a lack of foresight? jurisdictional uncertainties in the regulatory interface between the hfea, the...

© 2007 The Author. Journal Compilation © 2007 The Society of Legal Scholars. Published by Blackwell Publishing,9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA

Legal Studies, Vol. 27 No. 3, September 2007, pp. 511–535DOI: 10.1111/j.1748-121X.2007.00055.x

A lack of foresight? Jurisdictional uncertainties in the regulatory interface between the HFEA, the UK Stem Cell Bank and beyond

Dr Ryan Morgan*

University College Cork

Much of the legal attention surrounding human embryonic stem (ES) cell research withinthe UK has, to date, focused on cloning techniques. Whilst this is both understandableand appropriate given litigation on this topic, there has been less focus on other areas.This paper identifies and analyses areas of incoherence and deficiency within the regula-tory architecture governing human ES cell derivation and research within the UK. Thisis not merely a theoretical exercise, as there are indications that many of the policyobjectives currently being pursued in this area have, at best, a shaky jurisdictional basis.It is all too easy to recall that lobby groups have challenged the Human Fertilisation andEmbryology Act 1990, the legislative foundation for embryo research and most infertilitytreatment, on the basis of jurisdictional uncertainty and statutory interpretation. Whilstmany pro-life campaigners are opposed to ES cell research on ethical grounds, thearguments utilised thus far in relation to litigation have been entirely legal, involvingissues of statutory interpretation and whether the regulator, the Human Fertilisation andEmbryology Authority (HFEA), or the Department of Health have acted ultra vires the1990 Act. This paper will reveal that there are a number of further areas which might beopen to attack on this basis.

From a legal perspective, perhaps the most significant criticism which may belevelled at the governance of human embryonic stem (ES) cell research in the UK isthat it has been forced to conform to regulatory mechanisms ill-suited to the task.When the Human Fertilisation and Embryology Act 1990 (the 1990 Act) was passed,human ES cell research was not truly foreseen by legislators as a possibility. Indeed,it was not until 1998 that the first reported derivation of a stem cell from a humanembryo was published.

1

Nevertheless, when scientific developments in this areaemerged, policy makers (both legislative and executive) responded by trying to

* This paper has its basis in a PhD thesis entitled

The Regulation of Human EmbryonicStem Cell Research in the United Kingdom

(Cardiff University, 2005). I would like to extendmy thanks to my supervisors, Professors Bob Lee and Andrew Grubb, and viva panel, Profes-sors Jean McHale, Søren Holm and William Lucy. I would also like to thank the two anonymouspeer reviewers of this paper and Professor Jenny Steele for their thoughtful and constructiveadvice. Responsibilty for any remaining errors rests with myself.

1.

JA Thomson et al ‘Embryonic stem cell lines derived from human blastocysts’ (1998)282(5391) Nature 1145.

512 Legal Studies, Vol. 27 No. 3

© 2007 The Author. Journal Compilation © 2007 The Society of Legal Scholars

‘shoe-horn’ ES cell research into a template not designed for this purpose. There isa mix of hard (legislative) and soft (guidance-driven) regulation in this field that is aproduct of attempts to accommodate perceived benefits and detriments to novel areasof research without revisiting the operative legislation. This was not the best approach,as it prevented an holistic reappraisal of the law surrounding embryo research in lightof emerging technologies and scientific opportunities. Other commentators

2

haveillustrated many of the obvious ambiguities surrounding interpretation of the 1990Act and the Human Fertilisation and Embryology (Research Purposes) Regulations2001, SI 2001/188 (the 2001 Regulations). This paper will explore some other poten-tial hazards implicit in the application of the current regulatory model to the burgeon-ing field of ES cell research. Specifically, this paper examines the implications ofpolicy surrounding the ‘banking’ of embryonic stem cells in the UK Stem Cell Bank,the regulation of secondary research using ES cells withdrawn from the bank, andthe apparent disconnection between the current regulatory model and the prospect ofES cell-based therapies.

Such discussions are timely, in that the government has announced two initiativeswhich will most likely involve a restructuring of the regulatory architecture. The first,which is motivated by a desire to cut perceived costs and bureaucracy associated witharms-length bodies, is to abolish the HFEA and the recently established HumanTissue Authority (HTA) and subsume their powers into one ‘super-regulator’, theprovisionally entitled Regulatory Authority for Tissue and Embryos (RATE).

3

Thesecond, perhaps more substantive, development is the ongoing review of the operationof the 1990 Act.

4

Whilst this review encompasses issues both distinct and broaderthan ES cell research, it provides an opportunity to address the jurisdictional uncer-tainties identified herein. In order to facilitate both these reforms, the government has

2.

See, eg, R Brownsword ‘Regulating human genetics: new dilemmas for a new millen-nium’ (2004) 12(1) Medical Law Review 14; R Brownsword ‘Stem cells, superman, and thereport of the Select Committee’ (2002) 65(4) Modern Law Review 568; S Halliday ‘A com-parative approach to the regulation of human embryonic stem cell research in Europe’ (2004)12(1) Medical Law Review 40; A Grubb ‘Cloning (cell nuclear replacement): the scope of theHuman Fertilisation and Embryology Act 1990’ (2003) 11(1) Medical Law Review 135; APlomer ‘Beyond the HFE Act 1990: the regulation of stem cell research in the UK’ (2002)10(2) Medical Law Review 132; D Morgan and M Ford ‘Cell phoney: human cloning after

Quintavalle

’ (2004) 30 Journal of Medical Ethics 524.

3.

Department of Health

Reconfiguring the Department of Health’s Arm’s Length Bodies

(2004) pp 12–13, available at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID

=

4086081&chk

=

y4UIfP. Within this policy document, it was proposed that the new consol-idated body should be entitled the Regulatory Authority for Fertility and Embryology (RAFT).However, now RATE has been adopted as the favoured nomenclature (see White Paper, belown 5, p 26, para 3.2).

4.

See ‘Speech by Melanie Johnson MP, 21st January 2004: Donor anonymity and review’

Department of Health Speeches

(21 January 2004), available at http://www.dh.gov.uk/en/News/Speeches/Speecheslist/DH_4071490 and Department of Health

Review of the Human Fertili-sation and Embryology Act: A Public Consultation

(2005), available at http://www.dh.gov.uk/Consultations/ClosedConsultations/ClosedConsultationsArticle/fs/en?CONTENT_ID

=

4123863&chk

=

zy5dcI.

http://www.dh.gov.uk/PublicationsAndStatistics/Publications/

http://www.dh.gov.uk/en/News/

http://www.dh.gov.uk/

A lack of foresight? 513


recently published a White Paper,

5

with the intention of putting into effect the aboveinitiatives. The suggested reforms are an attempt to ensure that the broad areas ofassisted reproduction and embryo research are governed by a ‘forward-looking reg-ulatory scheme that is targeted and proportionate, as well as intelligible and enforce-able’,

6

and that the legislative framework underpinning the regulation is both‘effective and fit for purpose’.

7

Presently, there is an opportunity to address some ofthe more longitudinal concerns discussed below.

WHAT ARE ES CELLS?

Human ES cells were first derived by Dr Jamie Thomson in 1997.

8

At the outset, itwas recognised that ES cells possessed some startling qualities. First, ES cell linesappear to be ‘immortal’ in that they can be propagated indefinitely in culture withoutdifferentiation into more specialised cell types. Secondly, and not withstanding thischaracteristic, ES cells are ‘pluripotent’. This means that they may differentiate intomore specific stem cell types (‘multipotent’ or ‘adult’ stem cells), or even somaticcells. ES cells may differentiate into any cell type which makes up the human body.

9

The potential applications of ES cells for clinical tissue therapy, or even engineering,are obvious. Moreover, research using ES cells will lead to greater understanding inembryonic development and cellular behaviour (including cancer).

10

In particular, itis hoped that research using ES cells will provide indicators on how to reprogramme(or ‘dedifferentiate’) adult cells into more pliable states. This would allow a patient’sown cells to be used to create differing tissue types for therapy. However, the currentshortfall in scientific knowledge surrounding ES cells is prohibitive for anything otherthan research. In particular, the pluripotency of ES cells makes controlling theirpropagation exceptionally difficult. The prospect of uncontrolled cell growth leadingto tumours akin to cancer is a particular worry.

11

Moreover, ES cell lines are

5.

Department of Health

Review of the Human Fertilisation and Embryology Act

Cm6989, 2006, available at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_073098.

6.

Ibid, p v (foreword of Caroline Flint MP, Minister of State for Public Health).

7.

Ibid, p 1, para 1.2.

8.

Thomson et al, above n 1.

9.

The interested reader should refer to the Chief Medical Officer’s Expert Group Reviewingthe Potential of Developments in Stem Cell Research and Cell Nuclear Replacement to BenefitHuman Health

Stem Cell Research: Medical Progress with Responsibility

(2000), available athttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuid-ance/DH_4065084; President’s Council on Bioethics

Monitoring Stem Cell Research

(2004),available at http://www.bioethics.gov/reports/stemcell; and National Institutes of Health

StemCells: Scientific Progress and Future Research Directions

(Department of Health and HumanServices, 2001), available at http://stemcells.nih.gov/info/scireport/2001report.htm.

10.

