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

A Demonstration to Save Herbal Medicine

A Demonstration to Save Herbal Medicine

In support of

For statutory regulation of the profession

November 2

nd 12 - 4pm

Meet on the Paved Area (not the grass) of Old Palace Yard (right opposite the long side of Parliament).

Nearest tube is Westminster (District and Circle Line). Nearest Mainline station is Charing Cross (Northern and Bakerloo Lines) and Waterloo Station just over Westminster Bridge (connects to the Docklands Light Railway (DLR) and the Northern and Bakerloo Lines. Victoria Station is a 20min walk away straight along Victoria Street.

Placards are not permitted on buses and tubes. If coming from the north arrive at Euston or Kings Cross and go by Victoria Line tube to Victoria and walk to Parliament .

From the west coming in at Paddington go by Circle Line travelling anti-clockwise to Westminster.

Numbers are required by the Police
so please ‘RSVP’ to hayley@foremanandjones.co.uk / 01303 760001 / 07989 541847 or Afifah on 01243 868108 / 07792 614717 or Lynn at Lynn@rootsofthyme.wanadoo.co.uk

http://ehtpa.eu/pdf/home/Demonstration_to_Save_Herbal_Medicine.pdf

EHTPA interview by the American Herbal Guild

Answers to questions from the American Herbal Guild

From Michael McIntyre, Chair of the European Herbal and Traditional Practitioners Association (EHTPA) 10/01/2010

1. Can you please give us a synopsis of the way UK herbalists were regulated prior to this latest political challenge?



The basis of the legal system in the UK is common law: in contrast to most of the rest of Europe which is based on Napoleonic Code, UK common law has it that unless an action is said to be illegal, it is not against the law. This is important because it means that, providing a patient is willing, it is legal for them to be treated by someone else whether or not that person is a registered medical doctor. This remains the case today but medicines law is now determined by the European Union and this is one reason why herbalists are now seeking statutory regulation.

In April 2011, the new European Traditional Herbal Medicinal Products Directive (THMPD) becomes fully operational and this will effectively replace one of the two pieces of legislation under which herbalists practise in the UK. This is Section 12(2) of the 1968 Medicines Act which currently allows finished herbal products and prescriptions to be supplied to patients by a third-party herbal manufacturer or supplier. From April 2011 such supplies would require a traditional medicines registration under the THMPD and while this may be appropriate for over-the-counter herbal products, it certainly is not viable for small quantities of herbal products that are used for specific patients. It takes months or years to acquire a THMPD licence and costs thousands of dollars so this route is closed to practitioners using herbal medicines tailored to treat individual patients. Thus full implementation of the new THMPD will see the end of the right of practitioners to access finished medicines from manufacturers and herbal suppliers 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 third-party herbal prescription services that supply individualised herbal prescriptions (including those comprising 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. All that will remain will be herbal medicines prepared by practitioners from their own premises under another still existing statute – Section 12(1) of the 1968 Medicines Act.

Section 12(1) allows a practitioner (the word herbalist does not appear in the legislation) to prescribe a herbal medicine to a patient provided the practitioner has seen the patient in person and supplies the medicine from premises capable of being locked from the public (i.e. not a market stall) of which he or she is the occupier. This essential part of the 1968 Medicines Act is still viable in 2010 and beyond because, the products supplied are made up on the practitioners own premises and are not "industrially produced". The phrase "industrially produced" is used in the main EU Medicines Directive (2001/83/EC) to define medicines that must have a full market authorisation (i.e. licence). Because the prescriptions herbalists make on their own premises are not industrially produced, they do not need a medicines licence.

Nevertheless the loss of third-party supply is a huge blow to herbalists and their patients. Without statutory regulation, from this time onwards, many patients will be unable to obtain their usual medicines. The loss of this facility will put many practitioners and several of their suppliers out of business. Statutory regulation solves the problem because it enables 2

herbalists to be recognised as "authorised health professionals" under the main EU Medicines Directive and as authorised health professionals, herbalists will be able to commission herbal products and finished prescriptions from third-party suppliers.

2. Were consumers pretty satisfied with the care they received from herbalists?

Herbal medicine is extraordinarily popular. Recent research by Ipsos MORI for the Medicines and Healthcare products Regulatory Agency (MHRA) has found that millions of people in the UK use herbal medicines and that more than a quarter of the population had bought herbal medicines over-the-counter in the previous two years with one in twelve consulting a practitioner of Western herbal medicine and about one in twenty consulting a practitioner of traditional Chinese Medicine. It also noted that 77% of adults agree it is important that herbal medicines are regulated, with this figure rising to 87% among regular users of herbal medicines (defined as those who have used a herbal medicine within the last 2 years).1

1 MHRA website - Ipsos Mori report http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON036071, Jan 2009.

3. Have there been a lot of complaints about untrained herbalists treating or hurting people



There is ongoing concern about the safety, in particular, of traditional Chinese and Ayuvedic medicines some of which have been found to be misidentified or adulterated with western medicines or heavy metals - see Medicines and Healthcare products Regulatory Agency’s website at (www.mhra.gov.uk). It is also the case that under current regulation (common law), anyone can call themselves a herbalist and set up in practice. In these circumstances it is difficult for the public to distinguish between the good, the bad and the ugly.

If statutory regulation does not go ahead the danger is not from the well trained and competent herbalist. It is from the unregulated internet sites and bogus practitioners who sell dangerous, toxic products to an unsuspecting public. Statutory regulation will enable the public to recognise properly trained and qualified herbalists.

4. Can you explain what statutory registration is?



Statutory regulation is when the state licenses practitioners to practise on the basis that they have the required training and do not have disbarring criminal convictions (e.g. being on the sex-offenders register). In addition, practitioners have to show, by completing required annual continuous professional development programmes, that they are up to speed with their ongoing training. The register of practitioners is held by an independent regulator to whom patients can complain if a patient thinks that he/she has been badly treated. In the case of herbalists, the likely regulator will be The Health Professions Council (HPC) that already regulates a number of health professions such as physiotherapists and occupational therapists. The HPC, in conjunction with the professional herbal associations, sets standards of training, accreditation of training institutions and practice. The HPC would be responsible for any disciplinary proceedings and in the last recourse has the power to strike someone from the register which would mean that person could not call themselves a herbalist (or whatever the regulated and protected title is determined to be –this has not been decided yet). 5. What was the impetus behind the push for statutory registration?

The two main motives, public protection and secondly continued access to a full range of herbal medicines, is explained in the first three answers above. 3

6. Who is supporting statutory registration?



Statutory regulation is supported by far the majority of UK herbalists and the main professional associations as well as the Health Professions Council and the Prince of Wales Foundation for Integrated Health.

The Department of Health Recently consulted on the proposed statutory regulation (closing date Nov 16 09) of herbal/traditional medicine, TCM and acupuncture practitioners.

This matter has been under consideration for a decade since the call in 2000 from the House of Lords’ Select Committee on Science and Technology for the statutory regulation of practitioners of herbal medicine and acupuncture. The Government itself backed statutory regulation of this sector in 2001 and more recently key regulatory bodies, the Health Professions Council (HPC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have both concluded that, like the osteopaths and chiropractors, acupuncture and herbal medicine practitioners should be subject to statutory regulation. As recently as 2006 the DH website recorded that "The Government is committed to the statutory regulation of herbal medicine, acupuncture and traditional Chinese medicine practitioners."2

2 DH Workforce Update
file:///c:/Users/Mic/Documents/EHPA/Workforce%20update%20%20The%20Department%20of%20Health%20-%20P&G%20Human%20resources%20and%20training.htm

Over the past eight years the DH has initiated three working groups to look at implementing this policy. All three working parties strongly supported the aim of statutory regulation of this sector. In 2005, the DH ran a public consultation on the statutory regulation of herbal medicine and acupuncture. This registered a 98% response in favour of statutory regulation. As a consequence the DH published a timetable for the statutory regulation of this sector with a section 60 order (the legal process to bring this about) to be published later that year. This timetable has not been adhered to. The Government says it will make a decision on this matter but continues to dilly-dally. 7. Who is opposing statutory registration?

