JOINT COMMITTEE ON EUROPEAN AFFAIRS (Sub-Committee on European Scrutiny) debate -
Thursday, 2 Oct 2003

Vol. 1 No. 41

Department of Enterprise, Trade and Employment: Presentation.

Chairman

We will commence in public session with a presentation by officials of the Department of Enterprise, Trade and Employment. As the sub-committee will be aware, the European Commission put forward a proposal in July 2003 ^ COM (390) 2003 - a copy of which members were circulated by the secretariat and which seeks to set down guidelines for EU funding of human embryonic stem cell research. This proposal is due for consideration by the Council of the EU on 27 November and seeks to amend an earlier decision of that Council - the so-called "Competitiveness Council", the remit of which includes research matters. That resulted in the adoption of a specific programme of research and technological development for the Union integrating and strengthening the European research area. A copy of this document has also been circulated for the information of members. I note from the conclusions of the Competitiveness Council of 30 September 2002, which took the decision to establish the fund, that the research programme was adopted by QMV and that one member state - Italy - voted against it.

I welcome to the sub-committee the following officials of the Department of Enterprise, Employment and Trade - Mr. Ned Costello, Assistant Secretary, and Mr. Bill Brandon, Assistant Principal. I thank them for the additional briefing on this proposal which was received yesterday and which was circulated to members yesterday evening. I will invite the officials to make a short presentation followed by questions and answers.

Mr. Ned Costello

Thank you, Chairman. I will start by saying a few words about stem cells themselves without going into a great amount of technical detail. Essentially there are 200 cell types within the body and stem cells are the cells from which those cell types evolve. There are two types of stem cells - adult stem cells, which are found in a fully developed body, and embryonic stem cells, which are found in the embryo within a very short space of time after fertilisation. The difference between the two cells is that embryonic stem cells can develop into any of the 200 cell types in our bodies whereas adult stem cells have a much more limited form of differentiation. They can form particular kinds of cells, for example, blood cells. That is the difference between the two but the distinction is important in the context of the proposal and of the science.

The reason this area is of interest in medical research terms is that there are a number of diseases, particularly degenerative diseases such as Alzheimer's disease and various neuromuscular diseases which are currently impossible to cure. It is felt that stem cell research has the potential to offer cures for these and for other diseases such as chronic ulcerative diseases of the digestive system, for example.

There is some divergence in the scientific community in that some feel that embryonic stem cells offer the best possibilities of developing therapeutic treatments and the best possibilities of it answering the area of knowledge, others feel that adult stem cells offer equal possibilities and others feel the two lines of research will converge somewhere in the middle but that all are aimed at developing these treatments for these diseases which are difficult to cure. That is a brief word on the scientific background to the issue.

As the Chairman said, the background to this issue is that this area of research is part of the overall European framework programme for research and development. That is the programme by which the European Union organises almost all of its collaborative research and development which is aimed at improving the competitiveness of the Union.

The current framework programme is the sixth in a number of multi-annual framework programmes. The common position on that programme was agreed at Council in December 2001 and formally adopted on 27 June 2002 following co-decision procedure with the European Parliament. The programme runs from 2003 to 2006 and the budget for the programme overall is €16 billion for research. The programme is organised in a range of thematic areas, including genomics and biotechnology for health, information society technologies, nano technologies, food quality and safety, sustainable development, global change, eco systems and so on. The fundamental aim of the programme is to contribute to the growth of European industry and competitiveness. In relation to this issue, the focus of the discussion was on establishing a common position on one of the thematic areas, the thematic area being 1.1.1 genomics and biotechnology for health. The total amount of funding allocated to that area is €2.5 billion.

In the adoption of the overall framework programme - I again stress this point of the adoption of the overall area and the issue to which we are coming - the agreement formally adopted in June 2002 provided that research activities carried out under the programme should respect fundamental ethical principles. That is contained in Article 3 of the decision.

