02 March 2018

Traditional Medicine and Free Range Food

'Ethical responsibilities of pharmacists when selling complementary medicines: a systematic review' by Amber Salman Popattia, Sarah Winch and Adam La Caze in (2018) Interational Journal of Pharmacy Practice comments
The widespread sale of complementary medicines in community pharmacy raises important questions regarding the responsibilities of pharmacists when selling complementary medicines. This study reviews the academic literature that explores a pharmacist's responsibilities when selling complementary medicines. 
International Pharmaceutical Abstracts, Embase, PubMed, Cinahl, PsycINFO and Philosopher's index databases were searched for articles written in English and published between 1995 and 2017. Empirical studies discussing pharmacists’ practices or perceptions, consumers’ expectations and normative studies discussing ethical perspectives or proposing ethical frameworks related to pharmacists’ responsibilities in selling complementary medicines were included in the review. 
Fifty-eight studies met the inclusion criteria. The majority of the studies discussing the responsibilities of pharmacists selling complementary medicines had an empirical focus. Pharmacists and consumers identified counselling and ensuring safe use of complementary medicines as the primary responsibilities of pharmacists. No formal ethical framework is explicitly employed to describe the responsibilities of pharmacists selling complementary medicines. To the degree any ethical framework is employed, a number of papers implicitly rely on principlism. The studies discussing the ethical perspectives of selling complementary medicines mainly describe the ethical conflict between a pharmacist's business and health professional role. No attempt is made to provide guidance on appropriate ways to resolve the conflict.
The authors conclude
There is a lack of explicit normative advice in the existing literature regarding the responsibilities of pharmacists selling complementary medicines. This review identifies the need to develop a detailed practice-specific ethical framework to guide pharmacists regarding their responsibilities when selling complementary medicines.
'Community pharmacists’ views on the regulation of complementary medicines and complementary‐medicines practitioners: a qualitative study in New Zealand' by Joanne Barnes and Rachael Butler in the same journal comments on an examination of community pharmacists’ perspectives on CMs regulation in New Zealand
where proposals for CMs regulations had recently been suspended and where, currently, CMs are only weakly regulated. 
The authors report on
 Qualitative, in-depth, semi-structured interviews with New Zealand practising community pharmacists are identified through purposive and convenience sampling. Data were analysed using a general inductive approach. 
Participants held mixed views regarding harmonisation of CMs regulations across Australia and NZ; some supported an NZ national regulatory framework for CMs, based on the Australian system. Participants recognised the current CMs regulatory framework in NZ as inadequate, that regulation was required to some extent, and that mandatory regulation was not necessarily required. A key reason given in support of CMs regulations was the need for greater assurances around quality of CMs. Participants also supported a regulatory framework that incorporated assessment of the safety of CMs, but were less convinced of the need for, or feasibility of, requiring evidence of efficacy from clinical trials. Participants believed that regulation of CMs practitioners, such as herbalists, and CMs retailers was important, although there were mixed views as to whether regulation should be statutory or whether self-regulation would be adequate. 
On the basis of these findings, pharmacists would be expected to welcome proposals for national regulations for CMs in NZ: such regulations should address concerns regarding product quality, inappropriate health claims and supporting evidence, and therefore should support pharmacists in meeting their obligations under the NZ Pharmacy Council's Code of Ethics.
They note that
In the early 2000s, there were proposals for a joint medicines regulatory agency with Australia – the Australia New Zealand Therapeutic Products Authority (ANZTPA) – which would have regulated all medicines, including CMs, blood products and medical devices, across the two countries; as Australia already had regulations for CMs, ANZTPA would have introduced regulations for CMs in NZ.  However, following political, industry, media and public opposition, due to concerns around perceived loss of NZ sovereignty, and increased manufacturing costs, the ANZTPA initiative failed to achieve support in the NZ Parliament and was suspended in 2006. 
Thus, in NZ, CMs remain only weakly regulated. Herbal and homoeopathic remedies are defined in the NZ Medicines Act 1981, but are exempt from requirements to obtain premarket Ministerial approval through provision of satisfactory evidence of quality, safety and efficacy, and are not currently required to adhere to the principles of good manufacturing practice (GMP). Further exemptions in the Medicines Act allow ‘natural health’ practitioners (not defined) to make herbal remedies and other ‘individualised’ natural health treatments for specific patients, but these exemptions are not intended to allow large-scale manufacturing. Most CMs are currently regulated as ‘dietary supplements’ under the Dietary Supplement Regulations 1985 and the Food Act 1981. These regulations provide some restrictions on ingredients of dietary supplements; no therapeutic claims are allowed and, in general, do not require adherence to GMP nor premarket approval or notification of products. New regulations for CMs in NZ were proposed in 2010 (see note 2),  but it is now unclear if they will ever be introduced into legislation.  
Most community pharmacies in NZ sell CMs, and pharmacists working in community pharmacies (irrespective of whether the pharmacy sells CMs) are a source of information and advice on CMs for consumers. Users may also access CMs through consultations with CMs practitioners, such as herbalists, naturopaths, traditional Chinese medicine practitioners or other traditional healers; some CMs practitioners practise within pharmacies. 
At the time of this study, the New Zealand Pharmacy Council's Code of Ethics (2004) included statements indicating that pharmacists are expected to stock, sell and supply only CM products that are safe, are effective and meet appropriate (i.e. GMP) quality standards. It is important to understand pharmacists’ views on current and future regulation of CMs in NZ, as medicines regulation is the framework that underpins and provides assurances on quality, safety and efficacy.
