Blood, tissues, cells and organs

Evaluation of the EU blood and tissues and cells legislation

On 11 October 2019, the Commission published its Evaluation on the EU blood, tissues and cells legislation. An Executive Summary in English, French and German is also available. This was the first evaluation of the legislation since the adoption of the basic Acts in 2002 (blood) and 2004 (tissues and cells). The evaluation was conducted in line with the Commission’s Better Regulation Guidelines and aimed to assess whether the legislation achieved its original objectives and whether it is still fit for purpose. The evaluation consisted of several steps, starting with the publication of a Roadmap and including a study by an external contractor and extensive consultation of stakeholders. Reflections on follow-up actions are now underway in the Commission.

The results of the evaluation were disseminated at a Conference in Brussels on 28 October 2019.  The conference allowed stakeholders to discuss the findings and express their views on the way forward. A summary report of the event is published.

Roadmap

The Commission published a Roadmap on the evaluation of the EU blood and tissues and cells legislation. This Roadmap was a first step in the evaluation process and outlined the purpose, content and scope of the evaluation. Stakeholders were invited to submit comments on the Roadmap up to 15 February 2017. To view the feedback received, please click here (Zip file).

External Study

An external contractor was commissioned to prepare a study to support the evaluation. This study was based on Commission documents and reports, the relevant published literature, documents developed by other bodies (such as the European Parliament, the Council of Europe or the World Health Organisation) and the results of the public and targeted consultation. Where information gaps remained, the contractor explored additional sources of information.

A request for services was sent to the 4 eligible contractors who had signed a framework contract with DG SANTE on evaluation and impact assessment in public health.

ICF Consulting Services Ltd. was selected to perform the study and their work commenced in 2017. ICF had supported several evaluations of EU legal frameworks in the field of health and food safety and they sub-contracted experts in blood, tissues and cells to support their work on this study. They conducted an extensive literature review and consulted stakeholders through interviews and focus groups. The External Study, together with an Executive Summary was published together with the BTC evaluation.

Stakeholder Consultation

Stakeholder consultation was one of the key sources of evidence that was used to support this evaluation. The aim was to collect views and opinions on the implementation of the blood, tissues and cells legislation, to gather factual information on what works well and where there is still room for improvement and to gather data and knowledge about the impact of the legislation. Stakeholders were consulted in the following ways:

  • An Online Public Consultation was launched on May 29th, 2017 and ran until September 14th. Submissions were received from 158 organisations and 43 citizens. A summary of the outcome, together with the individual submissions (consent permitting), is published here.
  • Meetings with key stakeholders were held throughout the period of the evaluation to gather focused/specific input through direct interaction. Summary minutes are published on the DG Health and Food Safety website.
  • A Stakeholder Event was held on September 20th, 2017 in Brussels. The event attracted a high level of interest with over 200 stakeholders attending. A summary of the issues raised is provided in this report.