Part IV: The International Situation
1. Britain[1] - A Glance at the Future of Biotechnologies for the World
In the world of biotechnologies and utilitarian bioethics, the rule seems to be, “Where Britain leads, the world follows”. Britain was among the first countries in the world to make abortion legal, and was the first in the world to legalize the cloning of human beings for research. The nation that established the world’s modern concepts of democratic rights and freedoms has become a world leader in devising ways to withhold these from the unborn. Keeping a close eye on developments in British law is a good way of answering the question, “Where next?” for cloning, embryo research and related fields.
Britain pioneers IVF
In 1978, Louise Brown, the first child conceived outside a woman’s body to survive to birth was born on 25 July 1978 in Oldham, Greater Manchester. She was conceived in vitro after the development, by Patrick Steptoe, an obstetrician and gynaecologist and Robert Edwards, a physiologist, of the technique previously devised for use on farm animals.
In the same year and after the massive international controversy over Louise Brown’s conception, the British government established the Warnock committee to investigate IVF and embryo research, and to make recommendations for legislation.
The Warnock committee insisted that the beginning of human life was an ethical rather than a biological question and settled upon the limit of 14 days, a day before the appearance of the primitive streak (a precursor of the neural tube) in the embryo as the beginning of human life. This was in direct contradiction to the findings of the science of human embryology that states clearly, “Human development is a continuous process that begins when an ovum from a female is fertilized by a sperm from a male... a zygote is the beginning of new human life”[2]. Despite this contradiction to the science, the 14-day limit, as recommended by bioethicists, has become the standard for most, if not all, legislation regarding the use of embryos for research around the world. The Warnock Committee reported that the decision was made arbitrarily and had no relation to the nature of the embryo. “We agreed that this was an area in which some precise decision must be taken, in order to allay public anxiety.”[3]
The Warnock committee’s report was released in 1984 and the 1990 Human Fertilisation and Embryology Act incorporated the committee’s recommendations into
law. The Act established the Human Fertilisation and Embryology Authority (HFEA) that creates guidelines for researchers based on what is allowed in the law and grants research licences.
By 1997, one in 80 children (1.2%) born in Britain was the result of IVF treatment.
In 2000, an audit of Britain’s 118 IVF clinics revealed that frozen embryos had been destroyed as a result of power failures, or implanted into the wrong women as a result of mistakes in data collection. The audit by the Human Fertilisation and Embryology Authority (HFEA) found that electricity disruptions at “various” centres had led to the deaths of an undisclosed number of embryos in frozen storage. Errors in data collection led one former HFEA inspector to suggest that 1,000 IVF babies may have been implanted into the wrong women, leading to as many as 30 live births.
The first mammal, a successfully cloned using the somatic cell nuclear transfer technique was born on 5 July 1996. Professor Ian Wilmut and his team at the Roslin Institute, Edinburgh, had cultured 277 cloned sheep embryos for six days, after which 29 of them which appeared to have developed normally to the blastocyst stage were implanted into surrogate ewes. 148 days later, Dolly was the only lamb to be born alive.
On 24 June 1999, the British Government called for a moratorium on human cloning and established the Expert Medical Group on Human Cloning (known as the Donaldson committee) under Professor Liam Donaldson, the government’s chief medical officer. This committee’s report made a distinction between reproductive human cloning (the transfer of any cloned human embryo into the uterus of a woman) and so-called therapeutic cloning (which it called cell nuclear replacement).
On 16 August 2000, the United Kingdom became the first country to authorize destructive research on cloned embryos. The department of health accepted all the recommendations in the Donaldson committee’s report, and this was followed by votes in both houses of parliament to amend the Human Fertilisation and Embryology Act
1990 authorizing research on cloned human embryos for the treatment of “serious disease”.
The Human Fertilisation and Embryology (Research Purposes) Regulations 2001, which came into force on 31 January 2001, added three grounds for research on human embryos to those which are authorized by the Human Fertilisation and Embryology Act 1990: increasing knowledge about the development of embryos; increasing knowledge about serious disease; enabling any such knowledge to be applied in developing treatments for serious disease. The measure did not mention either cloning or cell nuclear replacement.
On 7 September 2000 the European parliament passed a motion calling on the British government to review its stance on human embryo cloning and noted that “an attempt is being made to use linguistic sleight of hand to erode the moral significance of human cloning”. After the vote in the House of Commons, Edelgard Bulmahn, Germany’s science minister, commented: “We are united with all other European Union countries that the cloning of embryos steps over ethical and moral boundaries.”
On 15 December 2000, Yvette Cooper, the Public Health Minister, told the House of Commons, “Between 1991 and 1998, more than 750,000 embryos were created through IVF. Some 48,000 were donated for use in research and 237,000 were destroyed. The rest were either used in treatment or held for future use.”
Under the Act, IVF embryos cannot be experimented upon without the consent of their biological parents. After 10 years the embryos must be destroyed unless the parents consent to their continued storage.
In November 2001 the British government passed additional legislation specifically allowing human cloning for “therapeutic” purposes and banning the implantation of cloned human embryos, requiring them to be killed before 14 days. The Human Reproductive Cloning Act 2001 that allows “therapeutic cloning” under license from the HFEA. The first licence was granted on August 11, 2004 to researchers at the University of Newcastle to allow them to investigate treatments for diabetes, Parkinson's disease and Alzheimer's disease.
