Select Committee on Science and Technology Fifth Report

5  Operation of the HFEA

193. The recommendations and conclusions in the previous Chapter require a new role for the regulator when the legislation is revised. This Chapter provides further guidance on the role of the regulator, but some of the recommendations are relevant to the HFEA as presently constituted, reflecting the fact that it is likely to be at three years before new legislation can be implemented.

Nature of the HFEA

194. The HFEA is a non-departmental public body under the Department of Health. However, the Department classifies it as a body at arm's length to Government and while Ministers over see the performance of the organisation, they do not intervene in the policy decisions made by the HFEA. The Authority is funded in part by grant in aid and by licence fees. In 2003-04 fee income was around £3.5 million and grant in aid was around £4 million. According to its 2003-04 annual report, the Authority is supported by 91 employees, working out of central London offices.

Composition of the HFEA

195. Membership of the Authority is set out in Schedule 1 of the HFE Act, which states that all the members of the Authority (including the chairman and deputy chairman who shall be appointed as such) shall be appointed by the Secretary of State. This is now undertaken in accordance with the guidance from the Commissioner for Public Appointments (the 'Nolan' Guidelines). The Act sets out several criteria for membership. First, the Chair or the Deputy Chair must be lay members, i.e. they cannot be someone who is, or has been, a medical practitioner; someone who is, or has been, concerned with keeping or using gametes or embryos outside the body; or someone who is, or has been, directly concerned with commissioning or funding any research involving such keeping or use, or who has actively participated in any decision to do so. There must be a lay majority on the Authority but no more than two thirds and there must be at least one medical practitioner and at least one with experience of assisted reproduction. The number of members is not specified in the Act but in practice there have been around 20 and at present there are 17. The composition and status of members (as of January 2005) is shown in Table 8.Table 8: Current membership of the HFEA.

Member	Category	Expertise	Date app. Started
Suzi Leather	Chair (Lay)		06.03.02
Hossam Ibrahim (Sam) Abdalla	Professional	Clinical	01.10.04
Tom Baldwin	Lay	Philosophy	26.02.01
David Barlow	Professional	Clinical	10.12.97
Chris Barratt	Professional	Embryologist	15.01.02
Ivor Brecker	Lay	Management & Dentistry	09.05.01
Clare Brown	Lay	Patient Experience	02.12.02
Iain Cameron	Professional	Clinical	26.02.01
Neva Haites	Professional	Geneticist	02.12.02
Richard D Harries	Lay	Bishop of Oxford	07.11.03
Jennifer Hunt	Professional	Clinical	07.11.03
Emily Jackson	Lay	Law	12.06.03
Maybeth Jamieson	Professional	Embryologist	02.12.02
Simon Jenkins	Lay	Media	10.05.01
Walter Merricks	Lay	Patient Experience, Law & Finance	02.12.02
Sara Nathan	Lay	Media	07.11.98
Sharmila Nebhrajani	Lay	Management, Accounting & Media Scientist	02.04.98

EXPERTISE

196. We have heard two principal concerns about the membership of the Authority. The first is that it lacks sufficient expertise. While the lay membership may have considerable expertise in genetics, bioethics and medical law and comprise non-medically trained health care professionals, the Authority will have between six and nine professional members (currently seven). This imposes severe constraints on the range of expertise available. We are aware for example that for much of the HFEA's life there was no clinical embryologist member, which is remarkable given that these are the individuals who are handling and manipulating the embryos. It also means that it is likely that there will only be one individual with first hand experience of PGD (since the HFEA website lists only eight licensed centres), which is one of the most contentious areas that the Authority handles. Given that not all members can attend all Authority meetings, it is likely that no spectrum of scientific and clinical opinion will be present and possible that policy decisions are made without any genuine expert opinion at all. Generally, attendance by Authority members is good, which reflects well on the commitment they have to the work of the HFEA. For the 20 meetings between September 2002 and July 2004, the average attendance approached 15 and on only three occasions went as low as 10. We should not be surprised at the lack of expert membership since the lay majority was seen as important by the Warnock Committee. It recognised that the regulating body would need access to scientific and medical expertise and that there should "significant" representation from these areas. However, it made clear that the body "is not exclusively, or even primarily, a medical or scientific body. It is concerned essentially with broader matters and the protection of the public interest". It recommended that there should be "substantial" lay membership and that the chair should be a lay member.[248]

197. The Department of Health considers the HFEA "to have the appropriate expertise and balance of membership to deal with the complex ethical, legal, scientific and technological issues it faces", placing it in a very small minority.[249] The Royal College of Obstetricians and Gynaecologists (RCOG) believes that "the body regulating this area should have sufficient expertise in its make up to tackle some of the difficult clinical, scientific and ethical issues presented to it".[250] The RCOG says the expert component of the Authority has been reduced in recent years and would like to see professional bodies formally represented. The strains on members to get to grips with technical issues was made clear by the academic lawyer, Emily Jackson. Quoted in the April 2004 edition of HFEA Update, the organisation's newsletter, she says "It can […] be difficult for non-scientific members to get to grips with some of the technical questions that arise in the licensing process."

198. Comment on Reproductive Ethics (CORE) agrees that the HFEA lacks both the scientific background and organisational structure to become involved in the complex issues of embryonic stem cell research and the authority, expertise and sufficient neutrality to make important ethical decisions in relationship to fertility treatment or stem cell research.[251] It also contends that the HFEA is dominated by those with an involvement or vested interest in IVF. We share the widespread concerns about the extent of the scientific and clinical expertise of Authority members, but recognise that the principle of the lay majority is important and should not easily be discarded. We believe that ultimate authority on issues of public concern should lie outside of the scientific and medical communities. At the same time, it is important that any decisions are informed by the science and medicine.

199. The HFEA has a Scientific and Clinical Advances Group, which currently has 10 members. The group is appointed by the Chair from the Members of the Authority and consists of not less than five members, including a proportion of lay members. Non-Authority members may be co-opted on to the committee, subject to ratification by the Authority but these must always be in a minority.[252] The group can meet up to six times a year and its principal functions are to keep under review scientific and clinical developments affecting activities in which the Authority has an interest and to make recommendations about such developments to inform the Authority's discussions and policy formulation. The presence of lay members on SCAG is curious since it has no powers and lay input can easily be made at Authority level. We shall consider the HFEA's use of evidence in support of its policies in paragraphs 266-278. Suffice to say, at this point, that the HFEA's announcement of an international Horizon Scanning Expert Panel in December 2004 to provide an assessment of upcoming scientific and technical developments rather suggests that SCAG was not well equipped to fulfil its duties.

200. These problems in the composition of the HFEA stem from the fact that the HFE Act sought to combine expert and lay representation on the Authority. It is clear that the Warnock Committee intended lay members to be the ultimate authority, in which case we suggest that the Committee's aims would be better served by an Authority comprised exclusively of lay members but which was informed by a properly constituted advisory committee that fully reflected the range of scientific and medical views and expertise. It is also possible that professional bodies could be given formal observer status, as the Department of Health is on the Authority (and on various HFEA committees) and the Human Genetics Commission is on the HFEA's Ethics and Law Committee.

Licence committees

201. Licence committees are made up of six members drawn from the Authority. Thus the danger that relevant expertise is not present to inform a decision is even higher, particularly since anyone on the Authority who worked in a field that was the subject of a licence would be unable to take part in the deliberations. In the past, the workings and membership of licence committees have been shrouded in mystery. However, the HFEA published minutes of the research licence committee relating to its decision to award the Roslin Institute a licence to conduct therapeutic cloning.[253] This meeting makes an interesting case study. Of the six members on the committee - Emily Jackson, Ivor Brecker, Maybeth Jamieson, Neva Haites, David Barlow and Sara Nathan - only the first three attended. They had plenty of company, however, with Sam Abdalla (an Authority member and Clinical Adviser), Trish Davies, Director of Regulation, Frances Clift, Legal Adviser, Ross Thacker, Research Officer, and Claudia Lally, Secretary to the Committee, also in attendance.[254] We appreciate that this licence application was unusual for a number of reasons but we a struck by the number of non-members present at the licence committee meeting needed to help it reach an opinion.

REPRESENTATION

202. A second but related issue is the extent to which the HFEA should somehow be representative of society, and in particularly in respect of the limitations placed on membership by the Department of Health. CORE told us that "Nobody from a pro-life perspective who has applied to join the HFEA over the last thirteen years has even been called for interview. The job description for membership openly stipulates that those who apply must subscribe to the objectives of the HFEA".[255] The Minister insisted that the Authority represented a "very diverse set of backgrounds representing all the ethical, scientific, patient, lay, as well as professional issues that you might want to see" except anyone who is "fundamentally opposed basically to the work the HFEA is doing". However, she maintained that "I do not think anybody is not allowed to be on the body".[256] The HFEA's Chair is more hostile to the idea: "I think that you must subscribe to the acceptability of IVF and the acceptability of embryo research. I do not think that you could sit on the Authority and exercise the kind of decision-making that we have to do if you were fundamentally opposed to the activities that we regulate. To me, that would be a nonsense. It would be extremely difficult to make decisions".[257] It is curious that the Chair of the HFEA said that appointments have "historically been a matter for ministers" as the Minister maintained that she did not get involved in the "detailed handling arrangements".[258] The Department told us that future appointment exercises will be conducted by the NHS Appointments Commission, with input from the Chair of the HFEA but that the final decision on the appointment of members will remain with the Secretary of State.[259]

203. We are unable to find anything that actively excludes those who have a principled opposition to assisted reproduction in the literature produced by the Department of Health in 2003 but evidence provided by the Department demonstrates that Authority members were sought with well-defined areas of expertise and experience. In 2002 the Department advertised for members in the following areas:

a)  Clinical genetics

b)  Embryology

c)  The ability to represent the wider patient experience

d)  Finance, accountancy and resource management

204. In 2003, members were sought in these areas:

a)  Legal

b)  Medical practitioner with expertise in assisted conception treatment (involving in-vitro fertilisation and donor insemination);

c)  Religious/faith ministry or theology;

d)  Infertility counselling.

205. We requested information from the Department of Health on how many applications to join the Authority had been turned down because the individuals had a principled opposition to assisted reproduction. The answer, for 2002 and 2003, is, we learn, zero. However, if we assume that no-one with such views is likely to be employed in assisted conception services, the number of categories for which someone opposed to assisted reproduction could apply is limited. It is interesting to note that for each of the eight vacancies advertised since 2002, there were around 30 applicants.[260] Even if certain views are not excluded, as such, the odds are very stacked against a successful application. Given that the HFEA's Chair will in future provide input to the appointments process, these odds have lengthened still further.

206. Perhaps it is worth considering whether the Department should explicitly seek members with a principled opposition to assisted reproduction. On one hand this could create problems. The Authority is charged with regulating assisted reproduction and embryo research within the limits set out in legislation. As the HFEA's chair pointed out, it is hard to see how someone with such views could contribute to discussions on a licence committee to consider, for example, an application to derive stem cells from an embryo.[261] On the other hand, campaigners such as Josephine Quintavalle have made a valuable contribution to various debates and it could be argued that her application for judicial review in relation to preimplantation tissue typing is a valuable public service.

207. An important distinction must be drawn between encouraging applications from individuals with certain views and any attempt to make the Authority representative. The Christian Medical Fellowship complains that "The composition of the HFEA does not accurately reflect the range of ethical views held by scientists, ethicists and faith communities in the UK".[262] It is hard to see how any appointment process could achieve this is in practice. As Professor Neil McClure from Queen's University, Belfast put it, "I do not have a problem with a pro-life representation but there are so many different facets of society - religion, colour, pro-life, pro-abortion, the whole range - which small groups that make up society are you going to have representation from?".[263] We have sympathy with the view that those with principled opposition to assisted reproduction should be represented have been unreasonably excluded from a place at the principal forum for debates on assisted reproduction and embryo research. It cannot, however, be a simple matter of reworking the job description for Authority members, since the presence of those opposed to assisted reproduction and embryo research would change the very nature of the organisation. The representation of views needs to be considered as part of a thorough assessment of the regulatory and advisory structures operating in this field. The composition of the regulator must either be substantially reformed or mechanisms found to improve the range and quality of advice it receives.

