Statutory Regulation

On 16 February 2011 the Secretary of State for Health announced in a Ministerial Statement issued by the UK Department of Health that the Health Professions Council (in August 2012 renamed to Health and Care Professions Council) has been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines.

However, as a result of repeated delays, statutory regulation has not been implemented yet. In fact, due to legal issues (arising from the need to harmonise UK law with EU law), the UK Government is currently not only questioning the feasibility, but also the necessity of statutory regulation again. They have now convened another Working Group to look into these issues and advise the Government on how to proceed. The final report of the WG is scheduled for March 2015.

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For a more comprehensive review of the history of statutory regulation of complementary and alternative medicine in the UK, including Ayurveda, please see the following summary with essential reference documents below.

History of Events (2000-2008)

The move towards statutory regulation of complementary and alternative medicine (CAM) practitioners originated from the House of Lords Select Committee on Science and Technology’s Report on Complementary and Alternative Medicine (HMSO, 2000) and the Government Response (Department of Health, 2001) to it. The report recognised that CAM systems are now widespread and increasing across the developed world and that this has implications for patient safety. The Committee identified that there was considerable diversity of standards amongst the professions and that, for some therapies, the public was at risk from practitioners with inadequate or inappropriate training.

Statutory regulation, however, would ensure that appropriate training is established. This would result in competent practitioners with an understanding of the evidence base for their therapy along with an appreciation of the limitations of the treatments they can provide. Safe practitioners would understand when to refer. Effective regulation would therefore seek to safeguard the public from incompetent practitioners. It would also identify practitioners suitably qualified to use a range of potent remedies that are not appropriate for over-the counter sale.

The House of Lords Select Committee on Science and Technology’s Report on Complementary and Alternative Medicine (HMSO, 2000) stated that CAM included a large range of therapies and that while some had well-developed regulatory structures, others were fragmented with no consensus about regulation. It proposed that CAM therapies should be classified within three groups. Therapies assigned to Group 1 included the most organised CAM professions where NHS provision is increasing and where research into their effectiveness had either already commenced or was likely to be beneficial. The therapies assigned to Group 2 also have support from the NHS, but are used in a complementary way alongside conventional medicine. They require further research and need to develop their regulatory structures. Those therapies assigned to Group 3 were considered to have no evidence base for clinical effectiveness.

Initially, Ayurveda was included in the third group, but the Ayurvedic community made strong objections against this inappropriate classification. After a presentation on the scientific evidence base of Ayurveda by an expert delegation from the Government of India, it was resolved to include Ayurveda in Group 1. However, rather than classifying Ayurveda in its own right as a Traditional System of Medicine, it was incorrectly grouped as a sub-branch of Herbal Medicine. The UK Department of Health has so far ignored the demands from various Ayurvedic stakeholder groups to correct this mistake. The refusal to recognise and regulate Ayurveda as a Traditional Medicine System poses an enormous threat to the future practice of Ayurveda in this country.

The Government Response (Department of Health, 2001) to the report from the House of Lords recommended that Herbal Medicine and Acupuncture should work towards statutory regulation under the Health Act 1999 and that this was both in the interests of practitioners and patients. Taking account of the public health risks, statutory regulation should be implemented as soon as practicable.

In January 2002, the Department of Health, together with the Prince of Wales’s Foundation for Integrated Health (FIH) and the European Herbal Practitioners Association (EHPA) established the Herbal Medicine Regulatory Working Group. The remit for the Group was to make recommendations on the regulation of Herbal Medicine practitioners and on the reform of Section 12(1) of the Medicines Act 1968. In 2003, the HMRWG published its report Recommendations on the Regulation of Herbal Practitioners in the UK.

The HMRWG report includes a parallel report on the regulation of herbal remedies made up to meet individual needs and supplied to the public after a personal consultation under the provisions of Section 12(1) of the Medicines Act 1968. Proposals in this latter report aim to ensure that the herbal remedies supplied by practitioners are of the necessary quality to ensure public confidence in herbal treatment. In its response to the House of Lords Report, the Government agreed that future regulatory arrangements relating to the ingredients and products used by individual practitioners should safeguard quality and safety standards while recognising the diversity of practice. The Government indicated an intention to hold discussions with herbal interest groups on this issue to consider the way forward and said that in the light of this they would consider whether any changes in legislation would be required in order to reach a satisfactory regulatory position. In effect, the work of the HMRWG on the issue of possible reforms to the regime of unlicensed herbal remedies supplied under Section 12(1) of the Medicines Act 1968 represents the first stage in the process of exploration and dialogue envisaged by the Government. It needs to be seen as distinct from, but complementary to, the wider European negotiations on the proposed Directive on Traditional Herbal Medicinal Products, which relates to industrially produced traditional herbal remedies sold over-the-counter direct to the public.

