239. We have also heard concerns about the functioning
of licence committees. One is that they are insufficiently open.
It has been difficult to determine the membership, meeting times
and agendas of licence committees. We accept that patient and
commercial confidentiality may be at stake in some cases, but
we urge the HFEA to publish as much as it can on its website without
being asked. GeneWatch catalogued the problems it had had in extracting
information about the therapeutic cloning application from Newcastle
Fertility Centre, despite there being "no legal obstruction
to the HFEA's licensing committee minutes or other relevant information
being in the public domain". Genewatch was eventually supplied,
several months after the application had been awarded, with a
copy of the first cloning application together with peer reviewers'
comments and the minutes of the licensing committee.
During this inquiry, the HFEA has made great efforts to distinguish
between licensing decisions and policy decisions, particularly
relating to preimplantation tissue typing. Its task would be easier
if the functioning of its licence committees were not so opaque.
It is unacceptable
for the HFEA to attempt to withhold information relating to licence
applications if it has no legal basis for doing so. Information
relating to licence applications and licence committees should
be made available on the internet as a matter of course.
240. In some contentious cases, the patient has sought
to discuss their treatment with the committee but been refused.
Jayson Whitaker, who sought a licence for preimplantation tissue
typing, complained that "the HFEA, decided our case without
coming to see us and without talking to us. They would not speak
directly to us, it had to go through the clinic. Our clinic did
a very good job of putting the application in for us but we did
ask them whether we could bring our own specialist witnesses and
whether we could apply ourselves and speak to them in person and
if they could come and see our life for a day and then pass judgment,
but instead they just relied on their rules and regulations.".
] they just carte blanche said, "No, it is not possible.
You are not invited. It is not public.". 
The Masterton family, who wished to use PGD to select a female
embryo, had similar experience. Mr Masterton told us "I knew
the PGD issue was a contentious issue. I asked whether I could
represent our position at that lay member committee. I said I
would be happy to come, present our position and leave after our
case had been considered. I received a letter from HFEA about
a week later saying that these decisions were made behind closed
doors and there was no facility.".
There are good reasons why patients should not have direct access
to the licence committee. It could be argued that the committee
needs to make a dispassionate appraisal of the information before
it yet many cases may have tragic circumstances that could have
a significant emotional impact on the committee. The HFEA seems,
however, to have had a change of heart. At its January 2005 meeting
it agreed that "written representations would be accepted
though all stages of the Licence Committee process and that patients
could attend in person at the representation stage" if the
initial application has failed. There
may have been good reasons why licence committees were unable
to hear directly from the patients, but cases must be dealt with
sensitively and without needlessly erected bureaucratic walls.
We are pleased that the HFEA has decided to adopt a more open
policy in the future.
241. In our short inquiry on Developments in Human
Genetics and Embryology, which reported in July 2002, we heard
criticisms from researchers about the way research licences were
issued. Professor Austin Smith, a stem cell researcher at Edinburgh
University, reported that the HFEA was "inefficient [
and lacking in specialist knowledge" and "a slow and
Dr Robin Lovell-Badge from the MRC's National Institute for Medical
Research reported that researchers had found the HFEA frustrating
to deal with and that there has been criticism from researchers
regarding the time the HFEA takes to process licence applications.
In 2000-01 the HFEA had missed its targets for licence renewal
(for both treatment and research) by some margin, especially for
research licences. We concluded that "Britain is well placed
to be a world leader in human genetics and embryology research
and it is crucial that our scientists, in complying with regulatory
requirements, are not hampered by bureaucracy". During this
inquiry, Professor Robert Winston from Imperial College told us
that approval from the HFEA was "time-consuming and laborious"
and reported that "a leading British embryologist [
left the field simply because she found the HFEA and its overbearing
approach on her research to be so invasive".
The Association of Medical Research Charities warns that "Licensing
and inspection should not involve a heavy-handed approach, but
should start with the assumption that scientists are applying
to carry out such work for the public benefit and with integrity".
242. Since our last report, the HFEA has set up a
dedicated Research Licence Committee, and has recruited specialist
research regulation staff, who have the appropriate level of experience
and expertise. The new staff will be primarily dedicated to research
regulation and will give this work priority at all times. This
reflects criticism about the speed with which research licence
applications are dealt with. The Better Regulation Task Force
(BRTF) report on scientific research regulation recognised the
need for regulation in this area of science, and highlighted the
importance of demonstrating that HFEA licence decisions are independent
We will discuss the process by which research applications are
approved in our discussion on local research ethics committees
in paragraphs 331-343. We welcome
the efforts that the HFEA has made to improve its research licensing
procedures and we hope that these prove effective. However, we
believe that there needs to be a thorough analysis of the process
by which research involving embryos is approved so that we do
not lose sight of what the process is trying to achieve.
Preimplantation genetic diagnosis
243. In January 2005 the HFEA has announced a new
policy to streamline the approval of applications for PGD. Under
the new guidelines, if a clinic with proven expertise in performing
embryo biopsies applies for a licence to carry out screening for
a particular condition, which is already being carried out successfully
in another clinic, the HFEA will approve the application without
having to go through the full licence committee process, providing
the same technique and methods are used. However, some applications
will still be considered on a case-by-case basis:
a) PGD/HLA tissue typing;
b) PGD for late onset conditions;
c) PGD for susceptibility genes.
Previously, centres had to submit an application
to the HFEA for each new condition for which they wish to test
and for each new test that they wished to use.
The Progress Educational Trust had criticised this process on
the basis that licensing decisions could take six months and this
might have a significant impact on the ability of older women
to conceive. The
HFEA's streamlining of the licensing process for preimplantation
genetic diagnosis will have been good news for clinics. However,
it does undermine its Code of Practice since it effectively introduces
an accepted list of conditions for which PGD is available. In
this case, it would be preferable for the HFEA to publish a list
of conditions for which PGD would be acceptable.
regulation of preimplantation testing is highly unsatisfactory.
We recognise that the HFEA has legal jurisdiction but this does
not mean that it has a duty to regulate its use beyond ensuring
that it is performed to the highest standards within statutory
Preimplantation tissue typing
245. The HFEA first considered the issue following
a public consultation on PGD, conducted by the then Advisory Committee
on Genetic Testing (see Table 13). The Human Genetics Commission
took over responsibility for this subject when it was formed in
December 1999. A joint HFEA/HGC Working Party was established
in late 2000 and its conclusions were published in November 2001.
Unfortunately, the consultation document had not sought responses
on the preimplantation tissue typing issue but the Joint Working
Group concluded that "there were sufficient ethical difficulties
with this approach [where an embryo is selected to provide a tissue
match for transplant to an existing family member] that it should
be subject to further discussion before its use was considered".
Table 13: Timeline of HFEA policy on preimplantation