Regulatory and legislative protections for consumers in complementary medicine: Lessons from Australian policy and legal developments PDF

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+Model EUJIM-322; No. of Pages 11 ARTICLE IN PRESS Available online at www.sciencedirect.com ScienceDirect European Journal of Integrative Medicine xxx (2014) xxx.e1–xxx.e11 Original article Regulatory and legislative protections for consumers in complementary medicine: Lessons from Australian polic...

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+Model EUJIM-322; No. of Pages 11

ARTICLE IN PRESS Available online at www.sciencedirect.com

ScienceDirect European Journal of Integrative Medicine xxx (2014) xxx.e1–xxx.e11

Original article

Regulatory and legislative protections for consumers in complementary medicine: Lessons from Australian policy and legal developments夽 Jonathan (Jon) Wardle a,b,∗ , Michael Weir c , Brenda Marshall c , Eloise Archer c,d a

Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), Faculty of Health, University of Technology Sydney, 235-253 Jones Street, Ultimo, NSW 2007, Australia b Network of Researchers in the Public Health of Complementary and Alternative Medicine (NORPHCAM), Australia c Faculty of Law, Bond University, Qld 4229, Australia d Discipline of Public Health, Flinders University, Sturt Road, Bedford Park, SA 5042, Australia Received 14 August 2013; received in revised form 26 February 2014; accepted 2 March 2014

Abstract Introduction: Complementary and alternative medicine (CAM) use historically has been high in Australia, with Australia often an early adopter of regulatory and policy developments related to CAM, with varying degrees of success at ensuring consumer safety and protection with respect to both CAM products and CAM practitioners. Methods: This article uses a policy analysis framework to explore some of the outcomes of these developments and their implementation, reviews the success of legislative and regulatory approaches to ensuring consumer protection in CAM Australia has enacted, and examines the lessons that can be learnt from the Australian experience. Results: The Australian experience highlights the importance of developing health-specific legislative and regulatory guidelines, ensuring that regulators are actively empowered to fulfil their functions, and avoiding a reliance on self-regulatory authorities to fulfil roles better performed by statutory authorities. Conclusions: These experiences may assist decision-makers and public authorities to develop regulatory and legislative protections that are practical, sustainable and appropriately fulfil their public protection role. This article belongs to the Special Issue: Ensuring and Improving Patients’ Safety in Integrative Health Care. © 2014 Elsevier GmbH. All rights reserved. Keywords: CAM; Policy; Regulation; Consumer protection; Law

Introduction As the utilisation and prevalence of complementary and alternative medicine (CAM) – a diverse group of healthcare practices not generally considered to be part of conventional

夽 This article belongs to the Special Issue: Ensuring and Improving Patients’ Safety in Integrative Health Care. ∗ Corresponding author at: Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), Faculty of Health, University of Technology Sydney, 235-253 Jones Street, Ultimo, NSW 2007, Australia. Tel.: +61 2 9514 4813. E-mail addresses: [email protected] (J. (Jon) Wardle), [email protected] (M. Weir), [email protected] (B. Marshall), [email protected] (E. Archer).

medicine – increases internationally, issues of public protection and safety around the use of CAMs are emerging as a significant public health issue requiring more detailed critical examination from relevant research, policy and practice communities [1]. The increasing integration of CAM into healthcare delivery raises a number of policy, legal and ethical issues, many of which have been the subject of detailed government and institutional inquiries internationally [2]. For various historical, cultural and social reasons CAMs have played a particularly large role in Australian healthcare when compared to comparable developed nations, even in the presence of a public healthcare system providing subsidies predominantly for conventional healthcare services, with only very small public funding for limited CAM disciplines such as chiropractic [3] and acupuncture [4]. Recent Australian studies suggest national out-of-pocket expenditure

http://dx.doi.org/10.1016/j.eujim.2014.03.008 1876-3820/© 2014 Elsevier GmbH. All rights reserved.

