REGULATION OF OTHER MEDICAL PRACTICE
322. Since the HFE Act was passed, the regulatory
environment for medical practice has changed substantially. Large
numbers of bodies have been set up by Government to regulate clinical
standards, medicines and healthcare products and equipment and
the conduct of healthcare professionals. The current vogue is
to merge these bodies and the key organisations are described
Medicines and Healthcare Products Regulatory Agency
323. From 1 April 2003, the Medicines and Healthcare
Products Regulatory Agency (MHRA) replaced the Medical Devices
Agency (MDA) and the Medicines Control Agency (MCA). It is an
executive agency of the Department of Health which aims to protect
and promote public health and patient safety by ensuring that
medicines, healthcare products and medical equipment meet appropriate
standards of safety, quality, performance and effectiveness, and
are used safely.
324. The draft technical standards produced by the
professional bodies demand that: "All procedures shall be
validated for their intended use prior to introduction, and the
methods used and results obtained shall be recorded.".
This requires a process by which new techniques can be introduced.
The MHRA's brief does not currently include medical procedures
but we see little fundamental difference between a new drug and
a new surgical technique.
Commission for Healthcare Audit and Inspection
325. The Commission for Healthcare Audit and Inspection
(the Healthcare Commission) was set up on 1 April 2004
under the Health and Social Care (Community Health and Standards)
Act 2003. It replaces the work of the Commission for Health Improvement,
takes over the private and voluntary healthcare functions of the
National Care Standards Commission and covers the elements of
the Audit Commission's work which relate to efficiency, effectiveness
and economy of healthcare.
The Inspectorate will:
a) Encourage improvement in the quality and effectiveness
of care, and in the economy and efficiency of its provision;
b) Inspect the management, provision and quality
of health care services and tracking where, and how well, public
resources are being used;
c) Carry out investigations into serious service
d) Report serious concerns about the quality
of public services to the Secretary of State;
e) Publish annual performance ratings for all
NHS organisations and produce annual reports to Parliament on
the state of healthcare;
f) Collaborate with other relevant organisations
including the CSCI;
g) Carry out an independent review function for
326. Professor Allan Templeton, President of the
Royal College of Obstetricians and Gynaecologists told us that
abortion regulation could be usefully compared to assisted reproduction.
He suggested that its hands-off, more focused approach, informed
by a more professional input into the accreditation system standards
with a professional inspectorate had merits.
Abortion clinics are inspected and registered by the Healthcare
Commission on a 4-yearly basis, although they are charged an annual
fee, which might typically be around £3-5k. We understand
that the Government wishes the Healthcare Commission to pass on
the full costs of regulation to healthcare providers and that
the figures currently charged reflect about one third of the full
costs. While it might be unwise to make too much of the relative
costs of regulating abortion and assisted reproduction facilities,
a large IVF clinic could face regulatory bills in excess of £100,000.
Relationship of the HFEA with other regulators
327. The HFEA says it is its aim to minimise duplication
and to pool efforts and resources wherever practicable. It says
it is doing this by:
a) Working closely with professional bodies and
associations linked to assisted reproduction and developing agreed
protocols on the conduct of inspections.
b) Agreeing a memorandum of understanding with
the GMC and working towards similar agreements with other regulatory
bodies (such as MHRA and CHAI).
c) Close liaison with the HGC through mutual
co-optation of members and exchange of information.
d) Active involvement in the MRC's development
of protocols for the use of stem cells.
328. The extent of overlap with the Healthcare Commission
is the most problematic. The HC has published an agreement between
the main healthcare inspection, review and audit bodies in England,
aimed at reducing the burden of inspection on frontline healthcare
staff. The Concordat commits each organisation to a set of principles
which aim to support improvement in health services while minimising
disruption and duplication, ensure that information is shared
appropriately and encourage joint inspections. The HFEA reveals
in its 2003-04 Annual Report that it is holding discussions with
the HC to eliminate duplication.
329. It is important to establish what we mean by
ethics in this context. As the Warnock Committee pointed out,
medical ethics can be used to describe professionally acceptable
practice or the principles upon which these practices are based.
The distinction is important since the former could considered
to be an element of good medical practice, such as the way consent
is achieved or description of the duty of care owed to patients.
However, ethics can also be evaluated from the perspective of
the principles which underpin the enterprise itself, and we have
been concerned to engage with the latter interpretation. Ethical
oversight of assisted reproduction and embryo research can take
place at several levels. Legislation can set out boundaries, national
guidelines can then be set out by the HFEA. The conduct and scope
of clinicians' and researchers' work can also attract the attention
of local ethics committees, of which there are two forms, for
research and for the consideration of clinical cases. Currently,
national guidelines are drawn up by the HFEA.
330. A research project involving human embryos has
three bureaucratic obstacles it must overcome before it can proceed.
It must have an HFEA licence, it must satisfy a local ethics committee
and it must have funding. The HFEA has the power to grant research
licences for up to three years for individual research projects.
All licence applications, renewals and progress reports are evaluated
by an HFEA Licence Committee. Research ethics approval must have
been sought from a properly constituted research ethics committee
(REC) before an application is made. The HFEA then initiates peer
reviews which determine whether the application:
a) Comes within the statutory purposes of the
b) Requires human embryos to fulfil its aims
c) Requires the numbers and types of embryos
described in the application;
d) Meets the requirements of the HFEA's Code
331. In theory, the HFEA Research Licence Committee
does not give ethical approval, merely decides whether the proposed
research comes within the eight purposes set out in Schedule 2
of the HFE Act and conforms to its provisions in Section 15 on
the conditions of research licences and consent (Schedule 3).
As the HFEA's Chair, Suzi Leather, put it, "There are ethical
dimensions, of course, to the work we do; but essentially we implement
the wishes of Parliament. The legislation does not contain any
explicit ethical principles".
We asked the HFEA for what reasons research licences had been
refused. It gave three examples:
a) 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).
b) Because the applicants couldn't demonstrate
the required ability to select spermatids reliably.
c) Because the Committee felt that the proposal
was of "poor experimental design".
332. Research ethics committees are well established
in the UK and an English network now operates under a central
committee called the Central Office for Research Ethics Committees
(COREC) (see Box 12).