Select Committee on Science and Technology Sixth Report


CHAPTER 5: REGULATION

Which Therapies Would Benefit From Statutory Regulation?

5.51 The Department of Health's written evidence stated that the Government does not see a need to single out additional CAM professions for special regulation. However they go on to say: "There is scope for the larger professions to follow the osteopaths and chiropractors in gaining statutory self-regulation, and this would undoubtedly serve their professions well. However there are also ways in which other professions could strengthen their self-regulation without statutory powers. For them the first step must be the formation of a lead self-regulatory body for each profession" (P 101).

5.52 However we are aware that since submitting their written evidence in December 1999 the Government have now identified acupuncture and herbal medicine as specific therapies they would like to see achieve statutory regulation. This was something that Yvette Cooper MP, Parliamentary Under Secretary of State for Public Health, told us at the end of our Inquiry: "I think we would support their moves towards statutory regulation…We would strongly encourage them to continue the process towards proper self-regulation and statutory regulation as well…We do think that in the area of acupuncture and herbal medicine it is perhaps more important than in other areas. Whilst we have done considerable work, particularly with Exeter University, in providing support and detailed information for all professions in terms of increasing self-regulation, for these two we think we need to take additional steps. One of the issues we are looking at, at the moment, is whether or not we should be setting a timetable for moves towards statutory regulation, and we are considering producing a consultation paper on that at the moment" (Q 1875). We welcome this approach.

5.53 The Osteopathic and Chiropractic professions are now regulated by law. It is our opinion that acupuncture and herbal medicine are the two therapies which are at a stage where it would be of benefit to them and their patients if the practitioners strive for statutory regulation under the Health Act 1999, and we recommend that they should do so. Statutory regulation may also be appropriate eventually for the non-medical homeopaths.

5.54 Our main criterion for determining the need for statutory regulation is whether the therapy poses significant risk to the public from its practice. We believe that both acupuncture and herbal medicine do carry inherent risk, beyond the extrinsic risk that all CAMs pose, which is the risk of omission of conventional medical treatment. Our other criteria for determining the desirability of statutory regulation include whether the therapy in question has a sufficiently well organised voluntary regulatory system, and a consensus among its members that statutory regulation is the desired next step for the profession. Although if a therapy posed significant intrinsic risks and had a poor voluntary regulatory structure, it might be worth the Department of Health putting pressure on that therapy to come under a statutory regulatory system, we were not made aware of any such cases. A final consideration in determining the desirability of statutory regulation is whether the therapy in question has a credible evidence base to support its claims. As statutory regulation is likely to increase the profile of a therapy it is important that there is evidence of benefit to patients suffering from the conditions it purports to treat as well as evidence that it carries few adverse effects.

5.55 If the professions of acupuncture and herbal medicine receive statutory regulatory status, then all but one of the therapies in our Group 1 will have statutory status. The present position with respect to homeopathy is less clear-cut. Medical practitioners who are members of the Faculty of Homeopathy are already regulated by the General Medical Council (GMC). The Faculty wish to see introduced a form of regulation of the non-medical homeopaths who are less certain of the potential advantages. We do not at present make any formal recommendation about the homeopathic profession but, nevertheless, feel that statutory regulation may ultimately be appropriate. Other professions must strive to come together under one voluntary self-regulating body with the appropriate features outlined in Box 5, and some may wish ultimately to aim to move towards regulation under the Health Act once they are unified with a single voice.

5.56 We heard evidence from the principal professional associations associated with acupuncture and herbal medicine to canvass their opinions on obtaining statutory regulatory status. We also talked to the Homeopathic associations about their views on this subject:

ACUPUNCTURE

5.57 In the case of acupuncture we heard from the British Acupuncture Council, the largest body representing non-statutory registered acupuncturists. They told us that they were well prepared to take the next step towards statutory regulation: "…we have been on a long path of voluntary self-regulation over the last 20 years. We now have a single umbrella body with the British Acupuncture Council. We have the educational standards, codes of practice, of ethics, and of professional conduct, which we can enforce. We have taken many steps along the road on a voluntary basis" (Q 769).

