Dáil Éireann Debate, Wednesday - 19 September 2012
208. Deputy Billy Kelleher asked the Minister for Health if he will confirm that all of the processes and procedures have been put in place by him and the Health Service Executive to comply with the EU Directive 2010/53/EU which came into effect on 27 August; and if he will make a statement on the matter. [39512/12]
View answerEU Directive 2012/53/EU was transposed by the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations, S.I. No. 325 of 2012, which I signed into Irish law on 27 August. The Irish Medicines Board is the competent authority under the Regulations and it must authorise donation and transplantation in accordance with the requirements of the Regulations. The Regulations apply to donation, procurement, testing, characterisation, transport and transplantation of organs. They set out a clear legal framework for the application of quality and safety standards for human organs intended for transplantation.
My Department is working with the HSE and the IMB to ensure that hospitals meet the requirements in the Regulations. The HSE's National Organ Donation and Transplantation Office is overseeing the development of guidance documents, which will set out the appropriate processes and procedures to comply with quality and safety standards for all aspects of donation and transplantation. It is also assisting hospitals through its National Transplant Advisory Group, to comply with the Regulations. I am confident that hospitals will meet the requirements of the Regulations, when they are inspected by the IMB. Compliance with the Regulations will assure both donors and organ recipients that the organ donation and transplantation system is operating in accordance with the best possible standards of quality and safety.