Remit of the Authority

REGULATORY AND ADVISORY ROLES

208. The Authority has two principal functions: as a regulator and an advisory body. Section 8 of the HFE Act sets out the HFEA's role as an advisory body, charging it to "keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act, and advise the Secretary of State, if he asks it to do so, about those matters". This is quite distinct from its regulatory functions and this dual role is problematic. In short, while the regulatory role obliges it to work within the Act and discharge its duties accordingly, the advisory function challenges it to find fault with the legislation on behalf of the Government. We have heard concerns that these roles are incompatible and the All-Party Parliamentary Pro-Life Group argues that the regulatory and advisory role of the HFEA should be split, with the advisory role assumed by a national bioethics committee.[264] The problem is best illustrated by considering incidences where the Authority, either corporately or individually, has made statements that are at odds with the HFE Act. On an individual level, we have sympathised with the view that it would be inappropriate to appoint individuals to the Authority whose views are at odds with the principal aim of the HFE Act which was to allow assisted reproduction and embryo research to take place in a carefully regulated environment. Less clear cut is when an Authority member has a strong view that a particular element of the HFE Act should be amended or deleted.

209. Section 8a of the HFE Act states that the HFEA should "keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act, and advise the Secretary of State, if he asks it to do so, about those matters". In general advice given to ministers would be considered confidential and thus we cannot know how the HFEA has performed this function and in what circumstances. An obvious situation would be when the Authority feels that changes to legislation would be desirable. An early example in the life of the HFEA might have been in relation to the restrictions on confidentiality provided in the HFE Act, which, it became quickly apparent, were unworkable (see Table 2).

210. At the beginning of this inquiry, the HFEA provided us with a list of elements in the HFE Act which required attention. This has been very useful to this Inquiry. Chief Executive Angela McNab told us that there had been discussions about how the HFE Act needed looking at since she had been appointed nearly two years earlier. A recent example of advice to Government, concerning sex selection, is more open to scrutiny since it was commissioned by the Department of Health, came in the form of a published report and followed a public consultation.[265] We discuss its findings in paragraphs 362.

211. The HFEA's consultation document on the welfare of the child provision, Tomorrow's Children, recognises that in seeking the views of the public and professionals its questions must address the "how" rather than the "if".[266] Despite this, the HFEA's Chair Suzi Leather told us that "The Authority believes that the welfare of children is a sensible, central principle in the Act" but that has not prevented her from criticising the Act.[267] She told the BBC in January 2004 that "It is absolutely clear if you think about the changes in society and the different ways that families can be constituted that it is anachronistic for the law to include the statement about a child's need for a father[…]It seems to me a bit of nonsense to have that still in the legislation.".[268] She confirmed this in evidence in stating "My personal position is that children flourish best within a stable relationship between two people".[269]

212. The LCF has drawn our attention to Suzi Leather's introduction to the HFEA's Annual Report for 2002-03 in which she says "We must continue to be a watchdog for patients, a guardian of Parliament's intentions, a supporter of good clinical practice, a protector of disciplined and lawful research and above all a protector of the interests of all those whose births we have celebrated in this special year.".[270] The LCF points out that "It is not the Authority's role to be a guardian of Parliament's intentions. That is the constitutional role of our courts of law and, in certain circumstances, Parliament itself. The Authority's role, as a public body created by statute, is simply to perform Parliament's intentions as set out in the 1990 Act.".[271] The LCF may be guilty of an overly literal reading of Ms Leather's comments but the HFEA still needs to establish whether it can be a guardian of Parliament's intentions at the same time that it is seeking to promote legislation that is at odds with Parliament's intentions, even if she disagrees with those intentions.

213. Perhaps less contentious was Ms Leather's condemnation of reproductive cloning during her address to the HFEA Annual Conference on 21 January 2004. She commented on newspaper reports at the time in which Dr Pavos Zavos indicated that he had cloned a human baby: "I would urge the governments of all countries where people intent on reproductive cloning may seek to work, and professional clinical bodies worldwide vehemently to oppose the unethical ambitions of Dr Zavos". It is worth remembering that before Bruno Quintavalle made an initially successful application for judicial review on whether embryos created by cell nuclear replacement were covered under the HFE Act, it was Government's intention that the HFEA regulate - not ban - cloning. Ms Leather should not issue sweeping condemnations and recognise that, however, unlikely or inappropriate it may seem to her, Parliament might wish to keep a more open mind on this issue, which would place her in a difficult position.

214. The day before Emily Jackson joined the HFEA, she published an article in which she said "The welfare of children who do not yet exist is, in simple and crude terms, none of the law's business".[272] Professor Jackson told us that the article did not say that; it simply pointed out that the provision was "problematic" and "ambiguously worded" and recommended that we read the whole article. Her views were not incompatible with the legislation, she said.[273] We did re-read the whole article and found it most stimulating, and we agreed with most of what she said. However, the statement "the principle is an unjust and irrational barrier for people who need assistance in order to have children , and that it should be removed from the statute" is quite clearly incompatible with the HFE Act. We are disappointed that she chose to deny what she had written. We were not attempting to trip her up but explore to what extent Authority members should agree with the wording of the HFE Act, and why some contrary views appear in practice to be excluded, while manifestly others are not. Many of our witnesses have expressed similar sentiments on this issue, including the Royal College of Obstetricians and Gynaecologists. However, they do not have a legal obligation set out in Section 13 of the HFEA Act, to make decisions that "take account of" the welfare of the child.

215. In paragraphs 147-161, we discussed the issues surrounding the Government's decision to introduce Regulations removing the donor anonymity provisions set out in Section 31(4). It has been suggested to us in confidence that certain members sought to join the HFEA with the primary intention of pushing through this change. This would be a highly regrettable situation. We do not expect Authority members to join with completely open minds. For a daily payment of £169, we would expect the job to appeal only to those with a passionate interest in the subject; nevertheless we would consider it inappropriate to use the Authority as a lobbying platform.

216. There are further concerns is that the HFEA has been campaigning, corporately, for changes in legislation.[274] We are concerned that the HFEA has crossed the boundary from regulation to advocacy in its treatment of gamete donation. Its consultation on the Regulation of Donor-Assisted Conception published in November 2004 states that "As the regulator of donor-assisted conception, it is not the HFEA's function to promote or encourage donation or treatment".[275] However, the HFEA's corporate memory is failing it. In 1998, its Consultation on the Withdrawal of Payment to Donors states that it was the HFEA's intention that "payments to donors should be phased out in such a way as to minimise any adverse effects, particularly any reduction in the supply of sperm donors". As a result it set up a working group to consider ways of maintaining sperm supply and increasing egg supply.[276] More recently, in response to the Department of Health's consultation on donor anonymity, the HFEA stated that is has "been keen to encourage a culture of altruism with respect to donation[…] [and] that the withdrawal of payments to donors may negatively impact on the supply of donors," which implies that donation is a "good thing".[277] We have heard that membership of the HFEA has so far been reserved for proponents of assisted reproduction and embryo research. It is therefore not surprising that its individual members would wish to see greater availability of licensable activities. Nevertheless, by promoting gamete donation in its corporate publications it has acted outside its statutory remit and crossed a boundary that risks compromising public trust.

217. We appreciate that the HFEA might feel it is in a no-win situation. It is damned if it does not consider the legal implications of its regulation and damned if it suggests how these problems should be resolved. The HFEA's Chief Executive Angela McNab told us that "I think it is appropriate that the HFEA can draw to people's attention where there may be inconsistencies or where there may be a need for society and Parliament to review certain areas".[278] It is reasonable for the Authority to draw attention to problematic areas in legislation, indeed it would be negligent if it were not to do so, but there is a clear distinction between drawing attention to problems and inconsistencies and espousing solutions.

STATUTORY BOUNDARIES

218. There is concern that the HFEA has exceeded its remit and is, in the words of the Christian Medical Fellowship, "altering statutory boundaries".[279] The Lawyers' Christian Fellowship (LCF) has made a number of allegations, arguing that "the HFEA misunderstands its functions, purports to perform functions that are not within the 1990 Act, and indicates that it would like to extend its jurisdiction even further." The LCF draws our attention to the HFEA's core functions. It argues that "There is no statutory basis for saying that developing policy is a 'core function' of the Authority. Its core functions are set out in Section 8 of the Act. The word 'policy' does not appear there or anywhere else in the 1990 Act.".[280] The LCF is correct that the HFE Act did not define any policy-making role, but it is difficult to understand how it could discharge its functions without making policy. We have heard criticisms that there has been inconsistency in the decisions by HFEA licence committees.[281] We have also heard about the length of time required for the approval of licence applications, particularly for research.[282] The removal of the HFEA's policy function would mean that licence committees would be operating in a vacuum, forced to make decisions from first principles. This would be a lengthy process liable to result in different conclusions for similar cases. The HFE Act also demands that the HFEA provide advice to the Secretary of State on request. Once again it is difficult to see how this duty could be discharged without a reasoned discussion by the Authority based on a strong body of evidence leading to an agreed view, a process otherwise known as policy-making. The LCF further suggests that "The wording of the 1990 Act should be clarified so that there can be no doubts as to the functions to be performed. This is not to say that the wording of the 1990 Act should be extended to cover the functions that the Authority currently purports to perform.". It argues that "The statutory functions of the Authority should be separated out and performed by separate independent bodies".[283] We conclude that the HFEA could not have discharged its statutory duty without developing a policy-making function; nevertheless, any revised legislation should more clearly define the presence or absence of a policy-making role for the regulator.

219. The LCF also criticises the HFEA for publicising its own role. Section 8(b) says the HFEA should "publicise the services provided to the public by the Authority or provided in pursuance of licences". It says that there is a distinction between publicising its functions and itself. This seems a minor point and it should only concern us if in publicising itself it incurs significant sums of public money. The Authority has also issued press releases "welcoming" court decisions that support its interpretation of the law and scientific developments in therapeutic cloning.[284] The HFEA has to interpret the law as best it can but it should not be a matter of public celebration if the court's view coincides with its own legal advice.

220. In its leaflet Embryo Research the HFEA states that it "encourages research while ensuring that it is carried out responsibly and for good reason.". The LCF argues that the HFEA has no duty to encourage research. Section 8(a) of the HFE Act states that the HFEA shall "keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act". According to the LCF, "if anything, the function of the Authority is to act as a check on research rather than to encourage research in this area".[285] One might argue that the HFE Act says nothing about acting as a check either. The HFEA's function is to establish that the research applications it receives fall into one of the eight purposes for research currently allowable under the Act. HFEA Chief Executive Angela McNab told us that it was "appropriate in our regulation of research that we are not obstructive".[286] The Christian Medical Fellowship is resigned to the fact that it is "inevitable that scientific experts on the HFEA will be enthusiasts for new research and development" but Ms McNab should recognise that lack of obstruction is not the same as encouragement.[287] The HFEA must be aware that many individuals and organisations will pore over its statements for evidence of misdeeds. It is unfortunate that it has provided so much ammunition to its critics. As the Science and Technology Committee, we are pleased that the HFEA sees the value of scientific research; however, we accept that it is not its role to encourage licensable embryo research, merely to consider whether applications that it receives conform to the wishes of Parliament.

