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Wednesday, 5 Nov 2003

Vol. 1 No. 27

Embryo Research: Presentation.

I welcome Mr. Ned Costello and Mr. Bill Brandon of the Department of Enterprise, Trade and Employment, Professor Dervilla Donnelly, chairperson of the Commission on Assisted Human Reproduction and Mr. Peter Hanrahan, Principal Officer of the Department of Health and Children and secretary to the Commission on Assisted Human Reproduction.

This matter was referred to the committee for scrutiny on 9 October 2003, and it is proposed to adopt it at a Council meeting on 27 November 2003. The committee also invited the Irish Council for Biotech to assist in its consideration of this matter but the council indicated that it would be of little assistance until it had seen the report of the Commission on Assisted Human Reproduction. The commission was established in 2000 to prepare a report on the possible approaches to the regulation of all aspects of human assisted reproduction and the social, ethical and legal factors to be taken into account in determining public policy in this area.

The range of issues under its remit is highly complex and includes research on embryos. I understand it is expected to report shortly. I propose to ask Mr. Costello from the Department to give us the background to the proposal, and I will then ask Professor Donnelly to give us some details of the commission's work to date and to indicate when its report can be expected. I will then ask the members to make their contributions.

I draw the attention of witnesses to the fact that members of the committee have absolute privilege but this privilege does not apply to witnesses appearing before the committee. While it is generally accepted that witnesses would have qualified privilege, the committee is not in a position to guarantee any level of privilege to witnesses appearing before it. I also draw members' attention to the fact that they should make declarations of interest if appropriate either now or before the commencement of their contribution. I invite the Department to make its submission.

I thank you, Chairman, for this opportunity. I start by saying a few words about stem cells themselves because it is a somewhat complex scientific area but there are a few basic facts that are pertinent to this particular issue. There are approximately 200-210 cell types within the human body and stem cells are the basic cells from which these various cell types evolve. There are two fundamental types of stem cells, embryonic stem cells and adult stem cells. The embryonic stem cells arise in the embryo very shortly after fertilisation, within the first five days or so. The adult stem cells are found within the human body in various locations, including teeth and some vital organs, but they are found in much smaller numbers.

The difference between two types of cell is really defined by the technical term plasticity, that is, the ability of the cell to evolve into different kinds of cells. The particular feature of embryonic stem cells is the ability to evolve into any of the 210 different cell types, whereas adult stem cells are much less potent in their ability to evolve. They can generally only evolve into the kinds of cells of the organ or particular tissue they are resident in.

Why is this area of interest from a scientific and medical point of view? It is considered to hold great promise in addressing a number of diseases for which there is currently no known cure and, indeed, where there are very poor treatment prospects. These include diseases such as Alzheimer's, cardiac diseases involving heart transplants, for example, failure of the liver and so on. This is why there is a huge focus on this issue.

The focus of the research worldwide, to take a global perspective on it, is covering both embryonic and adult stem cells and there has been some reflection of that in the media. There are different scientific views as to the potential of the research. Some scientists feel that adult stem cells will deliver all of the necessary results whereas a significant body of scientific literature from people working on the embryonic area suggests that this area is the better in terms of prospects of delivering results. That is to put it in simple scientific terms, without dealing at all with the ethical issue.

That is the background to stem cells, where they come from and what they might be used for. Where would the stem cells come from in the context of the particular EU proposal before us? They would come from in vitro fertilisation treatments. The nature of IVF is such that it is currently medically considered more desirable to produce a number of eggs that can be fertilised above what are needed for single cycle treatment. Therefore, there may be eggs left over at the end of the treatment from which embryonic stem cells might be extracted in the context of this proposal.

To turn to the EU framework programme and the proposal itself, it arises as part of the EU framework programme for research and development. The framework programme is one of a number of multi-annual framework programmes for research and development. This is the means by which the EU organises its collaborative research, and Ireland has been a strong participant in the framework programme overall. Framework programmes over the years have covered a number of technological areas. It started off with a big focus on information technology in the ESPRI programme back in the early 1980s and has expanded from there. Ireland secured €115 million in EU research funding under the previous framework programme and we have been performing quite well in the current framework programme also, having secured €40 million in funding under the first round of the programme which is running from 2003 to 2006.

