Directions in Privacy Scholarship

The excellent 'Legal Scholarship on Data Protection: Future Challenges and Directions' by Lee Bygrave in Cécile de Terwangne, Elise Degrave, Séverine Dusollier and Robert Queck (eds), Liber amicorum Yves Poullet / Essays in honour of Yves Poullet (Bruylant, forthcoming) discusses

some of the future challenges facing legal scholarship in the data protection field and recommends prioritising particular issues, approaches and methodologies to meet these challenges. The essay argues that the ongoing rapid growth of law, policy and scholarship on data protection makes it increasingly difficult for individual researchers to maintain an up-to-date overview of the field, and it pressures them to specialise. With this specialisation comes a risk of data protection scholarship fracturing into silos of discourse that rarely speak with each other. Added to this come a variety of other risks, such as ongoing ‘Western’ bias in the scholarship and continuing ignorance of the history, heritage and actual practice of data protection law. The essay urges data protection scholars to embrace an open, cross-jurisdictional approach that not only leverages off insights drawn from other disciplines but also attempts to connect with other fields of legal study. The essay also recommends greater exploration of the historical dimensions of data protection law, the jurisdictional quandaries such law poses and the ways in which it is actually applied ‘on the ground’.

Bygrave comments

When Samuel Warren and Louis Brandeis penned their famous article ‘The Right to Privacy’ near the end of the nineteenth century, published literature on the matters taken up in the article was sparse. Thirty years ago, when I first delved into law on privacy and data protection, academic literature on such law had grown immensely. This literature, though, was still fairly easy to track down and digest, partly because other scholars had made efforts to systematise it. Yves Poullet is one such scholar. Already in 1980, he co-produced the first bibliography in French of literature dealing with legal issues related to use of computer technology. More relevant for present purposes, however, is an annotated bibliography edited by David H. Flaherty and published in 1984 which contains 1,862 entries dealing with privacy and data protection issues. Of these, 595 articles, chapters and reports concern legal aspects of privacy and data protection law. Remarkably, United States’ (US) literature makes up approximately half of all the entries, reflecting the North American origins of large-scale discourse on computer-related threats to privacy. 

The situation is now markedly different in several respects. To begin with, US scholarship, while still influential and increasingly voluminous, is not as predominant in international discourse on privacy and data protection as it used to be. Secondly, this discourse is now considerably more global than it was, and it accordingly involves scholars from countries and cultures that scarcely figured in the discourse of the 1980s or earlier – Chinese, Indian, African and Brazilian scholars being obvious examples. Further, back then, much of the scholarship dealing specifically with privacy issues was of a philosophical, sociological, psychological, economic, political or technological nature and it tended to discuss – in various permutations – the meaning and value of privacy, particularly in light of developments in computer technology. This type of scholarship fed into – and to some extent off – a smaller body of legal research on protection of personal data. Such scholarship is still undertaken, but its growth has been outstripped and partly overshadowed by the latter type of research. The last few decades have seen the build-up of a massive wave of academic endeavour focused on the legal dimensions of privacy and data protection. Concomitantly, just as lawyers no longer treat data protection law as a ‘poor cousin’ of law on intellectual property rights, so too is research on the former area of law no longer a quaint niche activity on the outer margins of legal science. This is evidenced in part by the emergence of specialist journals on data protection law along with a strong rise in the number of articles on data protection law issues being published in other journals. 

All up, then, data protection law as a field of scholarship is undergoing radical expansion. A disinterested observer might wryly see an apparent paradox to this development: as the basic societal bedrock supporting privacy dramatically erodes, scholarship on its legal protection flourishes. While this scholarship harbours a few eulogies for data protection law, the bulk of contributors appear to have their shirt-sleeves rolled up, ready for many years of future research in the field. Yet, the paradox (if any) lies more in the stark contrast between de facto privacy erosion and the increasingly elaborate legal structures aimed ostensibly at preventing that erosion. It is these structures’ growth and increasing density that largely explains the flourishing of legal scholarship. xxx The scale, speed and complexity of recent developments in data protection law are breath taking, particularly in a global perspective. Well over 100 countries now have relatively comprehensive laws on protection of personal data, and the rate of this growth has been almost exponential. In many of these jurisdictions, the legislative regimes in point are a tangled mix of omnibus and sectoral codes, often of different generations and with inconsistent terminological apparatuses. Ongoing reform processes add to the complexity – as those trying to make sense of current developments in European Union (EU) law in the field are acutely aware. Another complicating factor is the increasing amount of court jurisprudence. Just over fifteen years ago, I wrote an article asking ‘where have all the judges gone?’ in the development of data protection law. The question is much less pertinent today, at least if we look to the burgeoning data protection jurisprudence from the European Court of Human Rights and Court of Justice of the EU (CJEU) – jurisprudence that increasingly ties the hands of other law makers. Thus, there is no shortage of developments in this legal field to parse and analyse. ... 

