GKT2 Legal framework and organizational structure for transplantation services
The second component of the GKT provides information on laws and regulations applicable to transplantation activities in Member States including the following:
- Description of consent to donation and donations from living donors, including protection of minors, and from deceased donors with reference to the legal determination of cardio-respiratory and encephalic death.
- Requirements for the safety, quality and efficacy of human material for transplantation and transplantation procedures, ensuring the dignity of recipients and donors; requirements for consent to donation from deceased and living donors and requirements and restrictions for living donation.
- Prohibition of profit on materials of human origin for transplantation. Penalties in the event of commerce with donated cells, tissues and organs. Explicit prohibition of organ trafficking in the legal framework.
- Specifications or criteria for equitable allocation of human material for transplantation.
- Role of national health authorities in the regulatory monitoring and oversight of transplantation activities including, in particular, for the accreditation, designation, authorization or licensing of establishments where transplantation activities take place.
- Committees for defining and maintaining national guidelines on technical and ethical matters relating to transplantation regarding both recipients and donors.
It provides information on the implementation and organization of transplantation services in Member States and provide examples of:
- Organizational system for the provision of cell, tissue and organ transplantation services.
- Coordination of transplantation activities, whether from deceased or living donors, to facilitate donation from deceased donors, to manage waiting lists and to ensure optimal benefit for recipients.
- Oversight and monitoring of transplantation activities and enforcement of national requirements.
- National data collection, with recipient and donor registers, and initiatives and success in ensuring full transparency of transplantation activities as well as confidentiality and traceability.