Moving on to the specifics of this proposal, the common position on the sixth framework programme overall was agreed at Council in December 2001, and it was formally adopted on 27 June 2002 following a co-decision procedure with the European Parliament. It runs from 2003 to 2006 and involves a total budget of €16 billion for research activities. These research activities are organised into a number of schematic areas, and the relevant one in this case in genomics and biotechnology for health, but there are others such as nanotechnologies, food quality and safety, sustainable development, global change and eco-systems and so on.

The overall shape of the programme was adopted first by Council decision and, within that, the genomics and biotechnology for health area has a budget of €2.5 billion. Of that budget, €1.1 billion has been allocated for the area of stem cell research, but it is important to stress that this is for the overall area of stem cell research and it could comprehend both adult and embryonic stem cells. That was the overall shape of the programme as adopted.

Following that, however, there is then a requirement to adopt the specific programmes and this is where we drill down into the detail of the elements of the framework programme. The Council decision on the specific programmes, adopted on 30 September 2002 following consultation with the European Parliament, provides the following in respect of activities involving stem cells. Under the thematic programme life sciences, genomics and biotechnology for health, research will focus, inter alia, on developmentand testing of new preventative and therapeutic tools, such as somatic gene and cell therapies - in particular stem cell therapies, for example, those on neurological and neuromuscular disorders - and immunotherapies. The specific programme ruled out particular areas of research and these included research activities aimed at human cloning for reproductive purposes, research activities intended to modify the genetic heritage of human beings and research activities intended to create embryos purely for the purposes of research.

In addition, the specific programme provided that any research project involving the use of human embryos and human embryonic stem cells will be the subject of an ethical review and will be submitted to a regulatory committee established under the programme to assist the Commission in the implementation of the programme.

When the specific programme was being adopted on 30 September, the area of stem cell research did give rise to controversy and to disagreement among member states. As a result, it was agreed that a moratorium to the end of 2003 would be put in place with the specific purpose that the Commission would come back with detailed implementing guidelines to cover this activity under the framework programme.

It was also agreed that the Commission would conduce an inter-institutional seminar, which it did in April 2003, to further tease out these ideas. As a result of that activity, in July 2003 the Commission submitted its proposal for implementing guidelines - the proposal with which we are concerned and which is under scrutiny here today. That proposal provided specifically that the research could only be conducted on embryonic stem cells derived from IVF treatments, and being surplus to those treatments. It also provided that there would be a comprehensive range safeguards - this is what is in the text - under which that research would be conducted. A critical one of those was that the stem cells could only be derived from supernumerary embryos, which were donated for research by parents and which were created before 27 June 2002, and that potential research partners would have to seek ethical advice at national and local levels in member states, even where the seeking of that advice was not mandatory under the regulatory regimes in those member states. Importantly, throughout this whole issue there has been a guarantee that research, which is not legal and ethical in the member state in question, will not be funded by the framework programme in the member state in question. That is in there also.

There is a range of other safeguards and they are in the documentation which we have supplied. They include issues such as an important one that the embryos would only be used if the informed consent has been given by the donors in question, and they contain restrictions on trade in embryos and all those other issues. They are quite comprehensive.

That is the proposal. That proposal was discussed informally at the competitiveness Council in September 2003. It was an informal discussion which took place at a lunchtime discussion of Ministers. Our understanding is that a number of member states voiced opposition to the proposal, a number of other member states were happy to accept the proposal as it is and a number of states had concerns about the proposal because they felt that it was excessively restrictive relative to the regulatory and legal regime applying in their own countries. Therefore, there were differing views, both for and against the proposal, and a number of people in the middle. That is reflective of the fact that member states differ widely in their legal and ethical stance on this issue, and that is to a certain extent reflected in what we understand were the informal discussions that took place at the Council. However, it is fair to say that it is quite difficult to align the positions of member states in so far as they have been expressed, with the actual legal and ethical regime applying in the particular member states in question. There does not seem to be an absolute fit between the two.

The following is the position Ireland has taken to date on the proposal. It must be said that there has only been an opportunity to give an informal expression of this position. Following consultations between the Tánaiste and Minister for Enterprise, Trade and Employment and the Minister for Health and Children and other relevant Departments, Ireland has indicated that it would not oppose the Commission proposal as currently drafted on the following basis: that it does not allow for the funding of any research activity in Ireland which would not satisfy Irish ethical or legal requirements; that the framework programme activity will be strictly limited to research on embryos produced for medically assisted in vitro fertilisation to induce pregnacy, and that will not be used anymore for such purposes; that clear and comprehensive guidelines and conditions governing research on human embryos and human embryonic stem cells are established for the first time under this programme and that a scientific and ethical review will be required before any proposal for research activity under the EU framework programme is permitted.

