MSM DEFERRAL POLICY ISSUE DOCUMENT: MSM DEFERRAL ISSUE BACKGROUND

Transcription

1 MSM DEFERRAL POLICY ISSUE DOCUMENT: MSM DEFERRAL ISSUE Countries around the world are reviewing the policy of deferring from blood donation men who have had sex with men (MSM). Both Canadian Blood Services (CBS) and Héma Québec have made or will make submissions to Health Canada to reduce the deferral to 5 years; that is to say, that any man who has had sex with another man in the last 5 years will not be able to donate blood. BACKGROUND History In the 1980s, blood authorities around the world introduced a question in the donor questionnaire so as to be able to defer MSM. In Canada, the question became: Male donors: Have you had sex with a man, even one time since 1977? The year 1977 was chosen as this was the year HIV is thought to have entered the population. That question has not changed in more than 20 years. A test to detect HIV in blood donations was introduced in 1985 and the tests have been perfected over the years. Today, two tests are used: an ELIZA antibody test and a nucleic amplification test. Together they have reduced the window period, the period after infection when the tests do not detect infection, to 12 days. Automation and computerization have reduced the risk of test, handling or administrative errors. Current HIV risk The risk of an HIV positive unit escaping detection in Canada is now estimated by CBS at 1 in 8 million units donated. In practice, however, the risk has proven to be even lower. Since the addition of the nucleic amplification test more than a decade ago, no HIVpositive blood donation has escaped detection in Canada. More than 1 million donations are made each year. Modelling has estimated that a change to a 5 year deferral for MSM would result in an additional HIV positive blood donation in Canada every 500 years. There is little argument among blood safety experts, given current screening and testing, that a short deferral (e.g. one year) is necessary to protect the blood system against HIV through window period donations and errors. Current epidemiological data shows that men who have had sex with men are at much greater risk for HIV/AIDS infection than other people. While HIV in Canada is not restricted to the MSM population, the infection rate is tragically high in this group. Assuming that 5% of the male Canadian population are MSM, current Canadian epidemiological data places the HIV/AIDS prevalence at approximately 4.2 per cent for MSM. This compares to per cent in the non MSM, non IV drug user male population. In other words, using this analysis based on published CHS Board of Directors / Page 1

2 Canadian data, a male truthfully answering YES to the MSM question is 263 times (4.2/0.016) more likely to be HIV infected than a male who truthfully answers NO. Current laboratory tests used to test for HIV, HBV and HCV on collected blood are highly sensitive and can detect a unit as being potentially infectious shortly after acquisition of infection. However, a small risk of undetected infectivity remains due to the window period immediately following infection, false negative tests, technical errors and inappropriate release. Consequently, a donor deferral based on MSM activity remains critical. The question is how long. Other permanent deferrals Lengthy deferrals do not target only MSM. Examples of permanent deferrals currently in place to safeguard the blood system are: people who have spent more than three months in the United Kingdom or France between 1980 and This regulation is intended to reduce the risk from variant Creutzfeldt Jakob disease (vcjd), caused by the ingestion of bovine products infected with bovine spongiform encephalopathy (BSE) or Mad Cow Disease; people who have taken illegal drugs or illegal steroids with a needle, even one time; people who have taken money or drugs for sex, even one time; people who have ever taken clotting factor concentrates, such as hemophiliacs (even if they have used only recombinant products). Alternatives to the MSM question While there has been little pressure to review these latter deferrals, there has been considerable pressure around the world on the part of lesbian gay bisexual transgendertwo spirited queer (LGBTTQ) groups and student federations to reduce or eliminate the MSM deferral, based on the perception of unjust discrimination. These groups have proposed gender neutral questions based on high risk vs. low risk sexual behaviours, for example: How many sexual partners have you had in the last year? Have you practiced anal sex? Have you practiced safe sex? Experts in blood safety, however, consider gender neutral risk behaviour based criteria cannot be considered adequate to maintain the safety of the blood supply. To pressure for change, some university student groups have barred CBS and Héma Québec from holding blood drives on their campuses. Both CBS and Héma Québec are concerned that young people, perceiving that blood donation is discriminatory, will choose not to become blood donors, endangering future supplies in an ageing population. Legal challenges In Canada, a series of court and human rights challenges to the deferral have failed. The latest was the case of CBS vs. Freeman, at which the CHS was an intervenor. It resulted in a 2010 decision by the Ontario Superior Court. Justice Aitken found that: CHS Board of Directors / Page 2

