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* ‘It’s Never Over . . .’ Regulation of (some) Genetic and Reproductive Technologies in the UK: Human embryonic stem cells; embryo selection and the HFEA

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By Sarah Sexton, The Corner House, UK

The regulation of reproductive and genetic technologies in the United Kingdom – that is, in England, Scotland, Wales and Northern Ireland – is often portrayed, both within the country and outside, as exemplifying a responsible, measured, considered approach to such regulation.

For a start, the UK has government regulation, mandatory regulation, covering many (but not all) of these technologies, rather than free market regulation, or voluntary regulation, or no regulation.

The rules do not allow anything and everything, but neither do they ban anything and everything. The regulation takes a middle road: this is in many ways key to understanding British politics and British culture more generally – neither favour extremes.

The specific regulator that I focus on today, the Human Fertilisation and Embryology Authority, was the “first statutory body of its type in the world”. Established in August 1991, at 12, nearly 13 years, old, it is thus the oldest regulation system of these technologies – and by general consenus, it is in many respects out of date.

Commenting on the recent Canadian legislation, the Centre for Genetics and Society wrote:

“The important point is that the United Kingdom, Germany, Australia and now Canada all have laws on the books that prohibit unacceptable activities, require public oversight of acceptable activities, and establish socially accountable structures for revising policies or setting new ones. Nothing of this sort exists in the United States, or in most other countries, at this time.” (“Canadian Parliament Approves the Assisted Human Reproduction Act,

A Model of Responsible Policy,” )

Thus it seems churlish to complain or criticise or warn about the UK legislation. Having regulation, even if it is not “perfect”, even if it is not fully implemented, even if the rules are variously interpreted, undoubtedly gives campaigners, advocates an entry point, something to push against.

But regulation in Britain is clearly under pressure from all sides, pressure for change. The experience of regulation in Britain, particularly in recent years, illustrates that “it’s never over”.

Besides calling for regulation or just having regulation in contexts of fast developing technologies and a wider economic climate of de-regulation and re-regulation in certain (non-public) interests, of voluntary, corporate regulation rather than mandatory, state regulation, we also need to watch for who regulates to what purpose in whose interest and who pays for it.

Today, I’m going to outline briefly the functions of the HFEA, and then illustrate some of these issues with two current examples:

- regulation of embryonic stem cell research;

- regulation of embryo selection, using Pre-implantation Genetic Diagnosis (PGD) to select the sex of a baby and to select a child with a particular tissue type to be a tissue donor for an existing child.

First, an outline of the regulatory set up.

I think you know how the story usually begins: The first IVF baby, Louise Brown, was born in Britain in 1978. The IVF process was not regulated. As far as I’m aware, what Drs Steptoe and Edwards were doing was not illegal as such, even though it was experimental and in some respects hadn’t followed ethical practice of animal trials or informed consent.

The government in 1982 – Margaret Thatcher first became Prime Minister in May 1979 – commissoned an investigation headed by moral philospher Mary Warnock to look into the issues. She and her team deliberated and produced what is known as the Warnock Report in 1984. It was not until 1990, six years later, that Parliament implemented most of the Warnock Report’s recommendations in legislation. Thus Louise Brown’s birth to legislation took 12 years.

The title of the legislation perhaps indicates what it regulates: the Human Fertilisation and Embryology Act. The HFEA Act allowed research on embryos ‘left over’ from the IVF process as long as the research was for five specific purposes related to fertility and infertility, and was not beyond 14 days.

It allows embryos to be created for research purposes, something that I know several countries or advocates are adamant they won’t allow. Yet the records HFEA publishes every year indicate that few embryos are actually created solely for research – as long as there are so many ‘left over’ from IVF treatments, researchers have not needed to.

The HFE Act provided for setting up the Human Fertilisation and Embryology Authority (HFEA). The authority has a chair, deputy chair and then any number of members of its board, currently 18. All are appointed by the Department of Health, under whose remit the Authority comes. The Act says that half of the Board’s members have to be neither doctors or scientists invovled in human fertility treatment or human embryo research, so there is a recognition of the need for checks and balances.

The Authority has several responsibilities, but the main ones are to issue licenses to and monitor clinics, both public and private, that carry out IVF, donor insemination, and human embryo research. It also regulates the storage of eggs, sperm and embryos – but not eggs, sperm, embryos in general; it has no authority if these are not stored, ie. if they are ‘fresh, not frozen’.

Without an HFEA licence, any IVF work or embryo research is illegal. [I don’t know much about how this process works, how much the HFEA has to go around policing doctors and scientists. But I get the impression that the research community is rather law-abiding. One social scientist looking into the embryonic stem cell research now being carried out in London has said that the researchers are constantly checking whether what they want to do is within the law. Thus the effectiveness of the law may not be so much because of the active policing of clinics, but internal peer pressure as well.]

The HFEA also produces a Code of Practice, giving guidelines to clinics, and keeps a formal register of information about donors, treatments and childrn born from treatments. It publishes an annual report, so you can see the extent of IVF in this country and of research, although some information is not published because of privacy legislation (and possibly commercial confidentiality agreements).

