APPENDIX 91
Supplementary evidence from the Department
of Health
RESPONSES TO
SUPPLEMENTARY QUESTIONS
1. How can regulation be used to minimise
multiple pregnancies and promote single embryo transfer?
The Government is aware of concerns arising
from risks to mother and child associated with multiple pregnancies.
In principle, there are a range of regulatory approaches which
could be taken to influence the number of multiple pregnancies
and the number of embryos transferred. Insofar as currently regulated
treatments are concerned, the HFEA gave thorough consideration
to this issue in arriving at its current policy (as outlined in
the 6th edition of its code of practice), which aims to maintain
pregnancy rates whilst minimising multiple pregnancies. Compliance
with the code is a factor which is taken into account in licensing
decisions. Clearly there are a range of factors which need to
be taken into account in coming to a view on the need for further
regulatory intervention in this area; these factors include the
welfare of the child, considerations of reproductive choice, and
the proper scope for clinical judgement in individual cases. There
are also important roles to be played by guidance from the professional
bodies (including in particular the Royal College of Obstetricians
and Gynaecologists), and clinical guidance from the National Institute
for Clinical Excellence.
2. How many members will there be on the RAFT
Authority? On what basis will they be appointed? What efforts
will be made to ensure that the appropriate expertise is present?
The number of members and the composition of
the proposed regulatory authority have yet to be determined, and
are subject to primary legislation. However, it is clear that
the body will need to be able to draw on a sufficient range of
expertise in order to be able properly to discharge its functions,
which will cover a wide range of matters across assisted conception
and other uses of human tissue. The 1990 Act contains a requirement
for a minimum number of members with specified professional expertise,
and it may be desirable to retain such a provision in any revised
legislation. The Government will consider carefully any recommendations
in this regard that the Committee may choose to make. It is also
envisaged that the body, in common with the two regulatory authorities
that it will replace, will need to have substantial lay representation.
The appointments process can be expected to follow relevant good
practice and be conducted by the NHS Appointments Commission.
3. What consideration was given to the number
of Department of Health ethical and scientific advisory committees
during the Review of Arm's Length Bodies?
Consideration of the number of ethical and scientific
advisory committees was not within the terms of reference of the
Department of Health's Review of Arm's Length Bodies. Rather the
ALB review considered primarily those stand-alone national organisations
sponsored by the Department of Health undertaking executive functions,
which normally have boards, employ staff and publish accounts.
The ALB review is part of a wider programme to improve efficiency
and cut bureaucracy, to free up more resources for the delivery
of frontline services to patients.
4. What consideration was given to setting
up a national bioethics committee during the Review of Arm's Length
Bodies?
The possibility of a national bioethics committee
was considered during the ALB review because some ALB-related
functions could have been vested in such a committee. The Government
considered this possibility carefully, including taking account
of the views of key stakeholders, and concluded that the current
distributed system remains the best option as it provides for
specific bioethical issues to be addressed by dedicated groups
who are able to concentrate on the relevant field in question.
We cannot see sufficient justification for replacing this with
a single bioethics commission.
5. The Shipman Inquiry accused the General
Medical Council of not protecting the interests of patients. Would
you like to see stronger action being taken by the General Medical
Council to police bad and unethical practice in this area?
(see response to 6, below)
6. Would the Department of Health like to
see stronger action being taken by the General Medical Council
to police bad and unethical practice in assisted reproduction?
On 27 January the Government announced that
it wanted to help protect patients from poor medical practice
and misconduct. John Reid has asked the Chief Medical Officer
for England, Sir Liam Donaldson, to lead a review into patient
safety as part of the Department of Health's response to the Shipman
Inquiry. The Chief Medical Officer will report later this year
to minimise any delay to the introduction of measures both to
improve patient safety and ensure doctors are fit to practice.
The review will inform the Department's patient protection measures.
The review will seek to draw on the findings of the Shipman Inquiry
and the relevant other inquiries into the instances of poor clinical
performance.
The review will identify measures to:
— strengthen procedures for assuring
the safety of patients in situations where a doctor's performance
or conduct poses a risk to patient safety or the effective functioning
of services;
— ensure the operation of an effective
system of revalidation; and
— modify the role, structure and
functions of the General Medical Council (GMC).
An advisory group will support the Chief Medical
Officer throughout the review. The group's members include experts
from organisations representing consumer, healthcare quality and
professional interests.
