analysis report on the 2009 consultation - uk...

Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK Analysis Report on the 2009 Consultation

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Initial report on the consultation on statutory regulation of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems practiced in the UK

© Crown copyright Year 2011 First published February 2011 Published to DH website, in electronic PDF format only. http://www.dh.gov.uk/publications

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http://www.dh.gov.uk/publications

DH INFORMATION READER BOX

Policy EstatesHR / Workforce CommissioningManagement IM & TPlanning / FinancePerformaClinical nce Social Care / Partnership Working

Policy Document Purpose 14961 Gateway Reference

Title A Report on the Statutory Regulation of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems practiced in the UK

Author DH/Professional Standards Division

Feb 2011 Publication Date Target Audience PCT CEs, NHS Trust CEs, SHA CEs, Care Trust CEs, Foundation Trust CEs ,

Directors of PH, Directors of Adult SSs, Allied Health Professionals, GPs, Communications Leads, Privately practising Alternative Medicine Practitioners, UK professional bodies representing acupuncture, herbal medicine and TCM, NHS bodies (Scottish Health Boards, Local Health Boards in Wales, community Health Councils in Wales, the NI Ambulance Service, the Health and Social Care Board, Public Health Agency, Patient Client Council and the Business Services Organisation), Royal Colleges, UK Regulatory Bodies, consumer representatives, Herebal Industry, NHS Trades Unions

Circulation List Voluntary Organisations/NDPBs

Description A Report from Government following the consultation on whether, and if so how, to regulate practitioners of acupuncture, herbal medicine and traditional Chinese medicine practitioners. The Consultation ended in November 2009. .

Cross Ref Pittilo report Superseded Docs N/A Action Required

Timing Janet Smith By 00 Jan 1900

Contact Details Professional Standards Division2N11

LS2 7UE Quarry House, Quarry Hill, Leeds

0113 2545789

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For Recipient's Use

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Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK An Analysis Report on the Consultation

Prepared by: Professional Standards Division, Department of Health

Acknowledgements and thanks to Paul Cosens of Cosens Consultancy for analysis and preparation of this report.

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Contents

Page No. 1. Executive summary ……………………………………………………. 5 2. Introduction ……………………………………………………………... 8

3. Thematic analysis of consultation responses ………………………. 10 4. Annex A – Detailed analysis …………………………………………. 29

5. Annex B – List of organisations who responded …………………… 59

6. Conclusion ……………………………………………………………… 65

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Executive Summary

This paper presents the outcome of the joint consultation, on behalf of Health Ministers in the four UK countries, on Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and other Traditional Medicine Systems Practised in the UK. Headline Messages From Respondents RISK OF HARM 1. Perceived harm – there was a general perception of harm resulting from unregulated

practice of acupuncture, herbal medicine and traditional Chinese medicine (throughout this report referred to as AHMTCM), and a view that this harm should be addressed.

PRO-STATUTORY REGULATION – BENEFITS AND COSTS

2. Pro-statutory regulation – there was a clear majority of responses (85%) in favour of

statutory regulation. The main benefits of statutory regulation were perceived to be:

• Qualified practitioners – ensuring AHMTCM practitioners are qualified will be an important measure for assuring patient safety. Further work will be required to evaluate qualifications awarded as a result of training taking place outside the UK.

• Quality and safety of practice – enhanced quality of practice/products and safety would constitute an obvious benefit to practitioners as well as to the public.

3. Alternatives to statutory regulation not preferable – a strong message was noted that

safety would not be assured sufficiently by alternatives to statutory regulation. 4. Voluntary regulation as second best option – as an alternative to orthodox statutory

regulation, ‘voluntary regulation’ or a licence to practise were seen as preferable to no regulation.

5. Financial costs unclear – generally respondents expressed difficulty in evaluating the

financial costs involved in different types of regulation. ANTI-STATUTORY REGULATION

6. Anti-statutory regulation -–a significant minority of respondents (15%) including medical

Royal Colleges, considered that the scientific evidence base for efficacy of alternative treatments needs to be strengthened before statutory regulation can be considered.

7. Unjustified credibility resulting from statutory regulation – in the absence of such

evidence, a decision to statutorily regulate may give the impression that the current

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A report on the consultation on statutory regulation of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems practised in the UK

evidence base for alternative treatments is on an equal footing with that for mainstream clinical practice (‘orthodox western medicine’).

8. Clearer public information – need for clearer information for the public relating to the risks and benefits of alternative treatments and products, so they can make informed choices.

IMPACT OF EUROPEAN MEDICINES LEGISLATION 9. EU medicines legislation – as a consequence of complying with EU medicines legislation

in the UK, respondents estimated that unless practitioners were regulated the supply of alternative herbal products would decrease and that there would be a detrimental impact on ‘consumer choice’

REGULATE ALL THREE GROUPS? 10. Treat all 3 practices the same – the general consensus was that it would be simpler and

more cost effective to regulate herbalism, TCM and acupuncture in the same way. WHICH REGULATOR? 11. Regulation - The Health Professions Council (HPC) was the preferred option for

regulating all three practices. 12. Alternative regulation - establishing a ‘Complementary and Alternative Medicine’ (CAM)

Council was a popular alternative to HPC regulation. 13. Local regulation – considered by some that it would lead to complications and be

impractical for practitioners if they were required to register with multiple Local Authorities. PROTECTION OF TITLE AND/OR FUNCTION? 14. Protect title and/or protect function – popular support for both approaches. “GRANDPARENTING” OF EXISTING PRACTITIONERS 15. Grandparenting – many respondents were unfamiliar with the term ‘grandparenting’ and

seemed confused when asked to evaluate the implications of this approach. ENGLISH LANGUAGE COMPETENCE 16. English language ability- there was a general consensus that some level of English

language ability should be required in order to practise alternative medicine in the UK. Furthermore, most people expressing this view felt that the level of English language

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competence ought to be the same as for health professionals such as nurses and doctors within mainstream medicine. Interestingly, many respondents also felt that the use of interpreters would not be an obstacle to safe, effective practice. Finally, it was agreed that the cost of achieving English language competence should be borne mainly by the practitioner.

COMPLEXITY , CONFUSION AND QUALITY OF RESPONSES 17.Confusion – It was clear that many respondents, notably individual members of the public and practitioners, rather than organisations, found the consultation document confusing. Some respondents did not attempt to answer the questions at all but wrote in simply to express the view that they were in favour of statutory regulation. Many respondents said they had not read the Pittilo report on which the consultation was based. The evaluation of consultation responses has tended to focus on the views of individuals and organisations who considered the issues and provided evidence to back up their views. We have, of course, taken into account the number of respondents who favour statutory regulation.

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Introduction On 3 August 2009 the four UK Health Departments published a consultation paper on Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and other Traditional Medicine Systems Practised in the UK. This report is a factual analysis of the responses to the consultation. The consultation took place over a 15-week period and closed on 16 November 2009. The Department of Health alerted major stakeholders (relevant professional associations, statutory and voluntary regulators, educational bodies etc, including organisations in Scotland, Wales and Northern Ireland) to the consultation, which was published on the Department’s website. 6669 responses to the consultation were received by the closing date, and this analysis takes account of all these replies. A further 231 responses were received after the consultation closed, and this document does not take account of these. This paper sets out the factual analysis of the consultation, which focused on whether, and if so how, practitioners of acupuncture, herbal medicine, traditional Chinese medicine should be regulated. Ministers in all four countries, including Health Ministers in the previous UK Administration, decided to hold this consultation in view of the complex and controversial issues raised by the work of the DH Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and other Traditional Medicine Systems Practised in the UK, chaired by the late Professor Mike Pittilo, which reported to them in May 2008. The consultation focused on the purpose of regulation (i.e. public protection) and asked respondents to consider:

• the nature and degree of risk to the public associated with the practice of acupuncture, herbal medicine and TCM;

• whether these risks can best be managed by introducing statutory professional regulation or by some other means of (or no) regulation;

• the costs, benefits and impact of various kinds of regulation on practitioners, businesses and the public; and

• whether it is appropriate for these practitioners to be regulated in the same way, and to the same extent, as other healthcare professionals.