Neither the Act nor the Authority were much in the public eye until 1996-7 when thousands of frozen embryos were destroyed. The Act says that frozen embryos can be kept for five years, after which they have to be used or destroyed.

Since then, and since Dolly the cloned sheep was announced in 1997, it seems that regulation and the HFEA is often in the public spotlight.

Technology has developed faster and further than the existing regulations and the existing capacity of the regulator.

Technologies have developed that were not envisaged in 1990 and thus expose loopholes in the Act, areas that aren’t covered because they weren’t thought of in 1990. (I and others would argue that the 1990 Act actually intended to ban what we now call cloning, but its actual phrasing and definitions were worded so that current developments are assumed to be allowed. The law defined an embryo as being a fertilised egg – but a cloned embryo wasn’t ever fertilised. Likewise, it defined gametes as live eggs or sperm – but now scientists can grow and manipulate in vitro cells into eggs and sperm, thus according to the letter of the law, these are not regulated.)

Scientists, pressure groups, individuals: all seem to be expecting the HFEA to make decisions and pronouncements about everything to do with genetics and reproduction – even if the areas do not fall within the HFEA’s legal remit. “It’s time the HFEA showed some backbone”, said a member of the Pro-Life Alliance (a predominatly anti-abortion group) .

Thus pressures seem to be constant to amend the law, expand it, tighten it, clarify it. The current chair of the HFEA, Suzi Leather, has said publicly that the Act needs changing.

Because of controversies, because it and the issues seem more under the media spotlight, because the HFEA wants to be seen to regulate strictly rather than allowing everything, in several respects, its current policies and decisions seem to be sticking to the letter of the law.

Embryo Stem Cell Research

The main area where the law has been changed in recent years (ie, not just interpreted by the HFEA) is embryonic stem cell research.

In January 2001, the Act was expanded to allow three more purposes for which embryonic stem cell research can be carried out:

(a) increasing knowledge about the development of embryos;

(b) increasing knowledge about serious disease; or

(c) enabling any such knowledge to be applied in developing treatments for serious disease.

In practice, any research on the development of embryos is now allowed, but not in the creation of embryos.

“Serious” is not defined, nor is it defined in the 1967 Abortion Act. (The limit now in Britain for abortion is 24 weeks, but if the fetus is at risk of being seriously handicapped, the limit is 40 weeks, ie. birth.)

This change in the HFE Act allowing more embryo research was preceded by several years of debate and government-sponsored public consultations and committee investigations. Who regulates in whose interest? Who was on the committees? What Peter Drahos, an Australian academic who followed closely the negotiations within international multilateral trade negotiations in the 1980s and 1990s to get an agreement on intellectual property (patents, brand names, trade marks, and the like), writes of the global extension of the patent regime seems pertinent:

“Real power in the modern world . . . comes from sitting on committees that filter out other interested decision-makers or parties from key decisions, but that in some way or another can be read as representing the excluded. In such committees power becomes concentrated in the hands of the few. Its exercise is democratically legitimated by the symbolic links the committee retains with the many that are excluded from the real decision-making.”

The two goverment investigations into whether to change the law to expand embryo stem cell research were, I would argue, biased or weighted in favour pharmaceutical companies, scientists and others publicly in favour of research – and more generally in favour of the research: how can it be furthered while maintaining public confidence?

In the intervening decade between the initial legislation in 1990 and this amendment, I think the aspect of embryo research has come much more to the fore. The initial, main – and still professed – rationale for the HFEA was to regulate fertility treatments, to make sure women weren’t subject to cowboy operators, to set high standards of such treatment.

Now, it is much clearer that there is an additional goal: research. Thus IVF is now more explicitly not just an end but a means to end.

And the commercial interests behind such research are now more to the fore, although still rather subdued. Debates still focus on ethics rather than economics.

Thus, although the HFEA has always governed embryo research, with this change of the law in 2001, its remit, and the expertise it needs to have, have been significantly widened. How can the HFEA board, who have been accustomed to regulating fertility clinics, tell whether there is no other way of treating or researching Parkinson’s disease than through the proposed embryo research? It’s had to expand its capacity and its budget, now running at £5.2 million per year – US$10 million.

Interestingly, the HFEA now has a Business Plan for the current financial year, and a five-year corporate plan.

Of its budget, an estimated £3.78 million is to come from licensing fees, and just £1.5 million from the Department of Health. Without granting licenses in order to get fees, it wouldn’t be able to operate.

This reminds me of another point made by Drahos about patent offices around the world. In a context of privatisation, reduction in public spending (and redirection of public spending to the for-profit sector) and of making public bodies become self-financing, patent offices rely on the fees they charge patent applicants to keep going – thus it’s in their interest not only to grant patents but to keep their customers happy, and their customers are no longer “the public interest” or even governments.

