Give Blood England and Wales

Exclusion of Men who have Sex with Men from Blood Donation

Frequently Asked Questions

How can the National Blood Service justify a policy which discriminates against gay men?
The policy is in place for the sole purpose of protecting public health by minimising the risk of transmission of HIV and other blood-borne viruses to patients through the blood which we supply to hospitals. Men who have ever had sex with men are at a higher risk of carrying such viruses. Since it is specific sexual behaviour which places individuals at risk, rather than their sexuality, there is no exclusion of gay men who have never had sex with another man, nor of women who have sex with women.

The policy has been adopted by all of the UK Blood Services on the recommendation of the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) http://www.dh.gov.uk/ab/SaBTO/index.htm. This body provides the Government with independent expert advice on issues of safety relating to blood, tissues, cells and organs.

The criteria for the exclusion of men who have sex with men from giving blood is kept under regular review. The last review took place in January 2007, and a range of research (as outlined in the position statement) was commissioned. This research was presented to the July 2009 meeting of SaBTO, and forms part of the ongoing comprehensive review of the current policy.

Why is this policy necessary if all blood donations are tested?
The National Blood Service has a responsibility to assure the safety of the blood supplied to hospitals for patients. Although all blood donations are tested for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis and human T-lymphotropic virus (HTLV), there is a period after a person contracts an infection – known as the ‘window period' - when tests can't detect these viruses in the blood.

This rigorous approach has resulted in the National Blood Service's good safety record. Since the introduction of testing for HIV in 1985, there have been three cases of transmission of the virus to patients through blood from donors in the ‘window period'. Although the risk of such transmission is low, we work on the basis that any transmission is one too many.

Isn't this policy outdated, given the work which has been done to promote safe sex among gay men?
While campaigns have certainly done a great deal to promote safer sex, there is still no such thing as completely safe sex. Decisions as to who can give blood are made using up-to-date evidence based on patterns of disease in the UK population.

Men who have sex with men are currently at the greatest risk statistically of acquiring most sexually-transmitted infections, such as syphilis.

Why is this exclusion lifelong? Wouldn't a one-year deferral pick up recently-acquired infections?
Although most new HIV infections would be detected, there is a risk that some would still be undetectable. While changing the policy to a one-year deferral has been considered, the risk of transmission of HIV into the blood supply – based on current evidence – is deemed too high to justify a change in the policy. While the absolute risk is small, any transmission as a result of a change in policy would be one too many.

How can the National Blood Service continue to justify this policy in the face of the latest statistics suggesting that HIV is now more prevalent in heterosexuals than gay men in this country?
As a group, men who have sex with men have a far higher chance of carrying HIV than the heterosexual population..

Statistics also show that the majority of new cases amongst heterosexuals were acquired in countries outside the UK where HIV is very common, such as those in sub-Saharan Africa. For this reason, people who have been sexually active in such high-risk countries, or who have a partner who has been, are also excluded for one year after the last relevant sexual contact. This exclusion was agreed on the basis of the lower risk that this group presents overall and the need to maintain a sufficient supply of rarer blood types – such as Group B – for the treatment of conditions, such as Sickle Cell Disease, only found in patients from ethnic minority communities. This policy is also kept under regular review.

Why doesn’t the National Blood Service exclude promiscuous heterosexuals?
Current evidence shows that sex between men still represents the greatest risk factor for the transmission of infections which could be passed on through donated blood.

Heterosexuals who engage in activities, sexual or otherwise, which put them at risk of blood-borne infections are excluded from donating blood. The length of this exclusion depends on the specific activity. For example, anyone who has ever had sex for drugs or money – regardless of their sexuality – is excluded permanently from giving blood, as is anyone who has ever injected drugs.

How can it be fair to treat all gay men as high risk? What about those in long-term monogamous relationships?
There are, clearly, a range of lifestyles among gay men, with many practising safer sex and seeking regular HIV testing. However, given that the National Blood Service must collect 7,000 donations of blood every day to meet demand from hospitals, it is not feasible to take a detailed sexual history from every potential donor.

Isn’t there a risk of those gay men who don’t agree with the policy donating anyway?
The National Blood Service relies entirely on volunteers; and the underlying principle on which people give blood has to be one of mutual trust. Our only aim in applying this policy is to ensure the safety of the blood on which patients depend. We believe that the vast majority of donors understand and respect this.