That is what has happened to date in so far as there has been a discussion at the Council of Ministers on the issue. Subsequently the Council referred the dossier to the European Parliament for an opinion and the European Parliament is currently discussing the issue. The European Parliament is due to finalise its opinion by 18 November and the intention is that the dossier would return to the competitiveness Council of 27 November where one would expect that a vote would be taken on it. It has of course been the subject of a scrutiny process with the Joint Committee on European Affairs Sub-Committee on European Scrutiny and we are now involved in the scrutiny process here today. That is where we stand now.

Thank you, Mr. Costello. I welcome Professor Donnelly.

Professor Dervilla Donnelly

I am happy to be here today to speak to the committee on the work of the Commission on Assisted Human Reproduction. As I am sure the committee will appreciate, the commission is still in the process of finalising its report and therefore has not concluded its deliberations. I am not in a position to give the committee details of any conclusions or decisions we have made.

As the committee will be aware, and as you stated earlier, Chairman, the Commission on Assisted Human Reproduction was established by the Minister for Health and Children. The terms of reference were broad in a sense but also narrow - to prepare a report on the possible approaches to the regulation of all areas of assisted human reproduction and the social, ethical and legal factors to be taken into account in determining public policy in this area. The emphasis is on regulation.

The commission was specifically asked not to recommend on the question of funding. This, of course, is helpful to the commission when we are dealing with such a topic. We were also given a list of key issues that needed to be examined. This included legislation or reliance on medical ethics; replacement or freezing of embryos, the unborn, the status of persons, freezing of sperm and ova, artificial insemination by donor, restrictions on who may avail of the services, donor programmes, surrogacy, screening of embryos for genetic conditions and research on embryos and cloning. This list has been made available to anybody who is interested in the topic and we can hand the committee a copy of it.

The Commission on Assisted Human Reproduction has met on 18 occasions to date and will meet again next Thursday, 13 November. It adopted an interdisciplinary approach to the work. When dealing with projects such as this, the approach can be to get an expert to write a document and use commission members for discussions or the members can be divided into work groups. We chose the latter because of the interdisciplinary nature of the programme. Initially, each discipline presented its view of the situation. We received reports from the medical, legal, scientific and social members of the commission. Having completed the reports, it was clear everybody was thinking with a different hat on and our job was to get them to work together.

Subsequently, we laid out a plan and chose the topics and issues. The commission members were subdivided and allowed to choose the subject areas with which they were most comfortable and which would be to be the best advantage of the commission. These work groups were formed and they were chaired by a member of the commission. The first work group dealt with gametes and embryos, the second with donor programmes and surrogacy, the third with infertility treatments, services and information and the fourth with current trends and future directions of research using embryos and other implications.

The work groups met on a regular basis, very often on the morning of commission meetings. The work of commission members is entirely voluntary. They are professionals who are busy. Mr. Hanahan's great gift was that he managed to get them to meet at all together but that has been achieved. Consultation with the UK Human Fertilisation Embryology Authority was one of the requests made. We had to investigate research in the UK and Northern Ireland. We did this and I attended the meeting of the British Fertility Society with one member of the commission and the HSEA. They could not have been more helpful and we have continued to closely monitor their progress, procedures and guidelines.

We held a one day conference on assisted human reproduction - social, ethical and legal factors - for commission members at the beginning in an attempt to get the different disciplines to work together. This was a private meeting in Dublin Castle in September 2001. Even though the commission was appointed in 2000, we did not have staff, a secretariat or chairs and, therefore, we bided our time and started slowly. The meeting provided an opportunity to exchange views between experts in the various fields in Ireland and we brought in people from France, Germany and the UK.

In an effort to be as fully informed as possible on the current state of public opinion in Ireland on the matter the commission was studying, we placed a newspaper advertisement inviting interested members of the public, professional and voluntary organisations and other parties to make written submissions to us. We received 1,600 submissions in response to the advertisement.

