We will now have our discussion with officials from the Department of Health and Children on legislation to regulate assisted human reproduction in Ireland. I welcome Mr. Fergal Goodman, principal officer, Ms Colette Bonner, deputy chief medical officer, and Mr. Liam McCormack, assistant principal officer, from the Department of Health and Children. I invite Mr. Goodman to commence his presentation. I draw the attention of witnesses to the fact that while members of the joint committee have absolute privilege, the same privilege does not apply to witnesses appearing before the committee. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official by name or in such a way as to make him or her identifiable.
Assisted Human Reproduction: Presentation.
Mr. Fergal Goodman
I thank the Chairman and members for the opportunity to meet and brief the committee on the work we do in the Department on the development of legislation to regulate assisted human reproduction in Ireland. I will read a brief formal statement. That will not take too long. We will then be happy to answer questions.
When the then Minister established the Commission on Assisted Human Reproduction in May 2000, its terms of reference were to prepare a report on the possible approaches to the regulation of all aspects of assisted human reproduction, generally contracted to AHR, and the social, ethical and legal factors to be taken into account in determining public policy in this area. The commission comprised persons with an expert knowledge spanning the medical, scientific, social and legal domains. This expertise was a prerequisite to a precise examination of the issues concerned. The commission conducted an intensive and analytical examination of AHR issues.
The commission published its report in May 2005 and made 40 recommendations on assisted human reproduction services in Ireland. The key recommendation of the commission is that a regulatory body should be established by an Act of the Oireachtas to regulate AHR services in Ireland. The commission proposed that this body be accountable to the Minister for Health and Children and that it would have regulatory, advisory and executive powers in regard to permitted assisted reproduction services.
The other main recommendations may be largely grouped under five general headings. These are access to AHR services, donor programmes and procedures, surrogacy, procedures relating to human gametes, and possible approaches to issues surrounding the human embryo. The Government decided on completion and publication of the report to refer the report to the Oireachtas Joint Committee on Health and Children so that the committee could consider and report in due course on its views of the recommendations. The committee was considered an appropriate forum in which to subject the report to structured democratic and political analysis and scrutiny. In the meantime, the Minister for Health and Children, cognisant of the amount of work required, has instructed the Department to begin work on the development of an appropriate regulatory framework. Dr. Jim Kiely, CMO, has policy responsibility for this work. As part of our analysis of the complex issues involved in AHR, the report of this committee, when completed, along with the recent judgment of the High Court in the R v. R case, will be taken into account.
The commission's report was a first step in determining a policy response to assisted reproduction. This is a complex area and the full range of relevant issues needs to be examined, not only on their own terms but also as regards how any particular approach might impact on other areas of medicine, ethics, social policy and the law. The work we have been asked to undertake is intended to result in policy proposals that the Minister will in due course bring to Government for consideration and decision.
The key issues that arise for consideration at this stage include how AHR services should be regulated and whether a regulatory authority is the most appropriate way of ensuring such regulation; if a regulatory body were to be established, to what extent some matters might be the subject of primary legislation and others within the remit of the Minister or regulatory authority; how the embryo might be defined for the purpose of legislation; issues concerning legal parentage and adoption if donor programmes were to be permitted; the approach to be taken as regards surplus embryos created during IVF treatment but not used; whether, and if so to what degree, the State should seek to permit the provision of AHR services to persons in particular types of relationships or none; the different approaches to regulating, for example, the area of consent to treatment and approaches to safeguarding the best interests of the child; and, finally, exploring the issues that arise from certain practices on gametes and in vitro embryos. The issues involved are difficult and emotive for many. They go to the core of our concepts of human dignity and personhood. The commission has acknowledged that using technology to assist human reproduction raises important ethical issues for society.
