ethics, economics and the exotic: the early career of the hfea

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ph273-hcan-487885 HCAN.cls April 30, 2004 20:18

Health Care Analysis, Vol. 12, No. 1, March 2004 (C© 2004)

Ethics, Economics and the Exotic: The EarlyCareer of the HFEA

Derek Morgan1,2

The Human Fertilisation & Embryology Authority (HFEA) is the UK’s statutoryregulator of licensed assisted conception treatments. The past 10 years have, in-evitably, drawn it further and deeper into this area of legal, moral and politicalcontroversy. It is opportune to consider how it has fared in the new climate of pub-lic accountability and critical scrutiny, and whether reform or revision of its role,mandate or operation may be called for. Through a close analysis of its publishedAnnual Reports, it is possible to form a picture of a development of the HFEAwhich has not been consistent, coherent or comfortable.

KEY WORDS: reproductive health; embryology; regulation; legal reform

The HFEA was established in 1991 as an executive non-departmental bodysponsored by the Department of Health and has a staff which had grown to 45 by thetime of the publication of the 11th Annual Report3 but which now stands at around70. The HFEA’s creation reflected—it claims—public and professional uneaseabout the potential future of human embryo research and infertility treatments.4

Don Chalmers, however, has cautioned that “there is no doubt that much of theheady and excitable drive to regulation was a result of pressure groups rather thanthe formulation of good public policy.”5

The HFEA has not been bashful about the reach of its regulatory aspiration.“Underlying all its activities is the HFEA’s determination to safeguard all relevant

1Cardiff Law School, PO Box 427, Cardiff, United Kingdom.2Correspondence should be directed to Derek Morgan, Cardiff Law School, PO Box 427, Cardiff CF103XJ, United Kingdom; e-mail: [email protected].

3Human Fertilisation & Embryology Authority,11th Annual Report, 2003.4Above, note 3 at 4.5‘Professional Self-Regulation and Guidelines in Assisted Reproduction’ in Margaret Coady and KerryPeterson (Eds.) “Regulating Reproductive Technologies” (2002) 9Journal of Law and Medicine414at 425.

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interests—patients, children, doctors and scientists, the wider public and futuregenerations.”6 The Authority here identifies a diverse and potentially divided num-ber of important stakeholders, some of whose interests may be in direct conflict withothers, and not all of whom can be taken, unproblematically, to share the vision ofthe HFEA about its role, nor to understand or accept the alternative views which theHFEA must mediate. Whether the ambit of its formal powers under the 1990 Act en-ables it effectively to deliver the annual dividend which these diverse stakeholdersmight expect is something which needs careful study and reflection. Whether theAuthority does—as a matter of judgement—always correctly make these difficultcalls is a matter of public debate, political philosophy, practical ethics and realpoli-tik.7 And, as Margot Brazier, writing of the Human Fertilisation & EmbryologyAct 1990, has complained because there is “little conceptual depth underpinningBritish Law,” we consequently debate “the same issues in different guises.”8

The HFEA encourages a “broadly facilitative” approach9 and the “centralrole” granted to professionals is one of the “key features” of the Act. Hence it isnot surprising that Montgomery has suggested that as of 2000,

[the] Authority looked heavily professional in its make-up. . .The membership seemeddesigned to lend an air of wisdom and authority to the deliberations of the Authority ratherthan to reflect some form of representative democratic participation in open debate.10

Depending on the precise composition of the HFEA “it could operate as apublic control of professional expertise, or a form of self regulation.”11 Reflectingon the early career of the HFEA Ruth Deech observed that the Authority had been“more regulated against than regulating.”12 She claimed that “75% of the time of itsmembers and staff was taken up with purely regulatory issues.” And the Authoritymay have become a rather insular organisation, more visited than visiting, morehamstrung than networking; “Our finances were such that the HFEA could notafford, except very rarely, to send anyone to an international conference, so wewere reliant on people coming to us.”13 Then, the fixed gaze of the HFEA becamecaught, almost unawares, in the headlights of modern corporate governance and

6Human Fertilisation & Embryology Authority,8th Annual Report, 1999, p. 1.7Louis Waller, “Australia: The Law and Infertility—The Victorian Experience” in S. A. M. McLean,(Ed.),Law Reform and Human Reproduction, Dartmouth, Aldershot, 1992, at 37.

8Brazier M, “Regulating the Reproduction Business” (1999) 7Medical Law Review166 at 167. Asimilar complaint informs the recent work of Sheila McLean,Old Law, New Medicine, Pandora Press,London, esp Ch. 8.

9Emily Jackson,Regulating Reproduction: Law, Technology and Autonomy, Hart, Oxford, 2001, at259.

10Jonathan Montgomery,Health Care Law, 2nd ed., Oxford University Press, 2003, at 490.11ibid, 489.12House of Commons,Select Committee on Science & Technology, Minutes of Evidence, 24th April

2002, at Q2.13House of Commons, Science and Technology Committee,Developments in Human Genetics and

Embryology, Fourth Report of Session 2001–02, HC 791, Minutes of Evidence, 24th April 2002, atquestion 1.

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Ethics, Economics and the Exotic: The Early Career of the HFEA 9

public government. “We were always, maybe quite rightly, being held to accountfor one thing and another,”14 bemoaned Deech, who, in an intriguing paper onthe work of regulating assisted conception published in 2002 reflects on some ofthe years that she chaired the HFEA. Significantly the essay is called “Losingcontrol—some cases.”15

A review by the House of Commons Select Committee on Science & Tech-nology of the work of the HFEA is fascinating for the glimpses that it offers intothe HFEA’s understanding of its own role, the problems that it perhaps more thanother similar agencies has suffered, and further reflection in its work.16 And despitethe Constitutional posturing adopted by the Committee, the grandstanding of someof its members, and an extraordinary hostage to fortune loosed by Ruth Deech,the HFEA emergesreasonablywell from this bout of Constitutional politics. Andyet, the HFEA with its high turn over of members and staff is such that it hasbegun to seem like an organisation with no deep memory—that it is in danger ofbecoming an Alzheimer organisation—one “unaware of its own or anyone else’spast, ignorant of its own or anyone else’s present.”17

WHAT EVER HAPPENED TO THE HFEA? GREGOR SAMSA& THE MODERN REGULATORY ENVIRONMENT

In the 11th Annual Report, Suzi Leather writes in her first Chair’s introduc-tion since replacing Ruth Deech, that she commissioned an “independent steeringgroup to review the HFEA’s practices and make recommendations for improve-ments.”18 We read in that Report that “the HFEA aims to deliver a significantlymore efficient and effective service in the future.”19 The Authority acknowledgesthat it has “technical problems” which mean that it remains “unable to provide de-tailed information” (12), and that the “data was not available. . . while the HFEAis engaged in a large project to improve and update the Register” (31).

