Michael McIntyre - EHTPA

ePolitix.com speaks to Michael McIntyre of the European Herbal & Traditional Medicine Practitioners Association (EHTPA) about the organisation and herbal medicine practitioners.

Question: Can you tell me about the work and membership of EHTPA, and how other associations fit into the organisation?

History
The EHTPA was founded in 1993 when it became clear that with the development of the European Union, the legislative framework under which herbal medicine was practised in the UK and Europe was likely to undergo radical change. The main professional herbal practitioner associations in the UK affiliated with Irish and Danish herbal associations to form the European Herbal & Traditional Medicine Practitioners Association (EHTPA).

In late 1994, the basis of herbal practice in the UK was threatened by the sudden announcement by the Medicines Control Agency (now the Medicines and Healthcare products Regulatory Agency - MHRA) that existing European medicines legislation had swept away all those statutes in the Medicines Act 1968 that gave British herbal practitioners their legal right to obtain herbal medicines. The EHTPA found itself thrown headlong into the campaign to rescue the right of UK practitioners to obtain herbal medicines without the need for full medicines licences. This highly successful campaign did much to create firm bonds between its member organisations.

In 1990, the EHTPA worked with Irish colleagues to help get the ban on the use of St John's wort and other herbs overturned so that practitioners could continue using their use.

Composition
The EHTPA comprises some eight professional herbal/traditional medicine associations with a membership of around 1500 professional practitioners working across the UK. Member associations represent practitioners in western herbal medicine (phytotherapy), Chinese herbal medicine, Ayurveda, Unani Tibb and traditional Tibetan medicine. The EHTPA works closely with other national herbal organisations throughout the EU and has engaged with the World Health Organisation (WHO) in setting standards for herbal medicine on a worldwide basis.

EHTPA Work
Today our work focuses on the development of standards of training and education, accreditation of training institutions, strengthening the identity of the profession and working closely with key stakeholders on specific projects. For example, we are a key stakeholder, working closely with the Department of Health, in developing the path towards statutory regulation of herbal practitioners in the UK. We work with the MHRA on reviewing the standards of safety and quality of unlicensed herbal remedies and with the rest of the herbal sector on implementing the Traditional Herbal Medicinal Products Directive (THMPD).

The EHTPA has been active in negotiations with the EU Commission regarding the implementation of the Directive on Traditional Herbal Medicinal Products and with the Herbal Medicinal Products Committee within the European Medicines Agency. The EHTPA also gave evidence to the House of Lords Select Committee on Science and Technology that published a report in 2000 calling for the immediate statutory regulation of herbalists in the UK. The EHTPA was a stakeholder and played a lead role in the production of 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 in May 2008.

The EHTPA has played a lead role in agreeing professional standards of training and conduct adopted by professional herbal/ traditional medicine associations in the UK. This has lead to the agreement of a Common Core Curriculum and the running of the EHTPA Accreditation Board which operates under an independent chair. The EHTPA works within the Herbal Forum – a UK based organisation that is negotiating with the MHRA on the full implementation of the THMPD.

The EHTPA is dedicated to promoting access to best herbal practice and the benefit of herbal medicine as well as ensuring the continuing availability of medicinal herbs in the UK and Europe.

Question: How popular is herbal medicine in the UK?

• Survey data demonstrates high demand for complementary and alternative medicine. 10.6 per cent of the adult population of England had visited at least one therapist providing any one of the six more established therapies (acupuncture, chiropractic, homoeopathy, hypnotherapy, medical herbalism, osteopathy) during 1998 with an estimated 22 million visits. (Thomas K S, Nicoll J P, Coleman P C 2001. Use and expenditure on complementary medicine in England: a population based survey. Complementary Therapies in Medicine 9:2-11)

• The only UK estimate of consultation with herbal practitioners is from a 2004 study which estimated that of a random stratified sample of 1794 adults, 0.8 per cent of the sample had consulted a herbal practitioner. (Thomas K, Coleman P. Use of complementary or alternative medicine in a general population in Great Britain. Results from the National Omnibus survey. J Public Health (Oxf) 2004; 26: 152–157).

