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The disagreement between herbalists who want to be recognised by the state and those who don’t want to be organised is as old as the hills. Those of you who have willed for statutory regulation (SR) are on the eve of achieving your dream, and we hope you will make the very best you are able of the trials and the opportunities it will present. However, there is one last bit of business to attend to, which might even unite us briefly, in countering the proposal to reform Section 12(1) of the Medicines Act 1968. We hope you will take up this cause as it profoundly affects the future and security of those choosing to work in a regulated environment, as well as the rest of us.

Firstly, here is Section 12(1) itself:

Section 12. Exemptions in respect of herbal remedies

(1) The restrictions imposed by sections 7 and 8 [Licences and Certificates relating to Medicinal Products] of this 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 judgment as to the treatment required.’

Secondly, here is an extract from the statement released by the MHRA on February 16th 2011:

‘If practitioner regulation is in place for the purposes of creating an Article 5(1) scheme this also opens the way to reform Section 12 (1) of the Medicines Act 1968. Under Section 12 (1), practitioners may prepare unlicensed herbal medicines on their own premises for use following consultation with individual patients. It is intended to move to the position that only registered practitioners would be able to operate under Section 12 (1) after regulation of practitioners is in place.’*

*Greater detail on the background to this, for instance, what Article 5(1) is all about, is covered in ‘Statutory Regulation Facts & Fictions’. Meanwhile, here’s our analysis of the current situation:

Why we all need to keep Section 12(1) of the Medicines Act 1968 unchanged

To the UK Government: Reforming 12(1) is not necessary to comply with the Traditional Herbal Medicine Products Directive (THMPD). Restricting all unlicensed medicines to the exclusive use of regulated practitioners would effectively outlaw the many herbalists who will not register with the HPC. This is not simply a matter of bowing to pressure groups or even the wishes of the majority:  it’s also important to protect individual choice, applicable where such choices neither cost the public purse nor cause harm. Those who for whatever reason choose to consult with unregulated herbalists should still be able to do so legally under the caveat emptor principle, thus upholding fairness and common law rights. It also avoids the future potential embarrassment of prosecuting UK citizens for doing no harm.

It is clear from the disclusion of acupuncturists from the regulatory process that the Department of Health sees no need to regulate complementary therapies per se. To regulate herbalists beyond what is required to comply with the THMPD makes a mockery of the principle of proportional legislative impact, and thus inexplicably discriminatory.

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At the end of this article we copy a Ministerial Statement from Andrew Lansley, Secretary of State for Health, published on Wednesday 16th February, and also a statement from the MHRA published on their website on the same day.

The main substance of these announcements are: –

·      In order to comply with European Directive 2004/24/EC, (aka THMPD), herbal practitioners (of all traditions) will be statutorily regulated by the Health Professions Council (HPC).

·      Section 12(1) of the 1968 Medicines Act would be reformed so that unlicensed medicines can only be used in the practices of HPC registered herbalists.

·      The arrangements should be put in place by 2012.

·      Acupuncturists, (hitherto considered to be a necessary part of the regulatory package) will not be regulated as they are not affected by the directive.

Like everybody else, we are in shock. Every indication was that the whole SR enterprise had foundered – it was an ill-conceived and unworkable plan, and assumed to be unattractive to a government beset by much greater problems and determined to cut costs. You can review the Herbarium’s commentaries on this in the ‘Law and Herbal Medicine’ files, which we will retain for the time being to help give insight into why we feel that this is all such a self-destructive nightmare.

Some insight into how this extraordinary eleventh-hour success for the EHTPA could have been possible comes from the PR company, Cogitamus, engaged during the final months of the campaign, who quote EHTPA Chair Michael Mcintyre thus: “On behalf of our thousands of members, I cannot thank or praise you enough for the vital support and advice you gave to us when it really mattered. Your intimate knowledge and experience of the health sector, combined with your understanding of both the formal decision-making processes and informal political dynamics in Whitehall, Westminster and the devolved administrations was exactly what we needed. It is no exaggeration to say that I truly believe you made a significant difference between ultimate success and failure in the final decision. I would have no hesitation whatsoever in recommending your services to any organisation in the health world needing calm, professional and deeply experienced advice or advocacy.”