Perhaps the most salient challenge for current and future scholars is to maintain an accurate overview of the data protection field as it rapidly expands, both in terms of regulatory developments and in terms of research and policy discourse on those developments. At the same time, this expansion not only creates ever greater difficulties for individual researchers to keep the entire data protection field ‘under surveillance’, it also pressures them to specialise, either thematically or jurisdictionally. 

While specialisation has clear benefits, it also has a downside inasmuch as it can engender a fracturing of data protection scholarship into silos of discourse that rarely speak with, let alone acknowledge, each other. The notoriously US-centric focus of much privacy law scholarship in North America has long been a case in point, although recent years have seen systematic attempts being made by both US and European scholars to build transatlantic bridges. German scholarship on data protection law provides perhaps another case in point, in that much of it tends to refer predominantly to German literature. However, this tendency might be excused as a by-product of a legitimate need to maintain a scholarly discourse in the German language rather than being the product of a Weltanschauung viewing Germany as the whole of the relevant world – a view that one can be forgiven for thinking is paralleled in some US scholarship with respect to the global importance of the USA. 

The principal point, though, is that as we are inevitably pressured to burrow down into our respective areas of specialisation, it will be extremely important in the years ahead to keep our eyes on the ‘big picture(s)’ and stay alert to possible synergies between the various silos of study. Review articles – i.e., articles that survey and summarise previously published scholarship – can play a useful role in this regard. Such articles, however, are relatively few in the field of data protection, and anecdotal evidence suggests that getting them accepted for publication in reputable journals can be difficult as they are either too long or regarded as insufficiently ‘scientific’. This is a pity as they are crucial for mapping the research landscape and getting our bearings therein. Their status ought accordingly to be elevated in data protection scholarship. 

An under-communicated dimension of the specialisation problem is paucity of connection between scholars specialised in data protection law and scholars specialised in other fields of legal study. Data protection law is not an island; it does not operate as a discrete regulatory framework entirely separate to and independent of other regulatory frameworks

Medicines and TRIPS flexibilities

'Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016' by Ellen FM ‘t Hoen, Jacquelyn Veraldi, Brigit Toebes and Hans V Hogerzeil in (2018) 96(3) Bulletin of the World Health Organization 185–193 comments

Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.

The authors state

The extent to which countries have deployed TRIPS flexibilities, such as compulsory licences or public noncommercial use licences, for procuring medicines remains underreported. Previous studies have documented well-known and widely publicized cases of compulsory licensing, but have not examined the use of TRIPS flexibilities in procurement. Moreover, several reports in the literature perpetuate the belief that, since 2001, the use of TRIPS flexibilities has been sporadic and limited. 

The aim of our study was to document the use of TRIPS flexibilities to gain access to lower-priced generic medicines. Although we recognized that the TRIPS Agreement offers a range of flexibilities relevant to national pharmaceutical and patenting policies, including the right of countries to define and apply patentability criteria and to refuse to grant patents for certain subject matter (e.g. plants and animals), we focused on measures that can be directly applied to the procurement and supply of medicines. The most relevant measures for increasing access to medicines were: (i) compulsory licensing (including public noncommercial use licensing); (ii) the least-developed countries pharmaceutical transition measure; (iii) parallel importation; and (iv) the research exception. Parallel importation is the importation and resale of a product from another country (where the same product is legitimately on sale at a lower price) without the consent of the patent holder. The research exception refers the use of a patented product or process for research or experimentation without the consent of the patent holder.