POLICY-MAKING AND THE CODE OF PRACTICE

221. Policy decisions are communicated through three principal mechanisms. The first of these, and the most important, is the Code of Practice. The Authority is required by Sections 25 and 26 of the HFE Act to produce a Code of Practice. The Act states "The Authority shall maintain a code of practice giving guidance about the proper conduct of activities carried on in pursuance of a licence under this Act and the proper discharge of the functions of the person responsible and other persons to whom the licence applies.".[288] The HFEA is obliged to consult "such persons as the Secretary of State may require it to consult and such other persons (if any) as it considers appropriate" on the contents of the CoP and the Authority must seek approval from the Secretary of State.[289] While the CoP is not legally binding in theory, a licence committee is entitled to refuse a licence if the CoP is not observed. The most recent edition, the sixth, is over three times the length of the first (see Table 9). We recognise that the HFEA has attempted to produce more "helpful" documents with the HFE Act republished at the relevant points. It is also true that PGD was not covered in the first edition. Nevertheless, the HFEA should consider whether some of its "help" is either welcome or useful. Table 9: Date and length of editions of the HFEA's Code of Practice.

Edition	Date	Length in pages
First	1991	55
Second	1993	56
Third	1995	74
Fourth	1998	76
Fifth	2001	73
Sixth	2004	169

222. The Authority meets monthly and each meeting will generally make policy decisions. Table 10 gives some recent examples. In many cases, these follow consultation exercises or internal reviews.Table 10: Examples of significant policy decisions made during Authority meetings.

Meeting	Policy decisions
November 2003	Egg giving should no longer be permitted.[290]
May 2004	Storage vessels for gametes and embryos (dewars) should be alarmed and samples should be split for those patients whose fertility may be impaired by medical treatment.
July 2004	Preimplantation tissue typing should no longer be confined to cases where the child to be born is at risk of an hereditary genetic disease.

223. The HFEA communicates with licensed centres by letters from either the Chair or the Chief Executive. In general the Chief Executive's letters provide guidance rather than updates on policy (see Table 11). There are exceptions. In August 1999, the then Chief Executive wrote to centres on interim licensing guidance for PGD and guidelines for the licensing of embryo biopsy practitioners.[291] This was highly significant in that this placed restrictions on which clinics could undertake PGD. Table 11: Chief Executive's letters.

Date	Reference	Title
05-08-2004	CE(04)07	Various developments
01-08-2004	CE(04)06	Historic Audit Project
05-07-2004	CE(04)05	Freedom of Information Act and Communications with the HFEA
27-05-2004	CE(04)02	Correcting HFEA Data and new Forms
23-04-2004	CE(04)01	Duties of the Person Responsible

224. Letters from the Chair (see Table 12) often contain updates to the CoP. There is a clear anomaly in terms of the requirements of the Act with regard to the CoP and "letters" from the HFEA. While in many cases the HFEA may well have consulted on a policy change before informing the centres, there is no requirement to have done so. Since it is likely that any policy change will be contained in the subsequent edition of the CoP, it is likely that in some cases the views of professionals will only have been considered after they have been obliged to conform with a policy change.Table 12: Examples of Chair's letters.

Date	Reference	Title
04-08-2004	CH(04)05	New Guidance on Preimplantation Tissue Typing
03-08-2004	CH(04)06	Changes in the process for the recognition of ICSI and Polar Body /Blastomere Biopsy Practitioners. Revised guidance on preimplantation testing.
15-06-2004	CH(04)04	HFEA Donor information forms
07-06-2004	CH(04)02	Revised Directions on Witnessing
07-06-2004	CH(04)03	Guidelines on the safety of equipment used to store cryopreserved gametes and embryos in Assisted Reproduction Laboratories
28-05-2004	CH(04)01b	Arms Length Review
09-01-2004	CH(04)01a	Revised HFEA Code of Practice (6th Edition)

225. This anomaly is not the fault of the HFEA and we were pleased to see that it suggests in its evidence that new legislation should enable a more flexible approach.[292] It is right and proper that the HFEA should seek to update the protocols set out in the Code of Practice, which is, in effect, a rule book for centres licensed under the Act. The HFEA has not so far employed the internet to its full potential and we believe that its policy decisions should be consolidated in a single document as far as possible and as quickly as possible into a single digital entity.

Inspection and licensing

226. Sections 16-22 of the HFE Act set out the processes by which licences are awarded and the inspection process. Inspections cover record keeping (section 13), conditions for the storage and disposal of licensed material (section 14), and the suitability of staff, equipment and working practices (section 17). Following the granting of a licence, the inspection at any particular centre is annual unless a licence committee '[…]considers an inspection in that year unnecessary' (sections 9 and 10). The HFEA's application of the licensing and inspection procedure are shown in Figure 1.Figure 1: The HFEA's inspection and licensing process.

INSPECTION

227. We have heard a number of concerns about the adequacy of the inspections. Criticisms of the inspection process fall into two categories: the first relates to the HFEA's practice and the second to more fundamental issues relating to the nature of the inspection and licensing set out in the legislation (see Box 8 for a description of the inspection process). In particular, we have heard stinging criticism from three centres about the HFEA's practice. Mohamed Taranissi of the Assisted Reproduction and Gynaecology Centre made a number of complaints.[293] These were:

a)  His clinic was unable to correct statistical errors contained in an inspectors' report.

b)  The HFEA had provided inaccurate information to the media about another clinic's claim that it had been the first in the UK to use aneuploidy screening of embryos.

c)  An inspection team had been advised to take covert photographs during an inspection in case the clinic amended patient records following receipt of a critical inspection report. The same team had been requested to send its report the HFEA's senior management. Normal practice is for a draft report to be prepared for the inspection team. A revised draft report is then sent to the clinic to correct inaccuracies. The report is then sent to the HFEA's licence committee.

228. The London Fertility Centre, under its director Professor Ian Craft, is concerned that "decisions are inconsistent between IVF centres for similar breaches and disproportionate criticism has been levelled at LFC".[294] Robert Winston, Professor of Fertility Studies at Imperial College London, describes the inspection process as "flawed", citing conflicts of interest among inspectors, and inconsistent reports.[295]

Box 8: HFEA inspections

HFEA inspections are normally carried out by a team which includes:

a)  A Senior HFEA Regulatory Manager - Chair

b)  An HFEA Regulatory Officer (who will write up the inspection)

c)  An HFEA Clinical Inspector

d)  An HFEA Scientific Inspector

e)  An HFEA Social and Ethical Inspector

Inspections can take up to two days depending on the size and type of the centre, although most only take one full day. On the visit the inspection team will normally be expected to cover:

a)  General consideration of the licence application

b)  Meetings and interviews with the senior members of staff at the centre

c)  A full tour of the centre to inspect premises and equipment

The inspection team will, after the visit, prepare a report on the centre for the HFEA Licence Committee considering the application.

229. Problems with the HFEA's inspection procedures have not escaped the Department of Health. The HFEA is sent an "end of year" letter from the relevant health minister. In July 2002, the then Parliamentary Secretary of State for Public Health Hazel Blears wrote to Suzi Leather, Chair of the HFEA, complaining that a complete overhaul of its regulation and inspection procedures was essential, but that despite a number of recommendations from a whole raft of reports these had not been implemented. Ms Blears wrote that this was "unacceptable". In September 2002 the Authority set up an independent steering group to look at how the HFEA could improve its work and services, under the chairmanship of Robert Nicholls, a former Chief Executive of Oxford Regional Health Trust. The steering group concluded that while stakeholders were supportive of the HFEA's functions, they were deeply critical of its working practices. On the inspection process, the group recognised that any professional inspection can create an atmosphere of tension and mistrust but that there seemed to be "a particularly high degree of antipathy to the HFEA's inspection arrangements" and that inspections were perceived to be "strong on administrative detail but inconsistent and ineffective in identifying below standard or unethical practice".[296]

230. The HFEA's inspection processes were dealt with in some detail by Professor Brian Toft's Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire (see Box 9). Professor Toft concluded that these adverse events were caused by a mixture of inadvertent human error and systems failure. These "vulnerabilities within that inspection system" included several problems with the inspection process, in particular the role of the HFEA executive and the training of inspectors.[297]

Box 9: Adverse events at The Leeds Teaching Hospitals NHS Trust.

Professor Brian Toft's Review Panel investigated four adverse events at The Leeds Teaching Hospitals NHS Trust. The first incident involved the incorrect identification of sperm samples, mixed race twins were born to a Caucasian couple. In this case Professor Toft concluded that it was impossible to say with certainty at what point in the process the misidentification of sperm had occurred. However, a number of weaknesses were found in the practices and protocols used in the embryology laboratory.

The second incident also involved the incorrect identification of sperm samples, but in this case the error was identified and the embryos were not used. In this case the embryologist concerned was at a loss to explain how the error might have occurred. However, there was a shortage of staff at the time and as a consequence the embryologist concerned had a very heavy workload.

A further adverse event led to a patient's eggs being compromised following the failure of the cryopreservation process. The embryologist stated that she had simply forgotten to check the level of the liquid nitrogen before starting the freezing process. In this case a number of potential vulnerabilities were identified in the centre's induction training process.

The final event led to the embryos of a couple being discarded without their consent occurred because the letter they sent to the centre authorising the continued cryostorage of their embryos had not been filed with their medical notes. Professor Toft found that this was the result of a combination of scattered document storage facilities, an uncoordinated archiving system for medical records plus staff shortages and pressure of work at the centre.

Source: The Toft Report, paras 16-21

231. The HFEA has been aware of criticisms that its inspections were excessively burdensome. In 1999, the HFEA took advantage of its discretion to reduce the frequency of inspection allowed in Section 9(8-9). It introduced a system involving a full inspection for all organisations making their first application for a licence, which if successful, resulted in the organisation being granted a one-year licence. After three years a licence committee would evaluate the centre's performance and grant a three year licence if this was satisfactory. In its evidence the HFEA describes a number of further attempts it has made to improve licensing (see Box 10). Dr Simon Fishel of the Park Hospital in Nottingham agreed that improvements had been made: "It has been speeded up. The HFEA has changed in its practice dramatically in recent years to the better and in terms of interaction with clinics. We have seen a real effort to improve its communication and its involvement in the processes that we are concerned about".[298]

232. When the Department published the Toft report in June 2004, the HFEA declared that it was already complying with 85% of his recommendations. However, Professor Toft advocated that "an external body should look at the recommendations of any inquiry and make sure they are implemented in full or at least an explanation is given as to why they have not been implemented in full".[299] The Department has told us that it alone will be monitoring progress.[300] This seems to be a casual approach to ensuring that such "vulnerabilities" in inspection process are eliminated.

Box 10: The HFEA's improved licensing processes.

§  Targets to improve the regulation of clinics. These concern response times for licence applications (3 months for treatment, 4 months for research applications), the conduct and planning of inspections and the follow-up of inspection reports.

§  A dedicated website for all licensed clinics, outlining HFEA procedures, spelling out our targets and keeping licence holders informed of our activities.

§  A new incident alert system as part of an overall safety agenda, which also includes a programme of unannounced inspections.

§  Training and expanding our inspection team, including nurse and counselling inspectors. We have also piloted gathering patient feedback during inspections, which we will roll out in the whole inspection programme.

§  A new clinics database. Together with the improved register it can now be used far more effectively to streamline inspection processes (focussing on identified cases and practices that represent an increased risk) and policy making. In addition, we will now use a far broader range and depth of data to provide more meaningful information for the new edition of our patient guide.