The consultation discussed potential alternatives to statutory professional regulation such as:

• statutory or voluntary licensing schemes; • voluntary professional self-regulation; • product regulation; and • system regulation

which could be underpinned by some or all of the following:

• accreditation of regulators; • health and safety and consumer legislation;

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• local authority licensing regimes; and • better public information.

The consultation also considered related European and domestic legislation on regulating medicinal products and the effect of statutorily regulating, or not regulating, herbal medicine/TCM practitioners; and whether acupuncture should be subject to the same, or a different, regulatory regime as the other groups under consideration. Furthermore, the consultation covered a variety of issues which would need to be resolved should a decision be made to statutorily regulate these groups:

• who should the regulatory body be, and should it be the same for all three groups? • how should registration and ‘fitness to practise’ issues be dealt with for practitioners

eligible for regulation by more than one regulatory body? • should regulation be by protection of title, protection of function, or (in the case of

certain procedures) both? • what should the ‘grandparenting’ arrangements be for current practitioners who wish to

join the register but who do not possess the threshold entry qualifications? • what level of English language competence should be required of applicants seeking

registration?

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Thematic Analysis of Responses Whether to regulate – questions 1-13 Evidence of harm/risk of harm (Q1) The great majority of respondents considered there to be a risk of harm associated with the practice of AHMTCM, and that there is evidence some of this harm can be severe, particularly where the use of plant-based medicines is concerned. Evidence adduced included scientific literature reports of poisoning, and infections/deaths resulting from the use of needles/skin piercing in acupuncture. The incidence/likelihood appears to be low, but the results can be severe, even fatal. Responses from the European Herbal & Traditional Medicine Practitioners Association (EHTPA) in particular present examples of illness caused by potent and toxic herbs, adulterated herbal medicines and adverse interaction with conventional drugs. The great majority of respondents felt that the type and degree of risk involved warranted practitioner and/or product regulation. A small minority of respondents considered any risk from AHMTCM practice unjustified as they believed the treatments themselves to be ineffective and having no value other than placebo. They were concerned that some patients choose to forgo conventional treatment in favour of alternative treatments, resulting in avoidable morbidity and even mortality. They did not however consider statutory regulation to be a proportionate response to this risk, as they felt it would confer legitimacy on the treatments concerned and might actually increase the numbers of people willing to use them, possibly to their own detriment. Three important messages emerging from the responses concerned the lack of information to enable the public to make informed choices or to be able establish whether someone was a genuine practitioner; the need for clinical studies to inform a better evidence base for alternative therapies; and more stringent testing/regulation of herbal products. Overall, there is clear evidence that there are real dangers of harm associated with AHMTCM practice, though it is debatable whether statutory regulation constitutes the most appropriate way of mitigating these risks.

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Would statutory regulation lessen the risk of harm? (Q2) Again, the vast majority of respondents thought it would. Reasons given were that statutory regulation would ensure that herbal practitioners and acupuncturists are carefully and thoroughly trained. That training is subject to accreditation, evaluation and periodic review by independent educational and training professionals, and disciplinary oversight by a regulating body. Incompetent or unscrupulous practitioners could be struck off the register and prevented from practising. Qualified and trained practitioners would be far less likely to misidentify herbs, prescribe incorrect dosages, fail to take thorough patient histories or take into account interactions with conventional medicine. They could also be expected to have training in basic safety and management of complications. Reference was made to recent regulations in Norway requiring patients to have a diagnosis from a conventional medical practitioner, while the information from this diagnosis may be shared with any subsequent practitioner for treatment resulting from the conventional diagnosis. One respondent who argued that statutory regulation of practitioners was “essential” considered it needed to be combined with effective product regulation such as sourcing products only from an approved suppliers list. Both practitioners and products needed to be quality assured. Not all respondents considered that orthodox statutory regulation was the only or most appropriate way of addressing the risk of harm. One respondent considered regulation to be “extremely necessary” but suggested the public could be adequately protected through a combination of local government laws/trading standards and registration with voluntary regulatory bodies. A small minority were vehemently opposed to statutory regulation on the grounds that “statutory regulation….will make this situation worse by providing legitimacy to professionals using ineffective treatments”. One respondent argued that: “The introduction of statutory regulation for other practitioners will not remedy their lack of knowledge about the differential diagnoses for particular patients, their reliance upon a single treatment modality or their belief in health systems that do not accord with current scientific understanding of physiology and pathology. The introduction of statutory regulation would confer or imply a degree of scientific validity to systems of healthcare for which there is no scientific evidence.”

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Benefits and costs of statutory regulation (Q3 and 4) Benefits associated with statutory regulation (Q3) The overwhelming consensus was that a range of standards would be prescribed, maintained, improved, enforced and assured, to the benefit of both patients and reputable practitioners. General arguments put forward in favour of introducing statutory regulation include: “The public can be assured that any acupuncturist that they choose to visit fulfils the minimum criteria of competence required by the regulatory body. Should a member of the public encounter incompetence or be adversely affected by their acupuncture treatment then they are able to address their concerns to the regulatory body who, pending investigation, have the power to remove the acupuncturist from the register.” “The benefits to the public are primarily in receiving clinical excellence in the treatment of their disorders and deriving optimal results without risking their health. The benefits to the practitioners are professional recognition and having the safety guideline on which they can confidently practice and develop their professions. The benefits to business are assurance that there would be a legal framework to conduct their business and also increase patient confidence from general public as well as other medical and healthcare professions, which means positive future for their development.” “Significant benefit to competent herbalists. Incompetent practitioner that should not be practising as a herbalist would see no benefit... Significant benefit to companies supplying high quality products. No benefit to companies supplying low quality products. Companies that supply herbs to practitioners would need to review their manufacturing procedures and invest significantly in improving the quality of herbal preparations supplied to herbalists and TCM practitioners.” More specific comments include - Consumer choice / increased activity - “Statutory regulation will maintain consumer choice for patients, and would enable referrals to this sector from health professionals who are themselves statutorily regulated. Statutory regulation is likely to increase the number of patients seeking acupuncture, herbal and traditional Chinese medicine treatment.” Multi-disciplinary interaction - “It is important that there are clear rules for ensuring communication with a patient’s GP and other health care professionals, for ensuring that patients have a medical diagnosis, and for referring patients appropriately for conventional medical care.” “Above all the public would know who is and is not qualified. At present there is no way of knowing who is competent.” The main argument against the benefits of statutory regulation was summed up by the Academy of Medical Royal Colleges, who stated “Overall we believe that there are no benefits to the public, or rather, that the benefits are negative. The costs are therefore not justified.” Costs and burdens associated with statutory regulation (Q4)

