Statement by An Tanaiste and Minister for Enterprise, Trade and Employment Mary Harney T.D.

To Seanad Eireann regarding the proposal for a Council Decision on Embryonic Stem Cell Research

19 November 2003

I welcome the opportunity to address the House on this matter. It is helpful to begin by placing the matter of embryonic stem cell research within the context of the overall EU Framework Programme for Research and Development.

The Union organises the bulk of its R&D activity under the ambit of multiannual framework programmes. The current programme, FP6, is, as the title suggests, the sixth such programme. It runs from 2003 to the end of 2006.

The programme supports collaborative research involving industry, third level institutions and dedicated research organisations. Its fundamental aim is to enhance knowledge, understanding and innovation in Europe and so raise living standards. Over time the framework programmes have expanded the scope of their activity. The initial focus was on information technology whereas the current programme includes themes on: Genomics and Biotechnology for Health; Information Society Technologies, Nanotechnologies and Nanosciences, Food Quality and Safety, and Sustainable Development etc.

The Framework Programmes are an important source of support for R&D in Ireland, supplementing our substantial national effort to become a knowledge and innovation driven society. Irish researchers secured €115m in funding from the previous programme. To date, under FP6, which only commenced last January, we have secured in excess of €40m.

As the programme expands its scope of activities, it is inevitable that policy issues will emerge which requires debate. The proposal to provide for embryonic stem cell research is one such issue.

The Common Position on the Sixth Framework Programme (FP6) was agreed at Council in December 2001 and formally adopted on 27 June 2002, following co-decision procedure with the European Parliament.

That decision established the overall funding for the programme at over €16 billion and the allocations for the specific themes within the programme. This included an allocation of €2.255 billion for the theme relating to Life Sciences, Genomics and Biotechnology for Health - the latter includes stem cell research involving adult and embryonic cells.

Subsequently, Council was required to formally adopt the specific programmes to allow the European Commission to activate the relevant calls for proposals in each area. This was achieved by Council Decision on 30 September 2002. As part of that process, a number of member states, including Ireland, expressed concerns at the lack of clear guidelines and safeguards to govern the conduct of the research work on embryonic stem cells.

As a result of this, the Council agreed to a Commission proposal to impose a moratorium till December 31^st 2003, on the conduct of such research under the programme pending the development of detailed guidelines and safeguards.

It is worth noting at this point, however, that certain activities are explicitly excluded from the overall framework programme in their entirety. These are:

• Research activities aiming at human cloning for reproductive purposes;

• Research activity intended to modify the genetic heritage of human beings; and,

• Research activities intended to create human embryos solely for the purpose of research or for ¹the purpose of stem cell procurement.

The research on embryonic stem cells is confined to those cells derived from embryos resulting from in vitro fertilisation treatment designed to induce pregnancy (IVF treatment) and no longer required for that purpose.

On foot of the establishment of the moratorium (which expires at the end of this year), the Commission held an inter-institutional seminar to tease out the guidelines.

It subsequently presented its proposal in on 9 July 2003. The proposal is for a Council Decision to amend the research programme. It proposes to establish a detailed set of implementing provisions concerning any research activities involving human embryos and human embryonic stem cells.

Embryonic stem cell research is already provided for in the EU Framework Programme. Financial resources been provided for it within the overall allocation for genomics and biotechnology for health since the decision of December 2001. What is missing are guidelines and safeguards and this is precisely and only what the Commission's proposal now provides.

I would like now, a Cathaoirleach, to turn to the details of the safeguards and guidelines. The key elements and implications of the guidelines are that:

• The proposals are based on the principle of Ethical subsidiarity. In this context this means that the European Union will not support or fund research in a member state where such research is not legal or deemed ethical;

• All proposals for research will be subject to ethical review - both at local level firstly and also at EU level;

• The EU will only support research on supernumerary embryos derived from IVF and donated before 27 June 2002. The effect of this cut off date is that there must be no incentive to produce new embryos as a result of the programme. In addition, the creation of embryos specifically for research purposes is prohibited. This prohibition is in line with the Oviedo convention.

• There is a requirement to demonstrate that the research cannot be done using adult stem cell lines. This is a very important point that I would particularly bring to the attention of the House. Firstly, it means that there is no incentive to use embryonic cells rather than adult cells. Indeed, it means that researchers must thoroughly examine the potential of using adult cells (for which there is also funding available under the programme).

• No financial gain for donors is permitted. This is in line with related ethical considerations in the area, for example, of organ donations for transplantation purposes.

• Researchers will be required to make stem cell lines derived available to other researchers. This requirement has the potential to reduce the number of embryos used to derive stem cell lines. It also puts the research firmly into the public domain.

• The European Commission is to fund a European registry of stem cell lines. This again underscores the putting of the research and the results deriving from it into the public domain.

• Finally, the Commission undertakes to produce a report in 2005 on the research and its outcomes. This report will underpin the formulation of future policy in this area. It will also provide valuable help in informing the debate about the relative potential of embryonic and adult stem cells.