Much work has already been carried out using embryonal carcinoma (EC) cells takenfrom tumours (see, eg, PW Andrews et al ‘Pluripotent embryonal carcinoma clones derivedfrom the human teratocarcinomas cell line Tera-2. Differentiation i

n vivo

and

in vitro

’ (1984)50(2) Laboratory Investigation 147).

11.

M Tzukerman et al ‘An experimental platform for studying growth and invasiveness oftumor cells within teratomas derived from human embryonic stem cells’ (2003) 100(23)Proceedings of the National Academy of Sciences of the United States of America 13507.

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4065084

http://www.bioethics.gov/reports/stemcell

http://stemcells.nih.gov/info/scireport/2001report.htm



maintained in culture using animal feeder layers, and this creates its own concernsaround validation and xenozoonosis.

12

THE HFEA AND SECONDARY RESEARCH USING HUMAN ES CELL LINES

The regulatory system in the UK draws a de facto distinction between derivation ofhuman ES cells and research utilising subsequently propagated ES cell lines. Theformer comes under the aegis of the embryo research provisions of the 1990 Act, asit involves the instrumentalisation (and destruction) of a human embryo maintainedin vitro for the purposes of a licensable research objective. The latter, however, doesnot. Despite originating from a human embryo, and perhaps best classified as ‘embry-onic material’, a human ES cell does not fall within either the medical or legal

13

definition of a human embryo. In the same way that anatomical dissection of apreserved human heart does not in itself entail intervention on the human donor, sosecondary research utilising ES cell lines does not involve interfering with the originalembryo. This can only happen once – at derivation. ES cell lines propagated fromthis source might be used for a variety of different purposes, and may last indefinitely.Each subsequent use of an ES cell line does not entail, at least legally, utilisation ofa human embryo.

Consequently, the HFEA cannot exercise direct jurisdiction over secondary ES cellresearch, as it is only charged with regulation of human embryo research, not researchusing human ES cell lines. The better view is that the HFEA can authorise derivationas a means to an end for the purposes of a primary ES cell research project withlicensable objectives. These initial projects, of which 16 are currently licensed, comewithin the HFEA’s jurisdiction as they are inextricably linked with the utilisation ofthe human embryo in the first place. Indeed, it is the objectives of a research projectwhich, to some degree, legitimise the utilisation and destruction of a human embryo,and the infringement of its moral status. However, what of any propagated ES celllines left following conclusion of the licensed project? It is clear that these cell linesdo not come within the statutory licensing and inspection framework. Consequently,any regulation of secondary human ES cell research operates in an environmentdistinct from the legislative controls associated with embryo research and ES cellderivation. Indeed, a central repository for the collation and dissemination of allhuman stem cell lines, including ES cells, has been established and funded by theMedical Research Council (MRC) and the Biotechnology and Biological SciencesResearch Council (BBSRC). This repository is the UK Stem Cell Bank, and is notlicensed by the HFEA. This regulatory demarcation is evident from the bank’s ownliterature:

12.

Trans-species infection of pryonic, bacteriological or viral material via implantation ofanimal tissue into humans. However, the Centre for Genome Research at the University ofEdinburgh has made some headway in the development of feeder layers to circumvent thisproblem. A molecule developed by the centre, named ‘Nanog’ from the Gaelic ‘Land of theYoung’ (

Tír na nÓg

), might spell the end of using animal serums for the maintenance andpropagation of ES cell lines if replicated in human ES cell lines (I Chambers et al ‘Functionalexpression cloning of Nanog, a pluripotency sustaining factor in embryonic stem cells’ (2003)113 Cell 643).

13.

Human Fertilisation and Embryology Act 1990, s 1(1).



‘The HFEA’s regulatory responsibility is for research using human embryos.Stem cells taken from an embryo are no longer the subject of regulation by HFEAwith the exception of the requirement to fulfil conditions of the licence [for depositof cell lines in the Bank] . . . The conservation and use of human embryonic stemcells and stem cell lines is the responsibility of the Steering Committee . . .’

14

Nevertheless, it would be a mistake to assume that therefore the HFEA, and byextension the 1990 Act, has no bearing on secondary ES cell research. The interfacebetween the two regulatory environments, those governing derivation and secondaryresearch, is characterised by close liaison between the HFEA and the UK Stem CellBank. This relationship allows for the retention and imposition of some hallmarks ofHFEA licence restrictions on secondary research projects.

THE RELATIONSHIP BETWEEN THE HFEA AND THE UK STEM CELL BANK

It is a condition of all HFEA research licences authorising derivation that a sampleES cell line be deposited with the UK Stem Cell Bank upon completion of the primaryresearch project.

15

Indeed, standard licence conditions go further, insisting that if theoriginal derivor of human ES cells wishes to use a sample for a research project notspecified in the licence, then approval must be sought from the UK Stem Cell BankSteering Committee.

16

Similarly, the original derivor of an ES cell may not transfercell lines to a third party unless so named on the HFEA licence

17

or authorised bythe Bank’s Steering Committee.

18

This effectively establishes a dedicated supply ofES cell lines of which the bank is the sole beneficiary. The bank will then disseminateES cell lines in accordance with its own code of practice, with oversight of theSteering Committee. It should also be noted that the Chair of the HFEA has observerstatus on the Steering Committee.

19

However, the legal basis for this arrangement between the HFEA and the UK StemCell Bank has never been explored. Whatever the merits of the policy, does the HFEAhave jurisdiction to place positive obligations on the holder of a research licenceto pass an ES cell line sample to the Bank, and prevent them from using cell linesfor purposes outside the original licence or transferring samples to unauthorisedthird parties? This relationship between the HFEA and the bank is a lynchpin of

14.

UK Stem Cell Bank Steering Committee

Code of Practice for the Use of Human StemCell Lines Cell Bank

version 3 (2006) p 8, para 3.2, available at http://www.ukstemcellbank.co.uk/code.html.

15.

See Human Fertilisation and Embryology Authority

Twelfth Annual Report and Accounts2002–2003

(2003) p 21, available at http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-0E98DD41/hfea/hs.xsl/394.html; and Human Fertilisation and Embryology Authority

Regula-tion of Research on Human Embryos

(2004) paras 11, 16 and 18.

16.

UK Stem Cell Bank, above n 14, pp 7–8, para 3.2.

17.

Ibid, p 14, para 8.3.

18.

Ibid.

19.

Currently Ms Shirley Harrison. Previously, an additional member of the HFEA was alsoa full member of the Steering Committee (Professor Tom Baldwin, Department of Philosophy,University of York). Whilst Professor Baldwin remains on the Steering Committee, he is nolonger a member of the HFEA. In addition, Professor Sir Martin Evans (Professor of Mam-malian Genetics, Cardiff University) is a member of both the UK Stem Cell Bank SteeringCommittee and the HFEA’s Horizon Scanning Expert Panel.

http://www.ukstemcellbank

http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-



government policy in this area and, if the interface is not jurisdictionally sound, thenit will invite legal challenge. After all, it is accepted that ES cells, despite theirpotential, are not human embryos and, as such, do not come under the HFEA’s control.Consequently, how can the HFEA have power to direct its licence-holders as to thetransfer and use of ES cell lines?

A possible answer lies in an examination of the HFEA’s powers to direct thedisposal of embryos and embryonic material following its termination or destruction.The HFEA does not license embryos as such, but rather their instrumentalisation(including destruction) in projects of licensable research. A research licence can onlybe granted following thorough review of all aspects of the proposed protocol. Thiswill include methods of termination of embryonic development and disposal ofembryonic remains and material. The code of practice states:

‘The special status of the human embryo is fundamental to the provisions ofthe HFE Act. The termination of the development of a human embryo and thedisposal of the remaining material are sensitive and delicate issues. Treatment andresearch centres are expected to take this into account when considering how thedevelopment of an embryo is to be brought to an end and what is to happenthereafter. The approach to be adopted will depend on whether the embryos arebeing stored for treatment or to be used for research.’

20

The HFEA code of practice reflects the view that the method of disposal of anyremaining embryonic material is a matter of specific concern. An explicit, if partial,corollary to this can be found in the text of the Act, which states that the ‘personresponsible [must ensure] that proper arrangements are made . . . for the disposal ofgametes or embryos that have been allowed to perish’.

21

However, the broader powerlies in para 3(7) of Sch 2 to the 1990 Act, which states that a research licence ‘maybe granted subject to such conditions as may be specified in the licence’. As a licenceauthorises the whole of a research project, not just those specific parts of a protocolthat utilise human embryos, then clearly disposal of embryonic material falls withinthe licensing aegis. In the context of embryo research, para 9.2 of the code of practicestates:

‘Where embryos are used for research, the research centre is expected to decideat the outset:

(i) The duration of the culture period and

(ii) The method to be used to terminate development and

(iii) The procedure to be used to ensure that embryos do not develop after 14days or (if earlier) the appearance of the primitive streak.’

22

In the case of ES cell research, it is the isolation of the stem cells themselves whichis the method of termination. This also ensures that the embryo does not developbeyond the 14-day period. Furthermore, derived ES cells and propagated cell lineswill be remaining embryonic material within the meaning of para 8.10 of the code.

20.

Human Fertilisation and Embryology Authority

Code of Practice

(6th edn, 2003) p 82,para 8.10, available at http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-A3EFDADE/hfea/hs.xsl/371.html.

21.

Human Fertilisation and Embryology Act 1990, s 17(1)(c).

