The European Commission launched a public consultation on Thursday 21 January with a view to improving the EU framework for the safety and quality of blood, tissues and cells used in transfusions, transplantation and medically assisted reproduction. This consultation is open until 15 April 2021.
In October 2019, an evaluation of Directives 2002/98/EC on health and 2004/23/EC on human tissues and cells had highlighted certain weaknesses in the European framework, such as the incomplete protection of patients, the difficulties in offering them advanced therapies and the lack of availability of these substances.
In this context, the Commission has embarked on a consultation process with a view to presenting a new directive in the fourth quarter of 2021.
At the end of 2020, it published to that end an initial impact assessment in which it proposed three policy options: (1) introduce EU-wide quality and safety requirements defined by establishments where blood transfusions are carried out, with reinforced national inspection and European audits; (2) introduce EU-wide safety and quality requirements defined by European expert bodies, with reinforced national inspections and European audits; (3) introduce EU-wide safety and quality requirements in relevant legislation, with improved national inspection systems and classification boards.
The Commission states that this exercise will also take into account the lessons of the Covid-19 pandemic. (Original version in French by Sophie Petitjean)