In this regard, the programme decision contains a reference to relevant international instruments but does not provide detailed rules for applying these ethical principles nor does it specify any activities which would not be eligible for funding for ethical reasons. This was left to the subsequent decisions on the specific programmes which had to be adopted where the detail, or the meat, if you like, of the framework programme is.

In relation to the specific programmes adopted on 30 September 2002, the Council decision, following consultation with the European Parliament, provided the following in respect of research activities involving stem cells. It said that the research will focus, inter alia, on development and testing of new preventative and therapeutic tools, such as somatic gene and cell therapies and immunotherapies. It specifically - this relates to the programme on genomics and health - said that the following areas shall not be financed under the programme - research activities aimed 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 - this is relevant in the current proposal, in particular - solely for the purposes of research. It specifically excluded the creation of embryos purely for research.

In addition, the conditions provided that any research project involving the use of human embryos and human embryonic stem cells would be subject to an ethical review and that this would be submitted to a regulatory committee assisting the Commission in the implementation of the programme. It also provided that funding of research activities which are prohibited in a member state would, in all circumstances, be excluded under the programme. It included this important provision. This recognises the ethical debate and the different regimes in place in different member states.

As part of the adoption of that decision, the whole issue of embryonic stem cell research was discussed. A moratorium was agreed to the end of 2003. The purpose of this moratorium was to allow for further clarification on the part of the Commission of the guidelines and the safeguards underlying this particular area of research.

In regard to what was specifically agreed, detailed implementing provisions concerning research activities involving the use of human embryos and human embryonic stem cells which may be funded by the programme shall be established by December 2003. It stated that there must be detailed implementing provisions. In that regard, the Commission undertook to submit a legislative proposal to amend the relevant specific programme and it stated that the European Parliament would be consulted on it. During the period of the moratorium and pending the establishment of those provisions, the Commission would not propose to fund such research with the exception of the study of banked or isolated embryonic stem cells in culture, in other words, stem cells which already existed independent of the embryo.

Furthermore, it also noted that the ethical acceptability of various research fields is related to diversity among member states and it is governed by national law in accordance with the principle of subsidiarity and that research using human embryos and human embryonic stem cells was allowed in some member states but not in others. It reflected this principle of ethical subsidiarity, if one could call it that.

Following the adoption of that particular agreement, the Commission held an inter-institutional seminar to further tease out the issues involved and that led us to the Commission proposal in July 2003 when the Commission submitted, as it agreed it would, its proposal for amending the specific programme with a view to establishing the implementing provisions. Among the issues involved there are that the Commission proposes that a code of conduct for the research activities concerned in which, in particular, human embryos used in the procurement of stem cells must have been created before 27 June 2002. A key part of the conditions put forward are that only stem cells created before the start of the framework programme on 27 June 2002 can be used and that they must have come about as a result of medically assisted in vitro fertilisation. They must be embryos which are left over or are no longer required as a result of an in vitro fertilisation treatment which has been completed. There is a range of additional safeguards in the conditions and I think members received those in our briefing note in the other documentation, so I do not propose to go through them in detail.

In relation to the current position, on 22 September 2003, the Commission presented its proposal to the competitiveness Council and informal discussions took place on the proposal. Those discussions, and I suppose the discussions at the Council research group leading up to the Council, indicated that there are, as would be expected, divergent views among member states. Without going into too much detail on them, because the discussions were informal, what is clear is that a number of member states are opposed to the proposal in principle and have a reasonably strong level of opposition. There are other member states which feel the proposal is not sufficiently expansive because it is more restrictive than the ethical and legislative regime they have in place in their own member states. There are other member states which are willing to accept the proposal as drafted.

Having consulted the Department of Health and Children, which obviously has a broader range of knowledge and competence in the whole area of health research, the position Ireland has taken is that it will not oppose the Commission proposal as currently drafted on the following basis: that it does not allow for the funding of any research in Ireland which would not satisfy Irish ethical or legal requirements; that the framework programme will be strictly limited to research on embryos produced as a result of in vitro fertilisation; that clear and comprehensive guidelines and conditions governing the research are established - as I said, the guidelines in the proposal are comprehensive - and that scientific evaluations and ethical review will be required before any proposal for research activity under the EU framework programme is permitted. That is where we stand now.

