Current Issues

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

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