'The WTO “Paragraph 6” system for affordable access to medicines: Relief or regulatory ritualism?' by Muhammad Z. Abbas and Shamreeza Riaz in (2017) The Journal of World Intellectual Property comments

Regulatory Ritualism means acceptance of regulatory goals while losing focus in achieving them. In other words, it means ignoring of goals or objectives of a process or mechanism and focusing too much on regulations, rules, and formalities. Advanced countries and developing countries have been in a continuous negotiation over access to drugs ever since coming into effect of TRIPS Agreement. The Doha Declaration was a rare negotiation win for third world countries. This paper endeavors to apply the notion of Regulatory Ritualism to Paragraph 6 of the Doha Declaration 2001 and to subsequent WTO General Council's Waiver Decision 2003 which aimed at giving effect to Paragraph 6 flexibility. The first part of the paper discusses the historical background of the Doha Declaration and 2003 Decision. The second part of this paper analyses Paragraph 6 of the Doha Declaration and subsequent Waiver Decision in the light of the notion of Regulatory Ritualism and Rule Complexity, with a special focus on Apotex‐Rwanda case study, the case of India and the case of Australia. The final part of this paper sums up the discussion on the issue and provides suggestions.

The authors argue

The Trade‐Related Aspects of Intellectual Property Rights (TRIPS) Agreement required patent protection for inventions in all fields of technology including pharmaceuticals (WTO, 1994). An obvious and direct consequence of monopoly on drugs is an increase in prices of needed medicines; patent protection on medicines, therefore, emerged as a common issue for third world countries where purchasing power is too low to afford patented medicines (Rozek, 2000). The access to drugs problem was foreseen and TRIPS included public health safeguards like non‐voluntary licensing of drug patents but this flexibility was of little significance for least developed countries and developing countries with no drug manufacturing capacity because of the “domestic use” condition attached to it (WTO, 1994). This very issue was highlighted by human rights activists, NGOs, and public health advocates in the wake of the outbreak of HIV/AIDS in Africa in the very beginning of the Twenty‐first century. The Doha Declaration 2001 (Amendment of the TRIPS Agreement (TRIPS Amendment), 2005), and subsequent WTO General Council's Waiver Decision 2003 (WTO, 2003a, 2003b 2003, 2003c) aimed at reforming the existing system in order to resolve the issue of access to drugs for poorer countries. 

It has been observed that the issue of access to drugs has remained a hot issue even after breakthrough pro‐access developments like Doha Declaration (WTO, 2001) and 2003 Waiver Decision. The adoption of a resolution on “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” presented by 13 countries (Saez, 2016) in the 32nd session of the Human Rights Council (13 June 2016–1 July 2016) is a recent development in this regard (Kulkarni, 2016). The resolution notes that actual or potential conflicts exist between the implementation of the TRIPS Agreement and access to affordable medicines (Mitra‐Jha, 2016); the resolution urges member states to make full use of TRIPS flexibilities for affordable access to medicines (Human Rights Council, 2016) and specifically recalls the Doha Ministerial Declaration on the TRIPS Agreement and Public Health in this context (Kulkarni, 2016). The resolution fully recognizes the implications of pharmaceutical patent monopoly for policy coherence in developing countries.

The United Nations Secretary‐General's High‐Level Panel on Access to Medicines Report released on 14 September 2016, is another recent development. The Report found that the Paragraph 6 system has failed to provide a workable solution for countries lacking drug manufacturing capacity of their own. The Report recommended that “WTO Members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license” (UN, 2016). On one hand, World Health Organization aims that “by 2030, the deadline for the Sustainable Development Goals, all countries must be able to provide full coverage for quality health services to their entire populations” (Kieny, 2016) while on the other hand access to drugs remains an “illusive goal” for millions of people (Mitra‐Jha, 2016). 

Bilateral and regional free‐trade agreements, which set TRIPS‐Plus intellectual property standards, have arguably constrained the use of legitimate TRIPS flexibilities reaffirmed in the Doha Declaration (Abbas & Riaz, 2013). The Trans‐Pacific Partnership (TPP) — an ambitious free trade agreement that the United States has negotiated with 11 other countries (New Zealand, Australia, Canada, Japan, Singapore, Brunei Darussalam, Chile, Malaysia, Mexico, Peru, and Vietnam) — is the most recent example of such trade deals requiring enhanced rights and remedies for multinational drug companies. Article 18.6.1(b) recognizes the right of member states to utilize the Waiver flexibility but it neither makes any commitment for effective implementation of this public health solution nor puts any obligation on member states to take necessary steps to use this flexibility for the sake of improving access to essential medicines in the poorer countries. This provision stipulates that:

In recognition of the commitment to access to medicines that are supplied in accordance with the Decision of the General Council of August 30, 2003 on the Implementation of Paragraph Six of the Doha Declaration on the TRIPS Agreement and Public Health (WT/L/540) and the WTO General Council Chairman's Statement Accompanying the Decision (JOB(03)/177, WT/GC/M/82), as well as the Decision of the WTO General Council of December 6, 2005 on the Amendment of the TRIPS Agreement, (WT/L/641) and the WTO General Council Chairperson's Statement Accompanying the Decision (JOB(05)319 and Corr. 1,WT/GC/M/100) (collectively, the “TRIPS/health solution”), this Chapter does not and should not prevent the effective utilisation of the TRIPS/health solution (The Trans‐Pacific Partnership Agreement, 2015).

Most recently, the intergovernmental South Center organized a discussion on implementation of WTO “Paragraph 6” System alongside the WTO Council for TRIPS meeting held on 8 November 2016 (The South Centre, 2016). The panelists, including Yuanqiong Hu, Dean Foster, Denis Broun, and Suerie Moon, generally considered the Paragraph 6 system an unworkable solution to provide affordable access to medicines to patients in poorer countries. Roger Kampf, Counsellor at the Intellectual Property Division of the WTO, presented several issues for consideration such as: how to use the Waiver scheme as a practical procurement tool; how to actively engage ministries of health and procurement agencies in the process; and how to make generic drug companies’ participation in the scheme economically viable (Nightingale, 2016). Keeping in view the significance of access to a cheap generic version of medicines in attaining global public health goals, this paper aims at critically evaluating the practical implications of implementing Paragraph 6 of the Doha Declaration and the Waiver flexibility in the light of the notion of Regulatory Ritualism. 

According to John Braithwaite, Ritualism means, “acceptance of institutionalized means for securing regulatory goals while losing focus on achieving the goals or outcomes themselves” (Braithwaite, 2008). Similarly, according to Jolyon Ford, “The ‘ritualism’ concept relates to formalistic participation in a regulatory system, engaging in the institutional processes created to achieve substantive regulatory goals but taking these verification and reporting processes as the point of the exercise, while losing all focus on the goals themselves” (Ford, 2016). The central theme of this paper is that the flexibility provided under Paragraph 6 of the Doha Declaration has been over‐shadowed by the procedural formalities that are unnecessarily complex and burdensome and do not comply with the intended purpose of the flexibility.

'Compulsory licensing of pharmaceuticals reconsidered: Current situation and implications for access to medicines' by Kyung-Bok Son and Tae-Jin Lee in (2018) 13(10) Global Public Health 1430-1440 comments

To examine patterns and trends in attempts, distinguished from issuance, to issue compulsory licensing of pharmaceuticals and to assess related implications in the era of high-cost medicines. Documents from various civil society organisations were primarily used to search attempts, as well as published literature. The identified attempts were analysed by pharmaceutical level, national level, claimers, and the outcomes of the attempts. There have been 108 attempts to issue compulsory licensing for 40 pharmaceuticals in 27 countries since 1995. Most of the attempts were in Asian, Latin American, and African countries and mainly for HIV/ AIDS medicines. Moreover, when the claimer was the government, the likelihood of approval and positive outcomes increased. Compulsory licensing, which was devised to cope with the HIV/AIDS pandemic in low-income countries, became a practical measure in several Asian and Latin American countries, even for non-HIV/AIDS medicines. Resurgent compulsory licensing in 2012 and 2014, influenced by the global justice movement, might represent a policy window in the near future as the Doha Declaration did in the 2000s. In this context, various experiences should be circulated and analysed at the global level to better understand the circumstances under which successful issuance has been achieved at the country level. 

 The authors argue

Compulsory licensing occurs when a government allows someone other than the patent holder to produce the patented product without the consent of the patent holder (WTO, 2017). In international agreements such as the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) and the Trans-Pacific Partnership Agreement (TPPA), compulsory licensing is recognised as a valid legal right of a member country (Son & Lee, 2017). Legally, low- and middle-income countries can utilise compulsory licensing to protect public health in case of national emergency or for public non-commercial use. However, most low- and middle-income countries have not issued compulsory licensing (Beall & Kuhn, 2012; Bucknell, 2007; Consumer Project on Technology, 2010; WHO, 2008). 