22.

HFEA

Code of Practice

, above n 20, p 82.

http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-A3EFDADE/



This lends credence to the view that the extracted components of an embryo comewithin the remit of the research licence. Simply put, if a research project entails thederivation of cells from an embryo, then it is feasible to extend the remit of the licenceto cover what happens to the method of disposal of those cells, or an ES cell line, as‘remaining material’. The wide powers given to the Licence Committee underpara 3(7) of Sch 2 will allow for this. Essentially, licence conditions on the means ofdisposal impose further activities into the research protocol. However, disposal doesnot necessarily mean destruction, as para 3(7) of Sch 2 is certainly broad enough toallow a stipulation directing transfer of an ES cell line sample to an approved thirdparty, such as the UK Stem Cell Bank.

COMPARISON WITH JUDICIAL APPROACH TO PRE-IMPLANTATION GENETIC DIAGNOSIS

Further support for this view can be found in the Court of Appeal decision in

R(Quintavalle) v Human Fertilisation and Embryology Authority

.

23

That case involvedthe granting of a treatment licence by the HFEA for the purposes of Pre-implantationGenetic Diagnosis (PGD) and human leukocyte antigens (HLA) typing, more com-monly called ‘tissue typing’. Zain Hashmi, a 4-year-old boy, was born with betathalassaemia major. This blood condition is exceptionally life threatening and neces-sitates regular blood transfusions in conjunction with a significant drug regimen.Whereas his best hope for a cure was a donation of haematopoietic stem cells,unfortunately no one in his family was a matching donor. This led his mother, MrsShahana Hashmi, to seek IVF in order to produce and select an embryo which wouldbe a suitable match for Zain, whilst not carrying the genetic disease. This procedureentails fertilisation of a number of embryos by IVF, and then removal of a singleembryonic cell from each embryo at the six–eight cell stage. These cells are thenanalysed using molecular genetics in order to determine whether it is a carrier of betathalassaemia major (this technique is PGD). In turn, this procedure can be used toexamine the HLAs of the embryonic cell, thus establishing whether the embryo hasa compatible tissue type with the ultimate patient. Finally, if a suitable embryo wereidentified, then this would be implanted in the mother and brought to term. Haemato-poietic stem cells would then be taken from the umbilical cord in order to treat Zain.

The HFEA issued a licence permitting this combination of diagnostic and selectiontechniques for the twin purposes of producing a healthy child and treating an existingsick sibling. However, Josephine Quintavalle on behalf of Comment on ReproductiveEthics (CORE) objected to this and sought judicial review of the HFEA’s decision.She did so mainly on the basis that tissue typing is prohibited without a licence unders 3(1)(b) of the 1990 Act as the technique ‘uses’ an embryo but that nevertheless atreatment licence could not be issued by the HFEA under s 11(1)(a). According toMrs Quintavalle, this was because the definition of ‘treatment services’ under s 2(1)of the 1990 Act meant the ‘assisting of women to carry children’. As neither tissuetyping (nor PGD, for that matter) assists a woman to carry a child, then it is unlic-ensable. She was successful at first instance,

24

but this was overturned by the Court

23.

[2002] EWHC 2785 (Admin), [2003] 2 All ER 105; [2003] EWCA Civ 667, [2004] QB168; [2005] UKHL 28, [2005] 2 AC 561 (also called ‘the CORE litigation’ in this paper).

24.

[2002] EWHC 2785 (Admin), [2003] 2 All ER 105.



of Appeal.

25

The Court of Appeal’s judgment was subsequently affirmed by the Houseof Lords.

26

From the perspective of ES cell research and control of cell lines, it is the first ofMrs Quintavalle’s arguments that is of interest. She contended that both the biopsyof an embryonic cell and its examination for the purposes of tissue typing were the‘use’ of ‘an embryo’ under s 3(1)(b). The HFEA argued that, whilst removal of anembryonic cell is certainly using an embryo, subsequent utilisation and analysis ofthe cell is not. The parallels between biopsy for tissue typing and ES cell derivationare obvious. Both remove embryonic cells and both are permanently excised fromthe originating embryo. However, here the similarity ends. The biopsied cell wouldbe discarded following analysis, whilst an ES cell would be maintained in culture asa cell line. Also, the potential applications for the ES cell line are vast. Finally,derivation of an ES cell involves destruction of the embryo: embryonic biopsy forPGD or tissue typing does not. Nevertheless, from the point of view of jurisdictionalcontrol of embryonic cells, these are not so important.

At first instance, Maurice Kay J held that analysis of an embryonic cell did involvethe use of an embryo. He did so on four grounds. First, he referred to the HFEA’sown press release, which described tissue typing as ‘an additional step whereby theembryo is simultaneously tested for its tissue compatibility with an affected sibling’.

27

This is peculiar, as not only did Maurice Kay J adopt a very narrow interpretation ofthe HFEA’s statement, but a press release is a most unorthodox aid to statutoryconstruction.

28

Secondly, the heading of s 3 of the 1990 Act is ‘Prohibitions inconnection with embryos’. In the view of the judge, this tended against a narrowinterpretation.

29

Thirdly, Maurice Kay J reasoned that Parliament could not have intended thattesting of an embryonic cell should be outside the remit of the Act:

‘I find it inconceivable that an Act which goes to great lengths to provide forthe statutory control of the persons by whom and the places at which controversialactivities are carried out and subject to inspection, was intended by Parliament toleave an activity such as tissue typing outside the direct control of the Act. It cannothave been the intention of Parliament to draw a line between the extraction ofembryonic cells, which in itself gives rise to no real ethical problem, and thesubsequent genetic testing of them, which has the potential for misuse. The dis-tinction is artificial, unattractive and unnecessary . . .’

30

Of course, in the context of ES cell derivation it is the extraction of the embryoniccell which creates the most ethical problems, entailing as it does the destruction ofthe embryo. With respect, the views of Maurice Kay J are based on a misunderstanding

25.

[2003] EWCA Civ 667, [2004] QB 168.

26.

[2005] UKHL 28, [2005] 2 AC 561.

27.

Above n 24, para [12].

28.

A fact upon which Mance LJ commented in the Court of Appeal: ‘The language of theHFEA’s press notice and licence are open to the forensic comment that at points they equateembryonic cells with an embryo from which they have been removed, and treat PGD (hereboth screening and tissue typing) as activities themselves requiring to be licensed. But thesedocuments cannot construe for us the true scope of the legislative provisions’ (above n 25,para [111]).

29.


30.

Ibid.



of the licensing powers. A treatment licence authorises the use of an embryo in thetreatment of a woman for the purposes of carrying a child. There is no reason whythis could not encompass ancillary activities connected with embryo selection, suchas PGD and tissue typing. This, ultimately, was the view of the Court of Appeal.

31

Merely because a licence permits and regulates embryonic biopsy and subsequentanalysis does not equate embryonic cells with embryos. Rather, it is part of a packageof measures designed to enable a woman to have a suitable child. Maurice Kay Jshould not be overly criticised for this, however, for it was the HFEA who contendedat first instance that PGD and tissue typing, as opposed to the biopsy itself, did notrequire a licence at all as it was not a ‘use of an embryo’.

32

This forced the trial judgeto examine the issue and reach a determination of the matter, and ignored the fact ofembryonic biopsy as a necessary precursor to tissue typing. In the Court of Appeal,however, counsel for the HFEA dropped that aspect of the argument.

33

Finally, Maurice Kay J stated that para 1(1)(d) of Sch 2

34

and s 3(1)(b), whenconstrued together, equated any practices intended to determine the suitability of anembryo for the purposes of implantation with the ‘use’ of an embryo. Once again,this is a basic misunderstanding of the licensing powers under the 1990 Act. Merelybecause the terms of a licence may extend to supplementary techniques on embryonicmaterial is not to correlate excised embryonic cells with embryos themselves.

If the judgment of Maurice Kay J had been left undisturbed, then this would likelyhave had major repercussions for the HFEA and UK Stem Cell Bank. If instrumen-talisation of a biopsied embryonic cell could be equated with ‘use’ of an embryounder s 3(1)(b), then a strong comparative case could be made for similarly regardingES cells and cell lines. This would effectively extend the HFEA’s licensing authorityover ES cells, a prospect which bucked conventional wisdom. Moreover, as embryoresearch cannot take place outside the licensed premises,

35

the further implication ofthis would mean that all transfers of ES cells and cell lines to third parties, includingthe bank, would not be permissible.

However, the Court of Appeal unanimously overturned the first instance ruling.The main focus of the appellate hearing was on the second arm of Mrs Quintavalle’sargument – the definition of treatment services. It was conceded that the first issue‘did not go to the heart of the case’,

36

and so the focus of two of the appellate benchwas elsewhere. Schiemann LJ contented himself by stating that ‘No part of [tissuetyping] (with the possible exception of carrying out tests on the extracted cell) canlawfully be done without a licence . . .’.

37

Lord Phillips of Worth Matravers MR didnot consider it an important issue for the case and, consequently, did not resolve theissue at all.

38

31.

Above n 25, paras [43] and [44] (Lord Phillips of Worth Matravers MR); para [87](Schiemann LJ); and paras [126]–[127] and para [145] (Mance LJ).

32.


33.


34.

