Speech by Mr. John Moloney T.D., Minister of State at the Department of Health and Children – Private Members Motion (Seanad) Human Body Organs and Human Tissue Bill 2008

I wish to thank Senator Quinn for introducing his Bill and initiating the debate on this most important issue. My colleague, Minister Harney, could not be present this evening, but she has asked me to assure you that she takes a great personal interest in this issue and is most anxious to hear the views of the Seanad, and indeed the general public, on this question.

On 23rd September last, the Government approved the preparation of the General Scheme and Heads of a Human Tissue Bill to regulate the removal, retention, storage, use and disposal of human tissue from deceased persons, and consent for the use of donated tissue from both living and deceased persons for the purpose of transplantation and research. As with Senator Quinn’s Bill, the legislative proposals approved by the Government will address hospital post-mortems, which are voluntary procedures, as distinct from coroners’ post-mortems which are part of the legal process of determining cause of death. The Senator’s Bill encompasses consent for organ donation and I appreciate that this is a driving force behind the tremendous work done by him in getting his Bill to this stage. The Minister also proposes to address this in her own legislation. Senator Quinn advocates moving to one of the two major systems for demonstrating consent for transplantation – the ‘opt-out’ model – while the Minister is keeping an open mind on either ‘opt-out’ or the other side of the coin, which is the ‘opt-in’ model. There is also a third option of ‘mandated choice’, which is a variation of the ‘opt-in’ system.

These three models will be further examined by officials and Minister Harney has made a commitment that these models will be the subject of specific public consultation. The Minister has met with groups who argue for one or other of the consent models, and as I have explained, is keeping an open mind until the public consultation has taken place. Preliminary public consultation was held last year by the Department on the general legislative requirements in the area of human tissue, but few responses addressed the question of consent for organ transplantation in any detail. A more targeted consultation process with specific emphasis on consent for organ donation is now required. The first draft of the General Scheme of the Bill will be prepared on the basis of the ‘opt-in’ system, but the Minister has made it clear that the reason for this is to offer an initial focus for public debate. Until the consultation has concluded, all three options will remain on the table, and will be given equal consideration.

For those who may not be familiar with the different models for demonstrating consent for organ donation, let me explain. The ‘opt-in’ system requires the consent of the individual, or their next of kin, before organs or tissues are removed after death. This is the current system in Ireland, the UK, Netherlands, Germany, Australia, New Zealand and Canada.

The ‘opt-out’ system is sometimes also referred to as ‘presumed consent’ because it presumes that all citizens consent to donate their organs after death unless they have specifically expressed a wish to the contrary. This model has been implemented in France, Italy, Spain and most other EU member states. The U.K. which passed a Human Tissue Act in 2004 based on the ‘opt-in’ system, is now looking at the implications of changing to an ‘opt-out’ model, but I understand that the debate has not yet concluded one way or the other.

One of the points to bear in mind about the ‘opt-out’ system is that relatives of the deceased are approached as part of the donor screening process to seek a medical history of any high-risk behaviour. As part of this consultation, in most countries where the opt-out model is used, families are given the opportunity to register an objection to the donation if they wish. Even where the State has the legal right to take organs, I understand the position is that few hospitals will disregard the wishes of the bereaved family if doing so would cause them significant further distress at an already traumatic time.

This blurs the distinction between ‘opt-in’ and ‘opt-out’ countries and suggests that there may be other reasons to explain the difference in donation levels. At this point I have to signal a note of caution as the Department has yet to consult the Attorney General on the substance of the proposals and it has been suggested by some that the ‘opt-out’ model may have constitutional or other legal implications. Moreover, preliminary research by officials suggests that the consent model itself is not necessarily the determining factor in improving donation rates. Internationally, donation rates vary widely and while Spain, the country with the highest donation rate has the ‘opt-out’ system, Ireland already has a higher donation rate than many other European countries which have adopted the ‘opt-out’ model. Indeed, I have been told that the person responsible for introducing the ‘opt-out’ model to Spain in the 1970s does not attribute the success of the Spanish organ donation system to this model, but rather to other measures taken in Spain during the following decade. Factors, which may be of equal or greater importance to improving and sustaining high organ donation rates, include the organisation of transplantation services at a local and national level, national protocols, public education and awareness, more targeted co-ordination within hospitals, and between hospitals and bereaved families.

To date there has been little sustained public debate on the model of consent for organ donation. The issue is of such importance, and any change in the current system so radical, that Minister Harney is firmly of the view that the public must be given a chance to have their say. For this reason, as I have said already, the Minister has asked me to acknowledge the service done by Senator Quinn in initiating his Bill and starting off the public debate. Whichever model is chosen, the Minister and her officials are determined to provide a statutory basis for the donation process, to support and protect the altruism of organ donors and their families together with the staff working in transplantation services, and to promote and increase organ donation.

