to Lords Howe & Pearson
was particularly concerned to hear about your enthusiasm
for the creation of a statutorily regulated register of
herbal practitioners, possibly to be governed by the Health
Professions Council (HPC). As you may already be aware,
the HPC was recently defeated in court over its attempts
to regulate the profession of psychotherapy. There were
a number of issues taken into consideration in this court
case, which equally apply to the profession of herbal medicine,
in its diverse traditions.
the pressing arguments that the HPC was unable to answer,
was one relating to its legal competency to regulate the
profession in question. This is a point that I often raised
in the past with members of the House of Lords and members
of the past and present government. The European Commission
has openly admitted that appropriate monographs for herbal
medicine have not been created and that those that do exist
are based on a model created for allopathic medicine.
As the model of double-blind testing may be appropriate
for establishing the efficacy of isolated chemicals, this
model of testing is completely incompatible with the "patient
centred" practice of traditional medicine. This method
of testing is also inappropriate, since herbal medicine
used in its traditional form, uses the herb "totum", the
efficacy of which is reliant on the interaction of possibly
30 separate biochemical components. Because of this, the
accepted "knowledge (scientific) based evidence of efficacy
has never been established within the terms stated by the
HPC itself, as a requirement for its authority to regulate.
On this basis, the HPC would be in breach of its own constitution
if it were to proceed with this proposal. In addition to
this, the court case that has already been brought against
it successfully, might be used as a legal precedent to further
confound its reputation.
of the grounds, over which the HPC was defeated, was its
failure to establish the widespread agreement of the profession
it proposed to regulate. In the case of Herbal Medicine,
Acupuncture and Traditional Chinese Medicine there has been
a significant amount of misleading information that has
been put to practitioners to gain their support for statutory
spite of this, in the case of the National Institute of
Medical Herbalists (NIMH) only 28% of their membership
actually voted in favour of the proposal. Members of
the Unified Register of Herbal Practitioners (URHPs) were
threatened with expulsion from the register if they signed
a petition against this proposal. Several copies of the
e-mail, in which the threat was made, have already been
sent to members of the past and present government, so it
is impossible for any claim of ignorance of the facts to
be made when considering this issue.
more important still, is the alleged benefit and purpose
of pursuing the statutory regulation of the profession.
This has been well established as being a means to circumvent
the effect of the implementation of the European Directive
2004/24/EC in the form of THMPD.
has been widely stated, the requirements for the licensing
of the majority of manufactured herbal products cannot be
met. This has led to the prospect of ruination of small
and medium-sized manufacturing companies together with the
loss of virtually all, except the most profitable, products
made by the large companies. THMPD therefore represents
a financial disaster for the interests of the manufacturing
industry. This however has nothing whatever to do with the
continued practice or availability of traditional herbal
medicine. It is certainly the case that several vested
interests have put forward this myth, in pursuit of their
own agendas. The Medicine and Healthcare Regulatory Agency
(MHRA) have been very specific on this point, in a "Question
and Answer" document that they published in 2010 on matters
arising from the full implementation of THMPD at the end
of April this year.
document, the MHRA specifically states:-
the end of the transitional period affects herbal practitioners
herbal practitioners still be able to supply unlicensed
herbal medicines to patients under Section 12(1) after 30
Products supplied legally under Section 12(1) are regarded
by MHRA as non industrially produced, and hence outside
the scope of Directive 2001/83/EC as amended by Directive
2004/24/EC. Products supplied under Section 12(1) therefore
do not require a MA or THR to remain on the market.
Section 12(1) provides that the licensing provisions of
the Act "do not apply to the sale, supply, manufacture
or assembly of any herbal remedy in the course of a business
the remedy is manufactured or assembled on premises of which
the person carrying on the business is the occupier and
which he is able to close so as to exclude the public; and
the person carrying on the business sells or supplies the
remedy for administration to a particular person after being
requested by or on behalf of that person and in that person's
presence to use his own judgement as to the treatment required."
of the various types of herbal preparations used by herbalists
will require a licence from 30 April 2011?
Products prepared and supplied by herbal practitioners in
accordance with Section
do not require MA or THR
Unprocessed or processed ingredients sourced by herbal practitioners
to prepare unlicensed herbal remedies supplied under Section
12(1) do not require an MA or
Manufactured herbal medicines commissioned by herbal practitioners
come within the scope of Directive 2001/83/EC as amended
by Directive 2004/24/EC and therefore require an MA or THR.
(If, such products are legally supplied under Section 12(2)
and satisfy the requirements for transitional protection,
the requirement for an appropriate product licence applies
from 30 April 2011.)
What counts as an ingredient and what counts as a product?
of what would be regarded as ingredients are:
Unprocessed herbal ingredients
Tinctures or extracts the herbal practitioner buys in bulk
in order to blend to make products tailored to meet the
needs of individual patients.
of what would be regarded as products are:
Tablets, capsules and other such pharmaceutical
finished dosage forms bought in by the practitioner (whether
or not the practitioner sources them in bulk)
Any medicine the herbal practitioner
sources in the form and packaging it is to be supplied to
therefore perfectly clear, on the evidence of the MHRA (the
regulator of THMPD), that the practice of traditional herbal
medicine is in no way challenged by the introduction of
THMPD and that claims to the contrary are incompatible with
the truth. The government has therefore clearly been subjected
to an ongoing campaign of fraudulent misinformation, for
the purpose of manipulating legislation in favour of a financial
regulation by the HPC is through the implementation of "protected
title". This means that once the profession has become
statutorily regulated, it "owns" the title under which it
is known. As the majority of genuine traditions have not
been considered for statutory regulation, and because of
the criterion of "evidence of efficacy" would not qualify
either, their practitioners would be committing a criminal
offence if they were to continue to call themselves herbalists.
