Scottish National Blood Transfusion Service POSITION STATEMENT: WHY WE ASK GAY MEN NOT TO GIVE BLOOD: Revised: 14th August 2007 Key Messages The decision to exclude men who have had sex with men is not intended to infringe the civil liberty of any individual It is based on robust scientific evidence and on a sincere and honest desire to protect the safety of the blood supply and the patients who receive it. The UK blood services use state of the art testing systems but we cannot test for everything. We do test all blood for HIV, Hepatitis B & C, syphilis and HTLV. However, even the most sensitive test may miss infected donations during the ‘window period’ between getting an infection and the test being able to show a positive result. The most recent data on the risk factors associated with these infections are reviewed annually by a panel of experts from blood transfusion services, hospitals and universities throughout the United Kingdom and consideration is given to changing the donor selection criteria We recognise that many gay men sincerely wish to help patients and may be frustrated and angry as a result of this rule. We ask that those affected by this rule observe it for the sake of blood safety. Background The primary responsibility of the Scottish National Blood Transfusion Service is to provide safe blood for patients in Scotland requiring transfusion. We do this in two ways: by selecting donors who are at low risk of infections and by testing every donation. Selecting safe donors means that we have to ask some people not to donate their blood. SNBTS is legally required to permanently exclude anyone whose sexual behaviour puts them at high risk of acquiring severe infectious diseases that can be transmitted by blood (Blood Safety And Quality Regulations (No 50) 2005). Acting on the advice from the Joint United Kingdom Blood Transfusion Services and National Institute of Biological Standards and Control Professional Advisory Committee (JPAC), the four United Kingdom Blood Transfusion Services are currently unable to accept blood donations from men who have ever had sex with a man because the most recent epidemiology indicates that this group is still at a significantly higher risk of exposure to transfusion transmissible infections. This donor selection rule is often misunderstood and perceived to be discriminatory. The decision to ask gay men who are or have been sexually active is in no way prejudicial or discriminatory but is based on the most up to date epidemiological information available on the transmission of blood borne viruses such as HIV, HTLV, Hepatitis B and hepatitis C in the UK. How we assess the risks The most recent data on the risk factors and behaviours associated with HIV, HTLV, Hepatitis B and hepatitis C infections in the UK are reviewed annually by a panel of experts from blood transfusion services, hospitals and universities throughout the United Kingdom and Footnote: This statement has been prepared by SNBTS after reviewing the evidence available in October 2005. Since then the annual review has continued but the format of the risk assessment has changed. The evidence still indicates that there remains a significantly higher risk of HIV infection in men who have sex with men when compared to the heterosexual population. At this time, SNBTS await the UK guidance resulting from the most up to date risk analysis conducted in 2006. 1 Scottish National Blood Transfusion Service POSITION STATEMENT: WHY WE ASK GAY MEN NOT TO GIVE BLOOD: Revised: 14th August 2007 consideration is given to changing the donor selection criteria. These data are used to identify groups within the population who may be at higher risk of infection. Of necessity the UK blood services need to consider risk at a population level because we cannot accurately assess the risk posed by any one individual. Understanding the Facts And Figures This donor selection rule is often misunderstood and perceived to be discriminatory. This is not the case. Recent media coverage on the increase in incidence of HIV transmission in heterosexuals has led to the widely held misinterpretation of the data to suggest that the risk of HIV infection is greater for heterosexuals than for homosexual men. While the absolute number of cases of HIV in heterosexuals diagnosed annually is greater than for men who have had sex with men, when the size of the respective populations is taken into account it can be seen that the relative risk of exposure is very different. In the 10 years preceding 2005 46% of HIV cases diagnosed were gay men. If we consider that only 5-10% of the population are men who have had sex with men yet this group give rise to just under half of all new cases diagnosed, this would indicate that a man who has had sex with a man is still seven times more likely to contract HIV than a heterosexual. Moreover, the situations in which heterosexuals are at risk of exposure are for the most part well defined, and result in deferral of those affected, and their partners, from blood donation for one year after potential exposure. With respect to current (most recent) data on HIV prevalence in the UK (i.e. new cases), from unlinked anonymous HIV testing surveys undertaken throughout the UK in 2003, it is evident that the prevalence of HIV among men who have sex with men is between 5 and 10 times the prevalence of HIV among heterosexual men and women: these observations apply to individuals attending genitourinary medicine clinics and exclude persons already known to be HIV infected. For MSM throughout the UK, the prevalence ranged from 1.8 to 5.2% and for heterosexual men and women between 0.1 to 0.7%. Risk Factors in Heterosexual Men and Women The increase in incidence of HIV in heterosexual men and women is a cause for concern, but review of the risk factors indicates that 76% of all heterosexual cases are associated with sex while abroad or with a partner from overseas. The most common geographical link is with partners in or from sub-Saharan Africa. This risk factor has been known since the mid 1980s and the UK services have questioned donors on this risk factor and excluded donors for this risk since that time. The UK Blood Services are often asked why we do not exclude women who have oral or anal sex with men while we exclude men who practice the same sexual acts. The risk of infection does not relate to any individual sexual practice but to the sexual partner. Therefore the UK services do exclude women who have had sex (oral, anal or vaginal) with a man who has had sex with a man, an iv drug user or someone who has been sexually active in sub-Saharan Africa. Footnote: This statement has been prepared by SNBTS after reviewing the evidence available in October 2005. Since then the annual review has continued but the format of the risk assessment has changed. The evidence still indicates that there remains a significantly higher risk of HIV infection in men who have sex with men when compared to the heterosexual population. At this time, SNBTS await the UK guidance resulting from the most up to date risk analysis conducted in 2006. 2 Scottish National Blood Transfusion Service POSITION STATEMENT: WHY WE ASK GAY MEN NOT TO GIVE BLOOD: Revised: 14th August 2007 Recent Blood Service Experience In the 5 years preceding 2005 over 100 new cases of HIV were detected by the UK transfusion services. 