Administering a Chill Pill? Better Regulation and the Potential for Regulatory Chill in European Union Health Policy.

The European Union's "good governance" program, known as Better Regulation, seeks to improve the quality of EU legislation by controlling the policy-making process. Despite its importance, it is rarely accounted for in the EU health policy literature. Seeking to address this gap, this article introduces Better Regulation in the context of health policy making. It conceptualizes a model of regulatory chill, drawn from the literature on international trade, to interrogate the impact of Better Regulation on EU policy-making processes. Using examples from the literature and data from a series of interviews with EU officials, it explores potential pathways of response and anticipatory chill, identifying direct enforcement of Better Regulation, its utilization by corporate actors, interpretation of its provision by officials, and feedback loops as possible routes of influence. The article argues that such an approach not only presents methodological challenges but also offers a valuable way of conceptualizing the relevance of political institutions in general, and Better Regulation specifically, for health. As part of broader calls for attention to the political determinants of health, the article's findings highlight the particular, and often overlooked, importance of metaregulatory policy frameworks.

Why meta-regulation matters for public health: the case of the EU better regulation agenda.

Meta-regulation - the rules that govern how individual policies are developed and reviewed - has not received much attention in the study of health policy. We argue that these rules, far from value-free and objective, have significant potential to shape policy outputs and, as such, health outcomes. Channelling and operationalising wider paradigms like neoliberalism, they determine, for instance, what is considered 'good' policy, how decisions are made, based on which evidence, and whose voices matter. Exploring an archetypal example of meta-regulation, the European Union's Better Regulation agenda, we illustrate why meta-regulatory tools such as impact assessment, stakeholder consultation, and evaluation - and the norms that underlie their application - matter for health. In so doing, we concentrate especially on the ways in which Better Regulation may affect interest groups' ability to exert influence and, conversely, how actors have sought to shape Better Regulation. We argue that attention to meta-regulation contributes to counter-balancing the focus on agency within debates at the intersection of globalisation and health, and notably those on regulatory practices and coordination. Whilst research has noted, for instance, the origins of frameworks like Better Regulation and the increasing inclusion of 'good regulatory practice' provisions within trade and investment agreements, less attention is directed to the role that these frameworks play once institutionalised. Yet, as we illustrate, there is considerable scope for meta-regulation to enhance our understanding of the forces shaping health policy via, for instance, conceptualisations of the (social, economic, political, commercial) determinants of health. As such, we call for increased attention to the role of meta-regulation in research and practice aimed at improving human and planetary health.

Corporate political activity in the context of sugar-sweetened beverage tax policy in the WHO European Region.

BACKGROUND: Sugar-sweetened beverage (SSB) taxes have emerged as an effective and increasingly popular tool to reduce added sugar intake, an important contributor to obesity and non-communicable diseases. A common barrier to the implementation of well-designed SSB taxes is the opposition of commercial actors. Focusing on the WHO European Region, this study seeks to map if and how key stakeholders have experienced industry efforts to influence SSB taxes. METHODS: We identified 11 countries in the WHO European Region which have implemented SSB taxes or attempted to do so. Using an online survey informed by the global literature on industry interference with SSB taxation, we approached 70 in-country policymakers, advocates and academics. The data were analysed using an existing framework of corporate political activity. RESULTS: Twenty-three experts from nine countries responded to the survey. Transnational SSB producers and their business associations were identified as the most active opponents of SSB taxation. Industry claims that the policy would have negative economic effects were identified as the most common and powerful arguments. Direct lobbying was reported in all study countries. Shifts in political activity were recognisable across stages of the policy process, moving from outright opposition to attempts to delay or weaken the policy after its announcement. CONCLUSION: Those seeking to introduce effective SSB taxation can use our findings to pre-empt and counter industry opposition. We identify several measures for preventing and mitigating industry interference with SSB tax policy.

Corporate political activity in the context of unhealthy food advertising restrictions across Transport for London: A qualitative case study.

