Regulation of Practitioners of Herbal Medicine, Traditional Chinese Medicine and Acupuncture

Position statement

Introduction

The Prince’s Foundation for Integrated Health believes that public and

patient safety is best protected by statutory regulation of complementary

therapies that provide diagnosis to individual patients and/or prescribe

medicines or undertake invasive procedures. It has vigorously

campaigned to bring that about over many years and was a member of

both the Department of Health Acupuncture Working Group and the DH

Herbal Medicine Regulatory Working Group.

The Department of Health is currently carrying out its second public

consultation on whether practitioners of acupuncture and herbal medicine

(including Traditional Chinese Medicine and other traditional medicine

systems) should be statutorily registered. The consultation questions are

unnecessarily complex but essentially offer three options:

·

full statutory regulation of practitioners

·

no regulation, with the possible option of repeal of Section 12(1) of the

Medicines Act 1968 which permits herbalists to practise;

·

a range of alternatives including voluntary regulation, local authority

licensing or a statutory or voluntary licensing system based on the

model employed by the Security Industry Authority, set up to control

the activities of wheel clampers, bouncers and security guards.

Consensus

This follows almost ten years of work by the Government and

stakeholders which has seen virtually universal agreement that statutory

regulation of this sector is the best way forward to protect the interests of

both patients and practitioners.

·

The House of Lords Select Committee for Science & Technology Report

on Complementary and Alternative Medicine (2000) found there was

an evidence base to herbal medicine and acupuncture, and strongly

recommended that the safety of the public would be best protected by

statutory regulation of these modalities. It said:

“Our main criterion for determining the need for statutory regulation is

whether the therapy poses significant risk to the public from its

practice. We believe that both acupuncture and herbal medicine do

carry inherent risk, beyond the extrinsic risk that all CAMs pose, which

is the risk of omission of conventional medical treatment.”

(par 5.54)

·

Three separate Department of Health Steering Groups have come to

the same conclusion, most recently the

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

(2008), chaired by Professor Michael Pittilo, Vice-Chancellor of Robert

Gordon University. It concluded that:

“. . . there is an urgent need to proceed without delay to statutory

regulation of practitioners of acupuncture, herbal medicine, traditional

Chinese medicine and other traditional medicine systems.”

(Page 20,

Section 26)

·

There was overwhelming agreement to statutory regulation in

response to the first Department of Health public consultation on this

issue (2004/05). The Government announced its support and published

a timetable for implementation. This proposed the publication in

Autumn/Winter 2005 of a Draft Order under Section 60 of the Health

Act 1999. In the event, this did not take place.

·

However in 2006, the Department again announced its commitment to

regulation:

“The Government is committed to the statutory regulation of herbal

medicine, acupuncture and traditional Chinese medicine practitioners.

We are in the process of setting up a Joint Working Group. We hope to

have the Working Group set up and the first meeting arranged around

June 2006 and to move gradually towards statutory regulation,

probably in 2008/9.”

·

Following the publication of the Pittilo Report (2008) the Health

Professions Council made a recommendation to the Secretary of State

for Health advocating the regulation of acupuncturists, medical

herbalists and Traditional Chinese Medicine practitioners. The HPC

stated it would welcome the opportunity to regulate these

practitioners. In a position statement published August 2009, it said:

“As a multi-professional regulator, the HPC is confident that it is well

placed to regulate these professions and has the necessary experience

of successfully taking on new professions and integrating them into the

Register. The HPC was set up in order to protect the public and we

strongly believe that statutory regulation can more effectively assure

that practitioners are meeting standards and are fit to practise.”

·

In addition, the World Health Organisation (WHO) published a

statement on Traditional Medicine December 2008. This said:

WHO and its Member States cooperate to promote the use of

traditional medicine for health care. The collaboration aims to:

o

support and integrate traditional medicine into national

health systems in combination with national policy and

regulation for products, practices and providers to ensure

safety and quality;

o

ensure the use of safe, effective and quality products and

practices, based on available evidence;

o

acknowledge traditional medicine as part of primary health

care, to increase access to care and preserve knowledge and

resources; and

o

ensure patient safety by upgrading the skills and knowledge

of traditional medicine providers.

Impact of European law on herbal medicine

The EU Traditional Herbal Medicinal Products Directive (THMPD) will be

fully implemented from 1

st April 2011, when it will replace Section 12(2)

of the Medicines Act 1968. From this date, the sale or supply of

“industrially produced” herbal products for prescription to individual

patients will be restricted to “authorised healthcare professionals”, that is,

practitioners who are statutorily registered.

This will have a considerable impact in two respects on both Western and

traditional herbal medicine in the UK. It will limit over-the-counter sales of

herbal products to those with a “traditional herbal registration”, available

only for medicines intended to treat “mild and self-limiting illness”. Many

remedies currently available direct to the public will be withdrawn. At the

same time, only statutorily regulated practitioners will be able to order

finished medicinal products for their individual patients. They will be

permitted to do so under Article 5.1 of the main EU medicines Directive

(2001/83/EC).

Because of this, if herbal medicine practitioners are

not statutorily

regulated, they will lose access to medicines from all third-party

manufacturers for prescription to individual patients.

This includes all finished products such as medicinal herbal pills, tablets,

capsules, dried herb mixtures and medicinal herbal ointments made up for

individual patients by third-party suppliers. Also under threat are thirdparty

herbal prescription services that supply individualised herbal

prescriptions (including tinctures and dried herbs) to named patients at

the practitioner’s request. Over the past 40 years this mode of supply has

become an essential part of herbal practice in the UK and many

practitioners are totally reliant on such services.

Over-the-counter herbal remedies registered under the THMPD will not be

suitable for the needs of most patients consulting herbal/traditional

medicine practitioners. All that will remain is the right of herbal

practitioners, via Section 12(1) of the Medicines Act of 1968, to compound

and supply herbal medicines for their patients from their own premises. It

is unclear that this will be sustainable in the long term.

The Medicines and Healthcare products Regulatory Agency (MHRA) has

proposed that third-party medicines supplied on request of statutorily

regulated practitioners for individual patients can continue under MHRA

licence via Article 5.1 of the European Medicines Directive 2001/83/EC.

The key point is that this facility would be available only to statutorily

regulated health professionals, but

not to those who are statutorily

licensed or voluntarily regulated.

If statutory regulation is not approved, there will be a particularly

devastating effect on Ayurveda and Traditional Chinese Medicine, used by

many in the South Asian and Chinese communities respectively, as well as

by the wider population. Both these systems rely to a considerable extent

on third party provision of herbal medicinal products and supplies.

The numbers affected if statutory regulation is not approved should not be

under-estimated. Research by Ipsos Mori for the MHRA, published January

2009, found that some 12.5 million adults in Great Britain had used herbal

medicines 2006 – 2008, and more than 6 million had used herbal products

obtained from a practitioner.

Risks to patients and the public

There is a significant risk to the public from treatment by unregulated

herbalists and acupuncturists:

·

Anyone, including those without knowledge or training, can describe

themselves as a herbalist or acupuncturist and then offer diagnosis

and treatment to the public. Whilst there is some control over

acupuncture through current local authority licensing, this is primarily

concerned with premises and the safe storage and disposal of needles.

It takes no account of the practitioner’s qualifications or expertise.

·

Many members of the public are unaware that no regulatory system

protects them from incompetent and dishonest practitioners; they take

it for granted that those offering acupuncture or herbal medicine must

necessarily be trained and qualified, and their practice regulated in the

same way as conventional practitioners such as physiotherapists or art

therapists. The public is understandably vulnerable to exaggerated or

false claims of the expertise of the individual practitioner and of the

efficacy of specific treatments.

·

Reputable, trained and qualified practitioners have no effective means

of differentiating themselves from the poorly trained or the

disreputable.