‘A licence may authorise any of the following in the court of providing treatment services. . . (d) practices designed to secure that embryos are in a suitable condition to be placed in awoman or to determine whether embryos are suitable for that purpose.’

35.

Human Fertilisation and Embryology Act 1990, s 12(a). This point was made in the Courtof Appeal by Mance LJ in the context of shipping a biopsied cell to a third party laboratoryfor analysis (above n 25, para [110]).

36. Ibid, para [20].37. Ibid, para [87].38. Ibid, paras [20]–[21].



Conversely, Mance LJ took the opportunity to examine the issue at some lengthand concluded that Maurice Kay J had significantly erred:

‘An embryo is distinct from embryonic cell material, which is extracted froman embryo leaving the embryo free to continue to develop . . . The points made bythe judge overlook the fact that the creation outside the human body, biopsyingand implantation of an embryo all fall within s 3. They can all only take placeunder a licence, which may impose strict conditions regarding the nature of anytesting permissible in respect of any embryonic cell material removed from suchan embryo.’39

This reasoning allowed for Mance LJ to state that, whilst a licence was necessary tobiopsy an embryo and that conditions could be placed on the nature and objectivesof the subsequent analysis, this does not lead to the conclusion that therefore anembryonic cell is an embryo, or that the analysis itself is a ‘use’ of an embryo. In theHouse of Lords, the argument concerning the jurisdictional status of excised embry-onic cells vis-à-vis the 1990 Act does not appear to have been discussed.

APPLICATION OF PGD APPROACH TO HFEA LICENCE CONDITION

If applied to ES cell derivation under s 11(1)(c) and para 3(1)(b) of Sch 2, theapproach of Mance LJ would tend toward a construction of the 1990 Act whichpermits the HFEA to license not only derivation of ES cells, but also their use inprojects of research and subsequent disposal and/or transfer of ES cell lines to theUK Stem Cell Bank.40 At the same time, utilisation of an ES cell or cell line wouldnot involve the ‘use’ of an embryo under the 1990 Act, but could, nevertheless, bean activity covered by the extent of the research licence. In essence, it is highlypersuasive authority to validate the HFEA’s ‘linkage policy’ with the UK Stem CellBank.

THE REGULATORY INTERFACE

Brownsword has commented on the ‘regulatory tilt’ and ‘regulatory mix’ with regardto the 1990 Act.41 The former concept relates to the policy objectives of regulation,whilst the latter concerns the blend of measures in place (including legislation) tomeet those objectives. Brownsword also stresses the need to maintain ‘regulatoryconnection’42 between policy objectives designed to take advantage of potential ben-efits from emerging technologies, on the one hand, and the substance of regulationon the other. In other words, the regulatory mix must reflect the policy objectives.Where elements of the regulatory mix are not designed with new policy objectivesor novel scientific advances in contemplation, this can lead to a lack of regulatory

39. Ibid, para [111].40. Agreed, derivation of an ES cell involves the destruction of the embryo, and as such doesnot fall within the definition of biopsy as envisaged by Mance LJ. However, it is difficult tosee how this is relevant from the regulatory perspective of the legal status of an ES cell.41. Brownsword (2004), above n 2.42. Ibid.



connection. For example, it was a lack of connection which allowed pro-life cam-paigners to launch judicial review proceedings in both the CORE litigation and R vSecretary of State for Health, ex p Bruno Quintavalle (on behalf of Pro-Life Alli-ance).43 In the Pro-Life Alliance litigation, the fundamental argument was that thedefinition of ‘embryo’ in s 1(1) of the 1990 Act was premised on the notion offertilisation. Consequently, embryos created via the cloning technique termed CellNucleus Replacement (CNR) fell outside the legislation. In the CORE litigation, thequestion was whether allowing the application of PGD for the purposes of tissuetyping for the benefit of a sibling rather than for the existing child could be regardedas falling within the definition of ‘treatment services’. Both cases involved noveltechniques not foreseen when the 1990 Act was drafted, but where the present-dayregulatory tilt is pitched toward a permissive attitude with regard to them. The courtsin both cases found it necessary to opt for quite creative purposive constructions ofthe legislation in order to maintain regulatory connection between the policy objec-tives, the novel technology and the 1990 Act.

To this lexicon, another term may be added: the ‘regulatory interface’. This conceptrelates to where two (or more) regulatory regimes intersect in relation to one form ofactivity. It describes the features which categorise the linkage between different formsof governance within the regulatory mix. Where the regulatory interface is imperfect,for example where the tilt of two forms of governance are not at the same pitch, thenthis may also lead to a regulatory disconnection. In the context of the current discus-sion, the regulatory interface between the 1990 Act and the UK Stem Cell Bank fallsto be examined.

There are a number of motivations behind the linkage policy between the HFEAand the bank. First, it represents a concerted effort to create a sizable resourcedepository of ES cell lines within the UK. Secondly, it will encourage comparativeresearch analyses with other stem cell types. The bank was not established to receivehuman ES cell lines exclusively. It is also open to deposits of adult multipotent stemcells and foetal stem cells. Consequently, researchers will, for the first time, haveaccess to well-characterised human stem cell lines of differing provenances forrelative study.

Thirdly, the HFEA’s insistence, via a standard licence condition, on deposit of anES cell line sample with the bank is based on a desire to limit the need for wider EScell derivation. If sufficiently diverse ES cell line samples are deposited, representinga broad selection of genotypes, then this might reduce the number of new ES celllines that have to be produced. Licence applicants will have, first, to satisfy the HFEAthat the objectives of their research could not be met through utilisation of a pre-existing banked stem cell line, embryonic or otherwise. This further fosters the moralstatus of the human embryo as identified by the Warnock Committee,44 and helps theHFEA to fulfil its statutory responsibility to license only research where use of anembryo is necessary. Allied to this, the HFEA will glean information from the bank,both through its position on the Steering Committee and via its peer reviewers, as tothe types of research being conducted using all types of banked stem cell lines. This

43. R (Quintavalle) v Secretary of State for Health [2001] EWHC Admin 918, [2001] 4 AllER 1013; [2002] EWCA Civ 29, [2002] QB 628; [2003] UKHL 13, [2003] 2 AC 687 (alsocalled ‘the Pro-life Alliance litigation’ in this paper).44. Report of the Committee of Inquiry into Human Fertilisation and Embryology Cmnd9314, 1984.



will provide a further aid for the HFEA when deciding whether the objectives of aresearch application are ‘necessary or desirable’ within the terms of para 2(3) of Sch2 to the 1990 Act, or are being pursued elsewhere. It is hoped that this will limitunnecessary duplication of research. This anticipation, that the UK Stem Cell Bankwill facilitate a more cohesive approach to stem cell research, was a major factor inthe approval of the initiative by the House of Lords’ Select Committee on Stem Cells:

‘The Department of Health’s proposal to establish a stem cell bank overseenby a steering committee, responsible for the custody of stem cell lines, ensuringtheir purity and provenance and monitoring their use, are endorsed. As a conditionof granting a research licence, the HFEA should require that any ES cell linegenerated in the United Kingdom in the course of that research is deposited in thebank. Before granting any new licence to establish human ES cell lines, the HFEAshould satisfy itself that there are no existing cell lines in the bank suitable for theproposed research.’45

This in itself was a refinement of an earlier recommendation by the Chief MedicalOfficer’s Expert Group for the establishment of ‘collections of stem cells for researchuse’.46 The Expert Group’s recommendation appeared to be born more out of aperceived need to derive ES cells within the UK, however: ‘The establishment ofcollections of stem cell cultures would provide a valuable source of ethically obtainedcultures for researchers which would avoid the need to import cell lines’.47

The system for regulating human embryo research within the UK was regardedby the Expert Group as ensuring ethical derivation. Consequently, a central repositoryfor deposit of these ‘ethically sound’ cell lines was regarded as necessary to avoidimport of ES cells from potentially immoral sources. The Expert Group’s originalrecommendation is outward looking; seeking to protect the jurisdiction from ethicallyincompatible ES cell lines by opting for a ‘home-grown’ alternative. The SelectCommittee’s view, however, was more modest. It recognised that in order for themoral status of the embryo to be given more than lip service, then some form oflinkage was necessary between the HFEA, which licenses derivation, and the ultimatesecondary users of ES cell lines. If the HFEA was kept blind as to the activities ofsecondary researchers, then the potential for unnecessary destruction of a humanembryo for the purposes of ES cell derivation was increased. Only if the HFEA waskept appraised of ongoing secondary research projects could it properly discharge itsfunctions.

OBJECTIVES OF SECONDARY ES CELL RESEARCH AND BANK RESTRICTIONS

However, the regulatory arrangements in place for the withdrawal and use of bankedES cell lines go further than this objective. Already, we have seen that the HFEArestricts the licensed deriver from using ES cell lines for purposes outside the original

45. House of Lords’ Select Committee on Stem Cells Report on Stem Cell Research HL 83(i)(2002), para 8.29, available at http://www.publications.parliament.uk/pa/ld/ldstem.htm.46. Chief Medical Officer’s Expert Group Report, above n 9, p 48, para 5.10, Recommenda-tion 9.47. Ibid.

