The European Parliament adopts the Regulation on Substances of Human Origins (SoHO)
On April 24, the European Parliament gave its final endorsement to the regulation on Substances of Human Origin (SoHO). This legislation was first proposed in July 2022, marking the beginning of a new era aimed at enhancing the protection of recipients and donors of substances of human origin, as well as children born from medically assisted reproduction.
What the SoHO legislation entails
- Clearer rules covering all substances of human origin except solid organs, such as fecal microbiota and human breast milk.
- Registration of all entities that carry out activities that could affect the safety and quality of SoHO.
- Reinforced expertise, building on existing technical bodies, notably the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines & HealthCare (Council of Europe), to keep technical guidelines up to date.
- More innovation, with a common procedure to assess and authorize SoHO preparations, proportionate to the risks these bring.
- Strengthened national oversight, and EU support for national authorities (such as training and IT).
- New measures supporting supply continuity that will help Member States to take action when the supply of critical SoHO is threatened.
- A SoHO Coordination Board (SCB) will be established, with and for Member States. It will support the implementation of the new regulation and provide legal clarity when needed
- Finally, the digital EU SoHO Platform will be created, to gather all required information, streamline reporting and increase visibility to citizens.
EHA’s take on the new SoHO Regulation
- EHA welcomes the revised Regulation, particularly its emphasis on strengthening patient and donor safety, improved coordination, and oversight, including quality standards and guidelines set by expert bodies. Additionally, the regulation introduces risk-based authorization and evidence-based benefit assessment of SoHOs, alongside facilitating access to plasma.
- EHA also appreciates the establishment of the EU SoHO Platform and its objectives. To enhance quality care within the Union, it is crucial that the Platform's implementation prioritizes the needs of professionals in terms of data sharing and usage, while also safeguarding the interests of patients and donors. Moreover, it should serve the requirements of regulators, companies, and institutions.
- Building on its involvement in the SUPPLY EU-funded project, which addressed shortages of Plasma Derived Medicinal Products (PDMPs), EHA is pleased to note that entities working with SoHO will be mandated to report their annual activity data for specific activities. This data will enable Member States to implement measures to improve donation rates or address shortages as necessary. Additionally, entities handling critical SoHOs will be obligated to notify authorities in the event of a sudden supply decrease and must have contingency plans in place to manage emergencies.
The implementation of the SoHO Regulation
The Council of the European Union will formally adopt the new revised legislation to increase the safety and quality of substances of human origin, which will become applicable by mid-2027.
Find more information on EHA’s activities on blood and blood components here.
Last Updated on Tuesday 07 May 2024.
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