The Committee of Ministers of the Council of Europe has adopted a recommendation encouraging member states to harmonise the collection of data on the availability and use of tissues and cells according to a predefined set of parameters and definitions. This text aims to support self-sufficiency in tissues and cells for human application and to facilitate data sharing across borders, with the ultimate goal of ensuring rational, fair, timely and equitable access to safe tissues and cells for human application. The fact that human tissues and cells can restore essential functions or even save lives underlines the extreme importance of gaining proper knowledge in this field.
To achieve this goal, governments need accurate data on what tissues and cells are available and what their populations needs are in this respect. Transplantation requirements can then be consistently met and an appropriate level of funding to support donation programmes maintained. This information is also essential in order to avoid overreliance on third countries (outside Europe) or on a few European countries, as well as to prepare for risk scenarios that might impact supply.
At present, only a fragmented and incomplete picture of tissue and cell activity is available, at both national and European levels. Current efforts to collect relevant activity data are undermined by the lack of consensus and clarity on the data needed for different purposes, harmonisation of the terminology used and a legal mandate to collect this type of data. The result is that data collection fails to achieve the desired goals, but is a huge burden for the establishments entrusted with the task.
This recommendation was drafted by experts of the European Committee on Organ Transplantation (CD-P-TO) of the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe. The CD-P-TO, the steering committee in charge of organ transplantation activities at the EDQM/Council of Europe, works to raise awareness on organ, tissue and cell donation for transplantation. Its work also focuses on elaborating ethical, quality and safety standards in the field of transplantation, promoting the principle of non-commercialisation of organ, tissue and cell donation, and strengthening measures to avoid trafficking.
The text of the recommendation is available on the Council of Europe Committee of Ministers’ website: Recommendation CM/Rec(2022)19 on establishing measures for the harmonised collection of activity data related to the availability and use of tissues and cells of human origin with a view to supporting self-sufficiency and facilitating international data sharing.
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