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licence without further Steering Committee approval. This was nowhere mentionedin either the Expert Group or Select Committee recommendations. Furthermore, theUK Stem Cell Bank will only allow withdrawal of ES cell lines for projects withinthe scope of the licensable research purposes listed under para 3 of Sch 2 to the 1990Act and the 2001 Regulations:

‘Unlike human embryos, embryonic stem cells do not have the potential tobecome a human person; so they do not have the moral status of human embryosand therefore the Government decided that research involving established stemcell lines does not need the same regulation to which embryo research is subjectto by the HFEA. However, as the generation of embryonic stem cell lines involvesthe destruction of human embryos oversight in form of a Steering Committee wasrecommended to ensure that research performed is in keeping with HFEA Regu-lations. The oversight mechanisms governing research involving establishedembryonic stem cell lines are voluntary. However, they are a condition of thestatutory regulation in the UK and there is an expectation by Government thatthese are adhered to.’48

This is an obvious attempt to splice together two regulatory mechanisms into some-thing of a coherent whole. With regard to the objectives of secondary ES cell researchusing lines withdrawn from the bank, the Steering Committee stipulate the following:

‘The Steering Committee expects that human embryonic stem cell lines areonly used by bona fide research groups for justified and valuable purposes thatreflect the requirements of the HFEA Regulations. This is:

(a) research which increases the knowledge about the development of embryosor has the long-term goal of helping to increase knowledge about serious diseasesand their treatment (as in the 2001 HFEA Regulations)

(b) basic cell research which underpins these aims (as recommended in theHouse of Lords Report 2002)

(c) development of cell-based therapies for clinical trials in respect of serioushuman diseases.’49

It must be noted that this extra level of regulation is entirely an innovation of the UKStem Cell Bank Steering Committee. Nowhere in the Expert Group or Select Com-mittee reports was it suggested that secondary ES cell research ought to be limited.Indeed, the Expert Group was of the view that separate regulation of ES cell researchprojects was inappropriate:

‘The Expert Group noted that any subsequent research involving cultures ofstem cells derived from embryos created either by egg or sperm or cell nucleartransfer would not fall within the controls operated by the Human Fertilisation andEmbryology Authority or any other body. Given the controls on research involvingthe extraction of stem cells from embryos, the Expert Group concluded that furtherscrutiny of individual proposals for subsequent research involving the use of stemcells derived from embryos was unnecessary.’50

48. UK Stem Cell Bank, above n 14, p 10 (original emphasis).49. Ibid, p 12, para 8.1.1 (original emphasis).50. Above n 9, p 42, para 4.34.



Similarly, the House of Lords’ Select Committee did not see the need for regulationof secondary ES cell research beyond monitoring and information gathering:

‘Particular sensitivities attach to certain types of tissue, for example humanfoetal and embryonic material. However, ES cells once established as a line, arenot embryos, and the committee does not see a need for special arrangements tobe made beyond those, such as informed consent . . . applying to the use of otherhuman material. The logic of this analysis is that the use of established ES celllines does not require the sort of regulation to which human embryo research iscurrently subject by the HFEA.’51

These conclusions are remarkably naive and simplistic. They ignore the moral statusof the originating embryo entirely. The ethical calculus for utilisation of a humanembryo in a project of research is essentially consequentialist. It recognises that thespecial status of the human embryo may be overridden where the potential benefitsof a particular research project outweigh the harm inflicted on the embryo. Hence, inorder to license a project, the HFEA must be satisfied that the objectives of theresearch are ‘necessary or desirable’.52 The degree of specificity does not end there,however. The project must also pursue legislatively prescribed research areas. Theseareas are identified and crystallised in the licensable research purposes containedwithin para 3(2) of Sch 2 to the 1990 Act and the 2001 Regulations. In effect, only‘necessary or desirable’ research into these areas can legitimise the infringement ofthe embryo’s qualified moral status. In other words, the benefits associated withresearch into these areas outweigh the harm done to the embryo – a classic conse-quentialist calculus.

However, if the regulatory environment allowed human ES cell lines derived undersuch legal and ethical constraints to be used for any purpose in secondary research,then the safeguards would be revealed as a sham. Such a system would allow forderivation, only for specific purposes, but would also allow for open-ended subse-quent use. It makes little sense to pass legislation allowing regulated research on anembryo for a specific purpose (eg ES cell research into serious disease), if it issubsequently used for another purpose entirely (eg research into hair loss).53 Thiswould not only be a regulatory inconsistency, but positively disingenuous. The instru-mentalisation of a human embryo is only permitted for licensable research purposesand, if ‘special status’ is to be more than a sop, then some degree of control over EScells derived from HFEA licensed embryos is required. Not to mention, of course,that the donors of the embryo can only provide ‘informed consent’ for derivation ofES cells which are within the licensable purposes. Consequently, if ES cells are usedfor secondary research outside these licensable purposes, then this might also beviewed as compromising donor consent. Both donors and the public could have alegitimate expectation, although no constraints have been put upon future use in linewith the Select Committee’s recommendation, that nevertheless ES cells will not beused for purposes outside the legislative imprimatur.

The decision by the Bank Steering Committee to impose restrictions on the typesof secondary research for which ES cells may be released is quite at odds withprevious policy recommendations. Nonetheless, it is an excellent innovation in

51. Above n 45, para 8.25.52. Human Fertilisation and Embryology Act 1990, Sch 2, para 3(2).53. Important though this is for some people.



concept. Insofar as monitoring and inspection is adequate, it allows for holisticvindication of the embryo’s special status. If ES cell lines derived under an HFEAlicence were used for purposes outside those listed in para 3(2) of Sch 2 and the 2001Regulations, then the original embryo would effectively have been used for purposeswhich do not outweigh its due respect. Moreover, it would significantly compromisethe ongoing integrity of regulation – promoting ethics in derivation and then blindlyignoring them in secondary research.

However, the actual parameters set by the Steering Committee – research intoserious disease and treatment, basic cell research facilitating those objectives, anddevelopment of stem cell based clinical trials for serious disease – are curious. If theUK Stem Cell Bank will not allow dissemination of ES cell lines for other purposes,then this similarly does not adequately reflect the licensable research purposes.Licences to derive ES cell lines have been granted not just on the ‘serious disease’provisions of the 2001 Regulations, but also under the pre-existing purposes underpara 3(2) of Sch 2. It does not make any sense whatsoever to allow secondary researchinto serious disease, but deny such research for infertility,54 congenital disease,55

miscarriage,56 contraception,57 detection of genetic or chromosomal abnormalities inan embryo58 and embryonic development.59 These research purposes are just aslegitimate as that of serious disease and, similarly, do not compromise the specialstatus of the originating embryo (at least within the internal logic of the 1990 Act).The Code of Practice for the Use of Human Stem Cell Lines ought to be widenedaccordingly.

IMPORTS OF ES CELL LINES

The bank is intended as the central resource for embryonic and other stem cell linesin the UK. To this end, the Steering Committee has included in the Code of Practicefor the Use of Human Stem Cell Lines the following constraint:

‘It is expected that there will be occasions when researchers wish to accesshuman embryonic stem cell lines from other sources (eg international cell linesnot deposited in the bank or cell lines not yet ready for distribution by the bank).However, all researchers wishing to work with human embryonic stem cell lines(whether accessed from the bank, from other sources in the UK or oversees) shouldinform the Steering Committee through the application procedure . . . The SteeringCommittee needs to satisfy itself that the research fulfils the criteria in section8.1.1. and that the human embryonic stem cell lines have been ethically sourcedwith fully informed and free donor consent.’60

54. Human Fertilisation and Embryology Act 1990, Sch 2, para 3(2)(a).55. Ibid, Sch 2, para 3(2)(b), although this may well come within the definition of ‘seriousdisease’ anyway.56. Ibid, Sch 2, para 3(2)(c).57. Ibid, Sch 2, para 3(2)(d).58. Ibid, Sch 2, para 3(2)(e).59. Human Fertilisation and Embryology (Research Purposes) Regulations 2001, SI 2001/188, reg 2(2)(a).60. Above n 14, p 14, para 8.3. See also Annex 5 to the code for application pro forma forimporting human ES cell lines into the UK.



This assertion, written as it is in absolutist regulatory terms, is something of ajurisdictional nonsense. Whilst it is true that the HFEA enjoys licensing powersover the import or export of both gametes and embryos, this is by virtue of the 1990Act under s 24(4). The HFEA exercises control over the import of embryos andgametes because Parliament conferred specific power to it via legislation. By con-trast, the UK Stem Cell Bank is entirely a creature of ‘soft’ regulation. It has nolegislative basis whatsoever. Indeed, it is due to the HFEA’s largesse, rather thanany intrinsic authority of the bank, that ES cell lines derived from embryos withinthe UK are to be funnelled into its repositories. Put simply, the UK Stem Cell Bankdoes not have the power to force compliance with its authorisation policy. Neithercould the HFEA enforce this policy on behalf of the UK Stem Cell Bank, as the1990 Act does not extend to imported embryonic material, but only human embryosand gametes.