There is a group of scientists and doctors called Sense about Science who are fiercely contesting herbal statutory regulation. Two prominent members are the Professor of Complementary Medicine at Exeter University, Edzard Ernst and a retired Professor of Pharmacology, David Colquhoun. Ernst says that while herbs sometimes are effective, there is no evidence that herbalists, who mix together a number of herbs for individual patients, are effective. Colquhoun says "you can’t regulate nonsense". But these are "armchair physicians"; neither of these two men actually sees patients!

On January 7th the Chair of Sense about Science, Lord Taverne, aiming to ridicule the conferring of statutory regulation on herbalists, put down an oral question in the House of Lords asking "To ask Her Majesty's Government whether, following their proposals to regulate practitioners of alternative medicine, they plan to regulate astrologers." His rather puerile attempt at irony made no impact and the health Minister, Baroness Thornton, rather gracefully put Taverne in his place. Before asking the question Taverne gave an interview to the political website ePolitix that gives a flavour of the kind of attack to which herbalists are being subjected. Taverne’s assault was responded to by Michael McIntyre. His interview and McIntyre’s response follow. 4

Lord Taverene:

"My parliamentary question about regulating astrologers is inspired by the government's proposed statutory regulation of alternative medicine. The government proposes to regulate practitioners of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems. This is clearly a response to intense lobbying by Prince Charles' Foundation for Integrated Medicine. The proposal is strongly opposed by Sense About Science (of which I am chairman), the Medical Research Council, the Academy of Medical Royal Colleges, the Institute of Biomedical science, the Medical Schools Council, the Physiological Society and the Royal College of Pathologists.

It would give practitioners of alternative medicine a spurious respectability, as being sanctioned by official regulation, which implies that their practices are evidence-based when there is little if any scientific evidence in their support. They offer accounts of basic physiology and pharmacology that are highly implausible. In fact, they have about as much scientific basis as astrology. So why not add parapsychologists or astrologers to the list?

In defence of alternative medicine systems, it is argued that they are popular. But astrology is even more popular. In fact, pseudo-science generally is fashionable. Several universities actually give 'science' degrees in homeopathy, ayurveda and reflexology and other forms of alternative medicine.

It is also argued that many of the practices must be effective because they have been around for centuries. So has witchcraft, or the belief that prayer can cure disease. But medicine is not like a piece of antique furniture, which becomes more valuable with age.

If the government is worried about patient safety it should require practitioners of alternative medicine to undergo conventional medical training. It should take a firm stand in favour of science-based policy, not appear to legitimise quackery.

Michael McIntyre responding:

As chairman of 'Sense about Science', the least we should expect from Lord Taverne is to write accurately and impartially. But his piece on the regulation of practitioners of acupuncture and herbal medicine is ill-informed, highly opinionated and surprisingly inaccurate. Worst of all, by arguing against regulation, Taverne actually puts the public at serious risk, since regulation will ensure the proper training of these practitioners and the quality and safety of herbal products they use. It is clearly in the public interest for statutory regulation to go ahead.

Taverne says that the government's move to statutorily regulate herbal medicine and acupuncture is a response to lobbying from Prince Charles' Foundation for Integrated Medicine (sic), but this is not true. As a Member of the House of Lords, Taverne should know that the impetus for statutory regulation actually came from the House of Lords' select committee on science and technology (on which sat several eminent scientists and doctors), which recommended in 2000 that acupuncture and herbal medicine should be statutorily regulated as soon as possible. In the light of this recommendation, the government agreed in 2001 that statutory regulation should go ahead.

Over the past eight years the Department of Health has initiated three working groups to look at implementing this policy. All three working parties strongly supported the aim of statutory regulation of this sector. In 2005, the DoH ran a public consultation on it. This registered a 98 per cent response in favour of statutory regulation. Given the thoroughness with which the DoH has examined this issue over the years, it is questionable whether the recent second public consultation was a good use of public money.

