APPENDIX 78
Supplementary memorandum from the Human
Fertilisation and Embryology Authority
HFEA DECISION MAKING
ON PGD/HLA
A: Background Information
The HFEA is both a policy making and a licensing
body. Policy is discussed and passed by the Authority itself.
Mostly policy takes the form of guidance to clinics (this is published
at regular intervals as the Code of Practice, and in between such
publications in form of Chair's or Chief Executive's Letters and
Directions). At other times, the Secretary of State might ask
the Authority to consider a policy area and to make recommendations
for policy and legislative developments. For example the Sex Selection
Report published by the Authority in 2003 outlined issues currently
lying outside the remit of the HFEA that should be considered
by Government. Finally, the Authority might be a stakeholder and
might express its policy view as part of a political process that
is driven by the Government. This was for example the case in
the Government's consultation and subsequent decision to abolish
donor anonymity.
In order to develop policy the Authority will
always liaise and consult with stakeholders (patient groups, professional
bodies, other regulators) and will at times also conduct a wider
consultation or opinion research process. Further, any Authority
decision will normally be preceded by discussion in the Authority"
s sub-committees (for example the Ethics and Law Committee—previously
called the Ethics Committee, the Scientific and Clinical Advances
Group, or the Regulation Committee).
For clinics to provide a number of treatment
services they require an HFEA licence (creation and handling of
embryos, storage of gametes and provision of donor services).
The HFEA discharges its duties as a licensing body through a number
of Licence Committees that regularly review existing licences
and also assess each application for a new licence. Usually, licences
are generic, ie they enable a clinic to perform a range of activities
for all their patients. For new or controversial treatments, however,
the HFEA might also require that each individual case is looked
at by a licence committee (this is for example the case for any
new PGD-test or for HLA typing).
Regarding preimplantation HLA tissue typing,
the Authority made both types of decisions: it passed policy,
and it also made licence decisions on a number of occasions. The
sequence of events is outlined below. It is important to recognise
how Authority policy relates to licence committees and their decision
making: Authority policy does not bind a Licence Committee.
This point is important for the functioning of the Authority as
both a policy maker and a licensing body. Were policy to simply
bind licence committees, clinics and the individual circumstances
of their patients and cases could not be guaranteed a fair handling
of their applications. Only the discretion of licence committees
can safeguard fair and appropriate decisions in all individual
cases.
Each licence committee, in exercising its discretion,
should consider the application in the light of the policy guidance
established by the Authority. However, the Committee's discretion
is not fettered by this policy guidance. If the application does
not comply with one or more aspects of the guidance then the Committee
should consider whether it regards compliance with the outstanding
aspect to be essential. The Committee may decide to grant the
application even if the policy guidance has not been complied
with in full, provided that the statutory criteria have been established
and the Committee considers that it is appropriate to grant the
application. The Committee should give reasons for its decisions.
Where an applicant is dissatisfied with a Committee decision,
he or she can appeal to the Authority and have their case reconsidered.
The appeal will then be heard by members of the Authority that
did not sit on the licence committee in question.
In making policy or licensing decisions, both
the Authority and Licence Committees will regularly seek legal
advice. Since November 2003, the HFEA employs an in-house legal
adviser, supplementing ongoing external legal advice provided
by Morgan Cole Solicitors, which means legal advice is now more
readily available and is provided during each Authority and Licence
Committee meeting.
B: The HFEA's decisions on HLA typing
— In November 2001, the Authority
agreed a relatively cautious interim policy on PGD/HLA
drawing a distinction between HLA typing in cases of inherited
conditions with a known genetic marker (HLA with PGD) and HLA
typing in cases where the condition does not follow a clearly
inherited pattern, or no genetic marker has been identified (HLA
without PGD). A precautionary approach to unknown risks entailed
in the embryo biopsy and child welfare considerations were important
factors influencing this policy.
— When the first application for preimplantation
HLA typing (with PGD) came before a Licence Committee in February
2002, the Committee agreed to issue a licence enabling Care
at the Park Hospital, Nottingham, to perform HLA typing with PGD
(the Hashmi decision).
— In March 2002 Judicial Review
proceedings were commenced by CORE (Comment on Reproductive Ethics)
challenging the Authority's policy decision and seeking a declaration
that the Authority had no power to grant a licence to perform
HLA typing.
