Proposals have recently been introduced in the United Kingdom to regulate the practice of medical herbalists and acupuncturists. In March 2004, the U.K. Department of Health published a public consultation document entitled “Regulation of herbal medicine and acupuncture—proposals for statutory regulation.”¹ Simultaneously, the U.K. Medicines and Healthcare Products Regulatory Agency published a second consultation document, MLX 299, proposing significant changes to the U.K. Medicines law in relation to the one-to-one prescription of herbal medicines.² These two documents pave the way for the statutory regulation of non-physician herbal practitioners and acupuncturists—the first time this has been contemplated anywhere in the European Union.

This major initiative by the U.K. Government had its origin in the House of Lords Select Committee on Science and Technology report on complementary and alternative medicine (CAM) published in 2000.³ The report recognized the risk posed by CAM practitioners with inadequate training as well as from the supply of unregulated herbal medicines. It recognized, however, that good standards of training were available in the U.K.; for example, eight British Universities currently offer undergraduate degree courses in herbal medicine.

In 2001, the Government responded to the Select Committee Report recommending that herbal medicine and acupuncture practitioners should seek, as soon as possible, statutory regulation under the Health Act 1999.⁴ In 2002, the Department of Health followed this up by setting up two independent committees, the Herbal Medicine Regulatory Working Group (HMRWG) and the Acupuncture Regulatory Working Group (ARWG) to consider how statutory regulation of acupuncture and herbal practitioners and their medicines could best be achieved. Both Committees met regularly, publishing their recommendations in September 2003.

Recommendations from the HMRWG

The HMRWG surveyed herbal practice in the U.K., estimating that there are currently 1,300 herbal practitioners who are members of voluntary registers in the U.K.; for example, the National Institute of Medical Herbalists. It noted equal numbers practicing western herbal medicine and Chinese herbal medicine—the numbers of practitioners of Ayurvedic and Tibetan medicine being small by comparison.

The HMRWG rejected an independent Herbal Council as an option for the registration of herbal practitioners. The HMRWG observed that while this might be perceived as giving herbal medicine a clear identity, the need to work across professional boundaries to deliver integrated healthcare favored shared arrangements among CAM professions. In addition, the HMRWG noted, the cost of a single Herbal Council was likely to be prohibitive to practitioners, particularly for those practicing both acupuncture and herbal medicine. For these reasons the HMRWG favored the adoption of a shared council (to be called the CAM Council) to include, at this stage, both herbal medicine and acupuncture, with the possibility of including other CAM disciplines at a later stage. The HMRWG argued that because of economies of scale derived from larger numbers of registrants, this option offered significantly lower costs of registration.

The HMRWG proposed that the CAM Council should determine minimum levels of education and training required for registration. Statutory registration would confer on registered practitioners the right to use a protected title that would identify competence in any particular tradition(s). A grand-parenting process was suggested to register those already in practice in the U.K. (Note: Grand-parenting is the gender neutral term for “grand-fathering,” the process whereby those who already function in a particular capacity are able to continue doing so once new rules and regulations determining qualifications for that function come into force. Sometimes those being “grand-parented” may be required to satisfy some basic rules and regulations; e.g., proof of safe practice for a period of time.) The HMRWG adopted a number of documents from the lead herbal body, the European Herbal Practitioners Association, including a Core Curriculum, Code of Ethics and Practice, and process for Continuous Professional Development. Lastly, the HMRWG also made recommendations concerning the prescription of herbal medicines by practitioners to their clients on a one-to-one basis.

Recommendations from the ARWG

The ARWG noted that not only is acupuncture provided by traditional acupuncturists, it is also offered by some conventional physicians, nurses, and physiotherapists, as well as osteopaths and chiropractors. Altogether, the ARWG estimated that there are about 7,500 health workers practicing acupuncture in the U.K., of which just over 2,400 are traditional acupuncturists. The ARWG suggested registering practitioners with differing approaches within a single acupuncture register, offering some facility to identify the training and background of a registered practitioner. Like the HMRWG, the ARWG proposed grand-parenting arrangements to accomplish registration of those already in practice.

One significant disagreement between the two working groups was over the matter of a shared or independent Council. The ARWG preferred the option of a single independent Acupuncture Herbal Council, which it argued would require fewer staff than a Shared Council and thus be more cost effective. The ARWG suggested that those registered with the Acupuncture Council, but regulated elsewhere by another statutory body, should pay a reduced registration fee, which would help to reduce the total financial cost of dual registration.

