The European Commission published, on 14 July, its proposal for a regulation to improve and update the rules on the safety and quality of substances of human origin (SoHO).
The regulation is to replace two directives: the one on blood and blood components (2002/98/EC) and the one on tissues and cells (Directive (2004/23/EC)).
The proposal is part of the EU’s new health strategy. The text aims to address the weaknesses of the previous legislative framework identified in a Commission assessment published on 11 October 2019.
According to the Commission, the proposal also aims to safeguard the principle of voluntary SoHO donation and to facilitate patients’ access to SoHO, notably by facilitating cross-border exchanges.
The new text now covers all substances of human origin, apart from solid organs.
The proposal introduces provisions for the protection of patients treated with substances of human origin, for example by introducing an obligation for Member States to put in place national plans for critical substances for these patients. States should also have a common procedure for the assessment. In addition, the text proposes an obligation to register entities whose activity could affect the safety or quality of SoHO.
A coordinating committee that would include the Member States should support the States in the implementation of the future regulation. According to the European Commission, the new framework, which would mobilise the expertise of the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines and Health Care (EDQM), should make it possible to standardise the updating of guidelines, while respecting the prerogatives of the Member States.
Link to the proposal: https://aeur.eu/f/2na (Original version in French by Emilie Vanderhulst)