Following the informal discussions at the Council, an opinion is now being sought from the European Parliament and, as the Chairman indicated, the matter will be returned to at the competitiveness Council in November.

Chairman

Mr. Costello, you made the point earlier about the difference between stem cells. Will you go over that point again?

Mr. Costello

There are two types of stem cells - embryonic cells and adults cells. Embryonic cells are present in the embryo at a very early stage - a matter of some hours to days after fertilisation. To go back even further, the original zygote is one cell - the original cell from which the entire human being evolves. The stem cells evolve from that but the embryonic cells can differentiate themselves into all the 200 cell types in the body whereas the adult cells, which are present further on the development process, can differentiate themselves only into specific tissue types - for example, blood cells. The embryonic cells have more potential to differentiate while the adult cells have less potential. Another relevant point is that the interesting thing about stem cells is that the stem cell produces one of its own kind - one stem cell - and one specific cell type. That is how it has the ability to repair itself. The difficulty with the body is that for many degenerative diseases, once the cells die, they cannot be replaced because the cell does not know how to reproduce itself.

Chairman

This is an important matter. I generally welcome the allocation of €16 billion for research activities for 2003-06, especially in relation to information society technologies, food quality and safety, sustainable development, global change and ecosystems. However, there are parts of the proposal for decision by the Council of Ministers jointly with the European Parliament which give rise to concern. You will be aware that we have referred Commission document 340, regarding the storage of embryos, to the Joint Committee on Health and Children for scrutiny before any decision is made at the Council. If this proposal is agreed, as I understand it, all EU states would fund research on supernumerary embryos, that is, embryos intended for in vitro fertilisation but no longer required for that purpose.

The Department's document states: "Also, funding of research activities that are prohibited in all the Member States is in all circumstances excluded". What does that mean? If it is allowed in some members states, or in one, could the funding of the research be allowed? Furthermore, the document states: "Pending establishment of the detailed implementing provisions, the Commission will not propose to fund such research, with the exception of the study of banked or isolated human embryonic stem cells in culture". Will you explain what that means because I am not too clear on it? Your document states: "Furthermore, it also noted that the ethical acceptability of various research fields is related to the diversity among member states, and is governed by national law in accordance with the principle of subsidiarity and that research using human embryos and human embryonic stem cells is allowed in several member states but not in others". I do not know what the point is; they fund it themselves. Their national legislatures have decided that. I do not know the relevance of that point in terms of this consideration. I do not think it is relevant.

The document states that "informal discussions" took place on the proposal - you used the term again this morning - at the competitiveness Council. As I understand it, this was done in private over lunch.

Mr. Costello

Informally.

Chairman

I have attended Council of Ministers' meetings and I know what happens over lunch. Your document describes the Irish position as follows:

Ireland, for its part, having discussed the matter with the Department of Health and other relevant Departments, indicated that it would not oppose the Commission proposal as currently drafted on the following basis:

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

If the Medical Council changed its rules, which it is currently considering behind closed doors, it could satisfy Irish "ethical requirements" as no law, other than the Constitution, governs this.

Furthermore, the Department of Health and Children, which you consulted, has a commission on bio-ethics which has not reported. How can it make up its mind on such issues without such an important report? Why were the Dáil and the Seanad not consulted through the relevant committee? We came across this in the context of Commission document 340 regarding the storage of embryos, otherwise we would not have known about it.

Your document also states that "Ireland has indicated that it considers it inappropriate to object to such research being carried out in member states where it is deemed to be both legal and ethical." That may be so but that is not the point. We are not being asked to object to such research taking place in other member states; that is a matter for their law makers. The proposal concerns all EU states funding such research and allowing it to take place in Ireland if, for example, the Medical Council changes its guidelines.

