Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application

What it is

PURPOSE: to ensure a high level of health protection for EU citizens and ensure access to safe and effective substances of human origin (blood, tissue and cells) (SoHOs). PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: every year, EU patients are treated with 25 million blood transfusions (during emergency surgery, cancer or other care), a million cycles of medically assisted reproduction, over 35 000 transplants of stem cells (mainly for blood cancers) and hundreds of thousands of replacement tissues (e.g., for orthopaedic, skin, cardiac or eye problems). The Committee on the Environment, Public Health and Food Safety adopted the report by Nathalie COLIN-OESTERLÉ (EPP, FR) on the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC. The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows: - exchange of information on availability and stocks of SoHOs, and promotion of actions relating to the security of SoHO supply; - coordination between competent authorities and the Commission and Union agencies in the event of SoHO related health emergencies. It should be noted that Members stipulated that this Regulation should not apply to breast milk that is expressed by a mother solely for the purpose of feeding her own child. Members stressed that the protection of donors and recipients should be ensured through the highest quality and safety standards. They suggested that the principle of voluntary and unpaid donation should be harmonised, in particular with a view to stopping differences in national rules from encouraging citizens to donate in other countries than their own for financial reasons. Members insisted that EU countries should allow for compensation or reimbursement for losses or expenses, related to their participation in donations, to living donors. This could be facilitated through for example, compensatory leave, tax reductions or flat rate allowances set at the national level. They stressed that compensation should not be used as an incentive to recruit donors, nor lead to the exploitation of vulnerable people. The report also called on the EU to enforce strict rules on advertising around SoHO donations, which should prohibit any references to financial rewards. Moreover, recruitment campaigns and advertisements should not refer to any compensation. The report also called for greater efforts to harmonise donation frequency rules between the Member States by giving the European Commission the power to adopt delegated acts on this specific matter. To ensure the autonomy of the EU’s supply of these substances, EU countries should establish national emergency and continuity of supply plans , which should include measures to ensure a resilient donor base,…

Official title: Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance)