Analysis of the April 2003 Draft Report of the
New Zealand Ministerial Advisory Committee
on Complementary and Alternative Health (MACCAH)

Section 2: Policy Issues Surrounding CAM

2.1 Regulation of CAM

[Comments in red by Stephen Barrett, M.D.]

Objectives of regulation

The main objective of regulation is improved consumer safety. It has been argued that effective regulation of the CAM sector is necessary to protect both consumers and the wider public interest (House of Lords Select Committee 2000). The Select Committee felt that statutory regulation is appropriate for some modalities and self-regulation for others. It recommended that statutory regulation be implemented for CAM modalities that potentially pose a significant risk to public safety (see pages 6--7). Likewise, all of the countries examined in Section 1 exercise some degree of regulatory control over CAM products as they recognise that, like conventional medicines, complementary medicines can pose risks to health.

Under the Health Practitioners Competence Assurance Bill, 'risk of harm to the public' is one of the key criteria for the statutory regulation of new professions. Currently unregulated or self-regulated CAM practitioners may therefore be eligible for statutory regulation in the future if their practice is judged to pose such a risk. The other test contained in the bill is whether it is 'otherwise in the public interest' that a profession be regulated. (HCPA Bill, clause 112)

Statutory versus voluntary regulation

The House of Lords Select Committee remarked that whether regulation is statutory or voluntary might ultimately be of less importance than whether it is delivered effectively -- by a single united body for each modality -- and succeeds in protecting the public. It recommended that each self-regulated CAM modality establish a single professional body, and that these should be well promoted so that consumers are aware of them and can approach them for information. [I am aware of no instance in which voluntary regulation of health profession a was effective. Moreover, many "CAM" practitioners are loners. It seems to me that the first question to face is whether people should be permitted to practice a health discipline without having to prove competence.]

However, some members of the Select Committee felt that encouraging formal selfregulation could endow some of the more controversial modalities with a status that was not justified by the evidence, and that this could potentially mislead consumers (Mills 2001b). [I agree.]

Effects of regulation on the CAM sector

For CAM practitioners, the advantages of effective regulation include enhanced professional status and the opportunity to enforce minimum standards for training and professional practice. Regulation may entitle practitioners to receive insurance-based or even mainstream health funding. Statutory regulation may also confer protection of title.

For practitioners, the main disadvantage of regulation is the cost of becoming registered. [Does MACCAH think that the requirements for practice eligibility will be so low that anybody who claims to be a "CAM" pracitoner will be eligible -- that the only barrier to registration will be cost rather than competence?] In addition, practitioners who are unable to meet the criteria or costs of regulation might lose the right to practise. Consumer choice could therefore be restricted and costs to consumers increased. The costs of statutory regulation tend to be substantially higher than those of voluntary regulation. [If regulation actually protects the public, any higher costs should be offset by the benefits of consumer protection.]

Some of the countries discussed in Section 1 (eg, Canada) are currently changing the way CAM products are regulated. As with practitioners, stricter regulation of CAM products has the potential to raise compliance costs for manufacturers. If products are priced higher as a result, and some products withdrawn, consumer choice could be adversely affected.

Question 1 In your opinion, what are the main benefits and drawbacks of different types of regulation (eg, statutory, voluntary) for: -- consumers and the wider public? -- CAM practitioners? -- other stakeholders?

[This question fails to address the validity of the practice, who does the regulating, and whether regulation can be effective in protecting the public. The only way to protect the public is to make it possible to stop improper practices.]

Mainstream health professionals who also practise CAM

Regulated mainstream professionals such as doctors, nurses and dentists who also practice CAM are currently subject to the general provisions governing CAM (see pages 3-4) and to their own professional statutes.

Under the Health Practitioners Competence Assurance Bill, the registration authorities for the health professions covered by the legislation will be required to draw up scopes of practice describing the activities that practitioners are qualified to perform. Practitioners will be required to maintain lifelong competence within their scope of practice. Activities that carry significant risk will be restricted to regulated practitioners with appropriate training. This would have implications for statutorily regulated biomedical professionals who wish to practise CAM, and also for CAM practitioners who achieve statutory regulation in the future.

Voluntary CAM regulatory bodies may make specific rules for members who are also regulated health professionals. In the UK, the House of Lords Select Committee recommended that biomedical professionals who practise CAM 'should be trained to standards comparable to those set out for that particular therapy by the appropriate (single) CAM regulatory body' (House of Lords Select Committee 2000: para 5.83). The Select Committee also recommended that the biomedical regulatory bodies should develop clear guidelines for their members wishing to practise CAM. They were encouraged to communicate with the relevant CAM regulatory bodies to obtain advice on competency, best practice and appropriate training courses.

Question 2 How should mainstream health professionals (eg, doctors, nurses) who also practise CAM be regulated? For instance, should they: -- have to obtain full registration as a CAM practitioner? -- be required to meet minimum competence standards for CAM? -- be exempt from additional regulation?