Eventually, the Government Consultation Document on the regulation of acupuncture and herbal medicine clearly opted for a Shared CAM Council. The Government also made it clear that it would prefer physicians and physiotherapists who practice acupuncture and/or herbal medicine to remain registered with their existing professional bodies rather than be registered a second time with the new CAM Council. The Department of Health suggests that there should be close cooperation between existing statutory councils for conventional practitioners employing herbs and/or acupuncture and the new CAM Council to maintain standards of herbal and acupuncture practice across the board. The Department of Health foresees that a CAM Council could potentially be extended to other unregulated CAM professions which would bring economies of scale and support practitioners working across professional boundaries. The Consultation Document asks for feedback on a number of questions, such as suggested protected titles for registered acupuncturists and herbalists. It also asks about the composition and key functions of the Council, about grand-parenting arrangements, and about continuous professional development programs.

The MLX 299 consultation document proposes a number of significant changes to that part of the 1968 Medicines Act that regulates one-to-one prescription of herbal medicines. In particular, it proposes that the use of a number of potent herbal medicines, such as ephedra (Ephedra sinica Stapf, Ephedraceae), should be limited to herbal practitioners on the new Statutory Register. It also proposes that herbalists on the Statutory Register can have specific formulations manufactured to their specification without the need for full medicines licences—this exemption from licensing also being granted for individual formulations made up by the herbalists on their own premises.

Under current U.K. regulations, anyone may be an herbalist with little or no training. The new proposals will limit use of legally protected titles (yet to be agreed upon) to practitioners on the statutory register. Two protected titles suggested by the Department of Health are “herbal practitioner” and “acupuncturist.” Such legally protected titles are designed to enable the public to determine who is a properly qualified practitioner and enable practitioners contravening agreed codes of ethics or practice to be struck off the register, thereby losing use of the protected title. The MLX consultation document proposes that the use of potent herbs (though as yet to be exactly decided, ephedra is definitely one) be limited to regulated herbalists. It also suggests that regulated herbalists should use herbs on a broad list agreed upon by their regulating body in consultation with the profession. The document recommends that herbalists wishing to use an herb not on this list be required to notify the regulatory Council of their use of this herbal medicine, thereby giving the profession an opportunity to either extend the list or advise the practitioner of any safety concerns. It is further proposed that herbalists will have to complete an agreed amount of continuous professional development each year to maintain their registration. Undergraduate courses at schools, colleges, and universities training herbalists to qualify for registration will be validated by an independent Accreditation Board run by the Regulatory Council. Aside from this there are no other limitations except those regarding the cost of registration. The exact fee is yet to be set.

The two consultation documents ask for feedback within a three-month period. After considering the responses, the U.K. Government plans to publish a formal proposal for statutory regulation of the acupuncture and herbal sectors together with draft legislation for this purpose. Based on this timetable, it is anticipated that the U.K. acupuncture and herbal professions could be registered as early as 2006, completing a process that famously began with the “Herbalists Charter” enacted by Henry VIII in 1543 to grant British herbalists the right and freedom to practice herbal medicine.

Michael McIntyre was formerly President of the National Institute of Medical Herbalists and has trained in herbalism and acupuncture in China. As Chairmanof the European Herbal Practitioners Association, he is negotiating for the statutory regulation of herbalists in the United Kingdom. Michael is also a Director for the Prince of Wales Foundation For Integrated Health.

References:

1. Regulation of herbal medicine and acupuncture. Department of Health, The Stationery Office, March 2004. Copies of the DH Regulation of Herbal Medicine and Acupuncture: Proposals for Statutory Regulation consultation document are available at www.dh.gov.uk/Consultations/LiveConsultations/fs/en. The consultation period closes on 7 June 2004. The proposals for statutory regulation apply to all 4 UK countries (England, Wales, Scotland, Ireland).

2. MLX299, MHRA Market Towers, 1 Nine Elms Lane, London SW8 5NQ, March 2004. Available at www.mhra.gov.uk. The consultation on Proposals for the reform of the regulation of unlicensed herbal remedies in the UK made up to meet the needs of individual patients (MLX299) is available at www.mhra.gov.uk. The consultation period closes on 7 June 2004. The proposals for statutory regulation apply to all 4 UK countries.

3. House of Lords’ Select Committee on Science and Technology, Session 1999-2000. 6^th Report. Complementary and Alternative Medicine. The Stationery Office, 2000.

4. Department of Health. Government Response to the House of Lords Select Committee on Science and Technology’s Report on Complementary and Alternative Medicine. The Stationery Office, March 2001.