We also engaged in a number of other information gathering exercises. We conducted a survey of the AHR services provided by the specialised clinics and we received generous support in obtaining information from these bodies. We surveyed the GPs, which is the primary group of medics meeting people who have fertility problems. The commission issued a survey instrument to a random sample of 50% of GPs and we received a high proportion of replies, which was satisfying. We conducted a survey of obstetricians and gynaecologists and we received a positive response.

We then decided we should consider public attitudes and we attempted to conduct a survey. The commission recruited a market research organisation to carry out a survey, a random sample of 1,003 over the age of 15 living in Ireland and classified by gender, age, socio-economic status and location. Interviewees were asked a range of questions about fertility treatments and associated support services and research procedures. The results were interesting. It was also important to survey the users of fertility treatments. The national information and support group, MISG, a voluntary organisation for infertile couples, made available, through its chairperson who is also a member of the commission, the results of a survey of its members carried out to establish the level of satisfaction with fertility treatment services in Ireland.

A public conference was held on 6 February 2003. An audience of 250 responded to the commission's invitation to attend. The purpose of the conference was to examine the current state of AHR in Ireland and abroad on the basis of presentations from acknowledged experts in the field. It also explored the legal and ethical issues surrounding the in vitro embryo and the contribution of AHR to the creation of families as distinct from individual children. The proceedings of the conference are available and Mr. Hanrahan has six copies for the committee.

All the information collected through the commission's surveys will be used to compile the commission's report and it is in the process of finalising its report. Given the difficult nature of the issues to be examined, the committee will appreciate it has not been an easy task and we hope to report to the Minister before the end of the year or early next year. The publication of the commission's report is only the first step in a process that we hope will provide the basis for informed public debate before the finalisation of a policy statement.

I refer to our function as a committee on this issue. This document has been examined by the Oireachtas Joint Committee on European Affairs, which has adopted a position, and it will also be scrutinised by the Oireachtas Joint Committee on Health and Children. Normally, ethical matters are not previewed by an enterprise committee. What is the role of the committee in terms of scrutiny of the document?

The issue of experimentation on human embryos is controversial. I refer to research permitted under the directive, should it be supported at the Council later in the year. Does this relate exclusively to research, under ethical guidelines, involving human embryos created prior to 27 June 2002, which are currently frozen, are supernumerary to in vitro fertilisation that has taken place and, in the absence of such research, will be destroyed? Is it the position that no other embryos can be used for research? Second, it is my understanding that there can be no such research in Ireland on any human embryo as it would be unethical and unlawful under our Constitution. Is that accurate and clear? Finally, I circulated a document to the committee because I am a member of the science committee of the parliamentary assembly of the Council of Europe which produced a comprehensive report on stem cell research in September 2003.

Are the clauses adopted by the parliamentary assembly of the Council of Europe, which set out very strong ethical standards for research in this area, adopted and accepted by the European Commission? The parliamentary assembly called on member states to promote stem cell research as long as it respects the life of human beings in any state of their development, encourages scientific techniques that are not socially and ethically divisive and urges that all member states sign and ratify the Oviedo Convention. Have we signed the Oviedo Convention which would prohibit the production of human embryos for research purposes and prevent their destruction in any such research? Those particular questions would be helpful to the committee in determining our role and the exact scope and nature of the proposal before us.

I am mindful that the Order of Business is approaching in both Houses.

The commission's report would have been very helpful to us in advance of the decision on 27 November 2003 but I can understand the difficulties alluded to and the dexterity of Mr. Hanrahan in getting people together on such a very important issue. His commission is probably surplus to requirements in this debate because we do not have its recommendations. We can understand the difficult process it must go through.

The key to this are the relevant constitutional provisions and how they are interpreted in terms of human embryo research and when life begins. What are the legal and ethical guidelines on which Mr. Costello bases his recommendation? I know it is a very complex area but it would help the committee to know the basis on which the Department has arrived at its recommendation to this committee. It would also be helpful to know the likely position that the Government will take on 27 November in the event of a vote.

Our position is not to oppose the Commission's proposal, so on what basis did the Department come to that decision? To what extent does it conflict or is in keeping with the provisions of the Constitution? What decision did the Joint Committee on European Affairs take on this issue, and what is the view of the Joint Committee on Health and Children? Perhaps Professor Donnelly could tell me about the membership of her commission. I do not have a list of the people on the commission and would be interested to know who they are.

