Effective regulation of the complementary and alternative health sector serves the public interest by protecting consumers from unsafe or inadequately trained practitioners, and from products that are unsafe or make misleading claims. [No country has achieved effective regulation of "the CAM sector" or of health-related "CAM" products that are unsafe or are marketed with misleading claims. How effective a law is depends on how it is written and how well it is enforced. Many laws and regulations serve only to protect what they are alleged to regulate.] All the countries surveyed in the first part of the discussion document regulate CAM products and practitioners separately. Some (eg, Australia) have or are developing a national system for regulating products, but regulate practitioners on a regional basis.
Regulation of practitioners can be statutory or voluntary. Both forms have similar functions, but only statutory regulation is upheld in law. Statutory regulation usually requires practitioners to register with a single national or state council or licensing board. It may also confer protection of title, allowing only registered practitioners to use a particular professional title.
Statutory regulation is most often applied to higher-risk CAM modalities. These include modalities that use interventions such as spinal manipulation (eg, chiropractic, osteopathy), invasive techniques (eg, acupuncture) or ingested substances (eg, herbal medicine). Products such as dietary supplements and herbal remedies may also be regulated by statute.
Voluntary or self-regulation of practitioners is more common in CAM than statutory regulation. [Voluntary or self-regulation usually means no regulation.] Professional bodies representing CAM practitioners who are not regulated by statute often establish protocols for self-regulation. The House of Lords Select Committee on Science and Technology has identified several key features of an effective self-regulating professional body. For example, such a body should enforce ethical and conduct codes, disciplinary and complaints procedures, and educational standards (House of Lords Select Committee 2000). [I am not aware of any such body that has done anything that actually protects consumers.]
NEW ZEALAND
Currently the only legislation that specifically regulates complementary and alternative health practitioners in New Zealand is the Chiropractors Act 1982. The Medicines Act 1981 and the Medicines Regulations 1984 impose some regulatory controls on CAM products. However, there are several legislative provisions and policies that have an impact on CAM practice and products.
Legislation and policies relating to the regulation of health practitioners and therapeutic products are currently in development. These are highly relevant to CAM. The Health Practitioners Competence Assurance Bill and the proposed joint Trans-Tasman agency for the regulation of therapeutic products are discussed below.
Regulation of practice
The following legislation and policies currently regulate individuals who practise complementary and alternative medicine: the Physiotherapy Act 1949, the Massage Parlours Act 1978, the Medicines Act 1981, the Chiropractors Act 1982, the Health and Disability Commissioner Act 1994, the Medical Practitioners Act 1995, the Fair Trading Act 1996, and the Code of Health and Disability Services Consumers' Rights 1996 (pursuant to the Health and Disability Commissioner Act 1994).
Health professionals who are regulated by statute (for instance, doctors, nurses and dentists) and who also practice CAM are subject to the above provisions as well as to their own professional statutes.
In some areas (eg, Auckland) the premises and equipment used by CAM practitioners also have to comply with local bylaws.
Chiropractors are currently the only statutorily regulated CAM profession in New Zealand. They must complete a recognised training course and register with the New Zealand Chiropractic Board. Membership of the main professional body, the New Zealand Chiropractors' Association, is voluntary. Members are required to participate in continuing professional development.
Practitioners of other CAMs may, if they wish, register with a voluntary, self-regulating professional body. These include umbrella organisations that represent many different CAM modalities, such as the New Zealand Charter of Health Practitioners (the Charter), or modality-specific professional groups, such as the New Zealand Register of Acupuncturists. Many of the latter organisations are affiliated with the Charter.
Many of the individuals currently practising CAM have received formal training from private training establishments registered with the New Zealand Qualifications Authority (NZQA). These offer a range of NZQA-approved courses on CAM. The various voluntary, self-regulating professional bodies usually require their members to hold specified qualifications. However, as membership of such bodies is voluntary, standards of training may vary between, and even within, the various CAM modalities. [Searching the NZQA database for "homeopathy" and "homoeopathy"I found four approved diploma courses, including one on "animal health." "Aromatherapy" yielded six courses. "Cranio-sacral" and "iridology yielded one each. Judging from the number of nonsensical practices NZQA approves, it appears that scientific merit is not among its criteria.]