Please cite this article in press as: (Jon) Wardle J, et al. Regulatory and legislative protections for consumers in complementary medicine: Lessons from Australian policy and legal developments. Eur J Integr Med (2014), http://dx.doi.org/10.1016/j.eujim.2014.03.008

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for CAM is higher than out-of-pocket costs for conventional healthcare services and products and the estimated number of practitioner visits to CAM providers is nearly identical to the number of visits to conventional medical providers [5], and in some areas of Australia CAM practitioners providing primary care services outnumber conventional primary care physicians [6]. Such high use has been long-established in Australia. The gold rushes early in the development of Australia, and with it a wave of Chinese immigrants, entrenched Chinese medicine as a significant part of the healthcare system that extended beyond the Chinese community, and comprised over one-fifth of all herbalists in Australia at the height of Chinese medicine in the 1920s [7]. Moreover, being a new nation Australia possessed no dominant medical profession with which competing medical systems such as the eclectics and homoeopaths had to compete: for nearly the first 70 years of its existence Australia did not have an allopathic medical school at all [8]. Even when the allopathic community had established itself as the dominant medical system, it focused its efforts on urban Australia, allowing new medical systems such as chiropractic and naturopathy to develop and flourish in rural areas [9]. Historically high levels of CAM use have meant that Australia has become a social laboratory for development of regulatory and consumer protection policy around CAM, which when combined with the election of both right and left-wing reform-minded governments over the past three decades has seen Australia often implementing regulatory reforms and CAM-specific policy earlier than other nations. Although considerable controversy has surrounded recent changes to CAM product regulation in the United Kingdom [10] and Canada [11], these have been long established in Australia [12]. The advanced stage of Australian CAM regulation compared to New Zealand, and the effects such a drastic increase in regulation would have on the ill-prepared New Zealand CAM sector, was cited as the major factor that stopped the merger of those countries’ therapeutic goods regulators in the mid-2000s [12]. Australia was also the first Western nation to statutorily regulate Chinese medicine practitioners (not as individual modalities such as acupuncture, but as a complex medical system) when the Australian state of Victoria initiated legislation in 2000 [13]. Chinese medicine now joins chiropractic and osteopathy as the three CAM professions in the National Registration and Accreditation Scheme, with naturopaths and herbalists also suggested for inclusion [14]. Increased focus on CAM policy and legislation was not only the product of reformist zeal of contemporary Australian politics, but was also coincided with one of the largest product recalls in Australian history (the Pan Pharmaceuticals recall), in which around 1600 CAM products were ordered to be removed by the Australian therapeutic goods regulator [15]. The fallout from this experience led the Australian government to conduct a formal inquiry into the policy, legislative and regulatory requirements around CAM issues [16], with many of these changes being implemented (and continuing to be implemented) into Australian policy [12]. The circumstances of high CAM use and high degree of government attention on CAM have created a scenario where Australia has faced the regulatory and legislative issues associated with protection of the

public when using CAM, albeit with varying degrees of success, before the issue has come to the attention of other nations. This article explores some of the outcomes of these developments, and discusses the lessons that can be learnt from the Australian CAM experience. Methods A descriptive and comparative study was conducted of CAM policies and legislative development focused on public protection through a case study analysis based on discussion in the legal cases, peer-review literature and lay media. Research databases in health/medicine (AMED, MEDLINE, CINAHL and EMBASE) and law/policy (WESTLAW, AUSTLII and LEXIS) were searched for articles discussing CAM policy developments in Australia. Lay media representation of CAM policy was searched using the FACTIVA newspaper database. This was complemented by an analysis of current case law in Australian courts, including all State Supreme Courts and Federal Courts, and legislative framework found in the Federal and State jurisdictions using doctrinal research methods. Documents were analysed through systemic classification, description and interpretation of their content, based on a policy triangle framework initially described by Walt and Gilson [17], which takes a political economy perspective of health policy analysis and explores the interactions between policy, actors, processes and context. Data analysis involved a directed content analysis approach. Data were extracted, grouped and summarised in a narrative manner according to key themes, which were developed in a cumulative manner. Illustrative cases studies were used to illustrate key points in each of these themes. Drawing upon this framework a summary of Australian legislative and regulatory approaches to public protection for CAM users a narrative summary of developments, and their outcomes and implementation, has been provided. Results Evidence of harm? The substantial level of iatrogenic injury and harm elicited by conventional medicine is well documented and alarming, and as such is closely regulated by the statutory regulatory system [18]. However, although generally exhibiting a lower risk profile than conventional medicine, there have been numerous documented cases of physical injury, including death and disability, associated with both the consumption of CAM products [19] as well as the use of CAM services [20]. In addition to these direct physical risks, numerous non-health and indirect risks exist, such as financial exploitation, susceptibility to misleading claims or titles and delayed diagnosis [21]. In the Australian legal and regulatory system there are numerous approaches to minimising these risks: Products regulation In Australia CAM products are regulated by the Therapeutic Goods Administration (TGA), a statutory authority whose