This is not to say, however, that other regulatory options do not exist which wouldcompel researchers to gain permission from the bank prior to import of such celllines. The most obvious method would be via funding mechanisms. The MedicalResearch Council (MRC), Biotechnology and Biological Sciences Research Council(BBSRC) and Wellcome Trust, amongst others,61 could make it a precondition offunding an ES cell project that import of ES cell lines is subject to bank approval.This is very likely, given that the MRC and BBSRC are jointly funding the bank itselfand the initiative has the approval of the Wellcome Trust. Nevertheless, purely privateresearch would not be obligated to follow the Steering Committee’s requirements.Such action, however, may sour the relationship between such researchers62 and thebank in the future. This may prejudice any attempt to access deposited stem cell linesfor other research projects and could act as a de facto deterrent.63

Moreover, the UK now comes under a duty to regulate imports of cell lines,including ES cells, which are destined for used in therapy under the Human Tissuesand Cells Directive.64 Whilst the current state of art does not extend to clinicalapplications of ES cell lines, the field is geared toward achieving such outcomes. Ifthe UK Stem Cell Bank does not have jurisdiction to control imports, then thisfunction will have to be met by some other agency.

ES CELL CLINICAL TRIALS AND TREATMENTS

The UK Stem Cell Bank contemplates the use of ES cells in a clinical setting. To thisend, the bank plans to receive, validate and disseminate both ‘research-grade’ and‘clinical-grade’ stem cell lines.65 If ES cell lines of the latter type are validated, theirprovenance and storage conforming to the requirements of the Code of Practice for

61. For example, the EU via FP6/FP7 funding.62. And their sponsoring organisations.63. The reader should note that a further regulatory mechanism, Research Ethics Committee(REC) approval, is put in place by the HFEA’s own rules represented in the Code of Practice(above n 20. p 93, paras 10.6–10.9).64. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004on setting standards of quality and safety for the donation, procurement, testing, processing,preservation, storage and distribution of human tissues and cells [2004] OJ L102/48, Art 9.65. UK Stem Cell Bank, above n 14, pp 9, 13 and 17.



Tissue Banks,66 Human Tissues and Cells Directive,67 Clinical Trials Directive68 andany further Medicines and Healthcare Products Regulatory Agency (MHRA)69

requirements, then it is envisaged that they might be used in direct therapeuticinterventions, such as clinical trials. Furthermore, ES cell lines might be of use topharmaceutical companies, for example in the development and toxicological testingof new drugs. Whilst the bank has acknowledged that ‘all stem cell lines . . . in theearly phase will be research grade only’,70 there is nevertheless a strong intention thatES cell lines will be used in clinical trials.71

JURISDICTIONAL ISSUE AND CHIEF MEDICAL OFFICER’S EXPERT GROUP

However, this all presupposes the solution to a jurisdictional issue. Does the HFEAhave jurisdiction to allow derivation of ES cell lines which might be used in clinicaltrials or applications? The Expert Group Report certainly was of the view thatlegislative adjustment would be necessary in order to allow for the advent of ES cell-based therapies:

‘At present the only treatment services using embryos which can be licensedunder the 1990 Act are medical, surgical or obstetric services to help women to“carry children”. The possibility of an amendment to the Act would need to beconsidered by Parliament if the research suggested that the use of embryo-derivedcells for broader treatment purposes was necessary and acceptable.’72

The government’s response to this observation was somewhat equivocal, however,stating that it accepted the ‘need to keep under review the possibility of legislation’to permit the clinical use of ES cells.73 This has two possible interpretations. The first,which is more consonant with the Expert Group’s reasoning, is that the governmentwould take steps to introduce legislation if an ES-cell-based therapy became a realpossibility – perhaps during or following a clinical trial. A second interpretation of

66. Department of Health A Code of Practice for Tissue Banks Providing Tissues ofHuman Origin for Therapeutic Purposes (2001), available at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4006116&chk=8VQR%2B5.67. Above n 64.68. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 onthe approximation of the laws, regulations and administrative provisions of the Member Statesrelating to the implementation of good clinical practice in the conduct of clinical trials onmedicinal products for human use [2001] OJ L121/34. The Directive has been implementedvia the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031.69. This is a relatively new body, which coordinates the activities of both the MedicinesControl Agency (MCA) and Medical Devices Agency (MDA).70. UK Stem Cell Bank, above n 14, p 13.71. Ibid, p 12 and Annex 2.72. Above n 9, p 34, para 3.14. This formed the basis for Recommendation 8: ‘The need forlegislation to permit the use of embryo-derived cells in treatments developed from this newresearch should be kept under review’ (p 48, para 5.10).73. Department of Health Government Response to the Recommendations Made in theChief Medical Officer’s Expert Group Report ‘Stem Cell Research: Medical Progress withResponsibility’ Cm 4833, 2000, p 6, para 10, available at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4123598.

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the response is that the government did not accept that legislation to permit ES-cell-based therapies was actually necessary in principle, but would keep this matter underreview. The government did not accept the need to produce legislation if an ES celltherapy came to the fore, merely that it acknowledged the necessity to keep underreview the ‘possibility’ of legislation.

PARLIAMENTARY DEBATE

Nevertheless, when the 2001 Regulations were being discussed in Parliament, it wasthe former interpretation which was propounded. In the Commons, Parliament wasassured that they were only voting on permitting research and that, if ES-cell-basedtreatment became a possibility, then that would be subject to a separate and futuredebate: ‘It would not be legal to use embryonic stem cells in treatment. The regula-tions purely allow the possibility of research using embryonic stem cells. Treatmentis a separate matter that the House would need to consider separately’.74

Furthermore, the impression was certainly conveyed in the House of Lords debatethat only ES cell research, not therapies, could be permitted: ‘It is, once again,important to note that that provision will not allow embryos to be used in treatments;it will only allow the research to take place’.75

Lord Hunt of King’s Heath’s assertion above is somewhat different in character tothat of his Commons’ counterpart, in that it refers to ‘embryos’ not being used intreatment. Quite obviously, if anything, it would be ES cell lines that would be usedin treatment, not embryos. Nevertheless, he is emphatic in that passage of the 2001Regulations will only permit research to take place. This is an explicit denial thatclinical applications would be allowed. Clearly, Parliament was led to believe that, ifES-cell-based therapies became a real possibility, then this would be subject to furtherlegislative scrutiny.

VIEW OF THE HOUSE OF LORDS’ SELECT COMMITTEE

When the House of Lords’ Select Committee considered ES cell regulation, it did notinvestigate the jurisdictional issues, preferring instead to focus on health and safetygovernance: ‘Therapeutic application of ES cells or cells/tissues derived from themis still some way off. If and when it does happen, existing controls will come intooperation, including those operated by the Medicines Control Agency’.76

In the Committee’s view, the government ought to establish a similar body to theGene Therapy Advisory Committee (GTAC) to oversee ES-cell-based clinical trials.Otherwise, it did not foresee that any further regulation of ‘the use of stem cells in

74. Hansard HC Deb, vol 356, col 1180, 17 November 2000 per Yvette Cooper MP, Parlia-mentary Under-Secretary of State for Health.75. Hansard HL Deb, vol 621, col 19, 22 January 2001 per Lord Hunt of King’s Heath(Parliamentary Under-Secretary of State for Health). Consider also the implication in thefollowing sentence, ‘Without these regulations we shall not be able to use embryos in researchleading to cures for serious diseases like Parkinson’s disease and Alzheimer’s disease’ (col 121per Lord Hunt of King’s Heath (emphasis added)). Once again, the focus is upon legitimisingresearch, maybe even applied research, but not outright therapy.76. Above n 45, para 8.23.



the treatment of patients’77 would be necessary. This does seem to ignore the funda-mental issues: can ES cell lines derived for research purposes be used in treatment,and can the HFEA license derivation purely for therapeutic application? Nevertheless,the implication is that the Select Committee accepted the premise that these issuesare not problematic. By discussing the best way to regulate emerging ES cell thera-pies, the Select Committee appears to believe that the use of ES cell lines in treatmentdoes not pose jurisdictional problems. Alternatively, maybe the Select Committeemerely did not give any thought to the issue.78 Most recently, the UK Stem Cell BankSteering Committee has constructed its codes of practice on the premise that clinicalgrade ES cell lines will be processed and stored, with a view to their use in clinicaltrials and therapies.

DIVERGENCE OF OPINION BETWEEN POLICY MAKERS

As can be seen, there has been a significant shift in thinking between that of theExpert Group and the Steering Committee. The latter, and to an extent the SelectCommittee also, is of the opinion that no legislative intervention is necessary to allowfor ES-cell-based therapies. Current regulatory arrangements, including the ClinicalTrials Directive,79 would form the basis for regulation of emerging treatments andproducts utilising ES cell lines. However, again this presupposes that there are nojurisdictional issues concerning the regulation of derivation that linger on to this stage.It is this which the Expert Group was highlighting, not just safety issues concerningthe implementation of such treatments. The basis for the Expert Group’s position isthat under the 1990 Act the HFEA can only grant three types of licence: treatmentlicences for the alleviation of infertility in a woman,80 gamete and embryo storagelicences81 and licences for projects of research, the objectives of which must fallwithin the ambit of para 3(2) of Sch 2 and the 2001 Regulations.82 Prima facie, theHFEA does not have authority to license derivation of ES cells where the objectiveis therapy, not research. The Act simply does not extend this far.

