Organ transplantation has become a worldwide practice, bringing immense benefit to patients. The use of human organs for transplantation has steadily increased. Organ transplantation is now the most cost effective treatment for end stage renal failure while for end stage failure of organs such as the liver, lung and heart it is the only available treatment.

The extensive use of organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases. Hospitals including procurement organisations and transplantation centres that perform any activity associated with the donation, testing, characterisation, procurement, preservation, transport or transplantation of organs intended for transplantation to the human body fall within the scope of the Organs Legislation. The HPRA shares responsibility for implementation of the Organs Legislation with The Office for Organ Donation and Transplant Ireland (ODTI) at the HSE. 

HPRA Role in Regulating Organs

The HPRA role is:

  • One of two competent authorities (CAs) for this legislation. The HSE, via The Office for Organ Donation and Transplant Ireland (ODTI) is the other competent authority.
  • Implementation of the legislation
  • Inspection and authorisation of organ procurement organisations/transplantation centres
  • Receipt, evaluation and follow up/onward reporting to ODTI (at present) of serious adverse reactions and events (SAR/E), as appropriate