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OCPHM bulletin: 1st February, 2014

The Government Backslides Again on Statutory Regulation

A New Working Group

On January 30th, 2014, the first meeting of the Department of Health’s “Herbal Practitioners and Medicines Working Group” took place. Good news, one might think. The Working Group was set up on the instructions of Dr. Dan Poulter, the Under Secretary of State for Health, to look again at how best to create a legal framework for the ongoing practice of herbal medicine in the UK. The Working Group is under the chairmanship of David Tredinnick MP, and Professor David Walker, UK Deputy Chief Medical Officer. But is it really good news? Once again the question of how herbalists should be regulated (voluntary self-regulation or statutory regulation) is up for discussion.

This question was supposed to have been decided in April 2011, when the Health Minister, Andrew Lansley, promised to introduce the statutory regulation of herbalists, thereby giving them the status of authorized healthcare professionals. This promise was never fulfilled. And yet his decision was the result of the recommendations of several Working Groups looking into this very question of how best to create a legal framework for herbal medicine. Each one reported in favour of the statutory regulation of herbalists. Is another Working Group really needed?

A Brief History of Ignored Working Groups

In 2000, the Science and Technology Select Committee of the House of Lords produced its Report on Complementary and Alternative Medicine recommending that herbalists should be state registered and that proper controls on the supply of herbs should be put in place. Two years later the Government established a Working Group on the regulation of herbal practitioners under the chairmanship of the eminent biologist Professor Michael Pittilo, who made specific proposals for the regulation of herbalists in his report, Recommendations on the Regulation of Herbal Practitioners in the UK (2003). This was followed by a public consultation in 2004 on the Regulation of Herbal Medicine and Acupuncture in which an overwhelming proportion of respondents (98.5%) were in favour of statutory regulation.

In 2006 the Government decided that another committee should be set up to investigate the question of the regulation of complementary medicine, including herbalism. Once again Professor Michael Pittilo led another exhaustive enquiry over the course of two years, between 2006 and 2008. His Report to Ministers from the Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practiced in the UK (2008) concluded: “We are firmly of the view that, in the interest of public safety, statutory regulation should now proceed with all possible speed” (p.10). In 2009 another public consultation was launched, with a series of questions – many of which were extremely technical and difficult for the ordinary lay-person to answer. Nevertheless, approximately 6,500 members of the public responded and once again an overwhelming proportion (85%) of respondents were in favour of statutory regulation.

At last, on February 16th, 2011, the Secretary of State for Health, Andrew Lansley, made his announcement that the Government would introduce statutory regulation, saying that this would be in place by April 2012. But to the dismay of all concerned, this did not happen. This is the background context for Dr. Dan Poulter’s decision to set up yet another Working Group to “gather evidence” and “consider viable options”, as if for the first time. Given the thirteen year history of parliamentary committees and Working Groups, reports and public consultations, all pointing unequivocally to the need for herbal medicine to be statutorily regulated, and given the Government’s landmark decision in 2011 to go ahead and implement the statutory regulation of herbalists, one wonders what the point of yet another Working Group is.

The Remit of the New Working Group

Along with the question of whether herbalists should be statutorily regulated or should come under some form of voluntary self-regulation, the new Working Group’s draft terms of reference include a proposed “product review”. Over recent years the trend has been for herbal products to be classified as unlicensed herbal medicines rather than as legal botanical food supplements, which means that unless their manufacturer can afford the time and expense of getting them approved as Traditional Herbal Remedies under the Traditional Herbal Medicinal Products Directive (THMPD), they are vulnerable to being made illegal. Any meaningful product review would have to move beyond this overly simplistic categorization of herbal products in order to allow practitioners the ability to prescribe herbs and herbal products that are not necessarily available to the general public, but which have not undergone prohibitively expensive clinical trials.

However this is done, the onus will still ultimately fall on the knowledge and expertise of the herbalists themselves, as to which herbal medicines are suitable for prescription in each case. The key point about statutory regulation, acknowledged by all three previous Working Groups, is that it means that the public can be assured of consulting properly trained and qualified herbalists, and are thereby protected from poor or bogus practitioners. Once the practitioners are statutorily regulated and granted the status of authorized healthcare professionals, the profession can set in place robust quality controls of herbal medicines used by all registered practitioners.

There is, furthermore, a need to clarify the question of whether or not practitioners using medicines produced by third-party suppliers will continue to be able to do so. Many herbalists (especially practitioners of non-European systems of medicine like TCM and Ayurveda) are dependent on third-party suppliers so this is a vitally important issue. At its first meeting on January 30th, the Working Group was informed that the European Commission had ruled out the possibility of having such medicines supplied under current medicines law (Article 5.1 of the EU directive 2001/83/EC). Under Article 5.1, only authorized healthcare professionals are allowed to prescribe unlicensed medicines to individual patients under their direct responsibility. Whether what the Working Group was told is correct is questionable, as legal advice taken by the European Herbal and Traditional Medicines Practitioners Association (EHTPA) seems diametrically opposed to this view. As the EHTPA are represented on the Working Group, this is not going to go uncontested. Meanwhile, at the end of April 2014, the supply of all remaining non-licensed herbal products from third-party suppliers is supposed to cease.

A Question of Timing

The Working Group is due to report to the Government in March 2015. As we all know, the next General Election is scheduled for 7th May, 2015. Given that the report will be handed in just weeks before the election, there is no chance that it will be implemented by the present administration. The timetable that has been imposed on the Working Group is inevitably going to lead to further delays. Considering the history of serial amnesia within the Department of Health, the report of this Working Group is as likely to be forgotten as all the other reports and consultations that have taken place over the last thirteen years. What is lacking is not more “evidence” or “viable options”: it is the will to act for the sake of the common good. In the absence of the Government grasping the nettle of statutory regulation, practitioners and suppliers of herbal medicine are going to find it increasingly difficult to stay in business, and the safety of the public will be further endangered as more and more people seek out herbal remedies from unscrupulous suppliers or from unqualified practitioners.


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NEWS

Nov 2017: Urgent need for progress on Statutory Regulation


March 2016: Continuing Prevarication over SR for Herbalists

April 2015: New Government Report on Herbal Medicine a Travesty

31st March 2015: Anglo-Saxon remedy kills superbug MRSA
(external link)

1st Feb 2014: The Government backslides again...

19th Jan 2014: Prince Charles makes plea on alternative medicine
(external link)

OCPHM Conference - articles to appear in Caduceus

9th November 2013: OCPHM Conference 'The Vital Contribution of Herbal Medicine' took place

9th July 2013: Minister makes statement on the Future of Herbal Medicine

10th July 2013: Michael McIntyre addresses OCPHM

24th April 2013: Demonstration and Parliamentary Lobby at Westminster