SI 325 of 2012 – European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012: Motion

Tuesday, 20th August 2013

I welcome the Minister of State. Today we are being asked to annul SI 325 of 2012 which gives effect to the European Union directive on standards of quality and safety of human organs intended for transplantation. We all know that Ireland was legally obliged to legislate under EU law to ensure a common set of standards throughout the European Union and that is something we can all agree on.

I signed the motion for recall last year but I did not sign it this year. I signed the motion last year because a statutory instrument was being brought in without consultation or debate. However, since last year I have participated into two Oireachtas debates on organ donation as a member of the Joint Oireachtas Committee on Health and Children. We have had two hearings in preparation for the forthcoming legislation, the human tissue Bill, and we will be continuing our work in this area in the autumn. On 18 April we heard personal experiences relating to organ donations and we heard from advocacy groups representing those affected by organ donations. On 25 April we heard from medical professionals working at the coal-face of organ donation and from representatives of hospitals throughout the country as well as from the legal community. I would have thought that was the ideal opportunity for Senator Daly to raise the issues, or, in his words, flaws, that bring us here today. At the hearing on 18 April I raised the issue of the absence of primary legislation in Ireland and I noted that we only had the statutory instrument to introduce the European directive requirements. Anyway, I have argued inside and outside the Chamber that too often Ireland gold-plates EU directives when we should be dealing with issues in primary legislation instead.

The EU directive deals with standards of quality and safety of human organs intended for transplantation. There is nothing in the EU directive to preclude Ireland from dealing with the issues raised in the lead-up to today and the other issues which have not yet been aired when we deal with the human tissue Bill. I have listened with interest to debate on this issue in the lead-up to today’s discussion and I believe we are conflating and confusing the issues. One can almost feel the stampede to the high moral ground on this issue, but the reality is that everyone in the Chamber is keen to improve our resourcing and the operational issues in respect of organ donation.

I was struck by the submission we received from the Irish Donor Network in advance of the debate. The submission of the network concluded by stating that people are dying on the waiting lists for transplantation in Ireland, but not because of the EU directive or its transposition into Irish law. The network further stated that to confuse the issue of EU regulation versus the issue of necessary infrastructure and national policy to improve transplant rates is to confuse the debate. Surely the human tissue Bill is the appropriate place for us to deal with the consent arrangements for transplantation and research? We need to deal with the establishment of a single body responsible for co-ordinating the drive to increase transplantation in the country, put in place organ donation co-ordinators in every hospital and ensure we put in place an effective awareness-raising campaign. These are some of the priorities I would set down.

The proposal today is to annul the statutory instrument without anything tabled as an alternative at this juncture. Is the legacy of today’s recall to amount to the Seanad leaving a legal vacuum with respect to the quality and safety of the donor and recipient processes which the statutory attachment provides for? The elements purported by Senator Daly to render the statutory instrument flawed – a premise I do not support – should have been raised during the committee hearings on organ donation in April and can be dealt with in the development of the human tissue Bill.

Members might not be aware that a meeting of the Joint Oireachtas Committee on Health and Children is scheduled for 19 September to consider submissions on the introduction of an opt-out system of consent for organ donations. That will provide an opportunity to discuss the issue in detail.

I signed the motion for recall last year but not on this occasion. I have clearly outlined my reasons for taking that position. It is almost as if Senator Daly is trying to invoke the memory of Bobby Ewing stepping out of the shower and forgetting the past year had happened.

The Lancet

In July 2021, Jillian co-authored an article in the world-renowned medical journal “The Lancet”