National Institute of Medical Herbalists

The National Institute of Medical Herbalists (NIMH) Response to a joint consultation on 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

 

NIMH welcomes the opportunity to respond to this consultation.

 

NIMH is the leading professional body representing Western herbal practitioners and students of herbal medicine. We maintain a register of individual members and set professional education standards and run an accreditation system for training establishments. Our members follow a mandatory set of professional standards and codes of conduct, ethics and practice.  As such we are best placed to respond on behalf of professional western herbal practitioners, our patients and our affiliated universities

 

Edinburgh Napier University, Scotland
Scottish School of Herbal Medicine (Validated by University of Wales)
University of Central Lancashire
University of East London
University of Lincoln
Middlesex University
University Westminster

 

The terms herbalist, medical herbalist and practitioner are all used to describe our members in this response.

 

General Comments

 

In 2007, the value of the UK market for herbal, homeopathic and aromatherapy products was expected to increase by 5% to £226 million at RSP, continuing the growth trend of recent years. The sales of these products were expected to grow by 20% by 2012 to an estimated £271 Million based on today’s prices. This projected growth reflects the increasing availability of CAM products, the continued ageing of the UK population, and the increasing integration of CAM therapies and traditional medicine .  Herbal medicine is the third most popular complementary therapy after homeopathy and acupuncture. It is estimated that £126 million is spent on herbal medicines each year. The world market is estimated at £41 billion .  In the UK, 10% of people visit complementary therapists 2. All of this underlines the fact that public awareness of Herbal Medicine as a therapy is increasing and that more and more people are using it as part of their healthcare.

 

Question 1

What evidence is there of harm to the public currently as a result of the activities of acupuncturists, herbalists and traditional Chinese medical practitioners? What is its likelihood and severity?

 

Each year, millions of people choose herbal medicine as their preferred form of medical treatment. When they seek treatment from a properly trained practitioner, the risks of incorrect dosages, the use of inappropriate herbs, or of missing vital medical ‘red flag’ signs are very low.  These practitioners source their herbs from reputable suppliers including a number who manufacture in line with Good Manufacturing Practice as monitored by the Medicines and Healthcare Products Regulatory Agency MHRA).  The MHRA reports about 70 cases a year of potentially serious adverse reactions from herbal medicines. None of these cases have involved a properly trained medical herbalist from the NIMH Register.  Evidence of harm in relation to western medical herbalism is therefore low . 

 

There are, however, examples of unscrupulous and inappropriately trained practitioners prescribing irresponsibly . The consultation document refers to a weight loss clinic in Belgium where cases of kidney failure were reported, due to misidentification of the herbs used, by staff who were not trained herbalists, and the MHRA website shows examples of unsafe weight loss products.  A trained medical herbalist would know how to ensure accurate identification, be trained to use the herbs safely and appropriately and would address weight loss as part of wider health issues not as a problem to be dealt with in isolation. The inappropriate use of aconite as highlighted in recent media reports  is another case in point.  Trained medical herbalists are fully aware of the dangers of aconite.  Together with eleven other herbs, aconite is defined as a schedule III herb because of its low therapeutic index.  These schedule III herbs can be safely prescribed by NIMH-registered herbalists .  These Schedule III herbs have proved safe when prescribed by members of a voluntary register  but their use could be potentially lethal in untrained hands.

 

The present situation is that reputable suppliers of herbs request evidence of training from the herbal practitioners they supply.  This, however, is a voluntary system and can be circumvented by, for instance, online ordering.

 

The identified risk of potential harm has been cited in various reports since the initial House of Lords report in 2000 .  The fact that untrained individuals can practice and prescribe herbal medicines does, in our opinion, represent a potential likelihood of public harm. 

 

There are various voluntary mechanisms in place to prevent harm. For example, the members of the European Herbal and Traditional Medicine Practitioners Association (EHTPA) and its associated organisations such as the NIMH operate a yellow card system on reporting adverse  events.  Members also receive regular guidance on the latest evidence of risk or potential risk, an example of which is Hypericum perforatum (St. John’s Wort) .

 

The potential risk to the public, therefore, derives from the lack of awareness of safety in an unregulated market rather than from the activities of practitioners who are members of voluntary registers.  A system of voluntary regulation cannot, therefore, fully protect the public.

 

In terms of gathering evidence and solid statistics on risk, the lack of regulation and cohesion in the profession of herbal medicine represents a fundamental weakness, since the unregulated practitioners operate outside of formal pharmacovigilance procedures .  In practice, therefore, the true likelihood of risk, and the level of severity of that risk cannot currently be fully assessed.

 

Studies have shown that many patients do not inform other healthcare practitioners that they are using complementary medicine or taking herbal medicines .  The possibility of an adverse drug reaction to a herbal medicine may not, therefore, be considered.  This is potentially harmful to the public.

 

Question 2

Would this harm be lessened by statutory regulation? If so, how?

 

Yes – We strongly believe that statutory regulation would lessen the potential harm to the public.

 

When herbalists are statutorily regulated, members of the public will be able to easily differentiate between state registered and regulated practitioners on the one hand, and unqualified and unprofessional practitioners on the other. The protection of professional title would reduce the risk of harm, because unqualified practitioners would not be part of a statutory register.  If they continue to practice, or if they practiced using another title, then the public would at least be aware of the risks involved.  

 

Statutory regulation would require registration with the Criminal Records Bureau (CRB) for both practitioners and students of herbal medicine.  The majority of herbalists are independent practitioners and often work alone.  They regularly work with vulnerable people, such as children and people with mental health conditions.  For these reasons, the statutory regulation of herbalists is imperative to reassure the public that any practitioner listed on the state registers will have been checked and cleared by the CRB.  The present situation means that even if a practitioner is struck off the NIMH Register for misconduct, she or he can easily join another association and continue to practice using the title ‘herbalist’, or practise without belonging to any professional association and therefore not be subject to a code of ethics and conduct with its intrinsic disciplinary procedures.

 

All persons seeking help for health problems are in a vulnerable position as they rely on the professional to give them sound advice and treatment, to behave appropriately and to work within their competence referring for further investigation or treatment as the need arises. In a regulated environment every member of the public can be assured that this will happen or will have redress if it does not. Voluntary regulation does not afford the same assurances as practitioners can chose to belong to the register or not.

