The EU Council’s negotiating mandate on the proposal for a regulation on blood, tissues and cells was adopted on Wednesday 25 October by the Committee of Permanent Representatives of the Member States to the EU (Coreper).
The term ‘substances of human origin’ (SoHO) includes human breast milk and intestinal microbiota, as well as any other substance of human origin that will be used for therapies in the future. The activities covered by the proposed regulation range from the registration and control of donors to the collection, processing and human application of substances of human origin (see EUROPE 13248/13).
The EU Council’s position guarantees greater harmonisation in order to facilitate cross-border trade and access to therapies prepared with substances of human origin, in particular through the creation of an EU SoHO coordination and advisory body.
The national competent authorities will supervise activities relating to substances of human origin in an independent and transparent manner. They will also be responsible for authorising the organisations carrying out these activities. Additional authorisation and inspection requirements will apply to entities that process and store, release, import or export substances of human origin.
The principle of voluntary and unpaid donation is also included in the compromise text in order to preserve this important principle.
There are plans to create the EU SoHO platform, a new common IT platform for recording and exchanging information on related activities.
The text provides for a rapid alert system in the event of serious incidents or reactions likely to present a risk for recipients or donors. Member States will have to monitor the adequacy of supplies of substances of human origin in their countries in order to be able to respond to any critical shortages.
The agreement on the EU Council’s negotiating mandate allows the Spanish Presidency of the EU Council to begin discussions with the European Parliament as soon as possible, with a view to reaching an agreement by the end of 2023.
Link to the ‘4 columns’ document: https://aeur.eu/f/98t (Original version in French by Lionel Changeur)