BACKGROUND: Diets with high proportions of foods high in fat, sugar, and/or salt (HFSS) contribute to malnutrition and rising rates of childhood obesity, with effects throughout the life course. Given compelling evidence on the detrimental impact HFSS advertising has on children's diets, the World Health Organization unequivocally supports the adoption of restrictions on HFSS marketing and advertising. In February 2019, the Greater London Authority introduced novel restrictions on HFSS advertising across Transport for London (TfL), one of the most valuable out-of-home advertising estates. In this study, we examined whether and how commercial actors attempted to influence the development of these advertising restrictions. METHODS AND FINDINGS: Using requests under the Freedom of Information Act, we obtained industry responses to the London Food Strategy consultation, correspondence between officials and key industry actors, and information on meetings. We used an existing model of corporate political activity, the Policy Dystopia Model, to systematically analyse arguments and activities used to counter the policy. The majority of food and advertising industry consultation respondents opposed the proposed advertising restrictions, many promoting voluntary approaches instead. Industry actors who supported the policy were predominantly smaller businesses. To oppose the policy, industry respondents deployed a range of strategies. They exaggerated potential costs and underplayed potential benefits of the policy, for instance, warning of negative economic consequences and questioning the evidence underlying the proposal. Despite challenging the evidence for the policy, they offered little evidence in support of their own claims. Commercial actors had significant access to the policy process and officials through the consultation and numerous meetings, yet attempted to increase access, for example, in applying to join the London Child Obesity Taskforce and inviting its members to events. They also employed coalition management, engaging directly and through business associations to amplify their arguments. Some advertising industry actors also raised the potential of legal challenges. The key limitation of this study is that our data focused on industry-policymaker interactions; thus, our findings are unable to present a comprehensive picture of political activity. CONCLUSIONS: In this study, we identified substantial opposition from food and advertising industry actors to the TfL advertising restrictions. We mapped arguments and activities used to oppose the policy, which might help other public authorities anticipate industry efforts to prevent similar restrictions in HFSS advertising. Given the potential consequences of commercial influence in these kinds of policy spaces, public bodies should consider how they engage with industry actors.

Non-communicable disease governance in the era of the sustainable development goals: a qualitative analysis of food industry framing in WHO consultations.

BACKGROUND: The UN system's shift towards multistakeholder governance, now embedded in the Sustainable Development Goals (SDGs), invites a broad range of actors, including the private sector, to the policymaking table. Although the tobacco industry is formally excluded from engagement, this approach provides opportunities for other unhealthy commodity industries to influence the World Health Organization's (WHO's) non-communicable disease (NCD) agenda. Focusing on the food industry, this research maps which actors engaged with WHO consultations, and critically examines actors' policy and governance preferences as well as the framing they employ to promote these preferences in the global context. METHODS: All written responses from food industry actors to publicly available NCD-relevant WHO consultations held between September 2015 and September 2018 were identified, totalling forty-five responses across five consultations. A qualitative frame analysis was conducted to identify policy positions expressed by respondents, as well as arguments and frames used to do so. RESULTS: Though no individual companies responded to the consultations, the majority of participating business associations had some of the largest multinational food corporations as members. Respondents overarchingly promoted non-statutory approaches and opposed statutory regulation and conflict of interest safeguards. To this purpose, they framed the food industry as a legitimate and necessary partner in policymaking, differentiating themselves from the tobacco industry and referencing a history of successful collaboration, while also invoking multistakeholder norms and good governance principles to portray collaboration as required. Respondents contrasted this with the limits of WHO's mandate, portraying it as out of step with the SDGs and framing NCD decision-making as a matter of national sovereignty. CONCLUSION: We observed that the UN's call for partnerships to support the SDGs is invoked to defend corporate access to NCD policy. This highlights the need for more cautious approaches which are mindful of the commercial determinants of health. Systematic opposition to regulation and to governance approaches which may compromise commercial actors' insider role in global health by food industry actors shown here, and the strategic use of the Sustainable Development agenda to this purpose, raises questions about the value of collaboration from the perspective of international health agencies such as WHO.

A missed opportunity for public health: How impact assessment shaped EU rules on the marketing of unhealthy commodities to children.