I wish to ask a few questions of Mr. Costello. He said that adult stem cells are available for use in research and that the use of such cells, taken presumably from an adult, does not involve the ending of the life of that adult. I understand - and I can be corrected - that stem cells can also be obtained from afterbirth. Is that a source, as well as the umbilical cord, which can be drawn upon to obtain stem cells without ending a human life? Is the Government satisfied that we know for sure that those sources of stem cells are inadequate?

If the precautionary principle applies to the environment it should also apply to human life, and if one interprets the precautionary principle as having an application here, surely the approach should be to not use a source of stem cells that involves the destruction of human life until we are satisfied that no other viable and useful source is available. If, as Mr. Costello has said, many scientists feel that adult stem cells are sufficient to do the job, would he not agree that if the precautionary principle applies, we should wait until we are satisfied that adult, umbilical or afterbirth sources of stem cells are not adequate?

When three or four other sources of stem cells are available, we should be clearly satisfied that they are not adequate before proceeding to authorise the use of taxpayers' money on research using embryos and involving the ending of the life of those embryos. Can Mr. Costello confirm that obtaining stem cells from an embryo does involve killing the embryo? I ask Mr. Costello to indicate whether it is the view of the Government that an embryo is a human being.

I ask him to indicate also the Government's view of the applicability of the European Charter on Fundamental Rights, in particular Article 1, which refers to human dignity. Does an embryo have any right to human dignity within the meaning of the charter, which is to be incorporated in the new EU constitution? How has the Commission reconciled the idea that one would end the life of a human embryo for the purposes of obtaining its stem cells with respect for the dignity of that embryo? The reference to human dignity is contained in the first article of the charter, not some trivial thing pushed in at the end.

I of course understand that the intention of the research is to find cures for illnesses such Alzheimer's. It could be portrayed, however, as destroying a life in order to prolong a life. This brings one back to the fundamental question of whether the embryo is alive. Is it a life? I know these are questions on which even the most qualified ethicists cannot pronounce. These are questions for elected politicians to decide on, and there are of course a variety of views. Every view should be respected, and there is no one view that can be described as the right one. These are fundamentally questions of judgment. My view is only one within the committee, but I believe that a human embryo is alive, it is human, and therefore it should not be treated as a thing to be utilised for research, particularly if there are other sources available for obtaining the same research results. We have not yet established that these are not adequate.

Deputy Howlin has done the committee an enormous service by giving us this report. It states that the assembly of which he is a member says it shall not promote stem cell research unless it respects the life of human beings in any state of their development. There is no doubt the status of a pre-implanted embryo is a stage in the development of a human being. Simply destroying that life at that stage in its development for the purposes of research could be argued to involve - in the words of the committee - not respecting the life of that human being, particularly when there are possible alternative sources available, such as the umbilical cord, the afterbirth and adult stem cells which do not involve the destruction of human life.

There is something rather troubling about the fact that this was discussed over lunch. I find it inappropriate that a policy direction on a matter as profound as this should be taken when people were eating their food. What are the appropriate uses for an embryo? Should it be used for research or should it be used for food? Where is the distinction drawn between the two? What is the ethical distinction between using an embryo for research and using it for food? This is a scary and almost disgusting question. It is important that the distinction be clear and that this distinction be made by politicians and not by scientists.

It is important to recognise that there are commercial interests involved here. Those with commercial interests should not determine ethical questions. If funding is provided by the State through the EU for one aspect of research, this will release funds within that research organisation for other aspects of research, which may be considerably less acceptable than that which it is proposed to admit, on the basis of the substitution of funds. None of these forms of research is properly regulated. It would be interesting to know what will happen to the frozen embryos that already exist in this country. Are they to be destroyed or are they to be preserved in perpetuity and, of course, are they alive?

I believe the embryo is the smallest member of the human family. I would like to direct my remarks to Mr. Costello. There is strong disagreement over the efficacy of using embryos for research. I would like to quote the head of the Queensland Institute of Medical Research, Michael Good, and head of the Children's Medical Research Institute, Peter Rowe who stated:

Scientifically for serious technical reasons of tumour formation and immune rejection, embryo stem cells are highly unlikely ever to be trialed in humans while adult stem cells are already making dramatic advances in human trials even here in Australia, in spinal injury in Brisbane PA Hospital, in heart disease in Newcastle John Hunter Institute and in the months ahead Parkinson's disease in the Melbourne Peter McCallum Institute, not to mention the Australian children cured of "bubble boy" immune deficiency, cases of corneal blindness having been repaired in California, stabilising of advanced MS and lupus, and dozens of other clinical applications.

