5.1 The principal purpose of regulation of any healthcare profession is to protect the public from unqualified or inadequately trained practitioners. The effective regulation of a therapy thus allows the public to understand where to look in order to get safe treatment from well-trained practitioners in an environment where their rights are protected. It also underpins the healthcare professions' confidence in a therapy's practitioners and is therefore fundamental in the development of all healthcare professions. In 1999 the Department of Health commissioned Mr Simon Mills and Ms Sarah Budd at the University of Exeter to produce an information pack on the regulatory prospects for complementary and alternative medicine[34]. This pack states that the purpose of regulation in healthcare is: "To establish a nationwide, professionally determined and independent standard of training, conduct and competence for each profession for the protection of the public and the guidance of employers. To underpin the personal accountability of practitioners for maintaining safe and effective practice and to include effective measures to deal with individuals whose continuing practice presents an unacceptable risk to the public or otherwise renders them unfit to be a registered member of the profession"[35].

5.2 All our witnesses saw that some form of regulation was important; there was widespread consensus that regulation, handled appropriately, had many benefits for the public and the professions. FIM has been heavily involved in promoting better regulation within the various CAM therapies. They explained that: "…in any healthcare profession's therapy group, the quality of care, treatment and patient safety must have the highest priority. In order to achieve this, systems of regulation need to be established and maintained" (P 88). FIM's position is that effective regulation of CAM therapies is central to development in many areas of CAM. Mr Michael Fox, Chief Executive of FIM, told us that "…we do believe at the Foundation that this issue of regulation and working with the complementary professions is fundamental and if that was established properly a lot of things would flow from it" (Q 103).

5.3 In their Regulatory Information Pack (see para 5.1), Budd and Mills also discuss the collateral benefits of regulation. They explain that regulation not only protects the public, but that it results in "…improved professional status and respect; promotion of unity, order, consistency and accountability; greater ability to negotiate with the Government and the NHS; secure therapy-wide benefits such as indemnity insurance; and high common standards for entry and continuing practice"[36].

5.4 The Government view regulation as important. In the Government paper: The New NHS Modern and Dependable, it is stated that: "The Government will continue to look to individual health professionals to be responsible for the quality of their own clinical practice. Professional self-regulation must remain an essential element in the delivery of quality patient services"[37]. In May 1998, the then Secretary of State for Health, Frank Dobson, addressed a conference at FIM at which he stated that the Government expected CAM professions "to attain the same standards of professional self-regulation expected of other healthcare professions" (P 105). The Department of Health's evidence also explained their aims for regulation within healthcare: "In matters of regulation, it is the Government's intention to maintain freedom of choice whilst ensuring that appropriate safeguards are in place" (P 101).

5.5 There are two distinct types of regulation, statutory and voluntary. The difference between these two types of regulation will be discussed later in this chapter. However, the type of regulation is probably of less importance than whether the regulation (irrespective of its type) is delivered effectively by a single regulatory body. Professor Edzard Ernst at the Department for Complementary Health Studies, University of Exeter, told us: "The nature of regulation (e.g. statutory regulation or self regulation) seems of secondary importance. What matters is that regulation achieves its primary aim, which is to protect the public. As long as this can be demonstrated, any form of regulation would seem welcome" (P 230).