I would now like to outline some of the steps involved in developing policy proposals in this area. First, we have been working to scope the full range of issues and identify all the interrelationships between them. This includes identifying the issues which will impact on the remit of other Departments. We will also examine in detail how other countries have approached the regulation of this complex area. We have, therefore, begun examining other regulatory regimes covering assisted reproduction. This involves a detailed review of legislation and other relevant legal instruments by which assisted reproduction is regulated in other countries. It is important also that we gain an understanding, not only of what the legislation states but of how it has worked in practice, which legislation is working well and which provisions are not. This international dimension to our work will be complemented by a regulatory impact assessment of existing legislation in Ireland in respect of a range of policy options. The assessment will also involve, as necessary, consultation with relevant experts in what is a complex and difficult field.
As I indicated, since the Minister instructed us to begin preparations for legislation on assisted human reproduction, we have been working on the initial phase I described. Following this, it is anticipated that outline policy proposals and options will be developed for consideration by the Government. The committee will appreciate that as all of the key issues will have to be considered by the Government before we move to develop legislation, we are not in a position at this stage to predict the nature and extent of the legislation that will be produced.
I hope the committee finds this information useful. We will be pleased to provide any further information we can on the work we are carrying out.
I thank Mr. Goodman.
I thank the officials for coming before the committee. I express my disappointment that the Secretary General, Mr. Michael Scanlan, who was invited to be present and the chief medical officer who, according to the briefing material, has been designated as the official responsible chose not to attend. That is an indication that we are not making progress in dealing with this issue. When we raised it in writing with the Minister, she wrote in reply a very clear, unequivocal letter, which I welcomed and which I am hanging onto desperately in the hope that perhaps she means what she said. She stated: "I would like to inform you I have recently instructed officials in my Department to prepare the legislation for a specific scheme of statutory regulation of assisted human reproduction".
On what date was that issued?
It is dated 5 July 2006. Essentially, the presentation refers to policy proposals, a completely different matter. Perhaps the officials will comment in this regard. In my experience, when officials are asked to prepare legislation, that is what they do. It is not a matter of reinventing the wheel. However, with regard to the presentation, it seems what is happening is at variance with what the Minister has undertaken to do — I support her in that undertaking. It is important to record that Senator Henry, with the very limited resources available to her eight years ago, if she had any, was able to publish legislation.
Are the officials satisfied with the fact that there are nine clinics operating, providing in an unregulated environment IVF treatment for thousands of women, resulting in the birth of 1,000 babies per year? Does the witness feel that is something that can be accommodated within this extensive process whereby policy is being developed? It seems to me that all the commission's work is being dissected or put aside because policy proposals have to be developed, as if there was nothing there to work on. The commission spent five years doing this work. I find it dispiriting because there is a deep variation. I am a bit at sea now because the questions I was going to ask were straightforward. When is the legislation going to be published? Is the Department directly employing parliamentary draftsmen, now that it has policy responsibilities and no managerial responsibilities for the health service? I do not know if the Department has a parliamentary draftsman or not. Will the regulatory body be part of HIQA or not? These are the sort of questions we should be asking.
I find it difficult to understand why there has to be this approach, which is really beginning again, when people are availing of services — some of which are run by for-profit organisations — and nobody is protecting them. Is the Department going to do something specific about the management or regulation of clinics, while it is examining all the big issues, such as when life begins? That is what the witnesses are here to answer, with all due respect to them.
We are concerned about the specific problem of clinics and what will happen concerning their regulation. Will HIQA be responsible for the management and regulation of these clinics, or will nobody be responsible? Some time ago, Senator Henry made the point that the only legislation currently in place is the Sale of Goods Act. That is completely unacceptable. The Department should have a twin-track approach, otherwise we might as well just give up on it.
I thank Mr. Goodman for a straightforward presentation which was to the point. It was short in bulk but it dealt with many big issues with which we will have to grapple in the future. If we have not dealt with them in the next six months, many of them might possibly be shelved. The situation will give rise to many issues, however, which will have to be dealt with. There is a heavy agenda which will make issues like the age of consent and divorce look small by comparison. The issue must be addressed and we cannot leave it hanging in the air. Science is moving on at a rather rapid pace and is leaving us to deal with many moral and ethical issues. The timescale is moving much more quickly than most people imagine.
