Introduction

At present, herbal medicines sold and supplied in the UK are governed by Section 12 of the Medicines Act of 1968. Under its terms, herbal medicines are exempt from the requirement to obtain a medicines licence as long as the following conditions are met:

  • Section 12(1) – herbal medicines are made up on the premises from which they are supplied after a personal/one-to-one consultation.
  • Section 12(2) – pre-prepared or over-the-counter (OTC) herbal medicines must not make any written therapeutic claims.

Herbal medicines sold in the UK are also exempt from European medicines licensing legislation as they are regarded as not industrially produced. (The Human Medicinal Products Directive [Directive 2001/83/EC] requires industrially produced medicines to meet standards of safety, quality and efficacy in order to obtain a medicines licence).

SI 1977/2130, The Medicines (Retail and Supply of Herbal Remedies) Order 1977, allows herbalists to use a number of potent herbs, subject to strength and dosage restrictions (commonly called Schedule III herbs).

However, the future practise of herbal medicine in the UK is under threat from the state. A trio of laws, if enacted, will bring our hitherto independent profession under state control and its herbal medicines under the aegis of the UK’s medicines regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA).

Below is an outline of the scope of the proposed legislative changes, and, more importantly, objections to their implementation.

(1) Traditional Herbal Medicinal Products Directive (THMPD)

The THMPD (European Directive 2004/24/EC) comes into force on 30 April 2011. The section 12(2) exemption from licensing for herbal medicines will be withdrawn and all manufactured herbal medicines placed on the UK market will be required to have a Traditional Herbal Registration (THR) or Marketing Authorisation (MA) (effectively a product licence) from the MHRA. This applies to herbal products marketed and sold OTC.

Herbal medicines sold OTC are eligible for a THR or MA on the basis of evidence of 30 years safe use (the ’30-year rule’), of which 15 years must be in Europe. A product licence will allow minor ‘medicinal claims’ to be made for a particular herbal product.

Manufacturers of herbal medicines marketed direct-to-practitioner do not require medicine licences for their products. However, all manufacturers (of both licensed and unlicensed herbal medicines) are required to obtain a Manufacturer’s Licence (ML) from the MHRA. Manufacturers will no longer be able to argue that their products are not industrially produced and thus exempt from regulation. At present, to obtain an ML a manufacturer needs to meet approved standards of Good Manufacturing Practice (GMP).

OBJECTIONS

(a) The MHRA and the Pharmaceutical Industry

The THMPD gives control of licensed and unlicensed herbal medicines to the MHRA, a medicines regulator that is entirely funded by fees from the pharmaceutical industry. When funding is provided by those who are regulated, questions arise about the independence of the regulator. A House of Commons Health Committee Report from 2005, entitled ‘The Influence of the Pharmaceutical Industry’ is highly critical of the MHRA and its close relationship with the pharmaceutical industry. It states, ‘(t)here are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry …’1 It is therefore doubtful whether the MHRA can be trusted to serve the best interests of herbal medicines, herbalists and their patients.

(b) Cost of Licensing

The prohibitive cost of obtaining a ML (or even a THR) from the MHRA threatens the very existence of the handful of small, cottage-industry style manufacturers/suppliers that most herbalists rely on for their medicines. This makes the implementation of the THMPD look like a ploy to soften up the herbal medicine sector for pharmaceutical industry take over.

(c) Imposition of Pharmaceutical Protocols

The THMPD imposes pharmaceutical industry protocols (such as GMP) on our suppliers in an attempt to transform traditional, hands-on, low-tech herbal medicine into high-tech, industrial, laboratory-derived ‘product’. In a document entitled ‘EU Legislation and Natural Health’ the Alliance for Natural Health (2008) states that the THMPD imposes ‘stringent pharmaceutical requirements, including pharmaceutical stability tests that are wholly inappropriate for herbal products… given that these are organic, reactive products which contrast markedly from the stable, toxic, new-to-nature molecules which characterise most drugs.’2 The notion that herbal medicines can only be produced in environments and under conditions that mimic pharmaceutical laboratories is completely at odds with the vitalist philosophy that underpins traditional herbal medicine.

