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 and many conditions. By the end of 2015, more than 100 000 patients were waiting for a kidney, liver, heart, lung, pancreas or intestinal transplant in the European Union (EU), as shown in Newsletter Transplant 2016. Each day, 11 patients on the waiting list die due to the fact that there is no organ available. Long periods on the waiting list for organs/tissues may result in patients deteriorating or dying before having surgery.
In fact, these figures probably do not represent the true scale of patient needs. The epidemics of diabetes and arterial hypertension and the general ageing trend of the population have resulted in increased needs, so many more people could benefit from organ transplantation than the number presently receiving this kind of therapy.
The human right to health and dignity includes the recognition of all human needs for transplantation. Every country should progress towards the global goal of meeting patients’ needs based on their individual resource availability and levels of economic and health system development, and through regulated and ethical regional or international co-operation when needed. Therefore, all countries need a legal and professional framework to govern 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 prohibitions on unethical practices.
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, the Secretariat with responsibility for activities related to organ, tissue and cell transplantation was transferred to the European Directorate for the Quality of Medicines and 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.
- maintenance and realisation of human rights and fundamental freedoms.
- non-commercialisation of substances of human origin.
- protection of donors and recipients of organs, tissues and cells.