There can be no disguising the fact that 2002 was not a notably good year forthe HFEA;r Maureen Dalziel became the first Chief Executive of a next steps agency

to be fired;r the Authority was subject to excoriating criticism in a report by the House ofCommons Select Committee on Science & Technology noting, woundingly,

14House of Commons, Science and Technology Committee,Developments in Human Genetics andEmbryology, Fourth Report of Session 2001–02, HC 791, Minutes of Evidence, 24th April 2002.

15In Marie Therese Meulders-Klein, Ruth Deech and Paul Vlaardingerbroek (Eds.),Biomedicine, theFamily and Human Rights, The Hague, Kluwer, 2002, 581.

16House of Commons, Science and Technology Committee,Developments in Human Genetics andEmbryology, Fourth Report of Session 2001–02, HC 791, at para 7.

17John Simpson,News From No Man’s Land, Macmillan, London, 2002, at 88.18Human Fertilisation & Embryology Authority,11th Annual Report, at 3.19Human Fertilisation & Embryology Authority,11th Annual Report, at 4.

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that “Parliament does not need protecting and democracy is not served byunelected quangos taking decisions on behalf of Parliament”;20r the Committee further criticised the HFEA for apparently exceeding its ju-risdiction in the case of Zain Hashimi—criticism seemingly well foundedif we believe Mr Justice Maurice Kay’s poorly reasoned first instancejudgment inR v Human Fertilisation & Embryology Authority ex parteQuintavalle21—and by the Press for, in having done so, to appear to be split-ting embryological hairs by denying what seemed ex facie to be the sameopportunity to Ben Whittaker;r the Authority was remarkably late in publication of its 10th Annual Report(2000–01), its statutory account to Parliament on 28 June 2002, yet prema-ture in the publication ofThe Consultation Paper on the Modernisation ofRegulation & the New Fee Strategyin breach of all public guidelines forconsultation;r the HFEA was implicated either directly or by association in two highprofile and highly damaging cases, involving in the one case, deliberatefraud in the delivery of treatment services, resulting in imprisonment of anembryologist at Southampton Crown Court, and, in the other case what wasat best careless laboratory supervision resulting in a woman being—quiteevidently—implanted with the “wrong” embryos;r and Josephine Quintavalle and her family; first with cell nucleus replace-ment embryos and now with tissue typing, have punctured the legal ap-proach and advice that the HFEA has been operating with in its interpreta-tion of the 1990 Act.22

Although the HFEA has secured emergency grant aid from the Treasury tocover massive holes in the operating methods of the Authority and their dataretrieval system—to which I will return—this notable success can only have beenachieved at some cost to the Authority’s apparent independence. We may not seeit in the public domain, but the Treasury will be keeping a strict rein on the HFEAover the forthcoming years, and the Department of Health will have moved fromjust sponsor Department to keeping a keen parental eye on the teenage years ofthe HFEA

Not surprisingly, the HFEA has been subject to criticisms from all sides, someof which goes with its very contested territory. No regulatory body could havebeen established with the commission of the HFEA and expect to escape publicscrutiny and criticism. Yet the range of critics may be thought to be alarming; they

20House of Commons, Science and Technology Committee,Developments In Human Genetics AndEmbryology, Fourth Report of Session 2001–02, HC 791, at para 26.

21[2002] EWHC 2785 (Admin); since reversed on appeard.22RespectivelyR v Secretary of State for Health ex parte Quintavalle[2003] 2 AC 687; andR. (on

the application of Quintavalle)v Human Fertilisation and Embryology Authority[2003] 3 ALL ER257.

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includer predictable attacks by MPs such as Bob Spink [and Core & Life], whodeplored the additional public money given by the Government to the HFEAand called on the Government “to review in a transparent and democraticmanner the purpose, scope and funding of the HFEA”r by the campaign group CORE who have alleged that;r the HFEA is unduly influenced by scientists “working in the field;”r the composition of the HFEA excludes those who are critical of or have

reservations about the wisdom of the whole march of the “reproductionrevolution;”r the Code of Practice cedes to clinics far too much control over the workthat they do;r the requirement in the Act to prioritise “the welfare of the child” appearsat best to be submerged;r the HFEA has become “an arbiter” of fundamental ethical issues on whichthere is no widespread agreement;r and that consequently the work of the HFEA as a whole is compromised.23r by various lobby groups such as Peter Garrett of LIFE, alleging that “The

HFEA is falling apart at the seams”;r by the Parliamentary Ombudsman24 responding to a complaint of mishan-dling of a request to review policy on pre-implantation genetic diagnosisby Mr & Mrs Masterton;r by clinicians giving evidence to the House of Commons Select Committee,particularly Austin Smith of Edinburgh University, who snorted that theHFEA is “frustrating to deal with, inefficient and without adequate spe-cialist knowledge.” This was presumably prompted by Smith’s experiencesrecounted in a Scottish press report which claimed that Smith had prema-turely been granted an HFEA licence to grow stem cells from embryos.A letter from HFEA Policy Manager Dr Peter Mills appears to confirmthat Smith’s licence to “derive and characterise stem-cell lines from hu-man embryos” was granted in 1997. David Alton, fulminating in the Houseof Lords, has suggested that; “This licence was granted four years in ad-vance of parliament deciding on the issue. For the HFEA to have granted alicence. . .and for Austin Smith to have applied. . . was contemptuous andI think it was illegal.” Josephine Quintavalle, director of CORE is quotedas saying that: “This is a blatant example either of the supreme ignoranceor supreme arrogance of the HFEA.”r by fertility experts such as Lord Winston who has argued that the IVFprocess is over-used. Following research presented at a conference of the

23S. Smith and A. Sutton, ‘The Human Fertilisation & Embryology Authority: A Critique of its firstreports (1992–94), London, CORE, 1995.