Taverne also says: "If the government is worried about patient safety it should require practitioners of alternative medicine to undergo conventional medical training", but here too he displays ignorance. The agreed training in herbal medicine in the UK requires practitioners to be well versed in a wide range of conventional medical instruction including differential diagnosis and pharmacology. Taverne opines that official regulation would give practitioners "a spurious respectability, as being sanctioned by official regulation, which implies that 5

their practices are evidence-based, when there is little if any scientific evidence in their support". Here Taverne clearly misunderstands the role of regulation. Regulation is not a badge of rank but is all about public protection.

Herbal medicine is enormously popular. Recent research by Ipsos MORI for the Medicines and Healthcare products Regulatory Agency (MHRA) has found that millions of people in the UK use herbal medicines, and that more than a quarter of the population had bought herbal medicines over the counter in the previous two years, with 1 in 12 consulting a practitioner of Western herbal medicine, and about 1 in 20 consulting a practitioner of traditional Chinese medicine. It also noted that 77 per cent of adults agree it is important that herbal medicines are regulated, with this figure rising to 87 per cent among regular users of herbal medicines (defined as those who have used a herbal medicine within the last two years). Is Taverne really saying that the public is foolish in its use of herbal medicine and in its clearly expressed wish to have its practitioners properly regulated?

As to evidence; those in glass houses should not throw stones. Taverne clearly assumes that mainstream medical practice is mostly based on evidence-based medicine. Recent findings published in the BMJ's online Journal Clinical Evidence shows that far from having a complete evidence base, only about 13 per cent of 2,500 medical treatments surveyed are rated as beneficial, with 46 per cent "of unknown effectiveness". But there is plenty of evidence on the efficacy of herbal medicine; there are scores of scientific papers on the efficacy of commonly used herbal medicines such as ginger, garlic, hawthorn etc. Indeed, who could doubt the medical efficacy of botanic medicines, since many modern drugs are derived from plant medicines?

Interestingly, it is not just plant medicines themselves that modern medicine has exploited: more recently, it has come to adopt a strategy central to traditional herbal treatment which harnesses the healing potential of several medicaments together for their synergistic effect, rather than using one herb at a time. These days it is common for doctors to prescribe a number of drugs together, as seen in the treatment of a wide range of serious diseases like HIV, Aids, TB, malaria, diabetes, hypertension, cancer, MRSA etc.

Pharmacologists now acknowledge that the individual actions of one drug are subject to modification by a second drug and that multi-drug regimens ('combination therapy') may confer unique and beneficial new actions that do not occur when using each drug on its own. Moreover, it has become evident that combination therapy can frequently attain the same therapeutic effect as when using a single drug, but with fewer deleterious side effects. Last week scientists announced that they had found that a combination of pomegranate rind, vitamin C and a metal salt gave good results in combating the MRSA superbug.

Perhaps modern medicine has still much to learn from herbal medicine. The frank protectionism Taverne and his colleagues now display is yet another way that he and 'Sense about Science' ill-serve the public interest.

8. Do you feel it will be in the best interest of consumers to have statutory registration of herbalists or do you think it will impede access to herbalists?



There is no reason to believe that statutory regulation will impede access to herbalists and it is clear that without it, for reasons explained above, the public will lose access to a wide range of herbal medicines.

9. How would the different outcomes affect the common law statute of King Henry VIII?



Herbalists often cite the common law statute of Henry V111 (known as The Herbalists’ Charter). But many herbalists are not aware that from 1941 to 1968 under the 1941 UK Pharmacy Act, it was actually technically illegal for UK herbalists to treat their patients. The 1968 Medicines Act with its Section 12(1) and 12(2) mentioned above once more made it legal for herbalists to prescribe. Now we are losing Section 12(2) to European legislation, more than ever we need a sound legal basis for our practice. Statutory regulation will give us this. 6

10. Are professional herbalists united in their position on SSR? If not, why not?



Most are. A few are not. They consider that herbalists have a right to practise without any outside legal restraint and that any state interference is unwarranted. Unfortunately, with some 2000 herbal practitioners in the UK, working in an environment which is increasingly regulated, it is not realistic for herbal practice to survive in the long term without a firm legal basis. The introduction of the THMPD will see the loss of many medicines unless herbalists attain statutory regulation – something for which the National Institute of Medical Herbalists, the oldest body of herbal practitioners in the UK, has struggled for nearly a century. And what’s more the public agree with regulation. The Ipsos Mori report quoted in the answer to Question 2 found 77% of adults agree it is important that herbal medicines are regulated, with this figure rising to 87% among regular users of herbal medicines (defined as those who have used a herbal medicine within the last 2 years).

http://ehtpa.eu/pdf/home/news/Answers_to_questions_from_the_American_Herbal_Guild.pdf

Letter to practitioners to all herbal/traditional medicine practitioners

To all herbal/traditional medicine practitioners from the European Herbal and Traditional Medicine Practitioners Association

Dear colleagues,

The next few weeks could make or break our future!