(d) Serving Corporate Interests

According to the MHRA, the THMPD will provide consumer protection and ensure the quality and safety of OTC herbal medicines. While something may need to be done to address problems in the OTC trade in herbal remedies, no evidence has ever been produced that demonstrates poor standards and unsafe practice by the handful of direct-to-herbalist suppliers. Our suppliers are being unfairly tarred with the same brush as the OTC sector. Thus the THMPD appears to be less about protecting the interests of consumers and more about serving corporate interests by harmonising EU law and creating an EU-wide market in the trade of herbal products, whilst simultaneously eliminating any competition from traditional manufacturers.

(e) The Australian Precedent

In Australia, the 1989 Therapeutic Goods Act resulted in the introduction of GMP and pharmaceutical manufacturing techniques to the production of herbal medicines, with profound effects. Jagtenburg and Evans (2003) state that ‘(s)ince the entry of major pharmaceutical companies into the (Australian) marketplace, the regulatory requirements for herbal products has changed in their favour and (to) the disadvantage of small, low-tech manufacturers of traditional herbal products. The last 15 years has seen the disappearance of small herbal manufacturers, their place taken by larger herbal companies and pharmaceutical companies.’3

(f) Benefits of Licensing Overstated

The suggestion that submitting herbal medicines to a licensing regime will improve the quality and safety of these medicines is questionable. Orthodox drugs are subjected to a far more stringent licensing procedure, yet licensed drugs continue to be withdrawn from sale on the market and hundreds of thousands of patients are hospitalised due to their harmful effects.

(g) EU Directives and Regulations

Finally, there are 2 types of EU laws: Directives and Regulations. Regulations come into force within EU member states once enacted in Brussels. Directives, however, only come into force once transposed into statute by the parliaments of individual member states. Member states are under no obligation to implement EU Directives. Yet Directive 2004/24/EC (implemented in the UK as the THMPD) is being sold to UK herbalists as a fait accompli, a necessary evil that will destroy suppliers of traditional herbal medicines and override the common law legal rights of UK herbalists and their patients.

(2) Statutory Regulation (SR)

The Department of Health Steering Group Report on the SR of Practitioners of Herbal Medicine (2008) claims that it is in the ‘public interest’ that practitioners are ‘properly trained, understand the limits of their competence and know when and to whom to refer’. The Report further asserts that SR ‘can more effectively assure the standards of those regulated, protecting the public from poor or bad practice, because legal sanctions exist to remove individuals from a register.’3

The Steering Group Report suggests that SR proceed under the auspices of the Health Professions Council (HPC):

  • In order to join the HPC register of regulated practitioners, herbalists would be required to meet various state-set standards of training, practice and competence.
  • Regulated herbalists would be subject to disciplinary action for non-compliance with the HPC codes of conduct (sanctions would include suspension or removal from the register).
  • It is proposed that the title ‘herbalist’ be the sole legal preserve of practitioners that are members of the HPC (however, SR alone would not protect the ‘function’ of practising regulated herbalists – see below).

The Steering Group Report also suggests that members of existing Professional Associations (PAs) would automatically be transferred onto the HPC’s register of regulated herbalists (other practitioners would have to make individual applications, in order to be ‘grandparented’ onto the register).

It is foreseen that the future role of PAs would be similar to trade unions – looking after and protecting the interests of practitioners and their profession.

OBJECTIONS

A minority of herbalists (best described as the ‘institutional professionalisers’) have relentlessly pursued regulation with the state over many years. The protracted nature of the process, the lack of genuine debate within PAs, and pronouncements from organisations (the EHTPA4, for example) about the inevitability of SR has given rise to a sense of helplessness among the majority. By failing to oppose SR, herbalists are giving their implied consent to a legislative programme that may soon coerce them to join the HPC as well as divesting them of their common law freedom to practise.