The age of consent issue was mentioned and one sees concerned groups coming out after the recommendations have been made. I find it somewhat frustrating that people wait until recommendations are published and then act as hurlers on the ditch. Did Mr. Goodman bring these interested groups into the equation before the recommendations were issued? Such groups represent bishops, medical professionals, lawyers and others. The presentation referred to all aspects of human reproduction — social, ethical and legal. Have groups representing these sectors been brought into the equation or will they blow the recommendations out of the water? That must be dealt with.
I find it frustrating that those who are now making pronouncements did not make submissions to the relevant committee arguing their stated positions on the ethical or moral aspects concerned. Many ethical issues will arise in this respect, including those voiced by doctors. Assisted human reproduction involves major issues including donor programmes, surplus embryos and legal parentage. It will not be simple to solve them. Whatever we do, we must move on and provide some legislative framework. If such a framework is not available here, people will cross the Border into another jurisdiction. This is not the answer. In several other areas people who decide the law does not suit them travel to England, Scotland, Wales, Northern Ireland or elsewhere. Although this issue must be grappled with, all relevant bodies and interested parties should first be brought on board.
I thank Mr. Goodman for his presentation but, as with Deputy McManus, I am thoroughly disappointed with its contents. As a member of the joint committee which examined the issue of assisted human reproduction, I expected action to be taken in this area, as outlined in the letter from the Minister cited by Deputy McManus. I do not mean to be disrespectful but it is extremely disappointing to learn from the presentation that no progress has been made. The Commission on Assisted Human Reproduction did tremendous work. It canvassed a wide range of opinions on the issue and produced an extremely good report.
The steps Mr. Goodman outlined have already been taken. We know from developments elsewhere in Europe what needs to be regulated and how it should be done. As Deputy McManus stated, the Minister indicated to members that the matter would be dealt with in all haste.
I am glad the Secretary General did not waste his time coming to the meeting. Given that this is a paltry report, I understand the reason he decided not to report back to the joint committee.
I take my role as a Member of the House seriously. The efforts of the joint committee in trying to have this area regulated have not received sufficient support. I do not intend disrespect to the officials of the Department as I am being critical of the Minister in this instance. We were informed that the area of assisted human reproduction would be subject to regulation. Clearly, however, it has not been a priority.
I would like an honest, straightforward answer. Are the heads of a Bill ready? In the absence of political will, an issue can be delayed indefinitely, whereas an issue can be driven forward quickly if there is political will to do so. The type of regulation required has been demonstrated by the good work of the Commission on Assisted Human Reproduction.
The joint committee tangled with the question of when life begins and other difficult matters and was advised to park some of them because cases were before the courts at the time. We were led to believe, however, that legislation would be introduced. It is disappointing, therefore, to receive this progress report from which it is clear that no progress has been made.
I thank Deputy McManus for her comments on the Bill I introduced eight years ago. I also thank two legal friends who worked on the legislation, Dr. David Tompkin and Dr. Ian McAuley of Dublin City University. The reason I introduced the Bill was that it was perfectly obvious people were becoming involved in medical treatment in a highly emotional, expensive area which carried some risks for the women in question.
It is interesting that the section of the report listing the key issues failed to refer to the best interests of the couple or woman. This is a grave omission. My sole purpose in introducing legislation was to provide that a list of clinics be drawn up alongside the services they offered and their success rates and charges. I was well aware that problems had arisen as regards other issues but that is a completely separate matter. Surely the Department could make an effort to address this issue.
I ask in that regard because approximately six months ago a woman approached me and said that a specific treatment had been recommended to her, inquiring whether I knew anything about it. I told her that I did not, but that I would endeavour to look it up on her behalf. The treatment was to cost her thousands of euros, but it was described as experimental, with use recommended only in very specific situations. Another report said that it was useless. Do we not think about what is happening to patients or the best interests of the woman? The procedure would have involved some risk to her.
