On the update of the Blood, Tissues and Cell (BTC) Legislation

On July 14, the European Commission formally published its proposal updating the BTC legislation. Under the Commission’s proposal, the two Directives (2002/98/EC, for blood and blood components and 2004/23/EC, for tissues and cells) will be rolled into one Regulation, the SoHO (Substances of Human Origin) Regulation. The new regulation would have a broader scope and provide a higher degree of harmonization, two key asks from the community at large.

EUCOPE welcomes the proposal, and is especially glad to see that the Commission maintains the current classification and clear delineation between BTC and medicinal products in the Regulation. BTCs are important starting materials for ATMPs, therefore clarity on the distinction between them is key for the predictability of the system.

What’s Next?

The proposed reform, including the move to a regulation, is a welcome development in terms of bringing an important degree of harmonization between the Member States in terms of the collection, processing and distribution of SoHOs, facilitating access to safe and effective SoHO products. The Commission stops short of full harmonization, allowing for a degree of flexibility, addressing an important challenge in the current legislative framework.

Efforts to support the sustainability and continuity of supply are important, especially following the experiences of COVID-19. Upholding voluntary unpaid donations, EUCOPE would welcome the Commission’s support and encouragement toward Member States to develop appropriate strategies.

A key question remains regarding the future of the SoHO Coordination Board, its interplay with the EMA’s CAT, and the nature of the Board’s decisions.

EUCOPE is in the process of developing its response to the Commission’s proposal which will be submitted by the 8 September deadline. For more information about EUCOPE’s response, please contact Victor Maertens and Leander Vranken.