So, this was less about our patients’ needs, the balance of arguments and good sense, and more about money (probably quite a lot of it) spent on lobbying. You may draw your own conclusions.

Whatever bringing SR to fruition might mean to other larger herbal modalities in the UK, it’s not good news for traditional western herbal medicine. Without the weight of numbers from the acupuncturists, with a government keen to spend as little as possible of taxpayer’s money, with the HPC under pressure to regulate way outside their comfort zone – this will cost regulated herbalists very dear – so much so that, given the humble incomes of most of us, it is unlikely to be affordable by all but a very, very, few – maybe too few to be sustainable. For the rest of us, having lost the right to make our own medicines, or indeed to buy them, and no doubt with other disincentives in place, we would be forced underground to work outside of the law. This is not an obvious recipe for growth either.

How do we respond to this? No fear! The joy of a good pun is to be able to convey two things at once – we won’t be cowed into submitting to regulation, nor will we allow it to lure us back into the trap of fear that we’ve be doing so much good work to escape.

The statements of government ministers seldom prove to be infallible – as is so often the case, the devil’s in the detail. The schedule of a 2012 completion seems particularly unrealistic. There are at least two further public consultations to compile, publish, call in and analyse, parliamentary time has to be found to debate and vote on two streams of legislation, the HPC has to develop its new bureaucracy, the PAs and their members have to go through a multitude of adaptations. It may nonetheless be rushed through and be so full of holes as to prove unworkable. If it’s delayed for long, it may be delayed forever. It may anyway simply prove to be beyond the purse of any of the interested parties.

The Herbarium, as we often remind ourselves, was launched to try and give herbal medicine a future. This is not the future the whole SR rigmarole would assume – that the western world is recovering from a little recession and we can soon all get back to escalating our material consumption. It’s the future of climate chaos, energy descent, and the decline of global bureaucracies and power structures. (This is at the core of the Transition Herbal Medicine ethos). If it turns out that we’re a little premature, at least we’ve left a message in a bottle for our grandchildren. But if we’re right, and there are all the signs that we are, then our work – every sensible herbalist’s work – has to be in preparation for a very different working environment, and one in which we are again relevant and valued. So the message to everybody in the midst of our hurt is chin up, hold steady, and keep the faith. Herbalists are hard to kill – if history will out, impossible to kill. Remember that the worst-case scenario has happened before in living memory – herbal medicine was illegal from 1941 to 1968. It proved paradoxically to be a golden era for our forebears, and nobody was prosecuted. It was a consequence of sheer bloody-mindedness, weak legislation, and the reticence of successive governments to prosecute citizens for doing no harm. Those who battled to bring the thoroughly civilized and effective Section 12(1) into the new Medicines Act, however much they also dreamt of official recognition, must surely be turning in their graves at the horrors that foolish herbalists and jaded politicians have managed to cook up 50 years later. We will have no part in it.

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Now that the election dust has settled and, as expected, the political order has been shaken up, it seems a good time to cast a weary eye over the past decade and the ups and downs in the landscape of state regulation for herbalists. Let’s begin with some background on the biggest acronym in herbal medicine…

EHTPA

One of the chief protagonists in the drive for state-sanctioned ‘professional status’ for herbalists has been the European Herbal and Traditional Medicine Practitioners Association (EHTPA, formerly the European Herbal Practitioners Association, EHPA), a pro-regulation lobby group formed in 1993 to (in their own words) enhance the legal basis of herbal medicine practice across the European Union (EU). The EHTPA is an umbrella body which represents professional associations (PAs). Representation of PAs within the EHTPA is on an organisational level: individual members of these PAs have no voting rights and no say in how the organisation is run, although each member is obliged to pay an annual £50 levy to fund the activities of the EHTPA. The PAs have a combined membership of around 1400, made up of herbalists from various traditions. The EHTPA was represented on the Department of Health (DH) Herbal Medicine Regulatory Working Group and the Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK, both of which produced reports recommending the introduction of state regulation for herbalists in the UK. The EHTPA lobbied hard, particularly via letter-writing campaigns, demanding that MPs and the former Health Secretary, Andy Burnham, support state regulation for practitioners. This campaign appears to have been unsuccessful.