24Parliamentary Commissioner for Administration,6th Report session 2001–2002, case no c431/01.

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European Society of Human Reproduction and Embryology in 2002 thatconcluded that the some assisted conception techniques such as ICSI couldresult in a slightly increased chance of birth defects, the HFEA and theMedical Research Council (MRC) have established a joint working party,chaired by senior epidemiologist Professor Catherine Peckham, to fashionresearch to consider the long-term effects on children born using IVF tech-niques. In attempting to provide reassurance an HFEA spokeswoman wasquoted by the BBC as having said “it is simply that there is a lot we don’tknow and we are carrying out this study to try and find some answers.”25r implicitly, even by Dame Anne McLaren who suggested that “the HFEAseems to have a wider sphere of responsibility with every year that passes”;r and even the HFEA itself; in passing its unprecedented unanimous motionof no confidence in its Chief Executive Maureen Dalziel, thereafter removedby Chair Suzi Leather.

The HFEA, nonetheless, has its admirers and supporters domestically and in-ternationally. A background staff paper to the US President’s Council on Bioethicsobserved that “the HFEA remains nearly unique as a regulatory agency whose work. . .with a decade of experience,. . .may have a great deal to teach us about the waysin which assisted reproduction and embryo research may or may not be monitoredand regulated.”26 Sir Andrew Leggatt in a review of a the tribunal system remarkedthat the HFEA offers “a consistent and expert approach in this peculiarly sensitivearea.”27 And the House of Lords Committee on Stem Cell Research reported that:

The regulatory system established by the 1990 Act has worked well. The lynchpin of thesystem is the HFEA. Its work is highly regarded, both at home and abroad. It appeared fromthe evidence we received that it has the full confidence of the scientific and medical researchcommunity, and we believe that it has also been instrumental in reassuring the public thatregulation in a particularly emotive area of public policy is carried out effectively andsensitively.28

The House of Commons Select Committee reviewing the HFEA questionedthis conclusion, commenting, some what caustically, that “we are unclear” onwhat evidence the House of Lords based “this assertion.”29 And although it wenton to complain that the HFEA does “not appear to have made much effort tocommunicate more widely, yet the public has a legitimate interest in its workand administration,”30 it nonetheless concluded that “The HFEA has been largely

25BBC 22 October 2002.26Background staff paper, October 2002.27Tribunals for Users, One System One Service; Report of the review of Tribunals, March 2001, para

12.11.28House of Lords,Committee on Stem Cell Research(Session 2001–02 HL 83(i)), para 8.129House of Commons Committee, above, n 12, at 7, although it might be observed that the Select

Committee didnotremark that it was unclear on what evidence Professor Smith based his assessment;and, see Memo by Prof. A. Smith as appendix to the Committee’s. report.

30Ibid, at 8.

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successful in ensuring public confidence in its regulation of fertility treatmentsand research.”31 Ruth Deech claimed to MPs that “the HFEA maintains the con-fidence of the public and politicians” and that it regulates and hence protects thepublic. The HFEA has “movedwith the flow of science to investigating and licens-ing many new developments.”32 However, in a significant difference of opinionher predecessor Suzi Leather expressed the view in the same evidence sessionthat;

There have been very significant changes since the HFEA started. Certainly the science isvery fast moving, but there have also been changes in the public expectations about openness,accountability, consumer demands for information.. . .Maintaining public confidence inthe regulation of the fast moving area of science is quite difficult.. . . there is a heightenedexpectation amongst the public.. . . if the HFEA were being set up today it would be fundedat a different level.”

In response the Committee exhorted that “it is crucial that our scientists, incomplying with regulatory requirements, are not hampered by bureaucracy.”33 Ofcourse, this is merely to beg the question of what the regulatory system is therefor, and the Select Committee is unclear whether they are to be taken to meanbureaucracy or inefficiency. The Government in its response to the Committee’sreport acknowledges this, where it records that while it fully concurs that scientistsshould not be hampered by unnecessary bureaucracy, it is cautioned that it isessential that applications are considered carefully and thoroughly, and observedthat “the UK’s position as a world leader is enhanced by the robust nature of itsregulatory process.”34

The distinction is important becausesomedegree of inefficiency is a factof regulatory life; there are certain types of social problems that can only beaddressed through formal government control. Schemes for self-regulation tendto work best in situations in which an industry does not generate significant socialcosts (negative externalities). Then, where the issues are technical and apolitical,an industry has strong incentives to police itself. According to Francis Fukuyama,this was at one time true for food safety and medical experimentation, but is nottrue of present-day biotechnology, or of the kinds of bio-medical technologies thatare likely to appear in the future.35

There are now too many commercial interests chasing too much money forself-regulation to work well into the future. Most biotechnology companies willsimply not have the incentives to observe many of the fine ethical distinctions that

31Ibid, at 7.32Ibid, Evidence.33Ibid, 7: Recommendation.34Department of Health,Government response to the report from the House of Commons Science and

Technology Committee: Developments in Human Genetics and Embryology, November 2002, Cm5693.

35Francis Fukuyama,Our Post Modern Future; Consequences of the Biotechnology Revolution,London, Profile, 2002, at 184.

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need to be made, which means that governments necessarily have to step in anddraw up and enforce rules for them.36

In her characteristically reflective essay, Margot Brazier offered a more quali-fied review of the HFEA as “an apparently powerful regulatory body.”37 Regulationwas the price extracted for the primary goal that Warnock saw as that of a statu-tory licensing body—embryo research38—the “preoccupation with embryology”as Emily Jackson has called it.39 The HFEA has, primarily, been engaged in “man-agingthe fertility business and keeping public fears of scientific progress at bay.”40

The return for regulated research, then, was a broad range of clinical freedom leftto operate as a supervised free-for-all as long as the patients could continue topay. And this, the HFEA has been charged to do within a framework embracinglimited and pragmatic regulation of research and treatment focused on ensuringpublic accountability rather than philosophical precision. Thus, any compromiseof thismanagerial governancemust be judged as more significant than any breachof its negotiation of ethical engagement.41 I now turn to consider these two relatedissues; first, on issues of ethics.

