Access to blood donation for men who have sex with men: an assessment of the relaxed criteria in April 2020
Santé publique France has released a report on the second revision of the eligibility criteria for blood donation by men who have sex with men, noting that the data show no negative impact on transfusion safety.
Blood donation
thematic dossier
Santé publique France coordinates the epidemiological surveillance of blood donors and helps assess the risk that a blood donation may be infected with a pathogen transmissible through transfusion.
From 1983 to 2016, men who had had at least one sexual encounter with another man in their lifetime were not allowed to donate blood, due to this population’s increased risk of contracting HIV. Thanks to improvements in blood donor screening and the performance of screening tests, an initial change in blood donation eligibility criteria took place in 2016, allowing men who have sex with men (MSM) to donate blood provided they had not had sex with another man in the 12 months prior to donation. The evaluation of this measure, published in 2018, showed that this change had not had a negative impact on the residual risk of HIV transmission through transfusion—that is, it had not increased the likelihood that an infectious donation would go undetected by the screening tests used to qualify blood donations.
It is in this context that, in April 2020, the Ministry of Health further expanded eligibility criteria for blood donation by men who have sex with men by reducing the deferral period from 12 to 4 months without sex between men. The impact of this new expansion on epidemiological indicators was presented at the Congress of the Francophone Society of Blood Transfusion on December 1, 2023.
No negative impact observed following the 2020 changes to MSM selection criteria, but ongoing monitoring of syphilis cases
By comparing the two 30-month periods before (P1 – 10/01/17–04/01/20) and after (P2 – 04/02/20–09/30/22) April 2, 2020, Santé publique France demonstrated that this second change also had no negative impact on transfusion safety: the rates of donations testing positive for HIV, HCV, or HBV decreased between the two periods studied. Only the rate of donations testing positive for syphilis increased, rising from 1.10 per 10,000 donations in P1 to 1.29 in P2.
What factors might explain this increase in the syphilis rate?
Epidemiological: an increase in the number of syphilis cases in the general population between 2020 and 2022;
Technical: deployment by the EFS, starting in late 2021, of new, more sensitive tests;
Contextual: opening up blood donation to MSM, given that the majority of syphilis cases in the general population involve MSM and that the screening tests used by the EFS cannot distinguish between active syphilis and scarred syphilis (= past syphilis).
This increase is being closely monitored to determine whether it continues. However, it has no impact on the quality of labile blood products, as systematic screening of every blood donation ensures that any blood bag showing an abnormality is removed from the transfusion supply chain.
No negative impact on HIV, HBV, and HCV indicators
The evaluation results also show that the residual risks of HIV, HCV, and HBV transmission have remained at very low levels. Thus, the residual risk of HIV transmission was 1 potentially infected donation per 7,800,000 donations in Phase 1 and 1 per 10,500,000 donations in Phase 2; for HCV, it was 1 in 25,200,000 donations in P1 and 1 in 47,300,000 donations in P2; and for HBV, it was 1 in 6,400,000 in P1 and 1 in 6,000,000 in P2.
In March 2022, the selection criteria were revised once again, and the deferral period for men who have sex with men was changed from four months without sex with another man to four months without more than one sexual partner of any gender—a standard that applies equally to all blood donors. This latest change is still too recent to be evaluated, but it is being monitored regularly.
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Learn more about epidemiological surveillance of blood donors in France (1992–2022)