Regional International Organizations and Health: A Framework for Analysis.

CONTEXT: Regional international organizations (RIOs), from the South African Development Community (SADC) to the European Union (EU), are organizations that promote cooperation among countries in a specific region of the world. Asking what RIOs do to health and health policy by looking only at their formal health policies can understate their effects (e.g., a free trade agreement with no stated health goals can affect health policy) and overstate their effects (as with agreements full of ambition that did not deliver much). METHODS: We adopt a "three-faces" framework that identifies RIOs' direct health policies, the effects of their trade and market policies, and their effects on health via fiscal governance of their member states to better capture their health impact. We tested the usefulness of the framework by examining the Association of Southeast Asian Nations, EU, North American Free Trade Agreement, SADC, and the Union of South American Nations. FINDINGS: All RIOs had some impact on health systems and policies, and, in many cases, the principal policies were not identified as health policy. CONCLUSIONS: Such a framework will be useful in understanding the effects of RIOs on health systems and policies because it captures indirect and even unintended health effects in a way that permits development of explanatory theories.

Brexit and trade policy: an analysis of the governance of UK trade policy and what it means for health and social justice.

BACKGROUND: There is an extensive body of research demonstrating that trade and globalisation can have wide-ranging implications for health. Robust governance is key to ensuring that health, social justice and sustainability are key considerations within trade policy, and that health risks from trade are effectively mitigated and benefits are maximised. The UK's departure from the EU provides a rare opportunity to examine a context where trade governance arrangements are being created anew, and to explore the consequences of governance choices and structures for health and social justice. Despite its importance to public health, there has been no systematic analysis of the implications of UK trade policy governance. We therefore conducted an analysis of the governance of the UK's trade policy from a public health and social justice perspective. RESULTS: Several arrangements required for good governance appear to have been implemented - information provision, public consultation, accountability to Parliament, and strengthening of civil service capacity. However, our detailed analyses of these pillars of governance identified significant weaknesses in each of these areas. CONCLUSION: The establishment of a new trade policy agenda calls for robust systems of governance. However, our analysis demonstrates that, despite decades of mounting evidence on the health and equity impacts of trade and the importance of strong systems of governance, the UK government has largely ignored this evidence and failed to galvanise the opportunity to include public health and equity considerations and strengthen democratic involvement in trade policy. This underscores the point that the evidence alone will not guarantee that health and justice are prioritised. Rather, we need strong systems of governance everywhere that can help seize the health benefits of international trade and minimise its detrimental impacts. A failure to strengthen governance risks poor policy design and implementation, with unintended and inequitable distribution of harms, and 'on-paper' commitments to health, social justice, and democracy unfulfilled in practice. Although the detailed findings relate to the situation in the UK, the issues raised are, we believe, of wider relevance for those with an interest of governing for health in the area of international trade.

What Is EU Public Health and Why? Explaining the Scope and Organization of Public Health in the European Union.

Public health is notoriously difficult to define, and that is the case for public health in the European Union as much as other political systems. In this article, the authors try to identify the actual scope and meaning of public health as it is institutionalized in the EU political system. Using a mixture of historical policy and legal analysis, the authors show how the evolution of the institutional space called public health in the EU has been shaped by the EU's distinctive constitutional nature, its focus on regulation, and the legacy of its focus on market making as well as the preferences of its political leaders. The European Union does have an increasingly large space named "public health," in which health ministers, the health directorate-general, and invocation of its public health treaty article 168 can be found, as well as a much broader and older area of activities justified by the need to manage adverse health consequences of market-making policies in other areas such as labor standards and agriculture. The COVID-19 crisis of 2020 not only led to a strengthening of EU public health but also showed that the EU is one of the many political systems in which the legal and bureaucratic domain of public health is far smaller than the actual issues affecting the public's health.

How will Brexit affect health services in the UK? An updated evaluation.

All forms of Brexit are bad for health, but some are worse than others. This paper builds on our 2017 analysis using the WHO health system building blocks framework to assess the likely effects of Brexit on the National Health Service (NHS) in the UK. We consider four possible scenarios as follows: a No-Deal Brexit under which the UK leaves the EU on March 29, 2019, without any formal agreement on the terms of withdrawal; a Withdrawal Agreement, as negotiated between the UK and EU and awaiting (possible) formal agreement, which provides a transition period until the end of December, 2020; the Northern Ireland Protocol's backstop coming into effect after the end of that period; or the Political Declaration on the Future Relationship between the UK and EU. Our analysis shows that a No-Deal Brexit is substantially worse for the NHS than a future involving the Withdrawal Agreement, which provides certainty and continuity in legal relations while the Political Declaration on the Future Relationship is negotiated and put into legal form. The Northern Ireland backstop has varying effects, with continuity in some areas, such as health products, but no continuity in others. The Political Declaration on the Future Relationship envisages a relationship that is centred around a free-trade agreement, in which wider health-related issues are largely absent. All forms of Brexit, however, involve negative consequences for the UK's leadership and governance of health, in both Europe and globally, with questions about the ability of parliament and other stakeholders to scrutinise and oversee government actions.