ON ETHICS: A MARKET IN MORALS?

The HFEA is a hybrid sort of authority, part regulation, part independentcommission; the “primary focus is regulation” but “we have a kind of advice roleas well and that is important.”42 The HFEA will always be closer to patients thanthe Human Genetics Commission and consequently closer to some of the healthconsequences.43 These give rise to clear if nonetheless contested questions ofethics.

The HFEA’s engagement with ethical issues has been more long-standing andperhaps more successful than its managerial engagement. Of course, this separationbetween economic and ethical issues is somewhat artificial, for it can be argued

36Ibid, 184.37Above, note 8 166.38Ruth Deech (1997) 5Child & Family Law Quarterly337.39Above, note 9, at 185.40Above, note 8 at 174.41Of course, as Helen Szoke has reminded me, self-regulation and government regulation are not

mutually exclusive. They deal with different things; the danger of emasculating a profession bytaking away judgment and control means that it is important that the regulatory tasks are divided—the profession manages clinical, scientific and technical standards and the law deals with publicpolicy issues. Second a legitimate role of a regulatory body is legitimisation. Therefore it has the jobof keeping fears of scientific progress at bay. Thirdly, science and medicine has such a bad publicimage in the UK with Lords committees looking at it and the Wellcome trust running surveys thatthis is even more reason for government to satisfy itself that standards are being met and protected,and there is a means to look at the operation of this profession.

42Above, note 12, Minutes of Evidence.43Ibid.

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(and plausibly so), that issues such as fee structure, access to treatment services,and so on, is but a manifestation of wider ethical issues wrapped in economic form,and from the perspective of both political philosophy and more broadly conceivedapplied ethics that is probably undeniably so. It is sometimes forgotten that theHFEA was assigned this dual role by the HFE Act 1990. As regulatory body andindependent advisory commission on the ethics of assisted conception and thescience that both lies behind it and informs it, the HFEA must also engage inscientific read forward of developments from current practices and possibilities.

For the most part, the debate carried on through the Warnock Report44 was lessconcerned with the restriction of the new infertility treatments than their adminis-tration. This may have been a peculiarly British debate, conducted at a particularmoment in history. The Conservative Government of Margaret Thatcher had noinclination to expand welfare provision and saw no need to incorporate these newtreatment services within a National Health Service into which it already wishedto engender greater competition and efficiency. If the technologies were not to bemade available through the National Health Service, then how would one regu-late clinical standards within private services? Hence, one of the problems for theHFEA in both its regulatory role and its advisory role has been that whereas theconsideration of the apparent issues by the Warnock Committee was dominatedby a public supply model, the HFEA as in fact emerged as a private market reg-ulator. And it is a regulator not only with circumscribed Parliamentary powersbut with political limitations too. This can be illustrated clearly in two different“market” negotiations in which the HFEA has found itself engaged; the case ofDiane Blood’s husband’s sperm and the bloody case of husbanding sperm dona-tions. Taken together they form two of the three slow deaths that the authority ofthe HFEA has suffered.

Mrs Blood, in the Courts, With the Treaty of Rome

The HFEA “seldom” becomes involved in decisions about the treatment ofindividual patients, so that decisions are usually taken in the individual clinic. Andwhen the HFEA did become involved in an individual case, instigated by DianeBlood, it was ensnared again. Mrs Blood’s desire to use the sperm of her deadhusband collected from him specifically for this purpose appeared to have fallenirredeemably against the barrier of the express intentions of Parliament. The Courtof Appeal, however, was ready to assist Mrs Blood in her “agonising situation,”45

which it did in accepting her argument that the HFEA’s decision refusing to makespecific directions allowing access to the sperm for export was an interferencewith her rights under Articles 59 and 60 of the Treaty of Rome.46 While stressing

44Report of the Committee of Inquiry into Human Fertilisation & Embryology, (Cmnd. 9314, 1984).45[1997] 2 All ER 687.46See alsoU v W (Attorney General intervening)[1997] 3 W.L.R. 739.

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the HFEA’s dominion of the substantive issue, Lord Woolf produced the trump ofEU law to finesse the cards dealt to the HFEA by the UK Parliament, shuffled andre-dealt the cards for the HFEA to play with and left the applicant holding all theaces.47

This inscription of compromise has real costs and it is hardly surprisingthat when the HFEA does attempt to invoke some principle to leaven the diet ofpragmatism this perceived breach in the practical, political settlement is greetedwith a temper little short of apoplexy by the clinics. This tension is increased bythe clinics’ more or less complete freedom to treat whomsoever they wish and—subject to the HFEA’s Code of Practice—on the terms, finance included, that theydraw up. The clinics’ mood—and their power—can be illustrated in responses toattempts by the HFEA further to controlhowtreatment services are delivered—forexample in mandating two embryo transfer rather than three48—or with what—altruistically donated sperm rather than sperm for which payment is made. Thistension is clearly illustrated in the HFEA’s attempts to introduce a principle stanceon payment for donated gametes, a defining battle, an authority sapping debaclefor the HFEA.

Anonymous Donor, With a Blank Cheque, in the Clinic

When, on the issue of payment for “donated” gametes, but more especiallysperm, the HFEA Annual Report in 1999 disclosed that

We became increasingly aware that the issue of payment [for gametes] could not be con-sideredas an issue of principlein isolation from others.49

this almost beggared belief. Ruth Deech compounded this by commentingthat “we do not feel that payment of £15 is so wrong that we are prepared tothreaten the entire service.”50

In Rachel Cooke and Susan Golombok’s study of semen donors commis-sioned by the HFEA, 71% of donors reported that “payment was very or mod-erately” important,51 and 62% reported that they would not have donated at allif not paid. Given that the fear of potential legal liabilities under HFE Act 1990s4452 does not appear to act as a deterrent to donation, the belief that “the entireservice” would be under threat if this level of threatened withdrawal of donorsmaterialised, appears little short of fanciful. The clinics had faced down the HFEA

47Lord Woolf, above, note 45 at 700.48Thus trespassing on the clinics desires to meet client demands to achieve “high birth rates” both “in

order to retain their HFEA licence and attract new clients.”49Human Fertilisation & Embryology Authority,8th Annual Report, 1999, at 28.50‘Payment to gamete and embryo donors’ (1999) 6J of Fertility Counselling6–7.51Cooke and Golombok, ‘A Survey of semen donation—phase 2: the view of the donors’ (1996) 10

Human Reproduction951–59.52and see (then) HFEA Code of Practice 1998 para 4.5i,requiring that donors be informed of the

possibility of litigation flowing from undisclosed defects in sperm.