I have already referred to the further option of ‘mandated choice’ which is sometimes referred to as ‘required consent’ whereby the individual must be asked at a specified point, such as when applying for a driving licence or making tax returns to decide and record their position on donation of their organs after death. Under certain circumstances the individual, or where appropriate their next of kin, may also be asked to decide their wishes during a hospital stay. The ‘mandated choice’ model operates in some parts of the United States and elements of the model are being implemented in other jurisdictions in one form or another. Minister Harney is of the view that if the ‘opt-in’ model is the one finally chosen, then the option of combining this model with elements of ‘mandated choice’ would provide a very useful adjunct to transplantation services in promoting donation and increasing the number of donated organs, and ultimately the number of lives saved.

There is another feature of the Minister’s proposals which I would like to bring to your attention. In Ireland, the current position is that when a person has indicated his or her willingness to donate organs by way of carrying an organ donor card, or when the individual’s wishes are noted on a driving licence, the consent of the next-of-kin is always sought and the wishes of the next-of-kin in effect override those of the deceased. The public consultation conducted last year by the Department supports a move to change this so as to give legal precedence to the expressed wishes of the deceased. As with the ‘opt-out’ system, no one will force a hospital to accept an individual’s organs if doing so will cause significant added pain to a grieving family. Nevertheless, the Minister believes that giving a legal status to the stated wishes of the organ donor will encourage a change in mindset which regards the donation of organs as being the norm rather than the exception.

There are other elements of the Minister’s legislation which I would like to outline.The policy context behind the proposals lies in the discovery that post-mortems had been performed and organs retained without permission. These matters were documented by Dr. Deirdre Madden in her Report into Post-Mortem Practice and Procedures. A primary purpose of the Bill is to implement the key recommendation of the Madden Report that no hospital post-mortem examination should be carried out and no tissue retained for any purpose whatsoever without authorisation. This is perhaps the only element of Senator Quinn’s Bill on which the Senator and the Minister are in disagreement. If I am reading it correctly, it seems to me that the Senator’s Bill, as currently drafted, would introduce a system of presumed consent for all matters relating to human tissue, including post-mortem examination and retention of organs. Following the traumatic discoveries in recent years which gave rise to the Post-Mortem Inquiry, the Minister does not believe that this move would meet the recommendations of the Madden Report or the wishes of the families affected by organ retention, and her proposals are in fact diametrically different to the Senator’s in this regard. The Minister proposes that consent or authorisation will be the defining principle underpinning any of the specified activities involving human tissue i.e. post-mortem examination, anatomical examination, public display, transplantation, research, import/export of human tissue from deceased donors.

An important aspect of the Minister’s Human Tissue Bill is the inclusion of provisions for consent to retention of human tissue once the Coroner has concluded his investigations. These provisions will complement the Coroners Act 1962 and the provisions in the Coroners Bill 2007 which is currently awaiting Committee Stage in the Seanad.

To summarise, the Bill sponsored by the Senator contains many useful elements and is certainly heading in the right direction. In relation to the issue of consent for post-mortem examination and organ retention I feel that the Senator, in his concern to bring forward proposals to support transplantation, may not have taken into account the effects that his proposals for an opt-out consent model would have for post-mortem examination and related activities. I am sure that the Senator and I would not find it too difficult to reach agreement on this issue. In relation to organ donation, the principal area where Minister Harney’s proposals may, and I stress may, differ from Senator Quinn’s is in relation to the model of consent chosen. As I have explained, the Minister is not against the presumed consent model advocated by Senator Quinn, but feels that there must be public debate before such a fundamental change is made to current practice. The case for the operational benefits of the model needs to be proven and the input of the Attorney General is needed.

One area where the Minister’s proposals go further than Senator Quinn’s is in the area of regulation. The Senator’s Bill does not propose any formal regulation of the activities I have outlined above, while the Minister sees this as an important element of the legislation. The Minister has given the matter some consideration and has reached the conclusion that the publication of national guidelines and codes of practice on post mortem procedures, while they will have a place in the new structures, are not sufficient on their own to ensure compliance and gain public confidence. Self-regulation would not be acceptable in the aftermath of the Post-Mortem Inquiry, and the international evidence of similar practices in many other jurisdictions. Primary legislation is the only route for introducing the necessary safeguards and the introduction of regulation together with penalties for the wilful breach of that regulation is a proportionate response to the difficulties which have arisen. The Minister’s aim in this is to develop regulatory structures which will be sufficient to address identified need without being overly restrictive or prescriptive as to clinical practice. She is supported in this by the recommendations of the Madden Report on Post-Mortem Procedure and Practice and the outcome of the preliminary public consultation conducted by the Department. Again, I hope that these measures, which are designed to further support and protect tissue donors, bereaved families and healthcare professionals, will meet with the Senator’s support.

May I conclude by thanking Senator Quinn and his colleagues for affording me the opportunity of speaking here this evening and for opening this most important debate and to look forward to your support for the Minister’s proposals on human tissue matters in the coming months.