Harmonisation of conditions for stem cell donation in Europe

Subject: Harmonisation of conditions for stem cell donation in Europe

In its answer to Written Question E-001205/2020, the Commission stated that it was currently reflecting on the most suitable follow-up actions to deal with the shortcomings relating to stem cell donation that were identified in the question. The Commission announced that ‘this process will also take into account the points raised by the Honourable Member’.

In the meantime, the Commission proposal for a regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC has been submitted.

How does the proposal specifically address the issues and calls for action set out in Written Question E-001205/2020 (setting a common age limit for registration for stem cell donation and a guaranteed option of registering for stem cell donation in another EU Member State)?

Submitted: 27.9.2023

Answer given by Ms Kyriakides on behalf of the European Commission (7 December 2023)

The Written Question E-001205/2020 (1) refers to the maximum age limits of candidate donors of haematopoetic stem cells, and their rights to register their willingness to donate in registers in other EU Member States.

The Commission has now proposed a regulation for the safety and quality of substances of human origin, which is intended to apply on the donation and collection of these cells.

This legislative proposal is under negotiation, and therefore, the definitive content of the legislation will depend on the decision of the co-legislators.

The proposal foresees that the implementation of standards could be achieved by complying with safety and quality guidelines developed by expert bodies like the European Directorate on the Quality of Medicines (EDQM ) (2), who have the expertise to assess the scientific evidence in order to make recommendations on donor eligibility, including on the appropriate age limits. The future recommendations from these EU expert bodies would harmonise practices across the EU.

Any action will also need to respect the rights and responsibilities of the Member States in this field, in particular on the organisation of healthcare.

Donation and collection systems need to be aligned to local healthcare systems. Donor registration requires regular follow-up to ensure candidate donors remain fit for donation when a call arrives.

This will also require ad-hoc medical investigations and acts, to be performed in healthcare facilities close to the donor, in order to collect haematopoetic stem cells. Therefore, full harmonisation, across all Member States would not be appropriate.

1 ∙ ⸱ https://www.europarl.europa.eu/doceo/document/E-9-2020-001205_EN.html

2 ∙ ⸱ https://www.edqm.eu/en/guide-to-the-quality-and-safety-of-tissues-and-cells-for-human-application1