We have so many other methods of getting stem cells, including, as former Taoiseach, Deputy John Bruton, mentioned, placenta, neo-natal and bone marrow. There are adult stem cells in the skin. There are many uses of stem cells, which is to be welcomed. However, research on embryos is not to be welcomed. This has come from Europe, a new Europe that in all cases should be upholding and vindicating the right to life and the dignity and respect for life in every case considering Europe's history. Germany, Portugal and Italy have taken the right approach by rejecting research on embryos.

As I said at the start of my remarks, the embryo is the smallest member of the human family.

I support Senator Hanafin. Is it true to say there is no scientific evaluation and ethical review to support any proposal under this Framework Document? Given the right to life of the unborn as detailed in Article 40.3.3° of the Constitution, from an ethical point of view we would all be very concerned at the proposals before us today. Not alone should Ireland be taking a view of what it controls within its own country, but we should also be expressing the view that we dearly hold within Europe. Is it correct that at present the EU has banned inhuman research until the end of December 2003? If that is so, is this a solution to a European problem? Should we not be expressing our view to uphold those values? Surely there must be a constitutional issue here also. As politicians expressing the electorate, we should also express those views.

Deputy Bruton asked most of the questions I wished to raise and I do not want to indulge in any lecturing. I thank Mr. Costello and Professor Donnelly for their enlightening contributions. Politicians represent various cultural viewpoints. Irrespective of whether it is linguistic, culture or whatever, there is a morality governing most western behaviour - the same is true for eastern, southern and northern - which is whether we are destroying human life which can happen through a war in Iraq or the destruction of an embryo.

Mr. Costello referred to fertilised eggs that are left over. At the current stage of development is it necessary to kill embryonic life? Is it killing embryonic human life if a fertilised egg is created? I read that Professor Martin Clynes of DCU said the cells are available in the umbilical cord. If that is so, why is this form of research needed?

I will start in the order the questions came. It is correct that the proposal relates to stem cells deriving from embryos created before the specific date in question, before the start of the framework programme. In effect it would be embryos that are currently frozen because cryopreservation is the way of preserving embryos that are being used for IVF treatments. The embryos in question would be supernumerary because the informed consent of the donors is required. It would be a situation where the donors feel they no longer want to proceed with the IVF treatment. They may have already had a child as a result of IVF treatment and so the embryos are available and they wish to provide them for research purposes.

The question was whether in the absence of this being done they would be destroyed. I am sure Professor Donnelly can expand on this. After a period of somewhere between three to five years the frozen embryos would cease to have viability or would run the risk of genetic mutation if they were implanted, so it is considered that they are unsafe to implant and after a period of time they will no longer be viable as embryos. Regardless of whether they are disposed, there is a period in which they are viable but after that there are potential difficulties with them. As far as the health committee is concerned, my understanding is that the dossier was passed to that committee for information and to this committee and the Sub-committee on EU Scrutiny for scrutiny. Moving on to Deputy Hogan's——

I asked about the Oviedo Convention.

I understand that we have not signed it but that it falls within the remit of the Department of Health and Children. Regarding Deputy Hogan's points, as far as restrictions are concerned the Medical Council guidelines are the most relevant. Those guidelines state that "the creation of new forms of life for experimental purposes or deliberate and intentional destruction of human life already formed is professional misconduct." Other speakers have alluded to the constitutional situation——

From where was that quotation?

Medical Council guidelines. Moving on to Deputy Bruton's points, as regards the sources of stem cells and spinal cord and placental stem cells, these are effectively adult stem cells as well. They do not possess the same plasticity and pluripotency as embryonic stem cells. The are different but they are indeed a source of adult stem cells.

On the scientific issue generally, for every scientific opinion one will hear to the effect that one line of research is the best to follow, one will get a contrary opinion. Opinions are divided. Regarding why one should pursue one line as opposed to another, the view that seems to be coming from the scientific community is that this research is at such an early stage that we cannot, as Deputy Bruton asked, say with certainty that embryonic stem cell research is required.