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Generally, respondents conceded that there would be some impact on practitioners in a financial sense and clearly in a regulatory sense: “It would be important to demonstrate that these costs would not prevent practitioners from making a living. Most acupuncturists and herbal practitioners are self-employed in small independent businesses and some work part-time. A partial answer can be found in the increased likelihood of larger practices being established and inappropriately qualified practitioners, potentially including owners of high street shops, being driven out of business.” “In the private sector, registration fees resulting from a pre-registration individual assessment will inevitably need to be recouped either through increased work load or raised fees. The latter may result in loss of client numbers as most independent acupuncturists work privately. The exclusion of potential patients due to the cost will increase the burden on the practitioners who provide acupuncture free within the NHS”. A minority view was that “The regulatory burden and financial costs of SR would be immense; many small businesses would fold causing a great loss to the public, future generations and adding to the unemployment burden. Add to this the disastrous effects that the [European] legislation had and will have, it would seem not excessive to assume traditional herbalists and traditional medicine suppliers will be all but extinct. Regulatory burden and financial costs of statutory regulation could not be justified unless a definition of ‘risk’ and what is an accepted ‘risk’ were ascertained. Also, the “actual” and not the “assumed” benefits of SR need to be stated. Neither of these things have been achieved, therefore the burden is not justified.” Some felt that this cost may be offset by financial benefits accruing from increased business resulting from increased public confidence in alternative medicine. “Indeed regulation could in theory save the NHS considerable sums of money if GPs and other healthcare workers felt more confident to refer patients who might benefit from TCM”. In addition, there could be reduced costs resulting from economies of scale: “The cost to the Chinese medicine practitioner is in fact likely in fact to be reduced, since nearly all practitioners of Chinese herbal medicine also practice acupuncture, and currently often pay registration fees to more than one voluntary association. Registration with the HPC, if that body provides the regulatory home for TCM, will reduce the costs of registration because of the economies of scale within such a large body.” Some respondents argued that current businesses operating with high quality standards may be relatively unaffected by changes in regulatory practice or legislation. “High quality manufacturing companies would not see significant cost increases but the companies currently manufacturing to low quality standards would experience significant cost increases.” Overall, respondents felt that the regulatory burden and costs involved would be justified: “The benefits will significantly outweigh the cost incurred by statutory regulation. We believe that the cost is proportionate to the risks posed by the non-regulation of practitioners.” “If statutory regulation does not go ahead, the cost to the public, the practitioners and businesses will be huge, as there might be some severe consequences since poor unregulated practice may lead to the need for expensive medical intervention and even loss of life.“

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“Statutory regulation may increase costs for practitioners, but the level of professionalism will be significantly improved. In this way the cost increase will be well worth it”.

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Unlicensed herbal medicines - compliance with European legislation (Q5-7) This series of questions concerned the impact of European legislation post-April 2011 upon the availability in the UK of unlicensed herbal medicines commissioned from a 3rd party supplier: Unlicensed herbal medicines – should their use be restricted to statutorily regulated practitioners? (Q5) Unlicensed herbal medicines – how should risk be lessened if practitioners not statutorily regulated? (Q6) Unlicensed herbal medicines – effect if practitioners not able to commission these from a 3rd party supplier? Q7) The majority of respondents felt that prescribing of such medicines should be restricted to statutorily regulated practitioners, if the alternative meant that they would not be available at all. Most were concerned that the public should still have access to these medicines: “We do not think there are any other effective methods to regulate unlicensed herbal medicine prepared or commissioned by herbal or TCM practitioners other than through the statutory regulation of the practitioners. The reason for this is that regulations may be put in place to control the quality of herbs or herbal products, but this will not ensure the efficacy and safety of unlicensed herbal medicines, as only the qualified and competent herbal and TCM practitioners know the effective and safe clinical applications of the herbs.”

“Practitioners must be allowed to dispense unlicensed herbal medicine to the patients after April 2011 to ensure consumer rights and the freedom of consumer choice... In the case of Chinese herbal medicine and Ayurvedic medicine the denial could be considered as ethnic discrimination in European laws.” “I believe that it is wise to restrict the prescription of herbal formulas to only those qualified and a member of a professional body”.

A minority felt that anyone should be able to supply these products (though this could be problematic under European legislation):

“No, the right to prepare and commission unlicensed herbal medicines should not be restricted to SR Practitioners. Traditional herbal medicines have been used for thousands of years all over the world, in a variety of situations from home use prescribing for the family, to prescriptions from herbalists, naturopaths, nutritionists, aromatherapists, homeopaths and until relatively recently the medical establishment also prescribed them. It is the people’s medicine. Herbalists do not own herbal medicine and there is no evidence that traditional herbal medicines are a cause for concern.” “Unlike pharmaceutical drugs, the vast majority of herbal medicines are very safe with no side-effects. The vast majority of herbal medicines have also been used as food at some point in history, which is what makes the current trend towards unfounded regulation ridiculous. When is a herb a food and when does it become a medicine? Popular ‘scientific’ research and certain groups of herbalists would have us all believe that herbs are very dangerous. We must ask ourselves what they stand to gain by issuing such a message. Common sense is needed - are we going to ban potatoes and tomatoes because they contain harmful alkaloids?”

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Yet another opinion was that unlicensed products should not be on the market in the first place: “Unlicensed medicines should not be sold. This applies to herbal and non-herbal medicines. There is no scientific rationale for the licensing of one and not the other. Herbal medicines are likely to be more dangerous than non-herbal medicines because of contamination issues (e.g., often with toxic heavy metals such as lead or mercury) and dose issues. Calculating a safe dose is very difficult for herbal medicines with active ingredients because no two plants contain the same concentration of active ingredient (e.g., look at the history of digitalis as a treatment).” An alternative to statutorily regulating practitioners would be to vigorously pursue a policy of enforcing trading standards: “If explicitly or implicitly it claims to be a "medicine" or "remedy" it must prove what is says on the sales blurb. Endorsements (claims that "some people" swear by the product) should be as impermissible for herbal and TCM as they are for Pfizer and GSK. But this does not require statutory regulation of practitioners.” A similar point is made by the Academy of Medical Royal Colleges: “More rigorous application of advertising standards law and vigorous prosecution when such a practitioner causes avoidable harm as a result of providing a therapy that does not have scientific evidence of benefit.” If a decision were made not to regulate practitioners in a manner whereby they could legally continue to commission unlicensed herbal medicines from a 3rd party supplier, there would be a predictable impact on the supply of health products as well as concerns regarding the potential establishment/emergence of a ‘black market’ supply of unlicensed products. “Suppliers would go out of business, practitioners would be severely constrained in prescribing herbal medicines and the public would lose access to a very wide range of medicines.” “Businesses will close and the general public would be denied of their freedom of consumer choice and the benefits to their healthcare.” “The public, our patients, the environment, traditional medicines, choice, access and freedom will all suffer.” “If any member of the public felt they needed a particular product, they might obtain it from potentially unreliable sources or manufacturers e.g. via the internet etc which may not be of medicinal quality. This may provide a greater danger to the public than providing medicines via a practitioner, who will be able to also provide proper advice in the use of the medicine along with any cautions necessary.” Not all respondents agreed: Manageable impact - “It all depends on the efficacy of the European regulations and the objective nature of their development and application. If the regulations are politically motivated the impact could be severe but if they are developed by proper scientific and medical criteria the impact can be managed.” “European curbs would be good for the public, and in the case of some traditional Chinese "remedies" it would be good for wildlife and the planet as whole; but bad for the multimillion pound snake oil industry.”

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Alternatives to statutory regulation What alternatives to SR could reduce risk of harm?(Q8) Costs of alternatives to statutory regulation (Q9) Benefits of alternatives to statutory regulation (Q10) The general tenor of responses to these three questions was that there is no other option other than statutory regulation, on the grounds that the risk of harm would not be reduced by anything other than statutory regulation, and that the alternatives simply wouldn’t suffice. Statutory regulation was considered to be the most cost effective and efficient way forward. These are exemplified in two themes. Citizen vulnerability - “We do not believe that risk of harm to the public can be reduced significantly other than by a statutory regulation scheme, for the reasons we have already mentioned. Only under statutory regulation can the public be assured that practitioners have sufficient oversight and regulation of their training and practice. Other schemes would leave gaps and a citizen would be more vulnerable in such circumstances.” Consumer protection: “For example, if a member of one of the [voluntary] bodies is struck off from the register, he/she can still practise TCM, as there is no law to prevent them from doing so. ….Anyone can practise acupuncture, herbal medicine and traditional Chinese medicine. The only way to rectify this situation is statutory regulation. Consumer protection, trading standards and local council administrations have been put in place, but they have not been able to prevent unscrupulous “practitioners” from harming the public.” “Voluntary self regulation has never worked. Voluntary registration does not work either. Both fail because the very people that need to be regulated do not comply. Statutory regulation is the only way forward.” Although some suggested that strengthening or accreditation of the existing voluntary regulators would be a viable alternative: “Of all the examples mentioned in this question, the regulation by accreditation of the regulatory body and the statutory license regime are the only choices that may lessen the risk of harm to the public other than by statutory regulation.” “The best option is to strengthen existing regulators that are known to be effective when funded properly: MHRA, ASA and trading standards.” “We…suggest that the costs would not be great and that society should provide resources to uphold the law on advertising standards and consumer protection, and to prosecute those who knowingly or recklessly cause harm.” “The financial costs of self-regulation would clearly be lower than the costs of statutory regulation, assuming that statutory powers were properly monitored and enforced.”