 

Yes - It would lessen the potential harm to the public because all herbalists would be well trained.

 

Herbalists who are members of the NIMH, have been trained in accredited courses in herbal medicine.  The standards of training have constantly been upgraded.  Since 1999, students of herbal medicine are required to achieve an acceptable standard in the core competences of clinical medicine, anatomy and physiology, pathology, medicine, clinical skills, differential diagnosis, physical examination, laboratory science, effective communication, safe prescribing, medical ethics and jurisprudence, recognition of limits (when to refer), herbal pharmacopoeia, pharmacognosy, pharmacy, dispensary, herb/drug interactions and contraindications, and awareness of the key signs of serious or ‘latent’ conditions. 

 

Statutory regulation would lessen potential harm because it would ensure that all ‘herbalists’ were trained to these high standards in patient care.  A survey in Australia of practitioners of traditional Chinese medicine (TCM), with 1074 respondents, found that adverse events were more likely to occur where the practitioners had completed a short course rather than full training .  Statutory regulation would enforce high standards of training and safeguard best practice thus minimising risk to members of the public who choose to use herbal medicine.

 

Yes - It would lessen the potential harm to the public because all ‘herbalists’ would have to follow a good code of practice and risk assessment procedures.

 

If herbalists were regulated with the Health Professions Council (HPC) they would all have to abide by the extensive recommendations the HPC makes on advertising, standards of conduct, performance and ethics.  They would also have to undertake continuing professional development (CPD), and they would be subject to a cohesive complaints and disciplinary process.

 

At present, herbalists registering with the NIMH agree to subject themselves to strict guidelines on advertising, which have been in place since the 1970s, and to a formal complaints and disciplinary process.  Such standards, however, are not universal.  The extravagant or misleading claims made by some unregulated practitioners can in this current climate continue to go unchecked, as can poor standards of practice.  Statutory regulation would improve the impetus for practitioners to follow guidance on professional practice and the safety of herbal medicines.

 

Risk assessment of herbal practice and herbal medicines is currently under-regulated.  However, the HPC already has risk assessment criteria in place for ‘‘groups involved in invasive procedures, clinical interventions with the potential for harm, or unsupervised exercise of judgment with a substantial impact on patient health or welfare’ .  The report of the Extended Professional Regulation Working Group (EPRWG) (2009) cites the example of a successful risk assessment model developed in Ontario, which is similar to the HPC approach, in which herbal medicine is considered to satisfy the criteria for proper risk assessment procedures .  If we accept that there is a potential risk, which we do, then we must accept that herbal practice and herbalists require regulation under one umbrella and that statutory regulation will ensure proper risk assessment.

 

Yes - It would lessen potential harm to the public because herbalists are best placed to use herbal medicines. Changes to legislation on herbal medicines must be matched by the statutory regulation of herbalists.

 

Statutory regulation will reduce risk by enforcing quality assurance within the supply chain of herbal medicines.  The MHRA proposes that this should be covered by the code of practice of the professional register and the Profession Specific Standards of the HPC for herbalists.  These would therefore include standards such as ‘manag[ing] the dispensary in order to dispense a range of herbal medicines in a safe and hygienic manner with special regard to ensuring traceability of all ingredients of herbal medicines; apply[ing] the principles of good dispensary practice and preparation of herbal medicines with regard to current guidance from the regulator, professional associations, the MHRA and relevant statutory bodies’ .

 

Statutorily regulated practitioners would also receive updates on herb safety issues.  It would also become more difficult for unqualified practitioners to obtain herbs which are not in the General Sales List .

 

The likelihood of adverse drug reactions would be reduced by statutory regulation, because the people prescribing herbs will be properly trained, have a good knowledge of herbs, and understand the ingredients in over the counter remedies and online products, thus making them best placed to advise patients safely.  The documented risk of harm may well come from the fact that the public cannot access a register of statutorily regulated herbalists.

 

Yes - It would lessen potential harm to the public caused by lack of communication between healthcare practitioners and patients on their use of herbal medicine.

 

A statutory register would ensure that other healthcare practitioners would have confidence in the professionalism and standards of registered herbalists, and it would enable patients to make safe choices about their preferred health treatments.  It would reduce the risks of danger to the public from incompetent practitioners.  It would allow all members of a patient’s health care team including GPs, Consultants, and Medical Herbalists to communicate freely to the overall benefit of patient safety and well being.

 

This is particularly relevant to the issue of herb/drug interaction.  Studies have shown that only about half of cancer patients inform their clinicians that they are taking herbal medicines and supplements .  The reason for this is they fear clinician ‘disapproval’ of CAM products and therapies .  Clearly, statutory regulation would serve to strengthen trust and communication between herbalists, clinicians and their patients.

 

Herbalists are also well placed to inform clinicians and patients about herbs.  A survey of anaesthetists in the UK found that 82% of them felt that their knowledge of herbal remedies was inadequate  and other studies have shown that patients rely on friends and family to inform them about herbs15.

 

A study of patients taking warfarin found that of those also taking herbal medicines, only 28% believed that these could interact with conventional drugs .  A properly trained herbalist knows that herbs such as ginkgo, garlic, ginseng, feverfew and ginger may potentiate the action of warfarin and should therefore not be prescribed in conjunction with this medication.

 
We accept that people are using herbal medicine and have the right to choose to use it.  The benefit of statutory regulation is that patients will be more confident about seeking advice from a trained herbalist and less reluctant to discuss their alternative health care treatments with clinicians.  This in turn would help improve communication between clinicians and herbalists and lessen the potential for harm.

 

Question 3

What do you envisage would be the benefits to the public, to practitioners, and to businesses, associated with introducing statutory regulation?

 

Benefits to the Public

 

Members of the public would have confidence from knowing that mechanisms exist to train and monitor their chosen practitioner, and that they themselves could check the practitioner’s credentials on one unified register.  It would preserve the right of members of the public to exercise their choice in the selection of herbal medicine as a healthcare modality and to continue to have access to a full range of herbal medicine treatments. 