Public consultation proposals

1. As you no doubt know, the Department of Health is currently consulting on the proposed statutory regulation of herbal/traditional medicine, TCM and acupuncture practitioners (closing date Nov 2
3. nd!). After almost 10 years of commitment to this step in the public interest there is now a real possibility that the Government will not proceed with statutory regulation.
4. Instead, the Government is considering imposing a lesser licensing system on practitioners which will crucially confer no special legal rights when it comes to medicines law (see below) and will relegate herbal/traditional medicine and traditional acupuncture practitioners to a second-rate category, using a similar licensing scheme to that currently employed to regulate bouncers, bodyguards and wheel clampers. Another suggested possibility is that voluntary regulation continues in one form or another.

Voluntary regulation – no security for patients or practitioners

1. Voluntary regulation will mean that herbal practitioners will continue to be legally indistinguishable from ordinary members of the public. Failing practitioners cannot be prevented from practising, as would happen with statutory regulation, and there will be no long-term security of access to potent herbal remedies such as
3. Atropa belladonna (deadly nightshade) or Ephedra sinica (ephedra herb) granted for herbal use under legislation passed in the early 1970s.
4. In the long-term, lack of legal professional identity will undoubtedly undermine herbalists’ right to prescribe herbal medicines under Section 12(1) of the Medicines Act of 1968. Indeed, for the first time the current Government Consultation Document actually contemplates the repeal of this vital piece of legislation that enables herbal practitioners to prescribe herbal medicines for their patients.
6. It is clear that access to a full range of herbal medicines can only be preserved if herbal practitioners are statutorily regulated.

Voluntary regulation/licensing - no UK professional standards & no referrals

1. Maintaining the
3. status quo or imposing a lesser licensing scheme will mean that statutorily regulated health professionals (e.g. doctors) will not be allowed to make referrals to herbal/traditional medicine practitioners and acupuncturists. It will also fail to deliver the essential benefits of professional statutory regulation such as independent accreditation of training programmes, mandatory continuous profession development and the development of best practice towards which for the last decade the profession has been working in anticipation of statutory regulation.

Threat to full range of herbal medicines

1. If statutory regulation fails to go ahead there will be a loss a wide range of herbal medicines currently supplied by manufacturers and suppliers to practitioners. Full implementation of the new European Traditional Herbal Medicine Directive in 2011 will see the end of Section 12(2) of the Medicines

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Act of 1968 and with it the right of practitioners to access finished medicines from manufacturers and herbal suppliers 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 third-party herbal prescription services that supply individualised herbal prescriptions (including tinctures and dried herbs) to named patients at the practitioner’s request. Although we would still be able to use simple tinctures, extracts and dried herbs as ‘starting materials’ for our individualized prescriptions, over the past 40 years this third-party mode of supply has become an essential part of herbal practice in the UK and many practitioners are totally reliant on such services. All that will remain will be the herbal medicines we make up and dispense from our own premises.

Maintenance of herbal supply via statutory regulation

1. To solve this problem, the UK medicines regulator, The Medicines and Healthcare products Regulatory Agency (MHRA) has proposed that third-party medicines supplied on request of practitioners for individual patients can continue under MHRA licence via Section 5.1 of the main European Medicines Act 2001/83/EC.
3. 1 The key point, however, is that this facility is only available to statutory regulated health professionals.
4. In short, if herbal practitioners were to secure ‘authorized health care professional’ status through statutory regulation, they could legally commission herbal medicines from manufacturers for supply to their patients. These would have to be made to assured medicinal quality. The statutorily registered herbal practitioner would ensure high standards in the supply of the many useful traditional medicines for the benefit of patients.

