Blood, tissues, cells and organs

Overview

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
  • vigilance activities and project support

The overall objective is to protect citizens.

Action on COVID-19 outbreak

The COVID-19 pandemic represented a challenge to public health. With the purpose of a better and coordinated response to the outbreak:

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.

/health/file/donor-to-recipientjpg_endonor-to-recipient.jpg

Revision of the EU legislation on blood, tissues and cells

Following an evaluation of the EU legislation on blood and tissues and cells, published in 2019, the Commission plans to propose a revision to this legislation in the first quarter of 2022.

Cooperation

The European Commission collaborates closely with expert bodies such as the Council of Europe (CoE) and the European Centre for Disease Protection and Control (ECDC) in the development of practical guidelines that support blood establishments with the implementation of this binding legislative framework.

Funding for action

In addition to the regular work by the competent authority, the European Commission provides funding for actions on area of Soho.

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.

Guidelines

The Council of Europe regularly reviews and updates technical requirements in its

In addition, it prepares ad hoc guidelines on different topics related with the safety and quality of substances of human origin (SoHO).

The ECDC prepares risk assessments and preparedness plans whenever epidemiological outbreaks are of relevance for blood, tissues, cells and organs. Most recently ECDC has provided input on