I think the scientific community would say that it does not know for sure one way for the other and is not certain about the adult stem cell issue either. However, it is absolutely correct to say that adult stem cells are already showing potential for therapeutic purposes. In the treatment of anaemia, for example, bone marrow stem cells are already used. That was one of the earliest uses of stem cells. The point to bear in mind is that the proposal being looked at is not about the funding of this research or conducting of this research in Ireland because it includes the provision that such research will not be undertaken here if it does not comply with legal and ethical guidelines.

Deputy Bruton raised an extensive range of ethical questions, and he adverted to the fact that there are many different views on these ethical issues. It would obviously be inappropriate for me to comment on the ethical issues as they are outside the scope of my remit.

Is Mr. Costello not representing his Minister here?

Those are political questions, however, as the Deputy said. I cannot answer political questions.

Why is the Minister not here then if they are political questions? Surely the committee should hear answers to the ethical questions from the Government before making decisions. Mr. Costello is part of the Government.

The Minister was not invited, and she has been most helpful to this committee since it was set up a year ago. She has always attended when invited.

I agree with Mr. Costello. There is a distinction sometimes between what one considers ethical and what one considers political. It is not for civil servants to tell me what is ethical, and I do not want to know.

The requirement for a scientific and ethical review, which was raised, is a central part of the guidelines. It is worth reflecting that this proposal is about putting in place strong guidelines to govern the conduct of the research, guidelines which are not in place currently. There will be a grey area if the moratorium runs out and there are no guidelines in place. The activity is already provided for within the framework programme. That legal decision has been taken, so when the moratorium expires at the end of December 2003, in the absence of guidelines there is something of a grey area as to what will then happen.

Various questions were asked about the killing of embryos and what happens when the stem cells are extracted. We are talking of an embryo consisting of about 16 cells, so when stem cells are extracted from the embryo it would no longer be viable. That is the factual position. I think that covers most of the questions.

Have members any further questions before we come to a decision?

The precautionary principle is applied across Government in regard to various forms of innovation, whether it be environmental or in this area. I ask Professor Donnelly whether the precautionary principle is being applied here. We should not initiate the taking of a life until we have exhausted all other possibilities of achieving our objective, just as we would not initiate in the environmental field something that causes pollution unless we have satisfied ourselves that there is no alternative method of achieving a desired objective.

I ask why the precautionary principle did not apply in the Government's approach to this matter at this lunch. That is obviously a question Mr. Costello cannot answer. I assumed that Mr. Costello was here on behalf of his Minister rather than as somebody separate from his Minister, but I understand and respect the fact that he cannot deal with the ethical questions. I submit, however, that it is impossible to consider this matter without looking at the ethical questions. Before proceeding further the committee should get people here who can deal with the ethical questions and provide the committee with advice on them. It is clear that, by virtue of his mandate, Mr. Costello considers himself not capable of dealing with the ethical questions. Most of the questions I asked were ethical and he said he could not deal with them——

I do not think members would be affected one way or another by the views of a civil servant on the ethical matters.

Everybody has something to learn here——

Internationally, there are huge ethical questions on this issue. What is very important from this committee's point of view is that we have promoted biotechnology in this country and no matter what any of us say or do, experimentation on human embryos, which is at a very early stage of development, will take place. The value of the cells is that they can develop into any other type of cell.

The committee must look a bit further ahead. Suppose some of these biotechnology industries which we are encouraging here use such cells in the production techniques they wish to employ in this country. While the research would not be done here, what would be our view then? I am on the health committee and attended the Medical Research Council meeting recently in London on stem cell research on its behalf. What will our attitude be to the desire of patients to have treatments derived from embryonic stem cells? These are very important questions for this committee to consider.

We have heard a very broad outline of the issue. This matter was referred to our committee for scrutiny in October 2003 and is due for consideration at the Council meeting on 27 November. The joint committee is not in a position to fully consider this matter without further widespread consultation and the seeking of submissions from interested parties.

A level of consideration has already been carried out by the commission on assisted human reproduction, and it expects to present its report at the end of 2003. It would probably not be appropriate for the joint committee to duplicate the work already carried out by the commission and, in any event, such consultation could not be completed within the time available to the joint committee. That is where we find ourselves.

Like all members I welcome the benefits that could be brought by stem cell research; it is an exciting time. It is as important as the discovery of penicillin. Notwithstanding that, the basic principles have not changed and I suggest we send this back and say that the committee is not accepting it, that it is against a fundamental and basic human right and that, having regard to the fact that an embryo is the smallest member of the human family, we could not accept the proposal. I propose that we reject the Comm. 2003/390 proposal.