5.58 However, the British Acupuncture Council also told us that they had not yet reached consensus on whether they should take the step towards statutory regulation: "… initial debates within our community of acupuncturists have shown that opinion is somewhat divided on this point. There are concerns by some of our members around loss of autonomy and the cost involved in statutory self-regulation. However, on an informal basis, the profession is leading towards exploring the issues of regulation in more depth. We formed, for example, a Regulation Action Group, with expert advisers joining us, to look at the issues in more depth. We are starting patient focus groups to look at the patient perspective, and what would be in the interests of patients in terms of any moves towards statutory regulation: and informal discussion with osteopaths, to find out what we can learn from the path they have taken. As has been mentioned, we have made informal approaches to the Department of Health…but we would stress we need to carry the membership in any decision that we would move towards in terms of statutory self-regulation" (Q 769).

5.59 This evidence shows that under the guidance of the British Acupuncture Council the acupuncturists have worked hard to establish a voluntary regulatory structure which is commendable. They now have the prerequisites to obtain statutory regulatory status. Their concerns over taking this next step are founded on the ability to obtain a unanimous membership decision because their members may fear a reduction in their autonomy and an increase in the costs for which they are liable. We hope that these two fears will not prohibit this large, well-organised profession from striving to obtain statutory regulatory status. As we have discussed previously, the cost of achieving statutory regulation has been reduced with the provisions of the Health Act. The acupuncturists should also bear in mind the increased public and cross-professional confidence likely to result from statutory status; this will, we hope, allay their fears.

HERBAL MEDICINE

5.60 The European Herbal Practitioners Association, who represent the majority of United Kingdom herbalists, told us: "We feel that our future holds, in terms of statutory self-regulation, mostly prospects and benefits: the benefits for our members, but equally benefits to all the public, in ensuring competencies and safe practice. We do not see any threats. We do see uncertainties, however. There is still uncertainty about precisely what the 1999 Health Act will entail. It is a slightly different process to the one followed by osteopaths and chiropractors, so there is a certain amount that is unknown in regards to cost and financial implications"(Q 727). When asked if they thought the majority of medical herbalists will wish to seek statutory self-regulation they responded by saying yes, they did. The major incentive for this would be that there are a number of potentially harmful herbal medicines which they wish to be able to use, and currently are able to use under a schedule attached to the Medicines Act 1968. They expect that should they achieve statutory self-regulation, then registered professional herbal practitioners would be able to continue using those herbs (Q 728). The regulation of herbal practitioners is of course a separate issue from the regulation of herbal medicinal products. However the complicated issue of the status of herbal medicinal products will be discussed separately in the last section of this chapter.

HOMEOPATHY

5.61 The non-medical homeopaths were much the least enthusiastic of the three therapies in our Group 1 about pursuing statutory status. The Society of Homoeopaths told us: "I think it is true to say that we have decided that voluntary self-regulation is our current option but I would like to emphasise that we have also used the qualifying phrase "for the time being" because there are two strands to that if you like. One is to observe very closely and monitor the progress and experience of the osteopaths and chiropractors in their role post-statutory self-regulation. We do realise it has not been quite as seamless as it might have been in that perhaps there are building blocks, foundations, to regulation that were not necessarily in place before the statute was passed. So, for the Society we have recognised that we need to develop a very strong self-regulating profession with those key building blocks in place and then examine whether or not regulation by statute is appropriate (Q 687). "We look at it as an open question. We realise that the issue of protection of title is a very important one but currently we are not sure that it has been fully addressed by statutory regulation in that, as has already been said this morning, it is recognised that as soon as you make laws there are ways around it" (Q 688).

5.62 However the Faculty of Homeopathy, representing the medical homeopaths, already regulated by the GMC, told us: "We do strongly believe that to be the case [that homeopathy should only be practised by those statutorily registered]. This does not mean that the current practitioners who do good homeopathic work in the community should not continue to do so but perhaps their kind of practice should be regulated in such a way that it falls within safe practice. It perhaps calls for a new sort of profession of homeopathic practitioner" (Q 651).