 

The public have expressed their desire to use complementary medicine and for greater cooperation between conventional and complementary healthcare practitioners .  Patients would find it easier to tell clinicians that they are consulting a herbalist, acupuncturist or TCM practitioner. Open lines of communication are of benefit to the public and are a primary driver for the statutory regulation of herbal practitioners and other traditional medicine practitioners .

 

Benefits to practitioners

 

Practitioners would be working more closely with their peers in the healthcare professions, improving practice and understanding, and ultimately promoting patient welfare.  Working in a collaborative way would equally improve other professions’ understanding of the practice of herbal medicine.

 

Practitioners and students of herbal medicine, who have chosen to achieve a degree level qualification, would be able to identify themselves more clearly.  Both current students and students who have graduated since 2000 have anticipated that they were entering into a profession that was likely to achieve statutory regulation.  This is due to the many reports which have already recommended statutory regulation such as: The House of Lords Select Committee on Science and Technology 2000 report which recommended that practitioners of acupuncture and herbal medicine ‘strive for statutory regulation under the Health Act 1999 .  The Government’s 2001 response to this report stated that ‘“it would be desirable to bring both acupuncture and herbal medicine within a statutory framework as soon as practicable” .  Two independent regulatory working groups set up by the Department of Health (DH) and the Prince of Wales’s Foundation for Integrated Health published recommendations for the statutory regulation of herbal medicine and acupuncture in 2003 .  In 2004 the DH conducted a public consultation on statutory regulation, which demonstrated a 98.5% response rate in favour of statutory regulation . The DH consultation response gave a date for publication of a draft Order under section 60 of the Health Act 1999 in Winter 2005 .

 

This timetable was impeded while the DH considered the recommendations in the light of the Foster review and the Donaldson report in 2006 .  A Steering Group was set up in 2007 when, again, the DH asserted that ‘The Government is committed to the statutory regulation of herbal medicine, acupuncture and traditional Chinese medicine practitioner.  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’ ’.

 

Students have taken out substantial loans to enter higher education and some students, had they been aware that there was uncertainty over statutory regulation would have instead taken a place on a course leading to a qualification in a health profession which is statutorily regulated.

 

Benefits to Businesses

 

Herbal practitioners obtain supplies from wholesalers of dried herbs, tinctures, creams, aromatic oils, bottle and packaging suppliers. Just taking manufacturers of tinctures and wholesalers of dried herbs, there are nine companies. Of these, seven are in rural areas and one is in a former mining area with high unemployment. The nine companies employ approximately 153 staff. Three companies have already obtained a manufacturers licence from the MHRA.

 

Four of these suppliers have pioneered cultivation of medicinal herbs in the United Kingdom which was almost nonexistent 20 years ago. These suppliers therefore purchase horticultural supplies and provide employment in rural areas. Investment in land, organic certification, herb drying equipment, aromatic oil manufacturing equipment and premises for manufacture of fresh tinctures has been substantial.  Four companies have also built up substantial links with cultivators and collectors of organic and fair traded herbs in developing countries.  

 

Suppliers of herbal medicines would have a safe secure and guaranteed market for their products, and jobs would be safeguarded (many of which are in rural communities affected by high unemployment rates).  In addition, they would be encouraged to invest in research and better equipment.

 

Suppliers would be able to plan investment in their businesses knowing that investment in improved quality assurance would lead to improved sales.  The supply of herbs to untrained practitioners through internet sales would be hampered because statutorily regulated herbalists could be checked by the supplier on one coherent register.

 

Herbal medicine practices and clinics would have the assurance that their practitioners would be recognised by their customers as properly regulated and trained herbalists.  They would also benefit from being officially recognised as a good source of advice on herbal remedies.

 

Universities providing courses in herbal medicine and acupuncture have extra costs, because the courses include a substantial component of clinical training.  It is therefore of particular significance that they would be able to plan their course provision and their business case in a more stable market than exists at present. Currently, approved courses can be undercut by courses which do not meet the standards established under the accreditation processes of the NIMH and the EHTPA.  Universities already offering healthcare courses approved by the HPC would find the procedures familiar rather than the uncertainty of new procedures for course approval determined after accreditation by existing or new voluntary associations. 

 

Universities could also participate in the development of professional standards and research fields needed to further develop a solid evidence base for the benefits of herbal medicine.  This will increase the university’s reputation and revenue in the long term.  This has already been demonstrated for other healthcare professions, such as podiatry  where training is now provided in universities.

 

Question 4

What do you envisage would be the regulatory burden and financial costs, to the public, to practitioners, and to businesses, associated with introducing statutory regulation? Are these costs justified by the benefits and are they proportionate to the risks? If so, in what way?

 

Burden and costs to the public

 

Significant costs to the public purse have already been incurred by virtue of the range of reports which have been commissioned and the numerous consultation processes undertaken on the subject of regulation over the past ten years, starting with the 2000 House of Lords Report.  The clear message emerging from all of these reports and consultations is that statutory regulation should be introduced.  The Health Professions Council (HPC) has been recommended as the statutory body under which medical herbalists would be regulated and it has agreed to take on this role.  In view of the extensive experience of the HPC in regulating other healthcare professions, any additional costs associated with the statutory regulation of medical herbalists is likely to be negligible. 

 

Any costs arising from the introduction of the statutory regulation of medical herbalists will, in any event, be more than justified in terms of the reduced risk to the public from inappropriate and unsafe treatment by unregulated practitioners. 

 

Investing in statutory regulation will allow for the preservation of the right of access for the public to a full range of herbal medicines.  This is an important consideration in view of the increasing popularity of herbal medicine. 

 

Statutory regulation could also generate huge potential savings on the national drugs bill, estimated at £8 billion a year in 2007-08 .  Patients with long term chronic ailments, such as skin conditions, arthritis and IBS, have restricted treatment options and consequently absorb extensive NHS resources, in terms of both time and money.  If such patients were to be supported by herbal medicine, this could generate significant savings in terms of drug spend, as part of a continuum of treatment within public healthcare services.  Currently, doctors are not permitted to refer patients to medical herbalists because they are not included on a state register.  Statutory regulation would create an opportunity to widen communication and research on the treatment of these chronic ailments and to achieve substantial reductions in the drug bill in the longer term.

