On 24 July 2023, at the request of the transfusion service of the Swiss Red Cross (Swiss Transfusion SRC), Swissmedic approved the amendment to the blood donation criteria for “men who have sex with men” (MSM). Accordingly, the same exclusion criteria apply for all persons after new sexual contacts – regardless of whether these are heterosexual or homosexual.
Swissmedic amends donation criteria at request of Swiss Transfusion SRC
25.07.2023
Blood products are therapeutic products and are therefore subject to the Therapeutic Products Act. As the manufacturer of blood products, Swiss Transfusion SRC regularly verifies that the suitability criteria for blood donations are fully compliant with the current state of science and technology. Whenever it is planning to change its guidelines, it must submit an application to Swissmedic together with supporting scientific data. Swissmedic checks that the scientific data are in keeping with the current legal requirements and the international recommendations. Moreover, it must be possible to exclude any increased risk for the recipients of the blood donations.
Since 2017, men who have sex with men (MSM) have no longer been excluded wholesale from blood donation due to high-risk behaviour. In January 2017, Swissmedic approved a request by Swiss Transfusion SRC to this effect. Since then, donors have only been admitted for blood donation if at least 12 months have elapsed since their last MSM contact.
In keeping with the request from Swiss Transfusion SRC, a 4-month deferral period now applies to all persons after the last new sexual contact, or a 12-month deferral period if sexual contacts have taken place with more than two partners within the last four months. This rule applies to heterosexual as well as homosexual contacts. It is based on an updated risk assessment of various sexual behaviours and takes due account of the epidemiological situation in Switzerland as well as data from other countries that have already adapted their donation criteria accordingly.
Swiss Transfusion SRC has stated that preparations for practical implementation following Swissmedic’s decision will take a further 3 months.
In assessing the donation criteria, Swissmedic is guided by the provisions of therapeutic products legislation as well as international regulations. Specifically, the assessment is subject to the recommendations of the European Council on donation suitability criteria set out in Annex 5 of the Medicinal Products Licensing Ordinance, which are regularly brought into line with the current state of science and technology.
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