, he did not agree that the result of the over simplification was that it lowered the absolute risk involving the MSM group; Professor Kaldor noted that there may well be examples that increase the risk above that shown by the model (T975).

206. There were a number of other diverse criticisms of Professor Kaldor’s analysis: Mr Cain argued (Submissions in Reply, p41) that Professor Kaldor’s analysis did not calculate homosexually active men in monogamous relationships for 5% as well as 10% prevalence. The Tribunal notes from the table that the category of MSM in monogamous partnership where condom use is 100% is not divided into the 5% and 10% prevalence as for other MSM categories. It is wrong, however, to assert that the estimate has not been provided for 5% as it is clear from the assumptions stated at the outset of the analysis that 5% in MSM is assumed but that the analysis does also make certain assumptions with regard to 10% prevalence of HIV in MSM. In this case, where only one figure is provided, this figure is taken to be based on 5% prevalence as stated in the assumptions, which is the assumption most favourable to Mr Cain.

207. Drawing on the evidence of Dr Halpern regarding insensitivities of analysis he had identified in relation to the Kaldor analysis, it was also argued by Mr Cain (Submissions in Reply, p42) that “Higher prevalence of HIV among homosexually-active men dramatically increases their risk range, compared to heterosexually-active people”. It was further argued that this means that while more sensitive mathematical modelling would reduce the risk associated with heterosexually-active people, this reduction would be not nearly as dramatic as it would be for homosexually-active men. This argument was mounted in an attempt to undermine Professor Kaldor’s assertion that assumptions in relation to risk assessment such as frequency of sexual contact applied equally to heterosexual and homosexual couples. It does, however, seem to be contrary to other aspects of Mr Cain’s case. By the same token, it might be seen that other assumptions, for example, the 95% condom effectiveness, may favour the MSM group. Principally, it seems, these criticisms attach essentially to concerns about Professor Kaldor’s data on prevalence; this is addressed more fully below.

208. Calculating the relevant risk is a complex matter. It involves ascertaining the MSM group and then calculating prevalence and incidence of HIV in the MSM group. A central fact in dispute in this case is the prevalence and incidence of HIV in the MSM group and related to this, the proportion of the population who are in the MSM group.

Prevalence and incidence
209. Estimating the risk of HIV transmission through blood transfusion is not simply about the riskiness of the sexual activity per se. In highlighting the significance of the background prevalence of the group, Professor Kaldor stated that you can be doing the riskiest form of a sexual act such as receptive anal intercourse in a heterosexual setting where there is very low HIV prevalence and potentially have lower risk than if you are doing something that is in itself a low risk behaviour such as sex with condoms in a setting where there is very high prevalence in that underlying partner population. So, the actual risk of the act depends on what you do and the prevalence in the partner group (T863).

210. It is essential to know the prevalence and incidence of HIV in the population under consideration. A critical issue in dispute in this case is the prevalence rate of HIV in the MSM group. Related with this is the issue of identifying the proportion of the population that is in the MSM group and, in turn, by what definition or criteria a person is identified as coming within that group.

211. Professor Kaldor provided helpful assistance to the Tribunal (T704) in explaining the distinction between prevalence and incidence and the implications of each for the purposes of blood safety. He stated that prevalence is the proportion of something within a given population at any give time. Incidence is the proportion over a specified time period of new episodes or events. For the purposes of blood safety, prevalence is relevant in terms of looking at how likely it is that a person who presents for a blood donation has an established HIV infection that they have acquired in the past. With the routine testing of blood, established HIV infection of this kind would almost certainly be picked up through testing. He explained that there is an important relationship between prevalence and incidence in that prevalence is the underlying source of the infection but it translates into incidence of infection (T843). Professor Kaldor told the Tribunal that incidence, focussing as it does on new episodes or events, is important to determine the chance that you are going to miss some of those very recent infections because of the window period of infection which cannot be detected through NAT testing.

212. Professor Kaldor gave evidence about the difficulty of accurately establishing prevalence and incidence of HIV in the MSM group (T708-T709). In the absence of being able to do a comprehensive population survey with a full response rate, he and his research collaborators rely on different sources of information to try to get some insight into the proportion of gay men who have HIV in Australia. He explained that they have relied on two or three sources of information (T709). One is regular surveys (periodic surveys) that are conducted in a number of the larger cities of Australia on an annual basis which include questions about HIV infection and responses give some indication of what proportion of gay men in different settings have HIV infection. He told the Tribunal that another source of information that they use is based on people who appear in different clinical settings and are offered HIV testing which also provides another insight into the proportion of gay men with HIV infection. The third approach is based on a degree of mathematical modelling that brings together both empirical elements as well as the mathematical structure that is then used to translate empirical findings of data which is collected externally into estimates of prevalence. He gave evidence that whilst none of these sources are absolute or precise, generally they can provide you with a degree of confidence and by being repeated over time and by being cross-matched against each other you can get a sense of a degree of accuracy about them.

213. It was on the basis of this kind of mathematical modelling and drawing on data from the other two sources, that Professor Kaldor and colleagues provided calculations to the Tribunal of the estimates of HIV incidence in Australian men (Exhibit T6). These estimates were based on two separate estimates of prevalence of HIV amongst the MSM group in Australia: prevalence rates of HIV of 5% and 10%. It was Professor Kaldor’s position that it is appropriate to calculate prevalence based on these two figures. The Tribunal regards it as appropriate to rely on this opinion and accepts that these prevalence estimates represents an adequate range and approach. Professor Kaldor derived these figures from the Health in Men study which relies, in turn, on raw data from the Australian Community Gay Periodic Survey: Annexure 61, Dr Wylie (R47). Professor Kaldor sought to compare this prevalence rate in the MSM group with those who do not engage in male-to-male sex. He gave evidence that there is an extremely low prevalence of HIV amongst those who do not engage in male-to-male sex, amongst the lowest in the world (T816). Professor Kaldor’s evidence was that in the Australian setting, the difference in prevalence between the MSM and non-MSM group is in the order of 100 fold or more (T864). Exhibit T6 showed a significant difference between the categories heterosexual men in general and the MSM group in general, with the risk of the latter being more than a hundred fold greater: 5.75 compared with 348.25 (with a 5% prevalence estimate) and 696.51 with a 10% prevalence estimate.

214. Associate Professor Mitchell gave evidence in relation to the Gay Periodic Survey demonstrating that it is not representative of the broader MSM group. She gave evidence that this survey actively seeks to recruit community connected men from gay venues and sex on premises venues because they are a sample of interest with regard to HIV (T41). Professor Kaldor conceded the sample is not representative of gay men in the Australian population, or even of gay men in Sydney; that it is a particular group and they may reflect particular behavioural or other characteristics that you cannot necessarily generalise to the Australian population of gay men (T714-715). Professor Kaldor did qualify this, however, by explaining that whilst the absolute findings (for example with regard to prevalence) cannot be generalised, the findings that are relative, for example associations between certain risk behaviours and HIV, are generalisable (T795, T798). Whilst acknowledging that it would have been preferable to get a totally representative cross-section, he explained that this is methodologically impossible.

215. An alternative approach to estimating HIV prevalence and incidence among homosexually active men which was advocated by Dr Halpern and put to Professor Kaldor in cross-examination is the whole-of-population method. Having regard to the overall number of Australians infected with HIV through male-to-male sex as a proportion of the estimated number of homosexually active men in Australian (which he estimated at 5%), Dr Halpern arrived at a prevalence rate of 2.4%. Dr Halpern did acknowledge, however, that prevalence estimates based on population data are susceptible to incomplete reporting of cases although he thought that this was typically a much smaller problem in a developed nation like Australia with sound case surveillance (Second Statement C5, p2). Professor Kaldor acknowledged that this whole-of-population method was an entirely valid way to go about things and can be compared with different approaches (T874). He explained, however, that it was not his preferred approach because it was not model-based which was the approach that he and his collaborators use in their research.

216. The Tribunal notes Professor Kaldor’s opinion that use of a whole-of-population approach to determining prevalence of men who have sex with men in the population is a valid alternative method. It does not follow, however, that Professor Kaldor’s figures determined on a model-based approach are invalid; the Tribunal accepts that there may be a number of possible approaches that are valid and reasonable.

217. As noted earlier, Dr Halpern was critical of the prevalence calculations prepared by Professor Kaldor and his associates (Third Statement C4B, pp1-2). He reasoned that if there are approximately 12,000 HIV+ MSM in Australia, for this to represent a 10% prevalence among MSM would mean that there are 120,000 Australian MSM. He suggested that given that there are more than 20 million Australians or roughly 10 million Australian men, this would imply that the proportion of Australian men who are MSM is only 120,000/10,000,000 + 1.2% when in fact studies consistently show that at least 5% of men acknowledge being MSM. It was his view that as a result of these flaws, “it is likely (though difficult to prove) that there are certain groups of heterosexual men whose risk of transmitting HIV via blood donation is at least as high, if not higher than the risk among certain groups of MSM”.

218. In his oral evidence in response to the statement from Dr Halpern, Professor Kaldor acknowledged that this sort of analysis can always be the subject of debate and some uncertainty will remain whichever way one looks at it (T959). Further, he acknowledged that some of the underpinning assumptions could be challenged but explained that there simply was not the degree of detailed data to support more precise models. So whilst agreeing with some of the points made by Dr Halpern in critique, Professor Kaldor questioned whether Dr Halpern was in the best position to improve on the estimates that he had come up with. He noted that as a matter of epidemiological theory, it was possible to identify flaws with the model based approach put forward. He commented that unless Dr Halpern was in a position to come up with a better way to model it using a proper process which is credible, which would lead to a different estimate, it was of questionable value to identify those flaws, particularly as it was acknowledged that there are limitations with the whole-of-population approach due to the lack of accurate and reliable information (T962-963).

219. There were, however, a number of aspects of Dr Halpern’s critique made in his Third Statement (C5B) that Professor Kaldor expressly disagreed with: he suggested that the figure proposed by Dr Halpern that 5% of the male population is having male-to-male sex is ‘blatantly wrong’ (T960). He also challenged the criticism that the approach he had adopted is incredibly conservative. Professor Kaldor was of the view that his approach was realistic in the context of ascertaining risk information for blood safety (T961).

220. The Tribunal notes from the Submissions in Reply that issue has been taken with Professor Kaldor’s attempt to distinguish between Dr Halpern’s theoretical epidemiological principles and Professor Kaldor’s own more empirically-based approach (p42). It was asserted that Professor Kaldor’s calculations of risk are an extrapolation of existing data to no less an extent than Dr Halpern’s calculations and that the lack of empirical data applies to both approaches. It was accordingly suggested that Professor Kaldor had drawn an arbitrary distinction between his mathematical modelling and that of his critics. The Tribunal accepts that whilst there are differences in method (Dr Halpern’s calculations involving a whole-of-population approach), both approaches involve extrapolation from existing data; indeed, this was clear from Professor Kaldor’s explanation of the mathematical modelling approach outlined earlier. The Tribunal has also acknowledged the potential validity of both approaches. It seems that perhaps some of this criticism contained in the submissions was at cross purposes, and that Professor Kaldor’s critique of Dr Halpern’s ‘theoretical epidemiological principles’ related to the alleged deficiencies with his mathematical model and were made alongside other criticisms that Professor Kaldor was making about Dr Halpern’s proposed approach.

221. The Tribunal agrees with Professor Kaldor that blood banking and protecting the safety of the blood supply is of its nature, a conservative endeavour. Viewed in this context, it accepts that the model-based approach is reasonable, and is based on the best information available in Australia and provides the Tribunal with the most reliable guide to assessing prevalence rates for HIV among the MSM group. The question remains as to the assumptions that the prevalence figures are based on regarding the proportion of the population that is in the MSM group.

Proportion of population that is in the MSM group
222. As will be evident from the preceding discussion, a key determinant in calculating prevalence of HIV among the MSM group is the size of the MSM group; within the range of possibilities, a larger MSM group, will reduce prevalence estimates, as the known (and undiagnosed) cases of HIV would be distributed amongst a greater number.

223. Differences of view between Professor Kaldor and Dr Halpern with regard to estimating the proportion of men who have sex with men within the population have been noted: the calculations in Exhibit T6 prepared for the Tribunal are based on an assumption that 2% of the adult male population is in the MSM group. This is consistent with published research in Australia: see T876-877 and Grulich et al, (Annexure 80, Dr Wylie R47) which reported that 1.9% of men reported homosexual experience in the last year. In contrast, Dr Halpern had put forward a figure of 5% of the male population as having male-to-male sex, however this estimate has been strenuously challenged by Professor Kaldor.

224. Mr Cain’s position is that Professor Kaldor’s calculation of 2% of the adult male population is an underestimation of the number of men who have sex with men in the population. Associate Professor Mitchell gave evidence that the number is potentially larger, but also acknowledged the impossibility of accurately estimating the number of gay men in the community because of the difficulty of getting people to disclose their sexuality in a society which is generally homophobic and discriminatory and also because of the fluidity of all aspects of human sexuality (First Statement C4, p2). Associate Professor Mitchell referred to the study by Smith et al (2003) (elsewhere in this decision referred to as the study by Grulich et al - same study but different lead authors for different papers) on which the Kaldor estimate is based. That study, The Australian Study of Health and Relationships interviewed 20,000 people and is the largest study in this area ever conducted in Australia. That study found that only 2% of the population identify as non-heterosexual. She pointed out that when a more inclusive definition of sexuality was used which included the three domains of identify, attraction and experience, it is more likely to capture men who have sex with men but do not identify as gay (First Statement C4, p2). Drawing on the Smith et al study, Associate Professor Mitchell noted that it had found that 6% of men in the sample have had sexual contact with someone of the same sex. This evidence highlights that issues of characterisation of what is to be included in the MSM group will affect the estimates.

225. For the purposes of the analysis prepared for the Tribunal (Exhibit T6), Professor Kaldor made it clear that his working definition for inclusion in the MSM group is a man who has had sex with another man in the last 12 months. Associate Professor Mitchell in her Statement (C4B) noted the difference in estimates between herself and other expert witnesses and expressed her view that this is indicative of the fact that nobody knows how many gay men there really are (p3).

226. In light of the specific time frame under the Kaldor model, it is clear that not all the evidence before the Tribunal is directly comparable, and this helps to explain why the estimate of the proportion of men who have sex with men in the male population put forward by Professor Kaldor is lower than some other estimates. Given that the approach of Professor Kaldor also coincides with the donor questionnaire (male-to-male sex within the last 12 months) this seems to the Tribunal to be a sound approach.

227. The Tribunal concludes that the figure relied on by Professor Kaldor estimating the proportion of men who have sex with men in the adult male population appears to be the best and most relevant information presently available and while the figure of men who have sex with men in the population may be higher this is currently speculative. Here too, the Tribunal is of the view that it is appropriate and reasonable to be cautious and rely on the main study available rather than speculate that the pool may be larger and prevalence therefore lower.

Tasmania
228. Mr Cain focussed on prevalence in Tasmania and adopting a whole-of-population approach, sought to demonstrate through cross-examination of Professor Kaldor that the MSM group population may be larger than postulated by Professor Kaldor and the HIV prevalence significantly lower than the Health in Men study suggests.

229. Professor Kaldor explained that we do not have an accurate figure of the size of the MSM group living in Tasmania (T880). He conceded that it is quite likely that prevalence of HIV infection varies in different parts of the country and in different subgroups of men having male- to-male sex to a degree that we cannot measure very well (T882). On this basis, and in light of figures put to him in cross examination (based on known figures of HIV in Tasmania drawn from the 2008 Annual Surveillance Report, put in the context of the size of the Tasmanian population with an assumed 2% of the male population engaged in male-to-male sex) he commented that it is quite plausible that the prevalence rate of HIV is lower in Tasmania than elsewhere in Australia. He also raised the possibility of gay men representing a smaller proportion of the Tasmanian population compared with national figures in light of historical antecedents, in particular, that Tasmania was the last state to repeal its sodomy laws. Professor Kaldor did, however, make clear his view that it is not reasonable or plausible to try and chop the country up into little pieces based on variations in prevalence. According to Professor Kaldor “that would be totally beyond the scope of epidemiology to make those distinctions ... and beyond the scope of public policy and blood banking or blood safety policy, to try and make decisions on a patchwork of geographic differences” (T845). He also referred to the history of the Red Cross organisation which had not always been nationally organised due to Australia’s federal structure; he commented that the Red Cross had been criticised in the past for its inconsistent policies, and indeed, one of the reasons that the organisational structure was unified was to ensure consistency of policy (T848-849). Mr Bowtell’s evidence with regard to the history of the national policy also supported the view that it would be a retrograde step to go back to a state by state, territory by territory approach which he had described as incoherent and lacking in national application (T439-440).

230. It was Mr Cain’s position that by taking a Tasmanian perspective, it may be seen that the risk of HIV infection from men who have sex with men in Tasmania is below that of other tolerated risks such as heterosexuals who never use a condom. This is relied on to show the inequity in the current deferral policy and the need to reform that policy (Closing Submissions, p41).

231. The Tribunal found that the analysis of the Tasmanian situation was of limited relevance. It rejects the notion that disparate policies should be implemented in different geographical locations based on local risk. The Tribunal considers that given the historical background to the response to the HIV/AIDS epidemic, there is compelling and persuasive evidence that it is not feasible or plausible for donor deferral policy to be geographically driven and that a national and uniform policy is appropriate and is the most effective means to minimise risk to the blood supply.

232. It is noted that the Red Cross had also relied on the Tasmanian situation to promote its case. In particular, it had relied on evidence that HIV associated with male-to-male sex decreased to none in Tasmania in 2001 before increasing to 83% in Tasmania in 2006 (Closing Submissions, p3). According to the evidence of Dr Wylie, due to this figure of 83%, Tasmania was reported to have the highest proportion of HIV cases associated with male-to-male sex. The article by Guy et al was relied on in support of this proposition: “HIV diagnoses in Australia: Diverging Epidemics Within a Low-Prevalence County” (2007) 187 Medical Journal of Australia 437 (Annexure 55, Dr Wylie R47).

233. These figures were put to Associate Professor Mitchell by Mr Ruskin S.C. in re-examination (T83-84). She stressed the small numbers involved (6 new infections in Tasmania out of a total of 817 for the whole of Australia in 2006). She expressed her view that Tasmania has the lowest prevalence of HIV in Australia (T43). Whilst an increase of 83% may, at face value, seem significant, it must be understood in the context of no new reported cases in the previous period. Of the 6 new cases, 5 were related with male-to-male sex, leading to the calculation of 83% as representing 5/6 of the newly reported cases in 2006.

234. The Tribunal finds this statistic of 83% to be entirely unhelpful; as Associate Professor Mitchell points out, the figures are so small as not to be really meaningful. The numbers must therefore be read in context. What can be distilled from this data reported by Guy et al is that there was in this period a significant increase in Victoria attributable to an increase in unprotected anal intercourse.

235. The Tribunal notes the calculations that Counsel for Mr Cain had put to Dr Leiss, drawing on the Tasmanian data (see outlined in the Closing Submissions p70), namely that the risk associated with someone from the MSM group donating blood in Tasmania during the window period and having an undiagnosed HIV/AIDS diagnosis was ‘once every 5769 years.’ As those submissions explain, utilising the scientific evidence underpinning Dr Leiss’ witness statement, these calculations were based on the fact that since HIV/AIDS was first diagnosed in the early 1980s, 95 people had been diagnosed with HIV in Tasmania (to end of 2006). Relying on Dr Leiss’ review of the scientific literature, it was calculated that approximately 26 of those cases were undiagnosed, and further that approximately 2% of the MSM population would attempt to donate blood. It was calculated that the magnitude of risk that a person from the MSM group who was undiagnosed with HIV would attempt to donate in the window period was .52 or once in 192 years. The final step in the calculation was to include a question about safe sex and factoring in, again drawing on Dr Leiss’ review of the literature, the fact that approximately 3% of people may answer the question falsely. This led to the quantification of the risk of someone from the MSM group donating blood in Tasmania during the window period and having an undiagnosed HIV/AIDS diagnosis as ‘once every 5769 years.’ It was claimed that Dr Leiss had confirmed these calculations and a review of his answers under cross examination (T289-294) indicates he was not challenging the mathematics as such. However, in re-examination, he had rejected the premise on which these calculations were based, namely that one can look only at the Tasmanian figures, and told the Tribunal that one would need to look at the population statistics for Australia as a whole (T328-329).

236. The Tribunal has already rejected the possibility of disparate policies in different jurisdictions based on local risk and is of the view that there is no reasonable alternative to maintaining a national and uniform donor deferral policy. The Tribunal accordingly agrees with Dr Leiss’ conclusion that the premise on which these calculations are based must be rejected.

Conclusions on prevalence
237. Essentially, Mr Cain’s argument in relation to the Professor Kaldor analysis in Exhibit T6 was that it is flawed as it is based on incorrect prevalence estimates and assumptions regarding the proportion of men who have sex with men in the population and furthermore, does not take account of the Tasmanian situation. The Tribunal’s review of the epidemiological data leads it to reject this contention. Looking at the epidemiological data, including the key analysis in Exhibit T6, it is not the case that the safe sex MSM group are at a lower level of HIV risk than heterosexual groups: even on the lower prevalence estimate of 5%, homosexually active men in the safest group (monogamous partnership where condom use is 100%) produces a relative risk of 34.99, compared with the riskiest category of heterosexual men (men who never wear condoms) which produces a relative risk of 19.98, thus the MSM group being nearly twice the relative risk of the group of heterosexual men.

238. With regards to the critique in relation to the analysis, primarily from Dr Halpern, and Mr Cain’s claims of overestimate of risk associated with low risk homosexually-active men, the Tribunal is of the view that given that we lack empirical certainty, the data relied on by Professor Kaldor is valid and is a valid model that demonstrates an increment in risk would result if the policy was changed as urged by Mr Cain. The fact that the same analysis can be undertaken using other data as suggested be done by Dr Halpern (whole-of-population method) and producing a lower risk outcome than shown in T6 is acknowledged. In these circumstances, the Red Cross would have to be conscious that on an issue of importance (prevalence of HIV in the MSM group) there is a degree of uncertainty but that valid data and modelling has shown there would be an increment. Their obligation is to be cautious in this situation. This is the most plausible approach when the activity is one of policy making in a public health setting as opposed to epidemiological theorising (see Professor Kaldor T962).

239. In submitting that there is data showing that the low risk MSM group pose the same or a lower risk to the blood supply than other tolerated groups of donors, the submissions for Mr Cain rely on data from Tasmania regarding the prevalence of HIV in the MSM group and information regarding revised estimates of proportion of the MSM group in Australia. As noted above, relying on these figures amounts to a flawed approach. For the reasons set out above, the Tribunal prefers the data regarding the proportion of the Australian population belonging to the MSM group relied on by Professor Kaldor as reliable and valid for the purposes at hand. The Tribunal rejects an approach based on data relating to Tasmania for the reasons given.

Epidemiology and sexually transmitted diseases (STIs) and MRSA
240. Whilst this particular case concerns the risk of HIV transmission for the blood supply, the Tribunal accepts that for the purposes of blood safety, HIV cannot be considered in isolation and that the Red Cross must be vigilant in ensuring that the blood supply is kept safe from a range of risks, including relevant sexually transmitted infections (STIs). However, the Tribunal is of the view that these risks must be kept in context, particularly as the risk of transmission of STIs was not central to the Red Cross’ policy of deferral of men who have engaged in male-to-male sex in the last 12 months. Various statistics are relied upon by the Red Cross to show an increase in STIs among the MSM group and as a separate issue emerging evidence in America about an association with MRSA and the MSM group.

241. The evidence in relation to STIs was not fully explored before the Tribunal. The submission for the Red Cross had set out a whole range of points in relation to this matter (Closing Submissions, p5):

• There is emerging evidence in the USA of MRSA infection associated with MSM.