When pharmaceuticals that are in demand are not on the market or are not fully available (for example, given the high cost of medicines), a government can issue compulsory licensing. This is not, however, a magic bullet that can solve the limited access to medicines caused by patents. Limited access to medicines for HIV/AIDS, influenza, and tuberculosis in low- and middle-income countries is not solely related to patents (Van Gelder & Stevens, 2010). However, we cannot underestimate the importance of patents and their detrimental effect on access to medicines from the perspective of affordability (Cohen and Illingworth, 2003; Hestermeyer, 2007; WHO, 2006). Many HIV/AIDS patients in low- and middle-income countries are experiencing resistance or intolerance to old drugs, and an increasing number of patients need new and expensive ones presently protected by patents (Luo, Oliveira, Ramos, Maia, and Osorio-de-Castro, 2014; Over et al., 2007). Furthermore, the affordability of pharmaceuticals is an important issue regardless of income level. The high prices of new medicines are common problems even in high-income countries (Iyengar et al., 2016; Kesselheim, Avorn, and Sarpatwari, 2016; Vitry and Roughead, 2014). 

Since 1995, there have been continuous discussions regarding compulsory licensing of pharmaceuticals in the field of public health and law (Beall, Kuhn, andAttaran, 2015; Lybecker and Fowler, 2009; Reichman, 2009). However, relatively little information exists about the compilations of compulsory licensing, and studies of various past attempts to issue compulsory licensing remain an untouched area (Beall and Kuhn, 2012; Bucknell, 2007; Consumer Project on Technology, 2010; WHO, 2008). Among the available literature, Beall and Kuhn (2012) have constructed a significant database of compulsory licensing episodes with the active support of the government of a World Trade Organisation (WTO) member country. However, in their study, some episodes not characterised by an active governmental role, such as instances of compulsory licensing requested by non-governmental entities, were excluded. It is worth noting that even though a government alone can issue compulsory licensing, non-governmental entities can also request the government to do so. Given this, attempts by various actors, as distinguished from the government, are foregrounded in this study. This study was conducted to examine patterns and trends in attempts to issue the compulsory licensing of pharmaceuticals, and to assess the related implications for access to medicines in the era of high-cost medicines.

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.

ACCC Digital Platforms discussion paper

The Australian Competition and Consumer Commission (ACCC) has released an issues paper as part of its public inquiry into the impact of digital platforms on media and advertising markets in Australia.

The ACCC is seeking feedback on

•  Whether digital platforms have bargaining power in their dealings with media content creators, advertisers or consumers and the implications of that bargaining power. 
• Whether digital platforms have impacted media organisations’ ability to fund and produce quality news and journalistic content for Australians 
• How technological change and digital platforms have changed the media and advertising services markets, and the way consumers access news 
• The extent to which consumers understand what data is being collected about them by digital platforms, and how this information is used 
• How the use of algorithms affects the presentation of news for digital platform users. 

The ACCC is seeking submissions by 3 April 2018 and will issue a preliminary report into its findings in December 2018, with a final report by 3 June 2019.

As part of the inquiry the ACCC will use its compulsory information gathering powers to obtain information from digital platforms and media organisations that is not publicly available.

The discussion paper features the following questions -

1.1. Which digital platforms do you consider to be relevant to this Inquiry? 

1.2. Should the Inquiry consider digital platforms that do not currently provide access to news and journalistic content in Australia but may either provide news and journalistic content in the future and/or have an impact in relevant markets (e.g. Amazon,1 instant messaging applications)? 

1.3. What ‘news and journalistic content’ is particularly relevant to this inquiry? Should the ACCC consider a broad range of specialist suppliers of news and journalistic content? 

1.4. Should the Inquiry focus on news and journalistic content supplied to consumers in Australia or news and journalistic content produced in Australia? 

1.5. What are appropriate metrics for measuring the choice and quality of news and journalistic content? 

1.6. Are there any other issues relevant to the choice and quality of news and journalistic content that should be considered by the ACCC? 

3.1. What are the relevant media and advertising services markets for this Inquiry? Who are the key market participants? 

3.2. What are the relevant markets for assessing the market power of digital platforms? Who do digital platforms compete with? 