The UK government took its time about amending the HFE Act because many people in Britain over the last few years have been, if not up in arms, then certainly their arms have been up-rooting trial plantings of genetically engineered crops. Any amendment may not have succeeded, because of a general antipathy to anything involving the word ‘genetic’.

Although parliamentarians were given a free vote according to their consciences rather than political party, one prominent member of the upper chamber said she could not recall a free vote in which the government had lobbied so much.

I still find it something of a puzzle as to why the UK government was so keen to allow further embryonic stem cell research, and just who was lobbying for this change in the law, given that just two scientists at the time were interested in such research and little private money is being invested in this area.

Rather than embryonic stem cell research per se, I think the change of the law has more to do with the UK governemnt, and Prime Minister Tony Blair in particular, wanting to send a message to industry and investors that Britain is a place to do genetic research, to send a message to ‘big pharma’: we support you, especially when the public feeling against GM crops has been so strong. (The UK goverment finally gave permission in the last year for some GM crops to be grown, but the main company has said it’s not worth it doing so.)

Since then, the UK has gone on to establish the first bio-bank of embryonic stem cell lines, and clearly wants to be regarded as a legal leader in this field.

Embryo selection via PGD

The HFEA has a policy of allowing Pre-implantation Genetic Diagnosis (PGD), but under certain conditions. These conditions are being challenged in two areas: sex selection and tissue typing.

Sex Selection

The HFEA currently regulates all fertility procedures in the UK involving frozen or stored sperm or embryos, not fresh sperm. It has no authority over sperm sorting, therefore, (which is used to try and predetermine the sex of a child).

At the request of the Department of Health, and paid for by the Department of Health, the HFEA carried out a year-long consultation into sex selection. In November 2003, its resulting report recommended that that the government give it the power to regulate the use of sperm sorting for sex selection, that is, it suggested that clinics offering sperm sorting should be licensed by the HFEA.

It recommended that PGD should be used to select the sex of an IVF embryo only when an embryo is at risk of a serious sex-linked disorder, which is its current poilcy and practice.

The HFEA report said that 80% of public were against sex selection.

(Under the current 1967 Abortion Act, it would be illegal to have an abortion because of the sex of the child. Thus although hospitals and clinics use ultrasound routinely, some clinics refuse to tell prospective parents the sex of the child.)

Many people were surprised at this HFEA report, because there has developed a feeling in Britain that governemnt and government bodies will do anything to allow anything in this area. Public confidence in the HFEA’s ability to regulate is not guaranteed.

This may explain why the Authority is being so ‘responsible’ in its decision about using PGD in other cases involving ‘saviour siblings’. Two cases illustrate this.

The Hashmi family asked permission to test and select an IVF embryo, so that the resulting child could serve as a tissue donor for their son, Zain, who has thalassemia. The HFEA gave permission.

The Whitaker family asked permission to test and select an IVF embryo, so that the resulting child could serve as a tissue donor for their son, Jaimie, who has a life-threatening condition. The HFEA refused permission.

In the first case, the PGD was allowed on the grounds that the second child itself might have thalassemia and the tissue type selection posed no extra risk to the embryo.

In the second, the PGD was not allowed because there was no known risk to the second child: the condition of the existing child, Jaimie, was not genetic.

The HFEA was presented with another similar case in April 2004 and has yet to rule. Joe and Julie Fletcher want to have IVF, PGD and then tissue typing so as to have a child who will be a matched tissue donor for their son, Joshua, who suffers from Diamond Blackfan anaemia (DBA). It’s not possible to perform a genetic test for this version of the condition. The request for PGD is not for the purpose of ensuring that the child is free from the anemia, but solely to ensure that it can be a tissue donor to Joshua. The current HFEA policy will not permit such a use of PGD because it is being performed not for the benefit of the child who will be born, but for the benefit of an existing child, the prospective tissue donor recipient. The Fletchers’ doctor has indicated that he will take the HFEA to court if the request is turned down.

According to the legislation, in making its decisions, the HFEA has to consider the medical benefit, risk, and the welfare of the resulting IVF child – not any other child. As Dave King of Human Genetics Alert, a UK watchdog group, argues, “only benefit, risk and welfare considerations, taken on a strictly individual case by case basis, are legally defensible”.

The general feeling is that, in order not to lose its credibility, the HFEA is sticking to the letter of the law and not allowing certain practices. It might also be the case that publicity is being deliberated sought and generated in order to create further pressure to amend the legislation.

Dave King argues:

“what we need is legislation that goes beyond the regulation of infertility treatments and embryology and provides a comprehensive framework for dealing with scientific and technological developments in the field of genetics and reproduction . . . We need a Genetics and Reproductive Technologies Act, not a Human Fertilisation and Embryology Act.”

Given concerted pressure to change the law, to change regulation, the questions arais again: In whose benefit? In whose interest? With what long-term direction?

It’s Never Over.

1) Peter Drahos, Information Feudalism: Who Owns The Knowledge Economy? Earthscan London, 2002.

The agreement was on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and is administered by the World Trade Organisation (WTO)