(a) No Evidence and No Public Protection

SR is necessary, its cheerleaders tell us, in order to ‘protect the public’. Yet no clear evidence has been produced by the state that western herbalists are engaging in poor/bad practice or that patients are being abused or even that existing voluntary/self-regulating structures are failing to deal with any malpractice. Furthermore, there is no research that demonstrates that state regulation would in any way improve professional competence or enhance public protection. There are at least as many regulated as unregulated exploiters of patients, but the regulated ones are more dangerous because of their aura of credibility and trustworthiness (medical doctors are regulated, yet cases of malpractice continue to occur). It is ironic that SR is accompanied by an emphasis on ‘evidence-based practice’, yet there is no evidence base to the claims made on its behalf.

(b) Public Relations Exercise

SR is a symptom of a state-wide obsession with ‘risk management’ and ‘safety’. However, the absence of evidence that regulation can eliminate risk and protect the public by pre-empting malpractice exposes SR as nothing more than a state-sponsored public relations exercise. The state wants ‘to be seen to be’ doing something to ‘protect the public’ by means of a tick-box exercise (a triumph of style over substance). This is part of a wider trend towards ‘defensive’ practice – an approach that is more concerned with protecting practitioners from complaints than helping patients – and is ludicrous in the context of western herbal practitioners’ matchless safety record.

(c) Practitioner Disempowerment

The HPC is a state-sponsored accountability structure that is organised in a centralised, top-down, hierarchical manner. It is designed to promote power over practitioners as opposed to power with practitioners. As practitioners, herbalists attempt to empower patients by promoting autonomy, self-accountability and self-reliance. It would be incongruent for herbalists to enter voluntarily into arrangements designed to disempower them as people. The HPC cannot regulate practitioner integrity – practitioner accountability and competence arise from their relationships with patients and fellow herbalists. These relationships are best fostered in a decentralised, bottom-up manner, not by the state seeking to interfere in and control an activity contracted voluntarily between consenting adults. Moreover, patients can continue to seek advice/redress from self-regulating PAs or through the legal system as it stands.

(d) Loss of Autonomy and Status

Herbalists have a long tradition of being independent of orthodox medical structures. This attracts many patients, particularly those that have been failed by orthodox medicine. If implemented, SR would make herbalists part of, yet subservient within, the orthodox medical hierarchy, thus denigrating its reputation for autonomy and diminishing its status in the eyes of many patients.

(e) Standardisation

The rich diversity of therapeutic approaches within herbal practice will be subjected to the imposition of a framework of limiting standards and arbitrary competences. Under the auspices of the HPC, practitioner training would be rigidified and the practice of herbal medicine standardised. In order to conform to (what is euphemistically termed) ‘best practice’, practitioners would be obliged to override patient individuality and sacrifice the therapeutic process to the demands of a fixed method.5 This strikes at the heart of traditional herbal practice, and core doctrines such as holism. The HPC is an organisation incapable of living with difference or tolerating diversity of theory and practice. Under its auspices the practice of herbal medicine would become an enfeebled one-size-fits-all McHerbalism.

(f) Erosion of Common Law Rights

Under SR herbalists would be coerced into giving up their common law right to practise. At present, the practice of herbal medicine is a private matter between herbalist and patient (it is a lawful activity as it harms no one). Under SR, the state and statute law would be invited into herbal medicine. The practice of herbal medicine would then become a public matter as 3 parties are involved: herbalist, patient and the state. SR would essentially license the practice of herbal medicine (a perfectly lawful activity), making it a legal activity when the statute is obeyed and an illegal activity when it is disobeyed. Pro-SR herbalists are essentially in favour of giving up the freedom and autonomy conferred by common law in exchange for the mantle of ‘professionalism’ and the ‘privilege’ of paying the state to tell them how to practice herbal medicine.

(3) Reform of Section 12(1)

Section 12(1) is commonly referred to as the ‘herbalist exemption’ (even though the word ‘herbalist’ is neither used nor defined). As it stands, section 12(1) is seen to pose a potential public health risk because:

  • There is no statutory definition of who is entitled to carry out one-to-one consultations.
  • There is no stipulation that persons carrying out one-to-one consultations have any qualifications, experience, or abide by a professional code of conduct.
  • There are no regulatory requirements as to the safety and quality of the herbal medicines supplied after a consultation.