— In July 2002, the High Court
granted CORE permission to proceed with the application for Judicial
Review The full hearing took place in December 2002, when
the High Court decided that the Authority had no power
to allow HLA typing in order to test for tissue compatibility
with an affected sibling. The HFEA appealed against this High
Court decision.
— In July 2002, after permission
to proceed had been granted in the CORE case, a Licence Committee
turned down an application from the Assisted Reproduction and
Gynaecology Centre (ARGC), London, for HLA typing (without PGD)
in the treatment of Mr and Mrs Whitaker whose son Charlie was
affected by a sporadic form of Diamond Blackfan Anaemia.
Legal Advice was provided to the Licence Committee.
Central to the Lawyer's argument was the consideration of the
pending hearing in the High Court in the CORE case and the HFEA's
position in this court case. The legal advice pointed out that
any arguments the Authority wished to use had to be seen in the
context of the CORE judicial review:
"[ . . . ] This is because it is doubtful
that these arguments would be available to the Authority if a
licence for the HLA typing were to be granted otherwise than in
conjunction with PGD. The arguments are in the alternative:
1. The Authority has power to issue a licence
for HLA typing where it is granted in conjunction with a PGD licence.
[ . . . ]
2. In addition to the powers in paragraph
1(1) of Schedule 2, the Authority also has power in paragraph
1(2) to attach conditions to licences authorising the performance
of any of the activities in such manner as may be specified. [
. . . ] On this basis, the Authority could be said to have power
to authorise HLA typing (where it is used in conjunction with
PGD) by relaxing licence conditions that would normally restrict
the replacement of embryos that have been subjected to such testing.
[ . . . ]
In the CORE Judicial Review it is being argued
on the Authority's behalf that HLA typing is justifiable as it
will only be used in conjunction with PGD. If the Licence Committee
should grant a licence for HLA typing in isolation this is likely
to weaken the Authority's case in the CORE Judicial Review. [
. . . ]"
— The HFEA's appeal against the High
Court decision, however, was successful (May 2003). The
Court of Appeal set aside the earlier High Court judgement and
stated that it was open for the HFEA to conclude that an embryo
biopsy for the purpose of selecting an embryo with tissue compatible
with that of a very sick child was an activity necessary or desirable
for the purpose of "treatment services' within the meaning
of the 1990 Act (R (on the application of Josephine Quintavalle
on behalf of Comment on Reproductive Ethics) v HFEA [2003]).
This decision is subject to a pending appeal to the House of Lords.
— In February 2004, the HFEA agreed
to include a review of the HLA typing policy in the 2004-05
business plan. The Executive prioritised this review as it was
understood that there were families who might wish to seek treatment.
It was felt that as some time had passed since the initial decision,
with more data and evidence on the safety of embryo biopsy and
the welfare of donor children emerging, and in light of the above
Court of Appeal decision, it might be timely to review all the
available evidence and to decide whether the relatively cautious
interim policy was still justified.
— This policy review concluded in July
2004, with an Authority decision to extend its policy on HLA
typing, giving up the distinction between inherited and sporadic
disease (HLA with or without PGD). This decision was made taking
account of a wide range of scientific, ethical, psychological
evidence that was collated by the Executive.[301]
— On 6 September 2004, an application
from the ARGC to provide HLA typing (without PGD) for Mr and Mrs
Fletcher, whose son Joshua was affected by a sporadic form of
Diamond Blackfan Anaemia was considered by Licence Committee and
a licence was granted. Again, legal advice was available to the
Committee.
The Legal Adviser reminded the Committee that
it had the power to vary the centre's treatment licence (to allow
HLA tissue typing) if it was satisfied that:
— "This is a practice designed to
determine that an embryo is suitable to be placed in a woman.
— It is necessary or desirable for the
purpose of providing treatment services".
The Legal Adviser explained that the Court of
Appeal had decided in May 2003 that HLA typing, with or without
PGD was capable of meeting both the above legal criteria. And
that, "the Committee should proceed on the basis of the Court
of Appeal's clarification of the law, unless and until a different
conclusion is reached by the House of Lords".