Box 2    Status of Some CAM Voluntary Professional Bodies* in the United Kingdom.    Acupuncture — There are five associations representing non-statutory registered health professionals who practise acupuncture. By far the largest of these is the British Acupuncture Council which represents around 2020 acupuncture practitioners and is a result of a unification of five professional groups. The British Acupuncture Council are seen by Mills and Budd as having led the way in establishing verifiable standards of education for their profession. They are associated with the British Acupuncture Accreditation Board which, under an independent chairman, works with the relevant training courses to set out and audit standards of education and training. The British Acupuncture Council have a professional Chief Executive, a core curriculum and a revised code of ethics and practice. They have set up an acupuncture resource centre to encourage undergraduate and post-graduate research. Less is said by Mills and Budd about the other four professional associations in the acupuncture field, two of which failed to give information on how many practitioners they represent.    Alexander Technique — Because Alexander Technique professionals consider themselves not as healthcare professionals treating patients but as teachers teaching students, comparisons with other groups are difficult. Three organisations were identified which represent Alexander Technique Teachers; the largest of these is the Society of Teachers of the Alexander Technique which represents about ninety percent of therapists identified. They are the core group in wider discussions to create a new general council of teachers of the Alexander Technique. Most inter-group differences in this area are historical; however, one group, the Interactive Teaching Methods Association, was set up in 1993 with the view that any single body "should reflect the diversity" in the various training schools: therefore they aspire to be different.    Anthroposophical medicine — There are five bodies that represent Anthroposophical Medicine in the United Kingdom and each represents a different category of statutory practitioner so one is a medical association, one a nursing association, one an art therapists association and another a movement therapists association, while the last represents an approach that is limited to massage. This structure has inhibited moves towards the formation of a common body. Mills and Budd suggest it may be helpful for patients if there were an overarching standards group for all the associations involved.    Aromatherapy — There are twelve organisations representing aromatherapists who practise in the United Kingdom. Eleven of these are members of an umbrella association, the Aromatherapy Organisations Council which provides common codes of ethics and disciplinary procedures and represents the profession in legislative discussions. The one body that does not come within the Aromatherapy Organisations Council's remit is the Institute of Aromatic Medicine which is also the only body to try to use essential oils internally. The Aromatherapy Organisations Council is seen as an early precedent for trying to unite professional groups but there are signs of moves within some of the bodies they represent to establish their own working groups.    Cranio-sacral therapy — There has been an increase in the prominence of these therapy groups, in the wake perhaps of the registration of osteopaths. There are currently three organisations representing people practising these therapies, but recently there have been moves to integrate the cranio-sacral disciplines through the Forum of Cranial and Cranio-Sacral Practitioners.    Healing — There are twelve organisations representing healers practising in the United Kingdom. Five of these are represented by an umbrella body, the Confederation of Healing Organisations. Within this organisation is the British Alliance of Healing Associations which represents twenty-six additional county and church groups. Mills and Budd state that the Confederation has been an effective platform for a great variety of healing organisations and hope that a similar consensus will prevail over the coming years. One of the large professional bodies in this area has suggested that, considering the diversity of standards accepted by the various healing organisations, a two-tier registration with a statutory "professional register" and a voluntary "register" supported by different educational requirements would be appropriate.    Herbal medicine — Mills and Budd found that with the renewed popularity of herbal medicine in recent times there are a number of professional groups, some linked with other cultures or to particular approaches to diagnosis. Many are constituent organisations of the new umbrella body, the European Herbal Practitioners Association. The European Herbal Practitioners Association has declared that it is actively seeking statutory registration for its members and has been in discussions with the Department of Health already.    * The University of Exeter survey included as "professional bodies" those respondent CAM organisations with professional codes and appropriate corporate status and services to their members and the public. (See also Box 7 for the definition of a profession).    Homeopathy — Mills and Budd point out that homeopathy is practised by two separate groups; medical homeopaths are medically qualified practitioners regulated by the GMC, non-medical homeopaths are professionals who use homeopathy only. Four main bodies representing the non-medical homeopaths were identified. The largest of these is the Society of Homoeopaths. They have formally consulted their membership and committed themselves to pursuing a single register of homeopaths. They have begun to work with the second largest body, the UK Homeopathic Medical Association, and have agreed on National Occupational Standards and created a Joint Meeting of Organisations Representing Professional Homeopaths. Although this is evidence of improved co-ordination among professional homeopaths, there has so far been little communication between these groups and the bodies representing medical homeopaths.    Hypnotherapy — Professional organisation of hypnotherapists is complicated, partly because there is an overlap with the organisations representing psychotherapists who do not consider themselves complementary or alternative and so were not included in Mills and Budd's survey. They identified seventeen bodies representing hypnotherapists; five of these are members of the relatively new umbrella body, the UK Confederation of Hypnotherapy Organisations. Mills and Budd suggest hypnotherapy is an area where consensus has been 'particularly elusive' and there is a wide variation of educational standards and practice in the area. They hope the UK Confederation of Hypnotherapy Organisations will be a more successful initiative. And there are some doctors and dentists who practise hypnotherapy: many are members of the Society of Medical and Dental Hypnosis.    Massage therapies — Some massage treatments fall within the remit of beauty treatments but Mills and Budd only surveyed those that emphasise the health benefits of massage. They identified nine professional groups representing massage therapists and two umbrella organisations. The newest of these, the British Association for Massage Therapy, has been most successful at attracting the larger professional bodies and combines the four largest groups. However it is worth noting that many massage therapists also apply aromatherapy and may therefore be members of aromatherapy organisations or multidisciplinary organisations.    Naturopathy and nutrition — Although Mills and Budd looked at these two groups together they concluded they were different enough to justify the fact that they have different aspirations. The naturopaths are currently represented by two main voluntary bodies and the largest of these two bodies, the General Council and Register for Naturopaths, is actively moving to achieve consensus on regulation in the discipline. The nutritional therapists (non medical) are currently represented by three main groups although a new umbrella body, the Nutritional Therapy Council, has recently been set up to focus specifically on education and the development of National Occupational Standards. The largest of the nutritional therapy groups, the British Association of Nutritional Therapists, see a chance for the new Council to start playing a role in co-ordinating training colleges.    Reflexology -— There are many groups representing reflexologists, but there have been attempts to achieve consensus among them over recent years, particularly towards agreeing National Occupational Standards for the discipline. As part of a wider project with the Department of Health Mills and Budd identified the reflexologists as a useful pilot group to explore the practicalities of achieving greater consensus within a discipline. One outcome of this exercise is the recent launch of the Reflexology Forum that aims to represent every reflexologist in the country.    Shiatsu — Shiatsu was the only therapy which Mills and Budd found had become more fragmented over the past three years, even though it was originally a well-organised profession under one professional body. Over the past two years two new Shiatsu bodies have been created, resulting in five bodies overall. The Shiatsu Society, the oldest and largest Shiatsu body, supports the idea of statutory regulation, while the other Shiatsu bodies disagree and believe Shiatsu should remain voluntarily regulated.    Source: Mills, S. & Budd, S. (2000) (Op.cit.).    5.8 It is clear from Box 2 that the nature of the voluntary regulatory structures varies considerably across the CAM professions. In the light of such variations we asked the Department of Health if they were concerned about the lack of statutory controls in this area. The Department of Health made it clear that within each profession "CAM practitioners and products are currently subject to a wide range of statutory and non-statutory controls. Any concerns that CAM is insufficiently regulated must be set out in the context of this wide range of measures" (P 101). They outlined areas, shown in Box 3, where CAM is already subject to regulation of a general nature.

