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.