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The open public consultation evaluating the EU legal frameworks on blood, tissues and cells has found that that the majority of the respondents, who included both individual citizens and various groups, such as professional societies, donor and patient organisations and national authorities, consider that the legislation had made blood, tissues and cells safer in the EU.
Most respondents find that the legislation is not up-to-date with scientific, technological, epidemiological or societal developments and that the process of updating is not flexible or quick enough to adapt to them. They also believe that some requirements might be missing or are inadequate, among them:
- Inadequate provisions for the protection of the living donors;
- Lack of requirements to ensure quality of blood, tissues and cells, as opposed to safety;
- Lack of demonstration of safety and efficacy in the recipient;
- Absence of provisions for ensuring sufficiency of supply.
Next steps include further evaluation of the legislation through an independent study by a contractor, continuing meetings between the Commission and key stakeholder organisations and the publication of a Final Evaluation Report by the Commission at the end of the year.
Background
The consultation was launched online on May 29th 2017 and was open until September 14th 2017. Dedicated questionnaires were available for individual citizens and for administrations and organisations, in both cases based on the five assessment criteria: effectiveness, relevance, efficiency, coherence and EU added value. There were 43 responses from individual citizens and 158 from organisations including the key professional societies and donor and patient organisations, as well as many national authorities and industrial associations.
- Stakeholder consultation for the evaluation of eu legislation on blood, tissues and cells
- Evaluation of the EU blood and tissues and cells legislation
- EU action on Blood, tissues, cells and organs