3.3. How should the market power of digital platforms be assessed? What are appropriate metrics for measuring any market power (e.g. market concentration, profits, prices, number of users, access to user data)? 

3.4. Do digital platforms have market power? If so, which digital platforms and in which markets? In particular:

(a) What realistic alternatives are available to users (i.e. consumers, advertisers and media content creators) of digital platforms? Do these alternatives effectively constrain the behaviour of digital platforms? 

(b) Do users use multiple digital platforms for similar functions? Do you have any evidence or observations on switching between platforms or the growth of new platforms? 

(c) What difficulties do users encounter in switching between platforms? Do digital platforms engage in behaviour that makes switching between platforms more costly or more difficult for users? 

(d) Does increasing the number of users increase the attractiveness of that digital platform for other users? Does this mean that it is only viable for one or two digital platforms providing a similar service to consumers to operate at the one time? 

(e) What difficulties are faced by providers in establishing competing platforms? Does the threat of new entry limit the market power of digital platforms? Over what timeframe should the threat of new entry be assessed?  

(f) Are there examples where digital platforms have engaged in behaviours that indicate the exercise of market power? What types of users are most at risk from any exercise of market power by digital platforms? 

3.5. Do digital platforms engage in any behaviour that enhances their market position by excluding competitors or potential competitors, e.g. through the acquisition of rivals or restrictive contract terms? 

3.6. Describe the nature of any impacts (positive and negative) that digital platforms are having on media content creators? What causes these impacts? Are these impacts temporary or ongoing? 

3.7. What are the advantages and disadvantages for media content creators of using digital platforms to publish or distribute their content? 

3.8. What terms and conditions do digital platforms offer media content creators to publish or distribute their content? How do they differ from those offered by other distributors of media content? Do digital platforms offer different terms to different media content creators? 

3.9. Have digital platforms changed the price, quality or choice of media content for Australian consumers? If so, what are the implications of this for media content creators? For example, how easily can media content creators offer access to subscriber only content via digital platforms and how readily can they obtain brand attribution for content accessed via digital platforms? 

3.10. Do digital platforms have access to user data that is helpful to media content creators (e.g. readership statistics)? Does this access to user data create any information asymmetry between digital platforms and media content creators and, if so, how does this impact competition in the relevant markets? 

3.11. If so, how much do media content creators value access to such user data? How does the access to or control over user data impact the relationship between digital platforms and media content creators? For instance, how transparent are digital platforms about how content reaches consumers via their algorithms and how much notice do media content creators receive when significant changes are made? 

3.12. How important are digital platforms in delivering audience (and revenue) to media content creators relative to total audience and revenue? 

Implications for advertisers 

3.13. Describe the nature of the impacts (positive and negative) that digital platforms are having on advertisers? What causes these impacts? Are these impacts temporary or ongoing? 

3.14. What are the advantages and disadvantages of using advertising services offered by digital platforms for advertisers (i.e. advertising agencies and businesses directly advertising on digital platforms)? 

3.15. What terms and conditions do digital platforms offer advertisers? How do they differ from those offered by other suppliers of advertising services? Have digital platforms changed the price, quality or choice for advertisers? If so, what are the implications of this for advertisers? 

3.16. Do digital platforms have access to user data that is helpful to advertisers (e.g. return on investment statistics)? Does this access to user data create any information asymmetry between digital platforms and advertisers and, if so, how does this impact competition in the relevant markets? 

3.17. How much do advertisers value digital platforms’ access to user data? How does the access to or control over user data impact the relationship between digital platforms and advertisers? 

Implications for consumers 

3.18. Describe the nature of the impacts (positive and negative) that digital platforms are having on consumers? What causes these impacts? Are these impacts temporary or ongoing? 

3.19. What are the advantages and disadvantages of using digital platforms for consumers? 

3.20. What terms and conditions govern consumers’ use of digital platforms? How do they differ from those which apply when consumers obtain news and journalistic content from other sources? 

3.21. Are consumers generally aware of these terms and conditions? Specifically, do Australian consumers understand the value of the data they provide, the extent to which platforms collect and use their personal data for commercial purposes, and  how to assess the value or quality of the service they receive from the digital platforms? 

