Reproductive Opportunities and Regulatory Challenges
| Published date | 01 March 2004 |
| DOI | http://doi.org/10.1111/j.1468-2230.2004.00488.x |
| Date | 01 March 2004 |
| Author | Roger Brownsword |
of state activity they [the courts] have usually applied a highly traditional view of
what constitutes legitimate action’.
98
It would thus appear that, unless and until
the judiciary demonstrates a willingness to engage more fully with the changed
environment of rationing in the NHS, judicial review is likely to continue to
prove largely ine¡ectualas a mechanism for the facilitation of legitimate processes
of decision-making on the allocation of limited health care resources.
Reproductive Opportunities and Regulatory Challenges
Roger Brownsword
n
BACKGROUND
The plight of the Hashmi family has attracted widespread interest in the media.
Brie£y, one of the Hashmis’ children, Zain, was born with the blood disorder,
beta thalassaemia major.To rectify this disorder, Zain needs a stem cell transplan-
tation,using the cord blood orbone marrowof a donor who is free of thethalas-
saemia gene as well as being a tissue-match with Zain. None of Zain’s three elder
siblings being atissue-match, the Hashmis resolved to have another child (an in-
tended saviour sibling). The ¢rst child conceived by Mrs Hashmi was aborted
because prenatal tests showed that it had the thalassaemia gene; and the second,
althoughborn healthy, was not a tissue-match for Zain. In desperation, the Hash-
mis sought advice from Dr Simon Fishel, the Managing and Scienti¢c Director
of Centres for Assisted Reproduction Limited (CARE), the largest single provi-
der of IVF services in the United Kingdom.
Dr Fishel advised the Hashmis that aprocedure pioneered at the Reproductive
Genetics Institute in Chicago might assist them.This procedure involved remov-
ing a single cell from the early embryo bya biopsy; using pre-implantation genet-
ic diagnosis (PGD) to check that the embryo was free of the thalassaemia gene;
using a similarprocess, HLAtyping, tocon¢rm a tissue-match; and then implant-
ing an embryo that satis¢ed both requirements. However, Dr Fishel’s view was
that, before such a procedure could be lawfully undertaken in the UK, it would
need to be speci¢cally authorised by the Human Fertilisation and Embryology
Authority (the Authority). For, although there was nothing new about
PGD being carried out as part of IVF treatment licensed by the Authority,
1
98 n 42 above,3.
n
Professor of Law, King’s College London and HonoraryProfessor in Law, University of She⁄eld. I
am grateful tothe Leverhulme Trustfor its support in enabling me to complete this piece.
1 The framework legislation, the Human Fertilisation and EmbryologyAct 1990, does not deal ex-
plicitly with licensing PGD. However, the Authority takes the view that because (i) the Act expli-
Reproductive Opportunities and Regulatory Challenges
304 rThe Modern LawReview Limited 2004
tissue- typing had not previou sly been carried out as part of such t reatment.
2
Ac-
cordingly, on behalf of the Hashmis, CARE made the appropriate application to
the Authority, seeking clari¢cation as towhether a licence toadminister IVF treat-
ment might also include authorisation for tissue-typing.
In December 2001, the Authority announced that, in principle, it would be
prepared to license tissue-typing but only where PGD was already being licensed
for a serious genetic disorder. Such licences (for PGD plus tissue-typing) would
be grantedonly exceptionally ^ namely, where the particular genetic disorder was
severe or life-threateningand where the embryo itself was at risk of this disorder,
provided also thatal l other possible avenues for treating the a¡ected child (such as
Zain) had been explored, that the intended recipient was not a parent, that the
intention was to use only the cord blood, that the parents would be counselled,
that the family would be encouraged to participate in follow-up studies, and that
no embryo would be genetically modi¢ed to provide a tissue match. In ablaze of
publicity, in February 2002, the Authority gave the go-ahead for the Hashmis,
granting a licence to Park Hospital, operated by CARE in Nottingham, to carry
out the treatment.
The chances of the treatment being successful are not good. In the ¢rst round
of treatment, 15 embryos were produced; only one was a tissue-match but it
carried the thalassaemia gene. For the second round, the Hashmis travelled to
Chicago, where 10 embryos were produced. Two of these embryos seemed suit-
able; one was implanted; but no pregnancy resulted. At this juncture, however,
the Hashmis’ e¡orts were interrupted when Comment on Reproductive Ethics
(CORE), a group for whom absolute respect for the embryo is axiomatic, sought
a judicial reviewof the Authority’s December 2001announcement and,by exten-
sion, the licence granted thefollowing February. CORE argued that theAuthor-
ity had no power to issue a licence permitting the use of HLA typing to select
between healthyembryos.
CORE’s challenge was by no means a hopeless cause for the question of
whether the Authority has power to license t he testing of embryos (whether by
PGD, HLA, or both) is not straightforward. The framework legislation, the
Human Fertilisation and Embryology Act,1990, does not make speci¢c and un-
equivocal provision for such testing; and what we make of the Act largely
turns on how we read the provisions in Schedule 2. Here, it is provided in a
citly permits research on embryos, (ii) the possibility of developing methods for detecting gene or
chromosome abnormalities in embryos prior to implantation was recognised in 1990, and (iii) a
clinical trial to develop PGD for a life-threatening sex-linked disorder had just been undertaken
at the time, the Actimplicitly supports the l icensing of PGD for severe or life-threateni ng disorders
(see the HFEA and ACGT Consultation Document on Preimplantation Genetic Diagnosis (November
1999) para10). Currently, some eight clinics are licensed to carry out PGD for speci¢c medical
conditions.
2 Neither the Human Fertilis ationand EmbryologyAct1990, northe Authority’sown Code of Prac-
tice (5
th
edition, 2001),de als explicitlywith the question of tissue -typing.However,para. 9.5 of the
Code articulates the precautionary principle that,where embryos are subjected‘‘to proceduresthat
carry an actual or reasonable theoretical risk of harm to their development potential’’, then they
should not be used. Moreover, the onus is on treatmentcentres to ‘‘satisfy the HFEA that su⁄cient
scienti¢c evidence is available to establish that anyprocedures used do not prejudice the develop-
ment potential of the embryo.’’
RogerBrownsword
305rThe Modern LawReview Limited 2004
To continue reading
Request your trial