• Members of the public want their medicines to be prescribed by well-trained practitioners: "Although one in five people enjoy the convenience offered by complementary medicines because they 'are easy to buy because no prescription is required', moving to a prescription-based sales system could actually help promote sales. This would mean that people wouldn't need to know much about them if a trusted practitioner prescribes them. People may be more likely to buy products prescribed by a doctor than those that are just recommended." (Source MinteI Complementary Medicines, Market Intelligence, April 2007)

Question: You are currently pushing for statutory regulation, how effective is EHTPA's self regulation process? What difference will statutory regulation make for EHTPA, and the profession as a whole?

The EHTPA, in partnership with its professional Association member organisations, has developed a robust voluntary regulatory system but this, unfortunately is not enough to provide public protection from failing or fraudulent practitioners. Nor, as explained in the last paragraph of this section, will it allow well trained practitioners to continue to access a full range of herbal medicines when new legislation comes into force in 2011. As will be explained, current arrangements can only continue if practitioners become statutorily regulated.

Under the existing medicine's legislation which dates back to 1968, anyone can set up in practice as herbalist without any training and use some potentially potent herbal medicines. The need to move to statutory rather than voluntary regulation of the herbal sector has been clearly recognised by a House of Lords' Select Committee, by Government Ministers and by two advisory committees set up by the Department of Health in 2003 and again in 2006. Unfortunately as described below, progress to statutory regulation is taking an unacceptable length of time.

In 2000 House of Lords' Select Committee on Science and Technology's report on complementary and alternative medicine called for the immediate statutory regulation of herbal practitioners and acupuncturists because of risks to the public from unqualified or irresponsible practitioners. In 2001, the UK Government agreed that professions using either acupuncture or herbal medicine (thereby also including Chinese herbal medicine, TCM, Ayurveda and other traditional medicine systems) should, in the interests of public safety, be statutorily regulated and that "it would be desirable to bring both acupuncture and herbal medicine within a statutory framework as soon as practicable". (Department of Health 2001. Government response to the House of Lords' Select Committee on Science and Technology's report on complementary and alternative medicine. Stationery Office, London p.7)

In 2001 the Department of Health, in partnership with the Prince of Wales's Foundation for Integrated Health, established two Working Groups for the regulation of acupuncture and herbal medicine. The Acupuncture and the Herbal Medicine Regulatory Working Groups both reported in 2003 and, in March 2004, the Department of Health consulted on a set of proposals for the statutory regulation of herbal medicine and acupuncture. In February 2005, the Department of Health reported on the consultation indicating that it expected to publish a draft Section 60 Order for consultation later that year.

The delay in establishing the current Steering Group was partly due to the need to await the outcome of two reviews of professional regulation which were not published until July 2006 following which there was a further period of consultation. The first of these reviews, Good Doctors, Safer Patients, was undertaken by the Chief Medical Officer for England and the second, The Regulation of the Non-Medical Healthcare Professions, was led by the then Director of Workforce for the Department of Health in England. Following the consultation, a White Paper, Trust, Assurance and Safety - the Regulation of Health Professionals in the 21st Century, was published in February 2007.

This White Paper had significant impact with regard to the future statutory regulatory arrangements for practitioners of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems practised in the UK. In particular, the White Paper ruled out the possibility of the formation of new statutory councils to regulate professions aspiring to statutory regulation. It recommended instead that statutory regulation of emerging professions should take place through existing regulatory bodies – the preferred body being the Health Professions Council.