It is not clear whether a change to the policy would make people more or less likely to comply with it; this is currently being considered. This research is due to be completed by Summer 2010.

Other EU countries, such as Italy, have lifted this exclusion. Why doesn't the UK follow suit?
Although donor selection policies in Europe are guided by EU law, each Member State must make decisions within this legislative framework based on evidence regarding patterns of diseases which can be transmitted by blood in their population. Although men who have ever had sex with men are deferred from donating in most European countries, this can account for occasional variations in policy within the EU.

How can you justify excluding men who have sex with men from donating when there are blood shortages in this country?
There has been a safe and sufficient blood supply in this country for many years, although the rate of blood donations is subject to fluctuations. This is when we make particular efforts to ask the public – particularly those with rare blood groups – to give blood.

The safety of the blood supply is paramount; the exclusion of men who have sex with men from giving blood is in place to protect patient safety.

Will the current exclusion of men who have sex with men from giving blood ever be lifted or amended?
The criteria as to who can give blood are agreed by the Department of Health's Advisory Committee on the Safety of Blood, Tissue and Organs (SaBTO), made up of doctors, scientists, infection specialists and other independent experts. The committee makes recommendations to the Department of Health, with the current criteria being reviewed on a regular basis.

Research is currently underway as to whether this policy could be relaxed to allow men who have sex with men to give blood one year after their last sexual contact. However, the policy would only be changed on the basis of clear evidence that patients would not be put at jeopardy. In addition, scientific advances in virus testing and inactivation are monitored. Any significant new developments in this area could lead to the policy being reviewed.

Why can't gay men donate blood in the UK when they are able to donate organs?
As with all clinical decisions about the use of donated blood and organs, the difference in the selection criteria rests on weighing up the potential risks and benefits to patients.

There is a shortage of organs available for transplantation in this country, with more than 8,000 people currently on the waiting list, so every potential organ donation must be considered. The decision as to whether organs are suitable for transplantation is always made by a specialist taking into account the potential donor's medical history. The only two instances in which organ donation is currently completely ruled out are where the donor has been diagnosed with HIV or has, or is suspected of having, Creutzfeldt-Jakob Disease (CJD).

Blood is taken from all potential organ donors and tested for transmissible diseases and viruses such as HIV and hepatitis.

Whilst this difference in selection criteria may appear contradictory, weighing up the clinical benefits and risks to patients of any procedure is common medical practice.

Exclusion of Men who have Sex with Men from Blood Donation

Summary of International Policies relating to the Exclusion of Men who have Sex with Men from Blood Donation

Europe
EC Directive 2004/33 states that “persons whose sexual behaviour puts them at high risk of acquiring severe infectious diseases that can be transmitted by blood" must be permanently deferred from donating blood. The directive is legally binding for all EU Member States and is in place to protect the recipients of blood and safeguard a safe, high-quality blood supply in the EU. Donor selection criteria are laid out in the directive, and Member States must implement these in their national laws.

In March 2008, the Council of Europe also issued a "Resolution on Donor Responsibility and Limitations of the Right to Donate Blood or its Components" ( Resolution CM/Res (2008)5). This resolution concluded that the fundamental right of the patient to receive the safest possible blood overrides all other considerations, including individuals’ willingness to donate blood. This resolution was adopted by all Member States.

It is important to note that although donor selection policies in Europe are guided by EU law, each member state must make decisions within this legislative framework based on evidence regarding patterns of diseases which can be transmitted by blood in their population. Although men who have sex with men are deferred from donating in most European countries, this can account for occasional variations in policy within the EU.

The table below shows which EU member states also belong to the European Blood Alliance (EBA), an organisation established in 1998 for the purpose of contributing to the safety and security of the blood supply for the citizens of the Europe by developing and maintaining an efficient and strong network of partner blood services across Europe.

In 2005, the EBA reviewed policies on men who have sex with men and blood donation amongst its members. It also examined whether the exclusion of men who have sex with men was warranted on the grounds of blood safety. The conclusion of the report, to which all EBA members subscribed, was that available data on patterns of disease transmission indicates that sex between men has an associated high risk of acquiring infections which can be transmitted by blood (including HIV). The report further concluded that, despite improvements in testing, donor selection is the most powerful safety measure for recipients of blood. This report has been regularly reviewed.