I understand that, among others, Professor Martin Clynes, who carries out stem cell research at the National Institute for Cellular Research in DCU on animal embryos, bone marrow, umbilical cords, etc., and who is a leader in his fields, stated that it is not necessary to carry out research on human embryos. I do not know why as I am not an expert but I would like to know why the appropriate Oireachtas committee was not given the opportunity to hear the views of Professor Clynes and others for and against this proposal so that a considered decision could be made about this matter.

I am advised that at the Council meeting of 22 September 2003 in Brussels, many member states, as you mentioned, raised concerns in relation to these proposals. I understand that if these member states were to vote against the proposed measure on 27 November next, their votes would constitute a blocking majority. I cannot understand why Ireland is not part of that potential blocking majority as the matter has not been considered by the Oireachtas.

Mr. Costello, you will be aware that the European Union (Scrutiny) Act 2002 was passed last year by the Oireachtas to reinforce our terms of reference so that legislation coming before the Council of Minister could be duly scrutinised. The legislation refers to draft directives and regulations but not to draft decisions. This procedure of draft decisions is a strange way to do business and is a serious omission from the legislation. However, under the terms of reference given to us by both Houses of the Oireachtas, we are entitled to scrutinise such measures. It is my hope and intent that the Oireachtas will scrutinise this measure in detail before any commitment is given by an Irish Minister at the Council. Those are the issues of concern to me.

Mr. Costello

In relation to the first question on activities banned in all member states, the original decision specified certain activities in the area of genomics and life sciences that are specifically excluded from the programme. Cloning, to all intents and purposes, is an example of one of those activities.

In regard to banked or embryonic stem cells in culture, that refers specifically to stem cells which already exist - not embryos, but the actual cells themselves - so hence the term that they would be "banked". For example, they could be cryogenically frozen and then released. That is the factual provision - in other words, that they would have been extracted from embryos prior to the adoption of the decision and the cells themselves, as opposed to the embryos, banked.

In regard to ethics, the legal requirements and the rule change, the position is that if the relevant regulatory provisions change here, it would affect the manner in which the activity was pursued. The position which has been taken thus far leaves that possibility open. Equally, it does not foreclose on processes which are under way - for example, on the Commission on Assisted Human Reproduction.

In regard to consultation, I suppose this brings us to a point the Chairman made in the questions he raised. This is an evolving area in terms of how the scrutiny process operates. Departmentally, we are learning as we go along. One of the complexities of this particular issue is that the actual framework programme decision on the overall programme was adopted before the scrutiny process came into existence. This issue had gone a certain distance down the track, if you like, before the scrutiny process came into existence. Clearly, it is a matter of great interest to the sub-committee and I understand, as the Chairman said, it arose in relation to the cells and tissue directive. I think we provided a briefing note at that time on the activity. If it had not arisen there, it would probably have arisen in the context of the circulation of Council agendas. That might not be entirely satisfactory but being such a complex area, it was highly unlikely, if not impossible, that the activity would have been agreed at a single reading in Council. In fact, as we said, it received simply——

Chairman

Mr. Costello, it is an enormously contentious area on which the jury is still out. The commission on bio-ethics has not reported and the Legislature was kept in the dark. It is totally unsatisfactory and unacceptable.

Mr. Costello

We are always anxious to brief the sub-committee on any activities of interest to it. This is an area we all need to look at in terms of the possible differences in approach with regard to references and legislation. There is a need to try and fill the gaps as best we can.

With regard to the scientific view, I refer back to the comments I made at the start of my introduction. I am not a scientist but, looking at the literature, there are very different scientific views on the matter. That is a reasonable statement. Some people agree with the view articulated by Professor Klein while others take a different view. The member states that have regulated to allow this research would have gone through a fairly extensive debate and would have concluded that it is necessary. Others see it differently while the scientific community has a diversity of views on it.

On the question of the blocking minority issue, it is early days because we have not had any formal indication of the position of member states. However, clearly a number of member states are currently strongly opposed to the activity.