Box 3    General Statutory Regulation of CAM    -  The Health and Safety at Work etc. Act 1974 and its associated Regulations place a statutory duty on employers and the self-employed to ensure the health and safety of people affected by various activities undertaken on their premises;    -  The Food Safety Act 1990 controls the sale and supply of non-medical products for human consumption, which includes some products associated with CAM;    -  The provisions of the Trade Descriptions Act 1968 and the Consumer Protection Act 1987 are enforced by local authority Trading Standards Officers, and apply to professions which make claims for the goods or services they sell, including complementary therapists;    -  There is legislation relating to specific illnesses and medical conditions — for example, cancer and venereal disease — which prohibits non-medically qualified individuals from purporting to cure, or in some cases treat, them;    -  Many organisations which represent complementary therapists are registered charities or limited companies (or both) under the Charities and Companies Acts, and are subject to the provisions of those Acts;    -  The London Local Authorities Act 1991 requires the licensing of premises used for activities which include acupuncture, massage, and other special treatments;    -  Under common law all practitioners have a duty of care towards their patients;    -  In the private sector there is a contractual relationship between therapist and client, which is legally enforceable.    Source: Department of Health (P 104).

5.9 Another factor to be taken into consideration in relation to the regulation of CAM is that of the legal requirements for the practice of medicine. The Common Law right to practise medicine means that in the United Kingdom anyone can treat a sick person even if they have no training in any type of healthcare whatsoever, provided that the individual treated has given informed consent. (Treatment without consent constitutes an assault.) Persons exercising this right must not identify themselves by any of the titles protected by statute and they cannot prescribe medicines that are regulated prescription-only drugs. This means that, as long as they do not claim to be a medical practitioner registered under the Medical Act, then anyone can offer medical advice and treatment and can purport to treat a range of diseases, provided that they do not claim to cure or treat certain specified diseases as proscribed by law. The Common Law right to practise springs from the fundamental principle that everyone can choose the form of healthcare that they require. Thus, although statutory regulation can award a therapy protection of title, it cannot stop anyone utilising the methods of that therapy under a slightly different name.