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“The benefits to practitioners [of not regulating] would be that we would not have to bear the burden of extra costs of regulation. For the public and businesses I do not think there would be any outstanding benefits.”

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Should all 3 groups of practitioners be statutorily regulated? (Q11) Should acupuncturists be regulated in the same way as herbalists and TCM practitioners? (Q17) The majority of responses to these two questions supported the view that all three groups of practitioners should be subject to statutory regulation. The consensus was moreover that acupuncture should not be subject to a different form of regulation from that for herbalism and traditional Chinese medicine. A high percentage of respondents believed that acupuncture cannot be adequately regulated through local means, for example through Health and Safety legislation, Trading Standards legislation and Local Authority licensing: “Acupuncture should be regulated by the same regulatory body as Herbal Medicine as it requires the same understanding of what constitutes safe practice” “Many acupuncturists also practise a form of herbal medicine which would create confusion to the general public”. “We think these practitioners should be subject to similar forms of regulation and see no strong grounds for different approaches.” “Health and Safety legislation, Trading Standards legislation and Local Authority licensing do not in themselves provide an adequate form of regulation because they play no role in overseeing training standards, fitness to practise schemes etc”. “They barely have the funds to carry out inspection of premises. How could they assess a given practitioner's level of training or suitability to practice?” In line with the responses to previous questions, a minority did not think any of these groups should be regulated: “None of the groups justify regulation for the reasons stated above. These are practitioner groups that lack knowledge about the differential diagnoses for particular patients, rely upon a single treatment modality and believe in health systems that do not accord with current scientific understanding of physiology and pathology. The introduction of statutory regulation would confer or imply a degree of scientific validity to systems of healthcare for which there is little or no scientific evidence.” “I don't think any of them have sufficient evidence of efficacy to deserve statutory regulation. Furthermore, none have sufficient scientific basis to be funded for science research and scientific training at University level.” “Acupuncture plainly works inasmuch as it has a placebo effect. The theory is hocus pocus, so it doesn't matter where the needles are placed; but by all means let unregulated practitioners apply it provided they do not break existing consumer protection laws. Other CAMs, including herbal medicines and the vitamin pill industry generally do little harm and are best left unregulated. Psychotherapies may certainly be harmful but are almost impossible to police.” A small minority of practitioners also resist regulation for completely different reasons:

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“All three practitioner groups do not justify statutory regulation due to absence of any definition of actual risk and absence of any proven risk from these practitioners.; Statutory regulation would lead to dire consequences for our traditions and medicines, as stated above. The 1968 Medicines Act (pre 2005 legislation), Henry VIII charter, current Common laws and Statute laws are adequate to protect the public.” “Acupuncture is part of a traditional medicine system, Current laws are sufficient.”

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Should AHMTCM practitioners be regulated in a way which differentiates them from orthodox professions? (Q12) The great majority of respondents thought not. Some argued that the evidence base for acupuncture was in some respects as good as that for some statutorily regulated professions: “There are many clinical interventions that are widely used within physiotherapy (for example) that do not enjoy as robust an evidence base as acupuncture but physiotherapy is perceived as a “mainstream profession”. It is evident therefore that if acupuncture were to be regulated on the strength (or weakness) of its evidence of clinical effectiveness then this would suggest a re-appraisal of many other aspects of physiotherapy and indeed some of the other professions allied to medicine. It is therefore difficult to see the advantage of regulating acupuncture in a way that differentiates it from physiotherapy. The recently regulated professions of osteopathy and chiropractic currently reside in a rather grey area in this regard. There is a large component of training within these professions that involves orthodox medical science, but there are also significant elements related to assessment of a patient that involve theoretical concepts with more similarity to alternative medical systems than to current orthodox medical practice. According to a recent BMJ report, within the mainstream medical practice in the UK there are only 13% considered as evidence based, 23% considered as possibly evidence based, and the rest 64% is considered of no known evidence. If the BMJ report is valid, there is no distinction as far as evidence based practice is concerned, there are little differences between the mainstream medical practice and the three professions considered here in terms of clinical effectiveness. It will not be helpful to the public in differentiating these professions from the mainstream practice in terms of regulatory regime.” “Much of conventional medicine is practiced without the full rigour of an evidence base. Methods for measuring efficacy are sure to become more sophisticated and nuanced over time. The public has the right to know about any and all knowledge with respect to all modalities of treatment and care. In the meantime, there has to be a place for empirical evidence as well as the very narrow definition of that currently comprises "evidence-based." Unsurprisingly, responses were very polarised and a minority view was that if these groups of practitioners were to be regulated, it should be in a way which distinguished them from existing regulated professions: “The suggestion that treatments that do not ‘have an evidence base of clinical effectiveness’ should be regulated seems absurd. However, if regulation is nevertheless developed then this distinction should be made absolutely clear, or members of the public will be misled and serious harm will result. Please see the agreed statement of the Academy of Medical Royal Colleges.” “Yes. Regulating them alongside HPC professions such as Psychology and Physiotherapy would give them false credibility. It would also undermine the existing HPC professions.” Should consideration be given to not regulating, or deregulating, other groups? (Q13) The response to this question was that yes, in order to reduce the overall burden of unnecessary statutory regulation, there are some low risk healthcare therapies that could be voluntary self-regulated. Groups mentioned included art therapists, play therapists, ear-

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acupuncturists, auricular therapists, cosmetic and beauty acupuncture, tuina therapists, and Chinese nutritionists as well as Chinese lifestyle medicine practitioners. The overall message seemed to be that it depends on exactly how invasive the activities are which are being performed (i.e. the function rather than the title of the practitioner should determine the kind of regulation). Other factors to take into account would be the degree of supervision: “Treatment which is given under the supervision of a second professional should be less risky to patients if the treatment is non invasive; Where individuals work autonomously, often with vulnerable patients the provision of care is worthy of statutory regulation because of the risk inherent in the therapeutic relationship.” Other respondents questioned the notion that “because one sector clearly qualifies for statutory regulation another type of healthcare practice should be removed from statutory regulation. Public protection, not financial expediency, is at the heart of regulation.”

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How to regulate (questions 14 – 23) Who should the regulator be? (Q14 -15) The majority of respondents (including the HPC itself) favoured HPC as the regulator: “It would make economical and strategic sense for the HPC to regulate the provision of acupuncture... There is sufficient overlap between the practice of acupuncture and Traditional Chinese medicine to warrant a single regulatory body. The complex pharmaceutical actions of herbal compounds suggest that regulation by the General Pharmaceutical Council be more pertinent. However due to the overlap and the economies of scale … a common regulatory body such as the HPC would be the best option.” “Chinese medicine practitioners are not pharmacists, and therefore the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland are not wholly relevant to the profession” “If the Government chooses to go down the non-statutory regulation route at this stage, the recently established Complementary & Natural Healthcare Council (CNHC) could be an initial first step, before moving to statutory regulation in the future. The CNHC would seek to provide a single register, but would not provide patients with the safeguards provided by statutory regulation. This deficiency would mean that there could be a long term delay in moving to statutory regulation.” A few thought that neither the HPC nor the pharmaceutical societies would be appropriate: “None of them are right for regulating TCM, especially not a western pharmaceutical society. We do not think that the HPC is a good choice for regulating TCM. TCM should be regulated through joint administration by local government and professional bodies.” Some respondents argued that a completely different regulator should be chosen, to distinguish these groups from “professions operating in mainstream medicine and for which there is strong evidence base of clinical effectiveness.” “Regulating any of them alongside existing HPC professions would undermine the existing HPC professions.” “The HPC requires "practice based on evidence of efficacy" and so cannot regulate any of these professions without breaching its own fundamental rules. To oblige it to do so would be to subvert one of the most precious criteria for safeguarding health.”