Please cite this article in press as: (Jon) Wardle J, et al. Regulatory and legislative protections for consumers in complementary medicine: Lessons from Australian policy and legal developments. Eur J Integr Med (2014), http://dx.doi.org/10.1016/j.eujim.2014.03.008

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jurisdiction was established under the Therapeutic Goods Act 1989. This agency has a two-tier system for approving the manufacture and supply of therapeutic goods in Australia. Both tiers are required to undergo the same quality control (e.g. good manufacturing practice), with the key difference being the claims – and subsequently the evidence required to make those claims – that can be made on products. Registered medicines require an extensive appraisal of the quality, safety and efficacy based on controlled clinical trials, and is necessary for substances considered high risk. Listed medicines are medicines which are perceived to be lower risk. Listed medicines are also assessed for quality and safety, but do not require evidence of efficacy unless the product makes specific claims. Most complementary medicines are listed medicines, and complementary medicines form the largest part of this category [22]. However, this two-tier system has been controversial, with suggestion that it fails in its consumer protection role as it does not have adequate pre-approval processes for claims made on products [23]. The TGA, under the Therapeutic Goods Advertising Code (TGAC), does not allow claims in advertising for the treatment of serious medical conditions, largely based on the grounds that such conditions are not amenable to either self-diagnosis or self-treatment. Exemptions are made for advertisements solely directed to health professionals. A review of complaints about advertisements made to the Complaints Resolution Panel (CRP), the body which polices the TGAC, suggests that most complaints relate either to website advertisements that do not require pre-approval or in establishing whether the substance being advertised is a therapeutic good, and over the period 2007–2010 CAM was the largest component of complaints [24]. However, some advertising (such as in-store advertising) falls outside the remit of the CRP and is self-regulated by industry bodies, though recent reforms look to incorporate these into the statutory scheme. Several instances have been noted, however, where TGA consumer protections have failed as a result of poor implementation [23]. Lack of enforcement in instance of non-compliance One example of the consumer protection failure of the TGA in relation to CAM has been the failure of the TGA to prosecute claims against proponents of homoeopathic vaccination alternatives [25]. Although marketed as ‘homoeopathic’, these medicines rarely align with traditional homoeopathic principles and are rarely supported by qualified homoeopaths or professional homoeopathic organisations [26–28]. Nonetheless, many Australian CAM practitioners have caused controversy by capitalising on community concerns about the risks of childhood vaccinations by manufacturing and marketing ‘homoeopathic’ alternatives that are purported to have equal or greater effectiveness, without the associated risks [25]. Such promotion appears to have been effective, with a national survey indicating that 23% of Australians believe that homoeopathic vaccines are effective [29]. Most homoeopathic remedies (those which are not of human or animal origin or are dilutions of more than 1000-fold) are exempted from registration and listing on the Australian Register for Therapeutic Goods, but they are still subject to advertising