233. Poor practices are an obvious source of concern but criticisms of the underlying basis for inspections is potentially more damning. The British Fertility Society (BFS) considers the application of the regulations through the licensing and inspection process to be an overly bureaucratic, top heavy and time consuming process which does not address the key areas of medical concern. Inspection should be limited to trouble spots and applications for new licences with fewer inspections for the renewal of licences.[301] Dr Sue Avery of the Association of Clinical Embryologists is less complimentary: "There is no observation of practice; there is no time to take evidence that people are actually doing what they say they do and compared with […] other laboratory accreditation systems, the time that is spent looking at a practice is so small that it is really valueless".[302] It has been suggested that the current licensing system be replaced by a form of accreditation, which describes the processes that should take place rather than how they should be undertaken. This is the basis of ISO accreditation and tissue banking standards drawn up under the auspices of the British Fertility Society. Advocates of the role of the HFEA have argued that it has succeeded in maintaining public confidence in a highly contentious area. If this is the case, it is hard to see how this can be maintained if its inspection processes are attracting sustained criticism.

EU Tissue and Cells Directive

234. The EU Tissues and Cells Directive was adopted by the Council of Ministers on 2 March 2004 and published in the Official Journal of the European Union on 7 April 2004. The Directive introduces new legal requirements for all units involved in the donation, procurement, preservation, testing, processing, storage and distribution of gametes (but not embryos).

235. Although the Directive sets out the governing principles and the broad areas to be covered, it does not spell out the detailed regulatory requirements that tissue banks and assisted conception clinics will have to meet. These will be determined by an expert committee established by the European Commission and made up of Government representatives from the 25 Member States. A group of 9 Member States (including the UK) will meet initially to draft the requirements. This will be followed by a meeting of all 25 Member States in July and a stakeholder consultation, which ended on 1 October 2004. The Commission is currently finalising the requirements for the accreditation, designation, authorisation or licensing of tissue establishments. Among the most contentious issues are the required air quality standards. Member States are obliged to comply with its provisions no later than 7 April 2006. The Department of Health has decided to take up the option in the Directive that allows deferment (derogation) of its application for one year for those establishments already licensed by the HFEA at April 2004. The HFEA and the Human Tissue Authority have been named as the competent authorities, although the Government intends to merge these bodies (see paragraphs 376). As far as reproductive cells are concerned, the Directive will be transposed into UK legislation by an amendment to the HFE Act by way of regulations. The EU Tissue Directive will provide a welcome impetus to improve and maintain the technical standards in treatment centres. However, we urge the Government and the HFEA to ensure that the standards applied are appropriate and proportionate.

INSPECTORATE

236. The HFEA's inspectorate is made up of external specialist inspectors, who are typically individuals who work full time in some particular aspect of the work regulated by the HFEA. These fall into four categories and are listed in the Annual Report:

a)  Clinical inspectors (31 listed in 2003-04 Annual Report)

b)  Embryo biopsy inspectors (5 listed in 2003-04 Annual Report)

c)  Scientific inspectors (23 listed in 2003-04 Annual Report)

d)  Social and ethical inspectors. (15 listed in 2003-04 Annual Report)

e)  Others (2 listed in 2003-04 Annual Report)

The HFEA says that it in recruiting its own clinical inspector to carry out a proportion of inspections consistently and to monitor the performance of external inspectors.

237. At present, we understand that a site visit would generally take around four hours.[303] We have been told that it is "difficult to comprehend how, perhaps with limited time at their disposal, they are able to read and digest up to 1000 pages of information relating to a centre's activities, in some cases only a matter of a few days before the inspection is due to take place.". It is likely that the EU Tissue Directive will impose greater demands on inspection teams. Professor Neil McClure from Queen's University Belfast highlighted the problem of an increase in the length of inspections in that his university is unlikely to take kindly to paying him a salary to do someone else's work with no benefit to his employer.[304] Professor Robert Winston attributes some of the inconsistency in inspections to the large number of inspectors (76 in the 2003-04 Annual Report).[305] Suzi Leather told us that she envisaged that the HFEA will be moving shortly to an in-house professional inspectorate.[306] This will please Professor Winston, who reports that "for some years the HFEA has been urged to ensure that there is an established inspectorate, simply employed to do that job only".[307] We welcome the HFEA's decision to appoint an in-house professional inspectorate. However, it is important that these inspectors have the confidence of the assisted reproduction community and we recommend that its views are taken into account before appointments are made.

Comparison with animal procedures

238. A useful comparison can be made with the regulation of animal experimentation. Under the Animals (Scientific Procedures) Act 1986, a project licence shall not be granted for any programme unless the Secretary of State is satisfied that it is undertaken for one or more of the following purposes:

a)  the prevention (whether by the testing of any product or otherwise) or the diagnosis or treatment of disease, ill-health or abnormality, or their effects, in man, animals or plants;

b)  the assessment, detection, regulation or modification of physiological conditions in man, animals or plants;

c)  the protection of the natural environment in the interests of the health or welfare of man or animals;

d)  the advancement of knowledge in biological or behavioural sciences;

e)  education or training otherwise than in primary or secondary schools;

f)  forensic enquiries;

g)  the breeding of animals for experimental or other scientific use.[308]

The comparison of assisted reproduction with animal procedures is useful since regulation takes place in a changing environment, in this case due to the pressure to limit animal experimentation through the 3Rs (replacement, refinement and reduction). The inspection of facilities is undertaken by the Animals (Scientific Procedures) Inspectorate but there is a separate advisory body, the Animal Procedures Committee. The House of Lords Select Committee on Animals in Scientific Procedures considered the burden of regulation in 2002. The criticisms of the regulation it reported - that it is slow, bureaucratic and lacking accountability - sound eerily familiar. Key differences with the regulation of assisted reproduction and embryo research are that regulation is undertaken "in house" by the Home Office, that the inspectors are full time professionals and that the advisory body is distinct from the regulatory committee. While there is little demand that assisted reproduction should not have a distinct regulatory body, in other ways the framework is not dissimilar to the one we have recommended. It is worth noting that there have been criticisms that the inspectorate is too close to the people it is regulating and that it has been difficult to recruit inspectors. The Lords Committee also expressed concerns that the Animal Procedures Committee needed to be clearly separated from the Home Office regulators.[309] As with assisted reproduction, the costs of regulation are borne by those being regulated. The Home Office currently makes annual charges £252 for each establishment plus £226 per individual licence holder. An establishment may have up to 100 personal licence holders, thus a large establishment would have to pay in excess of £20,000 per year. There are significant structural differences between the regulation of assisted reproduction and animal procedures. With animal procedures, regulation is undertaken within a central Government department (rather than at arms length from Government) and is supported by an advisory committee (rather than an Authority supported by an executive, and has a professional inspectorate. While there are differences in the areas being regulated, is not clear to us that these justify the organisation differences that exist.

LICENSING

Licence committees

239. We have also heard concerns about the functioning of licence committees. One is that they are insufficiently open. It has been difficult to determine the membership, meeting times and agendas of licence committees. We accept that patient and commercial confidentiality may be at stake in some cases, but we urge the HFEA to publish as much as it can on its website without being asked. GeneWatch catalogued the problems it had had in extracting information about the therapeutic cloning application from Newcastle Fertility Centre, despite there being "no legal obstruction to the HFEA's licensing committee minutes or other relevant information being in the public domain". Genewatch was eventually supplied, several months after the application had been awarded, with a copy of the first cloning application together with peer reviewers' comments and the minutes of the licensing committee.[310] During this inquiry, the HFEA has made great efforts to distinguish between licensing decisions and policy decisions, particularly relating to preimplantation tissue typing. Its task would be easier if the functioning of its licence committees were not so opaque. It is unacceptable for the HFEA to attempt to withhold information relating to licence applications if it has no legal basis for doing so. Information relating to licence applications and licence committees should be made available on the internet as a matter of course.

240. In some contentious cases, the patient has sought to discuss their treatment with the committee but been refused. Jayson Whitaker, who sought a licence for preimplantation tissue typing, complained that "the HFEA, decided our case without coming to see us and without talking to us. They would not speak directly to us, it had to go through the clinic. Our clinic did a very good job of putting the application in for us but we did ask them whether we could bring our own specialist witnesses and whether we could apply ourselves and speak to them in person and if they could come and see our life for a day and then pass judgment, but instead they just relied on their rules and regulations.". […] they just carte blanche said, "No, it is not possible. You are not invited. It is not public.". [311] The Masterton family, who wished to use PGD to select a female embryo, had similar experience. Mr Masterton told us "I knew the PGD issue was a contentious issue. I asked whether I could represent our position at that lay member committee. I said I would be happy to come, present our position and leave after our case had been considered. I received a letter from HFEA about a week later saying that these decisions were made behind closed doors and there was no facility.".[312] There are good reasons why patients should not have direct access to the licence committee. It could be argued that the committee needs to make a dispassionate appraisal of the information before it yet many cases may have tragic circumstances that could have a significant emotional impact on the committee. The HFEA seems, however, to have had a change of heart. At its January 2005 meeting it agreed that "written representations would be accepted though all stages of the Licence Committee process and that patients could attend in person at the representation stage" if the initial application has failed. There may have been good reasons why licence committees were unable to hear directly from the patients, but cases must be dealt with sensitively and without needlessly erected bureaucratic walls. We are pleased that the HFEA has decided to adopt a more open policy in the future.

Research

241. In our short inquiry on Developments in Human Genetics and Embryology, which reported in July 2002, we heard criticisms from researchers about the way research licences were issued. Professor Austin Smith, a stem cell researcher at Edinburgh University, reported that the HFEA was "inefficient […] and lacking in specialist knowledge" and "a slow and reactive" body.[313] Dr Robin Lovell-Badge from the MRC's National Institute for Medical Research reported that researchers had found the HFEA frustrating to deal with and that there has been criticism from researchers regarding the time the HFEA takes to process licence applications.[314] In 2000-01 the HFEA had missed its targets for licence renewal (for both treatment and research) by some margin, especially for research licences. We concluded that "Britain is well placed to be a world leader in human genetics and embryology research and it is crucial that our scientists, in complying with regulatory requirements, are not hampered by bureaucracy". During this inquiry, Professor Robert Winston from Imperial College told us that approval from the HFEA was "time-consuming and laborious" and reported that "a leading British embryologist […] left the field simply because she found the HFEA and its overbearing approach on her research to be so invasive".[315] The Association of Medical Research Charities warns that "Licensing and inspection should not involve a heavy-handed approach, but should start with the assumption that scientists are applying to carry out such work for the public benefit and with integrity".[316]

242. Since our last report, the HFEA has set up a dedicated Research Licence Committee, and has recruited specialist research regulation staff, who have the appropriate level of experience and expertise. The new staff will be primarily dedicated to research regulation and will give this work priority at all times. This reflects criticism about the speed with which research licence applications are dealt with. The Better Regulation Task Force (BRTF) report on scientific research regulation recognised the need for regulation in this area of science, and highlighted the importance of demonstrating that HFEA licence decisions are independent and evidence-based.[317] We will discuss the process by which research applications are approved in our discussion on local research ethics committees in paragraphs 331-343. We welcome the efforts that the HFEA has made to improve its research licensing procedures and we hope that these prove effective. However, we believe that there needs to be a thorough analysis of the process by which research involving embryos is approved so that we do not lose sight of what the process is trying to achieve.

Preimplantation genetic diagnosis

243. In January 2005 the HFEA has announced a new policy to streamline the approval of applications for PGD. Under the new guidelines, if a clinic with proven expertise in performing embryo biopsies applies for a licence to carry out screening for a particular condition, which is already being carried out successfully in another clinic, the HFEA will approve the application without having to go through the full licence committee process, providing the same technique and methods are used. However, some applications will still be considered on a case-by-case basis:

a)   PGD/HLA tissue typing;

b)  PGD for late onset conditions;

c)  PGD for susceptibility genes.