3 Blood donation is a gift. A gift is freely offered, but must also be freely received or freely declined. Canadian law has never recognized a duty or requirement to accept the gift of blood from anyone. Therefore, there is no discrimination when that gift is refused for reasons of health and safety. The MSM donor selection policy does not discriminate on the grounds of sexual orientation. The deferral is based on health and safety considerations, namely, the prevalence of HIV/AIDS (and other blood borne sexually transmitted infections) in the MSM population. It is beyond debate that protecting blood recipients from the transmission of HIV and other such pathogens is an objective of pressing and substantial importance. There was insufficient evidence presented at trial to justify the indefinite deferral currently in place. The threat of emerging pathogens, however, must be considered when establishing deferral periods for populations at high risk for sexually transmitted infections. Pathogens may enter the blood supply and remain undetected or badly understood for many years. A deferral period for MSM in excess of 10 years might well be considered reasonably prudent to meet the objective of a safe blood supply. By their very nature blood donor screening and deferral criteria make distinctions among donor populations; however, legal judgments have found they are reasonably justifiable where they provide increased protection to public health. While the risk of HIV transmission through the transfusion of blood and blood products has been reduced significantly, the transmission of blood borne pathogens including HIV remains significant among men who have sex with other men. In the absence of perfect testing, donor screening, including MSM deferral, remains an essential component of blood safety. MSM deferrals around the world Around the world, the MSM deferral is changing. In the U.S., the deferral has remained since 1977 ; however, there is a research initiative to try to find alternative questions that focus on behaviour rather than gender. In both the U.K and Australia, the deferral has been reduced to one year. In Australia, more than 5 years of data ( ) have shown that the number of HIV positive donations has not increased statistically compared to the 5 years previously when the deferral was permanent. In New Zealand, the deferral was reduced to 10 years, and then to 5 years. A European Union Advisory Group will likely not recommend a change in the permanent deferral, but may refer the matter to the country level. Sweden has indicated it will adopt a 1 year deferral. Emerging pathogens The principal argument put forward by the CHS to maintain a longer deferral has been the risk of the next HIV that would follow the same path as syphilis, hepatitis B and HIV with high prevalence in the MSM population. To be a concern, such a pathogen would need to cause disease, be blood transmissible, be sexually transmitted and have a long period between the time it enters the MSM population, causes symptoms, is recognized and a CHS Board of Directors / Page 3

4 screening test developed. In 2011, to cover this silent period, the CHS Board adopted a policy calling for a deferral of at least 10 years. Blood experts around the world point out that none of the risks to blood safety that have emerged in the last 25 years have followed the MSM route. For example: Variant Creutzfeldt Jakob Disease: ingestion of infected beef, mainly in the U.K. West Nile Virus: mosquitoes, mainly in the U.S. Babesiosis: deer ticks, mainly in New England Chickungunya: mosquitoes, mainly in Iles de la Réunion Dengue fever: mosquitoes, mainly in Australia and southeastern Asia Chagas disease: reduviidae bugs, mainly in South America They also state that our collective capacity to respond to an emerging threat is far superior to what it was in 1977 when HIV began to spread. They cite: increased surveillance of emerging diseases, notably to quickly respond to a flu pandemic instantaneous communications better understanding of viruses faster development of blood screening tests a much lower threshold for action. As a result, it is difficult to argue that a 10 year deferral is actually safer than a 5 year deferral. Recent developments In Canada in 2011, the CBS Board of Directors voted to change the deferral to not less than 5 years and not more than 10 years. It undertook broad consultation with student, LGBTTQ and patient groups (including the CHS), as well as its own National Liaison Committee. CBS is currently preparing a submission to Health Canada to request a 5 year MSM deferral. Héma Québec is doing the same. Health Canada has the final word and has 90 days to respond. A 5 year deferral What would a 5 year deferral really mean? It would mean that any man who has had sex with another man, even once, in the last 5 years would be deferred from donating blood. Even MSM living in a monogamous relationship, and practicing safe sex, would be deferred. Those who would become eligible to donate would be: men who had been sexually abused in the past men who had sexually experimented with another man in the past. Epidemiologists have estimated that if a new disease were to emerge in the MSM population, it would more likely affect MSM having frequent sex with multiple partners than a person with rare, distant MSM activity. CHS Board of Directors / Page 4

