The EC will launch the revision of the blood and tissues and cells legislations in 2021

The European Commission has announced that in 2021 it will launch the revision of the blood and tissues and cells legislations.

The two legislations regulate:

• Blood: blood components for transfusion, plasma, etc.;
• Tissues and cells: donations (for example corneas, bone, skin and heart valves for replacement surgery, bone marrow and cord blood), transfusion and use.

The legislation was put together in the early 2000s following a series of scandals concerning transfusion blood contaminations in the 80s and 90s. The legislations have not been updated since inception.

The plan of the Commission is to propose its changes to the legislations during the spring 2021. Before that, the Commission will launch a public consultation to get feedback from stakeholders. The final approval of the new legislations is forecasted by the end of 2021.

The many scientific and technological innovations in the field are forcing policymakers to update the legislations. There are also several gaps already identified, that leave important sectors under-regulated: faecal microbiota transplants, breast milk banks, autologous serum eyedrops are few of those already identified.

The new legislation will have important impact on the development of new medical devices and ATMPs. Furthermore, it will intervene on key concepts like:

• Voluntary unpaid donation (VUD);
• Donor anonymity & traceability, donor studies (i.e.: secondary use), follow-up with donors (RRR);
• Genetic testing of donors;
• Cross-border sample transfers
• Standardisation and quality issues.

The review of the legislation opens also opportunities to regulate issues/topics that are not currently covered but are linked to the collection/storage of blood, tissues and cells.

BBMRI is already in contact with the responsible unit within the European Commission. BBMRI can facilitate early interaction between the BBMRI community and the Commission to flag issues and propose solutions to be integrated in the new legislations.

If you have any question, comment and would like to contribute, please write Francesco Florindi, Strategy & Partnership Manager at francesco.florindi@bbmri-eric.eu