Letter sent by Sandy Scott 19/01/2011

Letters to Lords Howe & Pearson

House of Lords
London
SW1A 0PW

Dear Lord Howe

I 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.

Amongst 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.

Another 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 regulation. 

In 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.

Perhaps 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. 

As 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.

In this document, the MHRA specifically states:-

How the end of the transitional period affects herbal practitioners

21)   Will herbal practitioners still be able to supply unlicensed herbal medicines to patients under Section 12(1) after 30 April 2011?

Yes. 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. 

Specifically, 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 where:

(a) 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

(b) 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."

22)   Which of the various types of herbal preparations used by herbalists will require a licence from 30 April 2011?

In summary:

•    Products prepared and supplied by herbal practitioners in accordance with Section

12(1) 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

TH R

•    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.)

23)     What counts as an ingredient and what counts as a product?

Examples 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.

Examples 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 the patient.

It is 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 vested interest.

Statutory 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.  

This would prove highly confusing to the public on two counts: 

1)     Genuine traditional practitioners would legally obliged to adopt a new title, which would be unlikely to be recognised by the public.

2)     The two-tier regime of regulation would tend to give the impression of a disparity of status. 

It 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 as astrology!

Dr 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. 

One 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.

Statistically Traditional Herbal Medicine is extremely safe, and should in no way be subject to the same level of regulation is pharmaceutical allopathic products.

Manufactured 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.

As 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.

Although 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.

If a 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.

The argument 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. 

Although 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 indefensible.

There 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 

The only 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.

The resolution 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 (1995).

which, under the heading "actions to be taken" states:-

C.   Encourage, subject to national legislation and consistent with the Convention on

Biological 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;

The World Health Organisation (WHO) officially stated:-

"The 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."

A 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.

I therefore look to the coalition government to take steps to correct this aspect of the appalling mess left behind by the former administration.

Yours faithfully
RAS Scott

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