Previously, centres had to submit an application to the HFEA for each new condition for which they wish to test and for each new test that they wished to use.[318] The Progress Educational Trust had criticised this process on the basis that licensing decisions could take six months and this might have a significant impact on the ability of older women to conceive.[319] The HFEA's streamlining of the licensing process for preimplantation genetic diagnosis will have been good news for clinics. However, it does undermine its Code of Practice since it effectively introduces an accepted list of conditions for which PGD is available. In this case, it would be preferable for the HFEA to publish a list of conditions for which PGD would be acceptable.

244. The regulation of preimplantation testing is highly unsatisfactory. We recognise that the HFEA has legal jurisdiction but this does not mean that it has a duty to regulate its use beyond ensuring that it is performed to the highest standards within statutory boundaries.

Preimplantation tissue typing

245. The HFEA first considered the issue following a public consultation on PGD, conducted by the then Advisory Committee on Genetic Testing (see Table 13). The Human Genetics Commission took over responsibility for this subject when it was formed in December 1999. A joint HFEA/HGC Working Party was established in late 2000 and its conclusions were published in November 2001.[320] Unfortunately, the consultation document had not sought responses on the preimplantation tissue typing issue but the Joint Working Group concluded that "there were sufficient ethical difficulties with this approach [where an embryo is selected to provide a tissue match for transplant to an existing family member] that it should be subject to further discussion before its use was considered".[321]

Table 13: Timeline of HFEA policy on preimplantation tissue typing.

1999	HFEA publishes interim policy on the licensing of PGD. Public consultation on PGD conducted together with the then Advisory Committee on Genetic Testing, which does not, however, directly address the question of preimplantation HLA typing
Aug 2000	Birth of Adam Nash in Colorado, the first baby to be born following PGD and HLA typing. Stem cells from Adam's umbilical cord were later used to treat his sister Molly, who was suffering from Fanconi Anaemia
Dec 2000	HFEA/HGC Joint Working Party established to take forward the findings of the 1999 HFEA/ACGT consultation on PGD and to make recommendations
Sept 2001	Application received from the Park Hospital, Nottingham, for PGD/HLA treatment for Mr and Mrs Hashmi whose son, Zain, was affected by â Thalassaemia major
June-Nov 2001	HFEA/HGC Joint Working Party agrees recommendations. They are adopted by both the HFEA and the HGC.
22 Nov 2001	Ethics Committee Opinion on selection of preimplantation embryos to produce tissue donors (after 3 previous discussions of the issue from November 2000 onwards). It recommends licensing of HLA typing both with and without PGD.
29 Nov 2001	HFEA agrees a relatively restrictive policy on HLA tissue typing, distinguishing between cases where PGD was necessary to avoid a disability in the future child - and cases where HLA was performed "on its own".
22 Feb 2002	HFEA Licence Committee agrees to issue licence to CARE Nottingham for the treatment of Mr and Mrs Hashmi.
12 July 2002	CORE granted permission to apply for judicial review (this permission was initially refused in May 2002)
29 July 2002	HFEA Licence Committee turns down application from ARGC for HLA tissue typing for Mr and Mrs Whittaker
20 Dec 2002	CORE application succeeds at first instance - HLA tissue typing held to be unlawful.
15 May 2003	HFEA issues revised guidance on preimplantation testing via Chair's Letter (03) 04. As the legality of HLA typing at the time is considered uncertain, the section relating to HLA typing is not included in this guidance. The new guidance on PGD moves away from an 'objective' list of conditions that would merit PGD and towards greater emphasis on the couple's and clinician's views and decision making. This guidance is incorporated into the 6th (and current) Code of Practice early in 2004.
16 May 2003	Court of Appeal overturns earlier High Court decision. It is within the powers of the HFEA to licence HLA tissue typing.
6 Nov 2003	Two further licenses granted to CARE Nottingham to provide HLA/typing with PGD for two couples with children affected by two inherited forms of Thalassaemia (Ms B and Mr A and Mr and Mrs L)
Feb-July 2004	HFEA conducts a review of its policy on HLA tissue typing. A new, extended policy is passed by the Authority on 21 July 2004, giving up the distinction between inherited and sporadic diseases.
4 Aug 2004	The new policy is communicated to clinics through Chair's Letter CH(04)05
6 Sept 2004	HFEA Licence Committee grants a licence to ARGC to provide HLA tissue typing for Mr and Mrs Fletcher whose son Joshua suffers from a sporadic form of Diamond Blackfan anaemia.
March 2005	CORE application on preimplantation tissue typing considered by House of Lords.

246. There are two strands evident in the development of the HFEA's policy and licensing decisions. (It should be noted that HFEA policy decisions are not necessarily informed by legal opinion and that licence committees are not bound by HFEA policy.) The first strand is the legal jurisdiction of the HFEA to license preimplantation tissue typing and the second is the HFEA's interpretation of the welfare of the child provision, which we discussed above in paragraphs 92-108. As we have stated, under the current Court of Appeal ruling, the HFEA can license PGD as means of identifying a "suitable" embryo for transfer. On 1 August 2001 the HFEA wrote to Mohamed Taranissi of the Assisted Reproduction and Gynaecology Centre, communicating its refusal to grant a licence to the Whitaker family. It gave two reasons. The first was that it was not consistent with the welfare of the child provision since (unlike in the case of the Hashmis) there was no risk of any of their embryos being born with the genetic disease in question. The second was that preimplantation tissue typing without PGD lay outside the terms of paragraph 1(1)d of Schedule 2 of the HFE Act, which states that the HFEA can issue treatment licences for "practices designed to secure that embryos are in a suitable condition to be placed in a woman or to determine whether embryos are suitable for that purpose" using the definition of treatment services in Section 2(1) which is "medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children". Mr Taranissi made this letter available to us.

247. HFEA licence committees are required to make their decisions in isolation from the rest of the Authority. The basis of this is that if there is an appeal against a decision a second licence committee may consider the application afresh. Also, licence committees cannot contain individuals with conflicts of interest and the Authority is likely to contain an individual with such conflict. In this case, for example, Professor Peter Braude, who is director of the biggest PGD programme in the country at Guy's and St Thomas' Hospital in London, was not able to sit on the licence committee.[322] This partially explains why, in questioning the HFEA on 21 July 2004, Angela McNab told us "My own recollection of the initial decision between the Hashmis and the Whitakers is that it was based on ethical and welfare of the child issues regarding the benefit to the embryo and the risks and benefits of the procedure itself, given that there might be no benefit to the embryo in one case and there would be in another case. It was not a legal issue.".[323] Since the HFEA's letter to Mr Taranissi cited legal grounds and the legal advice provided by the solicitors Morgan Cole to the licence committee, which was subsequently made available to us, argued strongly that the HFEA could not license PTT alone, Ms McNab's recollections were not accurate. Since the Authority was not privy to the licence committee's legal opinion, her error would be forgivable if the letter to Mr Taranissi had not been signed by Dr Chris O'Toole, who was sitting alongside Ms McNab when she made this statement.

248. Our inquiry has tried to focus on the legislative and regulatory needs of the future, yet its policy and licensing decisions on PTT have undermined our confidence in the HFEA's understanding and/or use of the law. It has equally raised concerns about decisions of such importance—even controversy—being taken in this forum and the outcome determined solely on the basis of a Code of Practice generated by that same body. Indeed, on 19 January 2005 Suzi Leather told us that the problems the HFEA had with PGD generally were partly attributable to the fact that it "does not appear on the face of the legislation".[324] She admitted that "I certainly think that some of the decisions we have made [e.g. pre­implantation genetic diagnosis and tissue-typing] must have seemed rather confusing for many people, with seeming contradictions".[325] While she professed herself "content with where we are now", she should not be content with the process by which the HFEA arrived at its decisions.[326] The criteria now employed, following its change of policy in July 2004, are published by the HFEA in a revision to its Code of Practice (see Table 14).Table 14: HFEA's decision-making criteria for the use of preimplantation tissue-typing.

The condition of the existing child	The possible consequences for the child to be born	The family circumstances
(i)  the degree of suffering associated with the condition of the affected child; (ii)  the speed of degeneration in progressive disorders; (iii)  the extent of any intellectual impairment; (iv)  the prognosis for the affected child in relation to all treatment options available; (v)  the availability of alternative sources of tissue for the treatment of the affected child, now and in the future; (vi)  the availability of effective therapy for the affected child, now and in the future;	(vii)  any risks associated with embryo biopsy for the child who may be born; (viii)  the likely long-term emotional and psychological implications for the child who may be born; (ix)  whether the treatment of the affected child is likely to require intrusive surgery for the child to be born (and whether this is likely to be repeated); (x)  any complications or predispositions for the child who may be born associated with the tissue type to be selected;	(xi)  the previous reproductive experience of those seeking treatment; (xii)  the view of the people seeking treatment and of the affected child of the condition of the affected child; (xiii)  the likelihood of a successful outcome, taking into account the reproductive circumstances of the patients[327] and the likely outcome of treatment for the affected child; (xiv)  the consequences of an unsuccessful outcome; (xv)  the demands of IVF/preimplantation testing treatment on the family whilst caring for an affected child; (xvi)  the extent of social support available; (xvii)  the family circumstances of the people seeking treatment.

249. It is instructive to dwell on some of the issues that weighed on the Authority when it drew up its policy in November 2001. We have commented on its use of the precautionary principle above.[328] As a members of the ethics committee, Professor Peter Braude counted himself as a likely dissenter from its recommendation to allow treatment such as that sought by the Whitakers and he reported the reaction of horror of geneticists as a conference in June 2000, at which Dr Yuri Verlinsky, director of the Reproductive Genetics Institute in Chicago, reported the successful birth of Adam Nash, the first to be born following PTT. Most revealing is his statement that "There were other members who were not persuaded by the concerns that the public might have over this".[329] This leaves us with the impression that while the Ethics Committee could deliberate in relative comfort, the Authority was more concerned with its write-up in the press than it was in coming to an informed and ethical judgement.

250. In our 2002 Report on Developments in Human Genetics and Embryology, we criticised the HFEA for not seeking recourse to Parliament, which, we argued, "does not need protecting and democracy is not served by unelected quangos taking decisions on behalf of Parliament".[330] We recognise that, faced with a licence application, the HFEA had little choice but to make a decision, but while it was clearly recognised that PGD raised important legal issues for the Authority in 1999, we have no reason to believe that any advice was given to the Secretary of State to that effect. The Christian Medical Fellowship argues that the HFEA "must be the servant of primary legislation making decisions only within its bounds".[331] Earlier in this Chapter, we accused the HFEA of pushing for legislative change. In this case, however, it has seemed content to rely on the courts' judgements rather than pre-empt any challenge. Suzi Leather has invited Parliament to clarify the law regarding PGD. It is unfortunate that her predecessor did not do so six years ago. The PTT story, as Suzi Leather pointed out, does not end here as the Hashmi licence decision went before the House of Lords in March 2005 and its decision is awaited.

251. We have no evidence that the use of preimplantation testing would be used for "trivial" reasons to a degree that would harm the children born as the result of these procedures. By invoking the welfare of the child provision in its decisions on preimplantation tissue typing, the HFEA has tied itself in ethical knots trying to reach policy and licensing conditions. We are not sure how this has served the interests of the public, the profession and, most important, the patients themselves. The development of the HFEA's policy and licensing decisions on preimplantation tissue typing has been highly unsatisfactory. We share the Chair's contentment with its current policy and agree that revised legislation must make it clear that preimplantation genetic diagnosis and preimplantation tissue typing can be undertaken within legal restraints .