• STIs are associated with MSM and STIs among MSM in Australia have increased e.g. a five fold increase in infectious syphilis in Victoria and a 20 fold increase in New South Wales.

• MSM are at high risk for Hepatitis A as well as Hepatitis B and syphilis.

• MSM are at high risk for Gonorrhoea which can increase the likelihood of HIV transmission occurring

• Syphilis can be spread through oral sex alone.

• MSM are at high risk of human herpes virus 8 (HHV-8). There is no test to detect the virus nor antibody to (HHV-8).

242. In reply, Mr Cain responded as follows (Submissions in Reply, p21) arguing that it is irrelevant and misleading to highlight the emergence of MRSA among a tiny group of already high-risk homosexually active men in the United States without an understanding of the epidemiological context of the disease and its relevance to Australia.

243. It was further argued to be irrelevant and misleading to highlight increases in STIs among homosexually active men, as the evidence called by Mr Cain showed that:

• these increases represent a tiny number of men because they come from a very low base;
• there have been increases of a similar or greater magnitude among high risk heterosexually active people including Aborigines and young people
• STIs are spread by unsafe sex and Mr Cain is proposing that people who have unsafe sex are deferred; and
• According to Professor Kaldor, rates of STIs are not relevant to blood ban safety.

244. While the increase in STIs among members of the MSM group is evident from materials before the Tribunal, there is a question about the relevance of that increase. The Tribunal makes a number of observations about the evidence regarding STIs. First, there is a lack of information comparing the risk of STIs in the heterosexual community compared with the MSM group. Obviously, the MSM deferral policy does not capture STIs outside the MSM group and an obvious question is the level of prevalence of STIs in the non-MSM group that is being tolerated by the current deferral policy. Further, a significant increase is not the same as a significant number. It depends on the base number of cases before the increase. (See for example, Jin et al [Annexure 86, Dr Wylie R47] reporting an increase from 6 cases to 162). Further, some studies referring to isolated outbreaks of STIs may not have relevance to the current situation (see for example, Stokes et al [Annexure 94, Dr Wylie R47] referring to an outbreak in 1991). The evidence suggests that many of the cases would be excluded in any event, regardless of the MSM deferral policy (see the paper by Guy et al which reports that half of new syphilis infections are amongst men who are already HIV positive), and the risk factors apply to a minority of the MSM group: (Guy et al, “Sustained Increase in Infectious Syphilis Notifications in Victoria” Annexure 74, Dr Wylie R47).

245. It is apparent from the historical analysis that the driving force for the current deferral policy of the MSM group is the HIV epidemic and not a concern about STIs. There is no suggestion that STIs emerge as part of the rationale for the existing deferral policy.

246. It would appear to the Tribunal that only some of the evidence put forward by the Red Cross in relation to STIs was relevant to blood banking and it would appear that to some extent at least, the main purpose for adducing it was to show irresponsibility in the MSM group. Given the way in which Mr Cain’s case has been framed, involving an alternative proposal based on safe sex and monogamous relationships, the Tribunal did not find this approach particularly helpful.

247. For example, a number of the conditions referred to are not transmissible by blood and some of the conditions referred to are not in fact normally characterised as sexually transmissible diseases (for example, Hepatitis A which is an enteric infection primarily transmissible through the digestive tract). The relevance of gonorrhoea seems to be that its presence can increase the likelihood of HIV transmission. With regard to syphilis (which is transmissible by blood), there was also evidence before the Tribunal highlighting the association between syphilis and cohorts within the MSM group, particularly gay men who are HIV positive (T765). The Tribunal also notes the evidence indicating that syphilis can be contracted through oral sex. The potential for transmission in this way then posing some risk to the blood supply was acknowledged by Professor Kaldor but described as a lower order of concern than HIV (T768). The Tribunal notes the evidence of Dr Wylie that the window period for syphilis is up to 118 days (First Statement R47, para 62).

248. The Tribunal notes the evidence in relation to risk associated with STIs but finds it of nominal significance in the determination of this case which has really focussed on the risk of a donor who is HIV positive donating blood in the window period when the virus is infectious and transmissible to blood transfusion recipients but not detectable by the NAT test. Whilst the data that was put to the Tribunal with regard to STIs and their increased incidence was peripheral to the core issue before the Tribunal, the Tribunal accepts that STIs represent a risk that the Red Cross must be alert to. If the current deferral policy captures and defers some of the MSM group who have a STI that is an added benefit of a deferral policy that was implemented and is maintained for reasons unrelated to the situation regarding STIs.

249. Potential risks associated with MRSA, which were most fully canvassed in Professor Holland’s First Statement (R48), would appear to be of a different order. MRSA stands for a “multi-drug resistant community-associated methicillin resistant Staphylococcus aureus clone” (para 74). Professor Holland’s statement noted that until recently, these bacteria had only been observed in hospital patients in clinical settings, but that there have been 300 cases reported in San Francisco and Boston among men in the MSM group. He suggested that if such infection were to spread to the MSM group in other countries of the world this would present a particularly challenging and difficult situation. He noted that MRSA is a blood borne bacteria and that the emerging and potential problem of MRSA has the potential to affect the blood supply, particularly as there are no specific tests for MRSA and only limited efficacy in picking it up through certain tests of bacteria in platelets (para 74). In cross examination of Professor Holland, it was suggested that MRSA involves bacteria on the skin and is associated with gymnasiums and health clubs. While accepting that that was an association, Professor Holland’s evidence was that men having sex with men were a major risk group for this particular infection which can get into places and cannot always be detected (T400). In the light of the history of the HIV/AIDS epidemic, and the application of the precautionary principle, it would seem appropriate for the Red Cross to be pre-emptive and keep a watching brief on MRSA despite the scant information currently available.

Social research
250. In addition to the epidemiological data, the Red Cross has sought to rely on social research in support of the current deferral policy of men who have had sex with men within the last 12 months (Closing Submissions pp5-6). In particular, reliance was placed on a study by Grierson et al, HIV Futures 4 State of the [Positive] Nation (2004) (Annexure 75, Dr Wylie R47) which examined the sexual practices of gay and bisexual men. This study canvassed a number of matters, including the number of partners, knowledge of HIV status of partners, condom use, and the delay in informing partners about HIV status.

251. The Red Cross’ Closing Submissions (p5) summarised the findings of this data as follows:

• 58% of respondents who identified as gay or bisexual men reported that in the six months prior to completing the survey they had sex with casual partners, regular and other partners or more than one regular partner.

• Of the respondents who admitted to sex with casual partners in the six months prior to the survey, 7% said their casual partners were HIV positive, 31.3% said some were HIV positive, 8.6% said none were HIV positive.

• Most (53.2%) respondents who had casual sex reported they did not know the HIV state of their casual partner.

• Of 464 men interviewed in the Grierson study, only 170 always used a condom with a casual partner whose HIV status they did not know – 37%.

• Of the HIV positive men interviewed in the Grierson study in long term relationships 10% waited weeks, months or years to tell their partner that they had HIV.

252. Dr Wylie’s First Statement (R47), which contained numerous supporting Annexures drawn from the social research literature, was relied on by the Red Cross in support of certain other propositions relating to sexual behaviours and experiences. This included comparing data from the studies of de Visser et al (exploring the number of partners in heterosexual relationships - Annexure 79, Dr Wylie R47) and Grulich et al (examining the number of partners in homosexual relationships – Annexure 80, Dr Wylie R47). According to Dr Wylie (para 176), this data indicated that homosexual men report significantly higher numbers of partners than heterosexual men: in the last year 10.7, in the last 5 years 31.9 and lifetime 79.1 partners for homosexual men, compared to 1.5 in the last year, 3.9 in the last 5 years and 16.7 lifetime partners for heterosexual men.

253. Dr Wylie’s First Statement (R47, para 183) was also relied on in support of the proposition that a high proportion of persons engaging in male-to-male sex with HIV infection are not aware of their status, and that published estimates of men who have sex with men unaware of their HIV infection range from 20% to 48%.

254. Further, Dr Wylie’s First Statement (R47, para 268) attested to the fact that the Health in Men Study found that 16% of respondents did not know the HIV status of their more recent primary regular partner and that over 60% of those who had other regular partners in the previous 6 months had a partner whose HIV status was unknown. The Health in Men Study was also referred to by Dr Wylie (para 270) in support of the fact that among the MSM group in Australia, many persons (27.1%) with a regular partner have no specific agreement prohibiting or allowing sexual activity to occur outside the relationship and further, that those who do have agreements, one fifth of the sample reported that they had broken an agreement with their primary regular partner about sex outside the relationship but only 58.6% had told their partner it had been broken. The Gay Community Periodic Survey (Annexure 61, Dr Wylie R47) was also referred to by Dr Wylie in support of the proposition that many men who have sex with men who have a regular partner also have casual partners.

255. This social research data that was presented to the Tribunal by the Red Cross is of an unrepresentative sample of the MSM group. Indeed, the difficulty of achieving representative sampling of the MSM group and obtaining data of ‘ordinary’ men who have sex with men was explained in evidence before the Tribunal by both Associate Professor Mitchell (T25) and Professor Kaldor speaking more generally about the Health in Men study (T794-796).

256. In particular, the Grierson et al study, relied on heavily by the Red Cross involves an entirely atypical membership of the MSM group. It was an anonymous, national survey of exclusively HIV positive people drawn from community venues. The cohort of particular interest to researchers is those members of the MSM group most at risk; they are the target of the research and the safe sex messages. A number of the other key studies relied on for this social research data are also unrepresentative. For example, the Health in Men study recruits its subjects primarily through gay community events, institutions and networks in Sydney. To be eligible for this study, the men in the MSM group must either live in Sydney or be a regular participant in gay community networks, events and venues in Sydney (See Mao et al, Health in Men: Baseline Data, National Centre in HIV Social Research [2002] Annexure 3, Dr Wylie R47, p1). Professor Kaldor had given evidence that the Health in Men cohort is not representative of all homosexually active men (T714-715). Similarly The Gay Community Periodic Survey has a very specific recruitment approach seeking to recruit gay and homosexually active men through a range of gay community sites in Melbourne: in 2005 the six sites used for recruitment were the Midsumma Carnival and five gay community venues – one social venue, three sex-on-premises venues and one sexual health clinic. The study by Grulich et al is, in contrast, a more representative study: that involved a random telephone survey of 20,000 Australians and sought nationally representative data. Mr Cain asserted that attempts to suggest that such unrepresentative studies can be applied to all homosexually active men is a form of stereotyping and should be dismissed (Submissions in Reply, p22).

257. Associate Professor Mitchell suggested that we are really looking at two communities within the MSM group: “those that are at risk remain at risk, practice unsafe sex, maybe don’t go for HIV testing and that group will always be the target of the research and of the safe sex messages. But there is a much wider community of men who have sex with men that aren’t at any risk - frequently excluded, deliberately excluded from studies” (T25). She gave an example of the Colvin study which had stated that they had actually excluded from their samples men who had said that they were in a monogamous relationship because they were not the men that they were interested in (T80). She also noted that data regarding men having sex with men with a great many partners are only a proportion of the gay community and this would be particularly noted in the groups that are researched and not in the groups of men who have sex with men who do not get into the research because of this low risk (T31-32). Associate Professor Mitchell explained that the research, particularly the research done in Australia, is all funded with HIV prevention money and therefore it is very directed at being able to recruit the people who may be at risk of HIV through their behaviours and the conclusions would be shaped in such a way as to give health promotion people a message about where the dangers or the sexual risk-taking might be in the particular group. In her view, it does not take account of the much wider gay community who is not of interest to the social researchers because they are not at any risk of HIV (T79). Associate Professor Mitchell’s opinion that the MSM group is much more similar to the heterosexual group is supported by the Vermont study (T78-79 Elder G., “The Non-significance of Significant Others: a National Geography of Gay and Lesbian Coupledom”, University of Vermont). This American study captured a very broad population of same-sex attracted couples and found that homosexual lives are much more like the general population than previously found to be the case in smaller studies concerned with groups of more concentrated and visible same-sex couples: A summary of the study spoke about the banality of the results of the analysis: (referred to in Mr Cain’s Closing Submissions page 58).

258. Furthermore, aside from this issue of unrepresentativeness, there are reasons for the Tribunal to question reliance on some aspects of the findings of this data. Cross examination of Associate Professor Mitchell revealed explanations for infrequent testing and poor knowledge of HIV status of partners that are consistent with adopting safe sex strategies (T23, T26-27, T28, T30). Indeed, her evidence to the Tribunal was that it can be riskier to rely on testing by partners than to adopt safe sex methods and that the status of your partner is irrelevant if you’re practising safe sex” (T30).

259. Because of the unrepresentative nature of the samples in the Grierson et al and other studies relied on by the Red Cross, the Tribunal found these studies of the most at risk cohort to be unhelpful in assessing the characteristics of the MSM group at large, and not directly relevant to the assessment of Mr Cain’s proposed alternative deferral model which is premised on safe sex within monogamous relationships. On this proposal, persons who do not engage in safe sex would be deferred.

Comparison with other tolerated risks
260. Having argued that there can be disaggregation of risk within the MSM group, such that some members of the group who practice safe sex can be identified as low risk, it was part of Mr Cain’s case that it was necessary to compare the low risk of that group with risks presented by other non-MSM groups that are currently permitted to give blood. It was not part of Mr Cain’s case that these higher risk groups should be deferred; rather, the argument was framed on the basis that this comparison provided a basis for arguing that if the risk presented by the safe-sex cohort of the MSM group is less than or comparable to that of other non-MSM groups who were eligible to donate blood, they should also be so eligible. The three groups identified by Mr Cain for comparison were young heterosexually-active people, heterosexually-active people who have sexual contact in the Asian region, and Indigenous People (Closing Submissions, pp34-37).

261. The epidemiological evidence before the Tribunal (Exhibit T6) unequivocally showed that the risks associated with safe sex within the MSM group were still greater than the risks associated with the riskiest unsafe sex practices within the heterosexual group (relative risk of 34.9 compared with 19.98). Professor Kaldor did not deny that some individual men in the MSM group would present less of a risk than some individual men in the heterosexual group but argued that the relevant evaluation is of the group or subgroup, not of individuals: his evidence was that, in a practical sense, for the purpose of blood safety and for the purpose of donor deferral you have to come up with pretty broad categories because that is how the system is going to be pragmatically applied (T977).

262. It should be noted that one aspect of Mr Cain’s argument is that the differential risk identified by the Kaldor analysis is in reality insignificant (Closing Submissions, p39), given the difference between absolute and relative risks. Dr Halpern had claimed that the Red Cross is only concerned with absolute risk. The Tribunal has earlier refuted this, accepting that the Red Cross must be concerned with both absolute and relative risks and both indicate increase in risk if there were to be a change of policy along the lines proposed.

Young heterosexually-active people
263. The evidence of Associate Professor Mitchell (First Statement C4, p2) was relied upon to support the fact that there is a high rate of unsafe sex among young heterosexually-active people (16-18 year olds) with inconsistent condom use. It was suggested that in light of the survey evidence of this age group, if HIV got into that cohort it would be easily transmitted. There was also evidence before the Tribunal of an increase in STIs in this group as well as HIV diagnoses attributed to heterosexual contact (Guy et al, “HIV Diagnoses in Australia”, Annexure 55, Dr Wylie R47).

264. Professor Kaldor made it clear in his evidence that what is significant is not risky behaviour per se, but the group in which that behaviour is conducted and the risk of HIV transmission within that group (T863). Accordingly, in order to evaluate the risks associated with this group, it is essential to have regard to the prevalence of HIV in that group. As noted, Professor Kaldor’s evidence was that there is presently an extremely low prevalence in Australia of HIV amongst those who do not engage in male-to-male sex, amongst the lowest in the world (T816). Further, as earlier noted, Professor Kaldor made clear that the riskiest form of a sexual act such as receptive anal intercourse in a heterosexual setting where there is very low HIV prevalence has lower risk than if you are doing something that is in itself a low risk behaviour such as sex with condoms in a setting where there is very high prevalence in that underlying partner population. So, the actual risk of the act depends on what you do and the prevalence in the partner group (T863).

Heterosexually-active people who have sexual contact in the Asian region
265. Mr Bowtell told the Tribunal that in the Asia pacific region, HIV is overwhelmingly a heterosexually transmitted disease. He referred to the danger that people from Australia may erroneously believe that if they do not engage in male-to-male sex they will never contract HIV. He stated that it was now more likely than before that young people could contract HIV through unprotected heterosexual sex (T467-468). This was consistent with other evidence, including that from Associate Professor Mitchell, that viewed within the international context, HIV was primarily a heterosexual disease (T55).

266. Linked with the above category of unsafe sex practices amongst young heterosexually-active people, this certainly appears to represent a potential risk which as a matter of prudence would need to be kept under careful consideration.

Indigenous people
267. There was evidence from Professor Kaldor (T765-766) that there has been a very large increase in syphilis amongst particular indigenous communities which was indicative of unsafe sex practices and consequently increased risk also of HIV transmission. Dr Wylie also attested to this, reporting statistics that indigenous people are 17 times more likely to have syphilis, 47 times more likely to have gonorrhoea and 6.5 times more likely to have chlamydia (T566). Significantly, there did not appear to be data drawn to the attention of the Tribunal directly relating to the prevalence of HIV within the aboriginal community. Dr Wylie explained, however, that in practice, there are very few donations from Aboriginal people. When it was put to him that the epidemiological data would justify deferral of all Aboriginals in light of the increased risk of STIs, this was strongly contested by Dr Wylie on the grounds that that would quite inappropriately entail exclusion of a group. He stated that the policy of the Red Cross was to defer people by reference to high risk activities rather than merely belonging to a group and that this approach would be effective in screening out high risk Aboriginal donors. Whilst there is clear evidence of an elevated risk of STIs in the indigenous community, the Tribunal has no clear evidence before it as to the prevalence of HIV within that population which is the central risk issue under consideration in this case. On the basis of the precautionary principle, and the need to assume that what could go wrong will go wrong, one could argue that in light of the high prevalence of STIs in the indigenous community, relying on the fact that few aboriginal people in fact present for donation (Dr Wylie, T568) seems an inadequate approach if there is a risk posed to the blood supply and that a more vigilant screening approach would be warranted.

268. For the sake of completeness, we also note that it is Mr Cain’s submission that the other higher risk tolerated group is that of high risk heterosexuals (no condom use) arising from the evidence regarding Exhibit T6. It is apparent from the Tribunal’s consideration of this issue and noting in particular the Tribunal’s acceptance of the evidence of Professor Kaldor, Exhibit T6 demonstrates that this group poses less risk to the blood supply than the low risk MSM group.

Conclusions with regard to comparison with other tolerated risks
269. The overriding conclusion to be drawn from the epidemiological evidence before the Tribunal, particularly Professor Kaldor’s evidence (T744 and Exhibit T6), is that whilst particular areas of risk outside the MSM group can be identified, due to the higher prevalence and incidence estimates, the risks associated with the MSM group outweigh these other risks, such that the low risk safe sex cohort within the MSM group still presents a higher risk than high risk heterosexuals who consistently practice unsafe sex. Professor Kaldor made the point on a number of occasions, that in his view, changing the deferral policy to allow donations from men who have sex with men on the conditions identified by Mr Cain (safe sex and within monogamous relationships) would introduce an unacceptable level of risk to the blood supply (T733, T748, T819-820, T885-886).

History of Blood Transfusion and HIV/AIDS in Australia

270. There was evidence before the Tribunal which detailed the history of HIV in Australia. The evidence came from a number of witnesses and was not challenged. The witnesses were Dr Wylie, Mr Bowtell, Associate Professor Mitchell and Professor Holland. A summary of the evidence follows.

271. Dr Wylie in R47 included the following explanation of HIV at para 60.1:

“HIV

(a) Human immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) are the recognised core-agents of AIDS. AIDS is short for the Acquired Immunodeficiency Syndrome and represents the progression of HIV. The disease is associated with the breakdown of the immune defence system, leaving the way open for potentially serious infections (viruses and other organisms) and a specific malignancy, Kaposi’s sarcoma, which the body would normally be able to defend itself against.

(b) In simplistic terms, primarily one arm of the two arm defence system of the body is affected. This arm is the one in which the cells called T-cells are normally primed to repel invasion by viruses and other organisms. The B-cells are left relatively intact to repel bacterial invasions.

(c) HIV was initially known as Lymphadenopathy-associated virus (LAV), HTLV-111, or AIDS-related virus (ARV). LAV, HTLV-111 and ARV are now referred to as HIV-1 which is responsible for the current AIDS epidemic in Central Africa, Europe, the Americans and other regions of the world. It is apparent that another type of HIV, HIV-2 has been identified in AIDS patients in West Africa.

(d) HIV-1 is distributed worldwide. However, HIV-2 is endemic in Western Africa with limited distribution to other regions of the world. Blood is screened for both HIV-1 and HIV-2 infections.

(e) …It was not until late 1984 that a blood test was formulated and used to show that HIV-1 was present in almost all people with AIDS. It is now firmly established that HIV is the cause of AIDS.”

272. The first AIDS cases were diagnosed in 1981 among young homosexual men in the United States. In January 1983, the first three AIDS cases were reported in the New England Journal of Medicine in the United States. These cases were in haemophiliacs (see Dr Wylie R47, paras 60 and 80).

273. The first reported case of AIDS in Australia was in October 1982 (see Mr Bowtell, T435). There was a new disease that very little was known about and there was great uncertainty as to how to effectively respond. A complicating factor was that the divisions of the Red Cross Society in each Australian State and Territory had established and maintained individual Blood Transfusion Services and these were operated separately. There was a national committee known as the National Blood Transfusion Committee which had members from the State and Territory Blood Transfusion Services but effectively the National Blood Transfusion Committee acted in an advisory capacity to the individual Blood Transfusion Services (see Dr Wylie R47 at para 15-18). It was not until August 1995 that the Red Cross Society formed a national blood service known as the Australian Red Cross Blood Service. This Service subsumed the eight Blood Transfusion Services and the National Blood Transfusion Committee (see R47, para 21). So, until 1995, the responsibility for protecting the blood supply was with individual Blood Transfusion Services in each State and Territory.

274. In June 1983, the National Blood Transfusion Committee recommended that an Information Sheet on AIDS be introduced which would be shown to all prospective donors, asking people at particular risk of AIDS not to give blood (Dr Wylie R47, para 84) This recommendation was implemented by the various Blood Transfusion Services in June 1983. In Victoria, homosexual or bisexual men who had sexual relations with ‘many’ partners were asked not to donate. In the other States and Territories there was reference to ‘multiple partners’. In both cases, it was for the donor to assess whether he was sexually active with multiple or many partners. Red Cross (Dr Wylie R47, para 85).

275. In July 1984, the first case of transfusion transmitted AIDS was confirmed in Sydney and by August 1984 there were four NSW cases of AIDS believed to have been transmitted through blood donations. In 1984 a test capable of detecting HIV/AIDS was not yet available, the blood supply was protected only through the selection of low risk donors.

276. By November 1984 the gravity of the situation became apparent.

277. It was in November 1984 that a person with haemophilia was diagnosed with AIDS and in Queensland, it was reported that …

[suppression order]

The investigation disclosed that the donor had continued to donate throughout the period when there had been a prohibition introduced to exclude homosexual men with “many or multiple partners”.

278. Mr Bowtell explained that when the [suppression order] episode occurred, the Government became very concerned and there was enormous pressure placed on the Red Cross to formulate one national policy. He said it was apparent that an urgent, stronger and more definitive national policy was needed and it was clear that self-deferral had not worked as a policy (see T439-431).