5 CBS and Héma Québec would carefully monitor infectious disease rates among donors to ensure that the change does not result in a higher risk donor pool. A change to a 5 year deferral could conceivably result in an end to the student boycotts of blood drives and greater willingness on the part of young people to become blood donors. According to an Ipsos Reid poll, 65% of respondents who are members of the Canadian Federation of Students would be more likely to donate blood if the deferral was reduced to 5 years. The number of new donors among MSM would be very small. Incremental change While there is broad support, even a consensus, among student and LGBTTQ groups in favour of the change to a 5 year deferral, it is clear that many of them see this as the first in a series of incremental changes. For many, the ultimate goal is a gender neutral, behaviour based questionnaire. They do accept, however, that maintaining the safety of the blood supply is paramount and that any change must be supported by well validated research showing that any change will maintain the current level of safety in the blood supply or even improve it. Written by David Page Reviewed by the CHS Blood Safety and Supply Committee: Tom Alloway, Ph.D.; Diane Bissonnette, RN; Sarah Crymble; Bill Featherstone; Michael King, MD; Martin Kukczyk; David Page; Mohammad Qadura, MD; Bruce Ritchie, MD; Craig Upshaw; Paul Wilton CHS Board of Directors / Page 5

6 Annex 1: CHS Policy on MSM Canadian Hemophilia Society Policy on the Donor Deferral for a Man Who Has Had Sex with Another Man Given that the donor deferral criteria regarding a mnn having had sex with another man (MSM) range from since 1977 (Canada, U.S., France, Ireland and many other countries in Europe) to 5 years (New Zealand) to 1 year (Australia, U.K.); Given that Canadian Blood Services and Héma Québec have recommended a 5 year deferral for MSM activity and this proposal will be submitted to Health Canada in 2012; Given that the Ontario Superior Court found in the case of CBS vs. Freeman that the MSM deferral does not discriminate on the basis of sexual orientation, and that it has a pressing and substantial objective; Given that the Ontario Superior Court also found that a permanent ( since 1977 ) deferral was not justified as regards known pathogens; Given that a time limited deferral is justified for known pathogens on the basis of the continued high prevalence of HIV, hepatitis B and other known blood borne pathogens in the MSM population compared to the non MSM population; Given that screening tests, while able to screen for known pathogens, are unable to reduce risk from new or unidentified pathogens with long periods between infection of potential donors and detection in the blood donation context; Given that pathogens that have affected the blood system in the last 20 years were introduced through consumption of beef (e.g. vcjd) and insect bites (e.g. Chagas Disease, chikungunya, West Nile Virus, babesiosis, Lime disease), and not through sexual transmission; Given that donor deferral of higher risk populations can be effective in reducing risk from emerging pathogens; Given that the silent period between emergence of a blood borne pathogen, symptoms in people, understanding of the epidemiology and development of a screening test was longer than 5 years before 1990 (e.g. HIV; 5 to 8 years; HCV: 15 to 20 years) but that surveillance, communications and test development have improved considerably over the last two decades; Recognizing that the risk of new pathogens transmitted through MSM activity remains theoretical and that the silent period cannot be predicted; Given that pathogen inactivation procedures are not yet available for the full range of labile blood products and won t be for several years; Given that alternate donor screening measures (e.g. gender neutral, behavioural based questioning) have been neither developed nor validated; CHS Board of Directors / Page 6

7 Given that the benefit to the blood system in terms of new donors if a 12 month deferral of MSM were to be introduced would be negligible; Be it moved that the CHS supports a donor deferral regarding MSM of 5 years and recommends that rigourous surveillance of transmissible disease rates among donors be conducted. In addition, the CHS supports the researching, development and validation of alternatives to the MSM question that will maintain the current level of safety. Adopted by the Canadian Hemophilia Society Board of Directors, September 29, 2012 N.B. This policy replaces the previous CHS policy adopted in November 2005 and amended in CHS Board of Directors / Page 7