The MHRA has thus proposed that section 12(1) be reformed. Access to and supply of herbal medicines (including Schedule III herbs) would be restricted to practitioners on a statutory register (administered by the HPC). The prescription of unlicensed herbal medicines to individual patients following a one-to-one consultation would continue to be permitted. However, manufacturers of direct-to-practitioner unlicensed herbal medicines would be required to obtain a Manufacturer’s Licence (ML) from the MHRA (under the terms of the THMPD).

The MHRA claims that by linking reform of section 12(1) to SR and the THMPD, the public would be assured as to the professional standards and accountability of practitioners, as well as the quality and safety of their unlicensed medicines.

Reform of section 12(1) would also see regulated herbalists designated ‘authorised health professionals’ (as per Article 5 of EU Directive 2001/83/EC). This would permit such herbalists to initiate the manufacture by a 3rd party of unlicensed herbal medicines (particularly complex herbal formulae that require ‘industrial’ processing) to meet the needs of specific patients (provided the manufacturer obtains a ML from the MHRA). This provision would also permit the use of 3rd party dispensary services that are not necessarily located on the premises where section 12(1) consultations take place.

OBJECTIONS

Many of the arguments put forward in support of SR and the THMPD licensing regime are also used to advocate section 12(1) reform (what might cynically be called, ‘three pieces of legislation for the price of two’). Our objections to SR and the THMPD will not be repeated here, but a few important points need to be made:

(a) Defining ‘Herbalist’

Section 12(1) has a major flaw, we are told by the MHRA and the EHTPA, because it fails to explicitly define ‘herbalist’, namely, the person engaging in a section 12(1) activity. This may be so. However, it can be argued that there is an implied definition in section 12(1), i.e. ‘anyone using plants medicinally’. The scope of such a definition is necessarily broad and inclusive: it is the inalienable right of all people to use plants medicinally. However, in the setting of a one-to-one consultation, it is the duty of patients (and not the state) to satisfy themselves as to the competence of practitioners claiming to be herbalists. Patients, as responsible adults, have the autonomy and freedom to consult and consent to treatment from those they choose and, if things go wrong, to seek redress from the legal system. As it stands, the provisions of section 12(1) have never been disputed or challenged in a court of law nor has any evidence been produced that its provisions are being abused by charlatans.

(b) Protection of ‘Title’ and ‘Function’

Nevertheless, a broad definition of ‘herbalist’ is not legally expedient. Instead, the state and the MHRA plan to redefine the word to mean ‘anyone on the statutory register administered by the HPC’. As made explicit in The Steering Group Report, admittance or ‘threshold entry route’ to the HPC would be via a Bachelor degree with Honours – in these terms, ‘herbalist’ is reduced to a person with a particular set of ‘qualifications’, achieved by compliance to a programme of study. The Steering Group Report also suggests that the HPC reserve the word ‘herbalist’ for the sole legal use of regulated practitioners (protection of ‘title’). In such a situation, unregistered/independent practitioners could continue to practice, but not call themselves by the same ‘title’ as regulated practitioners.

However, the reforms envisaged by the MHRA would restrict any section 12(1) activity to regulated practitioners only (protection of ‘function’). It would become completely illegal for unregistered/independent herbalists to continue in practice, particularly as the sale of unlicensed herbal medicines to such practitioners would be prohibited. Section 12(1) reform would (a) remove the patient’s right to choose between regulated and independent herbal medicine, and (b) effectively criminalise any herbalists taking a stance of principled non-compliance in the face of the state’s appropriation of our age-old natural healing tradition.

(c) Unsubstantiated and Exaggerated Risk

In December 2006 the MHRA produced a number of discussion papers that purportedly made the case for section 12(1) reform. However, their claims are based largely on supposition, speculation and hearsay. For example, the MHRA states that ‘(t)he case for improved regulation of s12(1) arrangements overlaps to a large extent with the case for improved regulation of OTC manufactured herbal medicines…’6 Problems in the OTC trade in herbal medicines may indeed need to be addressed (in part, the THMPD attempts to do this). However, the problems of quality and safety in this sector do not extrapolate to poor standards and unsafe practice by the handful of direct-to-practitioner manufacturers/suppliers of herbal medicines. Making such a connection in the absence of evidence is mendacious.