Senator Dardis

The Secretary General of the Department of Enterprise, Trade and Employment appeared before the committee earlier and gave certain assurances with regard to the generality of directives coming before us. We accepted what he had to say as we were concerned that we were not getting sight of them until a late stage. I accept there is a capacity within this research to advance the human condition and deal with some difficult diseases and, hopefully, to cure for them. These include congenital defects and so on and dealing with the understanding of how they might arise.

Am I correct in assuming that the recovery of the cells is always possible without any destruction of the embryo?

Mr. Costello

The recovery of the stem cells?

Senator Dardis

Yes.

Mr. Costello

No. If the cells are extracted from the embryo——

Senator Dardis

I understand it would depend on the stage of development of the embryo.

Mr. Costello

Yes, but at the point we are concerned with, we are dealing with an embryo consisting of the order of 16 cells.

Senator Dardis

With regard to our legislative framework, which you, Chairman, mentioned, we are governed by the Constitution, especially Article 40.3.3°. Am I correct in assuming that we have not dealt with this issue properly, or at all, within legislation?

What is the position regarding the specifics of the Italian exception? Why did Italy take its point of view? I note that Ireland entered a statement in the Council meetings. What is the substance of the statement?

Chairman

The Italians objected to the 2002 funding proposal and they and others objected to this matter.

Senator Dardis

Perhaps it should be dealt with by the Department of Health and Children, but I understand that because a scientific framework is involved and it is part of the sixth framework programme, it comes under the ambit of your Department. That may not be generally understood because at first sight it may appear that it should be dealt with by the Department of Health and Children.

Mr. Costello

On the question of legislation, the Senator is correct that this is part of a broader issue of the governance of human reproductive activity and issues that arise from it and it would fit within the broader framework of the work of the Commission on Human Reproduction which is under way under the aegis of the Department of Health and Children. In that sense, it falls to the Department of Enterprise, Trade and Employment because under the European framework programme and the research responsibilities, we are concerned with the framework programme overall. However, it is closely linked to other activities in the health area, which is why we have consulted with the Department of Health and Children.

Senator Dardis

Have there been any discussions with the General Medical Council?

Mr. Costello

Not between the Department and the council.

Senator Dardis

What about the statement Ireland entered to the Council?

Mr. Costello

The essence of the statement revolved around two issues, the first being the issue of ethical subsidiarity - if we buy into a collective framework programme for research and development should we object to some member states partaking in concerted activity in an area that is now allowed for nationally but which is allowed in those countries. It would be concerted activity. The essence of the framework programme is that it is about countries collaborating and, therefore, achieving synergies and getting better results than by working alone.

With regard to the Italians, the Chairman has correctly said that other countries have expressed opposition. Nobody has gone into any great detail why they are opposing the measure. If one considers the position of the various member states, there are differing regulatory provisions in relation to this activity. I will not go into the technicalities as it would not be helpful, but they range from not allowing the activity to allowing, for example, cells that are imported from other countries to be researched in the member state to a much more liberal regime. Given the current expression of views on the issue, it is difficult to associate a view with the provisions that are in place in the member state.

Deputy Harkin

You said that a number of countries are opposed in principle. Is Ireland opposed in principle? Senator Dardis asked about the specifics of the Irish statement to the Council. Are these linked? Am I correct in understanding that, with regard to Irish ethical requirements, there is no legislative framework and that, as such, we are at present relying on guidelines from the General Medical Council?

You referred to the principle of subsidiarity and where member states are buying into the research. Is there any mechanism whereby Ireland would not contribute to that funding?

Mr. Costello said things could change if the relevant regulatory provisions change here. If these relevant regulatory provisions are simply guidelines from the General Medical Council then they could change without any relevance to the Oireachtas or legislators. If that is the case, it appears the Department is willing to allow that to happen. I would consider that to be an extremely loose arrangement. You have indicated that there are many different views on this, particularly in that context.

Like the Chairman, I wish to express my concerns that this issue was not brought before the Members of the Oireachtas because it is very contentious. In some respects I am surprised at the way events are unfolding.

