APPENDIX 88
Memorandum from the London Fertility Centre
INTRODUCTION
London Fertility Centre (LFC) wishes to bring
to the attention of the Parliamentary Science and Technology Committee
its views about the Human Fertilisation and Embryology Authority
(HFEA) in accordance with the consultation into Human Reproductive
Technologies.
London Fertility Centre has been licensed by
the HFEA to conduct assisted reproductive treatment since the
HFEA came into being in 1991. The centre was set up on 1 August
1990.
London Fertility Centre is one of 75 centres
licensed by the HFEA for IVF across the UK and is one of the largest
centres in terms of number of treatment cycles. The Centre's views
therefore relate to being regulated by the HFEA.
CONCERNS
1. The HFEA have manipulated facts to support
their decisions
For example, recent correspondence from HFEA
to LFC claimed that: "Management of your centre is unstable,
as evidenced by the fact that you have had three persons responsible
in six months."
The facts are that LFC has had three persons
responsible in 13 years.
2. The HFEA have not been reasonable in giving
centres adequate time to respond to documents
For example, the HFEA imposed a six day deadline
on LFC to respond to a draft inspection report in the middle of
the summer holiday period, when some key centre staff were on
vacation. LFC received this draft report a full six weeks after
the inspection.
3. The HFEA do not appear to be accountable
for their errors
Example 1: The HFEA have sent LFC numerous
incorrect letters referring to patients who are not registered
with LFC but are registered with another centre. This is a breach
of the HFEA Code of Practice Sixth Edition, and if such a breach
occurred at a licensed treatment centre it would have to be reported
to and investigated by the HFEA in compliance with the HFEA adverse
incident policy. Who are these breaches of the Code of Practice
reported to, and investigated by?
Example 2: The HFEA have sent LFC a number
of incorrect documents relating to another licensed centre. One
particular document was a consultation document that had a deadline
attached. When LFC returned the document, we received the correct
document to complete in less than a week before its deadline.
We asked for an extension of the deadline because of the HFEA
administrative error. Our request was declined. We consider this
was unreasonable since the error was made by the HFEA. There are
numerous other examples of such errors, which we are happy to
provide on request.
Example 3: LFC recently received an invitation
from the HFEA to submit representations against a proposed licence
condition, which we did in good faith and with considerable effort
and time, only then to be informed later that they should not
have invited LFC to do so in the first place.
4. THE HFEA APPEAR
TO HAVE
DOUBLE STANDARDS
The HFEA have criticised LFC for having a high
turnover of staff and yet over the past two years, particularly
within the Regulation Department, they themselves have had a high
turnover of staff. It would be useful to discover how many members
of the Regulation Department from 2002 are still working within
the HFEA Regulation Department at present. We are aware that the
Regulation Department consisted of five Regulatory Officers and
five Senior Regulatory Managers throughout 2004. However, as of
the end of February 2005 there will be one Regulatory Officer
and only two Senior Regulatory Managers remaining at the HFEA.
Centres wonder how the HFEA can regulate
effectively when they have such a high turnover of staff. The
turnover of staff in IVF centres is used by the HFEA as a criticism
even to the extent of recommending for our centre that a condition
be placed on our licence for a management review, which proposed
additional condition we are contesting since LFC is recognised
as a training centre by those interested in pursuing a career
in IVF. It is also important for centres to have some element
of continuity with the HFEA and it is difficult to build any rapport
when the nominated HFEA first point of contact changes so frequently.
It is left to centres to discover that their point of contact
does not still work for the HFEA as centres are not informed of
their staff changes. However centres are obliged to inform the
HFEA of any changes to their staffing structure.
It could be argued that the HFEA have not helped
the problem of staff turnover at IVF centres by aiming to recruit
directly from those centres by sending two circulars since 13
October 2004. The first circular aims to recruit a full time Scientific
Adviser for the HFEA. The second circular aims to recruit Locum
Senior Regulatory Managers on secondment from centres. It is LFC's
understanding that the HFEA is desperately understaffed. The first
round of advertising of posts has not been successful and therefore
the HFEA is desperate. The HFEA has not considered the likely
effects of "poaching" staff on the centres themselves,
and in particular those centres who they have concerns about turnover
of staff.
5. THE
HFEA HAVE SUBJECTED
LFC TO DISPROPORTIONATE
CRITICISM COMPARED
TO OTHER
IVF CENTRES
We have compared recent inspection reports from
other similar centres (which we have received on request
from the HFEA under their Publication Scheme) with the LFC inspection
reports. On review of Licence Committee decisions made as a result
of these reports it is clear that decisions are inconsistent between
IVF centres for similar breaches and disproportionate criticism
has been levelled at LFC. There are a number of centres that have
not been complying with various aspects of the HFEA Code of Practice
and these points have not resulted in additional conditions,
or recommendations. For example, LFC had an additional licence
condition last year stating that the person responsible must ensure
that responses from the GP with respect to Welfare of the Child
assessments must be in the patient records. LFC is complying with
this condition. However, another centre's inspection report states,
"there was no evidence of correspondence between the Centre
and the patient's GP in any of these records." The
Licence Committee referring to that centre considered this point
and decided to impose an additional recommendation, but not
an additional condition. There are numerous other examples
of inconsistencies, which we are happy to provide on request.
