Ban on donation of blood imposed following male-to-male sexual contact to become temporary
The Finnish Medicines Agency (Fimea) has issued a new regulation on blood services. The most significant change is that male-to-male sexual contact no longer results in a permanent ban on the donation of blood. This change is based on a careful risk analysis and will not impair the safety of blood components in Finland.
Male-to-male sexual contact is a permanent or temporary obstacle to blood donation almost everywhere in the world. Based on infection statistics and risk evaluations, the risk of being infected with HIV for men who have sex with men is so high that it is viewed as posing an elevated risk to the safety of patients receiving donated blood.
According to the new official regulation, male-to-male sexual contact is still is an obstacle to blood donation in Finland, but the ban that was formerly permanent will become temporary, spanning the 12 months since the last sexual contact with another man. In practice, this change means that men who have had occasional sexual contacts with other men will be allowed to donate blood after the specified period has passed.
A temporary ban on blood donation after male-to-male sexual contact has been adopted for example in Sweden, Italy, the Czech Republic, Australia, Canada and England, while several other countries are currently investigating its possible adoption.
Selection of blood donors still important
The methods for testing blood donors have improved considerably and detect serious blood-borne diseases more reliably, and sooner after any infection, than in the past. Diseases tested in connection with blood donation include HIV, Hepatitis B and Hepatitis C. Among these, HIV is less common in Finland than on average in the EU.
Based on the risk analysis conducted in Finland, the safety of blood components will not be impaired by changing the ban on donation of blood after male-to-male sexual contact from permanent to temporary. This finding is supported by international risk analyses.
Although all blood donations are tested carefully, recent infections cannot be detected even by the best tests. Hence, careful selection of donors is still an important safety factor. Male-to-male sexual contact remains an obstacle to blood donation, as it poses a significantly higher risk of a fresh HIV infection than other types of sexual contact.
Other changes to the regulation
Fimea regulations 1/2008, 2/2008 and 3/2011 have been merged into one single regulation. At the same time, several amendments have been made. For example, in accordance with current practice, it was added that the selling and buying of sexual services will lead to a 12-month temporary ban on donations. Another addition clarifies various aspects of using blood components in urgent special cases.
Several amendments to the regulation address the quality control of blood components. Clarifications were also added to the requirements related to blood centres in hospitals. Furthermore, the content of the regulation was verified against other policies currently in force.
The regulation will take effect on 1 January 2014. By 1 June 2014 at the latest, the FRCBS must implement the new principles concerning eligibility to donate blood. The changeover period is needed in order to update procedures, survey forms and other material.