Initially, the Department relied on the Irish Medical Council, whose ethical guidelines were expected to cover everything. Then it realised that some of those involved in treatment were not medical practitioners but embryologists and other scientists. Having considered the issue, I feel that we cannot rely on what happens in the Department, and our best bet may be the Irish Fertility Society, which does its very best in an area where, through no fault of officials, there will obviously be no legislation in my lifetime — and I feel fairly healthy.
Not all such clinics are involved in the Irish Fertility Society. It is not only a matter of people crossing the Border to seek treatment, as Deputy Connolly suggested, since they are also going abroad to Spain and Ukraine. There is also the issue of surrogacy, which does not seem to be tackled at all, despite the fact that in the newspapers one reads of high profile cases of people from the UK and so on returning from California with twins. It is well known that many Irish people have used surrogacy services abroad. There seems to be a notion that if something is kept out of the country, there is no worry in that regard. It is another area where we are pursuing an Irish solution.
Deputy McManus mentioned that some clinics are run for profit, and it is not right that Irish patients should take out second mortgages on their homes and so on without clinics having to state verifiably what they do and what their success rates are. I recently heard Professor Lord Robert Winston of the Hammersmith Hospitals Trust speaking in the Rotunda, and he was very pessimistic about certain forms of treatment. Despite that, one sometimes hears grandiose statements regarding success rates.
This is terribly disappointing, and the very worst thing from my perspective is that the best interests of the couple, and particularly the woman, do not feature in this list.
Mr. Goodman
I will try to answer those points. As I said, the presentation was intended to be brief rather than exhaustive. The commission made approximately 40 recommendations on a wide range of issues. We were not about to list them as a filler, and negative inferences should not be drawn from any omissions. The Senator correctly said that other interests should be taken into account apart from those of the child. That demonstrates the range of competing and interlocking issues to be examined. That any one issue was not mentioned in my brief presentation should not imply an intention to downplay or downgrade it.
In the Minister's communication to the committee in July, she stated her desire that there be a specific scheme of regulation. However, as we understand our instructions, she did not suggest that we should move directly to preparation of the legislation.
In reply to a question on the Order of Business in the Dáil, the Tánaiste said that he expected the legislation to be published before the general election.
Mr. Goodman
It is not our place to comment on exchanges across the floor of the Dáil.
Does Mr. Goodman think it will be in before the general election?
Mr. Goodman
Rather than answering that question, it would be better if I were to say what we envisage doing. The commission made an extensive range of recommendations. Senator Henry has indicated her concerns about the issue of surrogacy, but I would detect from the comments of other members that it was felt that we should run with the commission's recommendations. I am not clear what we would be expected to do there.
I should say that we have spoken to the Minister on the timescale that is required and she is aware and understands that it will take some months to scope out what is involved — looking at the range of issues and the regimes in other countries. It is not that we would slavishly copy them, but there are different ways of approaching the issues and striking the balance between what goes into primary legislation and what might be dealt with by regulatory mechanisms. It then comes down to reaching a decision on particular options.
The Government decided to publish the report when it was completed but has not made a decision on the options, proposals or recommendations in the report. The report would have to go to the Government.
Does Mr. Goodman appreciate that the concern of the committee, if I may be so bold as to express what other members are saying, is primarily about the regulation of clinics and simple measures to protect patients that do not appear to be as complicated or as all encompassing as the issues raised by him? Perhaps I am being naïve, but I am sure Mr. Goodman is concerned about patient safety and others taking advantage of very vulnerable people who have a deep desire to have a child. It is remarkable that there has not been more exploitation of that desire. There is nothing in place that provides any basic regulation or sets out stages for such regulation. In other areas, such as care of the elderly or the care of children, the Department has produced some legislation. The Department has also produced regulations for professionals in ten health care disciplines and will cover more in time. Nobody expects everything to be done all at once. An easy way to avoid doing anything is to decide to do everything at once. What is of great concern is that nothing will be done.