6. THE HFEA ARE
INCONSISTENT WITH
RESPECT TO
RESEARCH LICENSING
LFC has been licensed by the HFEA to conduct
research under two separate licences for two different projects.
It took over one year to get the licence approval for the
first project after we had obtained ethics committee approval
from the UCH Research Ethics Committee. The project was being
undertaken in conjunction with that facility. At the time of the
renewal, the project had been licensed and under way for one year.
During the renewal process, the HFEA informed LFC that it had
to be re-approved by a Research Ethics Committee. This request
was not made during the renewal of LFC's other research
project, which was successfully renewed for another year.
Thus there were two different systems in operation simultaneously;
one with, and one without, the need for a further ethics committee
approval.
A research ethics committee reviewed the first
research project before the initial licence was granted and we
questioned the need for it to be reviewed again. It is not
a requirement for the project to be reviewed by an ethics committee
each time it is renewed. It is only necessary before the
project is licensed, and this project was licensed for a year,
as stated above. It is not clear to us if every research project
that is subject to renewal has need to be reviewed again by a
further ethics committee submission. The project's licence
expired in September 2004 and valuable research was forced
to stop. LFC has formed another Local Research Ethics Committee
which has been approved by the HFEA. This has delayed LFC's research
efforts and the potential to provide additional services to our
patients, for example Pre-implantation Genetic Diagnosis.
7. THE HFEA HAVE
INCONSISTENT POLICIES
WITH RESPECT
TO CONTROL
OF INFECTIOUS
DISEASE TRANSMISSION
IN ASSISTED
REPRODUCTION
For example, the HFEA restricts the use of CMV
seropositive (IgG+ IgM-) donors, based upon the theoretical risk
of transmission of the virus to any embryos created, and hence
to recipients. It is LFC's understanding that this policy was
written in consideration of British Andrology Society guidelines
on transmission using un-washed, neat semen. With IVF and
IUI all semen is routinely washed and sperm isolated. Neat semen
is never used.
The CMV policy, we were informed by the HFEA
following our enquiry, was to be definitively reviewed by the
HFEA in January 2004. However we have now been informed that this
review will not occur until 2005, but we do not know precisely
when. This restriction is having a very adverse effect on our
egg donation programme which is now running at 50% of the capacity
it was just two years ago and patients are now seeking advice
overseas. Our understanding from meeting the Head of the Virology
Department at UCH on two separate occasions, and from repeated
communications with the Senior Lecturer prior to that, is that
the virus does not get into the eggs and sperm themselves. It
is also prudent to note that the HFEA does approve of IVF in HIV
infected couples following washing of sperm and eggs. The recommendations
for different viruses seem to be disparate and not based on evidence
that shows there is a risk if washed gametes are used.
8. THE HFEA FREQUENTLY
PROVIDE A
"KNEE-JERK"
RESPONSE TO
MEDIA ARTICLES
WITHOUT AN
OBJECTIVE, IN-DEPTH
ASSESSMENT OF
THE ISSUES
For example, the HFEA have endorsed "Egg
Sharing" schemes, which provide eggs for both the sharer
and the recipient from one treatment cycle. Alternatively, "Egg
Giving" schemes whereby all the eggs from one treatment cycle
are given to a recipient in return for a "free" treatment
cycle where the egg giver receives all of their own eggs, are
not now allowed by the HFEA. We believe the HFEA has focused unduly
on the risk of OHSS and perceived payment to egg givers (with
respect to a "free" treatment cycle). The risk of OHSS
and multiple pregnancy to these patients would both be minimal
since low-stimulant protocols were planned. Furthermore, "Egg
Giving" would allow the participants (donor and recipient)
the potential prospect of having a complete family, from
fresh and frozen embryos, which routine egg sharing denies them.
Ironically, "Egg Giving" as described
above, is already implicitly approved in several major UK IVF
centres, which allow their egg sharers to donate all their eggs
in the first cycle if fewer than eight have been collected. This
decision may not now be made electively before the treatment
is commenced, although the HFEA has approved centres whose protocols
clearly identify that practice. In subsequent cycles, these egg
sharers/donors could use all their own eggs at no, or reduced
cost for the IVF cycle. Such an arrangement is open to abuse whereby
centres can deliberately modify the drug stimulation programme
to the donor's advantage. A transparent egg giving arrangement
avoids such manipulation.