The MHRA does, however, provide some slim evidence of poor quality and unsafe herbal medicines imported and prescribed by practitioners of Ayurveda and Traditional Chinese Medicine (tellingly, there are no such cases cited against Traditional Western Herbalists). The examples it gives are based on successful prosecutions carried out under existing legal provisions. Details of successful prosecutions can be found on the MHRA website under ‘Enforcing the Law – Our Prosecutions’7. Thus it appears that by upholding existing legislation the MHRA is more than capable of ‘safeguarding public health’. This begs the question: Why the need for reform?

In the discussion papers, the MHRA also refers to adverse drug reactions (ADRs) in relation to herbal medicines. The Yellow Card Scheme (YCS), which is run by the MHRA, informs the UK database of ADRs, and has included herbal medicines since 1996. Extraordinarily, herbal medicines are associated with less than 0.1% of fatalities listed on the database8. It should be further emphasised that the YCS does not attribute causality to the herbs listed (other factors, such as concomitant medication and underlying disease may also be contributory). In addition, the YCS does not record whether a herbal medicine listed was bought OTC or prescribed by a herbalist (in the UK, the majority of herbal medicines are self-prescribed).

Finally, the MHRA, an organisation fully funded by the pharmaceutical industry, cannot be trusted to regulate herbal medicines. A comparison serves to illustrate the point: the popular OTC orthodox drugs, aspirin and paracetamol, are responsible for thousands of ADRs and hundreds of fatalities (according to the MHRA’s own YCS). Yet Piper methysticum was banned by the MHRA in 2003 based on the assessment of just 70 ADR cases (4 fatal)9. Without exception, these cases (based on worldwide reports) were linked to standardised OTC products as opposed to traditionally prepared herbal medicines. It appears, therefore, that the MHRA is incapable of applying its remit to ‘safeguard public health’ consistently or proportionately.

Conclusion – The State of Play

The interrelatedness of the 3 pieces of legislation discussed above means that the timing of their passage into law is critical. For example, proposed reforms to section 12(1) are apparently dependent on SR, so without SR the MHRA would have to reconsider section 12(1) reform. Furthermore, according to the EHTPA, the effect of the THMPD coming into force in 2011 is ‘that third parties would not be able to provide prescriptions for patients on behalf of herbal practitioners working under s12(1) unless these practitioners were statutorily regulated and thus able to be recognised as ‘authorised health professionals’…’10 Without this status, herbalists will not be allowed to commission the production (and mixing) of herbal medicines from 3rd parties. This would have negative implications for dispensary services. However, a promised Department of Health public consultation on SR, in response to the final report made by its Steering Group, has so far failed to materialise…

The proposed legislative changes and the manner in which these are being introduced is a recipe for disaster. The damage these would cause to the interests of both patients and practitioners will be profound and may prove impossible to reverse. It is therefore necessary to resist the current legislative proposals. If these changes are enacted, we are most unlikely to consent and will be forced to adopt a position of principled non-compliance.

References:

1http://www.publications.parliament.uk/pa/cm200405/cmselect/

cmhealth/42/42.pdf

2http://www.anhcampaign.org/files/

080403_ANH_Info_Guide_Feb_2008_update.pdf

3Jagtenberg T, and Evans S. (2003). Global Herbal Medicine: A Critique. Journal of Alternative and Complementary Medicine 9:2: 321-329.

4http://www.ehtpa.eu/pdf/steeringgroup/

steering_group_report_16june08.pdf

5http://www.ehpa.org.uk/

6http://www.allianceforcandp.org/pages/AllianceStatement.htm

7http://www.ehpa.org.uk/pdf/medicines_legislation/

1%20Informal%20discusspaperOverviewFinalDec06.pdf

8http://www.mhra.gov.uk/Howweregulate/Medicines/

Enforcingthelaw/Ourprosecutions/index.htm

9Correspondence with the MHRA

10http://www.mhra.gov.uk/home/groups/es-herbal/documents/

websiteresources/con009312.pdf

11http://www.ehpa.org.uk/pdf/frankincense/Frankincense_Oct_2008.pdf

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