Use of research

252. As one would expect of an organisation of its kind, the HFEA has a "commitment to evidence based policy making".[332] There are a number of issues that relate to the gathering and application of that evidence:

a)  What research, if any, it should conduct or commission;

b)  What data collection and analysis it should undertake of data generated by treatment centres;

c)  What its role should be in contributing to the research priorities of research funders;

d)  How it should apply research findings, published or otherwise, to its decision-making.

RESEARCH FUNCTION

253. The HFEA has no formal research function and does not "have the budget or the expertise to conduct high level academic research".[333] Indeed it was an expressed recommendation by the Warnock Committee that the Authority would not have such a function.[334] It has been suggested that this should change. The Christian Medical Fellowship would like to see the HFEA have the "power and funding to commission research into relevant medical and social issues of the techniques they regulate. Regulation is not enough - society needs information on the results, far broader than just the number of babies born".[335]

254. In considering the research that the HFEA conducts, it is worth drawing a distinction between scientific and social research, at least on cost grounds. A three-year grant awarded in October 2004 by the Biotechnology and Biological Sciences Research Council to Professor Peter Andrews from Sheffield University to work on human embryonic stem cells cost £208,000.[336] In contrast, the Economic and Social Research Council will fund grants from as little as £2,000 and considers anything over £45,000 to be a large grant.[337] Despite having no budget, the HFEA has engaged in a number of research projects. Many of these have been literature surveys but in 1993, they did commission academic social research into the attitudes of donors and treatment centres towards sperm donation. If the HFEA is to retain its current functions, it is important that it has access to the best relevant data to support its decision-making. While research is not defined as part of its remit as such, it should have the budget to fund small scale unlicensable academic studies.

255. We have recognised the limits of the HFEA's ability to commission research to support policy formation. Nevertheless, this need not prevent it playing a proactive role in influencing the research priorities of other funders. We are pleased to see that the HFEA has recognised the importance of this. It initiated the Medical Research Council working group on safety and assisted reproduction, which we discuss below, and supported an outline proposal from the National Perinatal Epidemiology Unit at Oxford to set up a National Assisted Reproductive Technology Research Centre.[338] We are pleased that it is "starting to establish sustained working relationships with both the ESRC and Wellcome Trust in order to increase the knowledge and evidence base for the HFEA's policy making function".[339] The MRC Working Group contained a social researcher but the report gave little attention to the social impacts of assisted reproduction, despite being cited frequently in HFEA policy documents. We recommend that the HFEA ask the Economic and Social Research Council to set up a working group to look specifically at the social impacts of and attitudes to assisted reproduction .

DATA COLLECTION AND ANALYSIS

256. Section 31 of the HFE Act outlines the requirement of the HFEA to keep a Register and what information it should contain. This includes:

a)  the provision of treatment services for any identifiable individual, or

b)   the keeping or use of the gametes of any identifiable individual or of an embryo taken from any identifiable woman,

c)  or if it shows that any identifiable individual was, or may have been, born in consequence of treatment services.[340]

257. In theory, this should be a valuable resource in identifying any risks associated with assisted reproduction but for a number of reasons it is unclear what use it has been in this respect. A significant concern has been that the confidentiality requirements set out in Section 33, which states that no member or employee of the authority can disclose the information contained on the register, are excessive and reflect concerns that those undergoing or born as a result of IVF might be stigmatised as the technology was "unnatural and secretive.[341] The result has been that the data are isolated from a person's medical record and clinical databases such as the cancer registry. The RCOG describes this as "counter to the spirit of good preventive medicine" and sees "no purpose in maintaining this information indefinitely, unless the register is put to useful purposes".[342]

258. While in theory a relaxation of the confidentiality provisions could allow the Register to be more useful for researchers, a more fundamental issue has been identified. Professor Richard Fleming from Glasgow Royal Infirmary contends that the data have little use: "If the database were intended to be a prospective research tool, then comprehensive training in information entry would have been an integrated part of the research design. This was not the case.".[343] He comments that any grant application in which the researchers had no control over the primary source evidence would be rejected.[344] According to the MRC Working Group, the HFEA acknowledges variations in standards of data collection and missing data.[345] Despite this, Professor Catherine Peckham, who chaired the Working Group described the register to the Committee as "an incredibly rich, quite unique database, [which] is not being maximised and used to address new questions which perhaps were not asked in the same way previously. But there is huge opportunity to build on and strengthen rather than say that what is done now is not good.".[346] In contrast Professor Fleming concludes that the Register could only be used for crude analysis and points out the major cost to his centre incurred in conforming with the HFE Act's requirements.[347] Alison Murdoch, Chair of the British Fertility Society, said that any "central collection of other clinical or laboratory data by the HFEA […] would inevitably be a 'fishing exercise' for the data that may be relevant in the future".[348] The confidentiality provisions in the HFE Act have hampered efforts to establish the risks associated with assisted reproduction. We conclude that they are unnecessarily onerous and inconsistent with the widespread use of assisted reproductive technologies. We recommend that the data from the HFEA's register should be applied as far as is possible to research studies.

259. The MRC Working Group considered the database as part of its work. It suggested two options for making the Register available for research:

a)  A change in the law to the HFE Act section 33 to relax restrictions on consented data release direct from the HFEA database to a research database.

b)  Consented disclosure of information by licensed clinics rather than by the HFEA to a research database. Section 33 allows data transfer from the HFEA back to the clinics and the restrictions on disclosure of information from the clinics are less tight.

260. The Working Group pointed out that as a regulatory body, the HFEA is thus not best placed to maintain a research database or perform long-term follow-up studies and suggests that an independent group take on this function. It does not question whether these data need to be collected routinely on a national basis.

261. A distinction needs to be made between the data that already exist and future data collection. In theory, the Register contains 14 years of data which, even if of dubious quality, should be subject to analysis. It is less clear that the data should be added to for research purposes, still less that this should be a statutory obligation. ACE argues that in any case clinics are required to carry out regular audit of outcomes and records may be made available to external audit if necessary.[349] It seems reasonable that legislation should demand that certain basic data are maintained by treatment centres, but the removal of confidentiality provisions for treatment that does not involve gamete or embryo donation would enable the necessary follow-up studies to be undertaken. As the British Fertility Society suggests, only normal clinical records and routine birth registration are required. It says it is desirable for health and safety reasons that we monitor these children through adulthood and into the second generation but that this can be achieved through the existing health monitoring procedures and does not need the HFEA register.[350]

262. Our discussion is predicated on the assumption that the stigma of infertility and IVF is largely a thing of the past. However, we have received evidence from researchers at De Montfort University that confidentiality is extremely important for people from some ethnic groups who may object to certain forms of fertility treatment. [351]

263. The confidentiality provisions in the HFE Act have hampered efforts to establish the risks associated with assisted reproduction. We conclude that they are unnecessarily onerous and inconsistent with the widespread use of assisted reproductive technologies. We recommend that the data from the HFEA's register should be applied as far as is possible to research studies. We have criticised the excessive use of the precautionary principle in assisted reproduction. However, we recognise that there are public concerns about possible adverse risks associated with assisted reproduction Treatment centres should, as a condition of their licence, maintain a database in a suitable form which is available for peer reviewed research projects. As result, there will be a justifiable burden on clinics.

264. Maintaining the Register has been a headache for the HFEA. As Angela McNab put it with impressive understatement "there have been some difficulties with the IT system or the register system itself", i.e. the database was found to be corrupted and much of the data lost.[352] The Authority has had to spend around £5 million to reconstitute the data as part of its Historical Audit Project, going back to data held by clinics, in order to fulfil its legal obligation to be able to respond to an inquiry in 2009 (when the first children to be born from HFEA-regulated services reach 18 years of age). The HFEA has also been unable to publish IVF data. While the value of the Register for research has been open to question, it should have been able to provide data on the uptake of IVF and donor insemination and success rates to inform policy development on assisted reproduction and its provision. However, in recent years these data have not been published, which is unfortunate. We consider it to be a fundamental role of a regulator to provide information about the industry it is regulating.

USE OF EVIDENCE

Safety of assisted reproduction

265. Since 1978, over 1 million children worldwide have been born via assisted reproduction and 1-3% of live births in the developed world are now the products of ART.[353] Despite this there have been concerns that the risks to the mother and children born through assisted reproduction are poorly understood. This prompted the HFEA to approach the Medical Research Council (MRC) to set up a working group with the following aims:

a)  To take account of current knowledge of ART and its possible health effects, identifying the gaps in the basic science of human fertilisation and early embryo development, and heritable traits linked to subfertility;

b)  To provide broad scientific advice on research needed—whether retrospective or prospective—into ART, ranging from surveillance, epidemiology and data collection to biological mechanisms and hypotheses focusing on where the potential risks to offspring appeared to be greatest;

c)  To advise on how to meet research needs, taking account of the need for scientific quality, value-for-money and ethical and legal considerations.

The MRC's report concluded that "Although there is widespread acceptance, based on experience, that current ART procedures are generally safe, the evidence for this, particularly in terms of long-term safety, is relatively weak when compared to other similarly well-established clinical techniques". It identified a number of potential biological risks:

a)  In vitro manipulations might damage gametes or embryos. This damage might be mechanical, chromosomal or genetic, or result from changes in gene expression;

b)  Aspects of specific technologies, such as drugs (ovarian hyperstimulation syndrome), embryo culture, freezing, embryo biopsy or ICSI, may cause deviation from normal physiology; and

c)  The fact that conception occurs where at least one of the parents is infertile may pass on fertility problems or result in children with chromosomal abnormalities.

266. There have been suggestions that children born using assisted reproduction are more likely to have certain "imprinting disorders" such as Prader Willi syndrome, Angelman syndrome and Beckwith-Wiedemann syndrome. Other health risks seem to be associated with an increase in prematurity and low birth weight. Nevertheless, the Working Group was concerned by the lack of data and suggested that "all existing and emerging ARTs required careful evaluation as to their short-and long-term effects on the children produced". We take seriously the possible risks of assisted reproduction technologies. For this reason, we encourage research in this area, both to inform professional practice and in order that intending parents can be adequately and appropriately informed of any risk to which they are considering providing consent.

Multiple pregnancies

267. Although there are specific risks associated with assisted reproduction, the Peckham Report concludes that "By far the greatest risks to both mother and child arise from the practice of implanting several embryos to increase the chances of having a baby, and the consequences of a possible multiple pregnancy".[354] Women with a multiple pregnancy are at higher risk of a range of conditions, including gestational diabetes, musculoskeletal problems, anaemia and hypertension. Multiple births also cause increased rates of parental stress, maternal depression and child abuse. On the children's part, there is a higher risk of perinatal mortality and they are more likely to be born prematurely with a low birth weight, which is associated with problems such as chronic lung disease, adult-onset diabetes, coronary heart disease, high blood pressure, intellectual, physical and sensory disabilities, and psychological and emotional distress. As a result, multiple births are a significant strain on health service resources.

268. The HFEA likes to give the impression that its move to reduce the number of embryos per transfer from three to two embryos was a beacon of evidence-based policy when in fact it was dragging its heels behind the professional bodies.[355] This account of the HFEA driving forward good practice is not shared by the Professor Alison Murdoch, Chairman of the British Fertility Society, who told us that "For more than 10 years, both the RCOG and BFS have been arguing for and have published recommendations that a maximum of only 2 embryos be transferred during each IVF treatment. We have further argued that there should be no exception which is more restrictive than current HFEA regulations. A review of the HFEA reports of national data shows that a decrease in the number of 3 embryo transfer cycles has been steadily decreasing before any HFEA regulations changed.".[356] Looking around Europe, it is clear that some countries have done more than consider the change. For example, single embryo transfer is standard medical practice in many Nordic countries, notably Finland (see Table 15).[357] Table 15: Percentage of embryos transferred in Europe in 2000.