The Human Fertilisation and Embryology Authority
and the General Medical Council currently have an agreed memorandum
of understanding setting out co-operation and collaboration in
relation to licensed assisted conception services.
7. You suggested that patients were taking
a risk by seeking unregulated treatment overseas. What assessment
has the Department made of the risks of seeking treatment in other
countries? What advice does it make available to the public?
The Department has not made a formal assessment
of risk associated with seeking unregulated treatment overseas,
nor does it routinely make available advice to the public on such
matters. A copy of the HFEA publication "Thinking of going
abroad for fertility treatment or using donor material from abroad?"
is appended as an Annex for reference.
8. What restrictions should be placed on the
purposes for which research is conducted on derived embryonic
stem lines deposited in the stem cell bank?
The steering committee for the UK stem cell
bank and for the use of stem cell lines currently oversees access
to human embryonic stem cell lines deposited in the stem cell
bank for the purpose of research. The steering committee makes
clear in its application process for access to cell lines that
it must satisfy itself that embryonic stem cell lines will not
be used for trivial purposes. In addition EU Directive on tissues
and cells (Directive 2004/23/EC) will apply common standards of
safety and quality to tissues and cells used for human application—therefore
covering cell lines used for in vivo research on human participants.
The Government will of course study carefully any recommendations
from the Select Committee about the regulation of stem cells.
9. What merits do you see in regulating the
charges made to patients in the course of licensed fertility treatment?
At present the majority of licensed fertility
treatments are provided as privately funded services. As with
other markets for services, there are clear merits in consumers
being fully informed. The HFEA publishes information for patients
about available services in its publication "Your guide to
infertility", however the Government does not see the role
of the HFEA as being that of a financial regulator.
10. What mechanisms will be employed to ensure
that the recommendations from the Toft Report are fully implemented?
As a result of discussions that Professor Toft
had with the HFEA and the Leeds Teaching Hospitals Trust during
the course of his investigation, the vast majority of his recommendations
were already addressed by the time of the publication of his report.
The Department has monitored progress on the implementation of
the remaining recommendations through its normal forms of liaison
with the HFEA, including regular update meetings, and continues
to do so.
11. The EU Charter of Fundamental Rights demands
"the prohibition of eugenic practices, in particular those
aiming at the selection of persons". What consideration have
you given to the prospect of legal challenge to prohibit preimplantation
genetic diagnosis?
The Charter of Fundamental Rights of the European
Union is a political declaration and currently not legally binding.
It has been incorporated within the EU Constitution signed recently,
and if that is ratified and in force, the Charter will be binding
on the EU institutions, and on Member States in so far as they
are implementing EU law. However, the regulation of medical ethical
issues is not regulated under EU law, and as such, the Charter
would not apply.
12. What plans does the Department have to
review legislation on surrogacy arrangements?
Surrogacy arrangements are relevant to consideration
about the law relating to human reproductive technologies, although
they are primarily covered by legislation outwith the Human Fertilisation
and Embryology Act 1990. The Government will look carefully at
any recommendation from the Committee in relation to surrogacy.
13. Can you set out the appointment procedure
for Authority members, including the criteria for membership,
the interview process and the role played by the HFEA. How many
applications has the Department received in the last five years
from those with a recognisable pro-life view? How many applications
were refused on this basis?
The appointments process has traditionally involved:
— consideration by the Department,
in consultation with the Chair of the HFEA, of the skills and
experience that the Authority needs;
— with that in mind, which determines
the criteria that applicants should satisfy, the Department advertising
for new or replacement members;
— consideration of the applications,
including sift and interviews, by a panel comprising a Department
of Heath representative, the Chair of the HFEA and an independent
assessor;
— recommendations made to the
Secretary of State by the panel; and
— appointment of members by the
Secretary of State, in consultation with health ministers in the
devolved administrations.
Future appointment exercises will, in accordance
with overall Department of Health practice, be conducted by the
NHS Appointments Commission, with input from the Chair of the
HFEA. However, the final decision on the appointment of members
will remain with the Secretary of State.
In accordance with guidance from the NHS Appointments
Commission, documentation on appointment exercises is destroyed
after three years. For this reason, we can only provide information
regarding appointments made between 2002 and 2004.
2002
Four appointments were advertised seeking candidates
in the following categories:
— the ability to represent the
wider patient experience; and
— finance, accountancy and resource
management.