279. Dr Wylie stated that in November 1984 an AIDS Health Summit was held which was, in part, a response to the … [suppression order] … received extensive publicity and caused widespread public concern. It was as a result of this Summit in 1994 that the deferral policy was reinforced with a new requirement introduced by the Blood Transfusion Services in all States and Territories requiring that potential donors sign their declaration that they had not engaged in homosexual activity before a witness with legislative penalties for false declarations (Dr Wylie, R47, para. 96-97). By October 1984, all Australian States and Territories deferred men who had engaged in homosexual or bisexual activity for various periods of time and/or indefinitely (Dr Wylie, para 93). In New South Wales, Victoria, South Australia, Western Australia and Tasmania, the specified time frame was five years. In the Northern Territory it was ten years and in Queensland there was no time specified.

280. The Krever Inquiry reported that as at 1984 Australia had the highest rate of transfusion-related AIDS in the developed world (Krever Inquiry, Annexure 4, p798). Dr Wylie stated (Statement R47A, para 99) …

[suppression order]

281. Persons who had acquired HIV through blood and blood products commenced litigation. Dr Wylie stated that the plaintiffs in the litigation were …

[suppression order]

282. One of the central allegations of the negligence cases was that the Red Cross should have deferred all homosexual and bisexual men during the latter half of 1983 and through 1984 rather than allow a donation of blood if the donors stated they had not had ‘many or multiple partners’ (see Dr Wylie, R47, para 108).

283. Three of the cases proceeded to trial in Australia in the 1990s but there was no adverse finding made against the Red Cross. Following these cases, compensation schemes were established for those who had acquired HIV through transfusion of blood and blood products. The scheme required investigation of the circumstances of each transmission, including identification of the HIV positive donor and review of the donor’s risk factors (see Dr Wylie, R47, para 109).

284. There were investigations which included a ‘lookback program’. The lookback program involved record keeping of all blood donations so the donations could be traced back to their source. Investigations revealed that some HIV transmissions occurred from …

[suppression order]

However, as noted earlier, Mr Cain does not seek a self-deferral policy and the witnesses were at cross purposes on this issue.

285. The Tribunal also had the benefit of a statement from Gavin Finkelstein (see R53) who is the President of the Haemophilia Foundation (HFA). The HFA is the national peak body, which represents people with haemophilia, von Willebrand disorder and related rare inherited bleeding disorders. These bleeding disorders are life threatening without proper treatment. The treatment is given with regular infusions of clotting factor derived from either human plasma or genetically engineered recombinant clotting factor.

286. Mr Finkelstein explained the extreme vulnerability of people with severe haemophilia to the risk of blood borne viruses at paragraph 3 of his statement:

“In 1985 when the HIV antibody test was introduced about 30% of people with bleeding disorders using blood products at the time were found to test positive to HIV. Those with severe haemophilia were more likely to be affected. Many of those people have since died from their HIV illness. It is thought that up to 85-90% of people with haemophilia who were treated with plasma derived blood clotting factor were exposed to hepatitis C virus before the late 1980s. Exposure may have occurred multiple times if they were using concentrates regularly. These adults and children had been treated with pooled plasma made from the donation of thousands of donors.

HFA values the generosity of people who donate their blood for lifesaving therapeutic products in Australia, however the risk of blood borne viruses and agents through blood supply to patients using these products remains profound and they remain ‘the canaries in the mineshaft’ in terms of risk of known and yet unknown viruses and agents transmissible through blood. The experience of people with haemophilia through the HIV and Hepatitis C epidemics is evidence of their reliance on the safety of the blood pool and their extreme vulnerability…”

287. The history of the experience of people with haemophilia in the 1980s highlights the terrible and tragic impact of inadequate donor screening. It emphasises the caution that must be taken when making policy decisions affecting the safety and the integrity of the blood supply.

288. One blood donation can benefit many recipients. A blood donation may be used to treat up to three blood transfusion recipients and in some cases, up to four recipients and maybe pooled with several thousand donations for the manufacture of blood products. As a consequence, one infected donation has the potential to infect thousands of patients. Dr Wylie stated that the Australian experience shows that recipients of units of fresh blood products infected with HIV have all developed the infection with the exception of two cases (Dr Wylie, Statement R47, para 151)

289. Internationally, it is estimated that a recipient of a blood transfusion infected with HIV has a 90% chance of becoming infected with HIV (see the estimates by the Terence Higgins Trust, a UK based AIDS organisation: Morley and Power, Terence Higgins ‘Blood Donation Policy’, June 2000).

290. A significant development in the history of the HIV epidemic in Australia and its response was the introduction of the Nucleic Acid Testing (NAT) which commenced in Australia in 2000. This testing has advanced scientific screening. Table 3 at paragraph 62 of R47 sets out the screening agents used currently by the Red Cross on all blood donations. The scientific screens will not detect all infections. The scientific tests used in Australia detect antibodies, antigens and RNA for HIV-1 and HIV-2. The tests used in Australia include:

• antibody tests which will give negative results during the window period, an interval estimated to be between 3 weeks and 6 months, which is the time between the date of HIV infection and the production of measurable antibodies to HIV.
• NAT enables the detection of viral load and reduces the window period between infection and detectability (see Dr Wylie R47, para 65).

291. The Tribunal heard evidence that there have been fluctuations in relation to annual numbers of new HIV diagnoses. In 1995 there were 890 new HIV diagnoses, in 2000 there were 660, however, in 2004 there were 820. Further, newly acquired HIV infection increased from 151 cases in 1995 to 281 cases in 2003 (see Associate Professor Mitchell T86). There has been a doubling since the 1990s in the proportion of new AIDS cases in people with late HIV with 41% of cases having undiagnosed HIV until around the time of AIDS diagnosis (see Dr Wylie R47, para 184 and Associate Professor Mitchell T92-93).

292. Associate Professor Mitchell stated that it was the gay community who led the safe sex campaign in the 1980s and the 1990s. The campaign was enormously successful and undoubtedly contributed to the reduction in HIV numbers that were seen in 2000. Associate Professor Mitchell said that there had been much discussion and debate as to the reason behind the increase in numbers in more recent years. Her belief is that it is due to an increase in unprotected anal sex and the diminution of the effectiveness of the safe sex message. Her evidence was that the increase was predominantly in males aged between 30-39 years so they are males who are less aware of the safe sex message (see T12, 54).

293. The Tribunal now turns to how the deferral policies developed in response to what had occurred historically.

History of the Deferral Policy

294. As noted above, by December 1984 all Blood Transfusion Services had introduced a donor declaration form with a requirement for donors to sign before a witness that they had not engaged in homosexual activity. The donor forms were broadly similar but the time frames for deferral varied between the States and Territories. During the period December 1984 and 2000, the time frames for deferral that the States and Territories imposed altered at different stages and there was a lack of uniformity in those time frames between the States and Territories. Dr Wylie (Table 6 at p.45 of R47), sets out the different deferral periods imposed in New South Wales, Queensland, South Australia, Tasmania and Victoria. The deferral periods included permanent deferral for all donors ever having had male-to-male sexual contact, or having had such contact since 1977 and periods of 10 years, 5 years and 12 months from last male-to-male sexual contact.

295. A national 12-month deferral policy was developed through the 1990s. In 1992, national Guidelines were published (see Dr Wylie, R47 Annexure 32). The purpose was to have nationally approved guidelines for use in all Red Cross Blood Transfusion Services. In 1993, the Donor Deferral Working Party, which was a committee of the Society, reviewed the donor deferral guidelines and recommended that donors in the MSM group be deferred for 5 years. At this time, the testing for HIV was known as “third generation” antibody testing. It was believed that this testing would identify most HIV infected individuals within 3 months and all infections after 6 months. There was a paper circulated in 1993 to the members of the Donor Deferral Working Party, “Managing the Risk of Transmission of Human Immunodeficiency Virus”, (see R47, Annexure 34). The paper concluded that the donor deferral period should be 12 months.

296. In July 1993, the Donor Deferral Party decided to have the 5 year deferral period reviewed by experts. Professor John Kaldor was selected. In November 1993, in a letter to the Red Cross Blood Bank, Professor Kaldor advised the following:

“There is a substantial amount of inconsistency in the time periods used. If the objective is to exclude donors who may be in the window period, I would suggest that given the current sensitivity of HIV screening assays, one year would easily be enough in all categories of exposure.”

297. Then, in February 1994, the Blood Transfusion Services, Executive Sub-Committee endorsed changes to the 1992 Guidelines. The 1994 Guidelines stated:

“Men must not give blood if they have had sex with another man in the last twelve (12) months”

298. The implementation of the 1994 Guidelines was recommended as a minimum standard for the Blood Transfusion Services. The State and Territory Blood Transfusion Services still operated independently in conjunction with their respective State or Territory health authorities. The Blood Transfusion Services Executive Sub-Committee had no power to compel the implementation of recommendations. The Guidelines were regarded as recommendations only and the 12 months deferral was not implemented uniformly nationally (see Dr Wylie, R47, para 121). The Red Cross continued to review its policies and seek advice from Professor Kaldor. In 1996-1997 the individual Blood Transfusion Services came under the national body of the Red Cross. As time progressed, the national Red Cross controlled the donor selection process. In October-November 1998, the Red Cross recommended that the guidelines be implemented nationally unless constrained by State or Territory legislation as some legislation prescribed the donor deferral period.

299. Most Blood Transfusion Services implemented the 12 month deferral in 1999 (Table 6 Dr Wylie R47, p45). New South Wales were not able to do so until October 2000 due to legislative requirements.

Background to the Current Donor Questionnaire

300. The donor questionnaire is an integral part of protecting the safety of the blood supply. The questionnaire is designed to identify high risk donors who are then deferred.

301. Many potential donors of blood are deferred. There are numerous categories that require some assessment prior to donation. It is clear from the questionnaire that there is a large range of people who must be deferred once they are identified as posing a risk. Some examples are:

• persons who have worked in an abattoir in the last 12 months;
• persons who have spent more than 72 hours in a prison or lock-up in the last 12 months;
• persons who have had a tattoo within the last 12 months;
• persons who have had sexual activity with a male or female sex worker in the last 12 months;
• persons who have worked as male or female sex worker in the last 12 months;
• persons who to their knowledge have ever used drugs by injection or been injected even once.

302. The selection process identifies people who pose a risk to the blood supply or to themselves, for example, if you are pregnant or have low iron levels you would be deferred. Broad categories of people are deferred and once a potential donor is identified as belonging to the particular high risk group they are deferred. Dr Wylie estimates that approximately 32% of the Australian population would be deferred (see Dr Wylie, R47, para 52). As Dr Wylie noted, it is not possible for blood banks to eliminate all risk and therefore a certain risk has to be tolerated.

303. It has already been noted that blood bankers are concerned with the risk associated with categories or groups of people, not individuals within the group. This is clear from the Professor Kaldor’s evidence commenting upon and agreeing with Associate Professor Mitchell’s evidence that the blood of most homosexuals is safe. The point has been made that some individuals within the MSM group pose less of a risk than some individual men in the heterosexual group permitted to donate (see discussion above in relation to tolerated risks). Professor Kaldor has emphasised that the blood banker’s perspective relates to the risk posed by groups not individuals. The donor deferral scheme does not work as a process of investigation of individuals taking into account a complex range of considerations and ultimately locating individuals whose blood is safe; it works on a large scale, processing a volume of people and excluding categories of potential donors when, as a group, there is an elevated risk to the blood supply posed by the group.

304. The Tribunal turns now to the detail of how the donor questionnaire is administered. Guidelines are available to the person administering the donor questionnaire. Dr Wylie stated the Guidelines are designed to complement the donor questionnaire (R47 at para 146).

305. It is worth noting that there are other questions in the Donor Declaration addressing the risk of HIV transmission. Question 2 asks whether you “ever thought you could be infected with HIV or have AIDS?” and question 5 “Ever had a test which showed you had hepatitis B, hepatitis C, HIV or HTLV?” and question 6 “In the last 12 months engaged in sexual activity with someone you think would answer “yes” to any of questions (1-5)?”. Answering yes to any of these questions means that blood cannot be donated.

306. As previously mentioned, the Donor Questionnaire goes on to ask potential donors in question 8, whether, in the last 12 months, they have “had male-to-male ‘sex’”? In question 9 potential donors are asked whether within the last 12 months they had sexual activity with a male who “you think might be bisexual?”

307. Following completion of the Donor Declaration, the donor has a private interview with a nurse who reviews the Donor Declaration and asks the donor further questions about issues identified in the Donor Declaration. The Guidelines provide the nurses with guidance in relation to discussions about the Donor Declaration. If there is a query regarding ‘male-to-male sex’ by the potential donor then presumably the Red Cross nurse may refer to the Guidelines and explain that it is not kissing or mutual masturbation and that the use of condoms or number of partners does not alter the deferral period. Otherwise there was a lack of specific evidence regarding the triggers for discussion between the Red Cross nurse and the potential donor. In essence, it seemed to be that in relation to question 8 regarding male-to-male sex within the last 12 months, discussion would occur if there was a query regarding the meaning of the question or something said or written by the donor indicates the need for clarification. In the event that a donor is not eligible to donate blood, the Red Cross nurse will inform the donor of this during the private interview conducted at the conclusion of the Donor Declaration (for the evidence set out above see Dr Wylie, R47, paras 41-48).

308. The Tribunal gleans from this evidence that if the potential donor responds ‘yes’ to question 8 then the person is deferred without further questioning of the donor. Further, if the potential donor answers ‘no’ to question 8 then assuming there is no other reason why the person may be deferred, the donor is able to donate blood. It seems to the Tribunal that there would be no probing of such an answer in the interview and indeed, there would be no trigger to prompt discussion unless a particular query was raised by the potential donor.

309. Accordingly, it seems to the Tribunal that it is quite possible that a person may answer ‘no’ to question 8 believing that the activity they have engaged in, e.g. oral sex, does not amount to male-to-male sex, and there would be no further questioning and the person would be permitted to donate.

Current Situation with HIV and the Blood Supply in Australia

310. It is apparent that currently, Australia has one of the safest blood supplies in the western world. There has only been one infection since 1985 and none since the introduction of NAT testing in 2000. Dr Wylie concludes that at present, in Australia the residual risk of HIV infection through blood is estimated at less than 1 in 10 million (see Dr Wylie, R47 para 73). Australia compares well with the residual risk reported by other countries such as United States, Canada, New Zealand, South Africa, Germany, Italy and Spain which all have higher residual risks (see Dr Wylies’ table R47, para 74). Professor Holland stated that he was not aware of any other country in the western world that has only had one HIV transmission since 1985 (see Professor Holland R48, para 50).

311. The Red Cross attributes, to a significant extent, the safety of the blood supply to their donor deferral policy. Mr Cain asserts that there is no evidence of a link between the safety of the blood supply and the deferral policy and that it is impossible to conclude how much the deferral policy contributes to the safety of the blood supply.

312. The Tribunal takes the view that while there are, no doubt, a number of factors that contribute to the safety of the blood supply in Australia, it is reasonable to infer that, one of those factors is the deferral of the MSM group. Currently, the Red Cross has a system which is working particularly well in terms of safety and it is reasonable for the Red Cross to proceed on the basis that the deferral policy is one of the factors that contributes to that situation. Submissions for Mr Cain emphasised that it would be complacent for the Red Cross to think that because of the level of safety of the blood supply in Australia there was no need to review or change the deferral policy. The Tribunal accepts the validity of that point and to state the obvious, the Red Cross needs to remain vigilant as to the safety of the blood supply and should be open to developments which could lead to an improvement in the safety of the blood supply. Obviously, it would be remiss not to entertain and explore future opportunities to enhance the safety of the blood supply. It is noted that the evidence does not indicate that a level of complacency exists.

313. The evidence about the Australian blood supply also dealt with the sufficiency of the supply to meet expected demand. The evidence revealed that the Australian blood supply is currently sufficient to meet expected demand. The Red Cross has been able to ensure that Australia remains self-sufficient in meeting the needs of the community (Statement of Ms Willis, R52 and Dr Wylie R47, paras 246 and 331). Mr Cain questions the extent of this sufficiency and how long it may last. Mr Bowtell discussed how it was in the public interest to have more safe blood from more donors and we should be conscious that Australia is an ageing population requiring more blood, so it would be ‘prudent’ to consider means to increase the blood supply (see T459 and 462). Mr Cain refers to the Red Cross’ frequent advertising for donors on the basis that some blood stocks are low. Dr Wylie stated that the need for blood is constant and shortages are frequent and can develop quite rapidly (Statement, R47, para 38). It seems to the Tribunal that even with a self-sufficient commodity, there are periods when stocks are low and there is a need to ensure that supplies remain sufficient. Again, as with the safety of the blood supply, it is important for the Red Cross to be open to considerations of increasing the supply of safe blood in Australia.

314. Some limited consideration was given to the impact on the blood supply if low risk members of the MSM were able to donate. It seems clear that precise calculations can not be made in this context. Some factors are known. Approximately 2.5% of the Australian population donate blood and it is likely that under the present Guidelines at least 30% of the Australian population is ineligible to donate blood in any given year (Dr Wylie, R47, para 38, 48 and 55). Dr Wylie considered the factors that would impact on the assessment of the additional blood donations that would be received if some members of the MSM group were able to donate would include: an assessment of the number of MSM group currently deferred, an assessment of the number of that group that would be eligible to donate blood noting the likelihood of those donors eligible to donate blood actually attending and making blood donations (R47,para 227) taking into account the percentage of the Australian population that donates blood. While Dr Wylie did not embark on any precise calculations or advance a mathematical model, he stated that taking into account the highest estimate of new blood donors there would be an increase to the current blood donor population of 1.69%. (R47, para 242) He noted that the figure could be significantly lower. He also referred to an estimation published recently in New Zealand that by decreasing the New Zealand deferral of MSM donors from 10 years to one year would result in an increase of the total eligible blood donor population by less than 1% (R47,para 245). In submissions this assessment was not challenged but it was submitted (T1029) that there would be an increase to the blood supply and that it was likely that there would be a core group of altruistically inclined donors from the MSM group who require minimal questioning, have low rates of infectious disease markers and come in regularly to donate.

315. The Tribunal concludes that estimating the increase in donors that would result from reform of the policy regarding the MSM group is fairly speculative. Dr Wylie describes modelling the likely number of additional eligible donors to be a complicated task and no doubt that is correct. It would seem that some further work could be done to refine the estimates provided by Dr Wylie. The Tribunal considers that an increase in the number of donors in the order of 1% is not negligible and would be a worthwhile outcome if reform was not going to compromise the safety of the blood supply. As noted a number of times, reform is only pressed by Mr Cain if the blood supply in Australia would remain as safe as it is currently. An increase to the blood supply of that kind would be an added benefit of reform but it is not to be weighed against any additional risk to the safety of the blood supply.

New England Journal of Medicine Article

316. Mr Cain raises an issue through Dr Halpern about an article published in the New England Journal of Medicine that there are higher risks facing the blood service than HIV transmission from the MSM group and further, it impacts potentially on the sufficiency of the blood supply. The article relates to a study of the outcome of patients attending the Cleveland Clinic, United States from 1998-2006 for cardiac surgery. The patients had received blood transfusions and in simplistic terms, the study considered the storage time of the units of blood and complications that were experienced by the patients. The study concluded that “in patients undergoing cardiac surgery, transfusion of red cells that had been stored for more that 2 weeks was associated with a significantly increased risk of postoperative complications as well as reduced short-term and long-term survival”. The implication of the article relates to the potential sufficiency of the blood supply if an agency is not able to use blood more than 15 days old.

317. Dr Halpern (Second Statement C5A, para 4) opines that this article is indicative of the risk posed by old blood in transfused patients and that it may be appropriate to discard half of the used blood, dramatically curtailing the blood supply. Under cross-examination, Dr Halpern maintained that the article was beyond criticism. Professor Holland and Dr Halpern were in dispute in relation to the maths of the study. Professor Holland said after indicating that he read the article he believed there were several flaws and stated:

“The Article evaluated postoperative complications for 2,972 patients who received 8,802 units of blood that had been stored for 14 days or less (newer blood) and 3,130 patients who received 10,782 units of blood that had been stored for 14 days (older blood). This was an observational cohort study of records on cardiac surgery patients at the Cleveland Clinic in the USA between June 30, 1998 and January 30, 2008. The study did not directly assess the patients.” (Statement R48B, para 5(b)).

318. Professor Holland went on to say that:

“7. At best, the Koch et al, study provides impetus for properly designed studies on clinical effects of transfusing newer blood versus older blood but not a change in transfusion practice today.

8. At its May 30, 2008 meeting, the United States Advisory Committee on Blood Safety and Availability recommended no change in the use of older red-blood cells to the US Secretary for Health and Human Services.” (R48b, paras 7 and 8).

319. Professor Holland gave evidence that he believed that the article contained some interesting data but that it had been misrepresented and the groups, the subject of the study, were not comparable. Professor Holland did not accept the assertion by Mr Tree that the article identified an increased risk of mortality of one and a half per cent in the use of blood greater than 15 days old. Professor Holland said that the study was flawed and there were other explanations (see T373).

320. The Red Cross through Dr Wylie tendered a table, (R47B) which sets out the national average of the age of blood in Australia and for each State and Territory the average age of blood when it is transferred to the respective hospitals. The Table indicates that the average age for all blood types when it is transferred to the hospitals is less than 15 days. However the Table does indicate that some blood groups are sent to the hospital over 15 days old. This Table seems to be consistent with evidence from Mr Bowtell that that there are times when the blood supply is low in relation to some blood groups (see T462). The Tribunal accepts, however, that in Australia the turnover of blood is quite rapid. As previously discussed, Australia currently enjoys a self sufficient blood supply.

321. Dr Leiss also criticised the article. In summary, Dr Leiss commented (Statement R49A) on the fact that the article discusses other options other than the need to increase the blood supply from blood donations. He is of the view that Dr Halpern’s views that the Article and the implications for the blood supply suggest that the risks of allowing the MSM group to donate are outweighed by the risks of barring donation from the group are unsupported.

322. It was submitted for Mr Cain that the Red Cross’ approach in this case was one of denying that stale blood was a real risk to the blood supply rather than showing a willingness to investigate this issue in an open-minded and scientific manner. It was submitted that this reinforces the point that the Red Cross are focused on an illusory risk posed by safe homosexual activity at the expense of considering potentially much more serious risks posed by other population cohorts and by related blood banking procedures.

333. The validity of the article is not an issue that the Tribunal needs to resolve for the purposes of this Inquiry. It seems to the Tribunal that the article raises an issue that from the Red Cross’ perspective may represent an early warning sign and may be worthy of a watching brief.

The Harm Arising from the Current Deferral Policy and Benefits of Change

334. One of the benefits of reform is an increase in the supply of blood due to an increase in the number of donors discussed above in some detail. There are other benefits of changing the current deferral policy and removing a policy that draws distinctions on the basis of membership of the MSM group and provides for a more inclusive policy. The benefits of reform and the harm resulting from the current policy have been discussed fully in the evidence of witnesses for Mr Cain. Associate Professor Mitchell, Dr Halpern, Dr Cannold and Mr Bowtell have examined this matter in some detail.

335. The current deferral policy prevents individuals in the MSM group from satisfying altruistic desires to help others in the community. Dr Halpern spoke of altruistic motives as common and deeply held desires among humans (Statement C5 p2). Dr Cannold examined the notion of altruism as a fundamental human motivation; she described this as part of the repertoire of human social behaviour which implies that individuals denied the opportunity to act in this way may experience harm undermining their sense of worth and self esteem and this may damage their understanding of themselves and the view others have of them as contributing members of the community. According to Dr Cannold, the harm may be particularly significant for individuals who are members of stigmatised social groups like the MSM group (Statement C6). Dr Cannold argues that this harm associated with routine deferment of stigmatised groups means that it should, all things being equal, be avoided.