Background: The 2015-2018 revision of the European Union's Audiovisual Media Services Directive, which governs the marketing of alcohol and unhealthy food to minors, failed to align with international best practice. Previous research has explained this 'missed opportunity' with reference to deficient political will, difficulties advocating for health, and industry pressure. We explore another explanation: the role of the impact assessment (IA) process in shaping decision-making. Methods: We first conducted an in-depth comparison of three versions of the IA report, employing qualitative content and framing analyses to establish what changed in the substantive content, framing, and evidence cited. Second, we used process-tracing, a qualitative method drawing on multiple data sources, to explore causal mechanisms, to assess why these changes occurred. Data sources include policy documents published proactively and obtained through access-to-document requests. Findings: Previously unpublished versions of the IA report show that stronger rules on advertising were preferred early in the policy process but later abandoned, and that concern for 'balancing' consumer protection and competitiveness shifted to focus on the latter. Following review by the Regulatory Scrutiny Board, a revised IA report narrowed the policy options, removing a requirement for member states to prevent childrens' exposure to alcohol advertising. Consequently, decision-makers were provided with an IA that did not offer adequate information on available measures to protect children. Interpretation: Changes made during the IA process, which determines the policy options presented to decision-makers, side-lined health concerns. We argue that engaging with the institutional structures which shape decision-making is crucial for those working to further public health.

Framing Marketing Responses to National Regulation: The Four Ps in Transnational Corporate Political Discourse Comment on "Understanding Marketing Responses to a Tax on Sugary Drinks: A Qualitative Interview Study in the United Kingdom, 2019".

A growing evidence base indicates that sugar-sweetened beverage (SSB) taxes are an effective tool to help reduce excess sugar intake. The effects of SSB taxes and the mechanisms which underlie them, however, are dependent on a number of interrelated factors such as policy design and responses of industry and consumers. Forde and colleagues contribute to unpacking these mechanisms by exploring the way in which the UK's Soft Drinks Industry Levy (SDIL) shaped the four Ps of soft drinks marketing: product, price, placement, and promotion. This commentary builds on the authors' insights by connecting them to existing knowledge on corporate political activity and the commercial determinants of health (CDOH) more broadly. Specifically, I discuss the risk that an industry framing of regulation-induced marketing changes as a voluntary step towards corporate responsibility undermines the need for government intervention to address obesity in other contexts and countries. I conclude by arguing that the public health community would benefit from considering marketing responses to regulation alongside industry narratives about these changes.

Corporate Political Activity: Taxonomies and Model of Corporate Influence on Public Policy.

BACKGROUND: Non-communicable diseases (NCDs) kill 41 million people a year. The products and services of unhealthy commodity industries (UCIs) such as tobacco, alcohol, ultra-processed foods and beverages and gambling are responsible for much of this health burden. While effective public health policies are available to address this, UCIs have consistently sought to stop governments and global organisations adopting such policies through what is known as corporate political activity (CPA). We aimed to contribute to the study of CPA and development of effective counter-measures by formulating a model and evidence-informed taxonomies of UCI political activity. METHODS: We used five complementary methods: critical interpretive synthesis of the conceptual CPA literature; brief interviews; expert co-author knowledge; stakeholder workshops; testing against the literature. RESULTS: We found 11 original conceptualisations of CPA; four had been used by other researchers and reported in 24 additional review papers. Combining an interpretive synthesis of all these papers and feedback from users, we developed two taxonomies - one on framing strategies and one on action strategies. The former identified three frames (policy actors, problem, and solutions) and the latter six strategies (access and influence policy-making, use the law, manufacture support for industry, shape evidence to manufacture doubt, displace, and usurp public health, manage reputations to industry's advantage). We also offer an analysis of the strengths and weaknesses of UCI strategies and a model that situates industry CPA in the wider social, political, and economic context. CONCLUSION: Our work confirms the similarity of CPA across UCIs and demonstrates its extensive and multi-faceted nature, the disproportionate power of corporations in policy spaces and the unacceptable conflicts of interest that characterise their engagement with policy-making. We suggest that industry CPA is recognised as a corruption of democracy, not an element of participatory democracy. Our taxonomies and model provide a starting point for developing effective solutions.

