Latest developments in the framework of COVID-19 outbreak in the EU
Blood, tissues, cells and organs are used in a variety of medical therapies. Treatments based on these substances of human origin (SoHO) save lives (e.g. blood transfusion in case of trauma), improve the quality of life (e.g. kidney transplants), and even help create life (gametes and in vitro fertilisation).
Despite their benefits, the use of SoHO presents risks, in particular the transmission of diseases. The European Commission helps address these risks through its mandate to set high standards of quality and safety of SoHO, in accordance with Art. 168(4)(a) of the Treaty on the functioning of the EU.
To this end, it undertakes a range of activities, including drafting legislation and developing guidance, assisting national authorities with its implementation, accompanied by vigilance activities and project support. The overall objective is to protect citizens.
However, given that healthcare remains a national competence, decisions on authorised practices for SoHO are taken at national level. The Commission does not intervene in these decisions, which can vary between countries. Nevertheless, once practices are allowed and authorised by EU countries they need to be organised in line with the EU legal requirements on safety and quality. National authorities may however choose to add local, more stringent, requirements on safety and quality, for example an additional lab-test in response to a local epidemiological outbreak of a highly infectious disease.
Organisation of the sector
While donors and eventual clinical recipients vary for blood, tissues, cells and organs, a similar process-flow applies to most SoHO. Starting with a donation and ending with a clinical application, the flow includes collection, processing, and distribution of SoHO; as well as testing of the donor and often also storage (in particular for blood, tissues and cells). These steps take place in specialised medical establishments.
Evaluation of the EU blood and tissues and cells legislation
The Commission completed an Evaluation of the EU legislation on blood and tissues and cells in 2019. This was the first evaluation of the legislation since the adoption of the basic Acts in 2002 (blood) and 2004 (tissues and cells). This evaluation was carried out in line with the Commission’s Better Regulation Guidance and assessed whether the legislation achieved its original objectives and whether it is still fit for purpose. The Evaluation is described and its outcome is published.