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Should certain titles be protected?(Q18) The clear majority of respondents in favour of regulation thought that title should be protected, though some thought that function should be protected too: “For proper distinction from unqualified practitioners who may claim to be acupuncturists, herbalists, and [traditional] Chinese medicine practitioners, the professional titles MUST be legally protected.” Safety – “at present anybody can use the title acupuncturist even if they have done very short courses” “Ideally both title and function of the three professions should be protected.” Should certain functions be protected?(Q19) Overwhelmingly, respondents asserted that a new model of regulation should not 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. “The practitioner would still have to be regulated in some statutory manner”. “Why complicate it? If people are qualified in these therapies, they have earned the right to use the title acupuncturist”. “The public are more likely to want to know when they see a practitioner they are getting a qualified, regulated professional which is best served by title protection”. “Grandparenting” – existing practitioners who want to join register(Q20) There was a real divergence of opinion in response to this question. There were 3 themes expressed at similar levels by respondents: ‘Have not read Pittilo report’ (28%), ‘Do not agree with Pittilo report or grandparenting scheme’ (28%) and ‘Support Pittilo and grandparenting scheme’ (29%). There was some confusion about the Pittilo report as it seemed that many respondents either were unfamiliar with the report or had not read it. There was some support noted for grandparenting but, while this was not conclusive, further thought may be required prior to grandparenting arrangements being implemented.

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Language competence (Q 21-23) The majority (87%) of respondents agreed with the need for an English language IELTS score of 6.5 or above. One respondent felt that the suggested level was not high enough. There was a repeated concern for the need for the ability of practitioners to communicate clearly: “Practitioners who fail the English tests should not be dealing with the public in the UK.” “Clear communication, both understanding and speaking, is essential in a consultation for safety. It would be absurd to demand this of doctors but not of other practitioners who undertake direct patient contact. Communication is at the heart of being a health professional. ” “To treat holistically it is essential that you understand and can be understood.” Some respondents felt that practitioners who had practised without adverse effects should be allowed to continue and that others should have a 5 year transitional period to reach the required standard: “A transitional period of 5 years should be allowed to reach the IELTS score of 6.5 to encourage compliance, prevent unemployment and continuation of treatment of existing patients.” It was accepted that a proportion (around 70-85%) of practitioners would be unable to meet the standard and hence unable to register and pursue their livelihood in the event of statutory regulation: “If the majority of existing Chinese medicine practitioners, despite being well qualified in their profession, is unable to register the consequences will be disastrous. The choice is whether regulation emphases more on linguistic ability or on professional capability in qualitative delivery of treatment. Professional competence should be priority.” “The impact would be vast on practitioners, suppliers and patients. Practitioners ceasing to practice could endanger their patient’s health. Both of these scenarios would have a tremendous impact on the financial and regulatory burden of the UK and raise serious safety concerns.” “Minimal impact on the public. However, some ethnic groups may be served by some practitioners with limited English language skills and this may impact these groups.” Some respondents disagreed that practitioners should be allowed to practise with the help of interpreters: “Translation should not be used as it is important that practitioners can understand an assessment and to protect patients.” Others disagreed: “For existing TCM practitioners who have safely practised in the UK, are registered with established professional bodies, and whose level of language skill has never caused harm to the public should be allowed to be registered even though their English does not reach an IELTS score of 6.5. They should be allowed to continue to practise with the help of a translator. For future TCM practitioners there should be an English requirement.”

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“TCM practitioners have borne the cost of employing translators since TCM arrived in the UK twenty years ago. Communication between patients and TCM practitioners through a translator has not caused harm to patients. It has also saved millions of pounds for the government and NHS as the practitioners employed the interpreters on their own expense. If highly experienced TCM doctors are not allowed to practise by employing a translator, it will deprive the public of experienced practitioners, deprive practitioners of the right to practise in what has become their home, and deprive businesses of income.” It was accepted that having an interpreter obviously necessitates an extra cost, but this should be absorbed by the practitioners themselves, possibly with some help from their professional associations.

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Anything else pertinent? (Q24) Difficult questionnaire – “This was an extremely long and at times difficult to understand questionnaire.” One practitioner’s view – “I am a practitioner and wish to provide the public with a much needed and valued alternative to pharmaceuticals. I wish to be able to prescribe across the full range of herbal medicinal products offered by third party suppliers as I cannot possibly treat patients and prepare pills, tablets, creams and mixed herbs, at the same time. I have supported myself through 5 years of full time graduate and post graduate education and worked hard to meet the rigorous standards of professional practice. Regulation would ensure that these high standards are maintained by all practitioners. The public are seeking treatment from herbal/traditional medicine and acupuncture practitioners in ever increasing numbers and have the right to protection from poor practice that Statutory Regulation would ensure. The failure of the government to honour its long term commitment to statutory regulation of herbal/traditional medicine and TCM acupuncture is a betrayal of the public interest.” EHTPA/previous reports – “We concur with the comments and advice made to this question by the EHTPA in its Consultation Document response already submitted to the Department of Health. We feel it would be wrong and even irresponsible of the Government and wasteful of taxpayer's money to forego this opportunity to bring statutory regulation to herbal and traditional medicine practice, TCM and acupuncture. In the current world of internet buying, to give but one example, consumers will be more at risk if they cannot consult in person a qualified and properly regulated practitioner. The public has demonstrated that if wishes to use herbal medicines and acupuncture. Herbal medicines have a very good safety track record and herbal practitioners have demonstrated a willingness to ensure and maintain the highest standards of practice, ethics and conduct expected of all regulated healthcare professionals. To go against the advice of previous working group reports the Government would be missing the opportunity to put this sector on a sure health and economic footing. Statutory regulation is a significant step forward that will benefit the patient, the practitioner and healthcare as a whole.” Lack of UK research – “The Medical Research Council spent no money researching complementary therapies in 1998-1999 and in 1999 the UK medical research charities spent only 0.05% of their total budget (Kumar Pal, 2002). In the past 12 years the Indian Council of Medical Research has set up a network throughout the country for carrying out controlled clinical trials for herbal medicines. The Council has shown the efficacy of picrorhizia kurroa in hepatitis and pterocarpus marsupium in diabetes. Double-blinded and well-designed clinical trials have also been conducted with arogyawardhini in viral hepatitis, mucuna pruriens in Parkinson’s disease, phyllanthus amarus in hepatitis and tinospora cordifolia in obstructive jaundice. Similar research in the United Kingdom would be beneficial.”

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Annex A Detailed Analysis The following section provides a detailed numerical analysis of the responses to this consultation. 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? 1.1 EVIDENCE OF HARM – YES/NO Graph 1: Summary

1.1 Comment: The majority of respondents (88%) responded that evidence of current and/or potential harm exists. While some believed that the reason for this was a lack of agreed standards and regulation of alternative medicine, others questioned the evidence base currently available to support alternative medicine in the UK.

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Graph 2: Thematic Break down

1.2 Comment Of the top four themes identified, the greatest perceived harm to the public by far was noted as concern about ‘unqualified practitioners’ (48% of thematic responses to the question). The next most frequent concern was about a perceived ‘lack of evidence’ (12%) to support alternative medicines as legitimate forms of medical treatment in comparison with Western Medicine. At similar levels, ‘quality of products’ (9%) and worries about ‘unscrupulous practitioners’ (8%) were recorded.