336. Associate Professor Mitchell noted the substantial deleterious effects of homophobia and marginalisation on health and well-being and provided details of the harmful effects on individuals in the gay community. She went on to provide evidence that an official policy from an authority such as the Red Cross impacts on attitudes to homosexuals. It reiterates messages about the unacceptability of homosexuality and reinforces public understandings that gay people are “lesser and less responsible beings who can be legitimately rejected from social participation.” (Statement C4 p3) According to Dr Halpern, if government or public officials practice discrimination, this has an effect on the individual resulting in stigmatisation or ostracism and may even have a negative effect on society generally (C4, p4).

337. Associate Professor Mitchell drew a comparison with other categories of donors who are rejected on the basis of what they have done e.g. lived in the U.K. However, an important difference is that deferral of the MSM group is that it is based on who they are rather than what they have done and can be likened to deferral on the grounds of being Jewish or indigenous. The Tribunal accepts that Associate Professor Mitchell has drawn a valid distinction and that sexual activity of male-to-male sex is an aspect of sexual orientation - homosexuality, and that sexual orientation is integral to identity. Deferral on this basis has a wounding quality that does not accompany exclusion on the basis of what someone has done, for example, where they have lived or worked.

338. Associate Professor Mitchell also referred to some other harmful consequences resulting from the present deferral policy as sending the message that men having sex with men is a dangerous activity which no amount of effort can make safe and that this undermines the safe sex message and this consequence is detrimental to public health (C4, p2). Another harmful effect is that the current policy sends a message of disapproval causing the MSM group difficulty in reporting this stigmatised behaviour during the screening process (C4, p4).

339. Dr Leiss’ evidence questioned the degree of stigmatisation caused by the current deferral policy noting blood donation is a private confidential act (R49, para 49-53). The Tribunal notes that point, but observes that the criteria for donor deferral are publicly known resulting in the community having knowledge of the ineligibility of the MSM group. While the publication of information about the rationale for exclusion may assist in addressing stigmatisation, the policy may nonetheless endorse negative and stereotypical assumptions.

340. The Tribunal accepts that there is some harm that flows to the MSM group as a consequence of the current deferral policy as described by the witnesses. This is a harm that can be described as potentially affecting the individual who has been excluded and also, at a broader level, leading to some level of stigmatisation of homosexuals through reinforcement of negative stereotypes. That policies of donor deferral generate a form of social exclusion leading potentially to stigmatisation was acknowledged in the Final Report to the New Zealand Blood Service April 2008, p53. While it is difficult to quantify the extent to which it has this effect, it is a consideration that weighs in favour of reforming the current policy. It must be emphasised, however, that the Tribunal does not need to weigh this consideration against increasing the risk to the blood supply. There is no question of this consideration overriding the safety of the blood supply in Australia. Mr Cain has made very clear that there is no such issue for the Tribunal to decide (see Opening Address, T36). Mr Cain does not seek to imperil the blood supply and it his contention that the alternative proposal will result in no-greater-than-tolerated risk of disease infection through blood transfusion, (Closing Submissions, p22). Therefore, this is only a factor that will have influence in assessing reasonableness if, as Dr Cannold, says “all things are equal”.

International Situation

341. The international practice in many other countries, particularly western countries, is to exclude all donors that pose an increased risk to the blood supply, which includes the MSM group.

342. Dr Wylie (Statement R47, Table 9, p72) addresses the international situation regarding policies of blood donation with respect to the MSM group in 2004. In summary, other countries deferred this group for a range of periods as follows:

• All donors who have engaged in male-to-male sexual activity since 1977: United States, Canada and Switzerland.

• All donors who have ever engaged in male-to-male sexual activity; United Kingdom, including Scotland and Ireland, Denmark, Sweden, Hong Kong, The Netherlands, Finland and Singapore.

• All homosexual and bisexual men: Norway.

• All donors who have engaged in male-to-male sexual activity in the past 10 years; New Zealand.

• All donors who have engaged in male-to-male sexual activity in the past 5 years; South Africa.

• All donors who have engaged in male-to-male sexual activity in the last 12 months; Japan and Hungary.

343. Dr Wylie (Statement R47, Table 10, p73) sets out international deferrals for the MSM group as at February 2008. In summary the position in other countries is as follows:

• All donors deferred who have ever engaged in male-to-male sexual activity; Hong Kong, Singapore, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Sweden and the United Kingdom.

• All donors deferred who have engaged in male-to-male sexual activity since 1977; United States and Canada.

• All donors who have engaged in male-to-male sexual MSM activity in the last 12 months; Japan and Hungary.

• All donors who have engaged in male-to-male sexual activity in the last 6 months; South Africa.

344. The consistent reason internationally for western countries to defer donors who have engaged in male-to-male sex is to enhance the safety of their blood supply and that the prevalence and incidence of HIV is much higher in males who have male-to-male sex than it is in heterosexuals. The European Blood Alliance Working party on Blood Safety, 26 October 2005 at p2 states:

“The measure of excluding MSM is installed to enhance blood safety, primarily in light of prevention of HIV/AIDS transmission but secondarily for prevention of transmission of other infectious diseases.”

345. Canada, New Zealand, the United States and South Africa have considered the possibility of relaxing the deferral of donors who have engaged in male-to-male sex. Dr Wylie stated that there has been extensive research internationally reviewing deferral policies. Dr Wylie (Statement R47, paras 198-202) discusses the international reviews. He stated that the reviews demonstrate that there have been extensive inquiries into the issue of the MSM group being deferred. The reviews included literature reviews, seeking international expertise and considering alternate deferral options. He states that the conclusions of the reviews are “broadly similar”. At the following paragraphs he states:

“198. …The FDA and the Canadian Blood Service decided to maintain permanent deferral on all donors who had engaged in male-to-male sex since 1977. The authors of the NZBS Draft Report and Final Report recommended the deferral be maintained at 10 years (in the Draft Report) or reduced to 5 years (in the Final Report) for donors who have engaged in MSM. The authors of the Canadian report also recommended a 10 year deferral as an option for consideration.

199. It is also apparent that the Reviews enunciate a view held by the International blood banking community, which is that any decreases in the period of deferral applicable to donors engaging in MSM would increase risk within a very safe blood supply, which must be established by use of models…”

346. Mr Cain submits that it is inconsistent for the Red Cross to declare its blood service to be one of the safest in the world on the basis of their current 12 month deferral in light of other countries deciding that it is too risky to reduce their deferral policies to 12 months. Mr Cain submits that if blood banking agencies across the western world are wrong about risk associated with one year deferral, so too, they can be wrong about the risk associated with a deferral based on sexual activity rather than gender of the sexual partner.

347. The Tribunal acknowledges the irony pointed out in that submission. It seems to the Tribunal that the Red Cross must be conscious and alive to what is happening internationally with blood banking. The fact that many other countries continue to have longer deferral periods than Australia is relevant to Red Cross’ consideration of their own deferral policy and it is prudent for them to have regard to that international situation and the rationale and evidence supporting that approach.. The question arises as to what extent the Red Cross should be influenced by the policy approach taken by other countries. The weight to be attributed to this consideration in assessing the policy approach advanced by Mr Cain really depends on all the circumstances. It could be said that for Australia to depart from an international policy trend introducing a new policy approach would be a significant step. The Red Cross would need to exercise caution in taking such a step but if the epidemiology and other relevant considerations provide justification for that reform then Australia could lead the way as it has done in the past.

Italy and Spain

348. Mr Cain asserts that Italy and Spain allow some homosexually active men to donate blood if their sexual activity is considered safe. Professor Holland (First Statement at paragraphs 37-52) sets out his research in relation to this issue. The Red Cross in their written submission at p32 assert the following about Spain and Italy:

• “Italy and Spain do not have centralised or mandated collection systems.
• MSM may be deferred from being blood donors in Italy because of their behaviour (having sex with other men) and that Spain follows the European Union Directive 2004/33/CE that calls for the permanent exclusion of MSM donors.
• The residual risk of HIV transmission in Italy is 1.1 per million and in Spain is 2.48 per million. The residual risk of infection in Australia is 1 in 10 million.”

349. The Tribunal accepts the first and the third point. However, in relation to the second point, the evidence from Professor Holland was that it is Italy, rather than Spain that follows the European Union Directive (First Statement, R48, para 41). Professor Holland stated that he had spoken to Dr Maurizio Marconi who is the current head of the Policinico in Milan, which is one of the most prestigious blood centres in Italy. Noting that the Directive does not contain any express reference to the MSM group, Professor Holland went on to state:

“According to Dr Marconi, the Italian Ministry of health simply translated the Directive and the decision to accept or exclude MSM is made by the physicians assessing each donor. However, Dr Marconi informed me that at his centre the physicians have always followed the FDA rule of the United States that MSM, even once, leads to permanent deferral.” (para 41)

350. Accepting that Spain and Italy are allowing some homosexually active men to donate blood, there are many other countries that are deferring the MSM group for years or permanently. As noted above, the countries that have reviewed their policies in recent times have maintained their deferral of the MSM group.

351. Mr Cain accepts that Italy and Spain have higher rates of HIV infection through transfusion than Australia, which is attributable in part to larger populations of sub-Saharan Africans and that these rates may be increasing. As Dr Wylie points out (Statement R 47, para 292), the HIV epidemiology in Italy and Spain suggests that in both countries male-to-male sex is not the primary source for transmission of HIV/AIDS (see p85, Annexure 176). Mr Cain does not really argue with this information. What Mr Cain says is important is that with a deferral based on sexual activity there has not been an increase of HIV infection linked with the MSM group. Mr Cain relies on a paper by Velati et al, titled “The Risk of HIV Transmission by Transfusion in Italy Does Not Increase After the Abolition of Ban on Blood Donations From Homosexual Men” which is cited in Vox Sanguinis (2007). The paper concludes the following:

“Although the risk of transmission of infectious diseases (namely HBV, HCV, HIV and syphilis) by transfusion has become very low, the epidemiological surveillance shows that new residual cases of infectious diseases are still present in the examined blood donor population. A special attention is to pay to the increase of the number if HIV positive donors during the last 4 years. Sexual behaviours and in particular, heterosexual promiscuity is the major known reason of the new HIV infections among donors. Meanwhile HIV positive subjects with homosexual behaviours have not increased in a significant measure after the abolition of the ban from blood donation for men who have had sex with men.”

352. Professor Holland and Dr Wylie opined that the Velati article did not evaluate the risk of transfusion-transmission. The article is an abstract not yet published in a peer-reviewed journal and contrary to the title, there was a slight increase in HIV among the MSM group, not a decrease. Dr Wylie (Statement R47, para 297) makes the point that the residual risks of HIV transmission by transfusion in Spain and Italy are still significantly higher than in Australia. It is his view that donor selection criteria from Italy and Spain “should not be used as benchmarks in Australia, which has a much lower level of residual risk” (R47, para 298).

353. A clear picture in relation to the situation in Italy and Spain did not emerge through the evidence. Italy and Spain are not particularly compelling examples of countries successfully adopting deferral based on sexual activity. The Tribunal does not find the position in Italy and Spain persuasive when considered in light of their respective residual risks compared to Australia.

354. It was worthwhile for the Tribunal to be alerted to the position in Italy and Spain. It is the Tribunal’s view that from the perspective of the Red Cross, it is entirely reasonable for the Red Cross when reviewing its own policy, to give the approach taken in those countries minimal weight. The residual risks of HIV transmission through blood in these jurisdictions are significantly higher than in Australia and the information does not suggest the approach taken in those countries represents an advance in blood safety.

Efficacy of the Donor Questionnaire

355. Mr Cain asserts the donor questionnaire is vague and uses confusing language. The evidence given by the experts in this case reveals that there is ambiguity in the question about male-to-male sex.

356. Mr Bowtell stated that the term of male sex with a male is susceptible to confusion (see T464). This position was highlighted by some of the evidence given during the inquiry. Professor Holland said that in his experience donors generally understood the meaning of the phrase male sex with a male. However, he went on to say that the term male sex with a male and sexual activity included any activity that might involve the exchange of bodily secretions including kissing (see T345). By comparison, Professor Kaldor said that if he was asked to define, male-to-male sex, he would answer, anal intercourse (see T857). Dr Wylie was asked “was sexual activity sex or is sex, sexual activity, or are they mutually exclusive”, his reply in summary was that it takes some sorting out in the donor interview because people will define those terms differently (see T533).

357. The word ‘sex’ does include a number of possibilities and one person’s interpretation may differ from another person’s interpretation. Internationally, many other blood banks ask in their respective questionnaires if a man has had sex with another man or engaged in male-to-male sex (see Professor Holland R48, paras 28-33 and Dr Wylie R47, paras 189-202). The Council of Europe Guidelines (dealt with later in the decision, p150 and following) pose the question “have you ever had sex with another man”. Professor Holland made the point that the basis to judge the efficacy of the questionnaire is the record of the safety of the blood supply (see T417).

358. It was also noted by Mr Bowtell that given that the real risk to the blood supply was anal intercourse, he believed having a general question about male-to-male sex left wide open the possibility of differing interpretations, especially given Australia’s great number of ethnicities and cultural groups (see T470).

359. In light of the above considerations, the Tribunal is of the view that it seems that the current donor questionnaire may not be excluding all the donors that the Red Cross intends to exclude. While it would seem to be universally understood that the high risk activity of anal intercourse clearly qualifies as male-to-male sex and the questionnaire is working effectively to exclude that activity, it seems to the Tribunal that it may not be excluding all the potential donors that the Red Cross seeks to exclude under the term ‘male-to-male sex’. For example, the Red Cross’ intention is to exclude oral sex between men, and the evidence from the experts highlights uncertainty about whether the term male-to-male sex means oral sex. As noted in the discussion regarding Background to the Current Donor Questionnaire, there may not be an opportunity for the person administering the questionnaire to define or explain the terms if the potential donor answers no to the question, thinking they understand the term.

360. In the Tribunal’s view the activity that the Red Cross intends to be excluded should be clear and the terminology used capable of being accurately understood to be sure it excludes all the potential donors that the Red Cross intends should be excluded. It maybe that the Red Cross has balanced this consideration against asking probing or intimate questions. One possible modification to the donor questionnaire that occurs to the Tribunal is that the questionnaire incorporate a clear and explicit definition of male-to-male sex so there is no need for questioning and the donor could be saved the embarrassment of having to ask whether an activity such as mutual masturbation or oral sex amounts to male-to-male sex for the purposes of donating blood.

361. Mr Cain contends that the questionnaire should contain a set of questions that are capable of identifying low risk donors within the MSM group. In responding to this alternative approach, the Red Cross has raised practical problems associated with questions of this kind. Dr Wylie said that one of the things that the Red Cross has had to deal with is a constant calling for more detailed questions and the problem faced is that the questionnaire becomes longer and more detailed. That leads to a negative impact on the collection of blood because people walk out. The other point Dr Wylie raises is that people do not want to be asked numerous personal and intimate questions and it makes the whole administration of the questionnaire untenable (see T537).

362. The Tribunal accepts this as a valid concern. The longer and more complicated the questionnaire becomes the Red Cross may lose donors. Mr Bowtell gave some evidence about this issue. He went on to say that he believed Australians could cope with direct questions and that to obtain an honest answer you need to ask a direct question (see T457).

363. The Tribunal is of the view that a set of questions could be crafted to identify the low risk category of the MSM group. There would be a need to ensure that the questions were effective from a practical point of view. There was general agreement amongst the witnesses that alternative questions would have to be articulated, researched and tested using methods that did not impact on the safety of the blood supply. There have not been any questions formulated and indeed, there do not seem to be any studies or research on a set of questions that identify the sexual activity rather than the group.

364. It seems feasible that the questionnaire could be crafted to include relatively short and direct questions about protected anal intercourse with a monogamous partner without the need for lengthy interrogation in writing or orally.

365. A separate concern regarding a set of questions identifying low risk members of the MSM group is the reliability of answers given in response to questions about monogamy and protected sex. This is a matter that is dealt with below (under the heading Condoms) and it is sufficient to note here that this matter has implications for a donor deferral questionnaire implementing the approach urged by Mr Cain. The question about reliability is a valid concern that would require careful attention and no doubt, research ascertaining the reliability of answers given to such questions in a blood donation setting.

366. In making submissions, Counsel for the Red Cross and Mr Cain have given particular attention to oral sex and whether there is justification for excluding the MSM group when they engage in oral sex only (and not anal intercourse). As mentioned earlier, the justification for the inclusion of oral sex must lie beyond the epidemiology.

Oral Sex: non-epidemiological considerations

367. As previously noted, there is not an epidemiological basis on the grounds of risk of HIV transmission for deferring men having male-to-male oral sex. However, the Tribunal has also noted the risk of transmission of syphilis through male-to-male oral sex in its earlier consideration of STIs. The question to be determined is whether, in light of all the evidence and given the perspective of the Red Cross as a blood banker, it is reasonable to defer donors on the basis of having engaged in male-to-male oral sex. The Red Cross sought the advice of Professor Kaldor in 2001 as to whether this ought to remain as a ground of exclusion (letter dated 19 February 2001, Annexure 41, Dr Wylie R47), which had amongst other things sought clarification as to which sexual practices (such as oral sex) constitute appropriate deferral for male-to-male sex.

368. By letter dated 19 April 2001, Professor Kaldor had expressed his opinion in relation to the earlier request that “Based on currently available epidemiological evidence, there is no justification for excluding donors on the basis of oral sex or female to female sex”. This view was affirmed by Professor Kaldor when he attended a meeting with the Red Cross National Donor and Product Safety Committee in May 2001.

369. Whilst we know what the ultimate decision was, namely to retain an exclusion, we do not have the benefit of knowing what factors were relied on at the time in support of that decision, or, for that matter, why oral sex remains a basis for exclusion to this day. Dr Wylie confirmed in his evidence before the Tribunal that the policy with regard to oral sex remained unchanged. His explanation for this was that the precaution was continued to be taken and he commented that it has proven to be a very good decision (T519). When asked in cross examination whether he accepted that this question as to risk is properly one for an epidemiologist, Dr Wylie’s response was that “At the end of the day the final decision responsibility rests with the Red Cross. They were the organisation making the decision based on their own expertise, international precedent and advice as sought in this case from Professor Kaldor” (T521).

370. Professor Kaldor provided assistance to the Tribunal in examining the question of whether it was reasonable for the Red Cross to exclude donors on the basis of male-to-male oral sex. He gave evidence that the Red Cross must have regard to the UK Expert Advisory Group Statement despite other assessment of the risk as negligible. The Red Cross is expected to act in a pre-emptive way and such sources could be interpreted as warning signs that they should have heeded (T760). He described this as an overly conservative position that is justified in the context in which the Red Cross operates. Professor Kaldor also noted the biological plausibility for the potential transmission of HIV through male-to-male oral sex. Professor Kaldor also referred to considerations regarding the questionnaire itself relating to whether the questionnaire should probe issues regarding sex and whether there are any possible concerns surrounding donor’s comfort with acknowledging “what kind of sexual things they’ve done” (T889) and that the Red Cross may make a pragmatic decision with respect to this. This is particularly so when questions are only relevant to a small proportion of the population that is going to be in or out (T890). Elsewhere in his evidence, but not specifically with regard to oral sex, Professor Kaldor stated that “epidemiology doesn’t give you all the answers; it gives you a number of the answers but it then has to be put in the mix with several other considerations” (T743). Professor Kaldor had also stated that “protection of blood is a very conservative endeavour” and he had suggested the whole premise of how you set the risk parameters and how you put procedures in place for blood protection is done on the basis of extreme conservatism (T740).

371. It is noted that Associate Professor Mitchell’s perspective, focussing in large part on HIV/AIDS prevention education, as distinct from blood banking, is different. Even though she thought male-to-male oral sex represented a theoretical risk only, her evidence suggested she accepted the biological plausibility of transmission through this means, noting the advice given to gay men to be mindful of the integrity of their mouth if they are going to have oral sex, with a view to avoiding another male’s bodily fluids entering their blood stream (T67).

372. There is no evidence before the Tribunal as to what proportion of the MSM group this exclusion on the basis of male-to-male oral sex applies. Comments of a more anecdotal nature made in the course of evidence by Associate Professor Mitchell (T66-T67) and Professor Kaldor (T719) suggest that it would only relate to a small proportion. Some social research regarding the proportion of the MSM group affected by any modification to the questionnaire may be worthwhile. If it could be shown that there is a large number of homosexuals practising oral sex and not anal sex, so they would be eligible as donors if the questionnaire was modified, then this would be a consideration in favour of adopting a modified approach.

373. A relevant consideration in this context is that the question at issue concerned a possible relaxation of an existing policy. In light of the precautionary principle inherent in blood banking, and as noted in the earlier discussion of epidemiology, the safety of male-to-male oral sex is difficult to prove affirmatively. Noting, on the one hand, the lack of definitive proof from the epidemiology, and on the other hand, the biological plausibility for the potential of transmission via oral sex, the reports of oral sex giving rise to transmission of HIV, albeit dubious, but which could be early warning signs of risk, and the prevalence of HIV in the MSM group compared to other groups. It is not unreasonable for the Red Cross to adopt a very conservative stance and exclude the MSM group on the basis of oral sex. That is not to say that if oral sex was not a basis for deferral that that would be unreasonable: there can be more than one reasonable response to a situation. Further, the Tribunal notes that the risk of syphilis transmission through the blood supply, albeit of a lower order, may help to substantiate the Red Cross’ exclusion of homosexual men who have engaged only in oral sex within the last 12 months.

Condoms and Monogamy: residual issues

374. There has already been discussion with regard to the epidemiological evidence in relation to condom use in reducing the risk of HIV transmission in the context of male-to-male sex, as well as the relevance of the number of partners in assessing potential risk of contracting HIV, with monogamous relationships put forward as the safest form of relationship. Attention has also been given to social research relied on by the Red Cross and the difficulties associated with much of this data due to the unrepresentative nature of the studies involved. The following section examines whether there are any residual issues remaining with respect to condom use and/or monogamy that bear upon Mr Cain’s case which proposes a change to the deferral policy to allow donation from men in monogamous homosexual relationships who practice exclusively safe sex.

Condoms
375. A key component to Mr Cain’s alternative deferral policy is the consistent use of condoms for male-to-male anal sex. The evidence put before the Tribunal regarding unsafe sex practices by some within the MSM group are therefore not directly relevant. Attention has already been given to the efficacy of condom use, and the Tribunal has accepted the estimate of 80 effective as reasonable in light of the available evidence. Another consideration that was raised by Professor Kaldor in his evidence to the Tribunal relates to the relevance of context in which questions are asked and social expectations in regards to condom use. He expressed the view that in some contexts, questions about the use of condoms may be socially loaded in that there is a social desirability factor associated with the response (T724). The Tribunal takes note that context may impact on the reliability of answers when there are moral or health issues surrounding the event (e.g. unsafe sex or suggestions of infidelity). Professor Kaldor explained that researchers pay careful attention to the way in which interview questions are asked and ensuring that interviewees are made as comfortable as possible to facilitate truthful answers. He noted that a research context is more likely to elicit a truthful response, than, for example, a clinical context (T724). This could potentially be material to the context in which questions are asked in connection with blood donation which bears closer likeness to the clinical setting. Ultimately, however, nothing turns on this in view of the Tribunal’s findings in relation to the epidemiology.

Monogamy
376. There had been quite a deal of attention given by the Red Cross to the practices within the MSM group, with evidence of multiple partnering, the use of agreements to negotiate safe sex, but which in practice are often not kept, and the inherent unreliability of monogamous relationships. The Tribunal has commented earlier that this attempt to apply data about the practices of some clearly unrepresentative cohorts within the MSM group to all members of the group, as a means of undermining the reliability and commitment of all male-to-male relationships simply lacks validity. Professor Kaldor gave evidence that whilst a significant proportion of negotiated agreements are broken, the majority are kept (T779). On the issue of monogamy which is material to Mr Cain’s proposed change to the deferral policy, although the Red Cross’ case was that homosexual monogamous relationships are invariably less reliable due to the promiscuity of the MSM group, the Tribunal has no means of testing this proposition and in any event, finds it unnecessary to decide for the purposes of its decision in this case. The Tribunal notes that for the purposes of the assumptions underpinning the estimates of HIV incidence in Australian men provided by Professor Kaldor and his colleagues (Exhibit T6), the potential of some breach of a monogamous relationship is factored into the calculations. The Tribunal accepts this as reasonable, in that, as earlier noted and accepted by all of the witnesses, no purportedly monogamous relationship, whether homosexual or heterosexual, can be guaranteed by one of the parties to be exclusively monogamous.