In January 2006, Professor Ian Wilmut, the researcher who created Dolly the cloned sheep, applied to the HFEA for permission to create clones from human and rabbit tissue.[4] In November 2006, a team of British scientists from Kings College London and the North East England Stem Cell Institute (NESCI) asked the HFEA for permission to begin creating clones made from cow ova and human nuclei.[5]
The Labour government briefly considered banning the creation of mixed species cloned embryos, but backed away from a ban after a group of 45 scientists, ethicists and politicians published an open letter in January 2007 saying that a ban would hold back the advancement of British science.
New Legislation – The “Ratchet Effect”
Despite calls from the research community to ban the procedure, in December 2006, the British government tabled draft legislation that would allow the creation of human/animal hybrid clones as well as codifying a host of procedures previously allowed on a case-by-case basis by the HFEA. As of this writing, the legislation is awaiting examination by a committee and the public and a vote in Parliament.
The draft legislation codified in law the permissions given individually by the HFEA over its 17 years of existence. Anthony Ozimic of the Society for the Protection of Unborn Children described this as a “one-way ratchet effect” in which no reconsideration of the procedures already allowed can been made.
Procedures allowed under the Draft Bill would include the creation of cloned human embryos; the eugenic manipulation of clones and IVF embryos to acquire desired genetic traits; the creation of genetically selected children to be used as tissue donors; the creation of human-animal hybrid embryos for experimentation. The proposed law would abolish the requirement for a father for in vitro fertilization; it allows the screening of embryos for “serious medical conditions” and their creation as a source of genetically matched tissue for treatment of siblings.
The Society for the Protection of Unborn Children submitted a brief to the Joint Committee calling the Draft Bill “unsatisfactory”[6]. SPUC said that although a societal consensus has yet to be reached on these procedures, both the reproductive technology sector and elements of the research community have financial interests in promoting changes that are evident in The Draft Bill.
SPUC laid out the pro-life objections to the Draft Bill saying it:
- expands measures that entail the destruction of human life at its earliest and most vulnerable stage;
- manifests an eugenic mentality which underlies some of the its key proposals;
- manifests arbitrariness in its applied limits;
- accelerates the waning respect for human life that is marking scientific endeavours in the modern biotechnological era;
- fails to provide the leadership necessary for ethically sound goals to be pursued;
- has been devised on the basis of a one-way ratchet on the use of human embryos in research involving their destruction, and only changes that will extend this use will be considered;
- ignores critical scientific and ethical questions in what appears to be an attempt to allay public unease by the promise of tight regulations;
- by endorsing the destruction of human life at its most vulnerable stage, and seeking to extend the circumstances and ultimately the number of embryos so destroyed, is operating from a utilitarian ethic that is prepared to pursue potential goods such as health - that may never be realised – at the expense of the most fundamental good of human life itself;
- is a complex mix of acquiescence to scientific advances, commitment to various and at times conflicting ethics, inconsistent application of regulations and economically rationalist restructuring.
Where next? The Joint Committee recommends deregulation of embryo research and cloning
In August 2007, the Joint Committee on the draft Human Tissue and Embryos Bill issued a report that called for the HFEA, or other non-Parliamentary regulator, to have power to exempt whole areas of research from the need for a license. In these areas, scientists would have total freedom to create, manipulate and destroy any number of human embryos.
The Committee acknowledged that the bill lacked the foundations that provided a "partial ethical framework" for the 1990 Human Fertilisation and Embryology Act. The report suggested that the legislation itself should embody no ethical principle other than that the “regulator is king”. The report proposes that the government should be able to override the regulator's decisions but only at the regulator's own invitation.
The Committee report also recommended that if Parliament agrees to the creation of inter-species embryos, wide powers for the creation and use of such human-animal hybrids and chimeras should be given.
The Committee proposed a new definition of "inter-species embryo" which means any cross-fertilised embryo (human-animal) which does not have a full complement of 23 human chromosomes is not regarded as an inter-species embryo at all. An embryo made by taking a human sperm, deactivating one chromosome - or part of a chromosome - and fertilising a ewe's or sow's ovum, is not an "inter-species embryo" as defined, and so would not come under the law. The committee recommended that the HFEA - not the courts or Parliament - should have the power to interpret the definition of “inter-species” embryos.
Although such an embryo might have the potential to develop human characteristics, under the committee’s recommendation, scientists would be free to do almost anything with it as long as it was not implanted in a woman's womb. Implantation in an animal or artificial womb is not prohibited.
The report supported the repeal of the law banning so-called “reproductive cloning” - that is, transfer of cloned embryos to the womb. Instead certain embryos will be categorised as "permitted" embryos (permitted to be transferred to the womb). At present, cloned embryos would not be "permitted". The decision would be left to the regulator, with no opportunity for a debate in Parliament and the public scrutiny entailed.
[1] Much of the information for this section was taken from documents provided by the Society for the Protection of Unborn Children (SPUC). “A Way of Life – Affirming a Pro-Life Culture in Northern Ireland” SPUC 2002. http://www.spuc.org.uk/ethics/wayoflife2.pdf
[2] The Developing Human, K L Moore, W B Saunders, 1988, page 1
[3] The Warnock Committee, Report of the Committee of Inquiry into Human Fertilisation and Embryology, London (1984), HMSO, p.60
[6] http://www.spuc.org.uk/lobbying/HTEbillsub.pdf
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