On Thursday 14 December, the EU Council and the European Parliament reached a provisional political agreement on the proposal concerning quality and safety standards for substances of human origin (SoHO).
The European Parliament rapporteur, Nathalie Colin-Oesterlé (EPP, French), welcomed the agreement on the regulation on blood, tissue and cell donations, “which reinforces the fundamental principle of voluntary and unpaid donation and the non-commercialisation of the human body”.
The negotiators agreed in particular that Member States may compensate living SoHO donors, in accordance with the principle of voluntary and unpaid donation and based on transparent criteria, including through fixed allowances or through non-financial forms of compensation (see EUROPE 13281/24). The conditions for such compensation will be established in national legislation, including by setting an upper limit for compensation that aims to guarantee that no financial gain or loss is incurred by the donor as a result of the donation (financial neutrality).
Member States will have to ensure that promotional and publicity activities in support of SoHo donations do not make references to compensation.
The text extends the scope to include human breast milk and intestinal microbiota.
EU countries will establish national SoHO emergency plans, setting out measures to be applied when the demand or the supply situation for critical SoHO present a serious risk to human health. (Original version in French by Lionel Changeur)