Today, the European Commission adopted a proposal for a new Regulation on standards of quality and safety for substances of human origin intended for human application (Proposal). The Proposal is intended to repeal both Directive 2002/98/EC on blood (Blood Directive) and Directive 2004/23/EC on tissues and cells (T&C Directive). The Parliament and the Council of the EU will now examine and discuss the Proposal to agree on a final text, which is expected to come into force subject to transitional provisions.
The EU framework regulating substances of human origin currently consists of three primary Directives: the Blood Directive, the T&C Directive, and Directive 2010/45/EU on human organs intended for transplantation (Organs Directive). The Proposal covers blood, tissues, and cells, repealing the Blood Directive and the T&C Directive. Conversely, solid organs for transplantation will remain regulated under the Organs Directive.
The primary driver for the Commission’s Proposal is the need to update the existing legislative framework in light of the scientific and technical developments that have taken place in the sector. Moreover, divergent national interpretations and implementations of the Blood Directive and the T&C Directive caused fragmentation and barriers among EU member states. As the Proposal takes the form of a Regulation, after its entry into force it will be equally applicable in all EU member states, bringing a much desired harmonization and a higher level of safety and quality standards across the whole Union. However, the Proposal will still leave EU member states the possibility to add more stringent requirements, in particular to ensure alignment to the set-up of national healthcare systems.
The main takeaways from the Proposal are:
- Broader scope – The Proposal covers all substances of human origin (SoHO). These include blood, tissues, and cells, as well as other substances such as human breast milk or microbiota. Other substances of human origin that may, in the future, be applied to patients will automatically fall within the scope of this legislation;
- Strengthened safety – SoHOs have to be prepared and treated according to specific standards to ensure they are safe for patients. In addition to protecting patients, such standards will now be extended to protect offspring born from medically assisted reproduction, as well as donors;
- Oversight requirements – Entities working with SoHOs will be required to report their annual activity data. Entities working with critical SoHOs will need to alert their authority in the case of a sudden fall in supply and will be required to have emergency plans in place;
- Registration of SoHO entities – Organizations carrying out activities on SoHOs (SoHO Entities) will have to register with their national competent authorities;
- SoHO Establishments – These are a sub-set of SoHO Entities that process and store SoHOs. SoHO Establishments must obtain a specific authorization, have a Quality Management system in place, and designate a physician responsible for specific tasks, among other things; and
- Digitalization – The Proposal provides for the creation of the EU SoHO Platform. This Platform will support information sharing between competent authorities and with SoHO Entities, facilitating the timely submission of data and reports as well as improved transparency of national reporting and supervisory activities.
This will be a major development for life sciences companies operating in the EU, including companies developing advanced therapy medicinal products (cell and gene therapies) manufactured from or using SoHO. A public consultation is open until 8 September 2022.