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and inflicted significant damage on it in burying a flagship project. This issue ofprinciple had been foreshadowed as early as the Authority’s First Annual Report53

and announced fully in the Second Annual Report.54

By the Third Report (now informed by the Cooke and Golombok study) theHFEA had set up a Working Group to review payment and to consider “whetherwithdrawal of payment in money or in kind would result in a shortage of donors”55

and then convened a special conference to discuss the issues.56 By the 5th AnnualReport the HFEA was ready to announce its (still tentative) conclusions; “TheAuthority [has] concluded that a donation should be a gift, freely and voluntarilygiven.”57

Further delays ensued,58 and by the 8th Annual Report59 the policy, after aConsultation Paper and almost a decade of consideration, lay in tatters. Not onlywould the provision of donor treatments in the UK be “seriously undermined” byremoving payments, a surprising new vector had latterly entered the debate; “anemerging international trade,” facilitated through the internet, required a commit-ment to safe screened sperm through licensed centres in the UK which would bepreferable to the potential risks to patients in obtaining samples from abroad.60

Leave aside the non-sequitur, how this stored sperm was to be imported into the UKfor use in a licensed treatment centre without the HFEA’s imprimatur61 was not ex-plained. The gamete supply was at threat from the unwashed and un-screened fromabroad and the HFEA’s duty was clear. The Authority’s authority has probably yetto recover from the clarity.

ON ECONOMICS; THE SECRET LIFE OF THE HFEA, AGED 11 3/8

I observed earlier that themanagementfunction has emerged over the firstdecade of the HFEA’s existence as its most salient, critical area of responsibility.And here, it is now apparent, it has emerged at its most vulnerable to criticism. TheComptroller & Auditor General (Sir John Bourne) has disclosed that to ensure thatall treatments services are reported to the HFEA, the Authority has employed asystems data auditor to conduct a rolling programme of visits to licensed centres.This followed the reservation that the C&AG had added to the certificate to theHFEA’s accounts in 2001, as reported in the 10th Annual Report. There, Bourne

53Human Fertilisation & Embryology Authority,1st Annual Report, 1992 at 26.54Human Fertilisation & Embryology Authority,2nd Annual Report, 1993, at 29.55Human Fertilisation & Embryology Authority,3rd Annual Report, 1994 at 33.56Human Fertilisation & Embryology Authority,4th Annual Report, 1995, at 20–1.57Human Fertilisation & Embryology Authority,5th Annual Report, 1996 at 23.58Human Fertilisation & Embryology Authority,7th Annual Report, 1997 at 10.59published in 1999.60Human Fertilisation & Embryology Authority,8th Annual Report, at 28.61as required under HFE Act 1990 section 24(4).

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records that

. . . the evidence available to me was limited in respect of the £1.2 million recorded as licencefee income in the accounts. This amount is based on the number of patientsreported byclinics to the Authority. As I am not permitted access to patients’ records, I rely on the workof the Authority’s own staff in validating the number of treatments reported. The results ofsample testing indicated inaccuracies in reporting by clinics . . .62

In his Report (included for the first time in the HFEA’s 11th Annual Report),on the accounts for 2001–2002, the C&AG notes that following the appointmentof the data auditor “during 2001/02 only eleven out of 119 licensed centres werevisited, and of these eleven,fivehad under-reported their treatment cycles by anaverage of 3.1%.”63 Here we begin to get a better glimpse of the picture thatTheConsultation Paper on the Modernisation of Regulation & the New Fee Strategycoloured in the summer of 2002. The C&AG reports that:

. . . following my report on the 2000/2001 accounts, the Authority undertook a detailedreview to determine the possible extent of unbilled treatment cyclesover the previous nineyears.The Authority’s Internal Auditors64 estimated that the amount of licence fees whichwere properly due to the Authority, but had not been billed, was in the region of £600,000to £1.25 million, and could be more.65

The 11th Annual Report itself discloses that this internal audit indicated“significant errors” in the level of unbilled income.66 The implications of this arestaggering. They include the possibility of under or mis-reporting by the clinicsof treatment cycles that could affect their “success” rates; the possible failure by aclinic properly to comply with its licence, and hence statutory responsibilities, theparticular position of clinical members of the HFEA during those 10 years and, inthe immediate past, the positions and responsibilities of those who led the workof the HFEA.

The 10th Annual Report disclosed that Licence fee income for 2000/01 was£1.24 m compared with £1.58 m in 1999/2000. Apparently, clinics had been car-rying out fewer treatment cycles year on year, a surprising conclusion given thegeneral perception of the increasing “acceptability” and hence demand for assistedconception services. In the Statement of Internal Control we find a less than subtlechange of emphasis. While we are reminded, in terms similar to that accompanyingearlier Statements, that “the system of internal control is designed to manage ratherthan eliminate the risk of failure,” the then Chief Executive suggests that (for thefirst time) as Accounting Officer she has a responsibility to safeguard public funds

62Human Fertilisation & Embryology Authority,10th AnnualReport, at 50–1.63Human Fertilisation & Embryology Authority,11th Annual Report, at 38, emphasis added.64Incidentally changed from KPMG to Chantrey Vellacott DFK; Statement of Internal Control, Dr

Maureen Dalziel, Chief Executive HFEA, 15th July 2002,11th Annual Reportat 35.65Human Fertilisation & Embryology Authority,11th AnnualReport, at 38.66Human Fertilisation & Embryology Authority,11th AnnualReport, at 4.

