Creating an ethical framework for stem cell research in Europe

The use of human stem cells, in particular, embryonic stem cells (ES cells), creates many ethical, legal and regulatory issues. The countries of the European Union (EU) are divided as to the legitimacy of the research and the approach to take to regulate it. The Eurostem project, directed by John Harris, the Sir David Alliance Professor of Bioethics at the University of Manchester, was funded for three years by the European Commission's fifth Framework Programme. The objectives were to identify the social, legal and ethical issues involved and to make recommendations based on the findings. The Eurostem partners represent the variety of opinions throughout Europe from a range of disciplines: philosophy, academic law and industry with particular interests in the field of health care, medical ethics and policy.

The project had several main objectives, including analysis of European regulatory and legislative frameworks; analysis of the media coverage of stem cell research; the issue of economic competitiveness which occurs when only some countries permit research, and the development of an ethical framework for stem cell research. It was hoped that the ethical framework could be of use in forming a combined European approach to the regulation of this research.

The development of a European framework for stem cell research is challenging for a number of reasons. It is complicated primarily because of the differences between regulatory and legislative positions, or lack of regulation, in the countries involved. It is further complicated by what may appear to be inconsistent legislation within countries which permit abortion and IVF treatment but ban research on early embryos. This lack of consensus is largely grounded in conflicting views of the moral status of the embryo, but may also reflect a demarcation of what are understood to be legitimate areas for statutory intervention. The pursuit of fertility treatment and the requirement of abortion facilities are widely considered to be choices within the domain of individuals.

It is understandable that legislation and regulation is not always philosophically consistent as it is not merely moral considerations which drive policy.  The legislative and regulatory frameworks, where they exist, have their origins in, and are subject to, historical, political and cultural particularities. However, this does create tensions within and between countries as they try to balance the competing requirements of freedom of research, academic autonomy and the duty of governments to best serve the health needs, and other basic rights of their citizens.

When we came to developing the framework we focused on what our common interests are as a community of European nations as opposed to starting with our existing, very diverse positions. We are able to cope with the diversity of these positions by signing up to the 'Principle of Toleration and Pluralism' in recognition of the various historical and cultural backgrounds. This combined with the 'Principle of Solidarity', which insists that we rise above our individual differences to promote development through the spirit of cooperation, gives us a level ground to approach other aspects from.  The most intractable problems relate, of course, to research on the human embryo. This problem we dealt with by making the embryo an 'issue of scope'. This means that under the principle of respect for persons which embodies all human research, if the embryo counts as a 'person' under the legislation of that country then it will be protected accordingly.

This did leave us with the problem of the protection of individual researchers. Because of differences in national legislation, collaborative work in the EU is fraught with dangers.  For example, work done in one country which is forbidden in another exposes those undertaking this work to the risk of criminal liability for their involvement in this work. This also potentially excludes researchers from funding. In order to further include all researchers, and in view of the potential importance of this research, we promoted the 'Principle of Wide Availability' in regard to open access publishing; responsible partnering of public and private investment; and the 'Principles of Promotion of Research' and 'Protection of Individual Researchers'.

To this end we made the following specific recommendations:

1) To the extent that national laws prevent such co-operation and collaboration, we recommend that nation states and the European Commission work actively to find solutions for this problem.

2) The solutions cannot be the responsibility of individual researchers. No one working in the EU should be punished or rendered liable to prosecution, restriction or discrimination if they participate in research so long as the research is undertaken in a country permitting such research.

3) European research should be funded in a way that does not discriminate between individual states and researchers in the EU. This means that individual researchers should not be disadvantaged or be the object of discrimination by reason of their participation in research.

4) The funding policy of the EU should be aligned and made consistent with the  principles identified in the framework and should not disadvantage researchers in any member states.