Working in parallel to the HMRWG was the Acupuncture Regulatory Working Group, which was set up to make recommendations on the regulation of acupuncturists. The ARWG published its report The Statutory Regulation of the Acupuncture Profession in September 2003.

The HMRWG, unlike the ARWG, concluded that the two professions should be regulated together, thereby addressing the high practitioner costs of running small regulatory bodies and resolving the need for Traditional Chinese Medicine practitioners, who practise both Herbal Medicine and Acupuncture, to be registered twice and pay two sets of fees.

The Department of Health ran a consultation on the regulation of the two professions published as The Regulation of Herbal Medicine and Acupuncture: Proposals for Statutory Regulation in March 2004. The results of this consultation were published in February 2005 as Statutory Regulation of Herbal Medicine and Acupuncture: Report on the Consultation.

The MHRA ran a simultaneous consultation on Section 12(1) reform: MLX299: Proposals for the Reform of the Regulation of Unlicensed Herbal Remedies in the United Kingdom made up to meet the Needs of Individual Patients and published the results in January 2005 as Summary of Responses to Consultation Document MLX299.

Delays at the Department of Health due to the General Election in 2005 and pending developments in healthcare regulation stalled further work for nearly a year. However, the Government has recently set up an Acupuncture, Herbal Medicine and Traditional Chinese Medicine Working Group to consider how to progress the joint regulation of these professions. Although still incorrectly classified as a form of Herbal Medicine, Ayurveda is represented with two seats on this Steering Group, which met for the first time in June 2006.

The Department of Health has recently published two reports following the recent reviews of the statutory regulation of healthcare professionals in the UK. Sir Liam Donaldson, Chief Medical Officer, led a review of the regulation of the medical profession and Andrew Foster, Head of Workforce, led the review of the regulation of non-medical professionals. The Department of Health is consulting on the recommendations contained in the reports, with a closing date of 10th November 2006. Links to these three documents are given below.

  1. Foster Review: Regulation of the Non Medical Healthcare Professions (July 2006)
  2. CMO Review: Good Doctors, Safer Patients (July 2006)
  3. Department of Health Public Consultation on Healthcare Professional Regulation (July 2006)

In response to the sustained lobbying campaign by the APA for the inclusion of the term “traditional” alongside “herbal” in the European Herbal Practitioners Association (EHPA), the EHPA acknowledged the distinctiveness of different traditional medicine systems and announced this with an appropriate name change to the European Herbal and Traditional Medicine Practitioners Association (EHTPA) in May 2007.

Following this breakthrough achievement for Ayurveda in the UK, the final report of the Steering Group, which made recommendations to the Department of Health on the implementation of statutory regulation for various traditional medicine systems, was revised before its publication to include the term “traditional” alongside “herbal”. Their 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 Practised in the UK was published in June 2008. To see the full report, please click here.

Medicine Legislation

The UK legislative provisions for herbal medicines are to be found in the Medicines Act 1968, Section 12, paragraphs 1 & 2, and Section 56, paragraphs 1 & 2. Traditional medicines containing non-herbal ingredients are not yet included in these provisions.

Section 12(1) specifies exemption for herbal medicines from licensing provided that they are supplied subsequent to private personal consultation. Section 12(2) exempts herbal medicines provided that they are produced according to standard traditional, non-industrial methods. It also specifies that no written claims may be made for the use of the remedy.

Section 56 reiterates and expands upon the provisions of 12(1). In addition, Statutory Instrument 2130 1977 lists several herbs “in respect of which the exemptions conferred by section 56(2) do not have effect”. This removed the herbs so identified from general sale and specified that they may only be prescribed on consultation, or supplied under the supervision of a pharmacist. This list also specifies maximum permitted doses and daily doses for those herbs.

The obvious shortcomings of these provisions are the current exclusion of non-herbal ingredients and that there is no definition of who or what a practitioner is. The imminent revision of Section 12(1), alongside the statutory regulation of the CAM professions, is expected to redress these shortcomings.

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