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.
The European Commission has carried out an evaluation of the EU legislation on blood, tissues and cells. This was the first evaluation since the adoption of the basic Acts in 2002 (blood) and 2004 (tissues and cells). The exercise has assessed whether the original objectives were achieved and whether the legislation is still fit for purpose. The evaluation was published on 11 October 2019.
The Single European Code for Tissues and Cells (SEC) was introduced to assist National Competent Authorities in tracing tissues and cells from donor to recipient, and vice versa. The application of the SEC, a unique identifier for every unit of tissues or cells, by medical establishments and authorities, is supported by a publicly accessible IT platform. It allows users to access all relevant information on the origin and specifications of tissues and cells circulating in the EU.