APPENDIX 16
Memorandum from the Association of Clinical
Embryologists
SUMMARY
Embryologists are concerned that the scope of
the Act does not embrace all relevant techniques. In addition
the definition of embryo within the 1990 Act needs consideration
in the light of recent uncertainties in relation to cloning and
nuclear transfer. The Human fertilisation and Embryology Authority
deals with research applications in an inhibitory way, and the
decision making structure in relation to all licensing, does not
inspire confidence in the informed nature of any decisions.
The HFEA is not an expert body and needs to
make moves towards a separation of licensing and regulation, from
the accreditation and benchmarking of technical issues, which
requires technical expertise.
1. SCOPE OF
THE ACT
1.a. We are concerned that some treatments,
that would benefit from regulation, currently fall outside the
Act. These include intrauterine insemination (IUI) with partner's/husband's
sperm and GIFT. A recent risk assessment of assisted conception
techniques has identified IUI as one of the highest risk procedures
if not properly managed.
1.b. The definition of an embryo under the
act is still open to dispute, particularly in the light of challenges
in relation to cloning and nuclear transfer. The are also "embryo"
with no potential for normal development which are currently granted
the same legal status as those with the potential for development.
The Authority and the legislation would benefit from some consultation
to establish clear, acceptable and useful working definitions.
2. WORKINGS OF
THE HFEA
2.a. Research licences
While there are broad provisions under the Act
to allow research, such work is often inhibited by the cumbersome
licence application process, and the cost.
The way in which the HFEA process research applications
needs to be improved. There are lessons they could learn from
how funding bodies such as Wellcome Trust and MRC process applications.
Minimum standards of courtesy should apply. For example they should
acknowledge receipt of applications and provide a timescale fo
rthe approval process. Standards have recently plummetted in this
respect. Most importantly the proposal to charge £6,000 for
each application should be strongly resisted. This charge would
be prohibitive to the development of many important areas of research
2.b. Licence committees
The Association has had some concerns about
the system of licence committees within the HFEA. The licence
committee is responsible for decisions in relation to licensing
of individual clinics and research projects. License committees
are not permanent, and are assembled from a minimum of three members
of the Authority, none of whom need necessarily have any technical
background. The role of the licence committee is to make decisions
based on the findings of inspection teams, which may include technical
inspectors. However, these decisions, or, in the case of research
projects, peer reviewers. A licence committee might therefore
decide to place restrictions on a clinic's operations, or to ignore
warnings in relation to workloads or staffing levels, without
a full grasp of the implications for patients and staff. Similarly
decisions may be made in relation to scientific and clinical issues,
without a full understanding of their significance. While in general,
the decisions of licenced committees are balanced, and based on
good advice, and some efforts are made to have specialist members
present, this is not always possible. They remain vulnerable to
risky decision making, as their final decision may depend on who
happens to be present on the day. We would prefer to see either
a permanent licence committee, with a balanced membership of professional
and lay members, or some control over membership under the current
system.
2.c. Technical accreditation
The HFEA has, as part of it's inspection process
taken on the inspection of all technical aspects of assisted conception,
including clinical and laboratory processes. At this time there
exists no accreditation body for embryology laboratories. The
Clinical Pathology Accreditation scheme (CPA) has expanded its
portfolio to include andrology, but does not accredit embryology
laboratories as the field is considered "too controversial".
The current HFEA inspection process does not
amount to accreditation, in our opinion, for two reasons. Firstly
the time spent is insufficient. Secondly inspector training is
inadequate and inappropriate.
Accreditation is desirable because it would
examine technical processes in detail, as well as other crucial
aspects such as staff training and qualification, quality systems
etc based on a set of accepted professional standards. In addition,
accreditation based on the new standards, whatever they may be,
will inevitably follow in the wake of the European Cells and Tissue
Directive.
It has been proposed that the HFEA is the appropriate
body to administer this accreditation. However, it must be remembered
that the HFEA is not an expert body in any technical sense, although
it includes "experts" among its members. It was not
intended as such, and must have at least 50% lay members by statute.
In addition those members who are professionals within the field
of assisted conception are appointed in their own right, and are
not representative of any professional body or body of opinion.
It is difficult to see how such a body would be equipped to make
decisions regarding accreditation. It is possible that the infrastructure
and the executive might form the basis of an accrediting body,
but it is our view that this should be clearly separated from
licencing as a function.
Thus, accreditation may be a prerequisite to
licencing, and the presence or absence of evidence of accreditation
should be the Authority's only concern. The professional bodies
have drafted accreditation guidelines under pinned by guidance
on good practice, as part of an initiative partly driven by the
HFEA. However, this should not lead to an assumption that the
HFEA should administer them. Indeed it may make sense for the
Authority to restrict its inspection process to regulatory and
legal compliance, while an accrediting body deals with the technical
aspects, whether that body arises out of the HFEA or not. It is
crucial that such as a scheme is developed as it will play a major
part in raising and maintaining adequate risk and quality management
within Assisted Conception units.
It would also go some way to preventing reflex
responses to incidents, without adequate consultation or risk
assessment. An example would be the introduction of witnessing,
following a high profile incident involving the insemination of
oocytes with sperm from the wrong man. While it was clearly necessary
to take some measures, this was done without consultation with
the professions, and brought with it other problems leading to
new risks, and an impression that the Authority seemed to be more
concerned with being seen to react, than with actually dealing
with the risks.
May 2004
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