Stem cell research requires legislation and guidelines

This week brought the news that it is now possible to create tailored embryonic stem cells using cell cloning techniques, bringing the promise of personalised medicine one step closer.

Media have confused cellular or “therapeutic” cloning with people or “reproductive” cloning, leading many to groundlessly worry about an unregulated Orwellian future. In actuality, human clones already exist, even in Ireland: they are called identical twins and there is consensus among researchers and clinicians that an endeavour to artificially twin people is not only morally repugnan t but also of little scientific or medical interest.

The focus rather should be on our lack of biomedical legislation and the potential danger this vacuum creates for patients to be misled, scammed or have their lives put at risk.

Power of petri dish
The latest breakthrough means it will be easier to develop better drugs and understand many human diseases by recapitulating aspects of them using tailored stem cells in the petri dish. Cell replacement strategies, however, where a patient is given stem-cell-derived "matched" cells, are still years away. These require a much greater level of understanding than exists at present and further clinical trials are needed.

Over the years, Ireland has built itself up as a world leader in biomedical research, yet the lack of regulations on stem cell research has meant that Ireland risks leaving itself behind in this developing field of science. This is not only potentially detrimental to the development of treatments for patients in Ireland, but also means Ireland is likely to lose out on investment in biomedical research as companies opt to locate where no such legal vacuum exists.

Our own science funding bodies, Science Foundation Ireland and the Health Research Board, have stated that they will not fund such research until legislation is in place, so it is unsurprising that biotech companies have followed suit.

In light of the health and economic benefits that stem cell research is likely to bring, the lack of legislation in this area is incomprehensible.

Barriers to progress
Embryonic stem cell research has its opponents, yet two independent reports recommended the introduction of legislation. In 2005 the Commission on Assisted Human Reproduction (a government-appointed body) recommended the introduction of legislation in this area. It outlined detailed recommendations on the scope of the research and the licensing procedures that should be followed. The recommended legislation would have provided protections for the embryo and also brought legal clarity to this area.

This was followed by a report from the Irish Council for Bioethics which echoed many of the commission's recommendations and outlined an ethical framework for the legislation. Furthermore, in 2009, the Supreme Court clarified that the embryo is not protected by the Constitution and thus there is no constitutional barrier to embryonic stem cell research. In light of these developments regulations were promised in the programme for government, yet none has been forthcoming.

This gap in the law has resulted in two problems. First, despite the absence of a legal barrier to stem cell research, companies are unwilling to invest in a country where there is uncertainty in the law. Investors need to have a supporting legislative framework that encourages their research.

Furthermore, in the absence of legislation, research centres at University College Cork and Trinity College Dublin have been forced to develop their own ethical guidelines for embryonic stem cell research. While such guidelines are welcome and necessary for all biomedical research, relying on local guidelines runs the risk of a fragmented legal structure.

One set of national guidelines backed up by legislation would not only bring clarity for researchers but also ensure that each research centre followed the same protocols and thus encourage collaboration. Such collaboration is necessary for the development of good science and is a key feature of biomedical research.

Rogue elements
Second, in the absence of legislation, there are currently no restrictions on stem cell research in Ireland. This increases the potential for abuse by rogue scientists who may offer untested and dangerous treatment to seriously ill patients in Ireland. The introduction of legislation will not only ensure that such scientists cannot operate in Ireland but will also provide protection of patients.

In addition, legislation would allay any fears that the public might have in relation to other biomedical treatment such as genetic screening of embryos or designer babies. Legislation for embryonic stem cell research would provide a coherent structure in which biomedical research could take place in Ireland, thereby encouraging investment and international collaboration.

Ethical framework
Such legislation would provide an ethical framework within which all researchers would be required to work, while also providing public oversight.

The continued absence of legislation risks leaving a space for the development of the research with no legal, ethical or public oversight. With such issues at stake, the Minister for State with responsibility for Research and Innovation, Seán Sherlock, must introduce legislation.

Ciara Staunton is chief legal officer of the Irish Stem Cell Foundation and lecturer in law, technology and governance at NUI, Galway. H er PhD, The Regulation of Stem Cell Research in Ireland , is funded by the Irish Research Council (stemcell.ie)