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Question 2 - Would this harm be lessened by statutory regulation? If so, how? What are the disadvantages associated with introducing statutory regulation? 2.1 WOULD HARM BE LESSENED? Graph 1: Summary

2.1 Comment: From the answers to this question, approximately 85% of respondents supported statutory regulation of the three groups of practitioners on the grounds that it would reduce harm. Graph 2: Thematic categories

2.2 Comment Similar to the primary theme identified in responses to Question 1, ‘unqualified practitioners’ (50%) constituted the main cause of concern. The second most frequent issue noted was ‘safety standards’ (29%) of practitioners of alternative medicine. Approximately 10% of responses to this question also expressed concerns about ‘unscrupulous practitioners’. Respondents felt that regulation would help to address these concerns.

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Question 3 - What do you envisage would be the benefits to the public, to practitioners, and to businesses, associated with introducing statutory regulation? 3.1 BENEFITS Graph 1:

3.2 Comment Overall, the main benefits for the public to be gained from statutory regulation were perceived, by the majority of respondents to this question, to be from the assurance that practitioners are qualified and meet safety standards. Benefits to practitioners resulting from enhanced public confidence were perceived to be both reputational (because the quality of practitioners would improve) and financial. Respondents’ perception was that benefits were approximately twice as great for the public as for practitioners.

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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? 4.1 THEMES Graph 1:

4.2 Comment Similar numbers of respondents estimated that the majority of the financial burden would fall on the public (14%), as on practitioners (15%). Significantly, however, the majority of responses (64%) to this question considered that the benefits flowing from statutory regulation would be justified and would be proportionate to the regulatory/financial burden. It is worth noting also that few respondents estimated a significant regulatory burden on the public (1%), business (negligible) or practitioners (4%).

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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? 5.1 RESTRICTED – YES/NO Graph 1: Summary of opinion

5.1 Comment: There was overwhelming support (85%) in favour of the preparation and commissioning of unlicensed herbal medicines to be restricted to regulated practitioners. Graph 2: Thematic analysis

5.2 Comment Approximately half of respondents to this question were in favour of practitioners having a ‘license to practice’ (48%). A further 15% of respondents expressed a view that a ‘qualification to practice’ ought to be required, or “training” (9%). A minority (12%) of respondents to this question felt that herbalists should not be regulated - the public should have a choice as to who they dealt with, and/or that regulation could not be effectively enforced.

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A further 5% commented on the need to exclude people using herbs etc. for personal use from any regulation. There were further comments on the need to test and control the preparation of products as well as or instead of regulating practitioners.

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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? 6.1 THEMES Graph 1:

6.2 Comment An overwhelming message of support for Statutory Regulation was offered in response to this question (67% of responses felt this was the only way forward). The remaining three most frequently identified themes expressed a preference for the regulation of businesses (14%), voluntary regulation (10%) and product regulation (6%). Various suggestions were put forward but the general opinion was that voluntary regulation would be a ‘second best’ alternative to statutory regulation.

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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? 7.1 THEMES Graph 1:

7.2 Comment The three most common themes identified for responses to this question were more evenly balanced than with previous questions. Above all, people were most concerned about the impact on/reduction in patient choice (36%), though a small minority of respondents (3%) also thought it would improve patient safety. Approximately a third of respondents predicted that if practitioners were unable to supply manufactured, unlicensed, herbal medicines commissioned from a third party it would be more difficult for practitioners to obtain these products, with the inevitable result of reducing business volumes – a further 26% of responses predicted ‘reduced business for practitioners’.

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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? 8.1 THEMES Graph 1

8.2 Comment In response to this question there was an overwhelming response re-affirming support for statutory regulation (62%). Importantly, there was also a strong message in favour of clearer and more reliable information for patients / consumers (20%). Other responses included support for voluntary regulation (6%) and accreditation of voluntary registration bodies (4%).

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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? 9.1 THEMES Graph 1: Summary

9.1 Comment: More than half of respondents (59%) estimated that there would be a significant cost resulting from the alternatives to statutory regulation. Furthermore, 12% felt that a significant regulatory burden would result. Graph 2: Further thematic breakdown

9.2 Comment Respondents were generally not able to quantify the costs of regulation. However, it was felt that there would be a significant cost which would fall on practitioners and the public. Overall, the majority of respondents felt that there would be a significant degree of regulatory burden which would affect practitioners (24%) and that there would be a significant regulatory burden generally (19%). A proportion of responses (16%) felt that a significant regulatory burden would affect the public.

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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? 10.1 THEMES Graph 1:

10.2 Comment A clear message comes from the responses to this question. Approximately two thirds perceived there would be no benefits to the public, practitioners and businesses from implementing the alternatives to statutory regulation in question 8. This is one of the clearest messages from the consultation. On the other hand, a small proportion of responses indicated that an improvement in patient choice (8%) and patient safety (8%) would result from adopting alternatives to statutory regulation.

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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? 11.1 THEMES Graph 1:

11.2 Comment The message was very strong for regulating all three practitioner groups with 76.9% in favour of all three practitioner groups being statutorily regulated. It is worth noting that there is some individual variation in the practitioner groups which were supported by respondents with a total of approximately 95 % (Acupuncture – 32% / TCM – 31%; Herbal Medicine – 32%) expressing support for the statutory regulation for at least one of the three practitioner groups. A variety of reasons were given for differentiating between the three groups being considered in this consultation. With regard to acupuncture, concerns were often raised about the use of needles and, in particular, sterilisation. Herbal medicine raised issues relating to the quality and standardisation of products. TCM generally includes both acupuncture and herbalism. An occasional concern mentioned with regard to TCM was the use of body parts sourced from protected species for medicinal purposes.

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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? 12.1 THEMES Graph 1: Summary

12.1 Comment: An overwhelming majority of respondents (92%) felt that alternative medicine practitioners should not be regulated in a way different from mainstream medical practitioners. Graph 2: Thematic breakdown

12.2 Comment There was an overwhelming response to this question as respondents believed that the best way forward is to regulate all alternative medicine practitioners in the same way as mainstream professionals (61%). Notably, there was also a call for enhancing the existing evidence base for the effectiveness of alternative medicine (19%).

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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 ? 13.1 THEMES Graph 1:

13.2 Comment Half of all respondents (51%) considered that TCM was low risk and might be regulated in a less burdensome way. Herbalists (14%) and acupuncturists (14%) were considered low risk by some respondents also. Although expressed in low numbers, other professions were mentioned in this section as displayed in the pie chart above. However overall there was a strong pro-regulation message (86%) in response to this question, compared with 6% in favour of maintaining and enforcing existing laws and 8% against regulation.

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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? 14.1 THEMES Graph 1: Summary

14.1 Comment: There was a large majority (87%) expressing the view that if statutory regulation were to be chosen as the most appropriate way forward, then the HPC would be the best organisation to regulate all three professions.

Graph 1: Further breakdown

14.2 Comment Proportionately, this answer shows the most interesting balance of responses. There is a relatively even balance of responses in favour of the HPC regulating each profession (24% each for TCM, Acupuncture & Herbal Medicine). Furthermore, there is a similar level of responses in favour of some other form of regulation (14%) and against the regulation of alternative medicine altogether (13%). There is a clear preference for the HPC to be the main regulating body for all three practices.

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Alternatives to HPC mentioned MHRA, GMC, self-regulation, BACC, CAM Council / Alternative Medicines Professional Council, Local Government, professional bodies, voluntary accreditation.