Voluntary registration bodies may also require their members to undertake postqualification training and development. It has been suggested that continuing professional development is not common in CAM (House of Lords Select Committee 2000); however, the New Zealand Charter of Health Practitioners does require its members to undergo continuing professional development.
Regulation of products
Complementary and alternative health products can be categorised as medicines, dietary supplements or foods, and are regulated accordingly. The categorisation depends on the nature of the product itself and on the wishes of the manufacturer.
Complementary and alternative health products are currently regulated by the following legislation and policies: the Medicines Act 1981, the Food Act 1981, the Medicines Regulations 1984, the Food Regulations 1984, the Dietary Supplements Regulations 1985, the Fair Trading Act 1986, the Consumer Guarantees Act 1993, the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods 1993: Part 1: Manufacture of Pharmaceutical Products, and the Australia New Zealand Food Standards Treaty 1995.
Most CAM products are marketed as dietary supplements, which require no pre-market approval. Controls on safety and quality are minimal, and problems may only be detected if adverse reactions occur. There is currently no specific reporting system for monitoring adverse events related to CAM products. However, the Centre for Adverse Reaction Monitoring based at the University of Otago encourages the reporting of such events. It is currently illegal to make specific therapeutic claims for products such as dietary supplements and herbal and homoeopathic remedies. However, this situation may change under the proposed joint agency for the regulation of therapeutic products (see below).
Health Practitioners Competence Assurance (HPCA) Bill
The HPCA Bill is intended to protect the health and safety of the public by establishing processes to ensure that regulated health practitioners are competent to practise. It will replace the 11 existing health occupational regulatory statutes.
The HPCA Bill proposes a single overarching Act containing a framework for the governance and functions of registering authorities. It is intended to ensure consistency between the professions.
The proposed Bill will enable one currently unregulated profession, osteopathy, to become regulated by statute. It also provides a mechanism for other CAM professions to be added to the regulatory regime without the need for separate Acts of Parliament. In the future, new professions that meet the criteria for statutory regulation may be added by Order in Council.
The HPCA Bill provides for the statutory regulation of professions that meet one or both of the following criteria:
Proposed trans-Tasman agency for the regulation of therapeutic products
It has been proposed that a joint trans-Tasman agency be established to regulate therapeutic products. The proposal is outlined in a discussion paper (Medsafe 2002). The proposed agency would regulate all medicines, medical devices, dietary supplements and complementary and alternative health care products in Australia and New Zealand. It would replace Medsafe in New Zealand and the Therapeutic Goods Administration (TGA) in Australia.
Under the proposed agency, new legislation would be drawn up to specify the controls applying to therapeutic products in both countries. Items with a higher risk profile, such as prescription medicines, would be more strictly controlled than those with a low risk profile, such as dietary supplements.
The New Zealand and Australian governments have agreed in principle to establish such a joint agency, subject to satisfactory negotiation of governance and operational arrangements. If the proposals are approved, the new joint agency will be established in 2004.
Complementary and alternative practitioners and products in the UK are subject to a range of general statutory controls, including the Health and Safety at Work Act 1974, the Consumer Protection Act 1987 and the Food Safety Act 1990. Common law also impacts on the practice of CAM as it contains a right to practise medicine (House of Lords Select Committee 2000). Under common law, activities tend to be tolerated unless expressly prohibited. CAM practitioners in the UK are therefore largely free to operate so long as they do not falsely claim to be a member of a regulated profession (eg, a medical doctor, an osteopath), practise in protected disciplines such as dentistry or midwifery, or supply prescription-only drugs (Mills 2001a).
In the UK, osteopaths and chiropractors are currently the only CAM practitioners regulated by specific legislation: the Osteopaths Act 1993 and the Chiropractors Act 1994, respectively. Note that it is the practitioners, rather then the modalities, that are regulated. Other therapists may use osteopathic or chiropractic techniques provided they do not claim or imply that they are osteopaths or chiropractors.
