Maurice Cummins (Fine Gael) | Oireachtas source

The Government opposes the motion before us today, that the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012, SI 325/2012, transposed EU Directive 2010/53, which came into effect on 27 August 2012, be annulled.

Since last September, Senator Daly and the Fianna Fáil group in the House have had eight opportunities, during Private Members' business to raise this matter in the House and no less than 110 sitting days to submit a request for an Adjournment debate on the matter. These opportunities were not availed of by them. I believe it is a political stunt to call the House at this time to discuss this statutory instrument. We all want to see more organ donations, more organ donors and to see the issue highlighted, but the issue of opting in or opting out of donation is not the matter we are discussing today. However, I am sure we will have a debate on organ donations and that many people will use this time to discuss organ donations.

The motion before us deals specifically with the EU directive and that is the issue I will speak about here. In signing the regulations, the Minister for Health signed Ireland up to a clear legal framework for quality and safety standards for organs intended for transplantation. The aim is to ensure the safety and quality of organs and the protection of organ donors and recipients. The regulations provide for the authorisation of procurement and transplantation centres and activities, for traceability systems and for the reporting of serious adverse events and reactions. Moreover, they set requirements for the safe transportation of organs and for the characterisation of every donor and organ.

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. The HSE is the competent authority for the quality and safety aspects of the regulations, including the development of a framework for quality and safety in relevant hospitals to ensure thee standards of quality and safety set down in the regulations are met. Under the regulations, every hospital or health care facility in which any activity relating to a donation, testing, characterisation, procurement, preservation, transport or transplantation of organs takes place must be authorised by the Irish Medicines Board.

Following the granting of an authorisation the hospital or health care facility in question will be inspected by the Irish Medicines Board at regular intervals to ensure compliance with the requirements of the regulations. The Irish Medicines Board has an excellent reputation and considerable experience in the context of authorising blood and tissue establishments as set out in other EU directives and it was deemed appropriate to expand its remit to include organs as another area of its responsibility. Oversight of certain aspects of hospitals, for example, standards of equipment and theatres, rests with the HSE in consultation with the Irish Medicines Board.

I hope other speakers will stick to speaking about the actual directive and the regulations. I do not propose to accept the motion as proposed this morning.