 

Statutory regulation could also reduce costs for the patient by enabling them to easily identify practitioners on a state register who will be subject to formal codes of ethics and conduct, which means that they are open to public sanctions.  Consequently, the public will be facilitated in avoiding the costly and sometimes dangerous effects of what are often ineffective or inappropriate treatment regimes offered by unscrupulous practitioners.

 

Burden and costs to practitioners

 

As healthcare professionals committed to providing high quality care to the public, medical herbalists must personally invest heavily in education and professional development and in the establishment of their practices.  While statutory regulation may carry increased costs in terms of registration fees, we anticipate that any such increase will be modest.  We consider, in fact, that the creation of one state register will serve to reduce costs as compared to the operation of a number of smaller voluntary registers.  Currently, practitioners who are registered with one of the reputable registers identified in the Steering Group Report are already meeting their professional obligations in relation to continuing professional development, codes of ethics and conduct, professional indemnity insurance and complaints and disciplinary processes.  The benefit of statutory regulation would mean that all registered herbalists meet these standards.  This means that any additional costs or administrative burdens associated with the introduction of statutory regulation are more than justified when compared to the current risk to the public from unreliable practitioners.

 

Burden and Costs to businesses

 

Businesses that are directly involved in this sector are the growers, farmers and manufacturers and distributors of herbs and herbal medicines.  Currently, many of these are incurring costs associated with meeting Good Manufacturing Practice standards.  This is essential for the safety, quality and range of herbal medicines and so the costs involved are proportionate to risk.  Statutory regulation would push this movement forward to the benefit of patients and practitioners and would encourage manufacturers to make further investments since their market would be a healthy and growing one.

 

Companies which have made the investment required to obtain a manufacturers licence from the MHRA estimate that the set-up costs, for example in changes to premises, are around £250,000 and the ongoing costs in particular for staff to manage quality assurance procedures are substantial. These are small companies with relatively high costs and, if statutory regulation does not proceed, then this investment will have been an even greater risk. It would also send a message to the other suppliers that it was not worth making the requisite investment. While all suppliers implement quality assurance procedures, achievement of a manufacturers licence is very different in that it demonstrates that there is internal audit and external inspection of good manufacturing practice.

 

For businesses, quality assurance processes have costs, and for practitioners, compulsory continuing professional development has a cost, but again, in both cases, these costs would be offset by the advantages of greater stability in the sector.  Any extra costs for universities would be offset by the advantages of the HPC procedures with which they are already familiar.

 

Question 5

If herbal and TCM practitioners are subject to statutory regulation, should the right to prepare and commission unlicensed herbal medicines be restricted to statutorily regulated practitioners?

 

Yes. 

 

The report of the Steering Group recommended that Section 12(1) of the Medicines Act of 1968 be restricted to practitioners who are subject to appropriate statutory regulation.  ‘Public health protection is best served if there is a consistent approach taken to the competencies, training and experience required to practice herbal medicine safely.  Agreed standards of training and practice should be applied across the board to all those wishing to practice under Section 12(1) .  This measure would, in one step, substantially reduce risk to the public.

 

The point needs to be made that regulation of herbal medicines alone – without the statutory regulation of the profession - will not adequately protect the public.  It would serve to reduce the prescribing choices of non-regulated practitioners of other CAM modalities (e.g. aromatherapists) and of regulated healthcare practitioners from disciplines other than herbal medicine.  However, this restriction will be circumvented by virtue of the fact that many herbs will remain available as food supplements or as herbal medicinal products registered under the Traditional Herbal Medicinal Products Directive (THMPD)  and therefore these practitioners could continue to advise their patients to use these products.  This concern has been discussed in detail with interested parties by the MHRA Herbal Policy Unit.

 

The MHRA proposed in its consultation on the reform of Section 12(1) of the Medicines Act 1968 that statutorily regulated herbal practitioners could be regarded as ‘authorised healthcare professionals’ under EU medicines legislation, Article 5.1 of Directive 2001/83/EC. Under this provision, a Member State may permit the supply of manufactured unlicensed medicines, if ordered by, and made to the specification of, an ‘authorised healthcare professional’  to meet the special needs of an individual patient.

 

 At present many unlicensed medicines are available under the provisions of Section 12(2) of the Medicines Act 1968.  However, the protection for unlicensed products is transitional as, after April 2011, unlicensed products will be expected to be licensed under the Traditional Herbal Medicinal Products Directive (THMPD).  Herbs which are licensed under the THMPD have to be either on the General Sales List or considered suitable for addition to the General Sales List.  Many herbal products could not be licensed under the THMPD as the herbs are not sufficiently safe to be self-prescribed, or are used for indications which are not appropriate for self-prescribing.  A scheme to allow the availability of such manufactured herbal products under the Article 5.1 derogation is not regarded by the MHRA as legally viable for herbal practitioners unless statutory regulation of the profession is in place, as this is the only means of ensuring adequate safeguards to justify derogation under EU medicines legislation.

 

Herbs and herbal products are being regulated and it makes perfect sense, therefore, that the experts in these products, herbalists, should also be statutorily regulated.  One would not expect a fishmonger to work without fish or a florist to work without flowers.

 

Question 6

If herbal and TCM practitioners are not statutorily regulated, how (if at all) should unlicensed herbal medicines prepared or commissioned by these practitioners be regulated?

 

The question itself demonstrates the importance of introducing statutory regulation of the profession.  Put simply, there is no other professional group with the appropriate body of knowledge who can safely be allowed the right to prepare or commission herbal medicines.  . Failure to implement statutory regulation will mean that there is no safely defined group trained to understand and use these medicines.  This potentially removes the public’s right to safely access the full range of herbal medicines or specially commissioned medicines for their own use. This would infringe their right to choose their own preferred health care treatments.  The outcome may be that more members of the public will seek to access herbal medicine from questionable sources – e.g. via the internet.  This is not a desirable outcome and Government has no means of coping adequately with this risk.

 

Question 7

What would be the effect on the public, practitioners and businesses if, in order to comply with the requirements of European medicines legislation, practitioners were unable to supply manufactured unlicensed herbal medicines commissioned from a third party, after 2011?

