On January 21, 2021, the European Commission opened two public consultations on the review of the EU Blood Directive and the EU Tissues and Cells Directive. Both Directives are more than fifteen years old, and their implementation diverges widely across the member states. The rules on human blood and tissue gain increasing importance for companies active in advanced therapies, and are arguably no longer fully fit for purpose. Both public consultations will end on April 15, 2021.
These consultations represent a good opportunity for the industry to explain its experience and the issues it faces with existing legislation. This blog outlines the options for revision of the rules being considered by the European Commission. Providing input to the Commission will ensure that the future legislation will be appropriate and adapted to the need of companies involved in the sector.
Objective of the consultations
The Commission seeks to update the blood, tissues and cells (“BTC”) legislation to resolve gaps identified in the 222-page Evaluation Report of October 2019 (the report is available here). The main issues were the following:
- Harmonization of national rules. The different national interpretations and implementations led to significant barriers to movement of BTC, as well as to inequalities in terms of safety and quality. To some degree, it has been easier to export BTC to third countries, than to trade it between the EU member states.
- Address EU supply shortages. The EU is still heavily dependent on third-countries for the supply of BTC. The current legislation encourages sufficiency of supply through voluntary donations. The existing BTC Directives do not contain any measures to increase and improve those supplies. Patients are, therefore, at risk of disruption or shortage of BTC.
- Existing legislation is outdated. It needs to be updated to cope with innovative therapies. The fact the Directives lag behind prevents the healthcare actors involved in the supply of BTC from developing new technology. While new ways of processing BTC donations may bring benefits to patients, there is a need to implement new, appropriate procedures as the existing authorization procedure for new BTC processes does not require evidence that the risk is justified by benefits. Moreover, there are also issues with regard to the definition of the applicable legislative framework for novel borderline BTC, especially where medical devices and medicinal products are concerned.
- Existing legislation creates confusion. The evaluation reported that it is not always easy to know which of the two Directives applies to new therapies, which creates legal uncertainty. This is the case, for example, for breast milk. There is a need to clarify the scope of application of the Directives to ensure clarity and legal certainty, and enhanced patient protection.
- Insufficient protection and lack of efficient monitoring of BTC donors and children born from donated embryos, eggs or sperm. In particular, the requirements to report the donors’ adverse effects are too limited. Moreover, processes for the testing of sperm and egg donors for genetic conditions are out-of-date and need to be updated.
Policy Options Considered by the European Commission
The European Commission is considering various policy options to remedy gaps of the existing legislation.
The Commission is contemplating the following policy options:
- Self-regulation. The EU would establish general safety and quality principles, combined with technical specifications and requirements that will have to be defined and updated by the BTC actors. The objective would be to enhance the safety of donors, recipients and offspring. The companies active in the BTC sectors would have to substantiate their specific rules through scientific evidence and their own risk assessment, and update them whenever necessary. The Commission would perform controls in the EU Member States via an audit of the national systems of inspection, authorization and vigilance. This should improve trust among EU Member States and enhance access and use of BTC for patients. To address the sufficiency of BTC in the EU, the Commission considers introducing mandatory EU monitoring and notification of sufficiency data as well as measures for emergency responses. The scope of the BTC legislation would also be clarified to address innovative BTC therapies.
- Co-regulation. Safety and quality principles would be defined at the EU level, but BTC actors will have an obligation to comply with the technical rules defined by a group of experts at EU level (g., the European Center for Disease Prevention and Control). Other measures relating to reinforcing oversight and sufficiency would be similar to those outlined in the first option mentioned above.
- EU Binding Rules. The Commission contemplates introducing quality and safety principles at the EU level with binding technical rules, including requirements for their implementation and process for their regular updates. In this scenario, every aspect of BTC would be regulated at the EU level.
Finally, the Commission is not ruling out an option based on a combination of these three alternatives.
The European Commission opened:
- a general online public consultation on these policy options. This consultation is aimed at a broad public active or merely interested in BTC (including donors, patients and their associations, public authorities, academics, industry);
- an online targeted public consultation. This consultation is more specific as it is aimed at organizations or companies that are directly impacted or involved in the BTC sector. These specific stakeholders are invited to complete both public consultations in order for the Commission to obtain their valuable input and comments.
Companies interested in submitting their comments, share their experience with the existing legislation and provide input may do so by clicking here (for the general consultation) and/or by clicking here (for the targeted consultation).
Both public consultations will end on April 15, 2021.