Mr. Goodman
I do not accept that we are trying to avoid dealing with the issue. We are trying to grapple with a very difficult issue and come up with an appropriate set of proposals that will lead to this area being regulated. Members will accept that the issue has not just come on to the table in the past number of months while we have been endeavouring to get to grips with what would be required in legislation.
The Health and Social Care Professionals Act, to which Deputy McManus referred, was some time in preparation, but while its application and the commencement of different sections was staged, the Bill in its entirety had to be introduced and then enacted.
Let me add to what my colleague, Mr. Goodman, has said. Senator Henry raised the interests of the couple, particularly the woman, at the centre of assisted human reproduction. We are conscious that the burden of assisted human reproduction can be heavier on the woman than on the man. We made our presentation when we appeared before the committee in July 2005. That presentation set out the main points of what the commission had recommended. High on the list were issues related to supernumerary embryos and the practice of super-ovulation which has a strong patient safety dimension to it. We are conscious of the need to safeguard the safety and best interests of the woman concerned and any children born through IVF.
Deputy McManus asked if ultimately we were satisfied that the area was not regulated as matters currently stood. The commission's report was published in May 2005. When we met the committee around June or July that year, the report had been forwarded to it by the Government for structured political and democratic consideration. It was considered the committee was the appropriate forum for that consideration to take place. The committee's report, based on its analysis of the commission's report, will assist us in determining future policy direction. We are cognisant that the commission's report is the first step in so far as it is an elaboration of the cluster of surrounding issues.
There are dimensions which need a great deal of careful work and analysis. Regulators internationally are grappling with the issues that arise in the assisted human reproduction arena. As mentioned by Deputy Connolly, science is advancing so fast that any existing or future legislation is or will be attempting only to keep up with those advances. To develop the legislation we must have lengthened foresight and try to predict what could potentially happen in the future in how embryos may be created. Nobody predicted when the Human Fertilisation and Embryology Act 1990 was passed that embryos would be created by means other than fertilisation. This led to legal difficulties in the courts in 2001 in England. Lengthened foresight is needed to anticipate what may be around the corner in advances in science as referred to by Deputy Connolly.
I am sure that at some stage the Department will take into account the best interests of the couple concerned, particularly the woman. However, if there are no couples who wish to avail of this method to have a child, the issue does not arise. Without the agreement of the woman, there will be no child. It appears this issue is being considered from the point of view of the fertilised egg.
The Senator has raised an important point concerning the cluster of issues surrounding the issue of consent in the various stages of treatment and the storage of gametes and embryos. In some jurisdictions consent demarcates at every stage of the process. One cannot move to the next stage of the process without first obtaining in writing the consent of both parties procuring treatment. I am merely setting out the position based on work we have undertaken in reviewing legislation. In the United Kingdom written consent is required. Detailed procedures set out in the Schedules to the Human Fertilisation and Embryology Act 1990 describe what form consent should take. It is then left to the Human Fertilisation and Embryology Authority to elaborate further on this consent in its detailed code of practice.
In answer to the question as to whether the Department is satisfied with the lack of regulation in the area, when the legislation was introduced in the UK by Kenneth Clarke the then Health Secretary, he described it as being probably the most important legislation in 20 years. The significance of the legislation cannot be under-estimated. When we speak of a lengthened foresight, it ties in with the significance of this legislation. We must get it right on all the parameters that must be in place with the legislation, including questions to do with definitional issues such as the embryo. To achieve this, heavy analysis and work is required but we are doing this expeditiously.
Is it possible to deal expeditiously with regulation of the clinics rather than waiting for all the issues to be dealt with by means of legislation?
Dr. Colette Bonner
I apologise for the absence of Dr. Jim Kiely. We had a competing meeting within the Department which was equally important. I volunteered to come to this meeting and Dr. Kiely stayed to chair that meeting.
