Press Release

Statement by Minister Alex White on regulations on the quality and safety human organs intended for transplantation

Alex White, Minister of State at the Department of Health, today (Thursday, 15th August 2013) strongly endorsed the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 (Statutory Instrument No. 325 of 2012) which transposed EU Directive 2010/53/EU into Irish Law and which came into effect on 27 August 2012. This is against the background of the recall of Seanad Éireann to meet on 20 August to discuss a motion calling for the annulment of this Statutory Instrument.

Minister White said that these Regulations set out a clear legal framework for the quality and safety standards for organs intended for transplantation, pointing out that the aim is to ensure the safety and quality of organs as well as the protection of organ donors and recipients. “The Regulations provide for the authorisation of procurement and transplantation centres and activities, for traceability systems, as well as for the reporting of serious adverse events and reactions” said the Minister. “Moreover”, he added “they set requirements for the safe transportation of organs and for the characterisation of every donor and organ”.

“There is absolutely no reason to annul this Statutory Instrument” said Minister White. “Apart from putting Ireland in conflict with European legislation, such an approach would remove the statutory basis for vital aspects of a quality system for an organ donation and transplantation service thus exposing the citizens of our country to unnecessary dangers”.

The Irish Medicines Board is the competent authority under the Regulations for the authorisation of procurement and transplantation centres in accordance with the requirements of the Regulations, with the HSE being the competent authority for quality and safety aspects. Both organisations are in a position to undertake their respective roles very effectively.

“Under the Regulations, every hospital or healthcare facility at which any activity relating to donation, testing, characterisation, procurement, preservation, transport or transplantation of organs takes place must be authorised by the Irish Medicines Board” said the Minister. “Following the granting of an authorisation, the hospital or healthcare facility in question will be inspected by the IMB at regular intervals to ensure compliance” he added.

Minister White stressed that further steps are being taken to strengthen overall organ donation and transplantation systems to the benefit of all. He confirmed that the HSE is looking at the options for enhancing the system of donor coordinators across the hospital network with a view to streamlining procedures and endeavouring to ensure that as many organs as possible are made available for transplantation.

Meanwhile, the Department of Health has launched a public consultation on the system of consent for organ donation and interested parties are invited to submit their views by 20th September. However, the Minister stressed that the consent issue was totally outside the scope of the issues covered by the EU Directive.

The Department of Health is also advancing legislative proposals for a Human Tissue Bill which will address the giving of consent for the removal, retention, storage, use and disposal of organs and tissues from deceased persons in the context of post-mortems, transplantation, research, or anatomical examination. The proposals will also address consent for the use of organs and tissues removed from a living person in the context of transplantation and research.

“Taken together, the transposition of EU Directive 2010/53/EU, combined with the progress already achieved and the planned improvements, there is no doubt that we will have a very effective human organ transplantation service in place in our country to meet our needs” said the Minister. “This will result in life saving transplantations for many and some degree of consolation for the relatives of deceased donors”, concluded Minister White.