This proposal is therefore innately discriminatory against
the majority of genuine traditions. It would additionally
create a two-tier regime of regulation.
would prove highly confusing to the public on two counts:
Genuine traditional practitioners would legally obliged to
adopt a new title, which would be unlikely to be recognised
by the public.
The two-tier regime of regulation would tend to give the impression
of a disparity of status.
has been specifically stated by Dr Moira Livingston in the
report to government from the Working Group on Extending Professional
Regulation (WG on EPR) that the level of regulation should
be relevant to the risk to the public posed by the regulated
profession, as assessed by actuary tables used by insurance
companies. As you will already be well aware, "herbalism"
is currently assessed to be insured in the same risk group
Livingston also specifically exposed the dishonourable agenda
of certain "aspiring professions" to seek Statutory Regulation
in the hope of acquiring a degree of perceived (but unsubstantiated)
kudos in the public perception.
of the points that I find particularly disturbing is the misapprehension
that the creation of a statutorily regulated register of practitioners,
created for the purpose of circumventing the impact of THMPD,
would be in the public interest. This most certainly would
not be the case.
Traditional Herbal Medicine is extremely safe, and
should in no way be subject to the same level of regulation
is pharmaceutical allopathic products.
Herbal Products, owing to their unnatural concentration
of biochemical elements that have been separated from their
naturally occurring companions, can potentially pose a higher
level of risk than the original organic material from which
they are derived. Where problems have arisen, almost without
exception, it is these that have been the cause.
has already been pointed out by the MHRA, traditional herbal
medicine will continue to be available, as at present, under
section 12.1 of the 1968 medicines act.
it is widely accepted that THMPD is a totally inappropriate
licensing regime for manufactured herbal medicine products,
some form of appropriate and financially viable licensing
regime remains necessary, as has been demonstrated by the
disasters associated with Chinese herbal medicine products
containing illegal substitute, highly toxic ingredients, the
inclusion of which were not mentioned in the label.
regime were to be created that would allow practitioners to
prescribe manufactured products, that had not been licensed
or tested and over which there was no guarantee of appropriate
labelling, the public would be exposed to exactly the same
risk that has already led to kidney damage occurring to a
patient, using an existing unlicensed, toxic and inappropriately
labelled Chinese herbal medicine manufactured product.
therefore cannot be put forward that the creation of a statutorily
regulated register of practitioners, created for the purpose
of maintaining this potentially dangerous trade, is in some
way in the public's interest.
as a licensing instrument, THMPD is severely flawed, opening
an avenue through which to bypass it, without first putting
in place an appropriate alternative, is morally and ethically
are of course also practical obstacles to the efficacy of
this approach, even if it were within the competence of the
HPC to regulate these professions. The Royal College of Physicians
withdrew their approval for this form of regulation. Without
their approval it would not be viable to invest such a professional
register with “authorised healthcare
viable way to resolve this conundrum is to back the ANH challenge
to the legality of THMPD in the European Courts and get it
replaced with a viable regime of licensing that is appropriate
to traditional herbal medicine products, instead of one designed
specifically for allopathic pharmaceutical wares.
to the threat to one industry is not to be found in the destruction
of traditional herbal medicine, by forcing it to comply with
a regulatory regime designed for an incompatible paradigm.
Such a policy would be in direct conflict with the Beijing
Declaration and Platform for Action, Fourth World Conference
on Women, 15 September 1995, A/CONF.177/20 (1995) and A/CONF.177/20/Add.1
under the heading "actions to be taken" states:-
Encourage, subject to national legislation and consistent
with the Convention on
Diversity35 , the effective protection and use of the knowledge,
innovations and practices of women of indigenous and local
communities, including practices relating to tradition medicines,
biodiversity and indigenous technologies, and endeavour to
ensure that these are respected, maintained, promoted and
preserved in an ecologically sustainable manner and promote
their wider application with the approval and involvement
of the holders of such knowledge.
In addition, safeguard the existing intellectual property
rights of these women as protected under national and international
law. Work actively, where necessary, to find additional ways
and means for the effective protection and use of such knowledge,
innovations and practices, subject to national legislation
and consistent with the Convention on Biological Diversity
and relevant international law, encourage fair and equitable
sharing of benefits arising from the utilization of such knowledge,
innovation and practices;
World Health Organisation (WHO) officially stated:-
Beijing Declaration will serve to promote the safe and effective
use of traditional medicine, and to call on WHO Member States
and other stakeholders to take steps to integrate TM/CAM into
national health systems."
policy that restricts access to traditional medicine (which
does not include artificially manufactured products) and discriminates
against traditional practice is not commensurate with either
WHO or EU policy, to which THMPD also constitutes a breach.
look to the coalition government to take steps to correct
this aspect of the appalling mess left behind by the former