Mr. Costello said other member states have engaged in comprehensive debate on this issue. I wonder why Ireland has not. In response to a question on the possibility of a blocking minority you said it is early days yet. Does that mean you do not know if one is evolving? Apart from other countries, what is the current situation regarding Ireland's participation or non-participation in such a minority?

The adult stem cells are said to be multi-potent, that is, they can produce cells, but not all types whereas the embryonic cells are pluri-potent. Presumably that means they produce all types of cells. What can adult stem cells not produce?

Mr. Costello

On the question of opposition in principle, that is essentially a political matter, so I would prefer to leave it to that area. The specifics of the statement are provided in our briefing note and it may help if I read it.

Deputy Harkin

I have read the briefing note and did not recognise it. It is for the Chairman to decide if he wants you to read it.

Chairman

Mr. Costello perhaps you might read it for the record.

Mr. Costello

The statement reads:

Ireland, in supporting the adoption of the specific programmes to implement the sixth framework for research, recalls its statements pertaining to research that cannot be carried out in Ireland. Ireland also recalls the Council statement and its joint statement with Italy, Germany, Portugal and Austria pertaining to the further elaboration of detailed guidelines on ethical aspects.

Ireland welcomes the progress achieved to date in the elaboration of detailed implementing provisions, the recognition that its laws, regulations and guidelines apply in respect of any research carried out in Ireland, the Commission statement regarding non-funding in respect of research activities on human embryos or human embryonic stem cells under the sixth framework programme and the Commission's intention to present a proposal in 2003 establishing further guidelines on principles for deciding on Community research projects involving the use of human embryos and human embryonic stem cells.

In the course of this process, Ireland, which shares a number of concerns expressed by Italy, Germany, Portugal and Austria, will continue to focus on the need to ensure the utmost respect for human life and the protection of human dignity and, finally, the establishment of a regulatory committee which will consider any project proposals for research funding in ethically sensitive areas.

Chairman

I cannot find that note in the briefing.

Mr. Costello

We will provide it.

Chairman

You might circulate it.

Mr. Costello

That was the form of statement we made when the framework programme was being adopted. Subsequent to that we have had the informal discussion in Council. There is no formal statement, but it is as I outlined in my introductory remarks. To repeat, the statement I have just read was the statement we made formally when the framework programme overall was adopted in 2002, but we have not made a formal statement on the matter thus far because, to date, there have been no formal ministerial discussions on it. However, now that the guidelines have been elaborated, the position with regard to our current position is as I outlined in my opening statement.

Deputy Harkin

Do we have a formal statement?

Mr. Costello

That was the position when the framework programme was adopted in 2002. We currently do not have a formal position on this specific aspect because it has not been formally discussed at Council.

Chairman

Will you address the other questions raised by Deputy Harkin?

Mr. Costello

Nobody has formally stated a position in the ministerial Council on this and in so far as discussions have taken place at working group level, member states have not elaborated in any great detail why they are against or in favour of the proposal. The position is unclear; we simply have indications of intent rather than detailed explanations of the positions held by member states.

With regard to the blocking minority issue——

Deputy Harkin

Is Ireland a part of the blocking minority or is it considering its position on this?

Mr. Costello

Given that we have said we will not oppose the proposal, we are not part of any blocking minority that might exist.

Deputy Harkin

I find it strange that if we do not have a formal position we could or could not be part of a blocking minority.

Mr. Costello

We have stated our position on the issue in working group discussions and that position was carried through into the informal discussions at Council, which is that we would not oppose the proposal.

Deputy Sexton

There does not appear to have been any discussion in the Oireachtas and Ireland does not appear to hold a formal position, yet we have already agreed in principle not to be part of a blocking minority group or even to consider joining one. By comparison with other member states, there has been no comprehensive discussions in this country, especially at Oireachtas and legislative levels. It is a misnomer to say it is early days because at the Council meeting in September 2002, the Council and the Commission agreed certain matters. The deadline is 31 December.