I would stress to the House that the essence of this proposal is to provide guidelines and safeguards on the conduct of embryonic stem cell research and is supported by the EU framework programme in those countries where the research is legal and ethical.

Ireland does not think it appropriate to oppose the Commission proposal as currently drafted on the following basis:

• It does not allow for the EU funding of any research activity in Ireland which would not satisfy Irish ethical or legal requirements;

• Insofar as other EU member states carrying out such research, Ireland would prefer that it be done under regulation, with proper safeguards in place rather than a free for all.

What we want and what we support is that research in the area be conducted under the strictest of guidelines. In that context, I would like to bring to the attention of the House the uncertain and unsatisfactory situation which will arise if the guidelines are not adopted.

If the Council votes against the proposals, it is still open to the Commission to activate the research once the moratorium comes to an end. In other words, if the Council votes NO, there is a strong risk this research will go ahead anyway without any guidelines, or with more liberal guidelines, but certainly without guidelines that we would be able to influence.

There is a serious concern that a potentially unregulated scenario could open up if this were to happen. That is why we believe that there is a clear and strong case for putting in places the stringent guidelines and safeguards which are at the core of the Commission's proposal.

It has to be acknowledged that this is an ethically and scientifically complex area. In terms of the science there is divided opinion on the relative merits of researching adult stemcells versus embryonic stem cells and on the potential of the two kinds of cells to yield therapies.

At this point a Chaithaoirleach, I would like to draw the attention of the House, to a viewpoint expressed by the Catholic University of Louvain on the issue of stem cell -

"The benefit of stem cells is considerable. Although preliminary and no doubt extensive research is still essential, the hope is that this research will lead to major advances in treatment in several fields of medicine, in particular in the treatment of various degenerative diseases.

This research raises ethical issues hitherto unseen. Some of the research will involve the use of stem cells from embryos: this raises the question of respect for the human embryo, which from the very beginning of its existence is more than just biological material. Given the suffering on the part of so many incurable people today, research is also an ethical duty.

The Catholic University of Louvain therefore recognises that it has a two-fold duty to take the initiative but also to exercise precaution. We wish to place the ethical issues ahead of economic and scientific considerations, which themselves only have any meaning if human dignity is preserved.

We would also point out that any use of the human embryo must be accompanied by binding ethical and scientific guidelines: firstly, there must be a democratic debate involving the whole of society, and then transparent inspection and decision-making mechanisms must be defined."

It is clear that all those involved in the research are enthusiastic about its potential. The point of debate in the scientific community is about how that potential can be realised.

The ethical and legal issues involved relate not just to stem cell research, but to the entire area of assisted human reproduction.

IVF treatment is practiced in Ireland, as it is in many countries. As my colleague, the Minister for Health and Children has remarked: "major advances have taken place in recent years in the capacity of medical science to intervene in the process of human reproduction. Techniques such as in-vitro fertilisation, the freezing and storage of sperm and artificial insemination by donor are available in Ireland and have enabled many couples to conceive children despite impaired fertility."²

As a result of current medical practice in this area, surplus embryos arise. In Ireland these embryos can be frozen where after a period of some three to five years they will cease to be viable. Alternatively, they may be reinserted in the donor to be subsequently excreted.

In certain other countries, the legal and ethical regime allows for the donation of such embryos for research. This approach was described in the paper I already referred to by the Catholic University of Louvain, as follows: "When the parents have fulfilled their plan, rather than authorising the simple destruction of their embryos the parents could, in a spirit of ethical solidarity, donate their embryos for the removal of stem cells to be used in research or to care for other individuals".

It has become clear over the past number of years that this is a complex, legal and ethical issue. It is precisely for this reason that the expert Commission on Assisted Human Reproduction chaired by Professor Dervella Donnelly has been established. Professor Donnelly recently outlined the role and work of the Commission to the Joint Oireachtas Committee on Enterprise and Small Business during its scrutiny of this matter. The terms of reference of the Commission are: to prepare a report on the possible approaches to the regulation of all aspects of assisted human reproduction and the social, ethical and legal factors to be taken into account in determining public policy in this area. The Commission is due to report in the near future and I am sure that its findings will play a valuable role in informing the development of our national policy in this area.

In the latter regard, a Cathaoirleach, it is important to draw the distinction between the national and the European. There has been a tendency in some quarters to address the European Commission proposal as if it were legislating for embryonic stem cell research in Ireland when it is, transparently, doing precisely the opposite. It is, as I have stressed, providing for stringent guidelines and safeguards to underpin concerted European research only in those member states where it is ethical and deemed legal - and then only when the researchers in question have explored all possible alternatives to their planned approach to the research.

In conclusion, a Cathaoirelach, I would ask the House to recall that what is involved here is the establishment of clear guidelines and safeguards to govern research at European level in member states where it is legal and deemed ethical. It explicitly respects the positions of those member states whose legal and ethical regime forbids such research.

ENDS

ETE 1159

Footnotes

¹

² 25 February 2000 announcing the setting up of the Donnelly Commission