14 applications were received under the clinical
genetics category, 13 under embryology, 84 under patient experience
and 37 under finance etc (one applicant did not specify any category
and could not be placed from the information provided). No candidates
expressed what might be regarded as "pro-life" views
in their applications nor did they raise objections to any element
of the HFEA's work. No candidate was rejected on this basis.
2003
Two separate appointment exercises were carried
out during this year.
Spring 2003
The Department advertised for candidates with
legal expertise to replace a legal academic member who decided
to retire from the HFEA. 51 applications were received. There
were no "pro-life" views nor objections to HFEA regulated
activities. No candidate was rejected on this basis.
The Department takes the position that members
of the HFEA must always be mindful of the full range of views
held on embryology and assisted conception. These must, of course,
include those who sincerely believe that the IVF and related techniques
or research are intrinsically wrong. However, members also need
to accept the principles of the Human Fertilisation & Embryology
Act and the activities it has made permissible in the country.
Their duty is to ensure that these are provided as safely and
ethically as possible.
Autumn 2003
Three appointments were advertised seeking candidates
in the following categories:
— medical practitioner with expertise
in assisted conception;
— infertility counselling; and
— religious ministry/theology.
14 applications were received under the medical
practitioner category, five under fertility counselling and 11
under religious ministry/theology. Again, none expressed "pro-life"
views in their applications or objections to elements of the HFEA's
work. Again no candidate was rejected on this basis.
2004
In view of the Department's Arms Length Bodies
review, no appointment exercise was carried out. (A new appointment
was made to replace a clinical member who retired early. With
the agreement of the Office of the Commissioner for Public Appointments,
a medical practitioner who applied in Autumn 2003 and was classified
as suitable for appointment to the HFEA was invited to take up
the vacant post.)
14. What data were used to inform the statement
by Melanie Johnson on 18 May 2004 on donor availability in Sweden
that "there are indications in Sweden that, although donor
numbers dropped initially, they rose again".[373]
In the first half of 2003 the Department of
Health wrote to a number of potential sources of information in
Sweden, and commissioned a report on the position outside the
UK, including Sweden, from Professor Eric Blyth, University of
Huddersfield. The information received was as follows.
A clinician/published researcher at the Sophiahemmet
assisted conception unit (Dr Claes Gottlieb) advised that data
on the number of sperm donors is not, and has not been, collected
centrally in Sweden. He reported that in two clinics in Sweden
the number of sperm donors was approximately the same before the
legislation and one year after, and that for a short period in
between the number of sperm donors decreased. Dr Gottlieb also
provided this information to the HFEA, on behalf of Dr K-G Nygren.
Professor Eric Blyth reported in May 2003 that
although it is generally acknowledged that the change in legislation
in Sweden resulted in a decline in donor recruitment, it was not
possible to ascertain the scale of the reduction. He advised that
at Malmo University hospital the number of available sperm donors
decreased from about 30 before the change in legislation to 2*
PS(PH) haas queried this subsequently, although during this time
there was no advertising for new donors. He also reported that
at Malmo the current level of recruitment is about the same as
before the abolition of anonymity and that reports from other
Swedish clinics similarly indicate an initial decline in donor
recruitment but a subsequent revival, as indicated in research
by Daniels and Lalos in 1995.
15. What encouragement and support has the
Department given to treatment centres to achieve ISO accreditation?
The Department of Health has not encouraged
or supported clinics to achieve ISO accreditation specifically.
However, the Department (and the HFEA) have actively engaged with
treatment centres and representative bodies in connection with
the likely requirements of the European Union Directive on tissues
and cells (Directive 2004/23/EC). The Directive will set out common
quality and safety standards, and will particularly emphasise
the importance of a "quality systems" approach. This
is inspired by and has much in common with relevant ISO accreditation.
The Department does not collect data centrally on the number of
treatment centres currently holding ISO accreditation.
16. What would be the legislative implications
if the judicial review of the HFEA's decision to award Newcastle
Fertility Centre with a licence to clone human embryos were successful?
The judicial review process in question is ongoing,
and I would not wish to prejudice it by speculation. It is not
possible to assess "legislative implications" (if any)
without sight of the detail of the judgement in a particular case.
February 2005
373 Draft Human Fertilisation and Embryology Authority
(Disclosure of Donor Information) Regulations 2004, First Standing
Committee on Delegated Legislation, 18 May 2004, Column Number:
11. Back
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