Jimmy Devins (Sligo-North Leitrim, Fianna Fail)

I welcome the opportunity to respond, on behalf of the Government, to this Private Members' Bill sponsored by Senator Mullen. Stem cell research represents one of the most important and challenging areas of investigation that scientists and clinicians will undertake in the 21st century. Much of the work with stem cells raises no ethical issues or concerns. For example, bone marrow transplants have been available for some time. The use of stem cells has the potential for a significant impact on human health in the repair of damaged tissues and in tackling some of the most intractable diseases, such as type 2 diabetes, cancer and neurodegenerative conditions.

The hallmark of stem cells is their ability to develop into many other cell types and this fundamental property needs continued research and investigation if it is to be harnessed to greatest effect. Adult stem cells can be obtained from many parts of the body, including bone marrow, brain, blood, skin, eye, muscle, liver and hair. However, they are somewhat restricted in the number of cell types into which they can develop. On the other hand, embryonic stem cells are able to develop into almost all the different types of cells needed to form the human body. The removal of these cells from the embryo would, however, result in its destruction.

Adult stem cell research can be broadly categorised in three fundamental avenues, namely, identifying new populations and sources of stem cells, understanding the fundamental properties of stem cells and developing new modes of therapy using stem cells. In Ireland, scientists are engaged, to a greater or lesser extent, in each of these areas and are using adult-derived stem cells.

A major new challenge for stem cell research will be to identify sources, or ways of generating such cells. Perhaps the most exciting of these is the ability to endow stem cell-like qualities on cells that do not otherwise share the ability to differentiate into new cell types. While these cells — induced pluripotent stem cells, IPSCs — offer a great deal of hope, much research is needed before they will be routinely used in any clinical setting. IPSCs are made by genetically reprogramming ordinary adult cells and thereby transforming them into stem cells. They are claimed to be equivalent to embryonic stem cells in every respect tested. This area of stem cell research is still relatively new and has yet to be employed to any great extent in Ireland. However, it is hoped that this technology will offer great benefits to the basic research undertaken by scientists and clinicians in the coming years. Even with the evident promise of IPSCs, there is a need for continued adult stem cell research because it will only be through their being subjected to meticulous scientific study that we will gain a better understanding of how they develop and what controls their differentiation, thereby gaining a meaningful insight into how their potential to transform to new cell types might be best harnessed.

Only last week the potency of adult stem cell research was communicated worldwide through the case of Claudia Castillo, a 30 year old Colombian mother of two living in Spain. Ms Castillo received the world's first airway transplant using an organ partly grown from stem cells taken from her bone marrow. In this ground-breaking operation, surgeons replaced a section of Ms Castillo's windpipe, which had been damaged by tuberculosis, with a donated organ that was stripped of its cells and used as a scaffold for her own stem cells. Owing to the fact that her immune system recognised her own cells in the replacement organ, she has not faced organ rejection nor has she been obliged to take powerful drugs to suppress her immune system. This technique gives great hope to many patients whose organs are damaged.

Embryonic stem cell research is a sensitive subject and it evokes different views from particular sectors of society. The main source of human embryonic stem cells for research is from embryos produced, but not used, during in vitro fertilisation, IVF, treatment. As noted by the Commission on Assisted Human Reproduction, the surplus embryos not used for immediate transfer may be preserved in a frozen state for further use by the couple that produced them, thereby avoiding the necessity of repeating the risky and uncomfortable procedure of ovarian stimulation. If frozen embryos still remain after the couple has completed treatment, the available options include donation to another couple, donation for research, the embryos being allowed to perish or continued storage.

There are many who are opposed to human embryonic stem cell research on ethical grounds and who see an outright ban on this type of research as the appropriate approach but there are also those who pin their hopes on this research activity finding new treatments for some of the most serious and distressing diseases afflicting society at large. A significant body of researchers argue that embryonic stem cells offer the best possibility of generating the knowledge that will lead to new treatments.

Human embryonic stem cell research is considered to hold significant promise in treating diseases for which there is currently no cure, namely, Alzheimer's, motor neuron disease and spinal cord injuries which cause paraplegia and other disabilities. However, other researchers argue strongly that the sourcing of such stem cells and the resulting destruction of human embryos can never be justified and is unethical. These researchers point to work on adult stem cells or induced pluripotent stem cells, which do not give rise to ethical concerns, as the most appropriate approach to follow. The view is also held that research on human embryonic stem cells and human adult stem cells is complementary and that comparison between the two is an essential element for advancing basic research.

Currently, there is no legislation in Ireland governing intervention in the natural process of creating human life. Medical practice is governed by guidelines issued by the Medical Council, which provide that the creation of new forms of life for experimental purposes or the deliberate and intentional destruction of in vitro human life already formed is professional misconduct.

The development and use of technologies in this area, such as embryonic stem cell research, raises an array of legal, social and ethical questions that are complex and profound. It is an area that triggers diverse reactions in the public, some of which include unease and anxiety. A number of the issues involved in the broad field of assisted human reproduction treatment, science and human embryonic stem cell research go to the core of our concepts of human dignity and personhood. There was growing public concern at these developments and in view of their complex and potentially controversial nature, the then Minister for Health and Children decided that the establishment of a Commission on Assisted Human Reproduction would be an essential first step before any policy proposals were propounded. Its terms of reference included 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 largely comprised persons with expert knowledge spanning the medical, scientific, social and legal domains. This expertise was a prerequisite to a precise examination of the issues concerned. The chair also invited a number of additional experts with complementary expertise in specific areas to join work groups. These groups were established to explore particular aspects of assisted human reproduction and included experts and academics from sociology, philosophy, ecumenism and theology.

