Revision of the EU’s blood, tissue and cells legislation – EU Commission answer

EN
E-002002/2022
Answer given by Ms Kyriakides
on behalf of the European Commission
(25.7.2022)

The evaluation of the EU legislation on blood, tissues and cells¹ showed that a sustainable supply for plasma derived medicinal problems is a key concern, and this was included in the impact assessment for the revision of this legislation.

According to Article 168(4) of the Treaty on the Functioning of the European Union², the EU can adopt measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives. However, the organisation of blood services and collection of blood components, including plasma, is within the remit of the Member States.

The Commission will soon present a proposal to revise this legislation, in particular on the following aspects:
1. Improved definitions and a clear differentiation between different terms and concepts in order to ensure coherence with other relevant legislation.
2. New measures to monitor supply and notify shortages of critical substances of human origin. The proposal also strengthens donor protection, and provides for more frequently updated technical rules and more harmonised oversight. This is necessary for a responsible increase in plasma collection, in particular for frequent donors.
3. More coherence between the EU legal frameworks on blood, tissues and cells and on medicinal products to contribute, among other things, to a more sustainable supply of substances of human origin based medicinal products, such as plasma derived medicinal products.

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