In 2006 Jane Kennedy, then Minister of State in the department of Health launched another Steering Group to review statutory regulation of this sector in the light of the White Paper. This committee published its Report to Ministers from the Department of Health Steering Group on the Statutory Regulation of Practitioners of Chinese Medicine and Other Traditional Medicine Systems Practised in the UK in May 2008. The report stated that there is an urgent need to proceed without delay with the statutory regulation of practitioners of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems. It noted that the primary reasons for this recommendation are to safeguard the public by allowing removal of failing practitioners from the statutory register and to enable informed choice by those who wish to access these forms of treatment

The independent Chair of the Steering Group, Professor Michael Pittilo said:

"The current incoherent state of affairs is simply not sustainable. In the final analysis, without statutory regulation I believe that vulnerable members of the public will be at continuing risk and the efforts of responsible and well-trained practitioners to follow high standards will be undermined."

Question: What progress has been made on this?

As explained above, progress towards statutory regulation has been unacceptably slow. When the Report to Ministers from the Department of Health Steering Group on the Statutory Regulation of Practitioners of Chinese Medicine and Other Traditional Medicine Systems Practised in the UK was published in May 2008, Mr Ben Bradshaw, Minister of State for Health Services at the Department of Health determined that there should be a further public consultation on the recommendations of the Steering Group. As already mentioned, there has been a previous consultation on the statutory regulation of herbalists and acupuncturists. In March 2004, the Department of Health consulted on a set of proposals for the statutory regulation of herbal medicine and acupuncture. In February 2005, the Department of Health reported on this consultation in a document entitled "The Statutory Regulation of Herbal Medicine and Acupuncture". The DH website records that over 1000 copies of the consultation were distributed to interested individuals and organisations and a total 698 responses were received to the consultation, the majority of the responses indicating strong support for the introduction of statutory regulation in order to ensure patient and public safety. The Report noted that 98.5 per cent of respondents expressed support for a UK-wide system of regulation of this sector and concluded with an update on the timetable for this process, affirming that it expected to publish a draft Section 60 Order for consultation later that year. Unfortunately, this timetable proved to be wildly optimistic.

Thus, as 2009 arrives, we are still waiting for publication of the Department of Health's Consultation Document on the statutory regulation of this Sector which is also being reviewed by the Extending Professional Regulation Working Party under the auspices of the DH. In the meantime, the clock is ticking as in 2011 the DTHMP becomes fully implemented and this will mean that any herbal products that are manufactured by a third party for herbal/ traditional medicine practitioners to prescribe to individual patients will no longer be available. This is because, from this time on only those who are "authorised health professionals" under article 5 of the main European medicines Directive (Dir. 2001/ 83/EC), can make use of this manufacturing facility and such "authorised health professional" status is only granted to those who are statutorily regulated. If statutory regulation of herbal/traditional medicine practitioners does not happen by 2011, there will consequently be a significant loss of choice of remedies available to members of the public wishing to have herbal treatment.

Question: You have met with many influential figures, including the Prince of Wales, how supportive have these parties been in helping you achieve your goals?

The Prince of Wales has personally been most supportive and he has taken a particular interest in the process of statutory regulation of practitioners of herbal/traditional medicine, acupuncture and traditional Chinese medicine. Indeed, the Prince's Foundation for Integrated Health has led the way as a stakeholder of the first two steering groups and an active participant in the most recent Steering Group.

If we have had a problem, it has been with a constant coming and going of Ministers in charge of this project. This is compounded by the fact that there are at any time two ministers directly involved in the question of our statutory regulation – one at the Department of Health and the other responsible for the MHRA. The MHRA is actively involved in the process of our statutory regulation as this will require some changes to existing medicines law.

Question: Given the number of patients using herbal medicine and visiting practitioners in the UK, why do you think it has taken this long to get to this position?

See what has already been said. It seems that Ministers only act when there is a crisis and my fear is that an unregulated sector will sooner or later provide one!

Question: What steps are EHTPA taking at EU level to promote your agenda?

As mentioned we work with the European Medicines Agency and aim to help our colleagues across Europe to achieve recognition in their individual Member States. The statutory regulation of herbal/traditional medicine practitioners in the UK is an important precedent which will help this process to be replicated across the EU.