Public health: Commission launches consultation on EU legislation on blood, tissues and cells

The Commission has launched a public consultation to gather opinions on the proposed policy options for revising the directives on blood and on tissues and cells. The current legislation, adopted in 2002 and 2004, significantly improved the safety and quality of these substances. However, it is now outdated and does not adequately address new scientific and technical developments that have taken place in recent years, as documented in a 2019 evaluation.

Health and Food Safety Commissioner Stella Kyriakides said: “An evaluation of the EU legislation on blood, tissues and cells has shown that we need to update this framework as part of our effort to establish a strong European Health Union. The COVID-19 crisis has highlighted that need even more given our strong reliance on third countries for plasma. Medicines made from donated plasma are critical for the treatment of a large number of patients. I am looking forward the results of this consultation which should help us to keep transfusion, transplantation and assisted reproduction safe and effective well into the future.”

The consultation launched today will be a key step in the process of updating the legislation, with a view to putting in place a more flexible framework that is fit for purpose and future-proof. This will require alignment with scientific and technological developments, tackling the emergence and re-emergence of communicable diseases and protecting donors and patients in a sector with increasing commercialisation and globalisation. The process will take into account a number of lessons learned from the COVID-19 pandemic. A proposal could be tabled by the end of this year.

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