5.63 Of all the professions in our Group 1, homeopathy carries the fewest inherent risks in its practice, at least in relation to the consumption of homeopathic medicines. We are also aware that there is unusually strong contention about the evidence available for its efficacy. These two points could be seen as arguments against statutory regulation which could be considered unnecessary due to the limited risks and could also be seen as awarding a degree of legitimacy to a therapy about which much of the conventional scientific world has strong doubts and reservations. However, in our opinion there are reasons why homeopathy should still consider progressing towards statutory regulation. While the practice of homeopathy may itself be free from risk, it does create an opportunity for diverting conventional diagnosis and treatment away from patients with conditions where conventional treatment is well-established, as some patients seem to see it as offering a complete alternative to conventional medicine. Such attitudes mean that homeopaths are in a position of great responsibility. It is imperative that there is a way of ensuring that this position is handled professionally, that all homeopaths are registered, that they know the limits of their competence, and that there are disciplinary procedures with real teeth in place. Protection of title and a single statutory register would help ensure that this happens. It would also be encouraging if there was more collaboration between the medical homeopaths of the Faculty and the non-medical homeopaths of the Society, with more communication and agreement over information services for the public, making their options in choosing a homeopath clear, and with agreed educational standards to ensure that all those practising homeopathy are trained in homeopathic practice to a similar level. If the Society had statutory status, it might well facilitate communication and collaboration between them and the Faculty (see paras 5.84 - 5.86). Under the Society of Homoeopaths, the non-medical homeopaths have organised themselves well and their professional organisation should mean the transition to statutory regulation does not present too great an upheaval. For these reasons we would urge them eventually to consider the benefits they may derive from statutory regulation.

Single Umbrella Regulatory Body?

5.64 We have also considered the option of a single "umbrella" regulatory body to cover all CAM therapies, or a significant number of them. There are currently several umbrella CAM voluntary regulatory bodies which plan to regulate practitioners from a range of different disciplines

5.65 We received written evidence from the Institute for Complementary Medicine, one such umbrella body. They told us: "The Institute for Complementary Medicine favours a single Act which recognises the autonomous divisions of specialist treatments as being the most beneficial, cost effective and efficient method of protecting professional practitioners whilst offering a transparent service to the public" (P 136). However, we are uncertain as to what they would do to overcome the fact that the diverse range of therapies which come under the title of CAM have a huge range of different educational and regulatory needs, while some have a weak, or even non-existent, evidence base[40].

5.66 We also heard from the British Complementary Medicine Association. This claims to be "…the major Complementary Medicine multi-therapy umbrella body in the United Kingdom, representing some 45 single therapy organisations (some of which are in themselves umbrella bodies for a single therapy)" (P 32). The British Complementary Medicine Association told us how they thought the diversities could be overcome so that therapies could unite under one body: "The first breakdown should be into alternative and complementary, as we have defined it. That gives you a good structure - those who make a medical diagnosis and those who do not. Then you come to the others. The system we operate is that each therapy has its own organisation and some of them have achieved an umbrella group for themselves in one therapy. What we would like to do is to say that a therapy must get together, whether it is inside the British Complementary Medicine Association or not. There is only one way to go, which is to get a body representing all the therapists in a particular therapy. That is the way, we feel, that you can combine strength, good practice, good regulation and so on" (Q 622).

5.67 The option of a single umbrella body was not favoured by most of the evidence we received, including the evidence of the Department of Health. Yvette Cooper MP, Parliamentary Under Secretary of State for Public Health, told us that she "would be personally uneasy about going too rapidly towards umbrella organisations that do not have sufficient concentrated expertise or thoroughness when it comes to regulating a particular area" (Q 1876). We recommend against it for several reasons. Umbrella groups do not, in themselves, obviate the need for all practitioners within one particular discipline to come together and agree standards of training, professional practice and requirements for Continuing Professional Development. It is impossible adequately to enforce any code of practice unless these basic fundamental provisions are in place. In short, common codes of practice are irrelevant until there are agreed standards of clinical care for each discipline and only the practitioners of each discipline can determine this by coming together and achieving a consensus. Umbrella bodies may also give a cloak of respectability to practitioners who may have minimal training in one or more of the different therapies. They may also encourage multi-therapy practitioners who want to mix a number of different therapies without being properly trained in one or more of them. There is an argument that anyone practising more than one therapy should at least have a grounding in a discrete clinical discipline so they have been exposed to training in basic medical sciences.

