GKT3 Vigilance, Threats and Responses
- GKT1 Activity and Practices
- GKT2 Legal framework and organizational structure
- GKT4 Xenotransplantation
The third component of the GKT will provide information on threats to the success of transplantation, including information on the safety and ethics of practices and on measures to counter these threats.
From the ethical standpoint the GKT will contribute to transparency by reporting data on international trafficking in human tissues and organs, in particular on the outcome for individuals who have sold a kidney, and also data on recipients who acquire a kidney in a disadvantaged country. It will provide examples of measures taken by Member States to protect the poorest and vulnerable groups from 'transplant tourism' and the sale of tissues and organs.
Adverse events and reactions incurred by recipients and living donors need to be known and reported to enable appropriate decisions on safety measures to be taken and their timely implementation. With cell and tissue products this post-marketing surveillance is necessary because of the limited pre-clinical studies. But vigilance and surveillance and the rapid dissemination of information is especially important for the transmission of infectious agents by cell, tissue and organ transplantation. In recent decades new risks have regularly appeared. Their early identification and the dissemination of relevant information constitute a prerequisite for transplantation safety. The GKT will provide links to vigilance and surveillance systems set up by developed countries and will provide a single portal for information on safety. It will also provide tools to simplify vigilance and surveillance globally.