Statutory Obligations
377. In seeking to demonstrate that the Red Cross has acted reasonably in maintaining the 12 month deferral, one of the considerations briefly referred to in the Closing Submissions for the Red Cross is that the Red Cross is complying with legal requirements in applying the 12 month MSM group deferral (p39). As noted in the Submissions this issue is dealt with by Counsel in the context of the statutory exception in s24 of the Act. Likewise, the Tribunal deals with the issue comprehensively in that context. It is appropriate to make a few brief remarks about legal requirements in relation to the issue unreasonableness. As will be seen, s24 has a narrow application and is restricted to requirements of a State or Commonwealth and it is conceivable that there may be a statutory regime giving rise to an obligation that does not qualify as a requirement under s24 of the Act. It is sufficient to note here that such an obligation, as well as requirements of a law for the purpose of s24, are relevant considerations in relation to the question of unreasonableness under s15.

378. It is also worth noting that observance of workplace safety requirements and industrial relations issues are not relevant to the question of unreasonableness in this case because there is no question of any added risk to the blood supply or, as a consequence, any added risk to employees. Mr Cain has made it clear that he is not advocating change to the deferral policy if there is any added risk to the blood supply.

Conclusion in Relation to Unreasonableness

379. The Tribunal has reached conclusions, set out above, regarding the circumstances relevant to whether the deferral policy is unreasonable and also analysed and identified the ethical principles binding the Red Cross. In this part of the decision the Tribunal draws together those conclusions and now applies the ethical considerations to those circumstances bearing in mind the Red Cross’ role and perspective. As will be seen, the framework for this analysis remains the legal principles, set out at the commencement of the discussion, regarding unreasonableness.

380. In assessing the current donor deferral policy and whether it is unreasonable, the key issue is the risk to the blood supply posed by HIV transmission in the window period. The Tribunal considers that the current deferral policy regarding the MSM group is effective as one of the measures protecting the blood supply (in Australia the risk of HIV infection by blood transmission is less that 1 in 10 million). The deferral policy does this with a broad brush excluding the entire MSM group. This is justified by the Red Cross on the basis that the relative risk posed by the MSM group as a whole compared with the heterosexual group as a whole is substantial in the order of 100 fold. Yet, as the Tribunal has heard, the risk associated with the MSM group is due to the higher risk sexual activity of a cohort within the group. There are some negative consequences that flow from this broad brush approach for the MSM group, sending a message that the blood of the entire group is not safe and preventing individuals who pose a low risk from donating blood.

381. From the perspective of someone in Mr Cain’s position this policy seems unfair. There are members of the MSM group, adopting safe sex practices and in a monogamous relationship who would have confidence that their blood is safe. In fact, the epidemiological evidence establishes that the blood of the majority of homosexuals do not pose a risk to the blood supply. Indeed, focussing on the risk posed by particular individuals rather than groups, there are some individuals who are homosexual whose blood would pose less of a risk than the blood of some heterosexuals who are permitted to donate. However, as has been emphasised, the donor deferral policy must, as a matter of practicality, work on the basis of addressing broad categories of the population and excluding or deferring categories of donors when, as a group, there is an elevated risk to the blood supply rather than isolating individuals whose blood is safe.

382. Noting the Tribunal’s conclusion that the current deferral policy is effective in ensuring the safety of Australia’s blood supply, the question is whether there is an alternative approach that is just as effective in achieving that outcome and that avoids the negative effects of the current policy. The alternative proposed by Mr Cain is that the deferral policy should permit members of the MSM group who are in monogamous relationships and who have protected sex to donate. The question is whether, if this approach was adopted, the blood supply would be as safe or even, as claimed by Mr Cain, it would result in improved safety.

383. One of the benefits of Mr Cain’s approach is that the stocks of blood in Australia would be increased to some extent. That is not a key consideration for the Red Cross at this time in Australia. There is a question of whether it would make a material difference and anyway, the blood supply in Australia is generally speaking, adequate to meet demand. The question of whether the supply will be just as safe if Mr Cain’s approach is adopted is an overriding consideration and it is accepted by Mr Cain that if the supply will not be as safe then this would be a consideration determining the outcome of the case in favour of the Red Cross.

384. As set out in detail, in examining this question of whether there will be an increased risk to the blood supply if the policy is reformed, data has been gathered, social research analysed and a mathematical model, Exhibit T6, prepared for the Tribunal. The model addresses issues that have been raised in the case and appropriately accommodates key concerns raised by the Red Cross regarding the risk of the relationship not being monogamous and the risk of condom failure. That model shows that the low risk MSM group poses a relative risk of HIV transmission that is still higher than high risk heterosexual male donors, approaching twice the relative risk of that group of heterosexual men. The comparison with the group of heterosexual men in general is that the MSM group has approximately six times the relative risk (the low risk MSM sub-group has a relative risk of 34.99 to 1 compared with 5.75 for the general group of heterosexual men). However, it can be seen that the risk posed by this lower risk cohort of the MSM group is vastly different to the risk posed by the MSM group as a whole (assuming a 5% prevalence of HIV in the MSM group then the relative risk is 348.25 to 1 for the MSM group in general compared with 34.99 to 1 for MSM in monogamous partnership where condom use is 100%). It is interesting to note that the relative risk of members of MSM group in a monogamous relationship with only 5% condom use is significantly higher than if 100% condom use (105.49 if 5% prevalence compared with 34.99). Of course, the relative risk and the estimated HIV incidence per year increases substantially if the prevalence of HIV in the MSM population is actually 10% and not 5%.

385. The model is based on some assumptions. A critical question is the prevalence of HIV in the MSM group. There is scientific uncertainty in relation to some aspects of this issue. One of the uncertainties concerns the number of individuals belonging to the MSM group in Australia. The Tribunal has concluded that the data relied on to determine this figure is based on the best information available for the task of estimating risk to the blood supply. While accurate knowledge on this question is not possible, any other approach would be based on speculation. If the Red Cross was wrong and disregarded the known information - the reliable data, they would be making decisions affecting the lives of recipients based on an underestimate of the risk.

386. Another assumption is the prevalence of HIV in the MSM group. There is scientific uncertainty surrounding this question. The Tribunal concludes that the assumption is based on valid data. Another approach (whole-of-population method) relying on other data produces a different answer. That approach is also valid. The question may be posed how does the Red Cross as blood banker approach that situation. In light of the key importance of this issue and implications for public health, the ethical principles that guide the Red Cross require it to take the ‘precautionary approach’, to take the pessimistic view to assume that what can go wrong will go wrong. In determining whether to maintain the current policy, the Red Cross cannot ignore reliable data and an accepted methodology that indicates that there will be an increase in risk. The Red Cross has no choice in adopting this approach. It is ethically bound to do so as trustees of the blood supply.

387. In a sense, when given a range of risk, when either end of the range may be correct as an estimate of risk, the relevant information from the Red Cross’ perspective is the worst case scenario. This is the information that must dictate their response to a public health concern. The other side of the coin is that Mr Cain has demonstrated that the best case scenario could be correct, in which case the group to which he belongs, being those in a monogamous relationship and having protected sex, may, according to some current, valid data present a relative risk that is lower than that shown in the model, Exhibit T6. This observation amounts to a valid critique of the current system for the reasons explained but it is not an appropriate basis for amendment of the deferral policy.

388. It is noted that even if the whole-of-population data was shown to be correct, an adjustment to the model to reflect that would not be enough, on its own, to substantiate Mr Cain’s contention that the relative risk associated with the lower risk sub-group of the MSM group would be brought below that of other tolerated risks such as high risk heterosexuals. That contention was based on Tasmanian data regarding prevalence rejected by the Tribunal as inappropriate and also information regarding the proportion of the MSM group in the Australian population that is of dubious relevance to the Red Cross.

389. The Tribunal has not overlooked that the mathematical model, Exhibit T6, showing the risk of the low-risk cohort of the MSM group compared with other groups is a model concerning relative risk not absolute risk. Assuming the model is correct, the attributable or absolute risk resulting from change to the policy to include this low-risk cohort would represent a very small increase in risk to the blood supply. As Professor Kaldor stated in his evidence, (T750-751,T819-820) it is such a small increase that it is difficult to measure and it could be many years before the change to the policy resulted in an infection that would not otherwise have occurred. However, the Red Cross is bound to act to reduce the risk to a level as low as possible and it is not suggested by Mr Cain that it should do otherwise. Mr Cain’s case proceeds on the basis that change should only occur if there is to be no increase in risk to the blood supply.

390. Noting the Tribunal’s findings and observations, it is concluded by the Tribunal that there is reliable evidence that a change to the deferral policy, as advocated by Mr Cain, would result in an increase in the risk of HIV transmission in the window period. The issue of risk to the blood supply is of fundamental importance, indeed, evidence on this point is determinative of the issue of unreasonableness given the Red Cross’ ethical obligations.

391. The Tribunal has not overlooked the ethical principle of equity and fairness binding the Red Cross in its dealings with potential donors. However, this principle cannot override the safety of the blood supply. The safety and integrity of the blood supply is the paramount consideration for the Red Cross. This principle of equity should guide policy but cannot dictate change when it will result in an increase in risk. However, the Tribunal can envisage future circumstances where, if there was reliable epidemiology establishing no increase in risk resulting from change to the deferral policy, the principle of equity may be determinative and require the Red Cross to alter the deferral policy.

392. Some unrelated objections to the change proposed to the deferral policy have been rejected by the Tribunal. These include concerns about posing questions about monogamous relationships and protected sex practices and reliability of answers given to such questions. The Tribunal considers that there would be research and studies that would assist in assessing these concerns. Concerns that the questionnaire will be too long and too probing about private matters are not insurmountable obstacles if the change to the policy was justified.

393. Mr Cain has asserted that the exclusion of the MSM group who have had oral sex (and not anal intercourse) is discriminatory. This is an instance where the risk posed by this activity falls below that tolerated by the present donor deferral policy. However, the Tribunal has concluded that the policy is reasonable taking into account a range of considerations and that these are valid considerations given the perspective of the Red Cross as a blood banker.

394. There was evidence regarding sexually transmitted diseases. This evidence was inconclusive in a number of respects and has not had a bearing on determining the issues in this case. Having concluded that the Red Cross’ policy is reasonable based on all the considerations, it may be noted that the policy provides a protection to the blood supply in relation to other blood borne diseases that could enter the blood supply via the MSM group.

395. According to the current information, a case cannot be made out to show that the approach taken in Italy and Spain represents to the Red Cross as a blood banker operating in Australia, best practice. The residual risk of HIV transmission via blood transfusion is higher in those countries than in Australia and an increase in risk to the blood supply has occurred since the change and may be attributable to the change to the deferral policy

396. The deferral policy is appropriate and adapted to meet the risk of a donor who is HIV positive donating blood in the window period. The alternative policy advanced by Mr Cain, accommodating his interests, is not appropriate and should not be pursued by the Red Cross because of the increased risk to the blood supply. Given the ethical considerations binding the Red Cross the alternative is not a viable option in the circumstances that exist at the present time. The discriminatory effect of the policy is noted but outweighed by the increased risk to recipients that would result if the alternative was adopted. In light of the findings with regard to the circumstances, the Tribunal is in fact positively persuaded that the imposition of the deferral policy is reasonable in all the circumstances. Therefore, in light of this conclusion, Mr Cain has not established to the requisite standard that the condition imposed upon him that he was not eligible to donate blood if he had engaged in male-to-male sex in the last 12 months was unreasonable in all the circumstances.

397. Noting that Mr Cain has not established that the deferral policy imposed upon was unreasonable in the circumstances, Mr Cain’s case of indirect discrimination must fail. So that the significance of this conclusion is apparent to the parties, the Tribunal provides a brief consideration of the remaining elements of indirect discrimination.

Whether the Policy had the Effect of Disadvantaging Mr Cain

398. In the context of direct discrimination (para 403 and following) the Tribunal considers the question of whether Mr Cain suffered a detriment. It will be seen that the Tribunal considered the meaning of detriment and concluded that it amounts to a disadvantage that is real, a matter of substance and not trivial. The Tribunal goes on to conclude that Mr Cain suffered such a disadvantage. It follows from this conclusion that the Tribunal also considers that Mr Cain was disadvantaged by the policy for the purpose of s15.

Whether Mr Cain was Disadvantaged as a Member of a Group sharing an Attribute more than a Person who is not a Member of that Group

399. It is Mr Cain’s case that he has been disadvantaged as a member of a group who share the attribute of sexual orientation (homosexuality) or lawful sexual activity (male-to-male sex). Further, the disadvantage suffered by Mr Cain is more than the disadvantage experienced by people who do not share these prescribed attributes. It is submitted for the Red Cross that it is apparent that other categories of potential donors are deferred and are treated in exactly the same way as Mr Cain was treated. For example, sex workers, persons who inject or have injected drugs in the past or persons with HIV/AIDS are deferred as well (Submissions p14).

400. It seems to the Tribunal that Mr Cain is a member of a group of people who share a prescribed attribute (sexual orientation or lawful sexual activity). While it might be argued for the Red Cross that not all members of the group of homosexuals will be disadvantaged by the requirement or condition because they were not sexually active in the previous 12 months, that point does not undermine Mr Cain’s case. Section 15(1) does not require that all members of the group will suffer disadvantage.

401. It also seems to the Tribunal that Mr Cain and other members of his group are disadvantaged by the requirement more than a person who is not a member of the group. Section 15 does not require that all non members of the group must not experience disadvantage. The word ‘more’ qualifies disadvantage in s15 and so what is required is that a member of a group must be disadvantaged more than a non-member – not more than all non-members (for further discussion as to the meaning of s15 see Buchanan v Lindisfarne R&SLA Sub-Branch and Citizen’s Club and The Returned and Services League of Australia Limited 2003 TASADT 13 at para 105 and Lindisfarne R&SLA Sub-Branch and Citizen’s Club Inc & Anor v Buchanan (2004) TASSC 73 at para 11.)

402. As previously noted in the Tribunal’s conclusion that the imposition of the policy is not unreasonable, Mr Cains’ case of indirect discrimination cannot succeed. Having reached this conclusion that the Red Cross’ policy does not amount to indirect discrimination, the Tribunal now turns to consider the alternative claim that Mr Cain has been subjected to direct discrimination under the Act.

DIRECT DISCRIMINATION

403. Direct discrimination is defined in s14 of the Act which provides:

“Direct discrimination

(1) Discrimination to which this Act applies is direct or indirect discrimination on the grounds of any prescribed attribute.

(2) Direct discrimination takes place if a person treats another person on the basis of any prescribed attribute, imputed prescribed attribute or a characteristic imputed to that attribute less favourably than a person without that attribute or characteristic.

(3) For direct discrimination to take place, it is not necessary -

(a) that the prescribed attribute be the sole or dominant ground for the unfavourable treatment; or

(b) that the person who discriminates regards the treatment as unfavourable; or

(c) that the person who discriminates has any particular motive in discriminating.”

404. This section sets out the elements of direct discrimination and refers to a requirement that a complainant is treated ‘less favourably than a person without that attribute or characteristic’. As will be seen from the discussion of the cases that follows, this phrase involves two issues. The first issue is straightforward and involves the question of whether the treatment accorded to a complainant was equal treatment compared to others generally. The second issue involves a comparison with the way a complainant was treated compared with how another person, without that attribute or characteristic, would have been treated in the circumstances. As the cases establish, the second issue involves identification of a comparator and the surrounding circumstances.

405. The terms of s14 and the cases, as mentioned, give rise to the following issues that need to be determined in order to decide whether conduct amounts to direct discrimination:

1. Whether the reason for the treatment is on the basis of the prescribed attributes of lawful sexual activity or sexual orientation or a characteristic imputed to that attribute.

2. Whether the treatment of the complainant was less favourable or equal treatment.

3. The identification of the comparator - the person without that attribute or characteristic.

4. Whether the complainant suffered a detriment.

Whether the Reason for the Treatment is on the Basis of the Prescribed Attributes of Lawful Sexual Activity or Sexual Orientation or a Characteristic Imputed to Attribute

406. The submission made on Mr Cain’s behalf is that this is a case of discrimination on the basis of attributes of lawful sexual activity and sexual orientation.

407. The submission for Mr Cain is that the sole reason why Mr Cain’s attempted donation was refused was because of prescribed attributes of lawful sexual activity and sexual orientation. Further, it is submitted that there can be no doubt that the sole reason for refusal was because he acknowledged that he had sex with another man in the last 12 months (Closing Submissions for Mr Cain, para 3.3).

408. It is the Red Cross’ submission that the reason for declining Mr Cain’s offer to donate was not because of his sexual orientation or because he had engaged in lawful sexual activity (Closing Submissions for the Red Cross, paras 23 and 24). The refusal occurred in consequence of the application of the Red Cross Guidelines which defer donors who have engaged in male-to-male sex within the last 12 months before donation. The reason for deferring the MSM group is the statistically higher risk of being infected with certain blood borne diseases than potential donors who do not engage in male-to-male sex (para 24). Mr Cain was deferred because of his medical status as a member of a high risk group and not because he was homosexual or engaging in lawful sexual activity.

409. This submission is refuted by Mr Tree, Counsel for Mr Cain, on the basis that in reality, such a reason amounts to discrimination. The overwhelming majority of the MSM group do not have and will never contract HIV/AIDS or other STIs. It was submitted for Mr Cain that the reason advanced for the Red Cross’ deferral of Mr Cain being the high risk of infection is a fundamental aspect of the prescribed attribute. In other words, the reason for deferring Mr Cain is an unjustified stereotype imputed to all members of the MSM group. To treat Mr Cain as ‘high risk’ is to proceed on a factually baseless stereotype imputed to a prescribed attribute and accordingly, discrimination has still occurred. As such, the deferral was on the basis of his prescribed attributes.

410. The first step for the Tribunal to take is to ascertain the ‘true reason’ or the ‘genuine reason’ for the alleged discriminator’s act and to answer the question “why was the aggrieved person treated as he or she was?”: Kapoor v Monash University and Anor (2001) 4 VR 483 at 494, see also, Purvis v New South Wales (2003) 217 CLR 92 per Gleeson CJ at 102, McHugh and Kirby JJ at 142, and Gummow, Hayne and Heydon JJ at 163. The true basis for a respondent’s conduct is a different enquiry to a person’s motive or purpose or the effect of a person’s conduct (see section 14(3)). Motive, purpose and effect may have a bearing on the question of the true reason and in certain cases they may even be determinative of the question (see Human Rights and Equal Opportunity Commission v Mt Isa Mines Ltd (1993) 46 FCR 301 per Lockhart J at 321-326) but they are not substitutes: Gummow, Hayne and Heydon JJ in Purvis at 163.

411. At a superficial level, a focus on the reason for refusing a donation from Mr Cain leads to the answer because he answered yes to a question on the donor questionnaire. However, a further examination of the reason for the conduct is needed. In the case of a policy decision affecting a large number of people the identification of the ground involves a focus on the reason behind the policy (see Waterhouse v Bell (1991) 25 NSWLR 99 per Clarke JA at pp107-8). The Red Cross applied the donor questionnaire to Mr Cain as it would to all other donors as a uniform policy and therefore, in this case, the Tribunal should address the actuating reason behind the question on the donor questionnaire that resulted in refusal. The Tribunal must consider why did the Red Cross exclude all people who answered yes to the question of whether they had had male-to-male sex in the last 12 months?.

412. The true reason for excluding people answering ‘yes’ to that question is not because they are male homosexuals or because they had sex with a male in the last 12 months as an isolated fact. At the heart of the reason is the fact that the potential donors belong to a group, namely the MSM group and, of critical importance, that this group carries a higher risk of blood borne diseases than other groups. The Tribunal also accepts that the driving motivation of the Red Cross in excluding the MSM group is in order to protect the safety of the blood supply and blood products.

413. The evidence before the Tribunal, particularly the epidemiology, establishes that the MSM group carry a higher risk of HIV disease than other groups. The weight of the evidence also clearly establishes that the individuals within the group do not all carry an equal risk of HIV. There is no doubt that the sexual practices and risk taking behaviours of a percentage of that group cause an elevated risk attaching to the MSM group. There is no dispute about that and in fact, the central issue being probed by Mr Cain’s case is whether the lower risk component of the group can be disaggregated from the higher risk members of the group.

414. It was submitted by Mr Ruskin on behalf of the Red Cross that the real reason for the Red Cross’ conduct in rejecting Mr Cain’s donation was due to his presentation as a member of a high risk group. The submissions on behalf of Mr Cain referred to this submission as the reason of medical status as a ‘high risk’ donor and that the reason involves a factually baseless stereotype that all members of the MSM group are ‘high risk’ (Closing Submissions in Reply for Mr Cain, para 4.5).

415. The Tribunal regards Mr Cain’s submission as a subtle recasting of the Red Cross’ submissions. In the context of the reason for deferral, Counsel for the Red Cross did not refer to Mr Cain as a high risk donor but rather, as a member of a high risk group which is a different proposition.

416. In determining the reason behind the current donor deferral policy relating to the MSM group the Tribunal takes into account the uncontroversial evidence relating to the historical background to the development of the policy in Australia and the way the donor deferral policy works to defer broad categories of potential donors that carry a high risk rather than the selection of low risk individuals.

417. The Tribunal accepts the analysis on behalf of the Red Cross for its reasons for rejecting Mr Cain as a donor. It was due to his presentation as a member of a high risk group. The Tribunal considers that the Red Cross did not refuse Mr Cain’s offer to donate because he, as an individual, was high risk, per se, but rather because he belonged to a group in society which pose a higher risk of blood borne diseases than other groups.

418. An identical approach is taken by the Red Cross in relation to other individuals such as intravenous drug users. The fact that the Red Cross deferred other groups who pose a high risk of blood borne diseases underscores that the true reason for the conduct was membership of a high risk group not the attribute of homosexuality as an isolated fact.

419. The Tribunal concludes that in refusing Mr Cain as a blood donor, the Red Cross did not operate on the basis of a factually baseless stereotype imputed to all homosexuals that all individuals are high risk donors so that the deferral could be regarded as on the basis of the prescribed attribute of sexual orientation or sexual activity.

420. It is noted, as an aside, that the conclusion of the Tribunal is similar to the approach taken in Ferguson v Central Sydney Area Health Service and Anor (1990) EOC 92-297 involving a complaint of discrimination on the ground of homosexuality when a patient’s surgery was deferred because it was discovered he belonged to a high risk HIV infectious category. It was held that the causally operative factor in the decision to postpone was not the complainant’s homosexuality but his medical status: pp77-807. The case of Ferguson does not assist the Tribunal here because the identification of the reason for conduct turned completely on the facts of that case.

421. Arguably, there remains a question of whether the Red Cross has carried out ‘characteristic’ based discrimination. Section 14 is breached if the true reason for a person’s conduct is a characteristic imputed to an attribute of lawful sexual activity or sexual orientation. The question may be posed whether belonging to a high risk group is a characteristic of homosexuality or male homosexual practices?

422. There were no submissions about this question, no doubt, because it was Mr Cain’s case that he was discriminated against on the basis of the attribute namely a stereotype attributed to homosexuals that they are high risk of HIV. As set out above, the Tribunal has rejected this characterisation of the reason for the Red Cross’ conduct.