Moreover, it cannot be said that production of ES cells for the purposes of therapyfalls within the category of ‘enabling any such knowledge to be applied in developingtreatments for serious disease’ under reg 2(2)(c) of the 2001 Regulations. Whilst atfirst glance it might appear that this provision allows for the licensing of ES cellderivation for the purposes of therapy, it does not. First, examine the latent provisionwithin the 1990 Act which permitted extension of the licensable research purposesby affirmative regulations. It states: ‘Purposes may only be . . . [extended] with a view

77. Ibid.78. Similarly, the government response to this recommendation was that it would considerwhether any further oversight of ES cell clinical trials/applications was necessary. Again, thispresupposes that their use for such purposes is permissible (Department of Health GovernmentResponse to the House of Lords’ Select Committee Report on Stem Cell Research Cm 5561,2002, pp 16–17, para 8.23, available at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4083481&chk=D89A6d).79. Above n 68.80. Human Fertilisation and Embryology Act 1990, s 11(1)(a).81. Ibid, s 11(1)(b).82. Ibid, s 11(1)(c).

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to the authorisation of projects of research which increase knowledge about . . .disease, or enable such knowledge to be applied’.83

The important phrase here is ‘projects of research’. The new licensable purposescontained within the 2001 Regulations may only be pursued within the confines of aresearch project. Consequently, it is doubtful that the HFEA can license ES cellderivation for treatment of serious disease where this does not form part of a researchproject. When it comes to licensing derivation of ES cells for treatment of seriousdisease such as Parkinson’s disease, the HFEA hits a jurisdictional wall.

THE NATURE OF A CLINICAL TRIAL

It is within the possibility of ES cell clinical trials that a grey area exists. Clinicaltrials are a blend of both therapeutic intervention and applied research. From aresearch perspective, a clinical trial tests the efficacy of a proposed therapeuticintervention, whether pharmaceutical, procedural, tissue-based or otherwise. In manyways, a clinical trial is the final stage of research for developing a treatment. It isonly through ultimate testing of human subjects that research can become clinicalreality. Sometimes, the clinical trial will unearth results which challenge the precedingresearch data or reveal further areas of doubt or concern. In those circumstances, theresearcher/clinician must go back to the drawing board. However, if a clinical trial isa project of applied research then it is most certainly, at least for those subjects notin a control group, also an intervention with a therapeutic aim.

Whilst outside the scope of this paper, it ought to be pointed out that althoughstorage and dissemination of ES cell lines for research do not come within the scopeof the Human Tissues and Cells Directive, this exemption does not apply to clinicaltrials. Consequently, whilst the Directive will not apply to the bank in relation to itsactivities as a research repository, compliance will be necessary for any stem cell linethat is used either in an ‘accepted’ therapy or a clinical trial. Notwithstanding that itmay be possible to classify a clinical trial as ‘research’ for the purposes of thelicensing arrangements under the 1990 Act,84 nevertheless the Directive’s require-ments, including those relating to traceability,85 quality management86 and othertechnical requirements,87 will apply to any ES-cell-based clinical trials.88 Moreover,this might create a problem at some future point where it is proposed that an ES cellline or its derivative be used for a therapeutic purpose. In particular, requirementsrelating to validation and traceability might pose significant obstacles.

83. Ibid, Sch 2, para 2(3).84. See below.85. Article 8.86. Article 16.87. Article 28. The interested reader should also refer to the Commission Directives on thetopic, which provide far greater detail concerning quality assurance and procedures (Commis-sion Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of theEuropean Parliament and the Council as regards certain technical requirements for the dona-tion, procurement and testing of human tissues and cells [2006] OJ L38/40; and CommissionDirective 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the EuropeanParliament and of the Council as regards traceability requirements, notification of seriousadverse reactions and events and certain technical requirements for the coding, processing,preservation, storage and distribution of human tissues and cells [2006] OJ L294/32).88. Article 2(1) and recital 11.



THE JURISDICTIONAL LIMITS

From a jurisdictional perspective, it is quite probable that the HFEA could licensederivation of ES cells for use in clinical trials, as this would be a project of researchenabling knowledge about the treatment of serious disease to be applied. The factthat a clinical trial also has a treatment aspect does not prevent this. After all, if clinicaltrials do not come within the provisions of para 3(3) of Sch 2 to the 1990 Act andreg 2(2)(c) of the 2001 Regulations, then what would be their point? To whom (orwhat) would knowledge about treatment of serious disease be applied, if not clinicaltrial subjects?

Similarly, there is no reason to suppose that the HFEA could not license derivationof ES cells for toxicological testing of pharmaceuticals, insofar as the potentialbenefits of the developing drugs further the treatment of serious disease. At most, theutilisation of ES cells in this context can only indirectly be regarded as clinicalintervention, and could more naturally be regarded as facilitating the development orrefinement of new therapies, rather than being a treatment itself. Developing a newpharmaceutical is an ongoing project of research on a massive scale, albeit withultimate therapeutic and commercial objectives in mind. Furthermore, ongoing refine-ments of drugs and medicinal products are also aspects of research and development.

If the UK Stem Cell Bank is to respect the originating regulatory environment inits current manner, then it needs to address these concerns at the outset. Releasingclinical grade ES cells for the purpose of clinical trials or pharmaceutical developmentconcerning a serious disease does not, prima facie, impugn the licensable researchpurposes of the 1990 Act. These could be regarded as projects of research whichenable knowledge about treatment of serious disease to be applied.

However, here lies the regulatory Rubicon. If ES-cell-based treatments success-fully pass clinical trials and enter the realm of validated treatment, should the UKStem Cell Bank allow for withdrawal of cell lines for that purpose? In many ways,this would be the pinnacle of ES cell research to date – the emergence of a tangibleand tested therapy. Nevertheless, it would also be a jurisdictional crossroads. TheHFEA, under the 1990 Act, may not be able to license such a measure de novo. Suchan act could be construed as beyond its powers.

On the other hand, to refuse the dissemination of ES cell lines for use in treatmentwould be to contradict one of the main objectives of ES cell research – to alleviatesuffering and disease. From a different context, the words of Lord Phillips of WorthMatravers MR in the CORE case89 are certainly worthy of consideration. He notedthat the 1990 Act permitted research into alleviating congenital disease and seriousdisease, and that this could include research into PGD. Consequently, how couldParliament have intended that these and related techniques should not be applied ina clinical context?

‘[I]t would be strange if Parliament approved research to develop a method forachieving an objective which was prohibited elsewhere in the Act. The clearinference of permitting such research was that Parliament approved of PGD toavoid implantation of embryos carrying genetic defects . . . Parliament chose topermit the licensing of research. It makes little sense for Parliament, at the sametime, to prohibit reaping the benefit of that research, even under licence.’90

89. Above n 25.90. Ibid, paras [38] and [40].



Mance LJ was even broader in his analysis of the issue:

‘Regulations permitting licences for the purposes of increasing knowledgeabout the development of embryos and about serious disease and of enabling anysuch to be applied in developing treatments for serious disease have now beenmade . . . While it is theoretically possible that Parliament intended to permitresearch into methods of detecting abnormalities, or into applications of knowl-edge acquired about disease, which it would be impermissible to license forpractical use unless the Act was amended, it seems improbable that it was con-templated that research, a particularly contentious matter, should be permissibleinto methods and applications the use of which in practice Parliament had decidedto exclude.’91

Similarly, in the House of Lords, Lord Hoffmann in his leading judgment echoedthese points in relation to PGD when he stated, ‘It would be very odd if Parliamentcontemplated research to develop techniques which could not be lawfully used’.92 Allthese statements, if broadly construed, might be persuasive in interpreting the 1990Act as permitting the derivation of ES cells for the purposes of direct clinical appli-cation. To paraphrase Lord Phillips MR, might it not be ‘a clear inference’ of thelicensing of ES cell derivation for the purposes of research into serious disease, thatES cell lines may be used in treating such serious disease? Or, in the words of LordHoffmann, would it not be ‘odd’ if Parliament forbade clinical therapies arising outof legislatively permitted research? However, this would be to overlook two funda-mental issues. The first is that, unlike PGD and tissue typing, an assurance was madeto Parliament during the passage of the 2001 Regulations that the permissibility ofES cell-based therapies would be the subject of a future vote.93 Consequently, it couldbe convincingly argued that Parliament did not intend to allow for ES cells and celllines to be used in treatment without further legislative approval.

Secondly, PGD and tissue typing are both techniques used to determine the selec-tion of suitable embryos for the purposes of reproduction. The connection betweenthe objectives of research into these areas and medically assisted reproduction is closeindeed. HFEA treatment licences are issued on the basis of ‘assisting women to carrychildren’,94 and the Court of Appeal in the CORE case was of the opinion that thiswas broad enough to encompass licensing both PGD and tissue typing, where thosepractices are to be used in selecting an embryo with specific characteristics for thepurposes of implantation. Indeed, it was the extent of treatment, not research, licenceswhich was the fundamental issue in the appellate hearing. However, HFEA treatmentlicences do not permit the creation or use of an embryo for purposes which are notconnected with ‘assisting women to carry children’. Consequently, it is difficult tosee how the HFEA, through any one of the three licences it is permitted to issue,could authorise the derivation of ES cells for use in therapies unconnected with humanreproduction. Remember, the HFEA is only allowed to issue licences for the purposesof treatment, research or storage, and no more than this.95

91. Ibid, para [120].92. Above n 26, para [13].93. Above n 74.94. Human Fertilisation and Embryology Act 1990, s 2(1) and Sch 2, para 1(1).95. Ibid, s 11(1).



