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A Voice of Reason on HIV and Blood Donation – From Ireland

Posted on: October 15th, 2013 by Art Leonard No Comments

In the United States, men who have had sex with men (even once) since 1977 are permanently disqualified from donating blood.  This rule, adopting by the Food and Drug Administration (FDA) in the mid-1980s shortly after epidemiological studies had demonstrated that whatever was causing AIDS was probably a blood-borne pathogen, but also shortly before the particular viral vector had been shown and well before there was detailed information about how it was transmitted and what the risk of transmission was, has persisted, even though scientific evidence was mounting that it was unnecessarily imposing a categorical stigma on a segment of the population that was unwarranted by public health concerns.

Even though the vote was close, the most recent consideration of this issue by those empowered in the United States to recommend and make blood donation policy has failed to change the rule.  In other countries where these decisions are grounded more firmly in science and less in politics, changes have been made.  In Canada and Great Britain, the lifetime deferral policy has been abandoned and instead men who have had sex with men are placed in the same category as others whose sexual activities and behavior may subject them to heightened risk of contracting HIV and being able to transmit it through blood donations: such individuals may not donate blood within one year of their last risky behavior in England, Scotland and Wales, while Canada has adopted a five-year rule with some indication that it may be reconsidered in light of what the UK has done.  (Debate continues about how to define risky behavior for this purpose.  Should it include unprotected oral sex?  Should it include anal sex with condoms?)

In the U.K., an Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) recommended a one-year deferral rule, which was promptly adopted by the Health Ministers in England, Wales and Scotland.  But the Health Minister for Northern Ireland, one Edwin Poots, dithered and punted and indicated that he needed more information.  This was in the late fall of 2011.  After the lifetime deferral policy was lifted elsewhere in the U.K., an Irish resident who would have been disqualified under the new rule but who had experienced a religious conversion and had abandoned a “gay lifestyle” was angered that he would be subjected to a lifetime deferral rule and brought suit anonymously in the High Court of Justice in Northern Ireland, contending that the refusal of the Health Minister to adopt the new one year deferral rule recommended by the Advisory Committee was legally improper due to its irrationality in light of the scientific evidence, findings and recommendations of the SaBTO Report.  He also maintained that it was motivated by anti-gay bias, in violation of the European Convention on Human Rights.

On October 11,2013,  Mr. Justice Seamus Treacy stated his agreement with the anonymous applicant in Matter of an Application by JR65 for Judicial Review, [2013] NIQB 101, finding the Northern Ireland Health Minister’s decision to leave the lifetime deferral policy intact to be irrational and beyond his authority to do on a unilateral basis.  The applicant had suggested anti-gay animus, due to the Health Minister’s political affiliations, but Justice Treacy did not have to go there to reach his conclusions.  Having found that the Minister’s failure to adopt the SaBTO’s recommendations constituted a decision which could be challenged under judicial review, Justice Treacy reasoned that it was not totally irrational for the Health Minister to consider that men who had sex with men presented a higher risk of HIV transmission, in general, than other population groups subjected to non-lifetime deferral policies.  On the other hand, noting that all the other jurisdictions in the UK had adopted the recommendation, and that every year Northern Ireland required blood in excess of that collected locally and obtained it from sources that were using the new one-year deferral policy, Treacy found reason to question the rationality of the decision to maintain the more stringent rule for Northern Ireland.

He wrote, “The Minister has decided that MSM behavior creates such a high risk of infection to the donor  [I think he means to the recipient] that such donors must be permanently deferred with the result that such blood cannot enter the Northern Ireland Blood Stock. Importing blood from other places which do accept MSM donors, even in limited quantities, leaves the door open for MSM blood to do just that.  There is clearly a defect in reason here.  If there is a genuine concern about safety of MSM donated blood such the blood stock must be protected absolutely from such blood then the security of that blood must actually be maintained absolutely.  Applying a different standard to imported blood defeats the whole purpose of permanent deferral of MSM donors.  . . .  [W]hen blood is imported from the rest of the U.K., the authorities in NI do not request that such blood is not derived from the MSM community.”  Thus, in this respect, the Health Minister’s decision was irrational.

As to the charge of discrimination, Justice Treacy observed that the deferral category is based on behavior, not sexual orientation or identity.  Population studies show that a much larger percentage of gay men are HIV-positive than non-gay men.  “That male homosexual intercourse occurs mostly between men who are homosexual is unavoidable,” he said.

But he went on to develop at length the argument that the Health Minister was exceeding his authority when he made the decision to maintain the current system in the face of the SaBTO Report and its recommendation to shorten the deferral period from lifetime to one year, inasmuch as various laws and rules suggested that this was a matter that should have been brought before other authorities and not decided unilaterally by the Health Minister.   Indeed,the judge found a breach of the code of conduct binding on cabinet Ministers.  “The issue at hand is both controversial (it has generated much publicity and public debate, and views on the issue are highly polarized) and cross-cutting (it is acknowledged in the SaBTO report that it touches on equality issues, it further deals with the implement of EU Directives) and as such the Minister had no authority to act without bringing it to the attention of the Executive Committee.”

Thus, the court concluded that the “decision of the Minister was irrational” and “the application for judicial review is allowed.”

When I saw the first headlines about this ruling emanating from the press in Ireland and Britain, I thought the decision had taken a different route than it actually took to get to its conclusion.  Justice Treacy actually found that the decision could have been rationally and appropriately taken by the Executive Committee based on the scientific evidence to maintain the lifetime deferral if it were possible for Northern Ireland to get by without requesting additional blood supplies from other jurisdictions that have moved to the one-year deferral system.  I part company with him on this.  Based on the excerpts he quotes from the SaBTO report, it appears to me that the Report suggests that going from a lifetime deferral down to a 12 month deferral for men who have sex with men does not statistically increase the risk of HIV transmission through donated blood for a variety of reasons, including one that perhaps the Report does not even discuss:  that HIV-positive men who are adhering to the current generation of anti-viral drugs can so reduce the incidence of HIV in their blood stream as to almost entirely eliminate the risk of transmitting it, even in unprotected anal sex.  What the Report does show, through statistical analysis of cases of HIV transmission through blood donations, is that more such transmissions take place from heterosexual donors than from gay male donors, mainly from HIV-positive heterosexual women and IV-drug users of both sexes.  Furthermore, a more workably short deferral period  combined with major testing advances have reduced the dangerous “window” period during which recent infection does not trigger antigen tests to about nine days after exposure, during which a false negative test might occur.  Taking all these factors together, reducing the deferral period to a year does not increase the risk sufficiently to outweigh the harm of deferring many potential donors who present almost no risk, at a time of continuing shortages of blood, as shown by Northern Ireland’s need to import blood every year to make up the shortfall.   As public policy, it’s really not worthy of serious doubt; the lifetime deferral challenged in this case — and still in effect in the US due to the timorous Food and Drug Administration — is contrary to good public health policy.