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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? 15.1 THEMES Graph 1:

15.2 Comment There were mixed messages in response to this question. While almost half (47%) of responses were in favour of the HPC regulating herbal medicine and TCM, at the same time 44% of responses were in favour of neither the HPC, nor the GMC/PSNI regulating. This is an anomalous response compared with related responses from previous questions. Alternatives to HPC / PSNI mentioned Trading Standards, MHRA, Allied/CAM Health Profession Council (AHPC), Local Government, professional bodies, Chinese Medicine Council (CMC), the British Acupuncture Council (BAcC), and the European Herbal Practitioner Association (EHPA).

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Question 16 - If neither, who should and why? 16.1 THEMES Graph 1:

16.2 Comment There were two main themes in response to this question. Those in favour of ‘HPC’ were the most prominent category with 37% of responses. At the same time, many of the responses argued that ‘none’ of the alternatives should be utilised (31%), indicating that HPC was the preferred option. Other responses suggested a CAM Council (8%) or self-accreditation (10%) as alternatives, while a number of responses recommended the creation of a new body (possibly along CAM Council lines) without specifying what it should be (8%).

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Question 17 - a) Should acupuncture be subject to a different form of regulation from that for herbalism and traditional Chinese medicine? If so, what? b) Can acupuncture be adequately regulated through local means, for example through Health and Safety legislation, Trading Standards legislation and Local Authority licensing? 17.1 THEMES Graph 1:

17.2 Comment Two juxtaposed messages are presented among responses to this question. On the one hand, 30% expressed the view that all three main disciplines be treated in the same way rather than one being regulated in a different way from the other. On the other hand, 29% argued that the best approach for acupuncture is ‘self-regulation’. A notable concern relating to acupuncture addresses issues relating to ‘Health & Safety (10%). Also, some respondents were in favour of ‘trading standards’ (10%) and Local Authority regulation of acupuncture practitioners (10%).

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Question 18 a) Should the titles "acupuncturist", "herbalist" and "[traditional] Chinese medicine practitioner" be protected? b) If your answer is “No”, which ones do you consider should not be legally protected? 18.1 THEMES Graph 1:

18.2 Comment Overall, respondents favoured the proposal that titles for all three disciplines should be legally protected: TCM (38%), Herbalist (28%) and Acupuncturist (27%). Only a small minority were against the legal protection of titles (5%).

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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? 19.1 THEMES Graph 1:

19.2 Comment ‘Protection of title’ was felt to be important by a majority of respondents to this question (62%). At the same time, a high proportion were in favour of also protecting the functions of acupuncture, herbal medicine and TCM (29%).

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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? 20.1 THEMES Graph 1: Summary

20.1 Comment: Respondents to this question were split between those who agreed with the Pittilo ‘grandparenting’ recommendations (33%), those who disagreed (39%) and those who had not read the Pittilo report (28%) – it is worth noting that many in the latter category commented that they had not heard of the Pittilo report! Graph 2: Further breakdown

20.2 Comment There was a real divergence of opinion in response to this question. Themes consistent with preceding sections of the consultation emerged with regard to patient safety e.g. ‘existing dangerous practitioners are allowed to continue’ (1%), ‘concern about qualifications of existing practitioners’ (5%), ‘must have a safe record’ (3%). Interestingly a minority of 4% felt that even

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lower language competence would be acceptable (see ‘Lower English language competence required for prac’). A further consistent theme was noted with regard to strengthening the current evidence base (2%) prior to deciding whether to regulate.

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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? 21.1 THEMES Graph 1: Summary

21.1 Comment: An overwhelming majority of respondents (87%) to this question were in favour of a minimum standard of English language competence being set at IELTS level 6.5. Graph 2: Thematic breakdown

21.2 Comment In contrast, a large proportion of respondents (38%) did not consider translation to be an issue.

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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? 22.1 THEMES Graph 1: Summary

22.1 Comment: The majority of respondents (80%) felt that without a sufficient level of English language competence that there would be implications for patient communication and regulatory compliance. Graph 2: General themes

22.2 Comment The responses indicated a significant majority were of the view that additional costs of meeting language competence would be borne by practitioners (88%). The second most common view was that additional costs would fall on regulatory authorities (10%).

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Question 23 - What would the impact be on 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? 23.1 THEMES Graph 1:

23.2 Comment The majority of respondents (58%) estimated that some practitioners would not be able to practise any more as a result of being unable to meet a minimum English language requirement. There were mixed views as to whether this was a good thing for the British public or otherwise. Notably, other key themes included estimations that a ‘greater financial burden’ would fall on the practitioners (15%), there would be ‘improved patient safety’ (10%) and a ‘greater financial burden’ on businesses (9%). As with other preceding sections, concerns were expressed regarding the ‘evidence base’ for alternative treatments generally (5%).

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Question 24 - Are there any other matters you wish to draw to our attention? 24.1 THEMES Graph 1:

24.2 Comment This graph indicates that the majority of respondents to this question were in favour of statutory regulation (72%). The recurrent theme of expressing a wish for a stronger evidence base to be established for alternative medicine is reflected in approximately 11% of responses to this question. It is important to note that 8% of respondents found the questionnaire to be confusing, at least in part, with some questions being, in effect, several questions in one. In addition, comments expressed by an organised campaign group made this same point regarding the complexity of the consultation.

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Comments relating to vested interests This section highlights a concern noted within the consultation regarding vested interests of some respondents. Need for independent pan-national peer-reviewed research: “The risk to the public would be reduced by, and only by, making anyone who wishes to practise the forms of treatment in question provide a firm evidence base for the safety and efficacy of their treatments. This evidence base should be peer-reviewed and conducted by a variety of medical establishments across countries which do not have any vested interest in the 'success' of TCM, as Chinese medical researchers do. Any system of treatment unable to produce such evidence to the standard which modern, controlled medications require should not be allowed to practise and the only instances of such treatment should take place in the controlled environment of research which may produce such evidence.” Member of the public Need for evidence base: “I have nothing against "alternative medicine". Indeed, I meditate, do breathing exercises, have reflexology on occasion, etc. I have a chronic neurological condition and I find them relaxing. What is worrying is that there are plenty of people who claim these and other alternative treatments actually physiologically help and can even cure certain ailments. These people, often with vested interests, are given enough voice as it is by certain credulous sections of the media not to mention their ability to spin on the WWW, and are BELIEVED quite categorically by a large proportion of the public. Some alternative treatments MAY indeed be effective to varying degrees, but it's the lack of proper evidence that concerns me. Giving them the same regulatory control as scientifically proven medicines is, I believe, extremely dangerous and a massive step backwards in the continued search for treatments and cures for diseases.” Member of the public Pittilo committee: “I find it a bit odd that the Pittilo committee out of which this questionnaire comes consisted of five acupuncturists, five herbalists and five representatives of traditional Chinese medicine. Why was there was not a single scientist or statistician to help in the assessment of evidence? Is this because statisticians (no, wait, anybody with elementary maths) would smell something funny in the fact that almost all trials of Chinese medicine done in China come out positive, whereas almost all done elsewhere in the world come out negative? I have no financial interest in restricting alternative medicine. My only concern is with allowing the paying, and often scientifically illiterate public to discriminate between effective medicine, and "medicine" which has little or no effect, or effects derived from placebo. The members of the Pittilo committee, and many respondents to this questionnaire, *will* have a vested financial interest. I suggest you take this into account [...]” University Lecturer Pharmaceutical Society: “Definitely not the Pharmaceutical Society due to a professional conflict. The Pharmaceutical companies have a great deal of interest in maintaining the high usage rates of drugs and have a vested interest in discrediting the use of herbs and drug alternatives. Pharmacists themselves have no training or understanding of the way in which herbs work and my feeling is that many useful herbs would remain unregulated due to unfair bias. A separate body should