 

This would restrict public choice and potentially put practitioners and businesses out of business.  A recent survey of herbalists showed that over 90% of professional herbalists use this third party facility regularly as an integral part of their practice .

 

These third party medicines include cough syrups, some creams, pessaries and suppositories, blends of teas and powders and herbal capsules.

 

Herbal capsules are of particular benefit to patients who do not like the taste of herbal tinctures, or are intolerant to alcohol due to alcoholism, liver disease or when alcohol exacerbates a condition such as psoriasis. Herbal capsules are also essential to the treatment of some ethnic groups who avoid the use of alcohol. 

 

It is essential that any sort of medicine, whether herbal or pharmaceutical, is delivered in the form most suitable to effect a successful treatment outcome for the patient. If practitioners were unable to supply manufactured unlicensed herbal medicines commissioned by a third party when clinical judgement and successful treatment demanded it, patients would suffer, quite literally, as a result.

 

It is beneficial to patients and practitioners to have access to these third party medicines and beneficial to manufacturing businesses to continue to supply them.

 

Voluntary regulation would not provide adequate safeguards to allow herbal practitioners to be regarded as ‘authorised healthcare professionals’ for the purposes of complying with European legislation after April 2011.  Accordingly, those herbal practitioners would be unable legally to commission manufactured unlicensed herbal medicines from a third party under Article 5.1 of the European Medicines Directive 2001/83/EC. This would undoubtedly affect practice as many herbal products frequently used by herbalists would be unavailable to them. The public would not be protected as the responsible practitioner would not have the means to ensure that products were manufactured as specials by holders of a manufacturer’s license.  The complex questions surrounding these provisions have been discussed in detail by the MHRA .  Imported manufactured products have given the greatest cause for concern. Public safety demands that there is a link between the legal definition of the herbal practitioner and the provisions under medicines legislation.

 

Question 8

How might the risk of harm to the public be reduced other than by statutory professional self-regulation? For example, by voluntary self-regulation underpinned by consumer protection legislation and by greater public awareness, by accreditation of voluntary registration bodies, or by a statutory or voluntary licensing regime?

 

The suggestion of licensing herbalists has never been considered a viable option by any of the numerous groups that have worked on this process since the 2000 House of Lords report.  Neither the DH nor the MHRA have raised this as an option previously.  It is not at all clear as to what a ‘licensing regime’ could involve and it therefore seems inappropriate to include reference to this notion within this consultation.

 

While a ‘lighter touch’ regulation could include a criminal record check, it would not operate ongoing CPD, or foster communication and information-sharing in the areas of research and development among the healthcare professions. 

 

These options could lead to regulatory arbitrage between the different councils, where practitioners would have to meet different standards and pay different fees, simply by virtue of ‘postcode’.  This is likely to bring up issues relating to equal opportunity of provision, as practitioners may choose to practice one side or another of a ‘border’, with the result that practitioners who are unable to make such a move would be disadvantaged professionally and financially.  

 

Statutory regulation is the only satisfactory way to deal with all the issues.  Voluntary regulation would still not prevent unscrupulous, incompetent practitioners from posing a danger to the public.  Voluntary regulation would increase public confusion since there would be a multiplicity of registers.  These registers would be self-regulating, an approach which would lack credibility with the public.  Such an approach would be deeply inappropriate for modern healthcare professionals.  Voluntary regulation would not allow herbalists to have ‘authorised healthcare professional’ status and thus would crucially not make any provision for the protection of access to the full range of herbal medicine after April 2011. The effect of this has already been outlined in the response to Question 7 above.

 

To summarise – the only proposal that would deliver a safely trained, competent recognised body of herbal practitioners with full access to the range of herbal medicines is through statutory regulation of the profession.  This is clearly in the public interest.

 
Question 9

What would you estimate would be the regulatory burden and financial costs, to the public, to practitioners, and to businesses, for the alternatives to statutory regulation suggested at Question 8?

 

Statutory regulation of the profession is the most cost effective option. 

 

There are serious questions to be answered about the costs of alternatives to statutory regulation, such as who would meet the bill for incurred costs and administration of setting up and maintaining the licence, paying for enforcement officers and administering complaints procedures which are likely to be considerable since none of these procedures is in place and would all have to be created from scratch. 

 

The cost for the other options would be borne by the public in terms of not being able to guarantee access to safe competent practitioners and high quality herbal medicines.  In addition, some of the other options would actually cost more in terms of paying for poor quality inadequate regulation which would fail to deliver something ‘fit for purpose’.  The MHRA would have a substantially increased burden, considering the time and energy invested in their Herbal Policy Unit.  This would ultimately lead to further consultations and regulation in the future thus incurring increased long term costs.  The continuing uncertainty over standards would also increase costs for universities providing herbal medicine courses.

 

Practitioners would be forced into a situation where they would not have adequate access to the medicines they need to practice, making it difficult to prescribe effectively, by virtue of not being recognised as ‘authorised healthcare professionals’.  Overall this would incur further service and administration costs without any benefit to their practice.  Some practitioners may be forced out of practice which would burden their families and potentially state resources.  For a competent practitioner to provide ethical care in a given modality then the tools of the trade must be available.
Healthy businesses rely on a vibrant practitioner practice and poor/inadequate regulation that fails to deliver guaranteed access to the full range of herbal medicines would not give them any incentive to improve manufacturing standards with a subsequent negative effect on the provision of safe high quality herbal medicines.  Ultimately a number of businesses would be likely to fail. Any reduction in ability to enforce quality assurance in the supply chain for herbal medicine would not be beneficial.

 

Question 10

 
What would you envisage would be the benefits to the public, to practitioners, and to businesses, for the alternatives to statutory regulation outlined at Question 8?

 

We see no benefit to the public, practitioners or businesses for the options outlined at Question 8.

 

Question 11

If you feel that not all three practitioner groups justify statutory regulation, which group(s) does/do not and please give your reasons why/why not?

 

All groups should be statutorily regulated in line with the Government’s strategy and stated commitment to the statutory regulation of these professional healthcare groups. 

 

Question 12

Would it be helpful to the public for these practitioners to be regulated in a way which differentiates them from the regulatory regime for mainstream professions publicly perceived as having an evidence base of clinical effectiveness? If so, why? If not, why not?

