A case study by Ian Gibson

 

Can scientists have any influence on Government policy making?  

 A case study – The Making of the

Human Fertilisation and Embryology Act, 2008

 

Dr Ian Gibson MP

In May 2008 The Guardian ran the headline “MPs vote for hybrid embryos after Brown makes plea to make “moral endeavour.””  It went on to acknowledge that MPs were pushing back the boundaries of science in allowing the creation of interspecies – or “hybrid” – embryos which have a combination of human and animal DNA.  This technology allowed the injection of DNA from the nucleus of an adult human cell into a cow or rabbit egg from which the nuclear DNA had been removed.  The result is the creation of an embryo – a tiny ball of cells all of which would have more than 99% human DNA. Under the then current legislation, these could not be allowed to develop beyond 14 days.  However this is long enough for these hybrids to be used for the development of stem cells for research and avoided the use of scarce human eggs.  The other major policy decisions incorporated in what was to become the Human Fertilisation and Embryology Act 2008 allowed the creation of saviour siblings. These are created by in-vitro fertilisation and were closely tissue matched with a sick sibling with the prospect of using multipotent cells obtained from the umbilical cord as transplants to treat the sibling.  A further major change was that the need for a father was to be replaced by the need for ‘supportive parenting’. 

The debates in the House of Commons when the Human Fertilisation and Embryology Bill was going through Parliament were often highly emotive.  This was particularly true when a group of MPs proposed amendments in an attempt to reduce the current time limit on abortion from 24 weeks to 22 and 20 weeks.  Although abortion was not an matter covered in the Bill, as it was a Bill intended to amend the  Human Fertilisation and Embryology Act 1990 which did deal with abortion the issue, they could be legitimately be raised.  However the amendments were not agreed and so the attempt failed. There was moral fury from some religious MPs who were eventually allowed to vote with their consciences under a free vote system in all parties on the most contentious issues in the Bill.

The background to what was to become the Human Fertilisation and Embryology Act 2008 stems from scientific achievements in 1955.  Then Bob Edwards, a young PhD student in the Institute of Animal Genetics at the University of Edinburgh, was working on the fertilisation of mouse eggs and their subsequent development.  In 1960 he started to study human fertilisation and in 1968 he achieved the fertilisation of a human egg.  He then teamed up with the gynaecologist Patrick Steptoe and in 1978 his work led to the birth at Oldham General Hospital of Louise Brown, the first so-called test tube baby. He was awarded Nobel Prize in 2010 and given a knighthood in 2012.   This development meant that infertile couples now had the possibility of having a baby.  This development was not welcomed by all and there was a huge outcry and hostility from many sources including the Roman Catholic Church.  The Government refused to support his research and he and Steptoe carried on their work in the private Bourne Hall clinic which they founded in Cambridge.  It is estimated that by 2010 about 4 million children had been born by IVF. 

It took four years, to 1982, for the Government to set up a committee, chaired by the philosopher, Mary Warnock, to look into the social and moral impact of this new technology.  Hundreds of interested individuals gave evidence to the committee and, following the publication of a White Paper in 1987, the Human Fertilisation and Embryology Act 1990 was passed.  This Act provided for the establishment of the Human Fertilisation and Embryology Authority (HFEA), which was an independent public body and the first of its type in the world.  The HFEA regulated IVF treatment and human embryology research. It set out the terms of use of human embryos as well as the use of donation of sperm and eggs and their storage. It also issued licences for the creation of human embryos outside the body and their use in treatment and research.  Finally the HFEA was charged with keeping a database of all relevant research and treatment.  Despite the furore the Act was passed and the issue quietly slipped from the public gaze.  In the following years, for example in 2001, the HFEA established regulations which extended the purposes of embryo research and licensing to include knowledge about serious disease. 

These technologies were of course developing and necessitated a debate in Parliament. This debate, which was principally about embryonic stem cell research and therapeutic cloning, required the HFEA to consider the use of embryos necessary or desirable for these research purposes.  Attempts by the HFEA and opposition groups to resort to the law courts to determine the scope and use of these new technologies created a critical mood amongst the scientific community which required a further examination of the relevant laws. This lead to the passing of legislation in 2001  as a consequence of the novel technology that resulted in Dolly the Sheep. This Act forbade the cloning of human beings. There was also a requirement, determined initially by the HFEA, which enabled donor-conceived children, upon reaching the age of 18, to access the identity of their egg or sperm donor.  At the same time the European Union introduced common safety and quality standards for human tissues and cells across the Union and this was adopted by the UK in 2004.