The commission conducted an intensive and analytical examination of relevant issues and its conclusions derive from this wide research. Its report was prepared after 23 meetings. The early meetings were devoted to an exchange of information between the commission members. Each discipline, medical, scientific, legal and social, prepared a report outlining the current position on assisted human reproduction in that discipline. In its letter of establishment, it was indicated that the commission would be expected to consult widely, to seek submissions from the public and to establish the views of service providers and consumers.

The commission was also expected to consult philosophical and theological experts and relevant people in Northern Ireland and Great Britain. In delivering on this aspect of its remit, the commission consulted users of services in a survey organised through the National Infertility Support and Information Group; placed an advertisement in the national press inviting members of the public and interested organisations to make submissions, to which it received 1,700 responses; recruited a market research organisation to carry out a survey of a random sample of 1,003 people aged over 15 years; conducted a survey of the services provided by 1,163 general practitioners for infertile couples; conducted a survey of 114 obstetricians-gynaecologists in maternity hospitals-units; conducted a survey of the then eight clinics providing assisted human reproduction services in Ireland and contacted the chief executive officers of the health boards to ascertain their involvement in the provision of services.

The commission held two conferences, the first being a small conference of invited experts and the second a public conference of more than 250 people. Its report, published in May 2005, which was the first step in determining a policy response to assisted human reproduction, made 40 recommendations on services in Ireland. The key recommendation was that a regulatory body to regulate services in Ireland should be established by an Act of the Oireachtas. The commission stated that the legislation should specify the procedures to be allowed and provide for the establishment of an independent statutory body, accountable to the Minister for Health and Children, that would have regulatory, advisory and executive powers over the permitted services and activities. This body would license facilities engaged in these services and activities. In addition, it should be empowered to issue guidelines on the operation of the permitted services, including, as appropriate, the freezing, storage and uses of gametes and embryos and the fertilisation of ova.

A licensing and inspection model for assisted human reproduction services and activities, in line with the recommendations of the Commission on Assisted Human Reproduction, would seem to provide a robust system of oversight, monitoring and control over the activities that are now scientifically possible within this domain, including the area of human embryonic stem cell research. Such a statutory licensing procedure, supported by an inspection regime governing centres, would achieve, with others, this main overarching objective of statutory oversight. Ultimately, it would ensure that no service or activity for which a licence is statutorily required is undertaken in the absence of approval of the designated statutory authority.

The other main recommendations of the commission, which may be largely grouped under five general headings, are access to services; donor programmes and procedures; surrogacy; procedures relating to human gametes; and possible approaches to issues surrounding the human embryo. In the area of embryo research the commission recommended, by majority opinion, that embryo research, including embryonic stem cell research, for specific purposes only and under stringently controlled conditions, should be permitted on surplus embryos that are donated specifically for research. This should be permitted up to 14 days following fertilisation. The regulatory body should stipulate under what conditions and for what purposes embryo research is permitted. Those donating embryos for research must receive pre-donation information and counselling and must give informed consent for the use of donated embryos for research. No inducement, financial or otherwise, should be offered or accepted for the donation of embryos for research. Once embryos are used for research their subsequent use for reproductive purposes should be prohibited. The commission recommended that the generation of embryos through IVF specifically for research purposes should be prohibited. Again, by majority opinion, the commission recommended that regenerative medicine should be permitted under regulation.

The commission recommended unanimously that human reproductive cloning and the generation and use of inter-species human embryos should be prohibited, but that research on gametes should be permitted provided it is governed by strict conditions set out by the regulatory body and subject to informed consent from donors.

In 2005, the Government referred the commission's report to the Oireachtas Joint Committee on Health and Children for consideration. The committee will report in due course on its views of the recommendations of the commission. Given the amount of work required, the Minister for Health and Children instructed the Department to begin work on the development of an appropriate regulatory framework. Factors that will be taken into account include the report of the Joint Committee on Health and Children, when completed, with any judgment of the Supreme Court in the M. R. v. T. R. — frozen embryos — case. That case is on appeal to the Supreme Court and a hearing is expected in the near future. On that basis, the Government has not, to date, proposed legislation in this area but the Department of Health and Children has engaged in the complex preliminary work. The work that the Government is undertaking is intended to result in policy proposals for a legal framework for this area. This work involves exploring and examining areas such as legal parentage, practices on gametes and in vitro embryos — including embryonic stem cell research, arrangements for consent, and many other areas that are impacted by this wide and complex area. It is not an understatement to say that this area involves consideration of a range of ethical, legal, medical, social and scientific questions and issues that are divisive.

The work under way has a significant international dimension. The Department of Health and Children, as part of the complex preparatory work, has been examining the regulatory regimes introduced by other countries and how they went about devising their laws. This work involves a detailed review of legislation and other relevant legal instruments by which assisted human reproduction treatment and research is regulated in other countries. This is important as it gives an understanding of how legislation works in this area. The preparation for legislation on assisted human reproduction and human embryonic stem cell research involves setting out the full range of issues and identifying all of the interrelationships between these, including all of those mentioned in the Senator's Bill. Once completed, this body of work will form a platform from which a legal framework to govern the area will be derived. The Government looks forward to seeing this work completed expeditiously so that a comprehensive and robust legal framework for regulating the area can be created.

More recent scientific developments will also need to be taken into account. As mentioned earlier, induced pluripotent stem cells, IPSCs, have become available and are described as producing very promising results. This development postdates the report of the commission and is a very significant development, providing, as it does, another route to research on human stem cells without any negative ethical problems attaching to them.

The Government is embarked on a responsible and considered path to regulation in this area which requires that it receive the views of the Oireachtas Joint Committee on Health and Children and the Supreme Court decision in the M.R. v. T.R. appeal to inform the regulatory framework to be introduced.

I look forward to hearing the remainder of the debate on the Bill.