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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Written Ministerial Statement

DEPARTMENT OF HEALTH

Practitioners of acupuncture, herbal medicine and traditional Chinese medicine

Wednesday 16 February 2011

The Secretary of State for Health (Mr Andrew Lansley): The issue of whether or not practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated has been debated since the House of Lords’ Select Committee on Science and Technology’s report in 2000 recommended statutory regulation for the first two of these groups.

We have today published an analysis of the 2009 consultation by the four United Kingdom Health Departments which sought views on the possible regulation of practitioners of acupuncture, herbal medicine and traditional Chinese medicine.  This factual report has been placed in the Library and can be found on the Department of Health’s website at:

www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_124337

Copies are available to hon Members from the Vote Office and to noble Lords from the Printed Paper Office.

I can now set out how we intend to take forward the regulation of herbal medicine practitioners and traditional Chinese medicines practitioners, specifically with regard to the use of unlicensed herbal medicines within their practice. As this matter is a devolved matter in Scotland and Northern Ireland we have had discussions with Health Departments in the three Devolved Administrations which have been constructive and we are committed to a unified UK-wide approach to the regulation of these practitioners.

When the European Directive 2004/24/EC takes full effect in April 2011 it will no longer be legal for herbal practitioners in the UK to source unlicensed manufactured herbal medicines for their patients.  This Government wishes to ensure that the public can continue to have access to these products.

In order to achieve this, while at the same time complying with EU law, some form of statutory regulation will be necessary and I have therefore decided to ask the Health Professions Council to establish a statutory register for practitioners supplying unlicensed herbal medicines. This will ensure that practitioners meet specified registration standards.  Practitioner regulation will be underpinned by a strengthened system for regulating medicinal products.  This approach will give practitioners and consumers continuing access to herbal medicines.  It will do this by allowing us to use a derogation in the European legislation to set up a UK scheme to permit and regulate the supply, via practitioners, of unlicensed manufactured herbal medicines to meet individual patient needs.

The Health Professions Council is an established and experienced statutory regulatory body which has the necessary experience to be able to successfully establish and maintain a statutory register for practitioners wishing to supply unlicensed herbal medicines.  Subject to Parliamentary approval, such practitioners who wish to supply unlicensed herbal products will be required by law to register with the HPC.

The four UK Health Departments will consult jointly on the draft legislation once it is prepared.  This will give practitioners and the public the opportunity to comment.  Subject to Parliamentary procedures we will aim to have the legislation in place in 2012.

Until the new arrangements are in place the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to take appropriate compliance and enforcement action where products are in breach of the regulatory requirements.  In line with the MHRA’s normal approach, the action taken will be proportionate and will target products which pose a public health risk.  Guidance issued by the MHRA makes clear their view that, where practitioners hold stocks of unlicensed products on 30 April 2011 that legally benefited from transitional arrangements under the European Directive, the practitioner can continue to sell those existing supplies to their patients.

The 2009 consultation also looked at practitioners of acupuncture.  The practice of acupuncture is not affected by the EU Directive and, therefore, compliance is not required.  I am confident that acupuncturists have their own voluntary regulatory measures in place, which are sufficiently robust.  Additionally, local authorities in England have powers to regulate the hygiene of the practice of acupuncture, to protect against the risk of transmission of certain infectious diseases.  Similar measures are also in place in Scotland, Wales and Northern Ireland.

I am pleased to say that this decision resolves a long-standing issue, to the benefit of

both practitioners and the public who use herbal medicines.

…and from the MRHA: –

The Secretary of State for Health has made an announcement today about regulation of herbal medicine practitioners. The issue of whether or not practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated has been debated since the House of Lords Select Committee report on Complementary and Alternative Medicine in 2000.

The Health Professions Council (HPC) has now been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines. The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as “authorised healthcare professionals” to commission unlicensed medicines to meet the special needs of their patients.

Accordingly, a scheme would be created enabling registered practitioners to commission unlicensed herbal medicines to meet the special needs of their individual patients. Safeguards for the public would be provided by a combination of professional regulation and linked medicines regulation, for example, to safeguard manufacturing standards.

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.

A formal consultation exercise will take place on specific legislative proposals for establishing the register and proposed reforms of medicines legislation later in 2011.

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