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and the HFEA’s assets “for which I ampersonallyresponsible.”67 She promisesthat she expects to have the necessary procedures in place by the end of March2003 “to fully implement Treasury guidance on Turnbull.” As we now know, shewas not to survive in post to see this through;Ms Leather, with a borrowed stiletto,behind closed doors.

All of this has been proceeded in the Foreword to the Financial Accounts of2001/02 by an optimistic report from the Chief Executive in which a read forwardon 2002/03 “will see major developments in the modernisation of the HFEA.”These are said to include:r developing the corporate governance business processes of the HFEA so

as tourgentlyimplement recommendations of a recent review;r modernisation of the regulatory services to ensurerigorous, consistent andtransparentlicensing and inspection; andr processes that facilitate a more transparent approach to the work of theAuthority.68

It is those emphasised words that are truly alarming; urgently; rigorous; con-sistent and transparent. Things, as some one once said, can only get better.

The HFEA, Drowning Without Numbers, in the Computer Room

And yet, when we then turn to review the recent consultations on fees struc-ture,The Consultation Paper on the Modernisation of Regulation & the New FeeStrategy, we find whole-scale breaches of the Cabinet Office Code of Practiceon Written Consultations,69 and no Draft Regulatory Impact Assessment, as re-quired, again, by the Cabinet Office.70 The consultation paper calls for an increaseof the HFEA’s budget to £4.5 m pa, only obliquely indicating why this might berequired, and indicating “special project funding”71 of £1 m from the Treasury inaddition to other moneys which represented a massive budget increase for 2001–02. The delay in the publication of the HFEA’s 10th Annual report is noted, andthe Fees Strategy paper cross refers to the “problems with information technol-ogy” that have delayed “the publication of treatment statistics.” The Authority inits 11th Annual report recently has disclosed that licensed centres were asked toresubmit their data for 1999–2000 and 2000–2001, and that as of publication it “re-mains unable to provide correct detailed information on trends for the years since1999.”72

67Human Fertilisation & Embryology Authority,10th Annual Report, at 35, emphasis added.68Human Fertilisation & Embryology Authority,11th Annual Report, at 33.69Cabinet Office 2000,Code of Practice on Written Consultation.70Good Policy Making; a guide to Regulatory Impact Assessment, Cabinet Office 2000.71The Consultation Paper on the Modernisation of Regulation & the New FeeStrategy, para 28.72Human Fertilisation & Embryology Authority,11th Annual Report, at 12.

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The Fees Strategy Consultation paper had revealed that £3 m over 2001–02and 2002–03 is being made available for special project funding and that “projectfunding of about £3 m is likely to continuefor a few years.”73 Only obliquelyis the source of the problems requiring this funding eventually disclosed; the£3 m funding is “DoH ring fenced for the Data Register.”74 Evidently, then, thisenormous sum of money is to be made available to address the alarming indicationgiven in the HFEA’s 10th Annual Report that it had (while working on anotherissue) identified “technical problems with the quality of data for the period 2000–2001 and in the ease with which information could be retrieved to inform childrenborn as a result of licensed treatments.”75 A further indication of the possiblesize and scope of the “extensive project to correct this deficiency” is given inthe 11th Annual Report’s “Forward Look” where the HFEA discloses that theproject funding is to enable it to engage in the “capture, cleaning and transfer ofexisting” computer—held data. This in part will involve the “an historical audit ofinformation relating toall live births since the inception of the HFEA.” 76 Slowly,we can piece together that the HFEA has been drowning without numbers; that oneof thefundamental raisons d’etreof the HFEA is, or at least has been, at risk; themaintenance of a register about the licensed treatment services provided by clinics.

The HFEA records that it has been able to discharge its statutory responsibil-ities as a consequence of the “mutually supportive relationships” that it has built inthe Assisted Reproductive Technology community which includes clinicians, pa-tients, scientists, nurses, counsellors as well as professional and patient groups.77

Of course, this gives clinicians and the clinics a privileged status, one which to theirgreat discredit some of them have quite fragrantly and/or (surely) abused. Theremay be a lack of realisation that in terms of regulatory regimes the HFEA stilloperates within one of the most liberal laissez-faire schemes in Europe; a cursoryglance at the proposed Italian legislation of 2001 which successfully negotiated thelower house of deputies, would indicate that it is a privileged position that bringsboth private and public responsibilities towards the HFEA. Some clinics have beenfar too supine in the face of blatant attempts to wreck the HFEA’s authority. AsRuth Deech has put it:

There ought to be more trust and perhaps less paperwork all round. . . . the aim ought to bethat the departments [of government] trust the HFEA and the HFEA should trustmostofthe clinics.”78

Note that “most.” This leads into the final section, on the Authority’s engage-ment with the exotic.

73Above, note 71, at 62.74Above, note 71, at para 65.75Human Fertilisation & Embryology Authority,10th Annual Report, at 11.76Human Fertilisation & Embryology Authority,11th Annual Report, at 12.77Human Fertilisation & Embryology Authority,11th Annual Reportat x.78Select Committee on Science & Technology, Minutes of Evidence, 24th April 2002.

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OF EXECUTIVES, EXPERTS, THE ELECTED AND THE EXOTIC

The HFEA as a Public Body

The HFEA may have been well prepared in dealing with the statutory require-ments of the 1990 Act, although surprised by the nature and speed of scientificchange. But, and this is evident from the very earliest exchanges with Ruth Deechin the House of Commons Science & Technology Committee, it was not wellprepared for, and has until very recently responded to poorly (or badly in thewords of the C & AG) the new governance arrangements in place that seek ei-ther to supplement or supplant those measures for otherwise securing democraticaccountability.