423. The initial question that arises is the meaning of the word ‘characteristic’ in s14 and whether the Tribunal’s finding about the true or genuine reason for the Red Cross’ conduct, namely that Mr Cain belonged to a high risk group, could amount to a characteristic of homosexuality or male homosexual practices.

424. The Victorian Court of Appeal decision of Kapoor v Monash University (2001) 4 VR 483 considered characteristic based discrimination. In that case, the Victorian Civil and Administrative Tribunal had held that the Complainant, an Indian Hindu of the Brahmin caste, was not given a position because of her socially reserved disposition. The Tribunal held that being socially reserved was a characteristic of Indian Hindus of the Brahmin caste. The Victorian Court of Appeal held that it was essential that there was a link between the characteristic and race or religion of the individual. Obiter comments were made (p500) as to what constitutes a characteristic for the purpose of the legislation and it was stated that there is force in the argument that it needs to be a trait that is not found amongst a significant proportion of the population and must amount to a distinguishing trait. It was opined that being socially reserved was not so distinguished from like traits found in the community as to constitute a characteristic.

425. The Tribunal considers that those obiter comments should be seen as arising from the context of the facts under consideration where the trait did not have a clear link with the race of the individual and where there was no evidence that the Respondent even perceived the characteristic as pertaining to race or religion. It is noted that the terms of the legislation considered in that case are different and incorporate the phrase ‘generally imputed’ which may also have significance.

426. Further, it seems to the Tribunal that the whole point of extending the section to include characteristics is to prevent discrimination based on stereotyped characterisations: Boehringer Ingleheim Pty Ltd v Reddrop (1984) 2 NSWLR 13 at 18 and that often, these stereotyped characteristics are not distinguishing character or idiosyncratic personality traits. Examples of such characteristics may be that women who are mothers of young children are not as committed to their work as men or, to take a race related example, people of a certain race are lazy or dishonest.

427. Returning to the question of whether belonging to a group that is higher risk of blood borne diseases amounts to a ‘characteristic’ for the purposes of s14, assistance is gained from the ordinary meaning of ‘characteristic’. The Collins Dictionary includes two meanings: a “distinguishing attribute or trait” and also a “typical quality”. The Tribunal considers that to apply the ordinary meaning of characteristic promotes the purpose of the legislation. So, if laziness is erroneously imputed to people of a certain race as a typical characteristic of that race and that was the reason for failing to employ an individual of that race then that conduct would fall within s14.

428. Turning to the situation here, it does not seem conceptually correct that a ‘characteristic’ could be that of belonging to a group of higher risk of blood borne diseases than other groups in society and yet also difficult to articulate why that is so. The answer lies in the meaning of ‘characteristic’. Attaching to a group a higher risk of blood borne diseases is neither a distinguishing characteristic of homosexuality nor a typical quality of homosexuality. Assuming belonging to a high risk group could amount to an attribute, it is not a distinguishing attribute, other groups are also high risk such as intravenous drug users. On the other hand, it does not make sense to say that belonging to a group with a higher risk of blood borne diseases is a typical quality of homosexuality.

429. Noting the meaning of ‘characteristic’, there can be no justification for regarding the higher risk status of homosexuals as a group, as a ‘characteristic’ imputed to homosexuals or the MSM group.

430. The conclusion of the Tribunal in relation to the issue of the true reason for the Red Cross’ conduct is fatal to the application of s14 of the Act. However, given the attention given to this provision in submissions, it is appropriate to consider the other issues regarding s14.

Whether the Treatment of the Complainant was Less Favourable or Rather, Equal Treatment

431. In submissions for the Red Cross there was an argument touched upon that there was no differential treatment of Mr Cain because all applicants are required to complete the questionnaire relying on Lombardo’s case.

432. The Tribunal considers that the case of Lombardo is distinguishable because the complaint in that case related to the requirement to complete a further questionnaire. The complaint here is not about a requirement to complete a questionnaire. This complaint is that the unequal treatment is the refusal to accept the complainant as a donor.

433. It is acknowledged that everyone who answered the question as Mr Cain did would have been refused as Mr Cain was refused and so in that respect the Red Cross’ conduct was even handed. However, when the Red Cross refused to accept Mr Cain as a donor he was treated unequally compared to other people presenting as donors who were accepted. This is sufficient to amount to less favourable or unequal treatment.

434. However, as noted previously, there is a more specific question to be considered of whether Mr Cain was treated ‘less favourably’ with reference to a comparator – “a person without that attribute or characteristic”. This involves identification of the comparator in order to decide how that person would have been treated.

Comparator
435. Submissions for the Red Cross were made regarding the need to identify a comparator in order to ascertain whether the treatment is less favourable. Relying on the High Court case of Purvis v New South Wales (2003) 217 CLR 92 it was submitted that the circumstances of the comparator must be the same or similar or not materially different to that of the complainant. It was submitted that such a comparator is a donor who wishes to give blood but presents with a high risk of transmitting a blood borne disease to recipients of blood donations. It was submitted that Mr Cain was not treated less favourably than such a donor without the prescribed attributes of Mr Cain and in fact Mr Cain was treated in exactly the same way as a relevant comparator would have been treated.

436. The submissions for Mr Cain are that it is not appropriate to determine whether he was treated less favourably by comparing his treatment with another potential donor presenting with a ‘high risk’ characteristic and that the correct comparison should be a person without Mr Cain’s attributes (homosexuality and lawful sexual activity of male-to-male sex) but who was otherwise suitable to give blood.

437. The Tribunal notes at the outset that the Tasmanian Act is different to the equal opportunity provisions in Purvis which stipulated that the comparator must be in “circumstances that are the same or are not materially different”. This point of difference was considered by this Tribunal Lawler v The Mercury 2006 TASADT 07 and then later in Brinkley v Davies Bros Ltd 2008 TASADT 07 and it was considered by the Tribunal that the Tasmanian provision dealing with direct discrimination permitted a more general approach to the comparator. As stated in Brinkley v Davies Bros Ltd “The other person is simply a notional person similarly placed as the Complainant but without the attribute and in like circumstances enabling identification of whether the reason for the conduct was the attribute” (para 234).

438. The question may be posed, how would a person without that attribute have been treated – how would a notional person similarly placed as Mr Cain but without the attribute of homosexuality or the sexual activity of male-to-male sex have been treated? A further question arises as to whether the circumstance of belonging to a high risk group is attributed to the comparator.

439. In making the comparison, the purpose is to decide whether the person with an attribute received less favourable treatment than a person without that attribute. The issue of less favourable treatment is intertwined with the question of the reason for the conduct: Shamoon v Chief Constable of the Royal Ulster Constabulary (2003) 2 All ER 26 per Lord Nicholls of Birkenhead at para 8 made observations regarding the extent that the decision on the reason why issue will also provide the answer to the less favourable treatment issue: para 10. It is noted that these proceedings before the Tribunal are such a case in point. However, the Tribunal will consider this issue and set out its approach for the sake of completeness.

440. In order to assess the less favourable issue it is necessary to compare like with like. As determined in this case, the fact of belonging to a high risk group is not a characteristic of the attributes of homosexuality or sexual activity. Therefore it is permissible to take it into account (Purvis per Gleeson CJ p101, Gummow, Hayne and Heydon JJ at p161 and this is so even according to the minority judgment per McHugh and Kirby JJ pp133 -134) and there are sensible reasons for doing so in order to ascertain whether the treatment was ‘less favourable’ (see Shamoon at p4). That Mr Cain belonged to a high risk group is crucial to the Red Cross’ conduct and it would be artificial to ignore it when undertaking the comparison.

441. The Tribunal’s conclusion on this point is easily reached. It is plain that the Red Cross would have treated all individuals who belonged to a high risk group in a uniform manner and they would have been deferred. There was a policy of deferral in relation to other recognised high risk groups and it cannot be said that Mr Cain experienced less favourable treatment as required by the Act in order to substantiate direct discrimination.

Detriment

442. The phrase ‘less favourably’ has been treated as involving a detriment. All that is required is a differentiation of treatment resulting in detriment to the person affected: Haines v Leves (1987) 8 NSWLR 442 at 471. This concept has been considered in the context of victimisation which includes the notion of detriment.

443. The Tribunal accepts the submission for the Red Cross that whether a person has experienced a detriment is to be determined objectively and not subjectively: Bonella v Wollongong City Council (2001) NSWADT 194 at para 50. The notion of detriment does not involve a substantial disadvantage. In Bonella there was consideration given to the victimisation cases dealing with detriment in that context and it was noted that detriment has been held to involve a disadvantage that is real and not trivial and that it has its common meaning of “loss, damage or injury”: para 50 of Bonella.

444. In Borg v Commissioner, Dept of Corrective Services & Anor (2002) EOC 93-198 at 76,359 the Administrative Decisions Tribunal of New South Wales preferred a different approach and considered the meaning of the word detriment in the victimisation context required that the complainant has been placed under a disadvantage as to a matter of substance as distinct from a trivial matter (following Bogie v The University of Western Sydney (1990) EOC 92-313 at 78,147).

445. It is interesting to note that in Lombardo it was considered that the requirement of completing an additional questionnaire referred to as a Lifestyle questionnaire might be regarded as a detriment (para 38). This would arguably qualify as a real disadvantage but it is more difficult to regard it as loss, damage or injury.

446. The Tribunal proceeds on the basis that the notion of ‘detriment’ requires a disadvantage that must be real, a matter of substance and not be trivial.

447. The Tribunal considers that the deferral of Mr Cain amounts to a disadvantage to him that is not trivial. Drawing on the evidence referred to earlier in the context of indirect discrimination (see The Harm Arising from the Current Deferral Policy and Benefits of Change), Mr Cain lost an opportunity to perform a community service valued by our society. The value given to blood donation is promoted in the Donor Declaration form that states “Welcome to a special, select group of people who care”. Mr Cain was deprived of an opportunity to perform an altruistic act – an act that is recognised and valued by society. There is also a risk for homosexual donors that they may be stigmatised by society, reinforcing misconceptions that they, as individuals, are high risk carriers of HIV and other blood borne diseases and that their blood is unsafe and reinforcing negative discriminatory notions of homosexuals as posing a risk to the community.

448. It will be seen from the reasons and conclusion regarding detriment that the Tribunal has not needed to consider Mr Cain’s subjective feelings about being deferred. It is worth noting Mr Cain’s description of his feelings and reaction in the complaint lodged with the Anti-Discrimination Commissioner. While the complaint form was tendered for use on a limited basis and in particular, that it could not be used to enlarge the ambit of the proceedings beyond that defined by the evidence and submissions (T629-631), it is apparent that it would be appropriate to have regard to it in relation to obtaining an understanding of Mr Cain’s response to the incident in a broad sense given the uncontentious nature of this evidence. It is noted that Mr Cain described feeling hurt and that he resented the fact that he was not allowed to help people in need when he knew he did not have HIV/AIDS and when he knew that his blood was ‘healthy’ (C2, document, no. 1).

449. The critical issue in relation to direct discrimination is the real or genuine reason for the treatment and not the issue of detriment. So, while Mr Cain has established that he suffered a detriment, he has not shown the reason for the conduct was an attribute or a characteristic imputed to that attribute, and he has not shown that another person in the same circumstances would not have been treated in that way. In conclusion, the Mr Cain has failed to establish that he has been subjected to direct discrimination as defined in the Act.

STATUTORY EXCEPTIONS

450. A key question for the Tribunal to decide is whether there is any legislative impediment to the Red Cross accepting the donation of blood from men who belong to the MSM group. The Red Cross relied on two statutory exceptions in the event that Mr Cain was able to establish that the Red Cross had discriminated against Mr Cain within the meaning of the Act, in particular, the statutory exceptions contained in sections 24 and 25 of the Act. The majority of the submissions focussed on the statutory exception contained in s24, which in turn required consideration of a number of different Acts. The Red Cross’ initial “Points of Defence” had also relied on s47 of the Act dealing with infectious disease (permitting discrimination on the ground of disability where that involves an infectious disease and it is reasonable necessary to do so in order to protect public health), however, reference to s47 was removed from the Red Cross’ amended Points of Defence and no submissions were made in respect of this.

451. As the Red Cross is raising these statutory exceptions, it bears the onus of establishing them to the requisite standard of proof, on the balance of probabilities.

Section 24 Exception of ‘Statutory Authority’

452. Section 24 of the Act provides as follows:

“24. Actions required by law -

A person may discriminate against another person if it is reasonably necessary to comply with –

(a) any law of this State or the Commonwealth; or

(b) any order of a commission, court or tribunal.”

453. It was argued for the Red Cross that there are a number of distinct pieces of legislation which play a role in regulating the conduct of the Red Cross’ operations and which the Red Cross sought to rely on in order to invoke the application of s24 of the Act on the grounds that is was ‘reasonably necessary’ for the Red Cross to comply with this legislation. These comprised: 1) the Blood Transfusion (Limitation of Liability) Act 1986 (Tas); 2) the Commonwealth and State Therapeutic Goods legislation; and 3) the Workplace Health and Safety Act 1995 (Tas).

454. Each of these Acts will be considered in turn to examine whether they can found the basis of a statutory exception under s24. As a starting point, the Tribunal notes that whilst there is no dispute between the parties about the relevant legislative pathway in respect of the s24 exception, there is a dispute about the legal status of the various documents being relied upon including the status of the donor declaration form under the Blood Transfusion (Limitation of Liability) Act 1986 (Tas), and for the purposes of the Commonwealth therapeutic goods regime, the status of the Red Cross Guidelines and these are accordingly matters that the Tribunal needs to determine.

455. From the outset, it should be noted that in considering the application of s24 to this case, there is a difference in terminology between the Tasmanian Act and the relevant legislation in cases relied on in this matter, namely Waters v Public Transport Corporation (1991) 173 CLR 349 and in Norman v Australian Red Cross VCAT, unreported, 27 November 1998, that is, the additional reference to ‘reasonably’ necessary. As the Red Cross notes in its submission, this qualifying word was not present in the legislation under consideration in the Waters and Norman cases where the relevant legislation used the terminology ‘necessary’ to comply. The Red Cross argued that the word ‘reasonably’ should be given its ordinary meaning and is there for a purpose; the effect of its inclusion is to require a qualitative assessment of whether the alleged discriminator’s actions are reasonably necessary to comply with any law.

456. The Tribunal notes that in any event, the cases of Waters and Norman are of limited assistance on the interpretation of this limb: in Waters, it was unnecessary to consider the meaning of ‘necessary to comply’ as the court had found as a threshold issue that the statutory exception did not apply; in Norman, the case was decided on the basis of an alternative ground for exemption relating to conduct that is ‘authorised’ by legislation.

1. Blood Transfusion (Limitation of Liability) Act 1986 (Tas)
457. The stated object of the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) is to limit liability in respect of the transmission of Acquired Immune Deficiency Syndrome through the transfusion of blood and blood products. To this end, it stipulates the steps to be taken in relation to the donation of blood.

458. In particular, s4 of that Act sets out the steps to be taken by an authorised supplier of blood (which includes the Red Cross), including the requirement that the blood shall not be taken unless the donor has, not more than 12 hours previously, signed a declaration in an ‘approved form’. Under s3 of this Act, this is defined as approved by the Secretary of the Department by instrument in writing for the purposes of this Act.

459. The approved donor declaration form existing at the relevant time stated as follows:

“There are some people who must not give blood as it may transmit infection to those who receive it. To determine if your blood or blood products will be safe to be given to people in need, we would like you to answer some questions. These questions are a vital part of our efforts to eliminate diseases from the blood supplied.”

460. One of the specific questions included in the donor declaration form was as follows:

Within the last 12 months have you –

8. Had male-to-male sex?

461. A copy of the donor declaration form in use as at 2004 is Annexure 12 to Dr Wylie’s First Statement (R47).

462. This donor declaration form, which is used by the Red Cross in uniform terms throughout Australia, must be signed by the prospective donor and that declaration is witnessed by Red Cross staff. Further, s7 of the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) makes it an offence to knowingly make a false or misleading statement in a declaration signed for the purposes of s4, punishable upon conviction by a fine not exceeding 100 penalty units or imprisonment for a term not exceeding 2 years.

463. Section 5 of the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) specifies that no civil or criminal liability attaches to any person in respect of transmission to another person of the relevant virus or the disease known as Acquired Immune Deficiency Syndrome, or any other disease that is attributable to the relevant virus, by reason of the transfusion of certified blood or blood product. However, this immunity is lost if the Red Cross were to fail to follow any of the steps contained in s4, including the requirement that it only takes blood from donors who have completed the approved donor declaration form within 12 hours before donation.

Summary of Red Cross’ submissions
464. The essence of the submission on behalf of the Red Cross with respect to the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) was that the Red Cross was required to comply with the terms of s4 of the Act which regulate the manner in which the donation of blood is to be undertaken. In support of this argument, reliance was placed on the case of Norman v Australian Red Cross VCAT, unreported, 27 November 1998 where it had been held that the equivalent provision in the Victorian Health Act, had, by necessary implication, authorised the Red Cross to refuse to take blood from men who have had sex with men in the last five years. It was argued that this had led to the complaint being struck out as the Red Cross was entitled to rely on the equivalent of s24. Applying Norman to the present case, it was argued that the effect of s4(1) and s5 is that the Red Cross is entitled to refuse to take blood from men who have had sex with men in the last 12 months as the Act authorises this refusal by necessary implication.

Summary of Mr Cain’s submissions
465. The essence of Mr Cain’s argument is that s24 of the Act only applies where requirements of another Act (State or Commonwealth) are mandatory and specific. In support of this submission, Mr Cain principally relied on the High Court decision in Waters v Public Transport Corporation (1991) 173 CLR 349 asserting that the statutory authority exception should be read narrowly. Particular reliance was placed on the joint judgment of Mason CJ and Gaudron J where at 369-370 they stated:

“More importantly, the wide construction seems to us to be inconsistent with the general scheme of the Act. It is one thing to provide that the Act should give way to an express direction contained in an actual provision of another Act or in a statutory instrument. It is a quite different thing to provide, in effect, that the Act shall give way to any subordinate direction, no matter how informal, to which a provision of any other Act requires obedience. In that regard, it would seem inevitable that, if the wide construction is given to the words “necessary...in order to comply with a provision of...any other Act” for the purposes of s39(e)(ii), a correspondingly wide construction should be given to the words “necessary...in order to comply with a provision of...an instrument” for the purposes of s39(e)(iii). In a context where, prerogative aside, the Crown ordinarily acts through employees or agents exercising statutory powers, the result would be that the express provision in s5 that the Act binds the Crown would become almost illusory and the effect of the Act would be to confer an unfair advantage upon some Crown commercial instrumentalities, such as the Corporation, vis a vis, any private competitor lacking comparable immunity.

Indeed, if the Corporation’s argument be correct, it is difficult to see why the Director-General, an officer not directly responsible to the Victorian Parliament, could not validly give a direction to the Corporation and to the Roads Corporation requiring each of them to exercise its powers and discharge its duties without paying any regard at all to any of the provisions of the Act. Moreover, the undermining of the general scheme of the Act would not be confined to the case where a statutory provision authorizes the giving of directions to those in the service of the Crown. It would extend to any case where an Act or statutory instrument required that one person act in accordance with the directions of another.”

466. Reliance was also placed on the New South Wales Equal Opportunity Commission decision of Clinch v Commissioner of Police (1984) EOC 92-115 and the House of Lord’s decision in Hampson v Department of Education and Science [1991] 1 AC 171. Further to this interpretation, it was asserted for Mr Cain that there is no requirement under either State or Commonwealth legislation that the MSM group must not donate blood. In particular, with respect to the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) it was argued that this Act does not require the Red Cross to do anything; rather, it gives the Red Cross a benefit if it chooses to do so. It was submitted that this would never be a justification for discrimination and certainly is not the type of statutory compulsion which was referred to in Waters case. This reasoning was augmented with the argument that the Red Cross cannot rely on the content of the donor declaration form which it has itself proposed, as founding a statutory necessity simply because the form is approved by a State or Commonwealth government authority. Mr Cain argued that such an approval could not amount to a statutory necessity.

467. Mr Cain sought to distinguish the case of Norman v Australian Red Cross VCAT, unreported, 27 November 1998, in which Deputy President McKenzie of the Victorian Civil and Administrative Tribunal had decided that the equivalent to s24 in the Victorian legislation [s69 of the Equal Opportunity Act 1995 (Vic)] provided the respondent with a defence. It was argued that the decision is distinguishable as the Health Act 1958 (Vic) and the previous HBT-Code required men who engage in male-to-male sexual contact to be excluded, whereas there is no such requirement under Tasmanian law.

The Tribunal’s decision
468. There are some fundamental issues of interpretation that must be addressed. Firstly, the matter of whether or not s4 of the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) contains a mandatory requirement that all authorised suppliers of blood must comply with regardless of whether they seek immunity under s5. Secondly, there is the question of the circumstances in which s24 applies which depends in turn on the interpretation of the High Court in Waters v Public Transport Corporation (1991) 173 CLR 349.

469. As noted earlier, there was a submission that s4 of the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) granted a benefit in the form of an immunity if the Red Cross sought that immunity and that there was no statutory compulsion to comply with s4 (Closing Submissions, p73; Submissions in Reply, para 6.1.2 and T953). This is an additional aspect to Mr Cain’s submissions that s 24 of the Anti-Discrimination Act does not mandate the declaration form.

470. This question is a matter of statutory construction. The question is whether the section imposes a mandatory obligation that applies to authorised suppliers of blood (which includes the Red Cross), who wish to have the benefit of immunity under s5 of the Blood Transfusion (Limitation of Liability) Act 1986 (Tas), or whether it is a blanket statutory obligation that is cast on all authorised suppliers of blood (whether they seek immunity or not), and then as a consequence of the application of the statutory provision, they are provided with immunity.

471. This is a matter of statutory construction. Section 4 provides as follows:

“4. Steps to be taken in relation to donation of blood -

(1) Where an authorised supplier takes, or proposes to take, blood from a person for the purpose of being used, if suitable, for transfusion or for the derivation of a blood product that may be used for transfusion, the following provisions apply:

(a) the blood shall not be taken unless that person has, not more than 12 hours previously, signed a declaration in an approved form;

(b) as soon as practicable after taking the blood, the authorised supplier shall cause an approved testing procedure to be carried out in relation to the blood;

(c) where the results of an approved testing procedure carried out in relation to blood indicate the presence of the relevant virus, the authorised supplier shall dispose of the blood and any blood product derived from the blood in an approved manner;

(d) where those results do not indicate the presence of the relevant virus, the authorised supplier may, in an approved manner, certify that the blood is free from the relevant virus.”

472. Turning first to the terms of s4; firstly, the affirmative language used (e.g. s4(1)(a) the blood shall not be taken unless that person has, not more than 12 hours previously, signed a declaration in an approved form) is a prima facie indication of an intention to impose an obligation: see D. Pearce and R. Geddes, Statutory Interpretation in Australia (2006) p333. Secondly, the Tribunal notes that this section is not couched in conditional terms (for example, “in the event that the authorised supplier seeks immunity” or “in order to have immunity.” but in mandatory terms. The only condition or prerequisite for the application of s4 is for an authorised supplier to take or propose to take, blood from a person for the purpose of being used, if suitable, for transfusion or for the derivation of a blood product that may be used for transfusion [s4(1)(a)]. It is plain from the terms of s4 that the statutory provision is not giving the authorised supplier a choice about compliance with s4. Another important guide to statutory interpretation in determining whether a provision imposes a duty is to examine the effect of the consequences of the interpreting the provision one way or another: D. Pearce and R. Geddes, Statutory Interpretation in Australia (2006) p332. The rule of interpretation guiding judicial bodies is that if satisfied that the purpose or object of the provision would be defeated if a task were not carried out, the provision will be treated as obligatory e.g. Bradley v Commonwealth (1973) 128 CR 557. Having regard to the consequences of interpretation if the provision were not read as mandatory, in particular the significant blood safety implications if the donor declaration form were not uniformly administered, also supports a conclusion that s4 should be read as creating a stand alone mandatory requirement.

