Regulation of complementary medicine
and self-testing kits
8.41.Many witnesses were outraged at the lack of
regulation for some complementary practitioners and allergy diagnostic
self-testing services. According to Allergy UK, "currently
there is nothing to guide the consumer on whether the test, clinic
or service has been clinically proven in any way" (p 293).
The Royal College of Pathologists emphasised that "regulation
of non-NHS clinics and over-the-counter treatments for allergy
is not adequateextensive evidence that it leads to direct
harm to individuals is lacking, but there is clearly a legitimate
concern that ineffective or misleading advice may be harmful,
costly and may divert patients from effective evidence-based interventions"
8.42.The DH reported that "private and voluntary
healthcare providers are subject to regulation by the Healthcare
Commission if they provide services set out in current legislation.
Those services do not include over the counter allergy tests.
However, providers registered with the Commission might offer
allergy tests as part of a wider range of services" (p 7).
Mr Lewis told us that the DH was developing legislation to regulate
practitioners of acupuncture, herbal medicine and traditional
Chinese medicine. It had also "funded the Prince of Wales'
Foundation for Integrated Health to set up a voluntary register
of unregulated professions" and was establishing "a
UK working party to consider the criteria to be used to decide
whether a profession should or should not be statutorily regulated."
But the Department had no immediate plans to extend statutory
regulation of complementary practitioners further (Q 892).
8.43.Various steps had already been taken by some
societies of complementary practitioners towards voluntary self-regulation.
The Society of Homeopaths noted that its members were "subject
to a rigorous Code of Ethics" and that it was also "a
key player in the Council of Organisations Registering Homeopaths
working to establish a single register for the profession"
which would allow patients and healthcare workers "to be
sure of the professional standards, competency and accountability
of the homeopaths they employ" (pp 202, 204). The British
Institute for Allergy and Environmental Therapy also reported
that the "300 holistic allergy therapists" that it represented
were "obliged to accept the strictest standards of practice
and Code of Conduct." Admission to the Institute was via
its own Diploma course, and the Institute believed that "all
complementary therapists should be members of a well-regulated
professional association for their own therapy" (pp 224,
8.44.However, Professor Ernst was concerned that
regulation was "seen as a substitute for evidence,"
and that regulation of complementary therapies would cause further
research into their efficacy to cease. This was agreed with by
Professor Corrigan, who added that "regulation does not mean
the treatment is effective. At best, it may protect some patients
from being poisoned and it may protect some patients from charlatans.
Once you do license them, they are under less obligation then
to show that what they do is of any benefit, which is counterproductive"
8.45.With regard to allergy self-testing kits available
for public use, the in vitro diagnostic devices (IVDs)
are regulated by the Medical Devices Regulations 2002. Manufacturers
of IVDs in the United Kingdom must register with the MHRA, and
the self-test element of the IVD must be assessed by a third party
certification organisation, or "notified body," designated
by an EU member state (p 7). Mr Gutowski emphasised that the legislation
does "not regulate in any way the service provider or the
treatment regime" (Q 751). However, Dr Hart noted that "there
is confusion within different competent authorities within Europe,
my understanding is, of how the regulations are interpreted and
even within the notified bodies within the UK," and added
that it was very important for these services to be regulated
in the future (QQ 741, 752).
8.46.Despite the concerns raised, as yet there is
no conclusive evidence to show that the tests and treatments offered
by complementary practitioners, or the self-testing kits sold
to the general public, cause any direct harm. These consultations,
tests and therapies may indeed reduce patient anxiety and improve
their general sense of wellbeing, even though their underlying
allergy may not necessarily be diagnosed or treated. However,
we are concerned that individuals who use such tests or seek such
treatments without consulting a more conventional practitioner
may suffer indirect consequences to their health and may spend
large sums of money unnecessarily.
8.47.In 1999-2000 this Committee conducted a detailed
inquiry into complementary and alternative medicine,
and some of the recommendations regarding the regulation of certain
techniques are still being implemented. We therefore do not make
further recommendations at this point but support ongoing scientific