The recently published White Paper does not address this issue, although theredoes appear to be some tacit acceptance of the problem. The White Paper acknowl-edges that, if a therapy emerged which was proven to be ‘safe and effective’ (pre-sumably a reference to successful clinical trial protocols), then ‘it would be difficultto continue to consider it as research, bringing into question whether it could con-tinue to be licensed as research by the regulator’.96 However, the White Paper doesnot recommend any legislative changes in order to bridge the regulatory divide.However, there is an assurance that the issue will be ‘debated in Parliament as partof the consideration of revised legislation, and the need for the law to anticipate thescenario in question’.97 Hopefully, this paper will provide some legal perspective tothat debate. Such a tentative approach on the part of government is understandablefrom a pragmatic perspective. ES-cell-based therapies do not appear to be a pros-pect in the short term other than (maybe) for use in clinical trials. However, thereare a number of reasons why the regulatory interface between the HFEA and UKStem Cell Bank should be clarified at the present time. First, the UK Stem CellBank’s policy is to accept ‘clinical grade’ stem cell lines. Whilst at present clinicalgrade ES cell lines are not being produced, there nevertheless appears to be aregulatory shortfall between the stated policy objectives of the bank and the legisla-tive powers of the HFEA. Unless the promised parliamentary debates dictate other-wise, this shortfall will continue to apply to the proposed new regulator, RATE.Secondly, the UK Stem Cell Bank will disseminate ES cell lines to a number ofsecondary researchers, both within and without the jurisdiction. When one considersthe potentially ‘immortal’ qualities of ES cell lines and the corresponding ability topropagate samples, this may lead to difficult decisions as to whether a secondaryresearcher would use the ES cell line (or its derivative) for a therapy, and thepermissibility of such a prospect. This would be compounded by the necessarilyexperimental nature of any such activity and whether a clinical trial ought to beregarded as primarily research or therapy. Thirdly, what of the position where EScell lines are distributed to a secondary researcher who uses the sample to develop anew therapy, but where the cell line is not used in the ultimate product? This mightinclude the toxicological testing of new pharmaceuticals, the differentiation of theES cell line into more specialised forms of stem cells or somatic cells, or simply theuse of the ES cell line as a control sample for purposes of comparative research.Where an ES cell line is used in the development of a therapy, as opposed to beingintegral to the product itself, further uncertainties in the regulatory interface becomeapparent.

CONCLUSION

This jurisdictional uncertainty adds to the concerns surrounding the legal basis forES cell research in the UK.98 The regulatory interface between the HFEA and UKStem Cell Bank requires elucidation and possible rectification. Anything other thanclarity invites legal challenge by way of judicial review.

96. Above n 5, pp 23–24, para 2.79 (original emphasis).97. Ibid, p 24, para 2.80.98. Above n 2.



However, from a long-term perspective it is the area of emerging ES cell therapiesthat requires the most attention. After all, this is the ultimate aim of most researchendeavours in the field. There is a distinct lack of clarity on this issue, with the HFEAin a jurisdictionally shaky position. Whilst the words of Lord Phillips MR and ManceLJ are both persuasive and compelling, the 1990 Act simply does not permit thederivation of ES cells for use in therapy. This leaves the Steering Committee of theUK Stem Cell Bank in a difficult predicament. If it allows for the dissemination ofclinical-grade ES cell lines for therapy, then the entire regulatory regime loses coher-ence and integrity, as well as opening the way to legal challenge. After all, how couldthe HFEA in good conscience license derivation of ES cell lines which would beprocessed to clinical grade, deposited in the UK Stem Cell Bank and then passed toa third party for use in treatment? Both the HFEA and the Steering Committee wouldhave to consider whether it is has been disingenuous, especially given that the HFEAmembership has a presence on the bank’s Steering Committee.

Already, Parliament has fired a warning shot across the HFEA’s bows in relationto licensing of PGD and tissue typing without recourse to the legislature.99 Both theHFEA and UK Stem Cell Bank could be accused of collusion in manipulating theregulatory regime in order to produce ES-cell-based therapies. This would be anunenviable position for both the HFEA and the Steering Committee, and would beborn out of a wait-and-see policy lacking in foresight.

One could counter that concerns about a regulatory lacuna are answered by regu-latory mechanisms outside the bank’s internal policies. In particular, the UK StemCell Bank, if disseminating ‘clinical grade’ stem cell lines, will have to comply withthe Human Tissue and Cells Directive.100 Indeed, with regard to its clinical activities,the UK Stem Cell Bank must be accredited as a tissue and cell establishmentunder the Directive.101 Moreover, the Directive specifically brings ES cells within itsremit.102 Whilst accurate in theory, this misses a more fundamental point. Any con-sideration of whether the Directive will apply in the circumstances will be predicatedon an assumption that it is permissible to derive ES cells for therapy within the UK.The analysis above suggests otherwise. A similar observation might be made withregard to regulation of secondary researchers via ‘soft’ measures such as researchethics governance and funding mechanisms. Accepting that these are important con-trol mechanisms around research, they cannot legitimise the use of ES cells in therapywhere the underlying legislation does not permit it. This is not even to mention, ofcourse, that there may be great variance in the standards and procedures such bodies

99. The Committee concluded that the HFEA went beyond the scope of its own consultationdocument when allowing tissue typing alongside PGD. Particularly scathing was the followingcomment on the evidence of a former Chair of the HFEA, Dame Ruth Deech: ‘We take issuewith Dame Ruth’s assertion that the fact that the HFEA took the decision on PGD “protectsMembers of Parliament from direct involvement in that sort of thing.” Parliament does not needprotecting and democracy is not served by unelected quangos taking decisions on behalf ofParliament’ (House of Commons’ Science and Technology Select Committee Developmentsin Human Genetic and Embryology: Fourth Report of Session 2001–2002 HC 791, 2002, p 13,para 26, available at http://www.publications.parliament.uk/pa/cm200102/cmselect/cmsctech/cmsctech.htm#reports).100. Above n 64.101. Article 6 and recitals 20–21 and 25–28.102. Recital 7.

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may apply.103 Moreover, the policy of the bank is to disavow any requirement forresearch ethics committee approval for ‘research involving established human embry-onic stem cell lines’.104 Consequently, this form of governance will only come intoplay once a clinical trial is proposed. It ought to be stressed that this paper does notsuggest that the emergence of ES cell therapies would occur in a regulatory vacuum.Rather, it points out that the regulatory interface between ES cell derivation andresearch, on the one hand, and possible ES cell therapies, on the other, is not effective.This itself may lead to further legal challenges from lobby groups when clinicalapplications become a possibility.105

It is best that steps be taken to resolve these issues now, whilst ES cell researchand the bank are both relatively new and underdeveloped, than wait for problems toarise when the political temperature around an emerging therapy runs high. Thistiming would be especially appropriate given that Parliament is to revisit the operationof the 1990 Act on foot of the recent White Paper.106 Given that this review isoccurring following increased government investment into UK stem cell research of£100 million over the period 2006–2008,107 it would be preferable that the regulatorymechanisms interface correctly. It is desirable that the legislative and regulatoryframework, purportedly designed to further ES cell research for the purposes ofclinical application, is explicit on this point. Equally, if the other areas of jurisdictionaluncertainty highlighted in this paper necessitate legislative amendment, then govern-ment should not shy away. Otherwise, these jurisdictional weaknesses may be probedby judicial review. As scientific understanding of this area is still in its infancy, so islaw’s approach similarly immature. Given the government’s undertakings both toreview the operation of the 1990 Act and to subsume the powers of the HFEA andHuman Tissue Authority into RATE,108 this paper hopefully serves as a relevantreminder that further examination of the regulatory architecture is necessary in rela-tion to ES cell research.

103. For example, see C Middle et al ‘Ethics approval of a national postal survey: recentexperience’ (1996) 311 British Medical Journal 659; NA Maskell et al ‘Variations in experiencein obtaining local ethical approval for participation in a multi-centre study’ (2003) 96 TheQuarterly Journal of Medicine 306; J Savulescu et al ‘Are research ethics committees behavingunethically? Some suggestions for improving performance and accountability’ (1996) 313British Medical Journal 1390; M. Redshaw et al ‘Research ethics committee audit; differencebetween committees’ (1996) 22 JME 78. The interested reader should also note that theoperation of research ethics committees in the NHS has recently undergone a review chairedby Lord Warner which may lead to greater efficiencies in the area (Report of the Ad HocAdvisory Group on the Operation of NHS Research Ethics Committees (Department of Health,2005), available at http://www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment/ResearchAndDevelopmentAZ/ResearchGovernance/fs/en#6222539).104. UK Stem Cell Bank, above n 14, p 13, para 8.1.3.105. For excellent analysis of the rise of pro-life groups as legal actors within the UK, see DBeyleveld and R Brownsword Human Dignity in Bioethics and Biolaw (Oxford: OxfordUniversity Press, 2001) (particularly chapters 1 and 2); and R Brownsword ‘Bioethics today,bioethics tomorrow: stem cell research and the “Dignitarian Alliance” ’ (2003) 17 Notre DameJournal of Law, Ethics and Public Policy 15.106. Above n 5.107. Department of Health Government Response to the UK Stem Cell Initiative Report andRecommendations (2005), available at http://www.dh.gov.uk/PolicyAndGuidance/HealthAnd-SocialCareTopics/StemCell/StemCellGeneralInformation/StemCellGeneralArticle/fs/en?CONTENT_ID=4124082&chk=5mbZjS.108. Ibid.

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