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standards under the TGAC and as such fall under the jurisdiction of the TGA CRP. A number of complaints have been made to the CRP against homoeopaths promoting homoeopathic alternatives to vaccination. All complaints have been upheld as misleading, as sponsors were unable to provide satisfactory evidence to substantiate their claims. The latter point is particularly concerning given the grandiosity of the claims, which often suggested that homoeopathic alternatives were not only safer, but far more effective than conventional vaccination programmes for poliomyelitis, chickenpox, meningococcal disease, hepatitis, Japanese encephalitis, influenza, measles, pneumococcal disease, cholera, smallpox, typhoid, typhus, whooping cough, rubella, mumps, diphtheria, malaria, tetanus, yellow fever, dysentery and many other diseases, and which in some cases actively discouraged conventional medical treatment of these conditions in favour of homoeopathic alternatives [25]. Numerous sections of the code were breached, including sections relating to: non-compliance with the law; not containing correct, balanced and verified statements; being likely to arouse unwarranted or unrealistic expectations; being likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases; containing language which could bring about fear or distress; and encouraging inappropriate or excessive use of a therapeutic good. Despite the CRP ordering that the advertisements be withdrawn and a retraction statement published, one of the sponsors – Tuggerah-based homoeopath Fran Sheffield (responsible for two upheld complaints) – did not comply with CRP orders, stating that she ‘disagreed’ with the panel’s interpretations, including publicly dismissing the CRP’s order on a national televised news programme [30]. The hesitancy of the TGA to enforce the CRP’s statutory orders led the Australian Competition and Consumer Commission (ACCC) – the statutory authority that, amongst other roles, monitors advertising standards and claims – to instigate action in the Federal Court based on consumer law, on the ground that the website claims were misleading or deceptive and could potentially lead to serious health risks [31]. Such recalcitrance by those subject to CRP orders is not uncommon; with a recent audit by the Australian government’s national audit agency highlighting that one-third of sponsors who had had complaints about their advertising upheld failed to comply with orders [32]. Administrative and legal delays to enforcement of compliance Compounding recalcitrance by sponsors to comply with CRP determinations and orders, administrative issues at the TGA or legal action by sponsors may also delay action. Although the TGA does not openly publicise internal procedures related to referrals from the CRP, a recent decision in the Administrative Appeals Tribunal (AAT) of Australia (Health World Limited and Minister for Health and Ageing) [33] offers insights into this process. In this case a complaint about an advertisement for the sponsor’s (Health World Limited) herbal medicine product for urinary tract infection was upheld in February 2011 as being misleading as it had made specific therapeutic claims about efficacy (noting a 96.6% effectiveness rate) which could not be backed

Please cite this article in press as: (Jon) Wardle J, et al. Regulatory and legislative protections for consumers in complementary medicine: Lessons from Australian policy and legal developments. Eur J Integr Med (2014), http://dx.doi.org/10.1016/j.eujim.2014.03.008

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up by scientific evidence. The CRP requested the sponsor withdraw the advertisements and publish a retraction. The sponsor declined and the CRP referred the case to the TGA for further action and in April 2012 the TGA ordered the sponsor to comply with the CRP determination. The sponsor requested a review of this decision and in June 2012 the Secretary of the Department of Health and Ageing upheld the TGA decision. The sponsor then appealed to the AAT, with the case heard in February 2013 and judgement issued in June 2013. In August 2012 the sponsor had voluntarily withdrawn the advertisements and amended them to show claims being supported by traditional Chinese medicine use rather than scientific evidence. Accordingly, although the AAT agreed that the original advertisement was misleading, it also held that a retraction order was no longer necessary as the original advertisement had been withdrawn voluntarily. This case not only highlights the delays between referral by the CRP and enforcement by the TGA (over 12 months), but it also demonstrates a way in which manufacturers may be able to use the review process to prolong the use of misleading advertising material. Although the advertising material was later voluntarily withdrawn, the sponsor was able to continue using this material for 18 months whilst the review process was underway. Whilst this may represent due legal and administrative processes, it does little to support consumer protection against misleading claims. This case was not the first instance of a sponsor using court proceedings to delay or avoid regulatory action. In March 2011, after receiving notification that the CRP had received a complaint about their advertising material, the manufacturer of a weight-loss supplement (SensaSlim) instigated legal action for defamation against th...