'Not Free to Roam: Misleading Food Credence Claims, the ACCC and the Need for Corporate Social Responsibility' by Sharn Hobill and Jay Sanderson in (2017) 43(1) Monash University Law Review 114 comments
 This article explores misleading food credence claims. The article commences by drawing attention to a concomitant increase in differentiated foods (eg locally sourced, free-range or ‘healthy’) and information asymmetry (ie where food businesses possess more accurate and useful information than consumers). The article then examines attempts by the Australian Competition and Consumer Commission (‘ACCC’) to deter misleading food credence claims and identifies a taxonomy of misleading food credence claims including those made about a food’s: (i) provenance; (ii) manufacture or production; and (iii) qualities or characteristics. The article then situates the ACCC’s efforts within the dialectic of Corporate Social Irresponsibility (‘CSI’) and Corporate Social Responsibility (‘CSR’), and in so doing, within regulatory theory that espouses a mix of deterrence and cooperation. We argue that while the ACCC plays a crucial role in deterring misleading food credence claims its focus is on CSI: meaning that more needs to be done to encourage CSR in relation to accurate and unbiased food credence claims. By treating food credence claims as a matter of CSR, food businesses can support informed decision-making and perhaps even contribute to better health outcomes. Indeed, conceptualising food credence claims as CSR is an important and necessary step in ensuring that honest and accurate food credence claims become the norm, not just the law. 
The authors argue
Consumers increasingly demand foods with certain qualities or characteristics. As a result, there has been a proliferation of information and claims on food labelling, packaging and advertising, with foods commonly accompanied bylaims about whether they are ethically produced, locally sourced, free-range, organic, GMO free or healthy. Over the years, numerous government and industry initiatives have been introduced with the intent of simplifying, clarifying and improving the information and claims placed on food products. Despite these initiatives, it is still often difficult, if not impossible, for consumers to verify the information and claims placed on foods. This places consumers in a vulnerable position. 
If the information or claims on foods is inaccurate, consumers may be misled or deceived into purchasing foods that they do not want, or into paying more for the foods they do. Indeed, research in food studies and consumer behaviour has found that there is often an ‘information asymmetry’ in relation to food products. This means that food businesses have more accurate and useful information about the foods they sell than consumers. In relation to ‘free-range’ claims, for example, Lander J noted the trust consumers put in food businesses by explaining that ‘[o]nce the cage eggs were placed or mixed in the cartons or boxes … the customers had no opportunity to determine whether the eggs were free range or cage eggs’. The food information asymmetry is further exacerbated by the sheer volume and nature of information and claims accompanying food; often leading to consumer confusion, misunderstanding and ambivalence. 
addition to the various government and industry initiatives attempting to simplify, clarify and improve the information placed on food products, the Australian Competition and Consumer Commission (‘ACCC’) has prioritised the scrutiny of food credence claims. According to the ACCC, credence claims are claims made on food products that suggest a premium or quality to food that ‘the consumer cannot independently verify … themselves. These types of claims are a priority area for the ACCC largely because misrepresentations about food products allow companies to profit at the expense of both consumers and competitors, and in so doing may deprive consumers of the opportunity to make properly informed decisions about the foods they are purchasing. In cracking down on misleading food credence claims, the ACCC has used a combination of warnings, negotiation, infringement notices, court-enforceable undertakings and litigation to ensure that consumers are not misled or deceived about the qualities or characteristics of a range of food products including beer, ducks, honey, bread, eggs and water. 
This article examines attempts to deter food businesses making misleading food credence claims. The article begins, in Part II, by highlighting the increased consumer demand for differentiated foods and the concomitant rise in claims about food qualities or characteristics such as ‘free-range’, ‘healthy’, and ‘locally sourced’. As the information asymmetry makes it difficult for consumers to verify such food claims, the ACCC plays a crucial role in protecting consumers from misleading or deceptive food claims. Part III of the article identifies and considers a taxonomy of misleading or deceptive food claims targeted by the ACCC including claims that relate to the provenance of foods, the production or manufacturing of foods, and the qualities or characteristics of food. Part IV of the article locates the ACCC’s actions against misleading food credence claims within the dialectic of Corporate Social Irresponsibility (‘CSI’) and Corporate Social Responsibility (‘CSR’), as well as the responsive regulatory frameworks espoused by Ayres and Braithwaite, and Parker and Nielsen. In so doing we argue that, while the ACCC goes some way to protect consumers from misleading food credence claims, nevertheless, the ACCC is only part of the regulatory response to misleading food credence claims. According to Nielsen and Parker, ‘responsive regulation proposes a principled way in which to combine the insights from plural theories of compliance and enforcement’. By situating the ACCC’s actions against misleading food credence claims in the dialectic of CSI and CSR, we argue that there is a social responsibility for food businesses to avoid misleading claims about foods’ provenance, production or manufacturing, or qualities or characteristics. The argument for food businesses integrating CSR around food credence claims is justified on the basis of two dimensions of existing CSR: consumer issues and health impacts. By treating food credence claims as a matter of CSR, food businesses can support consumers making informed decisions, and help to minimise negative health impacts and support healthier food choices. Importantly, too, conceptualising food credence claims as CSR is an important step in making honest and accurate credence claims the norm, not just the law.