The House of Lords Select Committee on Science and Technology recommended in 2000 that acupuncture and herbal medicine should be regulated by statute. They also suggested that statutory regulation for non-medical homoeopaths might eventually be appropriate. The Select Committee recommended that the various voluntary bodies representing other CAM professions come together to form a single, voluntary, self-regulatory body for each modality. It cautioned against the establishment of multidisciplinary bodies (House of Lords Select Committee 2000). [Regulation of nonmedical homeopaths is pointless. Nobody without a medical license should be permitted to practice homeopathy.]
The herbal medicine and acupuncture professions in the UK are currently preparing to apply for statutory regulation. Such regulation is also expected to encompass traditional practitioners who use acupuncture or herbalism as part of their practice (eg, practitioners of Ayurvedic and traditional Chinese medicine). In the future, CAM professions who apply for statutory regulation in the UK will be able to do so under Section 60 of the Health Act 1999, rather than through the time-consuming process of pursuing their own Act of Parliament. In this way the Health Act 1999 resembles New Zealand's Health Practitioners Competence Assurance bill.
Legislation regulating herbalists could be drawn up by the end of 2004. The UK government may link such legislation to planned changes in the Medicines Act 1968. These changes are intended to improve the safety and quality of some herbal remedies that are currently unlicensed and only available from herbalists. The intention is to link access to such remedies to a requirement for registration under the new statutory regulation scheme for herbalists.
It is doubtful that legislation regulating acupuncturists will be in place before 2005 (A. Walker, Department of Health [London], personal communication 2002).
Medicines sold or supplied in the UK are regulated by the Medicines Act 1968. If defined as a medicine under the Act, CAM products require a marketing authorisation (or 'product licence') before entering the market. To be granted a licence, manufacturers must supply evidence of safety, quality and efficacy. Herbal remedies are exempt from licensing requirements if they meet the following conditions set out in Section 12 of the Act:
Although there are several hundred licensed herbal remedies on the market in the UK, the majority are unlicensed products.
New homoeopathic remedies must be registered before entering the UK market. Specific recommendations for their use are not permitted. Remedies must satisfy quality and safety criteria. Evidence of efficacy is not required.
Proposed changes to the Medicines Act 1968 might affect the regulatory status of some unlicensed CAM products that are currently only available from practitioners.
Osteopathy and chiropractic are recognised in all US states. Osteopaths are fully licensed physicians with the protected title Doctor of Osteopathy (DO). They are entitled to practise in any state and are generally regarded as part of mainstream medicine. Osteopaths have their own medical schools and are required to undergo training similar to that of biomedical doctors. Chiropractors are regulated in all states but, unlike osteopaths, are not licensed physicians and are not regarded as mainstream. Chiropractic achieved recognition despite sustained objections from the American Medical Association. The debate culminated in a Supreme Court judgement in favour of the chiropractors. US doctors are now obliged to refer to and receive referrals from chiropractors. [That is not true. Doctors are free to do whatever they believe is in the best interest of the patient.]
The situation with regard to other CAMs is complex, as each state decides its own independent policy on the regulation of practitioners within its jurisdiction. State Medical Practice Acts generally limit the practice of medicine to licensed professionals such as doctors. As state statutes tend to define 'medicine' broadly, CAM practitioners in the US can face legal risks (Cohen 2000).
Some states have developed regulatory or licensing arrangements for some CAM practitioners. For example, many regulate acupuncture and require practitioners to be trained to a specified standard. The National Certification Commission for Acupuncture and Oriental Medicine plays a role in setting standards in individual states. [The standard does not require the practitioner to make competent medical diagnoses.] Some states limit the practice of acupuncture to medical practitioners or to those under a medical practitioner's supervision. Naturopathic medicine is also recognised and licensed in several states.