[This question falsely assumes that "CAM" standards exist or can be developed. It is also questionable whether practitioners can be "mainsteam and "CAM" at the same time. Regardless, I believe that all professionals should be held to science-based standards. Practitioners should not be excused from competence by labeling themselves "CAM" practitioners. ]

Multidisciplinary CAM practitioners

Some CAM disciplines encompass more than one modality. For example, practitioners of traditional Chinese medicine (TCM) often use both acupuncture and Chinese herbs. Should they be regulated separately under each modality? Or should there be a distinct regulatory category for practitioners of TCM that covers both modalities? This could be problematic if such practitioners decide to pursue statutory regulation. [The more important question is whether they are competent to make accurate diagnoses and render appropriate treatment. In most cases, the answer is no.]

Similarly, there are CAM practitioners who offer multiple, discrete therapies that are not necessarily related (eg, reflexology and homoeopathy). Should they be regulated separately under each modality? Or should there be special regulatory arrangements for multi-modality practitioners? The House of Lords Select Committee cautioned against the latter approach and expressed concerns about 'multi-therapy practitioners who want to mix a number of different therapies without being properly trained in one or more of them' (House of Lords Select Committee 2000: para 5.67). The Select Committee went further and suggested that such practitioners should have a grounding in a clinical discipline and some training in basic medical sciences. [The nature and quality of the training should be suffcient to ensure competence.]

Question 3     4 Some CAM practitioners practise more than one form of CAM. In your opinion, how should such practitioners be regulated?   Should CAM practitioners be required to have sufficient medical science education to be able to:   -- make a safe diagnosis?   -- know when to refer patients on to mainstream health services?

[All practitioners who render health advice should be required to make appropriate assessments and referrals.]

Routes to statutory regulation

The Health Practitioners Competence Assurance Bill would enable CAM professions that meet the criteria (see page 26) for statutory regulation to become regulated in the future without the need for separate Acts. Such professions could simply be brought under the Act by Order in Council. (HPCA Bill, clause 111)

However, as well as meeting the risk and public interest criteria for statutory regulation, professions would need to work towards reaching a general agreement on qualifications, standards and competencies. [HPCA Bill, clause 112.] Because the CAM modalities vary widely in their stages of development and levels of organisation, it might be useful to develop a pathway or process to guide them to a common stage from which to apply for statutory regulation. [They key question is whether the government wants to require proof of competance.]

As statutory regulation will not be appropriate for all modalities, this pathway could include routes to alternative best practice options, such as voluntary self-regulation under a single, united professional association. [Voluntary self-regulation won't work.]

Question 5 The Health Practitioners Competence Assurance Bill may enable some CAM professions to become regulated by statute in the future. Do you agree that a clear process to achieve statutory regulation should be developed for such professions?

Can New Zealand learn from the experience of other countries?

New Zealand's approach to the statutory regulation of CAM practitioners differs from that of the other Western countries reviewed in Section 1 because it:

• regulates on a national rather than a state-by-state basis (unlike Canada, Australia and the United States)
• is proposing a single route to statutory regulation through the provisions of the Health Practitioners Competence Assurance Bill (the UK offers a similar option, through the provisions of the Health Act 1999, but the UK legislation offers practitioners two distinct routes to statutory regulation) (House of Lords Select Committee 2000: paras 5.41--5.50).

However, New Zealand may be able to learn from overseas experience in the area of voluntary or self-regulation, or in the regulation of CAM products. For example, it might be appropriate to adopt some of the House of Lords Select Committee's recommendations on the organisation of voluntary regulation within CAM, such as encouraging CAM modalities to organise themselves under effective self-regulatory protocols and strive to work together to overcome any conflicts within the profession.

Question 6     7 Should appropriate aspects of regulatory systems developed in other countries be adopted in New Zealand?   Which aspects would you suggest as most helpful? For instance, these might include overseas approaches to:   -- statutory regulation   -- voluntary regulation   -- regulation of CAM practitioners   -- regulation of CAM products   -- other (please specify).

[These questions falsely imply that "CAM" regulation in other countries is appropriate (effective)]

Is there an ongoing need for policy advice on CAM?

There is currently no ongoing capacity to provide advice on matters related to CAM at the national level. Given the growing popularity of CAM and the debate surrounding issues such as regulation, it might be appropriate for the Ministry of Health to include some capacity for an ongoing advice function in relation to CAM.

International models for such a capacity include the CAM team within the UK Department of Health. This is a small team that advises policy-makers on CAM-related matters, implements statutory regulation of CAM practitioners and promotes best practice in integration.

If the proposed trans-Tasman agency for the regulation of therapeutic products is established in 2004, some capacity for ongoing advice on CAM products would be built into the structure of the new regime. For example, the proposed joint agency would include a specialist sub-unit comprising staff with skills in CAM. It would obtain specialist technical advice from an advisory committee made up of New Zealand and Australian experts in CAM. [This falsely assumes that the best people to advise are people who have "CAM skills," which I assume means they have been trained to practice some "CAM" methods. I would argue that advice should come from people who have a realistic viewpoint, which means that knowledgeable critics are likely to give better advice.]

Question 8     9 Should the Ministry of Health develop an ongoing capacity to address regulation and other policy issues connected with CAM?   Do you have any other comments about the regulation of CAM?

[Whether the Ministry of Health should address policy issues should depend on whther or not its recommendations and activities will be science-based.]