Regulation of CAM

Statutory regulation

·       CAM products and practitioners are subject to a variety of legislative provisions.

• Currently, there is no specific legislation to regulate CAM practitioners, with the exception of chiropractors who are regulated by the Chiropractors Act 1982. However, the following regulatory provisions all have an impact on CAM practitioners:

 Fair Trading Act 1996

 Medical Practitioners Act 1995

  Medicines Act 1981

 Health and Disability Commissioner Act 1994

Code of Health and Disability Consumers’ Rights

 

• CAM products are regulated by an array of legislation. Different products can be defined as medicines, dietary supplements or food, and are regulated accordingly. The determination as to which category a product falls into may depend on the product, or the desire of the manufacturer.

 

• CAM products are currently regulated by the following legislation:

 Consumer Guarantees Act 1993

   Fair Trading Act 1986

  Food Act 1981

  Food Regulations 1984

 Dietary Supplements Regulations 1985

  Australia New Zealand Food Standards

Medicines Act 1981

 New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods.

 

• Most CAM products are currently marketed as dietary supplements. There is no pre-market approval process for dietary supplements and, therefore, no assessment of the inherent safety of their ingredients before they go on the market, and no adequate controls on the quality of the ingredients or the manufacturing process. There is no effective mechanism for detecting problems relating to the safety or quality of products until the product is on the market. Problems are identified and products removed from the market only after consumers have suffered harm (for example, from a toxic or contaminated ingredient).

 

• Because dietary supplements are foods, it is illegal for them to be marketed with any therapeutic claims. In order to be permitted to make therapeutic claims, products are required to go through the medicines assessment and approval process. It is unlikely that most CAM products would succeed in this process due to the stringent levels of evidence required.

 

Legislation and policy currently in development

The Health Practitioners’ Competence Assurance (HPCA) Bill

• The Health Practitioners’ Competence Assurance (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, including the Chiropractors Act 1982.
  

• As a single overarching provision,and containing a framework for the governance and functions of registering authorities, the HPCA Bill is intended to ensure consistency between the health professions.
  

• The HPCA Bill provides a framework for the regulation of health professionals in cases where:

-        practice of the profession may pose a risk of harm

-        it is in the public interest that the profession be regulated.

• The proposed Bill would enable osteopaths to become regulated by statute.  In the future, other CAM professions could potentially be added to the HPCA legislation by Order in Council, without the need for separate Acts of Parliament.

A joint trans-Tasman agency for the regulation of therapeutic products

• The proposals for a joint trans-Tasman agency to regulate therapeutic products are described in a recent consultation paper[i].  The proposed agency would regulate medicines and medical devices and products, including CAM products and therapeutic dietary supplements.

 

• The proposed joint agency would replace Medsafe in New Zealand and the Therapeutic Goods Administration (TGA) in Australia.

 

• Under the proposals, new legislation would specify the level of control applying to different products (according to risk category) in both New Zealand and Australia.  Products with a higher-risk profile, such as prescription medicines, would be more strictly controlled than those with a lower-risk profile, such as CAM products.

 

• The New Zealand and Australian Governments have agreed in principle to establish such an agency, subject to satisfactory negotiation of governance arrangements.

 

• If the proposals are implemented, the joint agency will be established in 2004.

 

Voluntary regulation

• Currently, only chiropractic is regulated by legislation. Osteopathy is also likely to become regulated by statute once the Health Practitioners’ Competence Assurance Bill becomes law.  While the other CAM modalities are not regulated by statute, voluntary self-regulation protocols have been put in place by some professional organisations that represent CAM practitioners.

 

• There is a wide range of professional bodies representing CAM practitioners.  Organisational structures and terms of membership vary widely.  In some cases there are multiple bodies representing the practitioners of a particular CAM modality.  For example, there are at least three professional organisations representing acupuncturists.

 

• The following are 'umbrella' organisations that represent practitioners who practise a range of CAM disciplines:

New Zealand Charter of Health Practitioners

·         The New Zealand Charter of Health Practitioners (known as 'the Charter') is the largest organisation representing CAM practitioners in New Zealand.  The Charter  has a comprehensive self-regulation protocol, which is outlined in their annual practitioner directory[ii].  Approximately 68 professional organisations are affiliated with the Charter. These organisations are known as 'affiliated signatories'. The Charter estimates that this represents around 75 percent of the CAM-related practitioner associations in New Zealand. 

·         Members of affiliated signatories are permitted to call themselves 'chartered health practitioners', provided they meet the level of competency required by the governing councils and are authorised by the presidential boards of the Charter.  The Charter comprises four presidential boards that oversee traditional Māori medicine, traditional Chinese medicine, natural medicine (for example, herbal medicine) and natural therapies (for example, massage).

·         The Charter has a code of ethics and standards of practice.  It includes a Standards of Practice and Ethics Committee that evaluates any breaches of professional conduct on the part of chartered health practitioners.

The New Zealand Register of Complementary Health Professionals

·         The New Zealand Register of Complementary Health Professionals (NZRCHP) is an institution 'formed by its member practitioners to ensure that members are well qualified to assist people with health and life problems within the avenues of their discipline'.  It claims that the practitioners listed in its directory are recognised as having trained and qualified in their particular healing discipline and as abiding by the code of ethics relevant to their practice.

·         The registration facility operated by NZRCHP does not have a code of ethics or standards of practice. It describes the facility as an 'honesty system' and states that 'it is taken that members will adhere to the ethics of their particular discipline'.  The NZRCHP has no disciplinary system.

 

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[i] Medsafe (2002).  A proposal for a trans-Tasman agency to regulate therapeutic products: discussion paper, June 2002.  Wellington: Medsafe.

 

[ii] New Zealand Charter of Health Practitioners. 2001. The 2001 practitioner directory.  Auckland: New Zealand Charter of Health Practitioners.

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