The European Commission (EC) last week proposed to overhaul the EU’s regulations on substances of human origin (SoHO) to improve the quality and safety of substances that are part of treatments and therapies like blood transfusions, stem cell transplants for blood cancers and medically assisted reproduction therapies such as in vitro fertilization (IVF).
The regulation, which is part of the European Health Union initiative, would not only cover better quality and safety measures for substances made from blood, tissues and cells, but also donated products such as breast milk and microbiota. Solid organs for transplantation are not covered under the new proposal and will continue to be regulated under a separate directive, the Commission noted.
“Every year, millions of EU citizens need either a blood transfusion during surgery or after an accident, bone marrow transplants to treat leukaemia or cycles of IVF to become parents. These are just a few examples of how important these treatments are,” Stella Kyriakides, Commissioner for Health and Food Safety, stated in a press release. “They form a critical part of healthcare systems across the EU and the stronger rules we are proposing today will ensure that our citizens can count on the highest standards of quality and safety of these vital products, whether it is for cancer care or emergency surgery. COVID-19 has showed us very clearly how important it is to have resilient health systems, today we are adding yet another important piece to our European Health Union.”
Serving as a comprehensive revision to the existing legal framework, the new regulation adds responsive technical rules for safety and quality of SoHO based on current risks and technologies, protections for donors and offspring, improved oversight requirement harmonization across EU Member States, greater support of innovation and measures for increased resilience of supply chains.
Specifically, the proposed regulation will allow new SoHO to automatically fall within the purview of the regulation, and new rules will be written by scientific experts within that SoHO’s given field. An entity working with SoHO in a capacity involving safety and quality will be required to register with their competent authority and are subject to additional requirements and inspections if they are involved in processing and storing SoHO. The EC said oversight requirements will be proportionate and based on risk for each SoHO to limit additional burdens on competent authorities. The creation of a digital EU SoHO Platform will allow authorities and stakeholders to communicate relevant information and serves as a “a central hub for access to information on registrations, authorisations and technical guidelines.”
In addition, the regulation will establish common authorization procedures for SoHO across the EU and create a SoHO Coordination Board (SCB) as an advisory body that will provide advice on regulatory status. “The SCB will develop common good practices for inspection and vigilance, provide advice on the applicability of the Regulation, and generally support the competent authorities in the oversight of the sector,” the EC wrote in a question-and-answer document. “The SCB will also increase cross-sector coherence and legal clarity by liaising with expert bodies and corresponding bodies in other legal frameworks regarding any regulatory borderline issues that might arise.
Some aspects of the old regulation will remain, the EC noted, such as the full competence by Member States to make organizing and ethnical decisions on using SoHO within their own health systems.
The goal of the updated regulation is increased protections for patients, donors and offspring while also promoting innovation, the EC noted in their press release.
“The proposal strikes a balance that protects donors from exploitation and from risks to their own health, while ensuring that they are not discouraged from donating. The approach builds on the principle of voluntary and unpaid donation and on published work by the Council of Europe and it promotes the approach of ensuring ‘financial neutrality’ for donors,” they wrote.
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