473. It is important to also have regard to the rest of the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) and check that there is nothing in the Act as a whole which undermines the obligatory nature of s4. There is nothing in s5 that grants an authorized supplier a choice about compliance. The Tribunal is of the view that s5 does not derogate from the mandatory nature of s4.

474. Particular note is taken of s5(3) which provides as follows:

“s5(3) An authorised supplier is not entitled to the protection of this section in relation to blood or a blood product if the authorised supplier fails to observe a requirement imposed on it by or under this Act in relation to the blood or blood product, or in relation to blood from which the blood product was derived.”

475. If an authorised supplier does not comply with s4, they do not have the protection in s5. However, that does not suggest that s4 is optional. Note is also taken of the wording in s5(3) which states that “if the authorised supplier fails to observe a requirement imposed on it by or under this Act…” which supports the view that the matters set out in s4 are a requirement.

476. Effectively, the choice of immunity is taken away by parliament. This is not surprising given the history of litigation with regard to blood transfusion in Australia. The obligatory nature of the declaration is reinforced by the scheme of the Act; for example s5 which sets out an immunity from liability but also the circumstances in which that immunity is lost, and s7 dealing with false statements in declarations and which links back to s5(2) and makes clear that a donor who makes a false declaration does not have the benefit of the immunity under s5.

477. The Tribunal concludes that it is clearly the intention of parliament that there would be an obligation on authorised suppliers such as the Red Cross to comply with s4 and it is, as such, a mandatory requirement.

478. In order to determine whether the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) can properly be the basis of a s24 statutory exception argument in this case it is necessary to give careful consideration to the High Court decision in Waters v Public Transport Corporation (1991) 173 CLR 349 on which Mr Cain has relied.

479. In order to correctly understand the Waters decision, it is necessary to look at the precise terms of the statutory exception under consideration in that case. The relevant provision at the time was contained in s39 of the (former) Equal Opportunity Act 1984 (Vic) and provided as follows:

“This Act does not render unlawful –

… (e) an act done by a person if it was necessary for the person to do it in order to comply with a provision of –

(i) an order of the Board;
(ii) any other Act; or
(iii) an instrument made or approved by or under any other Act.”

480. As noted earlier, there is a difference between this and Tasmanian statutory exception provision, in that the one under consideration in Waters specifically refers to “necessary to comply with a provision” of any other Act, whereas the Tasmanian section simply refers to “reasonably necessary to comply with any law”. The difference in terminology is potentially material in that the wording of s39 invites attention to a specific provision which has this effect, in contrast to the wording of s24, the more general terms of which arguably allows more flexibility in interpretation (less focus on any particular provision, allowing attention to be given more generally, to whether the discrimination was reasonably necessary to comply with any law.) This interpretation is supported in judgments in the Waters case, for example Brennan J at 381 who stated that “unless the ‘provision itself’ makes it necessary to do the relevant discriminatory act, s39(e) does not take the act outside the operation of the Equal Opportunity Act”. This may, for example, justify a conclusion that under the Tasmanian legislation, the requirement may come from a number of different sources which combine to create an obligation rather than a single, self-contained provision.

481. It had been argued before the Tribunal that a key threshold question in determining whether the statutory exception applies concerns the status of the legislation in question, in particular, whether is an ‘express provision’ within the meaning of Waters v Public Transport Corporation or comes within the meaning of ‘subordinate direction’. It was argued that none of the legislation being relied upon by the Red Cross fell within the category of an express provision specifying that men who have had sex with men must not donate blood. With particular reference to the Blood Transfusion (Limitation of Liability) Act 1986 (Tas), it was argued on this point that this Act does not require the Red Cross to do anything; the requirement comes from the form, not the Act itself.

482. In Waters, the relevant legislation under scrutiny was the Transport Act 1983 (Vic), s31 of which provided that a corporation to which it applies must exercise its powers and discharge its duties subject to the general direction and control of the Minister for Transport and to any specific directions given by the Minister. This was construed as conferring on the Minister a statutory power to give a direction to the corporation. It was by means of such a direction that the allegedly discriminatory conduct had come about (removal of conductors from trams and introduction of ‘scratch’ tickets and which had impacted negatively on people with disabilities). The High Court held that an exercise of statutory power by means of a ministerial direction did not qualify under s39 as the basis on which a statutory exception could be established. An important factor underlying this decision that was referred to in a number of the judgments (Mason CJ and Gaudron (at 368), with whom Deane J agreed; also McHugh J [at 414]) was the concern that to determine the provision widely would mean that “any myriad of persons possessing statutory power to give a direction to other persons would be empowered to exempt the conduct of that other person from unlawfulness under the Act, in circumstances where the Act conferring the statutory power required that such direction be obeyed by the persons to whom it was given”. It is also important to be clear that the particular factual scenario in Waters involving ministerial direction, explains why the High Court juxtaposed the concept of an ‘express provision’ with ‘subordinate direction’.

483. Waters is undoubtedly the key authority in this area and provides useful guidance to the Tribunal notwithstanding that it dealt with a specific scenario that is not on all fours with the present case. One important guiding principle that the Tribunal takes from Waters is the need to interpret the statutory authority exception narrowly in order to give maximum possible effect to anti-discrimination legislation. Thus, the exception is only available when the provisions of the other legislation which purports to override the operation of an anti-discrimination statute are ‘mandatory and specific’. Further, it is clear from Waters that in order to meet the threshold, the instrument in question has to have the status of a legal requirement, rather than merely a ministerial direction.

484. However, as Waters dealt with one particular scenario which was held not to be sufficient to establish the threshold requirement for making out the statutory exception, it does not provide a definitive statement of what is sufficient in other circumstances, thus leaving some questions open. In particular, it does not directly address, as it was unnecessary to do so on the facts of Waters, whether a self-contained, express mandated statutory requirement is needed, as Mr Cain has contended (i.e. that the legislation itself must directly mandate the deferral of men who have had sex with another man in the last 12 months) or whether something short of this will suffice (for example, as the Red Cross has argued, that the relevant requirement must be contained in legislation, even though its terms may not be expressly spelt out as such).

485. Further, as was noted at the outset, the decision in Norman’s case relied on by the Red Cross is of limited relevance in the interpretation of s24 as it relied on a particular part of the Victorian legislation relating to ‘authorisation’ [s69(1)] which is not paralleled in the Tasmanian Act.

486. Section 69 of the Equal Opportunity Act 1995 (Vic) provides:

“(1) A person may discriminate if the discrimination is necessary to comply
with, or is authorised by, a provision of -

(a) an Act, other than this Act;

(b) an enactment, other than an enactment under this Act.”

487. With the above stated principles from Waters in mind, it is necessary to evaluate the relevant Tasmanian Act under consideration and whether it meets the threshold. Reliance has been placed by the Red Cross on the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) however, the question which has been argued to be discriminatory does not appear in the Act, but in the donor declaration form which has been approved by the Secretary of the Department under s3 of the Act. This gives rise to the question as to the status of the donor declaration form. Whilst the donor declaration form is clearly not an Act, it may nevertheless comprise part of the ‘law of the state’ within the meaning of s24.

488. As the donor declaration form takes effect under the legislation by virtue of a process of approval by the Secretary of the Department by instrument in writing pursuant to s3 of the Act it is best characterised as an executive order or instrument (see D. Pearce and R. Geddes, Statutory Interpretation in Australia (2006) p2 and E. Campbell, E. Glasson, L. Poh York and J. Sharpe, Legal Research: Materials and Methods Law Book Co (1988) p167) or a form of ‘delegated legislation’ defined by D. Pearce and S. Argument in Delegated Legislation in Australia Butterworths (2nd edition) 1999 p1 as “a convenient general description for a legislative instrument made by a body which (or person to whom) the power to legislate has been delegated”.

489. There is some authority in support of the proposition that an instrument in the nature of an executive order or delegated legislation is part of the law: R v Walker [1875] LR 10 QB 355. In that case, s5 of the Epping Forest Amendment Act 1872 (UK) had authorised Commissioners to make orders prohibiting certain uses of land until the expiration of the session of Parliament next after their final report. Pursuant to this section, an order had been made by the Commissioners prohibiting certain activities within an identified piece of land. The defendant had acted in contravention of the order and when the matter was brought before the courts, the order was held to be valid and the court accordingly upheld the indictment against the defendant. Lush J in that case stated (at p358) that “An order made under a power given in a statute is the same thing as if the statue enacted what the order directs or forbids; the statute delegates to others, here the Commissioner, the power to say what shall or shall not be done”.

490. Drawing on R v Walker as authority, in Willingale v Norris [1090] 1KB 57 Lord Alverstone CJ stated “Where a statute enables an authority to make regulation, a regulation made under the Act becomes for the purpose of obedience a provision of the Act. The regulation is only the machinery by which Parliament has determined whether certain things shall or shall not be done”.

491. This statement has subsequently been endorsed by the House of Lords in Wicks v Director of Public Prosecutions [1947] AC 362 and was also referred to with approval by the High Court in The Queen v Kirby; Ex Parte Boilermakers’ Society of Australia (1956) 94 CLR 254. In addition, there have been a number of Australian cases which have referred to R v Walker with approval although these appear to have mainly involved regulations or rules made under a principal Act: Clyde Engineering Co Ltd v Cowburn (1926) 37 CLR 466; Young v Registrar, Court of Appeal [No 3] (1993) 32 NSWLR 262 at 288; Sunarso v Minister for Immigration and Multicultural Affairs [2000] FCA 57 at pp14-15).

492. In Clyde Engineering Co Ltd v Cowburn (1926) 37 CLR 466 (a case involving consideration of the status of the award making function under the Forty-Four Hours Week Act 1925) Isaacs J stated:

“If the parliament … does empower a named functionary to formulate what he thinks a proper rule, … his formulation, though not a law, may be adopted by Parliament so as to be law. The legislative adoption of the formulation is itself legislation on the subject matter, and the formulation is then part of the law, not by force of the formulation, but by force of the adoption.”

493. Thus, there is very clear authority that regulations are part of the law, but negligible recent authority on the status of executive orders or instruments. A direct analogy can be drawn between the facts of R v Walker itself where Commissioners had been authorised to make certain orders and the circumstances of the present case where the Act confers on another person the power to make an order or instrument in an approved form, in this instance, on the Secretary of the Department to approve the donor declaration form. Arguably, the reasoning from R v Walker which in general terms has been upheld as good law in a number of more recent cases, including by the Australian High Court, applies equally here to hold that the instrument made under the statute once the process provided under the legislation has been complied with, has the same status as if the statute enacted it. On this interpretation, the donor declaration form would form part of the ‘law of the State.’

494. On the basis of the foregoing reasoning, the donor declaration form itself is part of the law of the State and accordingly, clearly falling within the meaning of s24, as a law of the State that it was ‘reasonably necessary’ for the Red Cross to comply with.

495. In the alternative, even if the form is not itself part of the law of the State, it can nevertheless be argued that the Red Cross was legally required under s4 to have the form signed before blood could be taken, and to follow through on the questions contained in the form, leading to the exclusion of men who have had sex with men within the last 12 months.

496. This would also satisfy even the most stringent interpretation arising from Waters, namely, the need for an express and specific provision, in mandatory terms. Also significant in reaching this view is the fact that the form is very specific, dealing exclusively with the issue of blood donation, and thus is very limited in its effect. This is distinguishable from Waters which involved a broad power vested in the Minister to give directions. In this sense, the reach of the Act vis a vis the form is very direct and specific. The very specific and limited nature of the donor declaration form is relevant to the issue of floodgates that had clearly been a concern in Waters and the need to limit the possible erosion of anti-discrimination legislation: in the present case, the legislation is directed to a very specific and small group, namely blood suppliers.

497. As noted, Waters is good authority for reminding us that the exception of statutory authority should not be interpreted expansively. However, it is also important to avoid an overly literal, technical interpretation of s24 and rather address what is actually material, including the practical impact of the interpretation, and that effect is ultimately given to the section’s intended purpose. Viewed in this light, the essence of s24 would appear to be that there needs to be some form of mandatory requirement under the law of the state which implicates the discriminatory conduct. Consideration must therefore be given to whether the Blood Transfusion (Limitation of Liability) Act 1986 (Tas), viewed as a whole, meets the relevant threshold.

498. The Tribunal acknowledges that the Blood Transfusion (Limitation of Liability) Act does not, in so many words, expressly state that the MSM group must be excluded if they have had sex with a man within the last 12 months, which according to Mr Cain’s argument, is the only basis on which the s24 statutory exception can be made out. However, as suggested, alternative interpretations are open and the Tribunal is of the view that the section can apply in this case where the legislation sets out in mandatory terms steps to be taken for blood taking by authorised suppliers which result in men who have had sex with a man within the last 12 months being excluded.

499. In any event, it seems a semantic exercise for Mr Cain to contend that the legislation does not require the Red Cross to do anything. It is necessary to look at the process of blood taking as a whole and the Red Cross’ role in blood supply, and the Act mandates that where an authorised supplier takes blood then it ‘shall’ comply with the requirements of the legislation. This is a completely different situation to that in Waters in which theTransport Act did not require the Corporation to do any specific thing. If a blood supplier engages in taking blood, the requirements of the Act apply which invoke the donor declaration form and the question which is objected to. The Tribunal accordingly accepts the submission of the Red Cross that as a matter of law, the Red Cross is effectively required to ask donors the set of questions set out in the donor declaration form including question 8 concerning male-to-male sex within the last 12 months.

500. Once the threshold is established, and the statutory exception has potential application, Waters indicates that the next stage in analysis is to consider the ‘necessity to comply’ aspect of the exception provisions (or in the case of the Tasmanian legislation ‘reasonably necessary to comply’). Here again, a holistic view of the legislation, in terms of the activity of blood taking as a whole, is required. The Tribunal has come to the conclusion that it is ‘reasonably necessary’ for the Red Cross to discriminate in order to comply with the statutory scheme set out in the Blood Transfusion (Limitation of Liability) Act.

501. The Tribunal agrees with the Red Cross’ conclusion that the Red Cross taking steps to ensure that it has the benefit of the statutory immunity from negligence or other liability under this Act resulting from the transmission of HIV/AIDS by following the statutory requirements comes within the ordinary meaning of what is ‘reasonably necessary’. As noted earlier, the Tribunal has taken the view that it is a core mandatory requirement and it has to follow from this that it is reasonable necessary to comply with this section. However, the Tribunal also notes some other considerations which reinforce that compliance with this Act is in every practical essence essential. Indeed, in light of previous litigation against the Red Cross arising from infection of the blood supply it would be extremely reckless and imprudent for the Red Cross to expose itself to negligence liability as a result of not availing itself of the statutory protection created for this purpose.

502. As will be evident from other parts of this decision, the Waters case is of relevance in a number of respects in the interpretation of anti-discrimination legislation. There have been literally hundreds of Australian cases which have cited and followed Waters, however, only a small proportion of these have relied on the case for its interpretation of the statutory exception. These cases include David Jones (Australia) Pty Ltd v ‘P’ (1997) Supreme Court of New South Wales (BC9808138) (decision of the New South Wales Supreme Court) and Hashish v The Minister for Education of Queensland [1988] 2 Qd R 18 (decision of the Queensland Court of Appeal) in both of which, the statutory authority exception was held to have been made out, and Burrows v NSW Commissioner of Police (1994) EOC 92-654 (decision of the New South Wales Equal Opportunity Tribunal) and Sydney University Postgraduate Representative Association (SUPRA) v Minister for Transport Services [2006] NSWADT 83 (decision of the New South Wales administrative Decisions Tribunal, Equal Opportunities Division), in both of which the statutory exception was held not to be established.

503. Firstly, it is to be noted that these cases have unequivocally endorsed the authority of Waters in this area. In light of their particular facts and circumstances, they do, however, support the view the requisite compulsion may exist although not expressly stated as a single, mandatory legislative requirement specifically directed at the Respondent, and further, that the requirement might be based on an interpretation of more than one act: see Hashish v The Minister for Education of Queensland and David Jones (Australia) Pty Ltd v ‘P’. Moreover, the case of Hashish v The Minister for Education of Queensland indicates that lack of power or restriction of power can lead to compulsion.

2. Therapeutic Goods Legislation
504. Attention was principally focused on the Commonwealth legislation although brief reference was also made to the existence of equivalent state legislation (Therapeutic Goods Act 2001 (Tas)). Pursuant to s6 of the State Act, the Commonwealth Therapeutic Goods legislation under the Therapeutic Goods Act 1989 (Cth) applies as the law of Tasmania. Given this mirror effect, it is sufficient for the Tribunal to primarily consider the Commonwealth legislation, but noting also its parallel operation in Tasmania.

505. Whilst there was agreement between the parties on the terms of the relevant regulatory regime, at issue between them is the question of how binding this regulatory regime is on the Red Cross. In particular, the key question for the Tribunal to determine with regard to this Commonwealth legislation is the status of the Red Cross Guidelines for the Selection of Blood Donors which contain at paragraph 8 the question “have you had male-to-male sex within the last 12 months” and indicate that this is grounds for deferral of potential donors.

506. There were two strands of argument put forward by the Red Cross in support of the argument that the s24 statutory exception applies to this Commonwealth regulatory regime: firstly, with regard to the Therapeutic Goods (Manufacturing Principles) Determination 2000, and secondly with respect to the ‘standards’ - Therapeutic Goods Orders. The Tribunal found Ms Ryan’s flowchart handed up as an aid to the Tribunal, to be of assistance in helping to highlight these two strands of argument and identifying the relevant matters to be taken into account. To be able to evaluate each of these lines of argument, it is necessary to outline the operation of the Therapeutic Goods regime.

Summary of the operation of the Commonwealth Therapeutic Goods legislation
507. This area is governed by the Therapeutic Goods Act 1989 (Cth) and the relevant Determination made under this Act pursuant to s36 which allows the Minister to determine written principles to be observed in the manufacture of therapeutic goods for use in humans (Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2007). (See Annexure, Ms Armstrong’s First Statement R50A). There is no doubt at all that the Red Cross has to comply with relevant manufacturing principles as stated in the relevant determination, and that this qualifies as a statutory instrument which represents part of the law of the Commonwealth. Furthermore, by virtue of s10 of the Therapeutic Goods Act 1989 (Cth), the Red Cross has to comply with relevant standards in the form of Therapeutic Goods Orders (in this case, Therapeutic Goods Order 72). These standards also qualify as a statutory instrument which is part of the law of the Commonwealth.

508. Also relevant in this regard is s40 of the Therapeutic Goods Act which specifies that conditions of holding a license include that the license holder ensure the licensed goods conform to any standard applicable and observe any manufacturing principles.

509. However, neither the manufacturing principles or the standards prescribe what the Red Cross must do in relation to deferral (this is specified in the Red Cross Guidelines 2004); it therefore becomes critical to understand how these guidelines are integrated in the therapeutic goods regulatory regime and ascertain their status.

The Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2007
510. Looking first at the requirements flowing from the Determination: The Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2007 requires the manufacturer of blood or blood components to lodge a ‘Technical Master File’ with an application for a licence. There are Guidelines for the Preparation of a Technical Master File (see Annexure 9, Ms Armstrong's First Statement R50A, p8) which state that the Technical Master File must cover inter alia donor selection, assessment and deferral. Once lodged with the Therapeutic Goods Authority, the Technical Master File has to go through a process of approval by the Therapeutic Goods Authority and once approved, it becomes binding and cannot be changed without the approval of the Therapeutic Goods Authority.

511. The Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2007 further specifies that blood or blood components must be manufactured in compliance with the Australian Code of Good Manufacture Practice for Human and Blood Tissues and in a manner consistent with the ‘Technical Master File’ lodged by the manufacturer. The effect of this regime is that the Red Cross’ manufacture of blood and blood components must be in compliance with the Australian Code of Good Manufacturing Practice for Human Blood and Tissues, and in a manner consistent with the Technical Master File lodged by the manufacturer. (For convenient reference to these documents, see the Respondents Closing Submissions at p8 for details of the Annexures where the versions of these documents as they existed at the relevant time appear.)

512. The Australian Code of Good Manufacturing Practice for Human and Blood Tissues deals with donor selection. With respect to whole blood donations, the Code sets out the required pre-donation procedure at paragraphs 812 and 813. Paragraph 812 provides that medical assessment of the donor must be evaluated on the day of the donation. During private interview, the donor must sign the declaration form of the assessment information discussed, which is witnessed and signed by the interviewee (emphasis in the original).

513. Paragraph 813 of the Code states:

“The current Council of Europe guidelines for the selection of donors are the minimum acceptable requirements, together with any additional legislation requirement of the State or Territory in which the donation is taking place.”

514. The relevant Council of Europe guidelines at the time was the Guide to the Preparation, Use and Quality Assurance of Blood Components 9th edition (2003). This Guide seeks to ensure a safe blood supply through the careful selection of prospective donors. It states (at p33) that:

“In selecting individuals for blood donation the main purpose is to determine whether the person is in good health in order to protect the donor against damage to his or her own health, and to protect the recipient against transmission of diseases or drugs which could be detrimental to the patient.”

515. The Guide acknowledges (at p35) that complete medical and physical examination of blood donors is not possible and that one has to rely upon the donor’s answers to some questions concerning his or her medical history and health. One of the questions asked of men (p38) is “Have you ever had sex with another man”. The Guide goes on to state that “The donor’s medical history shall be evaluated, and the donor accepted, by a suitably qualified person trained to use accepted guidelines for selection of blood donors”.

516. The Technical Master File also addresses the issue of donor selection. It states as follows:

• “The function of the donor selection processes used by the ARCBS is to ensure that the collection and use of blood donations is based on safety of the person donation the blood and the individual receiving the blood.”
• “The processes by which the ARCBS achieves this result are documented in the “Guidelines for the Selection of Blood Donors”.
• “A list of the questions that must by asked of donors in defined in the “Guidelines for the Selection of Blood Donors.”

517. The Australian Red Cross Guidelines for the Selection of Blood Donors contain at paragraph 8 the question “Have you had male-to-male sex within the last 12 months” and indicates that this is grounds for deferral of potential donors.

The Standards (Therapeutic Goods Order No 72)
518. As noted, the second strand of the Red Cross’ argument relates to the standards. Section 10 of the Therapeutic Goods Act 1989 (Cth) allows the Minister to determine standards for therapeutic goods. Once determined, manufacturers are required under s40(4) of the Act to comply with those relevant standards in addition to the manufacturing principles. The relevant standard in force at the time was the Therapeutic Goods Order No 72. The Therapeutic Goods Order No 72 specifically refers to the need to comply with the Council of Europe Guidelines Guide to the Preparation, Use and Quality Assurance of Blood Components 9th edition (2003), details of which have been set out above.

Red Cross’ argument with regard to the therapeutic goods legislation
519. The Red Cross asserts that the Red Cross Guidelines (in which the question regarding having had sex with another man within the last 12 months is contained) are the embodiment of the manufacturing principles prescribed under the Therapeutic Goods Act and the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2000 and that it is unable to depart from or act contrary to the Red Cross guidelines as to do so would contravene the Therapeutic Goods Act. It drew on the evidence of Ms Armstrong paragraph 20 in support of its contention that all Red Cross Centres involved in the manufacture of blood, blood components and plasma are required to comply with the Red Cross Guidelines under the terms of the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2000.

520. In oral submissions to the Tribunal, the Technical Master File was described as being the lynchpin of compliance because “it is this document which mandates the procedures that must be followed, being those procedures set out in the guidelines” and because the Red Cross “must comply with the Technical Master File as part of its obligations pursuant to the manufacturing principles”.