	1	2	3	4+
Finland	27.0%	67.2%	6.0%	0.1%
Hungary	7.6%	19.2%	47.8%	25.5%
Iceland	9.4%	69.8%	20.9%	0.0%
Ireland	7.1%	40.4%	50.5%	2.0%
Italy	13.3%	33.4%	38.1%	15.2%
Poland	16.8%	56.9%	20.9%	5.4%
Portugal	10.8%	35.0%	48.2%	6.0%
Russia	10.6%	19.5%	33.1%	35.4%
Slovenia	20.4%	65.1%	14.4%	0.0%
Spain	27.0%	22.1%	44.4%	24.1%
Sweden	12.6%	83.6%	3.8%	0.0%
Switzerland	13.4%	57.8%	27.1%	1.7%
UK	8.0%	58.2%	33.8%	0.0%
Ukraine	9.2%	18.4%	29.1%	43.4%
All	12.1%	46.7%	33.3%	6.8%

Source: The European IVF-monitoring programme (EIM) for the European Society of Human, Human Reproduction, Vol. 19, No. 3, 490-503, March 2004

Embryo biopsy and PGD

269. The safety of embryo biopsy has been at the heart of the HFEA's policy development on PGD and PTT. The problem has been that the available data are limited. Professor Peter Braude, from Guy's Hospital, told us: "What has not been established and could not be established other than by long-term follow-up is, has this any impact later in life".[358] On the face of it, removing one or two cells from an eight cell embryo sounds as if it should have a major effect on the embryo's survival and development but at this stage all eight cells can form any tissue or organ in the body, and half of them will, in any case, form the placenta. The data that suggest that biopsy may not be damaging come from the results of implanting frozen embryos. Professor Braude said that "you might lose half the embryo […] [but] They will come out seemingly normal".[359] The MRC Working Group concluded that in humans the removal of one or two cells at the eight cell stage do not affect subsequent embryo growth and clinical data do not show reduced implantation rates.[360]

270. When the HFEA first considered preimplantation tissue typing in 2001, much was made of the theoretical harm to the embryo from the biopsy. Speaking to the Committee about the HFEA's anticipated change in policy on preimplantation tissue typing, Chief Executive Angela McNab said "What has changed in the area of PGD and HLA is that there is now two years' more data across the world of carrying out these kind of techniques. Therefore, there is information regarding outcomes, safety, and about the data, not just in this country because a relatively small number of these procedures are carried out worldwide, but there is collectively two years' worth of experience and in addition any update on the views of the public and on the wellbeing of the children.".[361] It could be argued that the amount of data has not changed radically but the efforts of the HFEA in surveying that evidence has done.

Psychosocial risks

271. Underpinning conclusions on assisted reproduction must be the findings of high quality social research. We are fortunate in the UK that we have excellent research teams looking at the social implications of assisted reproduction and genetics. Among these, Professors Susan Golombok and Martin Richards gave both written and oral evidence to this inquiry. Professor Golombok told us that while most studies had only looked at children born as a result of assisted reproduction in early childhood (Louise Brown is still only 26), studies had shown that "neither the quality of parenting nor the psychological well being of children is adversely affected by assisted conception".[362] There is particular concern for those couples wishing to conceive following donation. As well as the difficulties faced by the parents, it is important to discover how these families are functioning. Professor Susan Golombok from City University has undertaken research in this area, and her findings are reassuring: "the evidence is not there that there are particular problems for those concerned".[363]

272. In its discussion of the use of sex selection, the HFEA used the following welfare argument to support its recommendation that sex selection for social reasons should not be permitted:

"In our view the most persuasive arguments for restricting arguments for sex selection technologies, beside the potential health risks involved, are related to the welfare of the children and families concerned. There was considerable alarm among consultation respondents that children selected for their sex alone may in some way be psychologically damaged by the knowledge that they had been selected in this way as embryos.".[364]

Thus the most persuasive argument was not that there was evidence of harm but that there was evidence of concern about harm. This is not a satisfactory use of evidence to support policy advice.

PRECAUTIONARY PRINCIPLE

273. The origins of the precautionary principle lie in German environmental policy in the 1970s. Put simply, if there is only a risk of effects occurring, the possibilities of risk prevention have to be investigated and if the risk is high enough, preventive measures should be ordered. It has more recently been applied to advances in medical care, for which it implies that there should be proof of an absence or limited risk of harm, both physical and psychosocial, before treatments should be permitted. Several witnesses have invoked the precautionary principle in their evidence. The Rev Chris Johnson, a contributor to our e-consultation, wished to apply the precautionary principle as "the science is well ahead of the legislation" and this could avoid us taking decisions that we would later regret. Nothing should be permitted, he said, unless it had been thought through.[365] Dr Neville Cobbe, another contributor to our online consultation, applies the principle to stem cell research, arguing "I think we need to be exceedingly cautious. One thing I would be concerned about is why we want to rush ahead with human embryonic stem cells before the mouse studies have properly eliminated risk".[366]

274. The HFEA invoked the precautionary principle in its 2001 policy decision on preimplantation tissue typing. As we set out in Table 13 the Authority decided at the time not to allow preimplantation testing when the child to be born had very little chance of developing the disease, yet its decision was contrary to the advice of its Ethics Committee.[367] Professor Tom Baldwin, Deputy Chair of the Authority, was a member of the Committee at the time: "When that went to the whole authority, in my opinion, unfortunately they disagreed. Why did they disagree? Because […] of risks arising from embryo biopsy and it was felt that the Ethics Committee had not taken proper account of the absence of evidence of no risk [our italics]".[368] Another example can be found in its 2004 report on Sex Selection. It argued that "It is not possible to discount a theoretical risk to health" in relation to the use of flow cytometry for sperm sorting.[369] The BMA is concerned that the application of the precautionary principle leaves open the possibility of extending the licensing role of the HFEA to incorporate a range of additional treatments including GIFT (gamete intra-fallopian transfer) and ovulation induction both of which have been associated with high order multiple births and expose the mother and the children to an element of risk. The BMA believes, however, that a "theoretical risk to health" is not an appropriate level at which to set the requirement for licensing since this would encapsulate vast areas of medical practice that do not raise the type of sensitivities referred to above.

275. The Genetic Interest Group is critical of the use of the precautionary principle and does not believe that "current or near-future practice in these areas [PGD and embryo research] threatens to undermine humane values or carries with it any obvious risks that are not already under consideration. Indeed, if caution is required, it is in giving weight to speculative risks, backed up by little or no evidence, when benefits for parents making choices are clear, and research has only just begun.".[370] ".

276. Often the argument comes down to what weight you are prepared to give to existing evidence and this tends to betray attitudes to the technologies. In expressing their concerns about the application of the principle of reproductive freedom, Dr Alexina McWhinnie and Professor Alastair Bissett-Johnson from the Department of Law at Dundee University state that "Research and follow up studies are increasingly showing that there are potential risks for such children and the stability of their families and that they can experience psychological problems in childhood, at adolescence and as adults directly related to the methods used in their creation.[371] In considering the use of new reproductive technologies, Dr Elizabeth Allan informs us that "The psychological damage alone from […] abnormal parentage (unborn foetus as a mother; unborn embryo as a father or mother; no genetic father; mother and grandmother being identical, etc) could be profound".[372] These comments sound eerily like the concerns back in 1978 about IVF, which have, according to Professor Golombok, failed to materialise. Indeed, she says "I just think the evidence is not there that there are particular problems for those concerned".[373] The Epalan management consultancy describes the HFEA's invoking of the precautionary principle as an inevitable consequence of its separation from risk assessment: "In the absence of any information about the risks associated with the procedures they are licensing, they usually exercise caution," it argues.[374] No-one wishes to expose patients and children to physical harm or psychosocial stresses, but all medical practice has inherent risks and the only solution is a rational approach to risk assessment and management, coupled with strategies to undertake and apply the results of medical, scientific and social research.

CONCLUSION

277. We have identified serious shortcomings in the HFEA's use of evidence in informing its policy development. However, the picture is not all bleak. We recognise that the change in its policy on preimplantation tissue-typing owes a lot to better use of evidence. The joint MRC/HFEA working group has done some valuable work and should help to build better links between these organisations. In addition, the HFEA's international Horizon Scanning Expert Panel, set up in December 2004, is a welcome initiative. This panel aims to provide an expert assessment of upcoming scientific and technical developments and to identify priority areas for further scrutiny. We were surprised, however, that of its 17 members, none is a social researcher. Given the HFEA's fondness for citing welfare issues in its policy decisions, it is peculiar that it did not see the need to build up its social research knowledge base. We welcome the setting up of an international Horizon Scanning Expert Panel as a positive step in improving the HFEA's use of evidence. We are unclear why there is not even one social researcher on the panel and urge the HFEA to rectify this.

278. The Warnock report concentrated on the social, ethical and legal implications of the technology and the HFE Act placed little emphasis on the need to create a framework in which safety concerns about existing and new reproductive technologies can be identified. Indeed, there have been concerns that the Act is a major obstacle to attempts to establish the risks associated with assisted reproduction. The MRC Group concluded that "The current infrastructure in the UK allows AR technologies to be licensed and introduced with limited evidence of safety". We welcome the MRC's efforts to identify some of the safety issues facing assisted reproduction. It is unfortunate, however, that it has been unable to fund the proposal from the National Perinatal Epidemiology Unit at Oxford to set up a National Assisted Reproductive Technology Research Centre. We also understand that proposals to study the risks of ICSI and the effectiveness of blastocyst transfer have also failed to get MRC funding in recent years.[375] We would not wish to interfere with the MRC's peer review process but we hope that the MRC will give further consideration to how it can enable some of the research needs it identifies to be funded. By most standards, the safety of IVF lies within the boundaries of acceptability. Nevertheless, any risks must not be underplayed and patients should be made fully aware of them before treatment. We hope the Medical Research Council will look favourably on proposals to undertake national studies to establish the safety and effectiveness of assisted reproduction techniques.

Funding and licence fees

279. The HFEA generates income by charging fees to in-vitro fertilisation centres holding licences. In the past it was set an expenditure limit (£1,575,000 in 2000-01). The Department of Health and the devolved administrations funded the difference between the levied charges (£1,242,000 in 2000-01) and this expenditure limit. The funding mechanism ensured that the HFEA's income remains the same whatever the income raised by fees, and therefore that it has no direct incentive to award licences. In June 2002, the HFEA issued a consultation document on its future funding. It stated that the HFEA needs "ongoing operating funding of at least £4.5 million" to perform its licensing and regulatory functions. It cited scientific and clinical developments, public expectations and government policy as justifications for the increase. We were cautious in our 2002 report:

"The HFEA is asking for its income to be more than doubled. We accept that its activities have increased in recent years but, for such a large increase, it needs to make a more detailed financial case than its consultation document provides. If it can prove the need for such a large increase, it should be met by increased contributions from Government as well as from licensees. We are concerned that the Government's insistence that any increase in funding should be met from licence fees alone undermines the principle that the HFEA should have no incentive to award licences".

In the Government's reply, it announced that it had agreed with the HFEA's request to raise the further funds it had requested from licence fees. The Department has since ended the claw-back and provides a block grant to support activities such as policy formation and public consultation which are not integral parts of the HFEA's regulatory function. We welcome the changes in the funding arrangements for the HFEA, which recognise that the HFEA, as presently constituted, has a wider duty to the public beyond its role as a regulator.