Regulation of Conventional Healthcare Professionals Practising CAM

5.68 The current position relating to the regulation of statutory regulated health professionals such as doctors, nurses, dentists and veterinary surgeons, who wish to incorporate CAM practice into their repertoire of therapies is very different from the position of CAM practitioners.

5.69 The GMC, the regulatory body for doctors, gave evidence to us. The code of ethics and disciplinary procedures of the GMC extend to the use of all the therapies a doctor may use in treating patients and therefore the GMC is responsible for regulating the use of all CAM therapies by doctors. They acknowledged that under the Medical Act 1983 a registered medical practitioner is technically free to practise any form of CAM or other therapy they believe will help their patients (Q 1045). However, they told us that "...we would wish them to practise within their competence. If they practised outwith their competence we would have strong views on that" (Q 1045). "These individuals need to be appropriately trained for the practice that they are going to be pursuing. So there is a gradation of training from undergraduate to post-graduate and then when problems do arise there is the policeman role of the General Medical Council, which will deal with a very small minority of medical practitioners. It is an unfortunate necessity" (Q 1061).

5.70 The GMC acknowledged that problems may arise with doctors practising CAM poorly and needing to be subject to a disciplinary action that might be consistent with a CAM regulatory body's process, but inconsistent with a GMC disciplinary process. Because of this they stated that "…it does mean that where such a body could be set up the interaction with the General Medical Council has got to be very close…there is no reason to doubt that there could be a very smooth interaction between such regulatory bodies. The example, I think, is again the General Dental Council and the General Medical Council, which has worked extremely well" (Q 1051).

5.71 The GMC also explained that they could discipline a doctor, not only for practising a therapy for which he had not received proper training but also for putting patients at risk by practising a totally unproven therapy, not supported by any evidence (Q 1053).

5.72 The GMC has guidelines on the position of medical practitioners wishing to refer patients to other practitioners and, although these guidelines are general, they expect doctors to observe them in relation to CAM referrals as with all other referrals: "Where doctors refer patients to an alternative or complementary practitioner, Good Medical Practice requires doctors to be satisfied that the healthcare workers concerned are accountable to a statutory regulatory body" (P 96). In terms of the position of a doctor who delegates treatment to a non-statutory regulated practitioner and still retains full responsibility for the patient's healthcare they explained: "...the doctor cannot delegate responsibility completely to another non-professional colleague but could delegate part of the treatment task to that individual. They retain overall responsibility for the care of the patient. I think, because of that, they have got to take great care in what they seek to delegate to someone else" (QQ 1059 & 1060).

5.73 The regulatory body for nurses, the United Kingdom Central Council for Nursing, Midwifery and Health Visiting (UKCC), told us that their members could practise CAM as long as they did so within the general guidelines on conduct and professional practice set out by the UKCC to apply to all nursing practice: "The UKCC believes that any registered practitioner who chooses to practise complementary therapies within their own sphere of practice should do so in accordance with the standards expected of that practitioner, and that is within the Code of professional conduct and by the principles laid out in the scope of professional practice. They indicate that if somebody is going beyond what their initial training encompassed, they should actually look at those principles to guide any further development" (Q 565). The UKCC do not issue specific guidelines on what training courses they consider are of an appropriate standard for nurses who want to learn about specific CAM therapies, but they did say that if a nurse practised a therapy for which they had "not sought the appropriate training" (Q 566) this could be considered a breach of the code of conduct.

5.74 The UKCC's emphasis is on nurses practising self-regulation and they offer very little specific guidance on which therapies are safe or appropriate or on where to train in specific therapies. Considering nurses are a group known often to practise CAM, especially those therapies in our Group 2, this seems to be an area where clear guidelines would be beneficial. However the UKCC did tell us: "We are responsive to the needs of people on our register and if we do receive a large number of enquiries from nurses etc. about this particular aspect…that is how we develop new guidance in response to their needs. So, yes, we would be prepared to consider guidance if the need was evident" (Q 585).

