APPENDIX 92
Supplementary evidence from the Human
Fertilisation and Embryology Authority
RESPONSES TO
SUPPLEMENTARY QUESTIONS
1. How do you see your role in facilitating
and informing the research that is undertaken to support the Authority's
policy decisions?
The HFEA is not a research body. We do not have
the budget or the expertise to conduct high level academic research.
Clearly, because of our commitment to evidence based policy making,
many of our policy reviews will contain an element of research,
mostly literature reviews and at times also opinion research (both
qualitative and quantitative). From time to time, the HFEA has
commissioned research from outside experts to inform its policy
making, again, this research mostly consisted of literature reviews
(see question 7 below).
In recent years, the HFEA has started to develop
a more sustained approach towards the question of social science
and epidemiological research. It initiated the MRC/HFEA working
group that was explicitly tasked with identifying research needs
and ways in which these could be met, and is taking follow-up
action with the MRC. The HFEA has also supported an application
by the National Perinatal Epidemiology Unit to the MRC for funding
to conduct research into the long-term health outcomes for IVF
children. Follow-up action is also being taken up with the MRC.
We have now also identified and are starting
to establish sustained working relationships with both the ESRC
and Wellcome Trust in order to increase the knowledge and evidence
base for the HFEA's policy making function and the fertility sector
itself.
2. How many people are currently employed
in the HFEA's Regulation Department? How many vacancies are there?
What efforts have been made to fill these vacancies?
The Regulation Department is undergoing a period
of sustained change and modernisation, and is investigating plans
to move towards an in-house, full-time professional inspectorate.
The current staffing structure is therefore under review. Once
this review has concluded, it will become clearer how many positions—and
of which type—there will be required.
Currently, there are 20 people employed (this
includes the Research Regulation Function, Clinical Governance,
and administration functions) and two vacancies, with one more
shortly to arise.
One interim staff member has been recruited
and further candidates are being interviewed to cover two of the
vacancies. Advertisements for permanent staff are currently pending,
subject to agreement by the Arms' Length Review.
3. For what reasons have licences been refused
or not renewed?
It is relatively rare for licences to be revoked,
less rare for licences not to be granted in the first place or
renewed. It is more common for conditions to be imposed on licences.
"Formal recommendations" don't become part of a centre's
licence, but are another way in which a Licence Committee can
give guidance to a clinic.
Below is a list of typical reasons for which
the HFEA Licence Committees have taken action in order to manage
risks in clinics or labs.
RESEARCH LICENCES
Licence not granted
— Because there was no "research"
angle, and the application was effectively about training ICSI
or embryo biopsy practitioners (not within the law to grant such
a licence, but we have flagged up that we would like to be given
power to give such licences).
— Because the applicants couldn't
demonstrate the required ability to select spermatids reliably.
— Because the Committee felt that
the proposal was of "poor experimental design".
Licence not renewed
— Because the (then new) requirements
to deposit stem cell lines in the MRC stem cell bank were not
reliably met.
TREATMENT LICENCES
Licence not granted/altered
— Because guidelines on ICSI practitioners
could not be altered to accommodate one clinic.
— Because of doubts about the
suitability of the proposed PR.
— New centre not yet ready for
licensing.
Licence revocation threatened
— Because centre didn't report
data in accordance with general directions (centre took corrective
action and the proposal was dropped).
— Because of a serious incident
involving the use of the `wrong' sperm (centre took corrective
action and the proposal was dropped).
Licence not renewed
— Because centre was small, very
few patients and cycles.
Conditions put onto the licence
— Request for information regarding
counsellor's qualifications.
— Full audit of stored gametes
and embryos.
— Introduce version control for
patient information.
— Comply with section 8.14 of
the Code of Practice for home sperm production.
— Make available a customised
sperm production room.
— Comply with requirements of
Deceased Fathers Act.
— Audit all patient records.
— Separate screened and unscreened
samples.
Formal recommendations
— To develop counselling protocols.
— To change patient info.
— To change lab protocols.
— To get a new Dewar installed.
— To install a password protected
database.