Lacking Clarity or Strategic Ambiguity? Comment on "Competing Frames in Global Health Governance: An Analysis of Stakeholder Influence on the Political Declaration on Non-communicable Diseases".

This commentary engages with Suzuki and colleagues' analysis about the ambiguity of multi-stakeholder discourses in the United Nations (UN) Political Declaration of the 3rd High-Level Meeting of the General Assembly on the Prevention and Control of Non-Communicable Diseases (HLM-NCDs), suggesting that blurring between public and private sector in this declaration reflects broader debates about multi-stakeholder partnerships (MSPs) and public-private partnerships (PPPs) in health governance. We argue that the ambiguity between the roles and responsibilities of public and private actors involved may downplay the role (and regulation) of conflicts of interest (COI) between unhealthy commodity industries and public health. We argue that this ambiguity is not simply an artefact of the Political Declaration process, but a feature of multi-stakeholderism, which assumes that commercial actors´ interests can be aligned with the public interest. To safeguard global health governance, we recommend further empirical and conceptual research on COI and how it can be managed.

Big food and the World Health Organization: a qualitative study of industry attempts to influence global-level non-communicable disease policy.

INTRODUCTION: There is an urgent need for effective action to address the over 10 million annual deaths attributable to unhealthy diets. Food industry interference with policies aimed at reducing non-communicable diseases (NCDs) is widely documented at the national level but remains under-researched at the global level. Thus, this study explores how ultra-processed food industry actors have attempted to influence NCD policy at WHO. METHODS: A combination of inductive and deductive thematic coding of internal industry documents, academic literature and interviews with key informants from international organisations and global civil society was used to identify action-based strategies ultra-processed food industry actors employ to influence global-level policy. RESULTS: Ultra-processed food industry actors have attempted to influence WHO and its policies through three main action-based strategies: coalition management, involvement in policy formulation, and information management. Coalition management includes the creation and use of overt alliances between corporations-business associations-and more covert science-focused and policy-focused intermediaries, the hiring of former WHO staff and attempted co-option of civil society organisations. Industry involvement in policy formulation is operationalised largely through the lobbying of Member States to support industry positions, and business associations gaining access to WHO through formal consultations and hearings. Information management involves funding and disseminating research favourable to commercial interests, and challenging unfavourable evidence. CONCLUSION: We provide novel insights into how ultra-processed food industry actors shape global-level NCD policy and identify a clear need to guard against commercial interference to advance NCD policy. In their approach, the political behaviour of multinational food corporations bears similarities to that of the tobacco industry. Increased awareness of, and safeguarding against, commercial interference at the national as well as the global level have the potential to strengthen the crucial work of WHO.

Commercial use of evidence in public health policy: a critical assessment of food industry submissions to global-level consultations on non-communicable disease prevention.

BACKGROUND: Ultra-processed food industry (UPFI) actors have consistently opposed statutory regulation in health policy debates, including at the WHO. They do so most commonly with claims that regulatory policies do not work, will have negative consequences or that alternatives such as self-regulation work well or better. Underlying this are often assertions that industry is aligned with principles of evidence-based policymaking. In this study, we interrogate if this holds true by exploring the extent and quality of the evidence UPFI respondents employed to support claims around regulatory policy, and how they did this. METHODS: First, we identified all submissions from organisations who overtly represent UPFI companies to consultations held by the WHO on non-communicable disease policy between 2016 and 2018. Second, we extracted all relevant factual claims made in these submissions and noted if any evidence was referenced in support. Third, we assessed the quality of evidence using independence from UPFI, nature, and publication route as indicators. Lastly, where peer-reviewed research was cited, we examined if the claims made could be justified by the source cited. RESULTS: Across 26 included consultation responses, factual claims around regulation were made in 18, although only 10 referenced any evidence at all. Of all 114 claims made, 39 pieces of identifiable evidence were cited in support of 56 claims. Of the 39 distinct pieces of evidence, two-thirds were industry-funded or industry-linked, with only 16 externally peer-reviewed. Over half of industry-funded or industry-linked academic articles failed to declare a conflict of interest (COI). Overall, of only six claims which drew on peer-reviewed and independent research, none appropriately represented the source. DISCUSSION: UPFI respondents made far-reaching claims which were rarely supported by high-quality, independent evidence. This indicates that there may be few, if any, benefits from consulting actors with such a clear COI.