The issue of the quality of patient care and the safety of patients is profoundly important to the Department. I realise why the committee members are uneasy that legislation for this area does not exist. However, I understand that the nine clinics currently in operation here all employ registered medical practitioners who specialise in this area. These people are bound by a code of ethics under the Medical Council. I understand members may have talked to patients who may have had different experiences but I understand that there has not been any significant number of cases coming before the Medical Council from this area of medicine, even though this specialty has been operating here since the mid-1980s. I am not trying to make an excuse for the fact there is no legislation but because our clinics employ medical practitioners there is probably a code of conduct of ethics and safety within those clinics.
The European Union Directive 2004/23/EC relates to standards of quality and safety governing the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. This relates to reproductive cells, foetal tissue and cells and embryonic stem cells. All the representations from those nine clinics come to meetings in the Department of Health and Children regarding this area, so at least we know that donations have been given all the necessary tests to ensure they are free from viral markers, etc. I know this does not have anything to do with the quality of clinical services provided but the fact that our medical practitioners are running these clinics means they are run to a very high standard.
However, this is a very complex area and I realise that significant ethical issues are involved. Many countries such as New Zealand, Australia and Canada have introduced legislation in recent years as it is obvious they see the importance of legislating for this area. The UK introduced legislation a while back and we will introduce legislation in the future but because they are such complex areas it requires a study of what happened in other jurisdictions and a study of our existing laws that may have an impact on this. This is the reason the process will be prolonged but legislation will be introduced if there is agreement and this will come within the next 18 months, in all probability.
I thank the delegation for its responses. I have concerns about Mr. McCormack's approach although I appreciate the points he has made. Legislation is a process of evolution. We spend our lives here changing laws that have become obsolete or need to be changed. Therefore, the idea that we can capture future developments in one moment is not realistic, particularly in the area of medical advances.
I do not see legislation in the same way as Mr. McCormack, but perhaps I have misconstrued what he said. The preparation and development of legislation is an ongoing process because everything in life changes. Nowhere is that more true than in the medical area. What we need is legislation that will deal with the issues that now confront us, the main one of which is that thousands of women avail of services that are not regulated by anybody.
I have the highest regard for the Medical Council, but it is not sufficient as a safeguard. Anybody who has talked with a victim of Mr. Neary in Our Lady of Lourdes Hospital in Drogheda knows the Medical Council is not enough. When the HSE was set up, the health information and quality authority, HIQA, was to be established to provide the oversight required. Will HIQA have a role in this regard when the legislation, which is due shortly, is passed? Is HIQA not a vehicle through which we could ensure some safeguards are put in place and can we ensure that it has a role in overseeing these clinics? Is it the case that because these are difficult and complex issues, HIQA will not have no role? Assigning the role to HIQA would be a practical way of ensuring we had some safeguards in place other than the Medical Council. We are negligent in our duty if we leave it all to the Medical Council.
We are fortunate to have good medical practitioners, but there are issues with regard to such matters as the location of a clinic. Is it not better to link and locate a clinic with an acute hospital rather than have a stand alone clinic? Other practical issues should also be considered within the general framework of the decisions being made.
Mr. McCormack spoke about other legislation. What other legislation could be affected by the legislation we are trying to progress? The United Kingdom has confronted and dealt with the issue, which is one of our strengths. When I was a Minister I learned that we follow much of what happens in Britain. I do not infer we should ape the British, but the work has been done and surely we can draw what is appropriate from it and put it in legislation for ourselves, rather than try to reinvent the wheel.
Mr. McCormack pointed out the need for the legislation to anticipate what may happen. We are obliged to legislate for the current situation and for what may come down the road. However, I cannot see that we can anticipate what will happen. As Deputy McManus pointed out, the main issue with which we must deal is that of amending legislation on an ongoing basis. It seems to me that talking about anticipating futuristic legislation is a mechanism to stall progress. We will not produce such legislation. We must deal with what we have on our plate now, create legislation and bring it before the House.
Has the Department been in discussion with religious, medical or public interest groups on the ethical and moral issues?