The House of Lords Select Committee on Science and Technology

The campaign for state regulation started in earnest in November 2000 with the publication of the House of Lords Select Committee on Science and Technology report on Complementary and Alternative Medicine. Herbalists appeared to receive official public backing for state regulation as the report suggested that practitioners met key criteria, including (a) risk to the public from poor practice, (b) the existence of a voluntary regulation system, and (c) a credible, if incomplete, evidence base.

Statutory Self-Regulation (SSR) was to be introduced under Section 60 of the Health Act 1999, which empowered the Health Secretary to ‘fast track a profession to SSR’1 via the establishment of a single umbrella body, recognised by statute, to represent, register and protect the title of herbalists.

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Since the publication of the Department of Health (DH) consultation document on statutory regulation (SR) on 3 August 2009 a number of practitioners of traditional western herbal medicine have been gripped by, what can be best described as, regulation hysteria. A pro-SR demonstration was held outside the Houses of Parliament, letters demanding SR have been fired off to MPs, and an article entitled ‘Herbal drug crackdown: Millions face having to buy remedies on black market as Europe tightens the rules’ recently appeared in the Daily Mail. The European Herbal and Traditional Medicine Practitioners Association (EHTPA) and its members are offering herbalists a stark choice: get behind SR or face oblivion from European legislation! But is herbal medicine really on brink? Below we attempt to separate fact from fiction (with a little help from the MHRA).

Fiction: Unless SR is implemented by 2011, section 12(1) of the Medicines Act 1968 will be superseded by the Traditional Herbal Medicinal Products Directive (THMPD) and European medicines legislation, effectively banning the practise of herbal medicine in the UK.

Fact: Section 12(1) of the Medicines Act 1968 remains available to herbalists in the UK beyond 2011, whether SR is implemented or not.

In an email (dated 6 November 2009), Richard Woodfield of the MHRA clearly stated that beyond 2011 ‘the s12(1) exemption [will remain] available where herbal practitioners are carrying out activity in accordance with the terms of that exemption.’

What exactly are the terms of the section 12(1) exemption? The exemption appears in statute in the following form:

12. Exemptions in respect of herbal remedies

(1) The restrictions imposed by sections 7 and 8 [Licences and Certificates relating to Medicinal Products] of this 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 judgment as to the treatment required.’

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by Susun S. Weed www.susunweed.com

To anyone who thinks herbalists need licenses:

No to all licensing of herbs and herbalists. Never. No way.

Ask the midwives of North America. They fell for “let’s regulate ourselves before the big boys do.” And they regulated themselves out of existence. There are no midwives left, according to Jeannine Parvati; only medwives. I agree. Let us learn from their mistake. No licenses for herbalists.

Herbal medicine is people’s medicine. People don’t need licenses to care for themselves and their families. Licenses don’t protect people; they protect, and create, institutions. Herbalism is change, individuality, and uniqueness. Institutions don’t change. Licensing herbalists kills herbal medicine. Licenses, and their companion, liability insurance, set up protocols. The art of herbalism is re-placed with “evidence-based” science designed to protect healers, not heal patients. No licenses for herbalists.

I have taught and lived in Germany, where herbs and herbalism are licensed. In daily life, this meant my access to herbs was limited, and my students — many of whom are professional, licensed healers — were threatened with loss of their licenses when they recommended home-made medicines such as dandelion vinegar and St. Joan’s/John’s wort oil. No licenses for herbalists.

Any American who wants a license to heal with herbs can get one. There are plenty available. Be an herbalist and a massage therapist, an herbalist and a chiropractor, a naturopath specializing in herbs, an acupuncturist/herbalist, even an M.D. herbalist. Surely these are enough. No more licenses.

Licenses do not confer credit or merit or worth. They replace these things. We have an excellent system already in place for “certifying” herbalists: the apprentice system. We know each other, our strengths and foibles. We know who we have trained. And we talk openly. Licenses make people less secure, less likely to trust each other, less open, more protective. No licenses for herbalists.

