John Moloney (Laois-Offaly, Fianna Fail)

I thank Senators for the welcome they have extended to me. I want to make it clear that no political divide exists on this issue. At a time when our attention is on the economy, I commend Senator Quinn on his focus on saving lives. Differences of opinion may exist in one or two areas but I hope that, through this debate, Senators and the Minister for Health and Children, Deputy Harney, can work out the finer details and produce a Bill that meets everybody's expectations. I thank Senator Quinn for introducing this Bill and for initiating the debate on this most important issue. My colleague, the Minister, cannot attend this evening but she has asked me to assure the House that she takes a great personal interest in the issue and is most anxious to hear the views of Senators and the general public.

On 23 September, 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. I have heard the story of David Ryan and have come across similar cases in my own constituency involving Harefield hospital. Processes which appeared to be successful had failed by the following week. 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 this is a driving force behind the tremendous work done by him in progressing his Bill. The Minister also proposes to address this in the Government's legislation.

The Senator advocates moving to one of the two major systems for demonstrating consent for transplantation, the opt-out model, whereas the Minister is keeping an open mind on either opt-out or the other side of the coin, 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 the Minister has made a commitment that they will be subjected to specific public consultation. She has met various groups which have argued 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 consultations were held last year by the Department of Health and Children 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.

I will now describe the different models for demonstrating consent for organ donation. The opt-in system requires the consent of the individual or next of kin before organs or tissues are removed after death. This system is currently in place in Ireland, the UK, the Netherlands, Germany, Australia, New Zealand and Canada. The opt-out system is sometimes 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 UK, 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 been concluded.

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 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 a state has the legal right to take organs, I understand 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 other reasons for the difference in donation levels. I caution Senators that 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 is not necessarily the determining factor in improving donation rates. Donation rates vary widely internationally and while Spain, the country with the highest donation rate, has followed 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 to other measures taken 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 and 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 to the current system would be so radical that the Minister 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. That in itself underlines the Minister's interest in and awareness of Senator Quinn's aims. 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 staff working in transplantation services, and to promote and increase organ donation.

I have already referred to the further option of mandated choice, sometimes referred to as required consent, whereby individuals 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 on this matter 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 various forms. The Minister is of the view that if the opt-in model is the one finally chosen, 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 that I wish to bring to the attention of the Seanad. In Ireland the current position is that when a person has indicated his or her willingness to donate organs by 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 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 legal status to the stated wishes of the organ donor will encourage a change in mindset so that the donation of organs is regarded as the norm rather than the exception.

I will outline some other elements of the Minister's legislation. The policy context behind the proposals lies in the discovery that post mortems had been performed and organs retained without permission, as 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. I do not believe Senator Quinn had that specific area in mind, but I mention it for the purpose of full debate. 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 the Senator's Bill as 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 this move would be in keeping with the recommendations of the Madden report or the wishes of the families affected by organ retention, and her proposals are in fact diametrically different from 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, those being post mortem examination, anatomical examination, public display, transplantation, research, or the import or 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 or her investigations. These provisions will complement the Coroners Act 1962 and the provisions in the Coroners Bill 2007 which awaits Committee Stage in the Seanad.

The Bill sponsored by the Senator contains many useful elements and certainly is heading in the right direction. On the issue of consent for post mortem examination and organ retention, the Senator, in his desire to bring forward proposals to support transplantation, may not have taken into account the effects his proposals for an opt-out consent model would have on post mortem examination and related activities. I am sure the Senator and I would not find it too difficult to reach agreement on this issue. I would go as far as to say I could not see Senator Quinn and the Minister having any difficulty in sorting out this aspect of the legislation. With regard to organ donation, the principal area in which the Minister's proposals may — I emphasise the word "may" — differ from Senator Quinn's is the eventual choice of model of consent. As I have explained, the Minister is not against the presumed consent model advocated by Senator Quinn, but feels 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 required.

One area in which the Minister's proposals go further than those of Senator Quinn is that of regulation. The Senator's Bill does not propose any formal regulation of the activities I have outlined, 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 in view of 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 wilful breach of that regulation, is a proportionate response to the difficulties that have arisen. The Minister's aim is to develop regulatory structures that will be sufficient to address identified need without being overly restrictive or prescriptive with regard 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. I hope these measures, which are designed to support and protect tissue donors, bereaved families and health care professionals, will meet with the Senator's support.

I thank Senator Quinn and his colleagues for affording me the opportunity to speak in the House this evening and for opening this most important debate. I look forward to Senators' support for the Minister's proposals on human tissue matters in the coming months. The Minister supports the outline of the Senator's suggestions and I hope agreement will be reached in the near future on this important Bill.