I return to what Mr. McCormack said about consent. Consent and lack of proper consent were a serious problem in the case before the courts before the summer. We have no idea what consent forms in other institutions may be like, which is a difficulty. However, before dealing with the issue of consent, we must deal with the issue of information. To go back to Lord Winston's lecture, he certainly seemed to think exaggerated claims were made, not necessarily by clinics in Ireland, but in some of which he knew. It seems the association of people who have been patients with infertility — I believe it is called the National Infertility Support and Information Group — is the only one trying to help others in this situation. The Department of Health and Children is washing its hands of the matter and unconcerned about the information being given out.
Something amusing happened in regard to the tissue directive. I was asked by one clinic whether a derogation could be obtained in respect of some processes at clinics, given that sex was not a sterile act. I contacted the powers that be in Brussels to find out whether we could have a derogation and was informed that we could not because we had no legislation. There must be legislation before a derogation can be granted. Running clinics costs a lot of money. It is absolutely right that all imported sperm must be free of viruses. However, certain matters must be taken into account. As far as I know, the progeny of sperm donors in Denmark and Sweden have a right to know who they are. Does the legislation in those countries apply to children here if sperm has been imported from them. There is no sense of urgency in dealing with such issues until the chickens come home to roost which will probably happen rapidly, but that is not the fault of the members of the delegation. I am sure those who have sent directions have not said this must be worked on day and night.
Let me ask a question on legislation and regulation. Is it possible to bring forward a regulation before introducing legislation covering the entire area?
The Vice Chairman is asking whether we could regulate clinics first and later revisit other issues such as the prohibition on reproductive cloning-----
The other issues being more complex.
It depends on the scope of regulation. The question is whether piecemeal legislation is good legislation. Is it integrated? If clinics are regulated and there is a licensing system, what procedures will be licensed? What procedures will they be permitted to carry out? Will there be donor insemination? Will the donation of ova or embryos be allowed? If so, what will the consequences be for other legislation when issues of, for example, legal parentage arise? Should such issues be included with the regulation of clinics? Regulations applying to clinics can be prescriptive of what treatments are allowed and may restrict them in practising if they do certain things. It is what clinics are allowed to do under a licensing system, if that is the way the Government chooses to go, and the knock-on effects of this that build flesh around the legislation. This requires much analysis. I do not wish to give the impression that I am trying to predict what will happen in science 30 years from now. I am merely conscious of the fact that in the UK Human Fertilisation and Embryology Act there is a definition of "embryo" which assumes that an embryo will be created through the process of fertilisation. However, we now know that an embryo can be created in other ways, for example, through somatic cell nuclear transfer. It is the way in which Dolly the sheep was created. There was a High Court challenge as a result of that definition, which was won. The verdict was overturned on appeal to the House of Lords, but only because the House of Lords took a purposive interpretation of the law rather than a literal interpretation. I am not certain that is the way the courts in Ireland would view this question. This is what I mean when I refer to getting the science as it stands correct, and then trying to project that to some kind of medium-term or short-term future so that, for legislators, the public good is covered.
Mr. Goodman
To amplify that point, we all recognise it is difficult to draw up perfect legislation — it is an evolving process. Part of what would be involved in this regard would be establishing what the Government or the Oireachtas would want to make the subject of primary legislation — for example, certain prohibitions or permissions, and what matters would be left to a regulatory authority. Given the type of field in which we are involved, one could put wide and sweeping powers in the hands of the authority, which would be a matter for the Oireachtas to determine during the passage of such legislation. This is one of the aspects of seeking to strike the right balance while, at the same time, given it is an evolving scientific field, as we all recognise, we do not want to include changes in primary legislation only to find out after a relatively short time we have tied too many hands. It is about trying to strike the right balance.
Reference was made to HIQA. The option of making this area of regulation part of HIQA's ultimate responsibilities, for example, is one that can be examined. The question might come down to whether it would be better to have a completely separate authority in the area of assisted reproduction or whether it would be an adjunct or part of HIQA. As we know, HIQA is currently being constituted from a couple of different bodies. At this stage, I do not know whether this would make a material difference to the overall execution of tasks one would want a regulatory body to discharge.
