On Monday 28 October, the Commission will hold a conference with stakeholders to present and discuss the findings of its evaluation of the blood, tissues and cells legislation which was published on October 11. The conference will be opened by Anne Bucher, Director General of DG SANTE. Key challenges will be addressed by panels of EU experts from professional, patient and industry societies. A final panel, including the Directors of ECDC and EDQM (Council of Europe) will reflect on the way forward. Blood, tissues and cells allow for essential therapies for millions of citizens every year. The EU legislation helps ensure quality and safety for blood and tissues and cells, and has now been in place for more than a decade. In view of the very dynamic landscape – use of new biotechnologies, more disease outbreaks, and a more connected world - the Commission has evaluated whether this legislation has achieved its original objectives and is still fit for purpose. The evaluation carried out indicates that the legislation brought significant improvements to quality and safety in this field. However, a number of key challenges were identified. In particular, it proves difficult for legal requirements to adapt and reflect all these continuous changes. Shortcomings were identified in relation to the protection of donors, making blood, tissues and cells available, and in relation to the protection of children born from medically assisted reproduction.  Provisions to keep pace with innovation, to ensure robust oversight and to ensure sustainability of supply were also seen as gaps. The conference will be available via web-streaming. 

More information:

• EU action on Blood, tissues, cells and organs