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Council of European Union Approves and Publishes Final Compromise Text of Proposed SoHO Regulation

  • 05/02/2024
  • News

On 30 January 2024, the Permanent Representatives Committee (Coreper) of the Council of the EU (Council), which prepares the Council’s work, approved the final compromise text of 14 December 2023 of the proposed Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO) (SoHO Regulation) (see, Van Bael & Bellis Life Sciences News and Insights of 15 December 2023). Attached is a copy of the approved text.
Following Coreper’s approval, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) will vote on the text. This is expected to happen during the Committee’s next meeting on 14 February 2024. Next, the text will be voted in the European Parliament’s plenary and, if approved, be formally adopted by the Council. The SoHO Regulation will come into force three years after its publication in the Official Journal of the European Union.
The SoHO Regulation will replace the rules for safety and quality set out in Directive 2002/98/EC for blood and blood components and in Directive 2004/23/EC for tissues and cells. SoHO are defined widely as “any substance collected from the human body, whether it contains cells or not and whether those cells are living or not, including SoHO preparations resulting from the processing of that substance” (Article 3). Thus, the SoHO Regulation will ensure better protection for donors and recipients of not only blood, tissues and cells but also of other substances of human origin like human breast milk and intestinal microbiota, as well as for children born following medically assisted reproduction. The SoHO Regulation regulates a wide range of activities such as donor recruitment, processing of SoHO, distribution, import and export of SoHO and human application of SoHO. It also creates the institutional and procedural architecture that facilitates cross-border exchanges and access to SoHO.
Article 54 of the SoHO Regulation establishes the principle of voluntary and unpaid donation of SoHO. However, EU Member States may allow in their national legislation for the compensation (which is defined as “making good of any losses or the reimbursement of expenses associated with SoHO donation” – see, Article 3) of SoHO donors to guarantee that they do not incur a financial gain or loss as a result of the donation (this is the principle of financial neutrality – see, Article 3). Recital 18a to the SoHO Regulation notes that “[w]hatever the form of compensation, including through financial and non-financial means, compensation schemes should not result in competition between SoHO entities for SoHO donors, including cross-border competition and in particular between SoHO entities collecting SoHO for different purposes, such as the manufacture of medicinal products versus human application as a SoHO preparation”. 

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