Developing more detailed taxonomies of tobacco industry political activity in low-income and middle-income countries: qualitative evidence from eight countries.

INTRODUCTION: Historical evidence, predominantly from high-income countries (HICs), shows that the tobacco industry uses a recurring set of arguments and techniques when opposing tobacco control policies. This data formed the basis of a model of tobacco industry political activity known as the policy dystopia model (PDM). The PDM has been widely used in tobacco control research and advocacy and has subsequently been shown relevant to other unhealthy commodities industries in both HICs and low-income and middle-income countries (LMICs). Before it can be validated as a generic tool for researching corporate influence on policy, one needs to determine whether the PDM successfully captures contemporary corporate political activities in LMICs. METHOD: We conducted semistructured interviews with 22 LMIC-based advocates and used the transcripts as the primary data source. The discursive and instrumental taxonomies constituting the PDM served as the starting point for the coding framework. Using thematic analysis, we combined deductive and inductive coding to ensure we captured all strategies from the PDM and the interviews. RESULTS: This study found that the tobacco industry uses a set of discursive and instrumental strategies that is largely consistent across LMICs and with the PDM. We identified several minor contextual nuances absent from the PDM. Some of these nuances were characteristic to individual countries, while others to LMICs more broadly. They included the argument that tobacco control policies unfairly punish reputable tobacco industry actors, and an emphasis on instrumental strategies centred around maintaining a good image, rather than rehabilitating a tarnished image as emphasised in the PDM. CONCLUSIONS: Allowing for the nuances identified in this study, the PDM has been found to be fit for purpose. The revised model should now be tested through in-depth LMIC case studies and could be used to facilitate comparative studies of unhealthy commodity industries' political activities.

Prospective longitudinal study of tobacco company adaptation to standardised packaging in the UK: identifying circumventions and closing loopholes.

OBJECTIVES: UK standardised packaging legislation was introduced alongside pack size and product descriptor restrictions of the European Union Tobacco Products Directive to end tobacco marketing and misinformation via the pack. This paper aims to assess compliance with the restrictions and identify attempts to continue to market tobacco products and perpetuate misperceptions of harm post legislation. DESIGN, SETTING AND INTERVENTION: A prospective study of the introduction of standardised packaging of tobacco products to the UK. PARTICIPANTS AND OUTCOMES: We analysed commercial sales data to assess whether the legally required changes in pack branding, size and name were implemented. To explore any adaptations to products and packaging we analysed sales data, monthly pack purchases of factory-made (FM) cigarettes and roll-your-own (RYO) tobacco, tobacco advertisements from retail trade magazines and articles on tobacco from commercial literature (retail trade, market analyst and tobacco company publications). RESULTS: One month after full implementation of the UK and European Union policies, 97% FM and 98% RYO was sold in compliant packaging. Nevertheless, tobacco companies made adaptations to tobacco products which enabled continued brand differentiation after the legislation came into force. For example, flavour names previously associated with low tar were systematically changed to colour names arguably facilitating continued misperceptions about the relative harms of products. Tobacco companies used the 1-year sell-through to their advantage by communicating brand name changes and providing financial incentives for retailers to buy large volumes of branded packs. In addition, tobacco companies continued to market their products to retailers and customers by innovating exemptions to the legislation, namely, filters, packaging edges, seals, multipack outers, RYO accessories, cigars and pipe tobacco. CONCLUSIONS: Tobacco companies adapted to packaging restrictions by innovating their tobacco products and marketing activities. These findings should enable policy makers globally to close loopholes and increase the potential efficacy of standardised packaging policies.