European Parliament Adopts Proposed Regulation on Substances of Human Origin

• 22/09/2023
• News

On 12 September 2023, the European Parliament (the Parliament) adopted in first reading its position on the European Commission’s (the Commission) proposal of 14 July 2022 for a Regulation on standards of quality and safety for substances of human origin intended for human application (SoHOs) (the proposed Regulation; see, Van Bael & Bellis Life Sciences News and Insights, 15 July 2022). The Parliament’s position was adopted in plenary, with 483 votes in favour, 52 against, and 89 abstentions.

The proposed Regulation will apply to all SoHOs. The term SoHO includes blood, tissues, cells and any other substances of human origin like human breast milk and microbiota. Only solid organs intended for transplantation will remain regulated separately under the Organs Directive (Directive 2010/45/EU).

Some of the key changes made by the Parliament to the Commission’s proposal are the following.

First, the Parliament further integrated into the proposed Regulation the prohibition of Article 3 of the Charter of Fundamental Rights of the European Union on making the human body and its parts a source of financial gain. For instance, the Parliament introduced a definition of “SoHO donation” which clarifies that this donation must be voluntary and altruistic (new Article 3(7a)). Further, the Parliament complemented the text of Article 54(2) with a reference to “the principle of voluntary and unpaid donation” and added a new paragraph 3a to Article 54 specifying that “[c]ompensation or reimbursement shall not serve as an incentive for donations or engender financial competition, including cross-border competition, between institutions and entities that are seeking donors” and “shall not lead to exploitation of vulnerable persons in society”. New paragraph 3b of Article 54 provides that “[a]ny advertising of SoHO donations linked to a financial reward shall be prohibited” and that “[r]ecruitment campaigns and advertisements shall not refer to any compensation”.

Second, the Parliament introduced a new Article 34a requiring national competent authorities, as part of their plans to ensure the continuity of SoHO supply, to establish a digital communication channel through which they can exchange information on the availability of SoHOs in their respective national territories and on potential shortages. Information on the availability of SoHOs and the fluctuations in such availability over time, as well as trends in demand and potential shortages of SoHOs, will be exchanged between Member States through an EU SoHO Platform. This Platform will be established and maintained by the Commission.

Third, the Parliament added a new Article 36a on the “authorisation and registry of SoHO clinical studies”. SoHO entities wishing to conduct clinical studies should obtain the competent authorities’ authorisation. Each authorised SoHO clinical study will be published on the EU SoHO Platform. Not more than one year after the end of the clinical study, a summary of its results and conclusions, including a summary intended for the general public, will be published on the Platform as well.

The Council of the EU (i.e., the EU Member States) will now either approve the proposed Regulation as amended by the Parliament or, if it does not adopt all amendments of the Parliament or wishes to introduce its own changes, adopt a first reading position. In the latter situation, the proposed Regulation will return to the Parliament for a second reading. Once the final text is agreed, adopted and published, most of the provisions will take effect after a transition period of two years.