Failure to statutory regulate will disrupt herbal supply

1. Because this ability to order medicinal products from suppliers for individual patients is only available to statutory regulated health professionals, if statutory regulation of herbal/traditional medicine does not take place many patients will find that they will not be able to obtain their medicines.
2. If you use Chinese or Indian herbal medicines as finished products these will also disappear.
3. The loss of this facility will unfortunately put many practitioners and several of their suppliers out of business. This will further damage the UK economy and swell unemployment during the current economic downturn.

Three things you can do before November 2

nd (when the consultation closes)

1. Please respond to the Consultation Document yourself. Our critics are doing this against us – we must make sure we counterbalance their efforts. Please read the
3. Response to DOH Joint Consultation on the Report to Ministers from the DH Steering Group on the Statutory Regulation of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK written on behalf of the EHPTA to guide you. You can access this on the EHTPA website see http://www.ehpa.eu/. Also available at the same site is an EHTPA briefing paper, Severe Threat to Herbal Choices, which summarises the main points of the EHTPA esponse. The Consultation Document is very complex but do

2 1 1 This proposal can be read in detail on the MHRA website at http://www.mhra.gov.uk/home/groups/es‐herbal/documents/websiteresources/con2024908.pdf 29/09/2009 3

not be daunted. An incomplete response will also send your message just as well – maybe even better!

Points to make

1. The Consultation Document asks you to choose between several regulatory options. Please make the point that
3. only statutory regulation will allow the herbal practitioner to commission herbal medicines under the terms of Section 5.1 of Directive 2001/83/EC. Only this ‘authorized health care professional’ status that comes with statutory regulation will give the practitioner the legal right to do so.
4. Statutory Regulation gives herbal/traditional medicine practitioners a legal position that will enable them to defend threatened herbal medicines which is difficult to do if we are legally indistinguishable from ordinary members of the public.
5. It also will prevent failing practitioners from practising and enable high standards of training and CPD to be rolled out across the whole of our sector.
6. It will also enable other statutorily regulated healthcare professionals to refer patients to us.

The fight for legal recognition

1. Although some are philosophically opposed to any form of regulation, it is unrealistic to imagine that we can continue to have rights to prescribe herbal medicines without satisfactory legal status. Throughout the latter part of the nineteenth century and the twentieth century, UK herbalists fought an ongoing battle to gain a secure legal basis for their right to practise and access their medicines. We must not lose the opportunity to achieve this now!
2. Write to your MP to ask him/her to take up your concern with the responsible Minister Ann Keen MP, Parliamentary Under Secretary of State for Health.
3. Emphasise the risk of loss of consumer choice, increased risk to the public of poor quality products and the negative regulatory impact on your business and any threat to jobs you can see in your constituency.
4. Ask your MP if he/she is aware that the Department of Health has issued a Consultation Document and ask him/her to write the Health Minister to seek reassurance that the statutory route is not being abandoned.
5. Most importantly ask your patients to respond to the Consultation Document (http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_103567)
7. by closing date Nov 2nd and to write to their MPs. We must flood the system!
8. Please give your patients a copy of the
10. Briefing Paper from the EHTPA (see http://www.ehpa.eu/) together with the accompanying sheet "Dear Herbal Supporter" that outlines a number of points your patients can make.
11. Please explain that many questions in the Consultation Document are difficult to answer but it is more than sufficient that they make the main points in their response. This can be done via the DH ‘automated response system’ at: http://www.info.doh.gov.uk/questionnaire/ahmtcm_consultion.nsf/questionnaire?openform . They may also respond directly by email at hrdlistening@dh.gsi.gov.uk or alternatively by post to the AHMTCM Consultation Team, Department of Health, Room 2N09, Quarry House, Quarry Hill, Leeds LS2 7UE. Their response may be made public but if they prefer it to remain private they can make this clear in their reply.

Please get to work on this without delay. We can achieve our goal by working together! 29/09/2009

http://ehtpa.eu/pdf/home/EHTPA_Letter_to_practitioners.pdf