1.  INTRODUCTION

  1.1  The North-East England Stem Cell Institute (NESCI) is a collaborative organisation comprising the universities of Newcastle Upon Tyne and Durham and the Newcastle Upon Tyne Hospitals Foundation NHS Trust and involving numerous other organisations such as the Regional Development Agency One North-East, the Centre for Excellence in Life Sciences (CELS) and the International Centre for Life. NESCI aims to combine world class pure stem cell science with translational research, leading to therapeutic solutions and commercial activity. It also leads the way in legal and regulatory issues surrounding stem cells, being the only stem cell centre in the UK to have an in-house lawyer solely dedicated to this area. NESCI also contributes to consultations and debates on the future regulation of stem cell science at both national and international level.

  1.2  One of the groups that have applied to the Human Fertilisation and Embryology Authority (HFEA) for a licence to carry out a research project involving hybrid embryos is affiliated with NESCI. NESCI researchers are also the only UK group actively undertaking NT research using human eggs. Thus we are well placed to compare the need for both human and animal based study in this field. We would like to make the following points to the Committee on the creation of hybrid embryos in research:

2.  NATURE AND PURPOSE OF THE RESEARCH

  2.1  We feel that the true nature and purpose of the research that is being proposed has been misunderstood and misinterpreted by the media and thereby the public and has caused a level of concern that is not objectively justified. A nucleus from a human cell would be placed in an animal oocyte, but one that has been rendered merely an empty shell by the removal of the nucleus containing all the animal DNA from the egg. Whilst there may be very tiny amounts of mitochondrial DNA from the animal within the shell of the egg, the DNA of the developing entity would be human. The proposal is that once the cell begins dividing, it is allowed to do so for no more than 14 days (as is the current practice with standard human embryos used in research) and an attempt would be made to derive stem cells. The stem cells would be derived from human material and would therefore be human embryonic stem cells.

  2.2  No-one involved in this type of research is suggesting that such early stage embryos be implanted into any type of uterus, be it animal or human, nor is anyone suggesting that such embryos be allowed to develop any further than 14 days in-vitro. This procedure is viewed by the scientific community purely as a tool for the derivation of stem cells for research.

3.  LANGUAGE

  We would also like to draw attention to the fact that the language used by the media, the public and to some extent the scientific community as well, has contributed significantly to the level of concern being seen. Clearly, the definition of "embryo" and the suitability of the word to the early stage blastocyst from which stem cells are derived has been long debated, but there is no doubt that it conjures images of something that becomes a fully formed person in time in the minds of many people. Adding to this words like "chimera" and even "hybrid" in turn lead to images of fully formed, mythical looking creatures, which have been graphically illustrated in the press during coverage of this issue. They imply a living creature with features that are both human and animal and this is grossly misleading when compared to the reality of what is being proposed. Perhaps in future the scientists and the regulators could find some language that more accurately reflects the research that would be carried out and the entities that would be created.

4.  ETHICS

  There has been much talk about the ethical issues surrounding the creation of these embryos, but the fact is that their creation would reduce the demand for human eggs (which are in very short supply) in order to derive stem cells for research purposes. In recent months, the donation of human eggs for research, whether through egg sharing arrangements similar to those employed in IVF treatment or through altruistic donation has been the subject of debate both in the media and through the HFEA public consultation (see below). There is perceived unease about women incurring the risks associated with ovarian stimulation and retrieval of eggs and the number of eggs donated is low. We wish to clarify that we fully support egg donation and consider that there is still always going to be a need for human eggs in research projects. The ultimate aim is to produce human embryonic stem cells for research and therapy. We are at a very early stage of scientific understanding in this field in humans and any restriction on the use of either animal or human eggs will only delay the inevitable development of this science. It is recognised that NT techniques are species specific, ie techniques need to be modified to be successful in different species. Nonetheless, some of the problems in human NT could be addressed using animal eggs. Any solution that allows us to use animal eggs clearly allows scarce human eggs to be allocated to address human specific questions. It should be noted that the HFE Act does not permit research on human embryos to address questions that could otherwise be answered using animal cells.

5.  DIRECT COMMENTS ON THE WHITE PAPER

  5.1  The recently released government white paper suggests a ban on the creation of hybrid embryos such as those proposed in the current applications to the HFEA. While the fertility centre associated with NESCI has in the last few months been granted a licence amendment to allow both egg sharing and altruistic donation for research, the HFEA launched the public consultation and have made it very clear that if as a result, their policy on egg donation changes, that licence may not continue, thus cutting off the supply before it really begins to have any effect. If the use of empty animal eggs is also banned by legislation, the supply of reasonable quality eggs and therefore the ability of UK scientists to develop stem cell lines will be significantly curtailed and we will risk squandering the leading international position we have carved out for ourselves up till now. Attracting investment in commercial opportunities will also become more difficult if the science does not remain at the forefront on the international stage.

  5.2  We would also take issue with the wording of the white paper, which proposes an outright ban on the creation of hybrid embryos, but then indicates in very vague terms the possibility that their creation may be permitted by further legislation in the future for research purposes. Not only does this cause confusion, but it comes across as a strategy to appease public concern whilst not totally closing the door on what is clearly recognised as exciting and useful science. We would argue that this approach would simply delay the inevitable debate that will need to be had on this, whenever the government decides to allow it to go ahead and rather than hold science up for several years, it would be better to debate the issues and clarify the science for people now so that further progress towards treatments can be made.

  5.3  In our opinion, aside from the issue that public opinion should be considered but certainly not determinative of government policy and legislation, true public opinion has not yet accurately been gauged. The reasons for this include those outlined above such as language used, media coverage and the limited number of responses to the government consultation on regulation of this sector. Therefore, public opinion can not possibly be the basis for a decision to ban this promising scientific procedure from being carried out in the UK without much more debate, discussion and dissemination of accurate, non-biased information.

  5.4  We would also urge caution from a legal perspective against producing a piece of legislation designed to appease public fears, as such legislation will inevitably not represent public opinion a year after it is passed. In such a fast moving area of science, we need to be producing legislation that is able to be interpreted and implemented as the science and public perception of the science develops—our legislative process is simply too slow to be creating new law every time cutting edge techniques are proposed. An outright ban is simply not appropriate in these circumstances.

6.  NESCI PROPOSAL

  NESCI proposes that the creation of hybrid embryos using the method described above and in the current pending HFEA applications is permitted, subject to licence, ethical approval and HFEA monitoring and the current 14 day time limit on development.

January 2007