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be set up, the members of which should be come from a background of herbal medicine and alternative health practices.” Chartered Physiotherapist Pharmaceutical Council: “Pharmaceutical Council has vested interests in drug therapies and may not be favourable to herbal medicines.” Member of the Public Pharmaceutical Council “The pharmaceutical council has a vested interest in supporting the pharmaceutical profession - their own membership. Regulating practitioners and medicines used as an alternative to pharmaceutical products would create a conflict of interest for them, and therefore be inappropriate.” Drug companies: “None of these practices is big enough to finance expensive double blind type trials unlike mainstream professions bank rolled by vested interests like the drug companies. Therefore the SR should be different to avoid confusion to the public.” Member of the Public Drug companies & commercial interests: “The safety of herbal remedies has recently been subject to increasing amounts of scare mongering. The evidence of harm to the public as a result of using herbal remedies is in fact extremely small and much of the negative press has its origins in the drug companies and those with vested interests. The drug companies looe increasingly large potential profits to the increasingly large herbal market. More people are visiting herbalists every year, and this would not be the case if patients think they are being harmed. Qualified herbalists have never been complacent over the question of potential harm or interactions with other medicines and are fully aware of the dosage levels required of any herbal remedy to ensure safety. The CPP and MIMH also operate a yellow card reporting system for adverse reactions. As a qualified herbalist for 10 years, I've never had to use one. Most of the adverse reactions which have arisen from the use of herbal remedies have come from 'over the counter' remedies.” Medical Herbalist and Biomedical Scientist Commercial interests: “Unlicensed herbal medicines, which include all herbal medicines except those peculiar pharmaceutical preparations that have been granted licenses, can currently be prepared by anybody. I can see no valid reason for this to change. However, now that there is an incredibly stupid law, the Traditional Herbal Medicines, Products Directive, that has been formulated solely in the interests of capital and profit rather than health and safety, we now have to have some way of acknowledging a level of competence when it comes to making medicines that are not owned by capitalist vested interests. For example, a simple cinnamon and ginger decoction for clearing the tubes in the morning - a preparation that I freely give out to customers at my dispensary - will no longer be permissible without there being some acknowledgement that I, or whoever prepares it, is qualified to do so. Surely membership of a professional body, such as NIMH, should suffice?” Medical Herbalist

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ANNEX B Contributing Organisations The Department of Health would like to thank all of the organisations and professionals that contributed to this consultation with responses. Please see listed organisations for which responses have been received: Organisations which responded to the consultation ORGANISATION Alliance of Herbal Medicine Practitioners European herbal and Traditional Medicine Practitioners Association (ETMPA) Association Chinese Medicine Practitioners (UK) (ACMP) Acupuncture Society

Voluntary Regulatory Body UKAS UK Oriental Medicine- over 100 acupuncture practitioner members The Physiological Society Association Chinese Medicine&Acupuncture (ACMA) Association of Natural Medicine in Europe (ANME) The Association of Tradition Chinese Medicine (ATCM) Ayurvedic Practitioners Association Ayurvedic Trade Association BAcC and RCHM BMAS British Acupuncture Council British Medical Association Science & Education Department National Board Certified in Chinese Herbal Medicine Canadian Healthcare System Chinese Medical Institute and Register (CMIR) Chippenham Osteopaths Ltd Clinical Interest group of the

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Chartered Society of Physiotherapy University of East London, School of Health and Bioscience Complementary&Natural Healthcare Council Council for Healthcare Regulatory Excellence (CHRE) College of Practitioners of Phytotherapy Department of AYUSH (Ayurveda, Yoga, Unani, Siddha & Homoeopathy), Ministry of Health & Family Welfare, Government of India Doctor of Traditional Chinese Medicine - Sheffield Clinic of Complementary medicine Eden Herbs &Acupuncture Clinic European Ayurveda Association (EUAA) Federation of Holistic Therapists Federation of Taditional Chinese Medicine(FTCM) General Osteopathic Council Herbal Medicine Advisory Committee(HMAC) Individual Uk-Oriental Medicine Member Institute of Biomedical Science Irish Medical Herbalists Organisation (IMHO) Merton Group UK Ltd Microsystems Acupuncture Regulatory Working Group National Council of Medical Herbalists (NCMH) of Ireland NHS Peninsula Medicine School Pharmaceutical Society of Northern Ireland Register of Chinese Herbal Medicine(RCHM) Regulatory and Professional body Royal College of General Practitioners (RCGP) Save Our Herbs Campaign Sense About Sciene

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Speedwell and Wellbeing Trust State for Health Department of Health Statutory Body representing the views of the patients and public of Wales. Traditional Chinese Medicine Accreditation Board (TCMAB) The Association of Master Herbalists (AMH) The British Association for Counselling and Psychotherapy (BACP) The British Dietetic Association (BDA) The Trade Association of Producers and Suppliers of Ayurvedic Products from India The International Ayurveda Fundation The Herbal Forum The Aromatherapy Trade Council (ATC) The Ayurvedic Trade Association The British Herbal Medicine Association (BHMA) The Chinese Medicine Association of Suppliers The Council for Responsible Nutrition The European Herbal Practitioners Association (EHPA) The Health Food Manufacturers Association (HFMA) The Health Food Institute (HFI) The Natural Medicines Manufacturers Association (NMMA) The Proprietary Association of Great Britain The Small Growers and Producers Association (SGPA)

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College of Integrated Chinese Medicine(CICM) College of Traditional Acupuncture International College of Oriental Medicine (ICOM) London College of Traditional Acupuncture and Oriental Medicine

Northern College of Acupuncture University of Lincoln School of Health and Social Care University of Westminster School of Life Sciences College of Practitioners of Phytotherapy University of York Complementary Medicine Research Group Scottish School of Herbal Medicine Academy of Medical Royal Colleges College of Integrated Chinese Medicine University of Central Lancashire School of Psychology University College London Dept of Pharmacology University of Westminster Royal College of Physicians University of Warwick Business School British &International China College of Oriental (BICCOM) University of Lincoln University of Manchester University of Westminster Integrated College of Chinese Medicine (ICCM) College of Practitioners of Phytotherapy (CPP) Associate Dean of Undergraduate Medicine School of Medicine and Health Archway Campus Of Middlesex University Wolverhampton University

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Weleda (UK) Ltd Stephen &Carol Church Archway Clinic of Herbal Medicine The Fertility Support Company Archway Clinic of Herbal Medicine

Ashridge Consulting Ltd United Reformed Church Body Harmonics The Scottish Parliament Breast Cancer Haven Stroud Natural Health Clinic The King’s Fund The Herbalist's Clinic,Dispensary and Garden Solicitor - Sacker & Partners LLP Solway Holistics Somerbys Limited M. Bournetech Ltd Proline Botanicals herbal medicine factory Rebecca & Sascha Kriese

Wersten Herbal Medicine MSP for Clydebank and Milngavie Munro Health Co-Operative Ltd. Namaste Herbal Healing The Barn Practice Clinic of Interactive Medicine Jaguar Cars LACORS Mandarin Healthcare Ltd Medical School Council Panacea Health Ltd Herbal Infusion Balance Healthcare Limited Herbal World Herbs of Nature Natural Healing Centre Limited Natural Health Options Ltd Cavendish Cancer care CB Richard Ellis Investors /Strategic Partners Group Chain Operator of Chinese Medicine Geraldine Bethune Gracefield Theraphy

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Hamblys Natural Health Centre Exmoor Medical Centre Patient Participation Group The Journal of Chinese Medicine Charnwood Technic Art Limited Charter Daycare Ltd Hydes Herbal Clinic HealthWatch Intouch Bodywork

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6. Conclusion We would like to thank everyone who took the time to respond to this joint consultation.

It is now clear that this is a complex area and that opinions vary widely as to whether some form of regulation is needed. This report is issued as a factual analysis only. Discussions have continued between the four UK countries as to the most appropriate course of action, bearing in mind the need to protect public safety and against the background of EU requirements from April 2011. © Crown copyright 2011 First published February 2011 Published to DH website, in electronic PDF format only. http://www.dh.gov.uk/consultations

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analysis report on the 2009 consultation - uk...

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