On 24 April 2024, the European Parliament formally adopted the Regulation on Standards of quality and safety for Substances of Human Origin (SoHo) intended for human application (the SoHO Regulation). On the same date, the European Commission published a Questions & Answers (Q&A) document on the SoHO Regulation. Then on 27 May 2024, the EU Council adopted the new rules. For the final step in the legislative process, the new Regulation is due to be published in the Official Journal shortly.

The SoHO Regulation aims to introduce new and innovative measures to help ensure that high standards of safety and quality for SoHO are maintained across the EU and that SoHO activities are appropriately regulated.  A key goal is to facilitate cross-border exchanges and access to SoHOs across the EU, while ensuring high levels of health for donors, recipients and offspring from medically assisted reproduction. A more harmonised approach to the regulation of SoHO across the EU is envisaged, which will be welcomed by industry. However, Member States may still diverge and include more stringent measures under their national laws. The extent to which one Member State’s authorisation of a SoHO Entity, SoHO establishment or SoHO preparation is really “EU wide” therefore remains to be seen. Furthermore, the success of the SoHO Regulation is reliant upon cooperation and coordination between Member States, including the use of the SoHO Platform and seeking opinions from the SoHO Coordination Board on borderline issues. This will require continuous contact between Member States and a good understanding of the ever-developing and innovative uses of SoHOs. Guidance accompanying the new rules, as well as what measures need to be put in place from the outset, will need to be informative, clear and proportionate for the SoHO Regulation to make the differences it is intended to achieve.Continue Reading European Parliament adopts Regulation on substances of human origin (SoHO)

On 14 July 2022, the European Commission published a proposal for a Regulation on the safety and quality of substances of human origin (SoHO) intended for human application. When adopted, the proposed Regulation will repeal and replace the currently applicable Directive 2002/98/EC on blood (the Blood Directive) and Directive 2004/23/EC on tissues and cells (the Tissue and Cells Directive), with the aim of reforming and modernising the existing EU legislation. The proposal sets out requirements and standards for the safety and quality of blood, tissues, and cells (BTC), as well as other SoHOs, through a single instrument that will apply in all EU Member States in a (hopefully) harmonised manner.

This will be a major development for life sciences companies operating in the EU, including companies developing advanced therapy medicinal products (ATMPs, such as cell and gene therapies) manufactured from or using SoHOs. The Regulation will apply from donation to human application, unless the SoHOs are used in the manufacture of medicinal products or medical devices, in which case the Regulation will apply to donation, collection and testing of the substances only. A public consultation is open until 8 September 2022, and the proposal will also be discussed by the Council and the European Parliament. Once the final text is agreed and adopted, it will come into force, with the proposal setting out a 2-year or 3-year transition period depending on the provision.Continue Reading EU Commission adopts Proposal for a Regulation on substances of human origin