5.10 Issues arising from the different position of medically qualified persons who practise CAM will be considered as a separate issue in the last section of this chapter.

Weaknesses of the Current Situation

5.11 As the outline of the current regulatory situation indicates, there is considerable variation in the levels of professionalisation within the CAM world. Even within some therapeutic disciplines there is considerable fragmentation, sometimes resulting in several bodies, each with different training and educational requirements, codes of practice and complaints procedures, representing therapists in the same field.

5.12 The General Osteopathic Council (GOsC) (now a statutory regulatory body) referred to the time when the osteopathic profession had been highly fragmented and explained that: "This situation, inevitably, gave rise to considerable public confusion amongst members of the public" (Q 412). They also explained that once they had overcome this problem and developed a single statutory self-regulatory body this gave "members of the public who hitherto may have been reluctant to consult an osteopath the confidence to do so" (p 102). The experience of the osteopathic profession shows the benefits for the public and ultimately the profession of having a well-organised and coherent regulatory structure. One serious problem of therapies represented by several professional bodies is that the disciplinary procedures of those bodies have little weight; if a practitioner is struck off one register, he, or she, can find another. Not all therapies have yet reached a stage where the public can find reputable, well-trained practitioners. The public cannot have full confidence in those therapies where there is considerable professional fragmentation. We recommend that, in order to protect the public, professions with more than one regulatory body make a concerted effort to bring their various bodies together and to develop a clear professional structure.

5.13 There are currently no specific measures that affect the practice of CAM by practitioners trained abroad. Without statutory controls it is impossible to enforce entry criteria for practice in the United Kingdom. A considerable proportion of unregulated healthcare is, in fact, provided for British subjects of other ethnic origins, by practitioners of their own culture. This practice has raised particular concerns when it involves the import and supply of traditional medicines from areas in the world where European Union level production standards do not apply. The MCA, in their submission with the Department of Health, confirmed that herbal imports from Asia, Africa and elsewhere gave them some concern (Q 40).

Box 4    Modern Principles of Statutory Self-Regulation in the Health Field    Regulatory bodies:    •  Are accountable to the public and Parliament for their actions and performance.    •  Must set clearly expressed standards of the knowledge, skills, experience, attitudes and values necessary for continuing practice.    •  Should demonstrate that their activities are conducted in an open and clear manner.    •  Should concern themselves with the competence and conduct of practitioners at all stages in their careers.    •  Should not delay in taking action to protect patients from serious adverse outcomes of care when such circumstances arise.    •  Should demonstrate their objectivity in making assessments and forming judgements about performance.    •  Should show that their procedures are free of racial and other forms of bias and discrimination.    •  Should take proper account of the health service context when making interventions.    •  If involved in education, should produce clearly stated standards for professional education and training by which the providers of education and training can be monitored and held to account.    •  Should operate clear and independent disputes procedures.    •  Should supply appropriate and valid information on their regulatory activities.    •  Should demonstrate an ability to work across different regulatory boundaries to develop consistent standards.    •  Should retain high public confidence and have sufficient lay involvement to make an effective contribution in their governance and operation.    •  Should ensure that those being regulated understand what is expected of them and the role of the regulatory body in relation to their practice and wider health services.    •  Should review and update standards regularly taking account of feedback from patients, practitioners and other interested parties.    •  Should ensure that their procedures are well-defined and transparent, that they are operated in a way that is fair and sensitive, and that their efforts to enforce standards are targeted in a way that is proportionate to the seriousness of the problems involved.    •  Should work in partnership with the NHS and with other organisations that provide or manage healthcare, thus enabling NHS organisations to achieve high standards of quality care for all those for whom the NHS is responsible.    Source: Budd, S. & Mills, S. (2000) (Op.cit.).

35   Budd, S. & Mills, S. (2000) (Op.cit.). Back

36   Budd, S. & Mills, S. (2000) (Op.cit.). Back

37   The New NHS Modern and Dependable, Department of Health, HSC 1998/228: LAC (98) 32, 8 December 1998. Back