Blood donation must comply with certain rules that ensure the safety of both the donor and the recipient.

These rules are defined by a European directive, based on donor selection criteria common to all EU member states. In France, this directive is implemented through a ministerial decree.

Within this framework, a doctor or nurse from the EFS who has received specific training assesses potential contraindications with the donor during a confidential interview known as the “pre-donation interview.”

Contraindications to blood donation can be permanent or temporary. The latest update to these contraindications was established by the decree of January 11, 2022.

Permanent contraindications include active infections known to be transmissible through blood (viral hepatitis, syphilis, HIV or HTLV infection, Chagas disease, malaria); situations involving exposure to undetectable transmissible agents such as prions (cumulative stays of more than one year in the United Kingdom between 1980 and 1996, growth hormone treatment prior to 1989, a family history of prion disease, a history of corneal or dura mater transplantation, a history of brain or eye surgery prior to April 2001); a history of blood transfusion or organ transplantation, or intravenous or intramuscular drug use, including non-medical doping substances, due to a potential risk of exposure to an emerging pathogen.

Temporary contraindications are justified by a recent risk of exposure to an infectious agent, such as a new sexual partner or multiple sexual partners in the past 4 months, or an epidemic situation involving blood-borne pathogens (Chikungunya, Zika, dengue, etc.).

The evolution of the contraindication regarding men who have sex with men (MSM)

In France, men who have sex with men (MSM) constitute the population most severely affected by HIV, with a prevalence approximately 40 times higher than among heterosexuals and an incidence approximately 80 times higher. Furthermore, behavioral studies show an increase in risky sexual behaviors among MSM over time.

As early as 1983, in many countries, including France, MSM were permanently excluded from blood donation because they were considered to be at high risk of HIV infection.

For the past fifteen years or so, this permanent deferral of MSM has been the subject of debate and controversy, mainly because it can be perceived as discriminatory and outdated. Furthermore, this measure has not been fully enforced, as some MSM did not disclose that they had had sex with men during the pre-donation interview. To modify this permanent deferral criterion for MSM, the Ministry of Health organized a broad consultation with all stakeholders in 2015. After taking into account the assessment of HIV-related transfusion risk conducted by Santé publique France, the Ministry of Social Affairs, Health, and Women’s Rights announced on November 4, 2015, that MSM could donate blood under certain conditions. The decree of April 5, 2016, outlines the conditions for this opening to blood donation, as well as plasma donation.

Effective July 10, 2016, blood donation was authorized for MSM who had not had sexual intercourse with a man during the 12 months preceding the donation. As for plasma donation, it was opened to MSM who had had only one male sexual partner in the 4 months preceding the donation. This is because plasma allows for additional safety measures not applicable to other blood products.

This initial change was the subject of a study, named “Complidon,” which assessed blood donors’ acceptance of and compliance with the selection criteria, particularly the new criterion regarding MSM. Complidon estimated that 0.73% of men who donated blood between July 10, 2016, and December 3, 2017, had engaged in sex with men in the 12 months prior to donation. And more than half of them had not disclosed their sexual activity with men during their last donation, expressing, in this survey, their opposition to discrimination based on donors’ sexual orientation, or their desire not to be excluded from donating.

Despite these results, the outcome of opening blood donation to MSM on July 10, 2016, is very encouraging, as no increase in the residual risk of HIV transmission through transfusion has been observed since that date.

Based on this finding, the Ministry of Solidarity and Health decided in late 2018 to initiate a study to explore further opening up blood donation to MSM. To guide its decision, the Ministry relied on estimates of the residual risk of HIV transmission for the following two scenarios:

• deferral of men who have had sex with men in the 4 months prior to donation;

• deferring MSM who have had more than one sexual partner in the 4 months prior to donation.

Regardless of the scenario studied, the residual HIV risk remains very low. In the first scenario, it is identical to that observed for a 12-month deferral of MSM, and in the second, it is significantly higher and less robust to variations in the model parameters.

This risk associated with the window period was then estimated at approximately 1 blood donation contaminated with HIV and not tested positive every two years in France. This is an estimate and not an observation. Indeed, since 2002, no transfusion-related HIV infection has been reported, so the actual risk is likely lower.

In 2019, building on the work undertaken in 2015, the monitoring committee for the decree on blood donor selection worked with all stakeholders on the two scenarios under consideration, based in particular on epidemiological data and risk analyses.

In light of the available data and the opinions expressed by stakeholders, the Ministry of Solidarity and Health decided to proceed in stages. The first stage, ratified in the decree of December 17, 2019, and implemented on April 2, 2020, allows MSM to donate blood, provided they have not had sex with another man in the past four months.

This broader opening of blood donation to MSM was to be evaluated with full transparency to enable consideration, by 2022, of the adoption of selection criteria independent of sexual orientation and identical for all donors, namely a single partner over the past four months. This final step could only be taken on the condition that optimal transfusion safety is maintained.

In 2021, in accordance with Article 12 of the bioethics bill stipulating that selection criteria for blood donors “may not be based on any difference in treatment, particularly regarding the gender of the partner(s) with whom donors have had sexual relations, unless justified by the need to protect the donor or recipient,” the Ministry of Solidarity and Health once again organized a consultation with the aim of implementing selection criteria not based on the gender of the individual or their partner. Specifically, this involved eliminating the 4-month deferral period for MSM and for women whose partner had had sexual relations with a man.

Against the favorable backdrop of an extremely low residual HIV risk, following the opinion of the High Council of Public Health regarding the conditions necessary for updating the selection criteria, and following discussions by the Blood Donor Selection Monitoring Committee, in which all stakeholders participated, Olivier Véran, Minister of Solidarity and Health, announced the lifting of the deferral for men who have sex with men effective March 16, 2022. As of that date, donor selection criteria will therefore be identical regardless of the donor’s sexual orientation. Thus, the deferral criterion of “having had sexual intercourse with more than one partner in the four months prior to donation” now also applies to MSM.