Background

Organ transplantation is one of the great medical success stories of the 20th century and is the only life-saving treatment for end-stage organ failure. The COVID-19 pandemic was an extremely challenging period for healthcare systems and had a particularly heavy impact on procedures like organ and tissue donation and transplantation in Europe. While a rebound in donation and transplantation figures has been observed over the last two years (+14% and +7% in donation and +9% and +6% in transplantation, respectively), long waiting times continue to be a significant problem. The rate of transplantation consistently falls short of meeting the needs of patients and their families: in 2022, an average of 19 patients died every day waiting for a transplant.

These figures, however, probably do not represent the true scale of patient needs. The high prevalence of diabetes and arterial hypertension and the general ageing of the population have resulted in increased needs, which means that many more people could benefit from organ transplantation than those currently receiving this kind of therapy.

The human right to health and dignity includes the recognition of all human health needs, including for transplantation. Each country should therefore strive to meet patients’ needs using its own available resources, according to the level of development of its economy and health system, benefitting, where appropriate, from regulated and ethical regional or international co-operation programmes. All countries therefore require a legal and professional framework governing organ donation and transplantation activities, as well as quality management and transparent regulatory oversight systems that ensure donor and recipient safety and the enforcement of standards and the prohibition of unethical practices.

Mission

The work of the Council of Europe in the area of organ, tissue and cell transplantation started in 1987, contributing actively to the implementation of high standards for the protection of public health and for the promotion of human rights and dignity. In 2007, responsibility for the secretariat of activities related to organ, tissue and cell transplantation was transferred to the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe. The principles guiding the work of the EDQM in the field of organ, tissue and cell transplantation are:

• ensuring human dignity;
• maintaining and fulfilling human rights and fundamental freedoms;
• ensuring the non-commercial nature of substances of human origin;
• protecting donors and recipients of organs, tissues and cells.