Our greatest concern is that this matter never came before us. As other members have said, it is a contentious and potentially controversial area. The General Medical Council has postponed a meeting arranged to consider this while the 20 member committee established by the Minister for Health and Children to provide guidelines on stem cell research, particularly with regard to the ethical and moral issues, has also postponed its report until late autumn. Similarly, although the Competitiveness Council has considered the matter informally over lunch - I understand how that can happen - it has not reached any conclusion. In view of this, I do not understand why we have not decided at this early stage not to consider our position.

When the framework was discussed no common position could be reached because of divergent views among member states. To date, they have not indicated the nature of their objections but they clearly have serious concerns about its potential.

There are other concerns. An ethical, constitutional and moral framework is required but it must be something on which we can all agree. It has to be discussed, and Oireachtas Members must be included. I have no doubt that in most cases the intentions are honourable and are for the right causes, but I am concerned about who might benefit from the funding provided under the sixth framework programme. For example, I would want to be sure that no unscrupulous or for profit groups could avail of the funding and that it would have to be for the common good. I do not know if any of these things have happened. Do you know if these aspects have been included in whatever framework is being considered?

To decide that because at present there is no research in a certain area in Ireland it is not necessary to oppose it is perhaps the wrong approach. Eventually, Ireland will be a net contributor to European Union funding and, therefore, we would be contributing to this kind of research while being unable to control the ethical guidelines in other member states.

Other members have raised issues that concern me and I will not rehearse them. However, I am concerned that this matter almost slipped by this scrutiny sub-committee. The explanation for this does not persuade me that similar proposals will not be agreed on behalf of Ireland without Oireachtas Members having the opportunity to consider them in detail.

Chairman

Mr. Costello, have you any concluding comments?

Mr. Costello

With regard to the funding issue, the position is that nationally, Ireland contributes to overall Community funds in the same way as individuals pay their taxes. In that sense there is no, to use the technical term, "hypothecation", where €1 of Community funds will be allocated to provide €1 for a particular measure of Community activity. In that sense, if we are in, we are in for the activity overall.

With regard to unscrupulous groups and so on, while I did not elaborate in my opening statement, the specific conditions laid down in the proposal for a decision - the guidelines that are under discussion - are focused on ensuring that activity is regulated in a way which does not allow any nefarious activity of the kind referred to by Deputy Sexton. For example, it provides that the embryos will only be used if informed consent has been given by the donors, the donors will not be permitted to make any financial gain, the data on privacy and protection of the donors must be guaranteed and the traceability of the cells would be required. There are many other conditions, but those are some of the especially important one.

Senator Leyden

This matter was referred to the Oireachtas Joint Committee on Enterprise, Trade and Employment, but we considered we did not have the competence to deal with it. We are seeking outside advice from the Department of Health and Children and others.

Chairman

That is not relevant to this matter.

Senator Leyden

It is.

Chairman

It is not.

Senator Leyden

It is. I attended the meeting two weeks ago.

Chairman

The matter referred to the Oireachtas Joint Committee on Enterprise, Trade and Employment concerned the draft directive on the storage of stem cells. It is a different issue.

Senator Leyden

I have the full data with me.

Chairman

When we sent that proposal we included information on this, but the proposal concerned the draft directive on the storage of stem cells.

Senator Leyden

We are dealing with the matter in a broader sense and are seeking detailed outside advice.

Chairman

We saw what happened in the High Court in Britain yesterday, which decided it was not permissible for two women, who brought a case, to have their embryos implanted. For that and other reasons, the authorities in Germany only allow the number of embryos to be created that are going to be implanted or attempted to be implanted. Different practices prevail in different member states, which indicates how sensitive and difficult is this issue.

Three issues arise. The issue dealt with in the document means that if this goes ahead, all European Union member states will fund activities in those member states or groups of member states which collaborate on this research, in other words, Ireland will be engaged in such funding. The General Medical Council guidelines are the only impediment to allowing this research to take place in this country and apparently they are under review behind closed doors. In view of this, the real question is why this matter has not been brought before the Oireachtas.