— To improve the management of
consent procedures.
— To improve cryostore ventilation.
— To introduce witnessing protocols.
— To review and sign audit reports.
4. What factors influence your decision to
publish pregnancy rates for treatment centres?
Section 8 of the HFE Act 1990 obliges the HFEA
to provide information to the public about "services provided
in pursuance of a licence" and to provide information and
advice to persons who are receiving treatment services'. We have
traditionally understood this to include outcome data from the
all the licensed clinics.[374]
The Authority does believe that in the context of other crucial
information (such as what services are provided, pricing, locality
etc) the information about treatment outcomes can play an important
role in facilitating patient choice.
However, it is clear that comparing outcomes
(and thus defining "success") is difficult and that
certainly "success rates" should not be read in isolation.
This is why we set up a Clinical Information Working Group, consisting
of representatives from centres, the professional bodies, patients
and counsellors. This group decided that publishing outcome data
should be continued, but that a single unified comparator (a "success
rate") should not be included in this year's patients' guide.
This is because it would reflect the wide range of embryo transfer
practice before the introduction of the two embryo transfer policy
in 2004.
5. What was the result of your legal advice
on the status of a pro-nucleus?
Section 3(3)(d) prohibits "replacing a
nucleus of a cell of an embryo with a nucleus taken from a cell
of any person, embryo or subsequent development of an embryo".
The question arose whether this prohibition also covered the transfer
of the pronuclei from one zygote into an enucleated zygote (a
one cell embryo).
To answer the question, the HFEA considered
the following information:
— Professors Ian Wilmut and Keith
Campbell in their book: "The Second Creation" (Wilmut,
Campbell and Tudge; 2000, Headline Books) state: "Note that
the zygote at no stage contains a single nucleus. First, it has
two haploid pronuclei, then two diploid pronuclei, and then it
enters mitosis. There is no diploid nucleus, with a complete complement
of chromosomes until we reach the two-cell stage" "one-celled
embryos—do not contain single, diploid nuclei—"
— Furthermore, in one of the standard
text books on developmental biology (Gilbert, SF Developmental
Biology, Fifth Edition, 1997 Sinauer Associates Inc. Publishers)
it states that "a true diploid nucleus in mammals is first
seen not in the zygote, but at the two-cell stage."
— In addition, the Oxford English
Dictionary defines a pronucleus as "either of a pair of gametic
nuclei, in the stage following meiosis but before their fusion
leads to the formation of a nucleus of the zygote".
Therefore there is a biological distinction
between a nucleus and a pronucleus.
The HFEA also considered the following advice
form Morgan Cole Solicitors:
— Paragraphs 12.11 of the Warnock Report
referred to cloning by embryo splitting and paragraph 12.14 to
cloning by means of nucleus substitution. Paragraph 38 of the
White Paper made reference to both paragraphs 12.11 and 12.14
when setting out the intention to include an absolute prohibition
in the Bill. However, as Lord Bingham pointed out in the Quintavalle
case, Parliament did not actually introduce Section 3(3)(d) with
the intention of banning all cloning. He pointed out that cloning
by embryo splitting was not covered and that supported his conclusion
that Section 3(3)(d) could not be construed so widely as to prohibit
CNR. If the House of Lords had come to a contrary conclusion that
the intention was to ban all cloning then that would have supported
the prohibition extending to "pronucleus substitution".
The approach adopted by the House of Lords suggests that a narrower
construction is appropriate.
— Even if pronucleus substitution
is not within Section 3(3)(d), the Act still applies regulatory
control over any embryo that may be created. (It would still require
a licence from the HFEA). Accordingly, it is not essential to
the regulatory purposes of the Act that a pronucleus is regarded
as a nucleus.
It therefore seems that section 3(3)(d) does
not cover the transfer of the pronuclei from one zygote into an
enucleated zygote.
However, schedule 2 para 3(4) provides that
"a licence under this paragraph cannot authorise altering
the genetic structure of any cell while it forms part of an embryo,
except in such circumstance (if any) as may be specified in or
determined in pursuance of regulations." It therefore seems
that the transfer of the pronuclei from one zygote into an enucleated
zygote is prohibited by schedule 2 para 3(4).