EU member state	Member of European Blood Alliance
Austria	√
Belgium	√
Bulgaria
Cyprus
Czech Republic
Denmark	√
Estonia	√
Finland	√
France	√
Germany	√
Greece
Hungary	√
Ireland	√
Italy
Latvia	√
Lithuania	√
Luxembourg	√
Malta	√
Netherlands	√
Poland
Portugal	√
Romania
Slovakia
Slovenia	√
Spain
Sweden	√
United Kingdom	√

Italy
Since 2001, donors who engage in sexual activity with a high risk of transmission of diseases which can be transmitted through blood are permanently deferred from donating . If a person has sex with an occasional partner or a person infected with HIV, or hepatitis B or C, they are temporarily deferred for four months after the last relevant activity.

Spain
The Spanish Red Cross defers donors who have engaged in risky sexual behaviour (such as sex without a condom) for twelve months, but does not explicitly exclude men who have sex with men from blood donation.

United States
Donor selection criteria relating to donor and patient safety in the United States are determined by regulations and guidance publicly reviewed at meetings of the US Food and Drug Administration (FDA) Blood Products Advisory Committee. These are published as regulations and guidance.

At present, men who have ever had sex with men since 1977 are indefinitely excluded from donating blood or blood components. This policy was introduced in 1983 following changes in patterns of diseases which can be transmitted by blood, such as HIV, in the US population. In 2000 and then again in 2006, blood banking organisations in the United States recommended modification of the deferral criteria for blood donation by men who have had sex with men based on the availability of new tests and consideration of the decreased risk. The FDA has not, to-date, accepted these recommendations.

Canada
The Canadian Blood Service (CBS) currently excludes men who have ever had sex with men since 1977 on an indefinite basis. This policy is based on the much higher prevalence and incidence of HIV in men who have had sex with men, than among the exclusively heterosexual population in Canada (as per Public Health Agency statistics – December 2006).

The most recent review of the policy took place in 2007. This included an examination of existing literature, analysis of surveillance data, assessment of international MSM policies, an independent risk assessment, and stakeholder consultation.

Following this review, it was determined – in June 2007 - that the current policy of excluding men who have had sex with men from blood donation should continue, while conducting research to inform future decision-making on the issue. CBS is currently taking steps to improve understanding of emerging pathogens in specific populations, examine the risks and benefits of behavioural-based donor screening questions and monitor the experiences of blood services which have shortened the deferral period for men who have had sex with men.

Australia
Men who have sex with men and their male and female partners are deferred for twelve months after their last sexual contact in Australia. The policy was implemented on a national basis in 2000. Before then, each Australian State blood bank operated a range of policies, including permanent deferral of men who had had sex with men since 1977 and twelve-month deferral following the last relevant sexual activity.

Blood and blood components constitute therapeutic goods as defined in the Therapeutic Goods Act 1989 (Cth). As the manufacturer under a licence from the Therapeutic Goods Administration, the Australian Red Cross Blood Service is required to comply with the Act in relation to blood safety and quality. The Act requires blood and blood components to be manufactured in accordance with the Council of Europe document Guide to the Preparation, Use and Quality Assurance of Blood Components. This document therefore determines donor selection criteria.

New Zealand
The New Zealand Blood Service (NZBS) is responsible for establishing and managing donor selection criteria. NZBS is a government organisation, and, as such, is subject to the New Zealand Bill of Rights. The law requires that the restriction on individual rights should be no more than is required to achieve the goal, in this case, a safe blood supply. Any changes to the donor selection criteria must also be reviewed and endorsed by Medsafe (the regulator) before implementation.

Currently, men who have sex with men are deferred from blood donation for a period of ten years. This was introduced in 1999 as part of the standardisation of practice following the establishment of a national blood service. Before this, different policies were in place across the country, including permanent deferral and ten-year deferral.

At the end of 2007, an independent expert team was commissioned to review the current policy. The review concluded that the period of deferral for men who have sex with men should be changed to five years. This was based on an analysis of the scientific literature and epidemiology (disease patterns in the population) of HIV in New Zealand. Approval has since been obtained from the regulatory authority to make the change, and systems are currently being designed to support implementation of the new policy in March 2009.

March 2009