I am circulating a proposal to the members for their consideration. If they agree it will become the report of the sub-committee on EU scrutiny to both Houses of the Oireachtas dealing with EU embryo research - proposal for decision. It states:

The Joint Oireachtas Sub-Committee on EU Scrutiny has considered a proposal for a decision of the Council of Ministers, meeting as the Competitiveness Council, and the European Parliament, reference Commission Document 2003, No. 390. A copy of the proposal, which is to be again considered by the Council on 27 November 2003 and has already received consideration in private session on 22September, is attached. In short, the decisionbeing considered is the establishment of implementing provisions, including a code of conduct for research activities involving human embryos and human embryonic stem cells eligible for Community funding under the Sixth Framework Research Programme, SP6. This programme, which will run from 2003 to 2006, has been allocated €16 billion for research activities.

The sub-committee draws the attention of both Houses to the following:

(1) The sub-committee did not receive advance notice of this proposal and it has not been scrutinised by the Oireachtas.

(2) The sub-committee understands that a number of member states raised concerns at the Council meeting in Brussels on 22 September and that if these member states were to vote against the proposed measure on 27 November next, their votes will constitute a blocking minority.

(3) The proposal has constitutional, legal, ethical, moral, administrative and other implications which the sub-committee considers should receive appropriate consideration by the Houses before any decision is made by the Council of Ministers.

(4) Accordingly, the sub-committee has forwarded this proposal for decision to the Oireachtas Joint Committee on Health and Children for further scrutiny.

(5) The sub-committee recommends that this measure should be opposed by Ireland at the Council of Ministers until the Oireachtas has completed the scrutiny process and dealt with all relevant concerns.

(6) The usual procedures for legislative measures under Pillar 1 is by regulation or directive. The procedure being used here is a proposal for a decision under Article 166 of the treaty. Draft regulations and draft directives must come to the sub-committee for scrutiny within four weeks of being received from the EU Commission. As this is not a draft regulation or draft directive, it was not so submitted. This runs counter to the spirit of the European Union (Scrutiny) Act 2002. However, the orders of reference of the joint committee allow for such scrutiny. The joint committee orders of reference are attached. The sub-committee recommends that the 2002 Act be amended to specifically provide for scrutiny of draft decisions of this kind.

Are there any comments on this? I call Deputy Mulcahy.

Deputy Mulcahy

It is a good draft. The fifth point recommends that this measure should be opposed by Ireland at the Council of Ministers until the Oireachtas has completed the scrutiny process and dealt with all relevant concerns. Should we not ask the Minister for Foreign Affairs to request an adjournment of the discussion of this issues rather than opposing it? I welcome the call for the amendment of the 2002 Act. Could we send of copy of the report to the parliamentary legal adviser, ask her if she agrees that the Act needs to be amended and request her to present a short paper on how it may be amended to cover such situations?

Deputy Sexton

I have no difficulty with the draft and I do not see how it can be opposed, especially given that the fifth point mentions until such time as the Oireachtas has completed the scrutiny process and dealt with all relevant concerns. That should cover the concerns. We suggest that the Oireachtas should decide it first. I would have no difficulty with the sub-committee requesting legal advice on whether to amend it.

Senator Dardis

I propose its adoption with the inclusion of the recommendation that the parliamentary legal adviser be asked about amendment of the Act.

Chairman

That does not have to be included in the report.

Senator Dardis

No. I understand that.

Chairman

Given what Senator Leyden has said, perhaps No. 4 should be the Joint Committee on Enterprise and Small Business rather than the Joint Joint Committee on Health and Children.

Deputy Mulcahy

Could we also refer it to the Joint Committee on Justice, Equality, Defence and Women's Rights?

Chairman

We should send it to the Joint Committee on Enterprise and Small Business for detailed scrutiny and copy it to the Joint Committee on Health and Children for its information which is what we often do. Is the report agreed? Agreed. I thank Mr. Costello and his colleague, Mr. Brandon.