9. THE HFEA HAS
NOT RESPONDED
TO REPEATED
CORRESPONDENCE WITHIN
A REASONABLE
TIME SCALE
AND, ON
OCCASIONS, NOT
AT ALL
LFC has made repeated requests for national
live birth data and success rates for specific female ages which
patients should be able to receive to enable them to make informed
choices. These requests have never been met presumably because
the HFEA register of data is inaccurate and has not been validated
and yet the HFEA have never informed centres as to why they cannot
provide accurate live birth outcomes. If it is because the data
is flawed, or incorrectly coded, why in the spirit of openness
did the HFEA not inform centres to this effect rather than have
unnecessary and ineffective correspondence continuing?
It is LFC's opinion that fertility specialists
have an obligation to give national live birth data to patients
at the time of consultation.
10. HFEA'S RESPONSES
TO CONCERNS
FROM ASSISTED
REPRODUCTION PROFESSIONALS
ARE FREQUENTLY
TOO LITTLE,
TOO LATE
Donor expenses are still at the same level as
when the HF&E Act was passed in 1991. Donors are allowed to
receive £15 each time they donate in addition to travel expenses
and a maximum of £50 for loss of earnings and/or child minding
costs. Some of our egg donors have ended up with a financial loss
from donating. For example, one of our donors is a golf instructor
and earns a minimum of £150 per day.
Our centre believes that the £15 allowed
is an inadequate reward, which some donors could find insulting.
We were however criticised for providing flowers or a candle as
a token of the centre's gratitude: a gesture that has now been
stopped.
The HFEA are only now 14 years later reviewing
their policy on donor expenses as part of the consultation on
sperm, egg and embryo donation (SEED Review) in response to the
change in law on the loss of donor anonymity that comes into force
on 1 April 2005. LFC are concerned that this review is too
little too late. LFC publicly raised this issue and suggested
an "all inclusive" allowance to aid donor recruitment
in 1995 at an HFEA-sponsored Conference. For more details see
Craft, I, Thornhill, A (2005) "Would all-inclusive compensation
attract more gamete donors to balance their loss of anonymity?"
Reproductive Biomedicine Online (In Press).
11. THE HFEA
IS ONLY
NOW AUDITING
LIVE BIRTH
OUTCOMES FROM
ALL UK LICENSED
CENTRES
The Historic Audit Project as it is known has
been initiated to validate all entries made to the HFEA Register
between 1991 and 2002. This Project aims to ensure that the information
held within the register is accurate with respect to all centre's
records. Owing to a large number of inaccuracies identified in
the HFEA Register, a double-checking procedure has been in place
at the HFEA since 2002.
This validation exercise would not have been
necessary if the HFEA had validated every entry into their register
at the time of entry, as they do now. This exercise has created
a great deal of work for our records officer who has to make available
the required records for the HFEA and for the Centre Manager who
has to sign every correction and amendment made to the records.
This project, considered nationwide, must be costing the tax-payer
an inordinate sum of money for a situation, which was preventable
in the first place.
The need for this validation project raises
doubts as to the accuracy of HFEA data used in prominent publications
in the New England Journal of Medicine and The Lancet, which have
strongly influenced HFEA policy.
12. THE CONCEPT
OF HFEA "LEAGUE
TABLES" IS
FUNDAMENTALLY FLAWED
LFC does not support the use of HFEA "league
tables", or Patient Guide containing statistics, because
they do NOT compare like with like and they leave the system
open to manipulation by those centres who use them to promote
their practice by using more stimulant drug regimes in patients
with low FSH values to maximise the outcome. It is not correct
to compare a less stimulant protocol, for example using the LH
antagonist, with a well-documented lower live birth rate, with
an LHRH analogue protocol, even in a defined young age group.
Despite these obvious limitations, the HFEA are returning to the
"league tables" after just one year without them and
their introduction may afford some centres false prominence. This
is not in the patients' best interest.
For example, before March 2004 some centres
transferred three embryos in a large number of good prognosis
patients (with basal FSH values of under 10) thereby topping the
"league table". This practice in such centres is evident
by noting the number of declared triplets published by the HFEA.
Some of these centres do not provide comprehensive
fertility assessments and treatments and only provide IVF, ICSI
and frozen embryo cycles. The treatment of infertility is complex.
It is our belief that "league tables" in their present
form can never do justice to the scope of services and the overall
success in treating infertility at centres providing services,
which extend beyond IVF and ICSI.
SUMMARY
In summary, LFC does see the need for a regulatory
body in the field of Assisted Reproduction, however we question
the value of a Regulatory body that has a high turnover of staff,
is inconsistent with respect to policy and licensing, and is relatively
unresponsive to concerns from patients and professionals. It is
a sad indictment of the HFEA that owing to the errors and inaccuracies
outlined above, the General Functions of the Authority as defined
in the HF&E Act have not adequately been performed.
January 2005
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