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Evaluation of the EU blood and tissues and cells legislation

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The Commission is currently carrying out an evaluation of the EU blood and tissues and cells legislation. This is the first formal evaluation of this legislation since the adoption of the basic Acts in 2002 (blood) and 2004 (tissues and cells). This evaluation is in line with the Commission’s Better Regulation Package and aims to assess whether the legislation has achieved its original objectives and whether it is still fit for purpose. The evaluation will consist of several steps starting with a Roadmap and including a study by an external contractor and extensive consultation of stakeholders. The final evaluation report is expected to be published in the Autumn of 2019.


The Commission has published a Roadmap on the evaluation of the EU blood and tissues and cells legislation. This Roadmap is a first step in the evaluation process and outlines the purpose, content and scope of the evaluation. Stakeholders were invited to submit comments on the Roadmap until 15 February 2017 via this link

To view the feedback received, please click here (Zip file).

External Contract

An external contractor has been commissioned to prepare a study that supports the evaluation. This study will be based on the documents and reports provided, the relevant published literature, documents developed by other bodies (like the European Parliament, the Council of Europe or the World Health Organisation) and the results of the public and targeted consultation. Where information gaps remain, the contractor will explore additional sources of information.

A request for services has been sent to the 4 eligible contractants who have signed a framework contract with DG SANTE on evaluation and impact assessment in public health.

ICF Consulting Services Ltd (ICF) has been selected to perform this contract, and a kick-off meeting took place on the 13th of June 2017. ICF has done several evaluations of EU legal frameworks in the field of health and food safety, and has sub-contracted experts on blood, tissues and cells to support their work on this contract.

Stakeholder Consultation

Stakeholder consultation is one of the key sources of evidence that will be used to support this evaluation.  The aim is 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 are being consulted in the following ways:

  • An Online Public Consultation was launched on May 29th, 2017 and ran until September 14th. The consultation is now closed. 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 are ongoing to gather focused/specific input through direct interaction. Summary minutes are published on the DG Sante 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. The summary constitutes an important source of evidence that will be combined with the results of the Open Public Consultation, an independent study by a contractor and other evidence sources to form the final evaluation report for publication late in 2018.