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.