European Commission Publishes Proposal for Regulation on Substances of Human Origin
On 14 July 2022, the European Commission (the Commission) published its long-awaited Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application (COM(2022) 338 final; the proposed Regulation) and an accompanying Q&A document (see, attachments).
The proposed Regulation updates the current regulatory framework to improve safety and quality standards applicable to substances of human origin (so-called SoHOs). SoHOs include blood, tissues, cells and any other substances of human origin like human breast milk and microbiota.
SoHOs can be directly intended for human application but can also be used in preparations or in manufactured products. Article 2 of the proposed Regulation provides for a list of “SoHO activities” that fall within the scope of the proposed Regulation. The list includes activities such as donor recruitment, processing of SoHOs, distribution, import and export of SoHOs and human application of SoHOs.
The proposed Regulation will apply to all SoHOs. Only solid organs used for transplantation will remain regulated separately under the Organs Directive (Directive 2010/45/EU). In view of the broad definition of the term SoHOs, the proposed Regulation will be future-proof in the sense that it will automatically apply to new substances of human origin that can be applied to patients.
A key aspect of the proposed Regulation is that it empowers the Commission to adopt implementing acts regarding patient, donor and offspring protection. However, in the absence of such implementing acts, “SoHO entities” (which are defined in Article 3(24) as “organisation[s] legally established in the Union that carr[y] out one or more of the SoHO activities”) will have to apply standards established by the European Centre for Disease Prevention and Control and the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe. The aim is to ensure that technical rules applicable to SoHO activities remain updated and to avert the accumulation of obsolete rules which would stand in the way of novel SoHO-based treatments and new medical techniques.
For purposes of enforcement, the Commission devised a supervision mechanism based on national Competent Authorities. Chapters II and III of the proposed Regulation are dedicated to, respectively, “Competent Authorities” and “SoHO Supervisory Activities”. The rules enable extensive coordination between the different national Competent Authorities and the Commission.
According to the Commission, increased harmonisation in the field of SoHO activities between EU countries could bring significant improvements in treatments such as stem, cornea, or skin transplants. Facilitated exchanges of SoHOs could even save lives, especially for conditions like blood cancer for which blood supply is of critical importance.
The proposed Regulation will now be discussed by the Council and the European Parliament. Once the final text is agreed, adopted and published, most of the provisions will take effect after a transition period of two years.