Council of Europe – Evaluation on regulatory framework

The Council of Europe held on 20th September 2017, in Brussels, a Stakeholder Event organized by the European Commission services (DG SANTE ) within the context of the evaluation of the EU legal frameworks on blood, and tissues and cells. This first formal evaluation of relevant legislation for the tissue, cell and blood sectors since the adoption of the basic Acts in 2002 (blood) and 2004 (tissues and cells) was in line with the Commission’s Better Regulation Package and aimed to assess whether the legislation has achieved its original objectives and whether it is still fit for purpose. The process has involved extensive consultation of stakeholders. The final evaluation report is expected to be published by the end of 2018.

The main purpose of the event was to provide an opportunity to validate the main messages that emerged from open and targeted consultation activities, and to explore remaining evidence gaps. The event brought together members of the public, national authorities, patient and donor groups, professionals working with blood, tissues, and cells, industry representatives and other relevant stakeholders, who had the opportunity to express their views on key topics regarding the EU Blood, Tissues and Cells legislation. The meeting was open to all interested stakeholders who had to register online before participating. The meeting was structured around five main themes relating to the current legislation, which were discussed in five dedicated sessions: the key importance of donors: the gift of life ; regulatory oversight of the sectors - how to ensure safety and quality?; availability and sufficiency - are patients getting the blood, tissues and cells that they need?; legal consistency and coherence - regulatory pathways for Substances of Human Origin; the changing world – technological, societal, epidemiological and international developments.

The Report summarizing the outcomes of this event can be reached at:

Also available on the website is a “Road Map” that better describes the current regulatory scenarios and explains in more detail the desired outcomes of this consultation.

Sheli Kuperman