3.22. Have digital platforms changed the price of media content supplied to Australian consumers? 

3.23. If you consider the collection of data part of the effective price paid by consumers for use of the digital platforms, to what extent are consumers aware of and provide informed consent for the collection and use of their data? 

3.24. Have digital platforms changed the quality or choice of media content supplied to Australian consumers? Has the use of algorithms to select content changed the diversity of news supplied to consumers? 

3.25. How do consumers value digital platforms’ access to their data? Do consumers see it as a cost or a benefit (e.g. it enables customisation of the content displayed)? How does the access to or control over user data impact the relationship between digital platforms and consumers? 

3.26. How have the channels used by Australian consumers’ to access news and journalistic content (e.g. TV, newspapers, social media, search engines) changed in the past five to ten years? How will this change in the next five to ten years? 

3.27. How have the types of news and journalistic content accessed by Australian consumers’ changed in the past five to ten years? How will this change in the next five to ten years? 

3.28. How has Australian advertising expenditure changed over time? In particular, how have digital platforms impacted the advertising revenue of media companies, especially those involved in the supply of news and journalistic content, and how have media markets responded? 

3.29. Have innovation and technological change increased or decreased competition in the media and advertising services markets? 

3.30. Have the markets that digital platforms operate in changed over time and are they likely to change further in the future? For example, to what extent can digital platforms now be considered to be publishers rather than distributors of content, and is this likely to evolve in the future? 

3.31. How are the business models for news and journalism likely to evolve over the next decade and how sustainable is the commercial provision of high quality news in Australia? Do you have any other comments or observations on the impact of digital platforms or on the state of competition in the media and advertising services markets? 

3.32. Attachment B summarises the key existing regulation in Australia that applies to the media and advertising services markets. Are there any additional existing or proposed laws or regulations in Australia which should be taken into account by the ACCC in this inquiry? 

3.33. How do existing laws and regulations apply to the conduct of digital platforms? For example:

• are digital platforms required to verify news and journalistic content before distributing it? 

• do intellectual property and copyright laws apply to the conduct of digital platforms in a similar way as to other market participants?

If these laws and regulations do not apply to digital platforms, what are the implications for competition in the media and advertising services markets and how does this impact the quality and choice of news and journalistic content for consumers? 

3.34. Should digital platforms be subject to the same laws and regulations as other market participants in the media and advertising services markets (e.g. news and journalistic content creators or distributors)? 

3.35. What steps have been taken by digital platforms to address any competition and consumer concerns that have been raised (e.g. self-regulatory codes or guidelines). To what extent have these initiatives addressed concerns? 

3.36. Are the existing laws and regulations sufficient to address the activities of digital platforms? Is there a case for the specific regulation of digital platforms and, if so, what issues would proposed regulation seek to address?

Attachment B will be of particular interest for privacy and media students.

FOI and other oversight in Victoria

The Accountability and Oversight Committee of the Victorian Parliament Report into Victorian oversight agencies 2016‐17 offers insights about the State's FOI, Privacy and Ombudsman regimes.

The report notes that the Committee - constituted under Section 6A of the Parliamentary Committees Act 2003 (Vic) and with powers under the Ombudsman Act 1973 (Vic) - has the following functions —

a. to monitor and review the performance of the functions and exercise of the powers of the Information Commissioner; and 

b. to consider and investigate complaints concerning the Information Commissioner and the operation of the Office of the Victorian Information Commissioner; and 

c. to report to both Houses of Parliament on any matter relating to— i. the performance of the functions and the exercise of the powers of the Information Commissioner; and ii. any complaint concerning the Information Commissioner and the operation of the Offce of the Victorian Information Commissioner— that requires the attention of Parliament; and 

d. to examine the annual report of the Information Commissioner and any other reports by the Commissioner and report to Parliament on any matters it thinks t concerning those reports; and 

e. to inquire into matters concerning freedom of information referred to it by the Parliament and to report to Parliament on those matters; 

f. to monitor and review the performance of the duties and functions of the Victorian Inspectorate in respect of Ombudsman officers or the Judicial Commission; and 

g. to report to both Houses of the Parliament on any matter connected with the performance of the duties and functions of the Victorian Inspectorate in respect of Ombudsman officers or the Judicial Commission that require the attention of the Parliament; and 

h. to examine any reports made by the Victorian Inspectorate in respect of Ombudsman officers or the Judicial Commission; and 

i. the functions conferred on the Committee by the Ombudsman Act 1973; and 

j. if so required or permitted under this Act, to inquire into, consider and report to Parliament on the operation of the Judicial Commission of Victoria Act 2016. 