 

The purpose of statutory regulation is to ensure uniform high standards in training and best practice across all disciplines of medicine in the interests of pubic safety.  The creation of arbitrary differentiations between health modalities will not, in our view, contribute to achieving this purpose. ‘Evidence based’ medicine (EBM) is a form of research methodology, a theory to be debated, not an absolute. It should have no bearing on statutory regulation which is essentially about patient safety. 

 

The HPC currently regulates groups whose work is not measurable by the EBM methodology.  Art therapy and psychology, for instance, often use outcome measures as a way of assessing effectiveness.

 

The empirical evidence base for herbal medicine is strong. Western herbal medicine continues to use herbs which have been used in Europe for the last 2000 years .  The evidence base for the clinical effectiveness of herbal medicine is valid enough for the millions who seek out and use such therapies on an annual basis. Evidence in this case is often based on recommendations from friends, colleagues and family members, who have had positive experiences and found herbal medicine to be ‘clinically’ effective.  The fact that these patients are seeking out and using this therapy at their own cost is a powerful argument for effectiveness – people do not continue to pay for a service which fails to deliver benefits.  While opponents of herbal medicine criticize the quality of the evidence base, the public continues to consult herbalists and to benefit from herbal medicines regardless. 

 

The herbal medicine tradition as an academic pursuit was invigorated by nineteenth century texts  and has seen a growth in scientifically referenced texts in the past twenty years .  There is now a substantial body of work on the analysis and review of the constituents of medicinal plants and laboratory investigations of the pharmacological actions of whole extracts or constituents . Examples include Sage Salvia officinalis  , Horse chestnut Aesculus hippocastanum   and Nettle leaf Urtica dioica  .  There are already a plethora of scientific journals dedicated to herbal medicine research such as Fitotherpia, Planta Medica, Herbalgram and Evidence-based Complementary and Alternative Medicine .  Herbal medicine university courses include coursework that has to be rigorously researched and scientifically referenced.

 
Given the irresponsible claims made for herbal medicines in the media, an advantage of statutory regulation would be that the public could more easily identify a practitioner who is aware of the current evidence base.  Provision of university courses would lead to more graduates obtaining funding for PhDs and thus an increased evidence base.  People would also appreciate increased knowledge about herbal medicines and contact between herbalists and other healthcare practitioners .  Compulsory CPD would also ensure adequate knowledge of the evidence on the safety of herbal medicines .

 

The National Institute of Health and Clinical Excellence (NICE) has endeavored to implement EBM as a standard research practice.  The ‘gold standard’ double blind random control trial may be effective when assessing a single medication, but it is difficult to apply this methodology to a herbal, or indeed a conventional medical intervention, that includes an extensive consultation as part of the treatment or that includes a multiplicity of medications in the treatment.  Nor would EBM be a practical methodology to apply in circumstances, whether in herbal or conventional treatments, in which prescriptions vary substantially from person to person depending on the individual’s symptoms and constitution, not the disease.  A clinician must be free to use judgment in these matters and assess effectiveness by what the patient reports.

 

The evidence base in mainstream medicine is not absolute.  For example the efficacy of the HPV vaccine will not be known for another ten to twenty years and the only research carried out has been conducted by the manufacturers of the vaccine , yet teenage girls are already being immunised. 

 

The influence of pharmaceutical companies on ‘evidence based medicine’ must be considered.  An article in the BMJ called for doctors to ‘just say no’ to drug company lunches  and a 2004 House of Commons Health committee report on the influence of the pharmaceutical industry concluded that the industry had been left to its own devices for too long and should be forced into full publication of industry research .  Mainstream professions publicly perceived as having an evidence base of clinical effectiveness do not necessarily have a firm and reliable, independently verifiable evidence base. When comparing medical treatments, it is unethical to apply different standards of proof to the two modalities. 

 

There are randomised controlled trials of herbal medicinal products such as Ginger Zingiber officinalis , but the results are often difficult to interpret due to poor trial design .  There are almost no investigations into the practice of western herbal medicine partly because of the problems in investigating any healthcare which depends on a consultation .  Lack of funding opportunities and lack of interaction between the profession and healthcare researchers are cited as reasons .  A recent small randomised pilot study of the treatment of menopausal symptoms by herbal practitioners found that symptoms were significantly reduced and participants showed high satisfaction with the care received .  Statutory regulation would enable herbalists to access research facilities, patient groups and funding which would greatly aid the health care community in understanding the effectiveness of the work undertaken by medical herbalists in practice.  This should be a priority for the Government.

 

Public perception is formed by the information that is made readily available to them.  The evidence base for clinical effectiveness as a research methodology is not an absolute.  Neither is any system of medicine an absolute.  We accept this and as statutorily regulated herbalists, we would like to be part of the evolving picture of research and medical practice which is in tune with public choices for diverse forms of healthcare.

 

Question 13

Given the Government’s commitment to reducing the overall burden of unnecessary statutory regulation, can you suggest which areas of healthcare practice present sufficiently low risk so that they could be regulated in a different, less burdensome way or de-regulated, if a decision is made to statutorily regulate acupuncturists, herbalists and traditional Chinese medicine practitioners ?

 

This question presupposes that statutory regulation is a burden. From the patient’s point of view, the ability to identify a qualified practitioner is not a burden, but part of the trend in society for greater transparency in the provision of information.  It also enables regulated healthcare practitioners to identify qualified practitioners.

 

The regulatory body has already been established (HPC), and has agreed that it is able and willing to bring herbal medicine into its regulatory framework.  The preparatory work has been carried out by the DH’s Steering Group and all the structures for statutory regulation of these professions are now in place.

 

Failure to see this project through to completion would, in our view, represent a waste of tax payer’s money.  It would fail those students who have taken out loans to invest in education and training in the expectation that they would be entering a statutorily regulated profession.  It would fail practitioners by putting the tools of their trade at risk.  It would fail the public by restricting their right to access the full range of herbal medicines.  It would fail businesses, many of which are in rural areas with high unemployment rates.  It would fail to deliver on the clear statements of intent made by the Government in favour of the statutory regulation of our professions. 