45% of these cases were from heterosexual men and women who had sex while abroad, sex with someone from overseas or a partner from another high-risk group. 28% of these cases were men who had sex with men. This is extremely worrying. Most gay men do not give blood and it is estimated that up to 97% comply with our rules. It is also estimated that less than 10% of the population are men who have had sex with men. This means that less than 1% of the population give rise to 28% of the cases of HIV that we detect in the donor population. Approximately half were new donors but more worryingly, the other half of these cases were gay men who had become infected between donations and who had not previously declared their lifestyle. We recognise that gay men may well not perceive themselves to be at risk because they practice ’safe sex’ or are in a monogamous relationship or always know the HIV status of their partner. If these men did not consider themselves to be at risk of infection, how could we as a service accurately assess individual risk? The fact that we consistently diagnose infection in men, who did not consider that they were at risk, and therefore did not declare it to us, clearly indicates that these risks are very real. How safe is ‘Safe Sex’? Although condoms can reduce the risk of transmitting infections, they cannot reduce the risk to such low levels as to make sexual activity risk free. The term preferred by the Terence Higgins Trust is ‘safer sex’. Safer sex will keep most gay men free from infection, however recent research (Hart & Williamson 2005) indicates that in Scotland there has been a significant rise in sexual behaviours which would increase the risk of HIV infection, while at the same time there is a decreased awareness and perception of risk of infection. Additionally research shows that allowing gay men, as a group, to donate would increase the risk of HIV infected blood entering the blood supply. Abolishing the rule for gay men would increase the risk of an HIV infected donation entering the blood supply by about five times and changing the rule to allow gay men to donate one year after they last had sex with a man would increase the risk by 60% (Soldan & Sinka 2003). How effective is testing? There is a misconception that the need to exclude gay men is unnecessary because we test for everything. This is not true. The UK blood services use state of the art testing systems but we cannot test for everything. We do test all blood for HIV, Hepatitis B & C, syphilis and HTLV. However, even the most sensitive test may miss infected donations during the ‘window period’ between getting an infection and the test being able to show a positive result. Such donations can be highly infectious, and it is for this reason that transfusion services throughout the world regard donor selection based on risk behaviour as vitally important even when the most sophisticated testing strategies are in place. That’s why it is so important that donors read the health check carefully every time and answer the questions honestly. Many men who contact us tell us that they are regularly tested and that they therefore consider themselves safe to give blood, The results of regular testing, while reassuring to the individual, do not help us to assess the risk of a window period donation, since this can only occur in an individual who has been uninfected until a recent exposure has occurred. Footnote: This statement has been prepared by SNBTS after reviewing the evidence available in October 2005. Since then the annual review has continued but the format of the risk assessment has changed. The evidence still indicates that there remains a significantly higher risk of HIV infection in men who have sex with men when compared to the heterosexual population. At this time, SNBTS await the UK guidance resulting from the most up to date risk analysis conducted in 2006. 3 Scottish National Blood Transfusion Service POSITION STATEMENT: WHY WE ASK GAY MEN NOT TO GIVE BLOOD: Revised: 14th August 2007 How important is it to answer truthfully? Evidence of how important this type of donor selection is can be seen in the data which show that 76% of new heterosexual HIV infections in the general UK population result from sexual activity with a partner from an area outside the UK with a high prevalence of infection, while only 55% of the heterosexual cases detected in the blood donor population can be ascribed to this risk behaviour. This shows that the risk is significantly reduced by selecting safe donors and deferring affected donors until there is no risk of a ‘window period’ donation. Why are all MSM permanently excluded? We recognise that within the gay male community there is a variety of lifestyles and acknowledge that many gay men are monogamous, use condoms and seek regular testing. While it would seem logical to assume that this would significantly reduce the risk of contracting HIV or Hepatitis, the available data does not have sufficient detail to allow us to assess the remaining risk in order to consider changing the donor selection criteria. No alternative set of donor eligibility criteria (even including practice of safe sex or a low number of lifetime partners) has yet been found to reliably identify MSM who are not at increased risk for HIV or certain other transfusion transmissible infections. Legal Requirements In the UK (and the European Union) the Consumer Protection Act (CPA) requires the blood services to provide safe transfusions. This status of blood as a product required to be safe was defined in the 2001 judgement of Mr Justice Burton. It is conceivable that additional HIV transmissions by blood that occurred after a relaxation of the donor guidelines would not only represent a “non-standard” product under the CPA but could be interpreted as negligence, given that the ways and means of maintaining blood safety were known to the UK blood services but were wilfully relaxed. Civil Rights Every individual has the right to be considered to be a blood donor. Every donor who is not accepted to give blood has a right to receive a clear explanation as to why they cannot donate. The patients who receive blood are vulnerable and require the very best care that we can provide. They have the right to expect that the blood they receive is as safe as possible. We realise that many gay men sincerely wish to help patients and may be frustrated and angry as a result of this rule. The decision to exclude men who have had sex with men is not intended to infringe the civil liberty of any individual but is based on robust scientific evidence and on a sincere and honest desire to protect the safety of the blood supply and the patients who receive it. We ask that those affected by this rule observe it for the sake of blood safety. Footnote: This statement has been prepared by SNBTS after reviewing the evidence available in October 2005. Since then the annual review has continued but the format of the risk assessment has changed. The evidence still indicates that there remains a significantly higher risk of HIV infection in men who have sex with men when compared to the heterosexual population. At this time, SNBTS await the UK guidance resulting from the most up to date risk analysis conducted in 2006. 4