The birth and spread of the notion of corporate governance from the private tothe public sector has shone new light and imposed new burdens and requirements onpublic institutions thatbecausethey were public seemed to assume that their veryexistence was both conducive to the public good and amenable to the comfortableassumptions as to how they achieved that. Having been conceived in the corridorsof power, some next step agencies (the Passport Agency is another good example)appeared to have assumed that they could trade in the “corridors of indifference.”The HFEA seems to have been caught largely unawares that it may be subject toa regime of accountability other than that of its governing statute. As Ruth Deechwas to put it to MPs, “. . . it hasbecome very difficult to cope with. . . the ever morestringent requirements. . . on the budget.” With “more difficulty” the HFEA triedto cope with more requirementsimposedon it; “new attitudes towards corporategovernance, much more by way of paperwork, things like risk assessment, qualitycontrol, performance indicators, and so on.” She confessed that the HFEA hadfound these “more onerous latterly” and “we were always,maybequite rightly,being held to account for one thing or another.”79 In its 2ndQuinquennnial review,the reviewers recommended that the Authority should work towards having moreopen and transparent working practices.80

The HFEA is caught not so much by the mood as the temper of the timesand is entering a critical period in its 12 year history. The political exasperationoccasionally exhibited by the House of Commons Science & Technology Com-mittee has signalled a departure from and a desire to re-negotiate the democraticsettlement between science and society of which the HFEA, created at the end ofthe 1980s after Warnock, is emblematic. The 11th Annual Report of the HFEAheralds a dramatic shift of emphasis, from operating almost in camera to beingmore candid.

Calls for reform of the 1990 Act have been growing more shrill and insistentin the past five years. Not only is this not surprising it was much to be expected.

79Ruth Deech, above note 78, Evidence at 6.80Quniquennial Review 2 at 5.

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The Act is not a comprehensive code of fertility law, and although the Act whenpassed was incomplete it did not mean that it was unwelcome; “but it will notbe the last word on the subject.”81 Annotation was always likely to be necessary,and amendment in such an innovative field was also likely better to be able tounderstand the nature and type of regulation that is properly called for. This sortof opinion and approach had commended itself to the HFEA at the conclusion ofits review with the Human Genetics Advisory Commission ofCloning Issues inReproduction, Science and Medicine.82 They jointly observe that because of thepace of scientific advances, the issues need to be kept under regular review. Theyrecommended that the issues be re-examined in five years time, “in the light ofdevelopments and public attitudes towards them in the interim.”83

Inevitably, leading pro-life charities such as LIFE and CORE have remainedresolutely opposed to aspects of the HFEA’s work, notably any form of destruc-tive embryo experimentation. Peter Garrett of LIFE expressed their dismay at theHampshire Clinic’s “loss” of human embryos and the transfer of others to the wrongwomen. He called upon the Government to restructure completely the Human Fer-tilisation and Embryology Authority to prevent a proliferation of such cases; “TheHFEA had evaluated this clinic a short time before these serious problems cameto light and had given it a clean bill of heath.”

Of course, experimentation on human embryos is not aninherentlydesirableactivity, it is not something that any one would undertake without a serious andnecessary purpose. It is undertaken by those who most strongly defend the practicein order to produce real benefit to real and potential human patients. The mostcommitted supporters of embryo research justify research on the basis that theembryo, even of the human species, has no moral status, or none sufficient to justifyits special protection.84 The 1990 Act seeks to enshrine a different view, one whichholds that the embryocomes to acquire or attaina status worthy of protection, butonly at the beginning of the appearance of the primitive streak, or 14 days after theonset of the process of fertilisation.85 Those who, however cautiously, accept theneed for if not the necessary desirability of embryo research, those who attemptto understand the desire for IVF, do not have a monopoly of the wisdom here. It isfor that reason, and I think that I break few confidences of any consequence here,that Alastair Campbell and I insisted on a cautious approach—the “middle way”view that had commended itself to the US President’s Commission—in the finalreport of the CMO Expert Group on Stem Cell Research. I say cautious becausewe advised—advice that was accepted—that embryo research should be reviewedand if need be recalled if it was shown by subsequent scientific developments to

81Derek Morgan and Robert Lee,Human Fertilisation and Embryology: Regulating the ReproductiveRevolution, London, Blackstone Press, 2001, at p. 32.

82(London, HFEA, HGAC, 1998).83Ibid, at para 9.7.84Morgan and Lee, above note 81.85Section 3(1), (3)(a).

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be unnecessary. On this view, one might hold that, recognising the offence thatembryo research causes to others, it would be desirable and necessary both tominimise the amount of research undertaken and to continue to explore ways toreplace research on embryos altogether.86

The Government’s response to the Science & Technology Committee sendsan equivocal message. It was clearly stung by some of the views and recommen-dations of Ian Gibson’s Committee. While acknowledging that understanding andtechnology in the field of reproductive medicine has moved on since 1990, theDoH confessed that “we believe the 1990 Act is functioning reasonably well andprovides a framework within which new advances can be appropriately accom-modated.”87 Nonetheless they committed to keeping developments under reviewto ensure the legislation covers them effectively. The House of Lords Select Com-mittee on Stem Cell Research had already anticipated a need for urgent legislationif theQuintavalle casewere to go to the House of Lords (as it did) and the Govern-ment were to lose the final appeal (as it did not).88 And Gibson argued that even ifthe Court of Appeal’s judgment had stood, “it is likely that there will be a need forfurther legislation at a fairly early date to take account of developments that havetaken place since 1990.” Although the 1990 Act provides an in-built legislativebrake on research on human embryos, the House of Lords Committee called fora more strategic examination of the potential of adult stem cells “in the not toodistant future.”89

Concluding theDevelopments in Human Embryology and Geneticsreportthe House of Commons Science & Technology Committee clearly disclosed theirpreference for more whole-scale review, recommending that Government conducta thorough review of advice and regulation across medical genetics, embryologyand reproductive medicine.90

Towards a Mature HFEA; Experts and Exotica

the Authority has a responsibility to communicate effectively with the public. This is im-portant to enable the public to have input to the development of policies.”91

There is a gradually emergent tension in the 1990 Act as to whether theHFEA is a patient protection society or cheerleader for responsible Britishscience. In terms of public perceptions, there is probably very little detailed

86This of course is the view that commended itself to the Chief Medical Officers Expert AdvisoryCommittee in their report,Stem Cell Research: Medical Progress with Responsibility, London,Department of Health, June 2000.

87Above note 34 at 34.88House of Lords,Committee on Stem Cell Research(Session 2001–02 HL 83(i)), at para 8.17.89Ibid, at para 8.14.90Ibid, at para 13.91Department of Health,Government Response to the Report From the House of Commons Science

and Technology Committee: Developments in Human Genetics and Embryology, November 2002,Cm 5693.