5.75 We also heard evidence about the regulation of veterinary surgeons wishing to practise CAM. The Royal College of Veterinary Surgeons pointed out that the Veterinary Surgeons Act 1966 limits the treatment of animals to qualified veterinary surgeons although others can treat animals under the direction of a veterinary surgeon who has examined the animal and prescribed the treatments (p 193). Thus they told us: "The underlying position is...that complementary and alternative treatments which amount to veterinary surgery are already subject to statutory regulation" (p 193). We also heard from the Association of British Veterinary Acupuncture which represents veterinarians who wish to practise acupuncture. They told us: "We believe that veterinary surgeons are the only people sufficiently qualified to really fully assess the health of any animal, to make a diagnosis about conditions, to formulate a treatment and to present a prognosis. This applies to conventional or complementary medicine. The principles of this are embodied in the Veterinary Surgeons Act, which gives us a rather nice monopoly to look after the welfare and health of animals in our care" (Q 807). Although the Association of British Veterinary Acupuncture is in a good position to advise veterinarians wishing to practise acupuncture, we heard no evidence that the Royal College of Veterinary Surgeons or any other veterinary body has issued formal guidelines for veterinarians wishing to practise CAM, or on relevant training courses, but informal guidelines are emerging.

5.76 The General Dental Council (GDC), the statutory body for the regulation of dentistry, told us that: "Dentists may be involved in complementary and alternative medicine in a number of ways. The Council would expect that at all times dentists would act in accordance with those sections of the Council's ethical guidance which have a bearing on these matters" (p 75). The ethical guidance to which this quotation refers is published in the Council's document Maintaining Standards which deals with issues such as acting in the patient's best interests, providing a high standard of care, the obligation to obtain patient consent and the seriousness of making misleading claims in relation to any treatment. However, it does not explicitly refer to complementary medicine at any time. The GDC told us: "The Council does not consider that this guidance needs amendment although it anticipates, in the light of greater public interest in complementary and alternative approaches, more discussion on these matters particularly in relation to the exercise of its jurisdiction" (p 76).

5.77 The evidence we have heard from the conventional medical, nursing, dental and veterinary regulatory bodies makes it clear that they all take quite a passive position on their members practising CAM. None of them has promulgated clear guidelines for their members who may be practising CAM. This means that the position of those working in these professions who wish to practise CAM is not very clear.

5.78 However, one body that has issued guidelines in this area is the BMA. In their document New Approaches to Good Practice they state: "Medically qualified practitioners wishing to practise any form of non-conventional therapy should take recognised training in the field approved by the appropriate regulatory body, and should only practise the therapies after registration"[41]. This is not at present practicable.

5.79 We recommend that each existing regulatory body in the healthcare professions should develop clear guidelines on competency and training for their members on the position they take in relation to their members' activities in well organised CAM disciplines; as well as guidelines on appropriate training courses and other relevant issues. In drawing up such guidelines the conventional regulatory bodies should communicate with the relevant complementary regulatory bodies and the Foundation for Integrated Medicine to obtain advice on training and best practice and to encourage integrated practice.

5.80 Although the main conventional regulatory bodies are not providing guidance for their members on CAM practice, there are some bodies which represent conventional practitioners who practise certain CAM therapies. The Faculty of Homeopathy is one such body representing medical practitioners who wish to incorporate homeopathy into their practice. The British Medical Acupuncture Society is a similar body representing medically qualified acupuncturists. These bodies provide an information resource for doctors interested in this area; they also run training courses specifically designed for medically qualified people wishing to train in the therapy in question. These bodies have a valuable role in promoting and regularising the position of CAM in the conventional medical world; however, it is not compulsory for conventional practitioners who practise CAM to be members of these bodies and they are not regulatory bodies (as their members are already regulated by the GMC or the UKCC).