Deputy John Bruton put a question to Professor Donnelly. Does she wish to respond?

Professor Donnelly

It is not a question really that I could respond to.

I thought so, but I wanted to give the professor the opportunity. Are there any other proposals?

What do we mean exactly by rejecting the proposal? Are we instructing our Minister to veto it?

As I understand it, we have a proposal before us to approve EU funding for embryo research. It is sad that this new Europe would put such a proposal before us. We must be mindful in the new Europe of dignity and respect for life at all times. Thus, we could not accept this proposal because EU funding means our money, and I would not be happy to see our money being used for embryo research.

I have spent some time working with the European committee which outlines in very clear terms the respect for and development of human life at all stages in this research. It is my understanding from the answers we have got that what is proposed is to allow, under ethical guidelines, experimentation on frozen embryos that will be destroyed at the end of 2003 in countries where that is allowed.

The Tánaiste proposes to support that, and has supported it at the informal discussions. I share somewhat Deputy Bruton's concern that this was discussed in an informal way. It is not a normal subject for informal discussions around the lunch table. Before we make a decision, however, I would like to hear the views of the Tánaiste directly. I agree with you, Chairman, that we are not in a position to make a binding decision on this now.

I do not know whether everybody had a chance to read the full report that I circulated, but it goes into the extraordinary benefits from stem cell research. It goes into the types of cells involved in some detail, much more detail than Mr. Costello was in a position to do, outlining the restrictions and potential of each type of cell in attacking a range of disorders.

I am dealing in my clinic with a couple who have to deal with a serious degenerative disease that can possibly be treated in this way, but it is not ethical in this country now. However, they will be treated somewhere because if one's child is in that position one will look for that treatment. General principles are extremely important, respect for life is fundamental and the ethical guidelines that we establish must be absolutely immutable. I would like to hear the Tánaiste's thinking on this and why she has taken the decision she has before we make a binding decision on it.

Germ-line research is a separate issue. The actual application of the stem cell therapy is a separate issue and there are many areas we could discuss. The Deputy referred to a degenerative disease which could be cured by the use of stem cell therapy and the use of vectors. It is very important to understand that we have a proposal before us and that we are rejecting that proposal. If the Deputy wishes to call for the Tánaiste to appear before the committee, that is a separate issue. Thus there are two separate issues. One is the actual use of the stem cell therapy in germ-line treatment, but we are dealing specifically with EU funding for embryo research and my proposal stands.

The last thing the committee would want to do is prevent the type of research taking place that will lead to particular cures for various diseases mentioned in the documentation. There are opportunities available to researchers at present to ensure that this can happen.

Deputy Bruton in particular mentioned the precautionary principle. We are not closing the door on any opportunities in the future for further research but erring on the side of caution before we find out what the Government's position will be in terms of applying the precautionary principle to embryo research. The Medical Council guidelines given to us by Mr. Costello clearly state that there is a difficulty regarding misconduct. The Council of Europe's science committee, which Deputy Howlin kindly brought to our attention, has been very strong on this issue also. We should put the ball straight back into the Tánaiste's court by rejecting this proposal and asking her to come forward and state why she was not prepared to oppose this European Commission proposal.

Is that agreed? Agreed. Our next meeting——

What we were being asked to do was to agree to experimentation on embryos that were going to be destroyed——

It is agreed now. I will allow the Senator an opportunity to speak at the next sitting.

A good end does not justify an evil means.

The Senator is most welcome to speak on this again and I look forward to his many contributions during the lifetime of this committee. The next meeting of the joint committee is scheduled for 9.30 a.m. on Wednesday, 12 November 2003. Arrangements have been made to receive in public session representatives of Quinn Direct, Allianz and the IIF. A written briefing has been requested from each organisation in advance. I thank——

Has my proposal been carried?

Yes, it has been carried. I thank Mr. Costello, Mr. Brandon, Professor Donnelly and Mr. Hanrahan for being with us. I look forward to them coming before the committee many times in the future to assist us. In the interests of our country we will hopefully have a fruitful four years of working together.

The joint committee adjourned at 10.50 a.m. until 9.30 a.m. on Wednesday, 12 November 2003.