 

Question 14

If there were to be statutory regulation, should the Health Professions Council (HPC) regulate all three professions? If not, which one(s) should the HPC not regulate?

 

Yes, the HPC should regulate all three professions.

 

Question 15

If there were to be statutory regulation, should the Health Professions Council or the General Pharmaceutical Council / Pharmaceutical Society of Northern Ireland regulate herbal medicine and traditional Chinese medicine practitioners?

 

The DH Steering Group recommended that practitioners of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems practiced within the UK be regulated by the HPC.   This recommendation was based on discussions with the HPC and careful review of HPC policy and procedures.  The HPC already has the expertise and structure in place to be able to do this with the minimum of delay and expense, and has already in 2008 made an unequivocal recommendation to the Secretary of State for Health that Medical Herbalists, Acupuncturists and Traditional Chinese Medicine Practitioners should be regulated under Article 17 (a) of the Health Professions Order 2001 .

 

The Steering Group reviewed the Standards of Proficiency of the HPC and found that they were applicable to the practice of herbal medicine, acupuncture, and traditional Chinese medicine and that it would be possible to use the same format and include requirements which would ensure safe and effective practice.  The Steering Group was able to show that current professional associations would recommend the standards of conduct, performance, and ethics of the HPC to their members.

 

The HPC regulates practitioners and, as stated in their Standards of Proficiency, it is the components of the consultation which lead to safe practice.  The General Pharmaceutical Council/ Pharmaceutical Society of Northern Ireland regulate a profession whose practice is based on correct dispensing and not on the patient / practitioner consultation.  Their special rules on dispensing and prescribing are relevant to herbal medicines and would inform the HPC Professional Standards Committee within the HPC.  However, the General Pharmaceutical Council does not regulate professions in which a consultation between the patient and the practitioner is central and has no relevance to acupuncturists.  As such, herbalists would be opposed to being regulated by the General Pharmaceutical Council.

 

Question 16

If neither, who should and why?

 

See answer to 15.

 

Question 17

a) Should acupuncture be subject to a different form of regulation from that for herbalism and traditional Chinese medicine? If so, what?

 

No, acupuncture should not be subject to a different form of regulation.  This would lead to confusion for the patients of traditional Chinese medicine practitioners.  Many Chinese herbalists, as well as some Western herbalists, are also practitioners of acupuncture and frequently treat patients using both herbs and acupuncture.

 

b) Can acupuncture be adequately regulated through local means, for example through Health and Safety legislation, Trading Standards legislation and Local Authority licensing?

 

No, acupuncture cannot be adequately regulated through local means.

 

Question 18

a) Should the titles "acupuncturist", "herbalist" and "[traditional] chinese medicine practitioner" be protected?

 

b) Yes, the titles ‘acupuncturist’, ‘herbalist’ and ‘Traditional Chinese Medicine practitioner’ should be protected.

 

The word ‘traditional’ should be retained in the title ‘practitioner of traditional Chinese medicine’ to make it clear that this is a traditional medicine system and to reduce the possibility of confusion with registered medical practitioners.

 
b) If your answer is “No”, which ones do you consider should not be legally protected?

 

N/A

 

Question 19

Should a new model of regulation be tested where it is the functions of acupuncture, herbal medicine and TCM that are protected, rather than the titles of acupuncturist, herbalist or Chinese medicine practitioner?

 

No.  It is our understanding that the function of herbalists will be protected by the proposed MHRA changes to Section 12(1) of the Medicines Act.

 

The possibility of testing a new model of regulation has already been discussed and rejected by the DH some years ago.  By way of background, in 1994, the DH invited the herbal medicine profession to bring together the professional associations representing herbal practitioners and agree to common standards.  This work proceeded under the auspices of the EHTPA which was founded in 1993 by the NIMH, the Register of Chinese Herbal Medicine, and the International Register of Consultant Herbalists.  The first formal meeting between the EHPA, DH and the MCA (now MHRA) was in 1999 at which the possibility of statutory regulation using the provisions of the Health Act 1999 was proposed by the DH.  At a meeting in December 2000, the EHPTA stated that there was sufficient agreement within the professional associations to move forward, and the DH outlined a staged implementation plan for statutory regulation.  The DH drew up a scoping study setting out the legislative requirements in March 2001.  The professions have thus been working with the DH, the MHRA and other state bodies towards the statutory regulation of both herbal medicines and the professions for the last 15 years.

 

It is unclear now why, as emerging professions, herbal medicine and acupuncture would be asked to test a new model of regulation.  The MHRA has worked consistently to develop standards that could be implemented within the framework of statutory regulation.  We are at a loss as to why this suggestion is being put forward at this very late stage in an otherwise well developed collaborative process, it having been thoroughly examined by the DH and the MHRA in collaboration with the professional bodies and dismissed as unworkable some 9 years ago.

 

Question 20

If statutory professional self-regulation is progressed, with a model of protection of title, do you agree with the proposals for "grandparenting" set out in the Pittilo report?

 

Yes, the NIMH agrees with the proposals for "grandparenting" as set out in the Pittilo (Steering Group) Report.

 

The aim of the proposals was to ensure that as many existing practitioners as possible would apply for entry to the register as this would be in the interests of public safety and the cohesiveness of professional practice.

 

Question 21

In the event of a decision that statutory or voluntary regulation is needed, do you agree that all practitioners should be able to achieve an English language IELTS score of 6.5 or above in order to register in the UK?

 

Yes.

 

Question 22

Could practitioners demonstrate compliance with regulatory requirements and communicate effectively with regulators, the public and other healthcare professionals if they do not achieve the standard of English language competence normally required for UK registration? What additional costs would occur for both practitioners and regulatory authorities in this case?

 

No, we do not consider that practitioners will be able to demonstrate compliance with regulatory requirements and communicate effectively with regulators, the public and other healthcare professionals in such a situation.  The costs involved in bringing practitioners up to the required standard should be borne by the individual and / or professional body.  This topic was discussed extensively by the Steering Group.  

 

Question 23

What would the impact be on the public, practitioners and businesses (financial and regulatory burden) if practitioners unable to achieve an English language IELTS score of 6.5 or above are unable to register in the UK?