Herbs are not manufactured. They grow. Besides standards of purity and identity — which are in place — we do not need rules. Except perhaps to consider banning the use of herbs in capsules, which, to my mind, are more likely to be harmful than any other dosage form available.

I stand firm and proud for herbal medicine free of licenses. Reconsider your plan. Herbalists have a long heritage as revolutionaries. Don’t make Culpepper and Euell Gibbons, Maude Grieves and Adelma Simmons rise from their graves to remind us: No licenses for herbalists.

I, personally don’t want to be forced to go underground, like the Chinese acupuncturists in my area, who cannot legally practice because they don’t speak enough English to pass the exam and get a license. No licenses for herbalists.

I say “NO” to all attempts to license herbalists. Please raise your voices with me, in a lusty green yell:

TRUST YOURSELF; TRUST THE EARTH; NO LICENSES FOR HERBALISTS!

The practice of herbal medicine is a fringe activity that occupies a culturally unique space in our society. Traditional western herbal medicine (TWHM) in the UK is a vibrant, vital and evolving practise, which is largely beyond state control. State regulation, which is underpinned by a positivist worldview, threatens the essential nature of TWHM by standardising its rich diversity of practice and criminalising independent practitioners. Listed below are just a few of the lies told in order to manufacture consent to the statutory regulation (SR) and licensing agenda.

Lie #1: Herbal Medicine is Risky Medicine

In the recent past western herbalists were happy to say ‘herbal medicine is safe medicine’, but now, in order to serve the SR/licensing agenda, herbalists are required to say ‘herbal medicine is risky medicine’. Why?

It is alleged that the poor practice of western herbalists is putting patients and the public at risk, but data on levels of poor practice among practitioners of TWHM has yet to be produced. The Department of Health (DH) could easily commission research to gather such data so that a rational and informed decision about the need for SR/licensing could be made. This has never been done. There simply is no reliable evidence base demonstrating that the public need safeguarding from practitioners of TWHM. Furthermore, were SR/licensing to be introduced without a supporting evidence base, then future judgements about the success or failure of such schemes to reduce levels of poor practice would be impossible to make.

Bureaucrats can theorise about potential risks all day long, but without a reliable evidence base demonstrating that real harm comes from the activities of western herbalists the imposition of any regulatory scheme would be completely unjustifiable. The precautionary principle applies here: if the potential consequences of an activity are severe, in the absence of full scientific certainty the burden of proof falls on those who would advocate taking action.

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A Joint Consultation on the Report to Ministers from the DH Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK.

This extremely lengthy consultation paper was published by the Department of Health (DH) in July 2009 with a deadline for responses of  November 2nd, now extended to November 16th 2009. It runs to 56 pages along with a separate Impact Assessment document of 21 pages. Anybody, including members of the public, can access the document from this link: –

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_103566.pdf

Equally anybody can respond to it – the DH hopes that most will do so by using the electronic ‘Question & Answer’ form provided, although there are few if any who will be able to answer every one of the questions.

The DH Steering Group Report referred to in the title strongly recommended Statutory Regulation and was primarily concerned with the detail of how it should be achieved and administered. In somewhat unanticipated contrast the DH consultation appears to be going ‘back to the drawing board’ offering in addition no less than eight alternative ‘light touch’ approaches for consideration such as accredited voluntary regulation and even a voluntary licensing scheme.

The consultation does seem very concerned that any regulation of herbal medicine, acupuncture et al. should be proportionate to risk – ‘proportionate’ taking into account not only what is perceived as risk but also any negative impact on practitioners and their patients (expense, bureaucracy, interference), and in particular the cost to the taxpayer.

In most respects the consultation does appear to be painstakingly accessible, even-handed and inclusive. Conspiracy theorists can be forgiven in the light of recent government behaviour to interpret this all as ‘window dressing’, decisions having already been made by the Ministers. Others see signs that the DH is wavering and that the whole regulation issue will be shelved or scrapped. This latter contention is more likely – new, expensive, petty regulation will clearly not be a vote-winner during a deep recession, and there is a general election looming long before any new arrangements could be enacted.

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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.

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