APPENDIX 77
Memorandum from the Association of Clinical
Embryologists
SUGGESTIONS FOR
REGULATION OF
ASSISTED CONCEPTION
TREATMENT AND
RESEARCH IN
THE UK
The Association of Clinical Embryologists makes
the following recommendations for the future of regulation of
treatment and research involving human gametes and embryos, taking
into account:
1. The need for a legislative framework
as the basis for regulation, and as a means of providing public
reassurance.
2. The need to review the existing law that
arises from developments subsequent to the framing of the existing
legislation, not simply in terms of the science, but also in the
frequency and acceptability of IVF treatment.
Licensing and accreditation
Currently the only inspection process specific
to the use and storage of gametes and embryos is that carried
out by the Human Fertilisation and Embryology Authority (HFEA),
as a condition of licensing. This is carried out against the HFEA
Code of Practice, incorporating aspects of the 1990 Act. It is
beyond the scope of this current process to consider detailed
professional standards in terms of the technical operation of
scientific, clinical, nursing and counselling functions. In addition
the incoming European Union Directive will require an inspection
that examines technical and quality processes.
Accreditation should be the function of an expert
body, based on standards developed by the relevant professions.
While a number of members of the HFEA are "experts",
the Authority cannot be considered to be an expert body: indeed
it is prevented from becoming one by the existing statute. This
should continue to be the case if the Authority is to make policy
decisions that take into account the views of society at large.
ACE proposes that accreditation should be carried
out by a professional inspectorate based on standards developed
by the professions. Appropriate standards have been developed
by ACE, the BFS, BICA and the RCN Fertility Nurses Group. Achieving
accreditation should be a condition of licensing.
THE HFEA CODE
OF PRACTICE
Adopting a separate accreditation process will
render the HFEA Code of Practice irrelevant in its current form.
It would only be necessary to ensure that regulations in addition
to any fundamental legislation were regularly published and updated.
REGULATION OF
RESEARCH
Licensing of research projects that involve
human gametes and embryos should not be treated in such a radically
different way to other areas of medical research. All medical
research is subject to rigorous scrutiny by local research committees,
and research involving gametes and embryos would also be subject
to the constraints of any existing specific legislation and regulation.
The national procedures for research authorisation
are adequately controlled by the Central Office of Research Ethics
Committees, such that applications demonstrating scrutiny by a
local research ethics committee should only require checking for
compliance with the legislation.
THE REGISTER
There is a clear need to maintain a register
of gamete donors and children born as a result of donated gametes
and embryos, in the interests of those children. However, ACE
supports the view of the British Fertility Society, that the maintenance
of a Register which contains identifying information of all patients
having treatment (whether or not successful) and of any children
born is indefensible morally, neither is it clinically desirable.
The incoming EU directive lays down regulations in relation to
traceability of material used in treatment. It is difficult to
justify a requirement for mandatory collection of information
regarding material not used, or people, whose treatment is unsuccessful,
or does not involve donated gametes. The information that has
been collected to date has contributed little to our understanding
and knowledge.
Clinics are required to carry out regular audit
of outcomes and records may be made available to external audit
if necessary. However, it is difficult to justify to couples who
simply require medical intervention in their reproductive process,
not involving any third party, why a government body should be
informed about such an intimate area of their lives.
POLICY MAKING
This is the HFEA's area of strength, and the
purpose that seems to be enshrined in legislation. This should
be separated from regulation as it requires a different type of
body, with a necessarily different make up and approach. This
function should remain with the HFEA or any subsequent body, and
should take into account the views of all sections of society
in relation to new treatments and areas of research. Decisions
made by such a body would form the basis of licensing as distinct
from accreditation.
THE HFE ACT
The HFE Act has a protective role for patients,
embryos and the public in that it prevents any activities without
the specific consent of the gamete provider. Retaining control
over one's own genetic material is a fundamental right that should
be protected and this area of the law should remain unaltered,
even when there appear to be emotional grounds for reconsidering
the rights of one or other partner. It is duly noted however that
whilst this is the consensus, the alternative view that embryos
should be afforded some rights beyond the will and consent of
the gamete providers was also expressed.
However, there are areas that urgently need
to be re-examined, such as those below:
— The definition of an embryo:
this is ambiguous at present and presents difficulties in light
of recent research developments permitted under the 2001 Regulations.
We recommend clarification that the definition set out in Section
1(1) of the Act is the correct definition.
— Activities for which licences
may be granted: consideration should be given to allowing
new activities which the 1990 Act currently prohibits. For example,
the granting of either a treatment or research licence "to
authorise altering the genetic structure of any cell while it
forms part of an embryo" is prohibited so limiting progress
in the development and application of gene therapies for the purpose
of preventing transmission of genetic disease.
— Maintenance of an identifying
register of patients: see above.
— Restrictions on disclosure of
information: like the Register, the confidentiality restrictions
in the 1990 Act tend to stigmatise IVF patients; the widespread
acceptance of assisted conception now obviates the need for practices
beyond the universal concept of medical confidentiality.
— Criminal penalties for the Person
Responsible: there should be a review of the role of the PR
and the type and range of penalties that might be appropriate
for non-compliance with the Act.
— Welfare of the Child regulation:
this has profound problems and unfairly places the onus on clinics
without the procedures to enable them to fulfil this role.
— The requirement of the Authority
to provide a Code of Practice: see above—the purpose
of the CoP should be reviewed in light of accreditation standards
from professional bodies.
— Storage limits according to intended
use: there are inconsistencies in the way storage limits are
imposed and administered that must be addressed: for example,
the embryo storage limit may not be extended beyond five years
where they will be replaced into a surrogate host; extension can
only go ahead if for the patients' own use yet, once extended
they can be donated for other purposes. Another important consideration
is whether storage limits might be extended for research purposes,
where long term projects demand this.
November 2004
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