·

Untrained or inadequately trained practitioners may be unaware of the

limitations of their competence, leading to patients delaying necessary

– sometimes urgent – medical treatment.

·

There is evidence that many patients who use CAM therapies such as

herbal medicine and acupuncture alongside conventional treatment do

not tell their doctors they are doing so because they anticipate a

negative reaction. There is a significant risk of interactions with

adverse consequences.

·

The MHRA has logged a significant number of instances of Chinese or

Ayurvedic herbal products on the UK market of poor quality, containing

substituted ingredients or contaminated with heavy metals or

conventional medicines.

Because of the restrictions in access to herbal medicines that will come

about with the implementation of the Traditional and Herbal Medicinal

Products Directive, there is an additional danger of increasing public use

of unregulated internet sites that sell poor quality or contaminated herbal

products. Many patients who use herbal medicines have long term

conditions and are convinced of the benefits of the remedies they use in

relieving symptoms. If these are no longer available, it would not be

surprising if these patients risk purchasing from unreliable suppliers.

There have already been reported instances of inferior or adulterated

products sold from internet sites, some presenting a considerable health

risk to users. Without statutory regulation, this risk to public safety can

only increase.

While it is imperative that these risks are addressed, there are also

benefits to patients and to the NHS from improving public access to herbal

medicine and acupuncture. There is evidence of their effectiveness for

certain conditions, while patient satisfaction levels are reported to be high.

The Foundation suggests that they may be particularly useful in treating

long term conditions – and may contribute to a reduction in costs to the

public purse. Several observational trials provide evidence of reduced

prescriptions, reduced number of GP consultations and earlier return to

work. These results need to be confirmed by further controlled trials on

the model proposed by the recent King’s Fund report:

Assessing

Complementary Practice

. Long term conditions now account for some

78% of NHS spend on patient treatment. In the present economic climate,

increased NHS use of herbal medicine and acupuncture may offer real

financial benefits.

Benefits of statutory regulation

The alternatives to statutory regulation put forward by the Department of

Health consultation report are not capable of providing the same benefits

to the public and patients as statutory regulation of practitioners of

acupuncture, herbal medicine and Traditional Chinese Medicine. In

particular, statutory regulation is the only system that can:

·

Provide and enforce UK wide standards of practice.

·

Provide the public with full reassurance that any practitioner who is

described as a herbalist, traditional medicine practitioner or

acupuncturist is properly trained, accredited and regulated, and can be

relied on to provide acceptable standards of diagnosis and treatment.

·

Ensure the quality of professional training and education, including

continuous professional development.

·

Assess and, if necessary, remove unfit or failing practitioners from a

national register.

·

Maintain consumer choice in the range of herbal treatments available.

·

Permit practitioners of herbal medicine to access manufactured herbal

supplies from a competent, approved third party and to have individual

prescriptions made up by specialist suppliers.

·

Ensure herbal practitioners use quality-assured materials.

·

Address the problem of poor quality herbal products, including those

marketed as Ayurvedic or traditional Chinese remedies, by limiting the

use of Section 12(1) of the Medicines Act to statutorily registered

herbal practitioners

and requiring such practitioners to obtain their

herbal supplies from manufacturers and suppliers operating under

Good Manufacturing Practice (GMP).

·

Allow referrals from GPs and other medical practitioners to support

conventional NHS treatment, for example, as envisaged by the

recently published NICE guidelines on the treatment of low back pain

which recommend that patients be offered acupuncture as well as

orthodox care.

·

Give patients the confidence to discuss their decision to use

acupuncture or herbal medicine with their medical advisers.

Neither voluntary regulation nor a licensing system is able to provide

these benefits to public safety. If one of these alternative proposals is

adopted, then public access to herbal medicine, Ayurveda, Traditional

Chinese Medicine and acupuncture will be significantly curtailed.

http://ehtpa.eu/pdf/home/09.13LFIH_Regulation_Position_Statement_Oct_2009.pdf