 

If one accepts that public safety is a significant issue, then there must be some regulatory burden. This does present a problem for Chinese practitioners but healthcare is generally offered in the language of the host country. Transition arrangements should be made for such individuals already practicing in this country, as suggested in the ‘grandparenting‘ scheme as set out in the DH Steering Group report.  This would safeguard the treatments being given to those members of the public that are currently seeking help from these practitioners, whilst also safeguarding the practitioner’s business as they are working to meet the required standards.  Businesses could still continue to supply individuals working within such transition arrangements.  The funding of interpreters could be sought through charitable or statutory channels, as a transition arrangement, while individuals work towards meeting regulatory standards.

 

Question 24

Are there any other matters you wish to draw to our attention?
1)  Public choice

 

If herbal medicine and acupuncture are not statutorily regulated, the public’s right to the medical treatment of their choice will be restricted.  The loss of a traditional therapy with roots going back thousands of years in this country will cause a huge public outcry.

2)  Education

 

The consultation document makes no references to the interests of universities or of students. This omission is indicative of a lack of awareness of the current state of practice within the UK.  There are 350 students on NIMH accredited courses plus approximately 50 staff teaching in 7 different universities.  If herbalists are not statutorily regulated, the future of these courses is at risk.

 

3)  Loss of ability to commission medicine from a third party

 

There are a number of points to consider regarding the loss of a herbalist’s ability to commission medicine from a third party:

 

1. As many as 90% of herbal medicine practitioners commission medicine from a third party .  Herbalists using this service do so as a regular weekly or monthly part of their patient provision and it is therefore a crucial part of patient treatment.  Withdrawal of this service would lead to compromise of quality of patient care.

 

2. Without this service certain patients groups would be disadvantaged - for example, on religious grounds.  Many Muslim patients are reluctant to take alcoholic tinctures so third party commissioning is often essential for their treatment.

 

3. Many herbalists use this type of service as a way of accessing a wider range of medicines than they can personally stock.  There are several reasons for this;

 

• Perishability: Those new to practice, or part time practitioners, cannot use stock quickly and dried herbs are more perishable.  In order to preserve standards of good quality medicine whilst ensuring good economic practice in a small business, they use third party medicine suppliers.

 

• Storage space:  Storage space can be an issue for some herbalists - sometimes it is not possible to house a herbal dispensary, and so this prescription service is not only a convenient solution, but is essential to their provision for their patients.

 

• Cost:   Starting up in practice or starting a new practice when moving home can be prohibitively expensive.  This means that the only viable way such practitioners can offer the range of medicines essential to their patients is through third party commissioning – across the range of products including teas, tinctures and capsules.  Commissioning medicine from a third party also allows practitioners access to more expensive medicinal preparations such as fluid extracts, which they may not be able to carry as part of their own stock due to financial constraints.  In the current economic climate many practitioners are cutting down on the level and range of stock.  They are only able to manage this because third part commissioning allows them to request private prescriptions to be made up to their own specifications. 

 

• Frequency of use of individual medicines:  Third party commissioning also solves other problems such as when a particular tincture is required for one patient that the practitioner does not carry in stock.  To wait for a supplier to bulk deliver to the practitioner and then make up and post the medicine to the patient would involve unnecessary delays.  Third party make up of the prescription is therefore a useful option in these cases and leads to greater patient satisfaction.

 

If this service were not available, practitioners would be forced to try and manufacture these products for themselves, with resulting implications for the quality of the product - practitioners do not have the same quality assurance that specialist companies have.  Being able to use companies with GMP facilities to produce capsules has to be better for the end user as well because fill weights can be more accurate and cross contamination is less likely. 

 

Manufacturing products such as capsules could potentially cause staffing problems due to time taken up by manufacture, health and safety issues due to lack of GMP facilities, and space problems due to the need for a dedicated workspace.

 

Loss of this service would not only compromise ‘best treatment’ for individual patients, as well as ‘limiting trade’, but it would have severe implications for the survival of a number of herbal practitioners who rely on these services.  Third party suppliers are not a luxury; they are crucial to the practice of herbal medicine for many herbalists.

 

4)  Economic implications

 

If the government fails to deliver statutory regulation they will have failed to protect businesses and jobs involved in both supplying herbal medicines and acupuncture equipment, and in providing herbal medicine and acupuncture to the public.  Many of these jobs and businesses are in rural areas which are already affected by high unemployment rates.  The projected market for retail sales of complementary medicines in the UK in 2010 is £234 million, and it is projected that herbal medicines will make up £151 million of this.   The Government will also have failed students who have taken out loans to invest in education and training in anticipation of joining a profession which successive Governments have promised to statutorily regulate.

 

With a regulated profession and universities with established courses, the UK has the potential to market this specialist knowledge to the rest of the world, both attracting students to study at UK universities, and attracting research funding to those wuniversities. Failing to deliver on Statutory Regulation will remove that potential for income generation within the UK.

 

5)  The increased risk of public use of unregulated medicines

 

If certain medicines are not available to patients from their herbalist, the chance of patients buying remedies from unreliable and unregulated suppliers increases.  Increased use of unreliable remedies increases the chance of adverse events.

 

6)  Contribution to National Healthcare Provision

 

In 2003 a report carried out by Mintel, a renowned market research group, found that 36% of consumers believe that doctors should recommend alternative therapies and a third believe they should be available on the NHS. Homeopathy and reflexology are both now available in certain areas on the NHS .  The use of private appointments to see complementary therapists, such as herbalists, is a significant area of growth due to the long waiting lists to see CAM practitioners on the NHS; dissatisfaction with conventional drugs and treatment; an awareness of an alternative route to treatment; an increase in disposable income; and a consumer trend towards health and well being products .  Visits to a Medical Herbalist could also be motivated by the desire to have a chronic condition treated, increased media awareness and NHS recommendations, but it is also noted that 42% of people visit alternative practitioners on the recommendation of a friend or relative .  There is a bright future for complementary medicine and ultimately it could stand alongside conventional practices.

 

7) Overseas development and aid

 

Many herbs for use in the UK herbal medicine market are grown in the countries of Eastern Europe, Africa and South America. If UK herb suppliers are forced out of business through non-regulation of herbalists, there will be a significant impact on the communities around the world whose livelihood depends on that market.