521. With regard to the Standards and the need to comply with the Therapeutic Goods Order 72, the Red Cross argued that the Red Cross guidelines (which are submitted as part of the Technical Master File lodgment process) fulfills the requirements in the Therapeutic Goods Order that the Red Cross comply with the Council of Europe Guidelines. The Red Cross has argued that the Red Cross guidelines are more comprehensive than the Council of Europe Guidelines and clearly they are more specific on this key issue of deferral.

522. Further, it was argued for the Red Cross that it would be a breach of the Red Cross’ licenses and could result in its licenses being suspended or revoked, attracting criminal and or civil penalties.

Mr Cain’s argument with regard to therapeutic goods legislation
523. Mr Cain sought to challenge reliance on either the Red Cross Guidelines or the Technical Master File on a number of fronts. Firstly, on the ground that the Guidelines, and by their incorporation into the Technical Master File, “fulfil the requirement of the Therapeutic Goods Authority that the Red Cross comply with the Council of Europe Guidelines”. This was contested on the basis that the Council of Europe Guidelines do not mandate automatic deferral but rather have a filtering process by which potential blood donors are assessed on a case by case basis. It was further argued that the Red Cross’ reliance on the Council of Europe Guidelines as the minimal accepted standard to be complied with was undermined by the fact that the Guidelines refer to “ever having had sex with another man”, whereas the Red Cross had chosen a lower figure of male-to-male sex within the last 12 months. It was submitted this showed that the Guidelines were not in fact mandatory but a flexible guide, and consequently does not provide the sort of legislative requirement that s24 would attach to. It was argued that it could not be concluded that the Guidelines make necessary the exclusion of the MSM group.

524. Mr Cain further contended that neither the Australian Red Cross Guidelines for the Selection of Blood Donors nor the Technical Master File provided the Red Cross with a statutory exception under s24. It was argued that the Technical Master File does not expressly provide that men who have sex with men cannot donate blood, but more indirectly, refers to the Australian Red Cross Guidelines for the Selection of Blood Donors as setting out the questions that must be asked of donors.

525. In addition, Mr Cain sought to challenge these documents as constituting a valid basis for the s24 statutory exception on the grounds that they lack the status of statutory necessity. It was argued that guidelines approved by an authority exercising governmental power (the Therapeutic Goods Authority) after being proposed by an entity seeking a licence (the Red Cross) cannot in law amount to a ‘reasonable necessity’ under s24. In essence, it was argued that an ‘approval’ cannot amount to a statutory ‘necessity’. Drawing on the Waters case, it was argued for Mr Cain that documents which the Red Cross has developed and submitted for approval with the Therapeutic Goods Authority do not qualify “as an express direction contained in an actual provision of another Act or statutory instrument” as required in Waters. That case, (per Mason CJ and Gaudron J), had distinguished between express provisions in legislation and ‘any subordinate direction’; it was argued that a mere approval (by the Therapeutic Goods Authority) had even less status than a subordinate direction.

526. Further, it was argued that the interpretation in Norman v Australian Red Cross with respect to the Commonwealth legislation was irrelevant because at the time of that decision (1998), the relevant Manufacturing Principles contained under the therapeutic goods legislation had expressly provided that the National Blood Transfusion Committee Guidelines, for the selection of donors are the minimum requirements to be followed and these had relevantly provided that: Men must nor give blood if they have had sex with another man in the last 12 months. In contrast, it was argued that the Council of Europe Guidelines which are now stated to be the minimum standard under the Therapeutic Goods scheme, are much more broadly worded and do not expressly prohibit blood being accepted from a man who has had sex with another man.

527. It was accordingly argued that the Commonwealth legislation presented no legislative impediment to the ARCS accepting the donation of blood from men who have sex with other men or requiring preclusion from donation any man who has had sex with another man in the last 12 months.

Tribunal’s evaluation of the arguments
528. As noted at the outset of this section, a key issue for the Tribunal’s determination is the status of the Red Cross Guidelines within the therapeutic goods regulatory regime and whether this can be the basis for a statutory exception argument under s24. Whilst the Red Cross Guidelines are not in themselves a statutory instrument, they are referred to in the Technical Master File and could accordingly be said to be incorporated by that Technical Master File. This then raises the question – what is the status of the Technical Master File?

529. The Guidelines for the Preparation of a Technical Master File are instructive in that they help explain the purpose of the Technical Master Files and thereby help to shed light on their status. These Guidelines state that the purpose of Technical Master File is to “provide data and information to the Secretary of the Department and delegates of the Secretary in the Therapeutic Goods Authority, for review. It provides a medium to demonstrate that appropriate standards for product safety and quality have been met”.

530. The actual Technical Master File in question (see Annexure 11, Ms Armstrong's Statement) has the title “Australian Red Cross Blood Service Technical Master File” and the words 'Commercial in confidence' appear on the title page. Whilst there is no doubt that the Red Cross has to lodge the Technical Master File and once it is approved, is bound by it, it does not appear that the Technical Master File qualifies as a statutory instrument in the same way as the manufacturing principles and standards do. As accepted by the Tribunal (in the alternative) in relation to the Blood Transfusion (Limitation of Liability) Act 1986 (Tas), that even though the Red Cross Guidelines do not in themselves have legal status, it can be argued that as they are part of a more general scheme of regulation, they are to be seen as part of the law of the Commonwealth. Support for this view can be drawn from the fact that existence of the Red Cross Guidelines can be traced to the requirements of the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2000, which in turn specifies requirements in relation to the Australian Code of Good Manufacture Practice for Human and Blood and the Technical Master File as outlined earlier. With regard to the latter, it is noted that it states that once the statutory declaration in response to the questions in the guidelines is signed it is legally binding. Whilst neither the Australian Code of Good Manufacture Practice for Human and Blood or the Technical Master File expressly mandate exclusion of the MSM group, they do address the issue of donor selection and the need for careful scrutiny of donors in the interests of blood safety. As was noted the Australian Code of Good Manufacture Practice for Human and Blood uses the Council of Europe Guidelines as the benchmark which do contain a question in relation to male-to-male sex, although they do not prescribe automatic exclusion on this ground. Notably, though, these guidelines are stated to be the minimum acceptable requirements (para 813 of the Code). It can therefore be seen that the Red Cross Guidelines are intricately bound up with other aspects of the therapeutic goods regulatory regime, including with some instruments that clearly do have legal force. In these circumstances, it could be argued that the Tribunal is prepared to accept that taking the regime as a whole, the Red Cross Guidelines play an integral role within that and the Red Cross’ compliance with those guidelines involves compliance with a law of the Commonwealth.

531. Another way to view the situation is to ask is the Red Cross bound to comply with the Red Cross Guidelines? If so, how and why and what are the implications of its failure to do so? The answer to this seems clear - the Red Cross has an obligation to comply with the Red Cross Guidelines because those Guidelines are incorporated in the Technical Master File, and compliance with this is a requirement for the continuation of the Red Cross’ license (Dr Wylie R47, para 32). Indeed, this regulatory obligation for continuation of its license, could in itself be said to be compliance “with a law of the Commonwealth” as this requirement is clearly spelt out in s40 of the Therapeutic Goods Act 1989 (Cth). The question is whether such an obligation is sufficient to amount to a requirement for the purpose of s24 of the Act.

532. The Tribunal accepts that reliance on this Commonwealth legislation involves a less direct argument than the interpretation under the Blood Transfusion (Limitation of Liability) Act 1986 (Tas) due in part to the more ambivalent status of the Council of Europe Guidelines which do not expressly direct deferral of men who have had sex with men. It is noted that when Norman was decided, the situation was clearer as there was an explicit requirement to exclude the MSM group because of the National Blood Transfusion Committee Guidelines. The Tribunal is left with reservations given the gaps in the process whether or not the compliance with the Red Cross Guidelines can be regarded as a legal requirement. As noted these Guidelines are part of a wider Commonwealth regime and there is a strong case for the Red Cross to be compelled to comply in order to maintain its license and continue their operations but the Tribunal questions whether it is a requirement in close enough reach to the legislative requirement to make it a legal requirement. In these circumstances, and given our findings in relation to the State legislation, the Tribunal does not need to decide this issue. The license status of the Red Cross under the Commonwealth therapeutic goods regime and the fact that once approved, the guidelines cannot be unilaterally changed by the Red Cross, inclines the Tribunal to the view that there is in essence a legal obligation but given our reservations, the Tribunal declines to decide this issue.

3. Workplace Health and Safety Act 1995 (Tas)
533. The Red Cross’ reliance on s24 also extended to an argument that any alleged discriminatory conduct against Mr Cain was necessary due to the requirements of Workplace Health and Safety Act 1995 (Tas). In particular reliance was placed on s9 of that Act which requires employers to ensure that its employees are safe from injury and risk to health while at work.

534. That section provides as follows:

“9. Duties of employers

(1) An employer must, in respect of each employee employed by the employer, ensure so far as is reasonably practicable that the employee is, while at work, safe from injury and risks to health and, in particular, must –

(a) provide and maintain so far as is reasonably practicable –

(i) a safe working environment; and
(ii) safe systems of work; and
(iii) plant and substances in a safe condition; and

(b) provide facilities of a prescribed kind for the welfare of employees at any workplace that is under the control or management of the employer; and
(c) provide any information, instruction, training and supervision reasonably necessary to ensure that each employee is safe from injury and risks to health.

Penalty:

In the case of –

(a) a body corporate, a fine not exceeding 1 500 penalty units; or
(b) a natural person, a fine not exceeding 500 penalty units.”

535. It was the Red Cross’ submission that there is a residual risk that the Red Cross’ staff who take blood from blood donors and handle blood or blood products may be exposed to infection. It was argued that whilst protective measure are taken, such as the use of protective equipment, no safeguards can eliminate the possibility of accidents occurring, such as needle-stick injuries. It was contended on behalf of the Red Cross that the exclusion of high risk donors reduces the likelihood of infectious agents including HIV in the blood infecting Red Cross staff who handle blood and blood products provided by donors. In support of this submission reliance was placed on the evidence of Ms Willis, Tasmanian Regional Manager of the Australian Red Cross Blood Service and Dr Wylie who had given evidence that needle-stick injuries do occur.

536. This argument was strenuously challenged by Mr Cain, on the grounds that this legislation did not reasonably require the deferral of the MSM group from blood donation. It was suggested that if the Red Cross’ contention about the workplace safety legislation was correct, it would mean that any occupation that included the possibility of exposure to blood from men who have had sex with men would have the benefit of the statutory exception under s24, which Mr Cain argued, could not be the case.

537. The Tribunal is able to dispose of this aspect of the Red Cross’ argument quite summarily as it is plainly evident that s9 of the Workplace Health and Safety Act 1995 (Tas) lacks the specific and mandatory nature in order for the statutory exception to apply. It casts on all employers a very general duty to ensure the health and safety of their workforce, but does not directly deal with risks associated with HIV/AIDs transmission, much less giving any direction to an employer that persons who present a risk of this kind are to be excluded from the workplace.

538. As noted earlier, the High Court in Waters v Public Transport Corporation had made clear that the exception of statutory authority should not be interpreted expansively and to this end, had come up with formulations about how any legislation overriding anti-discrimination legislation should be in mandatory and specific terms.

539. The Tribunal notes that there is support for this conclusion from the cases of David Jones (Australia) Pty Ltd v ‘P’ (1997) Supreme Court of New South Wales (BC9808138) and Burrows v NSW Commissioner of Police (1994) EOC 92-654 in which similar arguments were rejected.

Section 25

540. The Red Cross had also presented an argument with respect to s25 of the Act; this came before the Tribunal by way of amendment to the Red Cross’ defence.

541. The relevant provision provides as follows:

“25. Disadvantaged groups and special needs -

A person may discriminate against another person in any area if it is for the purpose of carrying out a scheme for the benefit of a group which is disadvantaged or has a special need because of a prescribed attribute.”

542. It was argued for the Red Cross that the relevant prescribed attribute in this case was ‘disability’ and that the Red Cross in providing a blood service was carrying out a scheme, the purpose of which was to benefit a group, namely recipients who were disadvantaged or had a special need because of a disability within the meaning of s3(a)-(d) which provide as follows:

“(a) a total or partial loss of the person's bodily or mental functions;
(b) total or partial loss of a part of the body;
(c) the presence in the body of organisms causing or capable of causing disease or illness;
(d) the malfunction, malformation or disfigurement of a part of a person's body.”

543. Reliance was placed on the evidence of Dr Wylie and Ms Willis to substantiate the claim that the Red Cross was carrying out such a scheme. In support of this argument, reference was also made to a number of decisions which have dealt with this provision including Cahill v State of Tasmania 2004 TASADT 05 and Rail, Tram and Bus Union v Metro Tasmania Pty Ltd (No 3) TASADT 2004.

544. Mr Cain, in the Submissions in Reply, had argued that this provision has no relevance to the present case before the Tribunal. It was argued for Mr Cain that the purpose of this section is to provide an exception for ‘affirmative action’ programmes and policies designed to benefit a disadvantaged group. It was contended that on any analysis of the activities engaged in by the Red Cross in the collection and distribution of blood, it cannot be said that those activities amount to an affirmative action program, or a ‘scheme’ to benefit a ‘disadvantaged group.’

545. The ‘special measures’ category of exception, as referred to by commentators in this area (C Rolands, Discrimination: Law and Practice (2008, 3rd edition) Federation Press at pp157-161; N. Rees, K. Lindsay and S. Rice, Australian Anti-Discrimination Law: Text, Cases and Materials (2008) Federation Press pp455-457) is undoubtedly linked with affirmative action type programmes. Rolands explains (p158) that this exception is designed to promote actions to further implement the spirit and intention of anti-discrimination legislation by preventing a person who is not in a minority group for whom the program or policy is designed from complaining that they have no access to the policy or program and therefore have been discriminated against. So, for example, in the case of Bruch v Commonwealth [2002] FMCA 29, involving interpretation of the equivalent provision in the Racial Discrimination Act 1975 (Cth), it was held that the Commonwealth had not discriminated against a non-Indigenous Australian student by refusing to award him ABSTUDY because the ABSTUDY scheme constituted a ‘special measure’ for the benefit of Indigenous people within the meaning of that Act.

546. Some assistance can be gleaned from the dictionary definition of ‘scheme’; The Collins English Dictionary defines scheme as “a systematic course of action”. The Tribunal takes the view that this does not fit with what the Red Cross is doing: the Red Cross is providing a service rather than a plan of action. The word ‘scheme’ is far more apposite to affirmative action programs where there are specific goals and outcomes.

547. On reviewing the terms of the provision and relevant case law, also from other jurisdictions interpreting equivalent provisions, as well as academic commentary, the Tribunal has come to the conclusion that Mr Cain’s contention that this provision has no relevance to the present case, is correct. The section’s focus is ‘disadvantaged groups’ and people with ‘special needs’ and it is aimed at addressing systemic discrimination through schemes of affirmative action, as was, for example, the case in the Tribunal’s decision in Cahill v State of Tasmania 2004 TASADT 05.

548. The present case is clearly distinguishable from this kind of situation aimed at achieving affirmative action objectives. Whilst the honourable goals of the Red Cross are beyond question, providing a blood supply service to people who are in medical need simply does not come within the intended reach of the provision. The Tribunal is accordingly satisfied that the provision has no application in this case.

CONCLUSIONS

549. A very brief summary of the main conclusions reached by the Tribunal is as follows.

Indirect discrimination
550. The Tribunal is not satisfied that the Red Cross’ deferral policy amounts to indirect discrimination. Critically, the element of indirect discrimination that the policy is unreasonable in all the circumstances has not been proved. In fact, the Tribunal is satisfied that the current policy is reasonable. After careful consideration, the Tribunal has concluded that the alternative policy advocated by Mr Cain of allowing low risk members of the MSM group to donate is not viable given reliable evidence that it would result in an increase in the risk of HIV transmission. It is beyond question that the Red Cross is bound to keep the risk to the blood supply as low as possible.

Direct discrimination
551. The Tribunal is also satisfied that the Red Cross has not contravened the provision in relation to direct discrimination. The real or genuine reason for the application of the policy is not due to erroneous beliefs about homosexual donors or a mistaken assumption that individuals engaging in male-to-male sex all pose a high risk to the blood supply. In reality, the reason for the deferral policy is the fact that people who engage in male-to-male sex have, as a group, a high risk of HIV transmission.

Statutory exception: s24
552. The Tribunal has concluded that even if the deferral policy contravened the Act as either direct or indirect discrimination, s24 would operate so as to provide a statutory exception. It is a requirement of the law of the State, namely the Blood Transfusion (Limitation of Liability) Act 1986 (Tas), that the deferral policy be applied by the Red Cross to all potential donors. Thus, if the Act had been breached the policy would be lawful.

553. Having reached these conclusions the complaint must be dismissed. However, before doing so, it seems to the Tribunal that there are a few worthwhile observations that should be made.

Observations
554. A number of key points favouring Mr Cain’s position have been demonstrated during the Inquiry.

555. First, facts regarding the relative risk of allowing Mr Cain’s group of low risk members of the MSM group to donate are now available. These facts were not available at the commencement of the Inquiry but have emerged during the course of the evidence. The question of relative risks posed by various categories of risk based activity required careful consideration by the Tribunal. An important key point that has now been demonstrated is that the risk of HIV transmission posed by the low risk sub-group of the MSM group is, in fact, substantially lower than the MSM group as a whole. The statistics associated with the MSM group as a whole relating to the incidence and prevalence of HIV infection and the relative risk of HIV positive window period donation are far removed from the statistics and relative risk of Mr Cain’s low risk sub-group.

556. A second and related key point is that while it is still the case that the relative risk posed by the low risk sub-group of the MSM group is higher than other groups that are permitted to donate blood, the relative risk of this low risk group is much closer to the relative risk of other groups tolerated by the donor deferral policy than previously acknowledged.

557. A final observation relates to Inquiry process itself, rather than outcomes and findings. The Inquiry has resulted in close scrutiny of the donor deferral policy in light of current data and social research and a new methodology of assessing risk. It is interesting to note that the expert witnesses called by Mr Cain and the Red Cross were in agreement that the analysis undertaken by the experts in these proceedings and close consideration of the donor deferral policy is a beneficial process.

558. An interesting outcome of this case is that it is now evident that there is a method, a mathematical model (developed by Professor Kaldor and his colleagues and applied in Exhibit T6) available to assess and quantify the risk posed to the blood supply of various categories of risk based activity. This method can be applied by the Red Cross in reviewing their policy of donor deferral. This will be a useful aid for the Red Cross in making informed decisions about its policy in the future.

559. In a number of significant respects, the situation in Australia with respect to our blood supply and response to the HIV epidemic is enviable. Australia has one of the safest blood supplies in the world. We heard that the collection of surveillance data in Australia is comprehensive and longstanding and is envied in other parts of the world. The approach taken at a policy level in responding to the HIV epidemic based on trust and co-operation with the gay community is regarded as a model approach. We heard about political considerations in other countries which stultify review and reform. Finally it may be noted that an analysis and a method for modelling risk based activity prepared by Australia’s leading epidemiologist, Professor Kaldor and his colleagues in this case has not been undertaken in other countries.

560. It seems to the Tribunal that ongoing scrutiny of the current deferral policy is a positive feature of our blood banking system in Australia. Ongoing critical review of the policy will ensure that our blood supply is and will continue to be as safe as it can be and ensure that if other viable options are indicated then they will be assessed. New data, enhanced research and refined methods can be considered and the policy reviewed in light of those developments. It cannot be overlooked that this review and critical analysis will assist in maintaining public confidence in the blood supply.

561. The review of the donor deferral policy that has been undertaken in these proceedings as a consequence of Mr Cain’s sense of justice and altruistic motivations, have contributed to that beneficial process of review and scrutiny of the deferral policy. It remains for the Tribunal to mention that the responsible approach Mr Cain has taken in acknowledging the critical importance of the safety of the blood supply and the Red Cross’ ethical duty to keep the blood supply as safe as possible and his treatment of these as the foundation for his case, so that he only is advocating change if there is no increase in risk to the blood supply, has facilitated the Tribunal’s proper analysis of the issues in this case.

ORDER

562. The Tribunal is not satisfied that the Red Cross has breached the Act and accordingly, the Tribunal finds that the complaint is unsubstantiated and it is dismissed pursuant to s99(1) of the Act.

563. For ease of reference the Tribunal attaches to this decision a current suppression order made during the Inquiry which will continue to have application until further order. Counsel will be provided with an opportunity to make submissions regarding this suppression order and whether any amendments ought to be made to it.

THE TRIBUNAL’S DECISION	1
OVERVIEW	2
The Structure of the Decision	13
Table of Contents	16
Some Preliminary Matters	17
Terminology	17
Onus of proof	22
A COMPLAINT OF DIRECT AND INDIRECT DISCRIMINATION	25
Provision of Services	29
INDIRECT DISCRIMINATION	56
Imposition of Condition, Requirement or Practice	58
Unreasonable in all the Circumstances	67
Legal principles	67
The issues in relation to unreasonableness in all the circumstances	75
Witness and Evidence	88
The witnesses and their roles in assisting the Tribunal in determining this case	88
The categories of evidence and the value of the evidence provided	93
General observations of the witnesses	103
The Precautionary Principle and other Ethical Principles associated with Blood Banking	110
Risk Management Issues	131
Public Confidence and Perceptions of Blood Safety	143
The Perspective of the Blood Banker	147
Epidemiology and Science	151
The hierarchy of risk	157
Mathematical modelling	186
Prevalence and incidence	209
Epidemiology and sexually transmitted diseases (STIs) and MRSA	240
Social research	250
Comparison with other tolerated risks	260
History of Blood Transfusion and HIV/AIDS in Australia	270
History of the Deferral Policy	294
Background to the Current Donor Questionnaire	300
Current Situation with HIV and the Blood Supply in Australia	310
New England Journal of Medicine Article	316
The Harm Arising from the Current Deferral Policy and Benefits of Change	334
International Situation	341
Italy and Spain	348
Efficacy of the Donor Questionnaire	355
Oral Sex: non-epidemiological considerations	367
Condoms and Monogamy	374
Condoms	375
Monogamy	376
Statutory Obligations	377
Conclusion in Relation to Unreasonableness	379
Whether the Policy had the Effect of Disadvantaging Mr Cain	398
Whether Mr Cain was Disadvantaged as a Member of a Group sharing an Attribute more than a person who is not a Member of that Group	399
DIRECT DISCRIMINATION	403
Whether the Reason for the Treatment is on the Basis of the Prescribed Attributes of Lawful Sexual Activity or Sexual Orientation or a Characteristic Imputed to Attribute	406
Whether the Treatment of the Complainant was Less Favourable or Rather, Equal Treatment	431
Comparator	435
Detriment	442
STATUTORY EXCEPTION	450
Section 24 Exception of 'Statutory Authority'	452
1. Blood Transfusion (Limitation of Liability) Act 1986 (Tas)	457
2. Therapeutic Goods Legislation	504
3. Workplace Health and Safety Act 1995 (Tas)	533
Section 25	540
CONCLUSIONS	549
ORDER	562

Category		Estimated HIV incidence per year	Relative risk
Heterosexual men who always use condoms (partners not from high prevalence countries)		0.0015%	1 (reference)
Heterosexual men in general		0.0086%	5.75
Heterosexual men who never use condoms (partners not from high prevalence countries)		0.0300%	19.98
MSM in monogamous partnership where condom use is 100% (partner has risk of 0.5% p.a.)		0.05%	34.99
MSM who always use condoms	5% prevalence in MSM	0.09%	62.40
MSM who always use condoms	10% prevalence in MSM	0.19%	124.79
MSM in monogamous partnership: 5% condom use (partner has risk of 0.5% p.a.)	5% prevalence in MSM	0.16%	105.49
	10% prevalence in MSM	0.32%	210.98
MSM in general	5% prevalence in MSM	0.52%	348.25
MSM in general	10% prevalence in MSM	1.04%	696.51

Anti-Discrimination Decisions

[2009] TASADT 03

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