On 14 July 2022, the European Commission published a proposal for a Regulation on “substances of human origin” (“SoHO”) intended for human application. The proposed Regulation is intended to replace the existing and largely outdated Directives on SoHO, respectively on Blood and on Tissues and Cells. These sets of rules govern the sourcing and use of starting materials for innovative therapies, such as blood, tissues and cells. Pharmaceutical companies active in the manufacturing of advanced therapy medicinal products (“ATMPs”) are therefore well advised to closely monitor the developments surrounding the proposed Regulation.
The revised legal framework will uphold certain key principles from the existing rules, such as the general principle of voluntary and unpaid donation (although limited compensations for losses related to donor participation are permitted). EU Member States will also retain full competences on ethical decisions regarding the provision of SoHO-based treatments in their respective healthcare systems. However, the initiative also proposes a number of important changes to the existing legal framework on SoHO:
- Harmonized application of rules across the EU: With the proposed Regulation, the European Commission intends to “improve harmonisation, ensuring a uniform level of protection across the EU and simplifying cross-border exchange and access of SoHO therapies”. To this aim, the Commission will set up a “SoHO Coordination Board”, chaired by the Commission, which will act as an advisory body to support Member States in the uniform implementation of the Regulation (e.g., the SCB is tasked to develop common good practices for inspection and vigilance on SoHO). With the choice of the legislative instrument, a Regulation, the Commission aims at reducing disparities in the implementation of rules by Member States. At present, the roll-out of innovative therapies, such as ATMP, throughout EU Member States is hampered by disparities in the implementation of the applicable rules on SoHO. By harmonizing the rules governing, the sourcing and the use of SoHO, the proposed Regulation is expected to significantly decrease the administrative burden on pharmaceutical companies. The Commission’s initiative is therefore also a welcome and long overdue instrument to increase access to SoHO-based therapies for patients.
- Extended scope of application: The proposal extends the scope of the Regulation to any SoHO that are to be applied to humans. This means, in essence, that the Regulation will also cover substances such as breast milk, intestinal microbiota, and blood preparations that are not used for transfusion. As an exception, Organs will continue to be regulated separately under Directive 2010/53/EU. The proposed Regulation aims to provide a legal framework for all the activities to be performed on those substances, from donor recruitment to human application.
- EU-wide technical standards for the protection of donors, recipients and offspring: SoHO have to be prepared and treated according to specific technical standards to ensure their quality and safety. Under the proposed Regulation, such standards will be set out either by the European Commission through Implementing Acts or, in their absence, by the European Directorate for the Quality of Medicines & HealthCare (“EDQM”) and the European Centre for Disease Prevention and Control (“ECDC”). The standards adopted by these expert bodies, which are already widely applied in the sector, will therefore become the main means to meet the EU standards of quality and safety for SoHO.
- Enhanced self-sufficiency of SoHO supplies: The EU has historically been reliant on other countries for the supply of certain SoHO, such as the United States for plasma used to manufacture plasma-derived medicine. To counterweight this trend, the proposal lays down provisions meant to ensure EU self-sufficiency and guarantee continuity of supply in case of unforeseen events. EU Member States will therefore be expected to set up national SoHO emergency plans and alerts for SoHOs that are critically important for patients, in order to anticipate on EU supply interruptions and take timely action to mitigate those risks.
- New “EU SoHO Platform”: This proposed platform will be developed, hosted, and centrally managed by the European Commission and will be accessible to competent authorities, SoHO entities and establishments (including healthcare providers), patients, donors (and offspring), expert bodies and the Commission. The platform will allow for the collection and publication of data on donations, clinical use and possible adverse reactions.
The proposal put forward by the European Commission will now be discussed in parallel by the Council and the European Parliament. If adopted, the Regulation would come into force after a transition period (set at either 2 or 3 years). If you have any questions on this proposal, please contact Bart Van Vooren.