Reconceptualising the commercial determinants of health: bringing institutions in.

The concept of the 'commercial determinants of health' (CDOH) has been developed by public health researchers as a way to describe the political economy of corporations and the impact of their practices on health, social inequalities and climate change. In this analysis, we assess the conceptual work that has developed this field and the influence of the more established 'social determinants of health' models. We highlight the dominance of epidemiologic and biomedical concepts on understandings of structure and agency in the CDOH literature and argue that the terminology of 'risk factors', 'drivers' and 'pathways' reflects an agent-centred approach. We suggest that, as a result, there is a tendency to overlook the importance of political institutions in shaping the exercise of corporate power. Our analysis seeks to 'bring institutions in' to CDOH research, using the empirical cases of Health in All Policies and Better Regulation in the European Union to highlight how institutional contexts shape political legitimacy and accountability, and in turn the strategies of corporate actors. Institutionalist approaches, we argue, have the potential to develop and expand understandings of CDOH by opening the black box between agency and structure.

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.

Termites of Solidarity in the House of Austerity: Undermining Fiscal Governance in the European Union.

European Union (EU) fiscal governance, especially the European Semester, is an ambitious new governance architecture involving surveillance and discipline, across both Eurozone and non-Eurozone member state policies, in pursuit of fiscal rigor. It is the most recent of several attempts to expand EU powers over member state policy with the goal of austere budgeting, and one that has led to remarkable claims of authority by the EU over member state health policies as detailed as medical school admissions and the role of primary care. It is expected that it would be resisted not just by those who object to an EU role in the organization and delivery of health care but also by those who object to a particular austere approach to health policy. How well is it working? Using two waves of interviews and documentary analysis, and health as a policy case study, the authors document three key techniques that opponents use to undermine the semester's governance architecture: broadening goals, expanding the scope of conflict, and disputing and nuancing indicators. The result is that opponents of a narrow fiscal governance agenda are again successfully undermining the narrow focus of the semester.

Towards more comprehensive health law and policy research.

In this comment, and drawing on the papers in the special issue, we ask: what are the core questions for the future of research into health law and policy, and European health law and policy more specifically? We first sketch the general functions and values of health law and policy. We then outline how these functions and values are affected by globalisation and Europeanisation, on the one hand, and technological change and digitalisation, on the other. In light of these developments we carve out some questions for future research and the implications of this agenda for the academic community that is working on European health law and policy.

EU health law and policy: shaping a future research agenda.

The relevance of the European Union (EU) for health has been widely recognised within the health community for some time, and is increasingly apparent to European policy-makers and publics. Despite being an area of policy that national governments would prefer to keep exclusive control of, and though in the past it has rarely been at the top of the agenda, many elements of health have been gradually 'Europeanised'. This special issue marks the culmination of a British Academy-funded project - EU Health Law and Policy: Shaping a Future Research Agenda - which sought to build on the growing web of expertise in this field and reflect upon the future of health as an EU competence, at a time when it appeared to be under threat.

Using the Advocacy Coalition Framework to understand EU pharmaceutical policy.

Models of interest group politics can help public health professionals (PHPs) to identify potential allies and establish mechanisms of sustainable political influence. This article focusses on a particular model, known as the Advocacy Coalition Framework (ACF), and its explanations of coalition behaviour, the role of scientific information and the ways in which coalitions can bring about policy change. The analysis illustrates the relevance of the ACF for public health by drawing on examples from the recent policy debate on direct-to-consumer advertising of prescription drugs (DTCA-PD) in the European Union (EU). It explores the strengths and weaknesses of the ACF in explaining why 'control' of particular governmental units was key to the anti-DTCA coalition success, how the evidence base was used strategically and why the pro-DTCA coalition ultimately failed in bringing about major policy change. The article aims to equip PHPs with a tool which can be used to understand and engage with the policy process. Moreover, in offering a more nuanced view of this process, a case is made for moving beyond traditional, linear conceptions of the policy process and engaging in further research which uses political science concepts to inform the study and practice of public health. The article concludes with a set of recommendations for practitioners and researchers, emphasizing the value of political science for the former and the need for the latter to reflect on the accessibility of policy studies for PHPs.

Whatever happened to the Norwegian Medical Need Clause? Lessons for current debates in EU pharmaceutical regulation.

Until 1994, pharmaceutical products seeking market authorisation in Norway were required to demonstrate a fulfilment of unmet medical need. This clause enabled the national regulator to dramatically limit the number of products on the market whilst encouraging price competition to keep drug expenditure low and was credited with encouraging the development of drugs with genuine added therapeutic value and reducing the incidence of antimicrobial resistance. Norway was forced to abandon its Medical Need Clause (MNC) when it joined the European Economic Area as it was incompatible with the acquis communautaire of the European Union. This article reviews Norway's experience with its MNC in light of contemporary debates in European health policy. It discusses the potential contribution of an MNC-style regulation to improving health, reducing illness, ensuring sustainable health systems and fostering pharmaceutical innovation. It concludes by asking how these findings can inform current European Union debates over the growing cost of prescription drugs and direction of pharmaceutical development.

Can a medical need clause help manage the growing costs of prescription drugs in the EU?

Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe's health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU's role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe's health systems?

From DTCA-PD to patient information to health information: the complex politics and semantics of EU health policy.

RATIONALE, AIMS AND OBJECTIVES: Between 2001 and 2011 the pharmaceutical industry, supported by DG Enterprise, was engaged in an ongoing campaign to repeal/amend the European Union (EU) ban on direct-to-consumer advertising of prescription drugs (DTCA-PD). As it became increasingly clear that the ban would not be repealed, DTCA-PD supporters tried to shift the debate away from advertising and towards the provision of 'patient information' and the rights of patients to access such information. Meanwhile, a variety of national and European health organizations, supported by DG SANCO, sought to maintain the ban and oppose the industry-supported 'patient information' campaign. Instead, they promoted a concept of 'health information' that included all aspects of citizens' health, not just pharmaceuticals. This article aims to analyse the transition from DTCA-PD to patient information to health information and examine its implications for EU health policy as a complex policy space. METHODS: The article examines the emergence and development of EU health policy and the evolution of the DTCA-PD debate through the lens of complexity theory. It analyses the nature of the semantic, political and policy transition and asks why it occurred, what it tells us about EU health policy and future EU health legislation and how it may be understood from a complexity perspective. RESULTS AND CONCLUSIONS: The article concludes that the complexity framework is ideally suited for the field of public health and, in particular, the DTCA-PD debate. Having successfully shifted the policy-focus of the debate to patients' rights and health information, opponents of the legislation are likely to face their next battle in the realm of cyberspace, where regulatory issues change the nature of advertising.

Crossing borders: a critical review of the role of the European Court of Justice in EU health policy.

Over the last two decades, the European Union (EU) has steadily increased its involvement in the health policies of its member states, with considerable support from the European Court of Justice (ECJ). However, much of the literature examining the Court's role has focused upon the intersection between internal market law and the health services sector; the majority of studies have failed to examine the potential role for the Court in public health policy. Observers such as Greer have seen the development of healthcare as a clear case of neofunctional spillover, a view supported but qualified by Wasserfallen and others, who present a more detailed account of the mechanics of the process. Alternative analyses have focused upon the new modes of governance, soft law and other factors - this article reviews the current state of research in the field and the extent to which it should concern health policy actors and non-specialists in EU policy alike. It concludes that the Court has played and continues to play a crucial role in the development of EU public health policy, as well as in health services and broader social policy, where its influence has already been well documented.