Perhaps the most significant event however was in 2005 when the House of Commons Science and Technology Select Committee, with a little guidance from Downing Street and the Dept of Health, conducted an Inquiry and reported on human reproduction technologies and the law.  The purpose of this Inquiry was to look at the then legal framework in the light of technological advances and recent changes in ethical and societal attitudes. The Committee received evidence from a variety of different bodies and individuals, including members of the scientific community, which was all taken into account in reaching its conclusions.  Some aspects of the draft report however were met with opposition from some members of the committee and at its final meeting, just before the 2005 General Election, a significant number of members of the committee attempted to derail the report in its final discussion phase. They tried to amend it by tabling some 76 amendments and there is no doubt that various groups from outside Parliament who opposed the new developments, including the Roman Catholic Church and some secular bodies, played a significant role in these events.  When at 6 p.m. it looked like the report might fail because of this fillybustering, Dr Brian Iddon, a member of the committee, called for a guillotine for 9.0 p.m. This would mean that there could be no more amendments taken, there would be no more discussion and a vote would be taken on the report. This was a novel situation for a Select Committee and senior clerks in the House of Commons had to be called in to check that this was an appropriate action.  The Guillotine succeeded and the discussion terminated, but it was only my casting vote as the Chairman which ensured that the Report was accepted and could go forward. This was clearly a dramatic time and the Government welcomed the report which enabled them to eventually develop the 2008 Act.

Later in 2005 the Department of Health carried out a public consultation on possible changes to the law and regulations relating to human reproductive technologies. This was based on a number of reviews, studies and reports, and particularly that of the Select Committee, dealing with the emerging technologies, developments on the international stage and public attitudes.  The results of this consultation, which had elicited 535 responses from various bodies and individuals, lead to the publication at the end of 2006 of a White Paper “Review of the Human Fertilisation and Embryology Act: proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos)”. Then, in May 2007, the Government published the Human Tissues and Embryos (draft) Bill which was intended to revise the law on assisted reproduction and embryology.   A joint Select Committee was set up to scrutinise this draft bill composed of members of both Houses of Parliament.  The House of Commons Science and Technology Select Committee also conducted a more detailed Inquiry into the Government’s proposals to regulate hybrid and chimera embryos. Both Committees took oral evidence and also received written evidence which again covered a wide range of views and opinions.  The Commons Select Committee reported in May 2007 and the Joint Committee’s report was published in August 2007.  Both reports were generally supportive of research in the field of human-animal embryos but within an effective regulatory regime, including some restrictions, and they were critical of the Government’s proposals for inter-species embryo research as being too restrictive.

The Human Fertilisation and Embryology Bill then took into account the recommendations of these Committees and covered issues including the regulated creation of hybrid embryos. It began its Parliamentary journey in the House of Lords in January 2007.  In November 2008 the Bill became law as the Human Fertilisation and Embryology Act 2008.

The Act of 2008 revised the 1990 Act in significant ways.  It ensured complete regulation of the use and creation of human embryos outside the body, it banned the selection of the gender of offspring for moral and social reasons, it replaced the “need for a father” with the “welfare of the child”, allowed people in same sex relationships and unmarried couples to apply for an order to be treated as the parents of the child was born using a surrogate mother, and of course the one which created the most anger amongst opposition parties was allowing human admix embryos, that is with both human and animal material.  The HFEA was essential, it argued, in regulating this development. 

The debates in the House of Commons on issues such as the creation of human-animal hybrid embryos and saviour siblings were often emotive, with significant opposition particularly from some religious groups.  It is important to point out however that throughout the various Inquiry and debate processes the scientific community acted with one voice making their views known, explaining the science behind the new developments and providing a rationale for their positions.  The scientific learned Societies, the academies and Royal Colleges as well as individual scientists all provided powerful evidence and were joined by charities and patient groups who were concerned with human illnesses.  This had an important effect on the judgement of MPs on how to vote.  Ironically now we are hearing of the abandonment of the HFEA and its substitution by another committee.  It remains to be seen how effective this is.  However before the HFEA is dissolved it is considering the payment of compensation to donors, restricting the number of families a donor can donate to and, finally, deciding on a policy to reduce multiple births from fertility treatment.

There is little doubt that the current Act involved the input of many people and organisations with a wide range of different views but the role of the scientists was particularly important in providing the technical basis and understanding  – as The Guardian article points out.  There were times of despair and it could be thought sometimes that we were going too far to appease some of the religious groups and secular groups opposed to the new technology in this country. Had they had their way with regard to human/animal hybrids, for example, it would have had a profound and inhibitory effect on stem cell research in the UK. We could not have achieved the position of international pre-eminence in this area of science.  We would not be in a position to carry out significant research into the use of stem cells as therapies for some serious and life-threatening disease. However the careful explanations, arguments and campaigns paid off.  Further, as science continues to move on there will be an even greater need for Parliament to be informed of the nature and consequences of these new technologies and how they input into the social mores of this country. In this the scientific community must play a key role.  However it is for the Government and Parliament to ultimately decide, based on sound evidence, where the balance of views lies and the direction new law will take.

Dr Ian Gibson 

May 2012

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