5.81 One weakness in the current situation is the lack of communication between those bodies representing conventional medical practitioners who also practise specific CAM therapies and the CAM bodies representing individual therapies. This leads to little agreement on educational standards, little collaboration on research and, most worryingly, no clear agreement on information policies within a therapy to help the public understand their options when wishing to consult a practitioner of a particular therapy. For example, the British Medical Acupuncture Society told us that, although they are beginning to try and build bridges with the British Acupuncture Council (which represents non-medical acupuncturists), their meetings are at an "embryonic stage", and although they hope to discuss a way of helping the public understand their options this had not happened yet (Q 1021). In fact they told us that a member of the public might only distinguish between a medically qualified acupuncturist and a non-medical acupuncturist by "careful inquiry" and even then there may "still be some confusion" (QQ 1026 & 1027). Similarly the Faculty of Homeopathy told us there have not been any planned or significant discussions with the Society of Homoeopaths on giving the public clear advice on choosing a homeopath (Q 673).

5.82 We also heard from the bodies representing statutory regulated health professionals practising CAM about their attitude towards the level of training required of medically qualified personnel who wish to practise CAM therapies, in comparison to the level of training that should be required of non-medically qualified persons. The Faculty of Homeopathy told us that their core curriculum for training in the specialism of homeopathy has been developed independently of that of the Society of Homoeopaths because "we are not training the same people so a core curriculum for someone starting from scratch to become a homeopath is a completely different training pathway from the core curriculum for a doctor that has done undergraduate and postgraduate training" (Q 672). When we questioned them on which group was given more in-depth training on the principles of homeopathy itself (as opposed to physiology, research methods etc.) they said: "I think the membership exam in homeopathy in terms of homeopathic training for the homeopathic remedies, analysis and skill is probably similar to the Society of Homoeopaths" (Q 671).

5.83 We would encourage the bodies representing medical and non-medical CAM therapists, particularly those in our Groups 1 and 2, to collaborate more closely, especially on developing reliable public information sources. More collaboration on developing core curricula would be valuable, as it is important that both medically qualified and non-medically qualified practitioners are trained to the same level of skill in the therapy in question; sharing the knowledge of how to do this and spreading training resources will benefit both groups. We recommend that if CAM is to be practised by any conventional healthcare practitioners, they should be trained to standards comparable to those set out for that particular therapy by the appropriate (single) CAM regulatory body

5.84 The indemnification of medical practitioners and other health care professionals who wish to practise CAM is also an important issue. We were made aware of the guidance of the Medical Protection Society to its members on the use of CAM. This guidance is as follows:

    "The Society recognises the benefits from bona fide complementary techniques and does not wish to inhibit members from providing treatments proven to be beneficial to patients.

    "Practitioners should only undertake procedures which are in the patient's best interests and for which the practitioner has the requisite skill, training and facilities.

    "In the event of any claim, complaint or other legal challenge the practitioner must be able to demonstrate that he or she was acting in accordance with recognised medical practice, and that experts in the field would support that form of management.

    "The Society's Council considers it improper for practitioners to employ unproven or speculative techniques, and will not usually provide an indemnity in such circumstances. Council expects members of the Society to participate in continuing medical education to ensure that they remain fully up to date in their chosen areas of practice and participate in audit.

    "Practitioners offering alternative forms of medicine should notify the Society of the technique employed within their practice and answer any supplementary questions. Withholding information or providing false or misleading answers, will usually disqualify the practitioner from any benefits of membership for incidents arising from any form of medical practice."

5.85 Under the Dentists Act, individuals are restricted as registered dentists to undertaking the business and practice of dentistry. Therefore in providing CAM as registered dentists this must only be done in conjunction with the practice of dentistry. Should a dentist offer CAM treatment outside the scope of the practice of dentistry, then he would not be providing it as a registered dentist and such treatment would not be covered by any indemnity offered by a protection organisation.


40   Although the GMC represents doctors from a diverse range of specialties, a single regulatory body is appropriate as they all have the same basic training and core of knowledge, a claim which cannot be made for all CAM therapies. Back

41   British Medical Association. Complementary Medicine: New Approaches to Good Practice (Oxford University Press, 1993). Back