6. Can you supply the data arising from your
survey of UK clinics on the availability of donated gametes?
The survey summary can be found on the HFEA
website at:
http://www.hfea.gov.uk/AboutHFEA/HFEAPolicy/SEEDReview/seed%20review.pdf
.
7. In 1993 you commissioned two pieces of
work from Rachel Cooke and Susan Golombok, published as A Survey
Of Semen: Phase I—The View Of UK Licensed Centres and A
Survey Of Semen: Phase II—The View Of The Donors. What other
research has the HFEA commissioned and why?
As outlined above, the HFEA does not have a
regular research budget and also does not have the necessary expertise,
resources and statutory role to commission large-scale academic
research. From time to time, and as part of wider policy reviews,
the HFEA has commissioned small-scale research projects, mostly
in the form of literature reviews.
These include:
— 2002, Olga BA van den Akker,
BSc PhD C Psychol AFBPsS, Reader in Health Psychology: a literature
review on donor conceived, step and adoption families.
— 2002, Dr Lars Bjrndahl and Professor
Chris Barratt: A review of the scientific and clinical literature
on sex selection.
— 2002, Dr Cathy Waldby: A review
of the social and ethical literature on sex selection.
— 2003, Professor Alison MacFarlane:
A review of British and American data on embryo transfer and treatment
outcomes.
8. Can you provide the full costs for the
Historical Audit Project and the number of staff employed, on
an annual basis?
The HFEA has statutory obligations under the
HFE Act to establish and maintain a register. It is imperative
that there is 100% accurate data about treatment outcomes on the
register, in particular where donated gametes have been used,
to give confidence to donor conceived children in the information
provided.
The historic difficulties with the HFEA's register
are addressed through the Historical Audit Project. The new improved
database which has been established through the Register Programme
will enable many mistakes to be picked up straight away. We are
also developing an Electronic Data Interchange, which eliminates
the possibility of errors being introduced by HFEA and will make
clinics' data reporting easier and faster in many ways. However,
clinics are being asked to correct errors and omissions identified
in previous information and future submissions.
Although at least 40% of mistakes and omissions
on patient forms have been introduced by clinics, we are trying
to minimise the burden for centres through the Historic Audit
Project. The HFEA provides the staff to perform this audit. However,
we do believe that this ongoing historic audit represents a necessary
effort, since the provision of reliable data is one of the most
important functions of the HFEA.
The Historic Audit costs are as follows:
2004-05 projected outturn expenditure (as shown
in the December Management Accounts): £1,547,000 with 57
staff in total by end of March 2005.
2005-06 estimated budget (as shown in the Business
plan): £3,236,000 with 58 staff as of April 2005.
9. The minutes of the February 2003 meeting
of the Authority report that "Discussion was held considering
the HFEA role in research given that this function has never been
in the HFEA remit or budget. There was a suggestion that the HFEA
should undertake social research in relation to welfare of the
child issues. It was agreed that the Authority should receive
a paper on research priorities at its May meeting when future
action concerning research should be decided." What did the
Authority decide in relation to the commissioning of social research?
The HFEA initiated the MRC/HFEA working group
to identify medical and epidemiological research priorities. With
regard to social science research, it is clear that the HFEA does
not have the resources or expertise to conduct or commission large-scale
academic research projects. From time to time, the HFEA will commission
research, as part of wider policy reviews or consultations (see
questions 1 and 7 above).
10. Have you ever received a research application
to culture an embryo beyond 14 days? If so, what decision was
reached and why?
No, we have never received an application to
culture an embryo beyond 14 days. Scientific advice also tells
us that it is currently impossible to keep embryos alive in vitro
beyond 9 or 10 days.
Were we to receive such an application, we would
have to reject it under the current legislation (section 3, (3)(a)
and (4) HFE Act 1990).
February 2005
374 No outcome data was published for the year 2001-03
because of problems that had arisen with the HFEA's register. Back
| 