New York State passed an Alternative Medical Practice Act in 1994. New York now recognises all CAMs and supports consumer choice in health care. [This is not an accurate description. The law merely states that during disciplinary proceedings there must be input from someone who is identified as a "CAM" practitioner. The law has very little effect on the disciplinary process.]
The White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) recommends that 'states should evaluate and review their regulation of CAM practitioners and ensure their accountability to the public'. It also recommends that the Federal government assist states and professional associations in improving the regulation of CAM practitioners (WHCCAMP 2002). [The WHCCAMP report, which was very badly reasoned, has had no political effect and is considered "dead."]
CAM products that are defined as dietary supplements under the Dietary Supplement Health and Education Act 1994 are covered by a different and less rigorous set of regulations to conventional medicines. Manufacturers do not require Food and Drug Administration (FDA) approval before producing or selling dietary supplements. The regulations put the onus on manufacturers to ensure that supplements are safe prior to marketing. If safety concerns arise over a particular product, the FDA must prove that the product is unsafe before it can restrict its availability or remove it from the market. Manufacturers and distributors are not required to report any adverse reactions to the FDA. However, they must ensure that information on product labels is truthful and not misleading. [Passage of this law reversed a century of progress in consumer protection law and has caused the marketplace to be flooded with quack products. So far, the FDA has not been able to ban any dangerous herbal products. The law is a perfect example of what not to do.]
After products reach the market the FDA is responsible for monitoring safety. This is done mainly through voluntary adverse event reporting. The FDA also oversees the labelling and information content of dietary supplements. The Federal Trade Commission regulates the advertising of supplements.
In Canada each province may impose its own regulations on health professionals. There is, however, an umbrella organisation, the Federation of Medical Licensing Authorities, which has developed a set of criteria to guide provincial bodies on developing regulations for CAM practitioners. These criteria are aimed at promoting a level of consistency between provinces. They also recommend that, in all jurisdictions, practitioners be required to provide evidence on safety and efficacy. CAM practitioners are regulated by statute in the jurisdictions set out in Table 1.
| Practitioners | Jurisdictions |
|
Acupuncturists Chiropractors All provinces Massage therapists Naturopaths Osteopaths |
Alberta, British Columbia, Quebec Chiropractors All provinces British Columbia, Ontario British Columbia, Manitoba, Ontario, Saskatchewan, pending in Alberta Alberta, British Columbia, New Brunswick, Nova Scotia, Ontario, Quebec, Saskatchewan |
| Source: York University Centre for Health Studies | |
Many CAM modalities and practitioners remain outside specific regulation. They are, however, subject to 'laws of general application' such as the Criminal Code, relevant legislation on consumer protection, and laws governing civil matters (de Bruyn 2001).
In 1998 concerns over safety and quality led the House of Commons Standing Committee on Health to review the regulation of natural health products in Canada. The Committee's report, Natural Health Products: A new vision, recommended the establishment of a new regulatory body (Standing Committee on Health 1998). The Canadian government accepted all of the Standing Committee's recommendations on product regulation and a new Office of Natural Health Products was set up within Health Canada in 1999. That body is now known as the Natural Health Products Directorate (NHPD). The NHPD has recently published a new regulatory framework for CAM products. The regulations will require manufacturers of natural health products to be licensed and to comply with minimum labelling requirements. To obtain a licence, manufacturers will have to submit detailed product information and evidence for safety and efficacy before they can market their products. Holders of natural product licences will have to monitor adverse reactions associated with their products and report any serious reactions to Health Canada. Manufacturers and distributors will also have to meet standards for good manufacturing practices.
The new regulatory framework was published at the end of December 2001. Publication was followed by a 90-day consultation period. The regulations are now being implemented and will come into full force over the next two years. In the meantime natural health products will continue to be regulated under existing legislation as either foods or drugs.
Until the various State Medical Acts were passed, CAM practitioners throughout Australia were free to practise under a common law right similar to that of the UK (Fulder 1996). However, the regulation of CAM practitioners is now the responsibility of individual states or territories. Chiropractors and osteopaths are currently regulated in all Australian states. Medicare reimburses fees for osteopathic and chiropractic treatment. The State of Victoria has recently passed legislation to implement a regulatory system for practitioners of traditional Chinese medicine, and a Traditional Chinese Medicine Board has been set up to register practitioners. Queensland and New South Wales are expected to implement similar arrangements.