Once the Committee concluded that the statutory
tests were satisfied, then the Committee had discretion whether
or not to vary the licence to authorise the activity in this case:
"The Committee should carefully consider the written documentation
submitted in support of the application and any oral submissions
made".
Also, "in exercising its discretion the
Committee should consider the application in the light of policy
guidance established by the Authority. However, the Committee's
discretion is not fettered by the policy guidance."
— It is expected that the CORE appeal
against the Court of Appeal decision will be heard in March 2005.
— The Authority publicised its new
policy through Chair's Letter (04)05, in August 2004[302]
and expects to include its new guidance on HLA tissue typing in
a planned 7th revised edition of the Code of Practice.
C: PGD/HLA tissue typing timeline
| 1999 | HFEA publishes interim policy on the licensing of PGD. Public consultation on PGD conducted together with the then ACGT (Advisory Committee on Genetic Testing), which does not, however, directly address the question of preimplantation HLA typing
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| August 2000 | Birth of Adam Nash in Colorado—the first baby to be born following PGD and HLA typing. Stem cells from Adam's umbilical cord were later used to treat his sister Molly, who was suffering from Fanconi Anaemia
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| December 2000 | HFEA/HGC Joint Working Party established to take forward the findings of the 1999 HFEA/ACGT consultation on PGD and to make recommendations
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| September 2001 | Application received from CARE at the Park Hospital, Nottingham, for PGD/HLA treatment for Mr and Mrs Hashmi whose son, Zain, was affected by the inherited disease ßThalassaemia major
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| June-November 2001 | HFEA/HGC Joint Working Party agrees recommendations. They are adopted by both the HFEA and the HGC. Publication of the "Outcome of the Public Consultation on Preimplantation Genetic Diagnosis"
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| 22 November 2001 | Ethics Committee Opinion on selection of preimplantation embryos to produce tissue donors (after 3 previous discussions of the issue from November 2000 onwards). It recommends licensing of HLA typing both with and without PGD
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| 29 November 2001 | HFEA agrees a relatively restrictive policy on HLA tissue typing, distinguishing between cases where PGD was necessary to avoid a disability in the future child—and cases where HLA was performed "on its own"
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| 22 February 2002 | HFEA Licence Committee agrees to issue licence to CARE Nottingham for the treatment of Mr and Mrs Hashmi
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| 12 July 2002 | CORE granted permission to apply for judicial review (this permission was initially refused in May 2002)
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| 29 July 2002 | HFEA Licence Committee turns down application from ARGC for HLA tissue typing for Mr and Mrs Whittaker
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| 20 December 2002
| CORE application succeeds at first instance—HLA tissue typing held to be unlawful
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| 15 May 2003 | HFEA issues revised guidance on preimplantation testing via Chair's Letter (03) 04. As the legality of HLA typing at the time is considered uncertain, the section relating to HLA typing is not included in this guidance. The new guidance on PGD moves away from an "objective" list of conditions that would merit PGD and towards greater emphasis on the couple's and clinician's views and decision making. This guidance is incorporated into the 6th (and current) Code of Practice early in 2004
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| 16 May 2003 | Court of Appeal overturns earlier High Court decision. It is within the powers of the HFEA to licence HLA tissue typing
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| 6 November 2003 | Two further licenses granted to CARE Nottingham to provide HLA/typing with PGD for two couples with children affected by two inherited forms of Thalassaemia (Ms B and Mr A and Mr and Mrs L)
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| February to July 2004 | HFEAconducts a review of its policy on HLA tissue typing. A new, extended policy is passed by the Authority on 21 July 2004, giving up the distinction between inherited and sporadic diseases
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| 4 August 2004 | The new policy is communicated to clinics through Chair's Letter CH(04)05
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| September 2004 | HFEA Licence Committee grants a licence to ARGC to provide HLA tissue typing for Mr and Mrs Fletcher whose son Joshua suffers from a sporadic form of Diamond Blackfan Anaemia.
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| November 2004 |
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301
A summary of the research that informed the reviewed policy can
be found on the HFEA's website at: http://www.hfea.gov.uk/AboutHFEA/HFEAPolicy/Preimplantationtissuetyping Back
302
See http://www.hfea.gov.uk/HFEAGuidance/ChairsLetters/1092734673 Back
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