 It is also to

 a. to monitor and review the performance of the duties and functions of the Ombudsman; 

b. to report to both Houses of the Parliament on any matter connected with the performance of the duties and functions of the Ombudsman that requires the attention of the Parliament; 

c. to examine any reports by the Ombudsman that are laid before a House of the Parliament. 

 The Chair comments that

even as late as 7 February 2018, the Government unexpectedly introduced legislation into the Parliament to merge, at a later date, the Independent broad‐Based Anti‐corruption Commission Committee and this Committee into a newly expanded Integrity and Oversight Committee. Significant changes to the FOI framework also came into effect in September 2017, with the functions of the FOI Commissioner and the Commissioner for Privacy and Data Protection merging to form the Office of the Victorian Information Commissioner (OVIC). Mr Sven Bluemmel was appointed the inaugural Information Commissioner. In addition, Mr Eamonn Moran PSM QC was appointed to the role of Victorian Inspector from January 2018, replacing the inaugural Inspector Mr Robin Brett QC at the end of his ve‐year term. .... 

In terms of performance during 2016‐17, the FOI Commissioner reported that the Office:

• finalised the highest number of review decisions (456) and resolved the highest number of complaints (529) to date 

• responded to 8090 enquiries by phone and email 

• processed 90 per cent of FOI applications within the statutory timeframe of 45 days 

• received noti cation from agencies that full access was granted to applicants in 65.6 per cent of cases 

• noted FOI appeals to VCAT increased from 72 in 2015–16 to 91 in 2016–17 

• increased education and training activities to 42 in 2016–17, up from 27 in 2015‐16. 

 In 2016–17, the FOI Commissioner exceeded the quantity target of 550 completed reviews and complaints, with 985 reviews and complaints completed. However, as with previous years, there was an increase in the number of FOI review decisions carried over, with a total of 338 review decisions outstanding. 

Of the four key sectors in which FOI decisions are made, involving health, government, emergency and statutory authorities, the highest proportion of applications denied in full was in the government sector (13.69 per cent), with part access granted in 66.86 per cent of cases. Encouragingly, the health sector continues to have the highest proportion of applications granted in full (91.71 per cent). 

This reinforces the Committee’s recommendations from earlier reports that information that is frequently requested and routinely granted under the FOI Act should be released without the need for applicants to make a FOI request. The Ombudsman also completed a substantial amount of work in 2016‐17, with volumes slightly up on the previous year. 

Highlights included: 

• receiving 40,642 contacts to the Ombudsman’s office, 18,149 of which were redirected through the website or phone service to a more appropriate authority 

• completing 4614 formal enquiries, 25 of which were own motion 

• completing 29 formal investigations, 2 of which were own motion 

• delivering 39 presentations to students, community groups and state and local government organisations 

• tabling 10 reports in Parliament and contributing to reviews and inquiries. 

With the assent of the Freedom of Information Amendment (Office of the Victorian Information Commissioner) Act 2017, the Victorian Inspectorate attained additional oversight functions in relation to the OVIC and the Judicial Commission of Victoria, which commenced operations on 1 July 2017. The Committee recognises the importance to the public of the role of the Victorian Inspectorate, especially its work determining whether a complainant was a orded due process and procedural fairness and that, following a decision of the Inspectorate, guidance is provided on all available options.

 The Committee makes five recommendations-

1: That the Government amend the Freedom of Information Act 1982 to allow complaints to be submitted other than in writing. 

2: That the Office of the Victorian Information Commissioner provides data in its annual reports on the timeframes of complaint resolution. 

3: That the Government amend the Freedom of Information Act 1982 to provide the Office of the Victorian Information Commissioner with the power to compel compliance by agencies in relation to review decisions.. 

4: That the Government reviews the appropriateness of the Victorian Ombudsman’s target measure of 95 per cent of complaints resolved within 30 days. 

5: That the Government clarify the monitoring and oversight of the Office of the Victorian Information Commissioner in relation to the Accountability and Oversight Committee and the Victorian Inspectorate’s similar responsibilities.