280. A further issue is the extent to which the costs of regulation are passed on to clinics and thus to patients. The British Fertility Society is concerned that "The burden of funding of the regulatory process falls to those that are being regulated (the providers) and those that are the subjects of the regulation (the patients). Patients and public are not made aware of this burden. The cost far exceeds any similar levy that is applied by other quangos on a per capita basis and, in its scope, has no parallel in the health care setting. With the major shift to the NHS setting likely with the implementation of the NICE guideline, it is time to fund the HFEA adequately from exchequer resources and remove this iniquitous and anomalous burden from the provider and patient.".[376] There are two issues here. First, should we provide free regulation of private treatment? We are aware that for some it is an extremely lucrative business and it is not clear that the State should further subsidise this. The second point is that for NHS-funded services, the costs of regulation ultimately have an impact on the funding available for services so the issue is largely to do with the transparency of license fees. The problem may be that for other areas of health care regulation, the costs of regulation are not so transparent for clinicians and are less aware that these are being incurred in the course of treatment.

RESEARCH LICENCE FEES

281. In March 2004, the HFEA published a consultation on human embryo research licence fees and proposed changes in the application process. It stated that since the HFEA was established in 1991, most of the costs of research regulation have been met from grant-in-aid and from fee income from licensed treatment and storage centres. It pointed out that the HFEA is subject to Treasury rules, which do not allow for this kind of cross subsidy and that the costs of research licensing should be met from licence fee income paid by those being regulated. Furthermore, there was no prospect of the costs being met from other sources. The research licence fee had been set at £200 and the HFEA proposed that this was raised to an average of £6000. This horrified numerous witnesses, not least Anne McLaren, a distinguished embryologist and former member of the Authority, who told us that the questions on the consultation were of the "'Have you stopped beating your wife?' variety". In consequence of this "gargantuan increase in fees", "The UK's research reputation in this field would suffer, patients would suffer, basic understanding of early human development would suffer".[377]

282. When the Authority met in July 2004 to make a decision, the minutes reported that "The DH agreed this work should be included in the list of items funded by their grant in aid" and that "The Authority agreed to propose an increased fee of £500 for all small projects and a fee of £750 for large, complex projects". In other words, having undertaken a consultation on the basis that cross-subsidy was not an option, the HFEA discovered that it was an option at the last minute. We have no way of knowing whether the fault for this farce lies in the HFEA or the Department. Either way, they have succeeded in angering the research community and the HFEA's reputation has been damaged as a result.

Principles of good regulation

283. The Government's Better Regulation Task Force, established in 1997, has set out five basic principles of good regulation: [378]

a)  Proportionate: Regulators should only intervene when necessary. Remedies should be appropriate to the risk posed, and costs identified and minimised.

b)  Accountable: Regulators must be able to justify decisions, and be subject to public scrutiny.

c)  Consistent: Government rules and standards must be joined up and implemented fairly.

d)  Transparent: Regulators should be open, and keep regulations simple and user friendly.

e)  Targeted: Regulation should be focused on the problem, and minimise side effects.

284. We agree that these principles provide a sound basis for regulation and it is worthwhile to consider how the HFE Act and the HFEA itself stand up to these principles. We are aware that the HFEA has discussed these principles in relation to its policy on Dewar safety.

PROPORTIONAL

285. The degree to which the HFEA's regulation is proportionate depends largely on the perceived risks of not regulating. The HFEA receives around £3½ million a year in licence fees from close to 100 treatment centres. The size of the executive has increased rapidly on recent years. In 2002-03 there were 57 part-time and full-time employees and in 2003-04 there were 91. We understand that the figure is now over 100. We are aware that the HFEA has been stretched in recent years, as we discussed in our 2002 Report, although it has been argued that this was a result of expanding its own activities beyond its statutory duties rather than an increase in the workload imposed on the organisation. We asked the Minister whether she felt that the size of the HFEA's secretartiat was appropriate. In her view, the HFEA was "a very tiny organisation these days".[379] We do not dispute that there are many much larger organisations than the HFEA but the issue is whether it is a suitable size for the job it is required to do by statute. We discuss parallels with the regulation of animal experimentation and abortion clinics, both of which are contentious issues in paragraphs 239 and 327.

ACCOUNTABLE

286. One of the reasons for this inquiry was Ruth Deech's comment to us in 2002 that Parliament should be protected from making decisions on developments in assisted reproduction such as PGD. The current regime has shown a greater willingness to consult with the public and professionals and interact with Parliament, which is welcome. We will discuss the role of these groups in respect of the functioning of the regulator in Chapter 9.

CONSISTENT

287. We have discussed the consistency of the HFEA both in relation to its policy function and in the deliberations of licence committees. We argued that consistency could not be achieved unless the HFEA developed policy. A problem has been the dispute over the scope of the legislation (with regard to preimplantation tissue-typing) and high staff turnover. We have been told about the HFEA's short corporate memory, which irrespective of the calibre of the current executive (which by most accounts is high), has meant that contradictory statements have been made. We have heard particular complaints over the inconsistency of licensing and inspections.

TRANSPARENT

288. This is an area that has improved since we last looked at the HFEA in 2002. The website is more comprehensive and the minutes and agendas of Authority meetings are available, if not always promptly. However, we have concerns that the activities of HFEA committees, and in particular the licence committees, are opaque. We feel this has eroded confidence in the HFEA. On the positive side, the Authority's policy formation is being more fully presented.

TARGETED

289. We have heard concerns that the inspection processes being employed by the HFEA have not been effective in identifying poor practice. This has been chronicled in detail by the Toft Report.

290. The principles of good regulation adopted by the Better Regulation Task Force are appropriate and valuable. We regret that in many areas the HFEA falls short of these ideals. We recognise that the HFEA has improved its performance but it has been stretched by too much poorly targeted regulation. This needs to be addressed by refocusing its efforts. We will discuss our solutions in Chapter 9.

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264   ^{Ev223;wediscussthemeritsofanationalbioethicscommitteeinparagraphs347-353} Back

265   ^{seeauthorityminutes,March2002} Back

266   ^{HFEA,Tomorrow'sChildren:Aconsultationonguidancetolicensedfertilityclinicsontakinginaccountthewelfareofchildrentobebornofassistedconceptiontreatment,January2005} Back

267   ^Q1257 Back

268   ^{BBCNewsOnline,21January2004} Back

269   ^Q1244 Back

270   ^{HumanFertilisationandEmbryologyAuthorityTwelfthAnnualReportandAccounts2002/03} Back

271   ^Ev231 Back

272   ^{Fertilitytreatment:abolishthe'welfareprinciple',EmilyJackson,SpikedOnline,11June2003} Back

273   ^Q1254 Back

274   ^Ev218 Back

275   ^{February1998,para58} Back

276   ^para1.3 Back

277   ^{HFEA,ResponsetotheDepartmentOfHealth'sConsultationon'DonorInformation:ProvidingInformationAboutSperm,EggAndEmbryoDonors',July2002,para36} Back

278   ^Q476 Back

279   ^Ev217 Back

280   ^Ev230 Back

281   ^Ev419 Back

282   ^Ev419 Back

283   ^Ev235 Back

284   ^{Forexample:8April2003,CourtofAppealallowstissuetypingforhumanembryosunderstrictconditions;25June2004,Courtrulingonstorageofembryos:NatallieEvans.} Back

285   ^Ev232 Back

286   ^Q471 Back

287   ^Ev220 Back

288   ^Section25(1) Back

289   ^{Section26(1-2)} Back

290   ^{EgggivingistheprocesswherebyapersonseekingIVFtreatmentagreesattheoutsettogothroughonetreatmentcycleinwhichalltheeggscollectedaredonatedtoasecondperson,followedbyafurtherIVFcyclefortheirowntreatmentatreducedcost.Theissuewasdiscussedatthe20November2003meetingbutthedecisionwasnotminuted.However,theHFEAissuedapressreleaseon1Decemberstatingthatithadwrittentoclinicsaskingthemnottopractiseegggiving.} Back

291   ^CE.99.08 Back

292   ^Ev235 Back

293   ^Ev302 Back

294   ^Ev419 Back

295   ^Ev425 Back

296   ^{ImprovingtheperformanceoftheHumanFertilisationandEmbryologyAuthority,IndependentSteeringGroupRecommendationstotheHFEA,September2002} Back

297   ^Q411 Back

298   ^Q649 Back

299   ^Q389 Back

300   ^Ev428 Back

301   ^Ev216 Back

302   ^Q23 Back

303   ^Q23 Back

304   ^Q114 Back

305   ^Ev425 Back

306   ^Q1235 Back

307   E^v425 Back

308   ^Section5(3) Back

309   ^{HouseofLords,ReportoftheSelectCommitteeonAnimalsinScientificProcedures,Session2001-02,HLPaper150-I,paras5.28-5.52} Back

310   ^Ev422 Back

311   ^Qq568-573 Back

312   ^Q274 Back

313   ^{FourthReportoftheScienceandTechnologyCommittee,Session2001-02,DevelopmentsinHumanGeneticsandEmbryology,HC791,July2002,para7} Back

314   ^Asabove Back

315   ^Ev425 Back

316   ^Ev320 Back

317   ^{BetterRegulationTaskForce,ScientificResearch:InnovationwithControls,January2003,Section5} Back

318   ^{CodeofPractice,para14.7} Back

319   ^Ev294 Back

320   ^{OutcomeofthePublicConsultationonPreimplantationGeneticDiagnosis,HFEA/HGCJointWorkingParty,November2001} Back

321   ^para29 Back

322   ^Q624 Back

323   ^Q505 Back

324   ^Q1239 Back

325   ^Q1281 Back

326   Q¹²⁷³ Back

327   ^{i.e.numberofembryoslikelytobeavailablefortestingineachtreatmentcycle,thenumberlikelytobesuitablefortransfer,whethercarrierembryosmaybetransferred,thenumberofcycleslikelytobeundertaken} Back

328   ^{seeparagraphs}274-277 Back

329   ^Q628 Back

330   ^para18 Back

331   ^Ev217 Back

332   ^Ev377 Back

333   ^Ev377 Back

334   ^para13.12 Back

335   ^Ev219 Back

336   ^{www.bbsrc.ac.uk} Back

337   ^{www.esrc.ac.uk} Back

338   ^{Q1228;thisapplicationwasturneddownbytheMRCinDecember2004} Back

339   ^Ev377 Back

340   ^Section31(2) Back

341   ^Ev368 Back

342   ^Ev368 Back

343   ^Ev342 Back

344   ^Ev343 Back

345   MRC Working Group, Draft t^{echnicalreport} Back

346   ^Q1059 Back

347   ^Ev343,335 Back

348   ^Ev398 Back

349   ^Ev244 Back

350   ^Ev214 Back

351   ^Ev352 Back

352   ^Q534 Back

353   ^{MRCWorkingGroupDraftTechnicalReport} Back

354   ^p.4 Back

355   ^{Ev207,Q1288,HFEAreducesmaximumnumberofembryostransferredinsingleIVFtreatmentfromthreetotwo,HFEApressrelease,8August2001.} Back

356   ^Ev396 Back

357   ^Ev372 Back

358   ^Q613 Back

359   ^Q617 Back

360   ^{MRCWorkingGroupDraftTechnicalReport} Back

361   ^Q495 Back

362   ^Ev357 Back

363   ^Q972 Back

364   ^para139 Back

365   ^Qq130,133 Back

366   ^Q230 Back

367   ^{EthicalIssuesintheCreationandSelectionofPreimplantationEmbryostoProduceTissueDonors,HFEAEthicsCommittee,November2001,para3.14} Back

368   ^Q622 Back

369   ^{Sexselectionreport} Back

370   ^Ev277 Back

371   ^Ev410 Back

372   ^Ev268 Back

373   ^Q972 Back

374   ^Ev347 Back

375   ^Ev397 Back

376   ^Ev216 Back

377   ^Ev200 Back

378   ^{www.brtf.gov.uk} Back

379   ^Q1305 Back

---

Prepared 24 March 2005