I.  INTRODUCTION

  1.  The BioIndustry Association (BIA) is pleased to have the opportunity to submit evidence to the House of Commons Science and Technology Committee concerning the regulation of the creation of animal/human hybrid and chimera embryos for research purposes.

  2.  The BIA is the trade association for innovative enterprises in the UK's bioscience sector. We represent over 300 members, the majority of which are involved in realising the human health benefits that bioscience promises.

II.  UK BIOSCIENCE

  3.  The UK is a world leader in biomedical research, second only to the United States. Bioscience is one of the few fields in which the UK is a global leader with good prospects of remaining competitive for the foreseeable future, even in the face of growing competition from countries such as India and China.

  4.  Treatments developed by the bioscience sector have the potential to address an array of unmet medical needs. As way of illustration, more than 250 million patients worldwide have already benefited from approved biotech medicines and therapies to treat or prevent conditions including heart attacks, multiple sclerosis, breast cancer, cystic fibrosis and leukaemia.

III.  THE COMMITTEE'S ENQUIRY—OUR RESPONSE (1)

  5.  Firstly the Select Committee Inquiry is focusing upon: the appropriateness of the proposals for legislation of the creation of animal/human hybrid and chimera embryos for research purposes as set out in the Government's recent White Paper, Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos) (CM 6989).

  6.  The public consultation which informed the White Paper was focused mainly on regulation of fertility treatment; most participants opposed the creation of human-animal embryos. This was not what we would call a representative poll of the country at large. The Government has based its decision on an unrepresentative consultation, where the views of individuals have been given the same weight as the collective views of established scientific bodies. By way of contrast, in a BBC online poll to which almost over 15,000 people have responded, over half of the respondents said that the creation of hybrid embryos should be allowed compared to 40% against.

  7.  In early January 2007 a number of scientists linked to this research made their concerns known that preventing this research could undermine the UK's standing as a world leader in stem cell research and would slow the progress in developing cures for a number of diseases. There is widespread scientific and public support for this ground-breaking medical research into treatments for diseases such as multiple sclerosis, Parkinson's disease and motor neurone disease.

  8.  In the HFEA, the UK has a world class regulator in this area. The HFEA has shown genuine leadership on the challenges it has faced. Now, in the face of this challenge, we need the HFEA to lead and to ensure there is a robust regulatory system that inspires public confidence and is supportive of groundbreaking medical research.

  9.  The BIA supports the recommendation made in the Human Reproductive Technologies and the Law[20] report in 2005 by the House of Commons Science & Technology Committee, that to prevent hybrids and chimeric embryos being used for reproductive purposes, new legislation should:

—  Define the nature of these creations.

—  Make their creation legal for research purposes if they are destroyed in line with the current 14-day rule for human embryo cultures.

—  Prohibit their implantation in a woman.

  10.  The Science & Technology Committee's 2005 report also concluded, "While a chimera is unlikely to be able to develop very far, it may have value as a research tool, possibly as a means of testing the ability of stem cell cultures to form all forms of tissue. Similarly, hybrids formed by cell nuclear replacement might have value in deriving embryonic stem cells for research purposes." [21]

  11.  Government proposals in the White Paper on the Review of the Human Fertilisation and Embryology (HFE) Act would lead to a de facto ban on the creation of hybrid and chimeric embryos in vitro for research purposes. We think that would be terrible news for patients and for the UK.

  12.  We should not be in a situation where this innovative research could be banned. The Government, which has done many great things for health and science since 1997, has made a mistake with the White Paper and they should correct it.

III.  THE COMMITTEE'S ENQUIRY—OUR RESPONSE (2)

  13.  Secondly the Select Committee Inquiry is focusing upon: the impact of these proposals upon stem cell research in the UK.

  14.  These proposals would halt current innovative research into diseases such as Alzheimer's and motor neurone disease. They would also send out an incredibly negative message about the UK as a location for stem cell research and innovative biomedical research. The BIA does not believe that this is compatible with the Government's aim of ensuring the UK is a world leader in this field.

  15.  These proposals, if implemented, would have damaging consequences. The BIA believes therefore, that because of the potential benefits of the use of chimeric embryos to develop innovative life saving medicines, the law should permit the creation of human-animal hybrid or chimeric embryos for research purposes only (subject to the limit of 14 days culture in vitro, after which the embryos would have to be destroyed).

  16.  In making these assertions the BIA would wish to stress at all times why this research is necessary. The animal-human hybrid embryo research is a powerful research tool that will help scientists to learn more about the differences between diseased and normal cells. Currently this work is stifled by a lack of suitable cells for research. This research will be used to develop the techniques required for the production of stem cells. Stem cells could prove to be the source of treatments for diseases such as Alzheimer's and motor neurone disease.

  17.  It is also commonly asked why animal eggs have to be used. Put simply; to address the shortage of human eggs for stem cell research. Animal eggs are far easier to harvest. Researchers often only have access to a small number of human cells each month, but can access several hundred animal cells a day as they are currently just waste from slaughterhouses.

  18.  We believe that the potential benefits of the use of chimeric embryos in medical research, as stated by the Department of Health[22], could include:

—  Testing the capacity of embryonic stem cells to differentiate into a range of bodily cell types, as part of research into the treatment of serious diseases.

—  Deriving human embryonic stem cells, thereby circumventing the shortage of good quality human eggs available for research.

III.  THE COMMITTEE'S ENQUIRY—CONCLUSION (3)

  19.  The White Paper's suggestions in this complicated and deeply sensitive area are not the right ones for human health, or UK science.

  20.  Animal-human hybrid embryo research is a powerful research tool that will help scientists to learn more about the differences between diseased and normal cells. Currently this work is stifled by a lack of suitable cells for research. This research will be used to develop the techniques required for the production of stem cells. Stem cells could prove to be the source of treatments for diseases such as Alzheimer's and motor neurone disease.

  21.  There are clear signs already that the White Paper proposals are not well regarded, even by the HFEA. The BIA was pleased that the HFEA's announcement on 10 January 2007 did not support the proposed ban in the Government White Paper on research using hybrid embryos because as we have said, such a ban would seriously jeopardise the UK's position in the global research and development of stem cell research.

  22.  The BIA acknowledges the current concerns, recently publicised in the media, about the advances in medical research involving chimeric embryos. The BIA recognises that the use of human embryos in research will always be a controversial issue and an area of where there is likely to be a high degree of public concern.

  23.  The BIA believes there is a clear scientific rationale for the creation of chimeric embryos on the grounds of advancing human health, subject to the constraints noted above. Research should be conducted in a responsible and ethically sensitive manner, in a framework that address scientific, ethical, medical, and social concerns, and in compliance with all regulatory requirements pertaining to biomedical research in general.

  24.  As it stands today (January 2007) the BIA is deeply concerned by any possibility that there is prevarication over this crucial area of research. Science and reason should prevail.

January 2007

21   Human Reproductive Technologies and the Law. House of Commons Science and Technology Committee. Fifth Report of Session 2004-05. Paragraph 66. Back

22   Review of the Human Fertilisation and Embryology Act. A Public Consultation. Section 9.32. Department of Health 2005. Back