Reference was made to issues such as the location of clinics and so on. It may be a consideration but I am not sure it is one which would be as central in the general order of things as some of the more fundamental matters about which we spoke. An appropriate regulatory framework would perhaps be higher up the list of concerns than the issue of co-location. However, co-location might be a consideration at the level of the regulatory authority with regard to whether it had a particular view as to whether it facilitated the delivery of a higher quality service, or one more integrated with other clinical services. I will not rule it out as a consideration but it is not one that has been highlighted to a major degree to date.
With regard to other legislation that might be impacted, Mr. McCormack referred to the issue of parentage and adoption, which would be a crucial issue in any discussion of donor programmes. If surrogacy, which is recommended in the commission's report, were contemplated, major adoption issues would arise. As the committee is aware, one of the members of the commission gave a dissenting view on the issues around surrogacy, adoption and a range of associated issues. Similarly, the Equal Status Acts are discussed in the report. We talk colloquially about couples and so on but there are different understandings of what a "couple" might be in present day society. We must consider where we would go with this issue vis-à-vis equal status legislation and whether it is appropriate, depending on the policy direction the Government would wish to take, to ask what legislative measures, if any, might be needed in this area.
As regards following the UK legislation, that is certainly one example we would examine to a significant degree. However, we must recognise that the UK law was eventually enacted in 1990, some 16 years ago. As my colleagues have mentioned, such legislation has been passed in a number of jurisdictions more recently. It behoves us to look at those examples as well in order to bring together the best ideas. There is not always just one way, so we wish to take as many inputs as we feel are appropriate. This is not to be seen as some sort of time-buying exercise. We want to learn so that as far as possible we can do things right. We have been given a task to do and we want to get on with it. We have no intention of sitting on our hands and seeing how long we can make this last. Nobody would relish any task if that was what he or she was being asked to do.
Deputy Connolly raised the issue of public consultation. The commission engaged in a measure of public consultation in preparing its report. This committee has also done so. There is a balance to be struck in the formulation of legislation as regards what type of consultation might be needed. Clearly, the public interest needs to be considered as well as interest groups, including experts in the fields of law and medicine. The latter two are the most obvious ones but they are not exclusive. We do not want to throw the matter open in such as way as to have another big round of consultation, which could potentially take time, so a balance needs to be struck in that regard. The general approach in Government nowadays is that legislation needs to be developed but at appropriate stages there are opportunities for consultation. We have seen this in recent health legislation, such as the Medical Practitioners Bill. I anticipate that as we move forward this will be done to a certain degree.
I wish Mr. Goodman had not mentioned the Medical Practitioners Bill. I have been waiting for it for seven years. The then Minister for Health and Children, Deputy Martin, promised that legislation would be ready before Christmas seven years ago. I do wish Mr. Goodman had not mentioned it because he brought it all back again.
Mr. Goodman
The committee will have to invite some of our colleagues in to ask them about that.
That will not happen before the next election.
The point I was making about HIQA is that the legislation is coming before the Dáil in the next session. Is it not possible to insert some sort of basic, limited regulatory protections in that legislation? That was my point about HIQA, not that it would ultimately end up there, which is immaterial. The impression I am getting is that litigation is an issue, which is a matter of some concern. Mr. Goodman spoke about sweeping powers but it is not as if we are discussing a greenfield site, in the sense that nothing is happening. Sweeping powers are being exercised by people who want to make money. We are not talking about things that are going to happen — they are happening and have been for quite some time, yet there is no regulation.
I thank the delegation's members for giving us their views on this important issue. We found the presentation to be very informative.
Could I raise something about this when our visitors have gone?
In private.
I do not know if it necessarily needs to be in private. I just want to see where the committee and sub-committee are going with it.
Certainly.
Our visitors do not need to be present for this discussion.
I thought we were waiting for the Supreme Court to rule and then we would try to bring forward our report.
I think this discussion should be in private.
Okay. I thank the delegation for coming.