In April 2002 the federal government granted five CAM practitioner associations $A100,000 each to assist in the development of 'national uniform registration systems for suitably qualified practitioners in acupuncture, herbal medicine and naturopathy'. This is to enable practitioners to achieve registration before the introduction of goods and services tax (GST) in June 2003. After this date only 'recognised professionals' will be able to practise these modalities without charging GST. This is a one-off initiative and is not intended to replace the regulatory functions of the states and territories.
Australia has a national regulatory system administered by the Therapeutic Goods Administration (TGA) which covers all therapeutic products. The TGA includes an Office of Complementary Medicine, which deals specifically with CAM. A statutory committee, the Complementary Medicines Evaluation Committee (CMEC), has been established to provide the TGA with specialist advice on CAM products. CMEC evaluates new complementary medicines and considers the evidence to support any claims or indications for their use.
To be legally sold in Australia, products defined as 'therapeutic goods' must be included on the TGA's Australian Register of Therapeutic Goods. Regulation is on the basis of risk. Low-risk products must simply be listed on the Register. Their ingredients are evaluated for safety and quality, and manufacturers must have evidence for any claims that are made for efficacy. High-risk products have to be registered. They must be evaluated by an expert committee, which also examines the evidence on efficacy. Manufacturers of therapeutic goods must also comply with the appropriate codes on good manufacturing practice.
Raw herbs are outside the jurisdiction of the TGA.
Health care in Singapore is largely based on Western biomedicine. However, the Singapore health authorities recognise the importance of CAM and are taking steps to ensure it is practised safely. The Singapore Ministry of Health established a traditional medicine unit in 1995 (World Health Organization 2001).
The most popular form of CAM in Singapore is traditional Chinese medicine (TCM). Traditional Malay and Indian medicine are also available, as are 'Western' CAM modalities such as aromatherapy and chiropractic.
Regulation of TCM is currently being phased in under the TCM Practitioners Act 2000. This Act required all acupuncturists to be registered by the beginning of 2002. TCM general practitioners are to become registered in two to three years' time, and TCM herbalists will become registered some time after that. Apart from TCM there is no direct regulation of CAM practices, but some indirect regulation is provided by legislation covering biomedicine. The Singapore Ministry of Health is currently monitoring the situation (Wong Kum Leng, Singapore Ministry of Health, presentation, 2001).
All traditional Chinese proprietary medicines have to be approved by the Singapore Ministry of Health prior to import or sale. There is also legislation that governs the labelling of, and information provided with, traditional Chinese medicines. There is no legislation that directly covers any other CAM products.
Traditional Chinese medicine (TCM) is a complete diagnostic and treatment system dating back thousands of years. Its main tools are acupuncture and herbal medicines. China relied entirely on TCM until Western medicine was introduced at the end of the 17th century. By the end of the 19th century Western biomedicine had almost displaced TCM in urban areas. Although the Communist Party was originally committed to eradicating TCM, which they regarded as a legacy from imperial times, Chairman Mao felt that integration of the old and the new was the best way forward for the health of the nation. At the First National Health Conference in 1950 it was decided that TCM and Western medicine should be integrated into a universal health system (Fulder 1996). Today approximately 95 percent of general hospitals in China have traditional medicine departments (Bodecker 2001).
Practitioners are regulated by the State Administration of Traditional Chinese Medicine (SATCM). The regulations governing TCM are set out in the Anthology of Policies (SATCM 1997). Practitioners must have appropriate qualifications before they can offer TCM treatment. A degree is required to become a TCM physician. Holders of diplomastandard qualifications may practise TCM in a more limited fashion as a 'medical assistant'.
The regulations governing TCM products are set out in the Anthology of Policies (SATCM 1997). Products must satisfy quality and safety standards before they can be marketed in China or exported to other countries.