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understanding of the work that the HFEA does.92 Suzi Leather has said that theHFEA’s “core challenge” is “communicating what the possibilities of the scienceare, what the benefits and dis-benefits are.”93 A great deal of the public under-standing of science comes from the press;94 to that extent, the HFEA is itselfdependent on the press to get across information about its work. The WellcomeTrust’s findings that “the language chosen when describing scientific researchhas a major impact on participants” is relevant here. Wellcome reported that asinterviewees’ awareness increased, so did their “concern and apprehension.” Todate the HFEA has completed 11 formal public consultations and published theirlatest consultation document “Sex Selection: Choice and Responsibility in Hu-man Reproduction” in October 2002. The HFEA and HGC Consultation Paper,Outcome of the Public Consultation on Preimplantation Genetic Diagnosis, re-ported that of the responses to the consultation paper 68% were in favour of PGDin general. The salient point for the moment lies in the numbers; merely171responses.

The Committee on Science & Technology of the House of Lords observedin its report on the relationship between science and society95 that “Science todayis exciting, and full of opportunities. Yet public confidence in scientific advice toGovernment has been rocked.”96 Among the many conclusions of the report, whichrecommends a greater level of openness in the reporting of scientific endeavours,is this telling observation; “framing the problem wrongly by excluding moral,social, ethical and other concerns invites hostility.”97 ‘Experts’ have come to beseen as affording what Leon Kass has called an “accommodationist ethic” thatwill rubber-stamp all biomedical innovation, in the mistaken belief that “all othergoods must bow down to the gods of better health and scientific advance.”98 It ishardly any wonder, then, that in calling for greaterregulationFukuyama claimsthat the time when governments could deal with questions of bio-technology byappointing commissions that bring scientists together with “learned theologians,historians and bioethicists. . . is rapidly drawing to a close.”99 And here is a tensionin aspects of the HFEA’s dual role.

92House of Commons,Select Committee on Science & Technology, Minutes of Evidence, 24th April2002.

93House of Commons, Science and Technology Committee,Developments in Human Genetics andEmbryology, Fourth Report of Session 2001–02, HC 791, para 8.

94ibid.95House of Lords,Select Committee on Science & Technology, 2000, at 304.96Ibid.97Ibid.98Leon R. Kass, “The Wisdom of Repugnance.” In L. R. Kass and J. Q. Wilson.The Ethics of Human

Cloning. Washington: The AEI Press, 1998, p. 12.99Francis Fukuyama,Our Post Modern Future; Consequences of the Biotechnology Revolution,

London, Profile, 2002, 203–04.

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Scientific Citizenship and the EngagementWith the Exotic

Work on the public understanding of science has pursued an important goalof opening up to enquiry the essentially social processes of scientific consensus.But there remains much to do to in terms of completing the project “scientificcitizenship,” whichadditionally involves a critical examination and elucidationof the scientific understanding of the public. On the one hand, there has neverbeen a time when the issues involving science were more exciting, the publicmore interested, and opportunities more apparent. But, the “. . . public unease,mistrust and occasional outright hostility” which the House of Lords Committeenoted, “are breeding a deep anxiety amongst scientists themselves.”100 But whatthen follows in the Committee’s view, is discussed as almost exclusively an is-sue of the public understanding and acceptance of science, and not, also, viceversa. The Committee’s comprehension of what it calls “democratic citizenship”is essentially uni-directional.101 Where the House of Lords Select Committee onscientific citizenship envisages a uni-dimensional relationship, perhaps not sur-prisingly, that of the House of Commons foresees and calls for a more inclusiveone.102

The modern regulatory choices such as those with which the HFEA ischarged have been described by Alan Hunt as an engagement with moral poli-tics103—an appointment made at the interface of the political and the moral. Ifthis is so, much of what is expected of regulating biomedicine has as great apolitical as moral dimension. Increasingly, regulation is understood to be under-taken in, and as part of, the changing economic constitution of western liberaldemocracies. These decisions, then, are political in that they relate both to widerstructural questions within society, and also in their capacity to generate argu-ment between interest groups with strong affiliations to particular sides of theargument and government. Regulatory flexibility may be opportune in delimit-ing the extent to which government need stray into this realm of “moral poli-tics.”104 There is a striking illustration of this in the exchanges between RuthDeech and the House of Commons Science & Technology Committee. Respond-ing to a question on the HFEA’s mandate to take individual case-by-case decisionson pre-implantation genetic diagnosis, she argued that “the fact that the HFEAtook that decision protects Members of Parliament from direct involvement in

100House of Lords,Select Committee on Science & Technology, 2000.101Op cit., para 1.11.102House of Commons, Science and Technology Committee,Developments in Human Genetics and

Embryology, Fourth Report of Session 2001–02, HC 791.103Alan Hunt, Governing Morals: A Social History of Moral Regulation, Cambridge, Cambridge

University Press, 1999.104The previous Labour administration of the 1960s has been portrayed as a reformist liberal party

specifically in this arena of moral politics.

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that sort of thing, which I may venture to say is right.”105 Some matters underthe statute are “perhaps, too detailed for Members of Parliament to debate oneach separate occasion.” The delegation of regulatory discretion means that it isthe regulator that faces the challenge from those disappointed by the boundariesdrawn.

We need to be alert to ensure that scientific citizenship means an engagementwith ethics as well as with politics. But, involvement in ethics, unlike politics, isnot a simple matter of hustings and numbers. Scientific citizenship can, of course,be based as much on prejudice and ignorance, emotion and discrimination as onreason and conclusion. A simple instrumentalisation of ethics, a vote for everyexperiment, is as much a “decent into unreason”106 as unthinking applicationof scientific method without reflection. The second greatest challenge facing theHFEA is to contribute to and hold one of the rings in that debate. Managing thebalance between that and its licensing and regulatory function is probably its firstand greatest challenge.

105Select Committee on Science & Technology, Minutes of Evidence, 24th April 2002, at 2.106Tony Blair quoted in Department of Health,Government Response to the Report From the House of

Commons Science and Technology Committee: Developments in Human Genetics and Embryology,November 2002, Cm 5693.

ethics, economics and the exotic: the early career of the hfea

Documents