Brexit is just a symptom: the constitutional weaknesses it reveals have serious consequences for health.

Brexit has direct and indirect negative health consequences, whether from economic damage or from the political paralysis and distraction from public health that it has created. Brexit is a public health problem in its own right, as other literature has shown-but, we argue, it is also a symptom of deeper problems in the governance of the United Kingdom. In particular, the combination of executive dominance, partisanship and opacity that give rise to the constitutional casualism of the Brexit decisions has already affected public health policy and will continue to do so unless addressed.

What Is the Affordable Care Act a Case of? Understanding the ACA through the Comparative Method.

International comparisons of US health care are common but mostly focus on comparing its performance to peers or asking why the United States remains so far from universal coverage. Here the authors ask how other comparative research could shed light on the unusual politics and structure of US health care and how the US experience could bring more to international conversations about health care and the welfare state. After introducing the concept of casing-asking what the Affordable Care Act (ACA) might be a case of-the authors discuss different "casings" of the ACA: complex legislation, path dependency, demos-constraining institutions, deep social cleavages, segmentalism, or the persistence of the welfare state. Each of these pictures of the ACA has strong support in the US-focused literature. Each also cases the ACA as part of a different experience shared with other countries, with different implications for how to analyze it and what we can learn from it. The final section discusses the implications for selecting cases that might shed light on the US experience and that make the United States look less exceptional and more tractable as an object of research.

Normalizing Tobacco? The Politics of Trade, Investment, and Tobacco Control.

Policy Points Tobacco industry denormalization is a key strategy for tobacco control that has been formalized in the WHO Framework Convention on Tobacco Control. International trade and investment laws are a potential threat to tobacco industry denormalization because they do not automatically incorporate denormalization and, in theory, treat tobacco firms like other commercial interests. Countries that seek to defend tobacco control policies against international trade and investment challenges need to have good governance in two senses: good governance as understood by tribunals and good-enough governance to manage the processes and requirements that enable policies to survive international challenges. CONTEXT: Tobacco industry denormalization (TID), portraying tobacco product manufacturers as a deadly industry, is a major strategy for public health advocates. Using this strategy, activists around the world have successfully pushed for governments to enact tobacco control regulations, including the unprecedented international Framework Convention on Tobacco Control (FCTC). TID has been a distinctive legal and political strategy that has affected the place of tobacco in law and has both inspired and constrained those who would imitate the strategy in other areas of regulation, such as diet or alcohol. It is therefore a case study in the creation of a distinctive legal approach and of threats to that approach from the changing role of world trade and investment law, which creates a new set of venues that tobacco industry advocates can use to redefine tobacco as a normal good and to seek out "fair and equitable treatment" for their industry. METHODS: I review legal and policy documents pertaining to two major challenges to tobacco control policies in Australia and Uruguay aimed at controlling industry branding. FINDINGS: International trade and investment law challenges TID and raises fundamental questions about the role of the state in protecting public health. Recent trade disputes involving Uruguay and Australia illustrate this dynamic. Despite losing high-court challenges against packaging regulations in both countries, tobacco firms were still able to challenge states in a different way, through international trade and investment agreements. This article identifies the industry's strategies and the responses of those seeking to avoid renormalizing tobacco as a part of world trade. In particular, states must demonstrate that their tobacco control policies satisfy standards set by tribunals, which include standards of good governance, and they must prepare their policies in a way that reduces legal risk and requires good governance. CONCLUSIONS: Although TID has strengthened the hand of tobacco control advocates, TID strategies alone are not sufficient to defend public regulations against extraterritorial legal challenges in an arena that resists the basic TID technique of singling out a particular industry. Public health advocates might also note the FCTC's aid in helping governments defend themselves against these challenges and consider similar international instruments for other areas.

Lessons for the United States From Single-Payer Systems.

US political debates often refer to the experience of "single-payer" systems such as those of Canada and the United Kingdom. We argue that single payer is not a very useful category in comparative health policy analysis but that the experiences of countries such as Canada, the United Kingdom, Spain, Sweden, and Australia provide useful lessons. In creating universal tax-financed systems, they teach the importance of strong, unified governments at critical junctures-most notably democratization. The United States seems politically hospitable to creating such a system.The process of creation, however, highlights the malleability of interests in the health care system, the opportunities for creative coalition building, and the problems caused by linking health care finance and reform. In maintaining these systems, keeping the middle class supportive is crucial to avoiding universal health care that is essentially a program for the poor.For a technical term from the 1970s, "single-payer health care" has proved to have remarkable political power and persistence. We argue it is not a very useful term but the lessons from such systems can be valuable for those contemplating movement toward universal health coverage in the United States.

How will Brexit affect health and health services in the UK? Evaluating three possible scenarios.

The process of leaving the European Union (EU) will have profound consequences for health and the National Health Service (NHS) in the UK. In this paper, we use the WHO health system building blocks framework to assess the likely effects of three scenarios we term soft Brexit, hard Brexit, and failed Brexit. We conclude that each scenario poses substantial threats. The workforce of the NHS is heavily reliant on EU staff. Financing of health care for UK citizens in the EU and vice versa is threatened, as is access to some capital funds, while Brexit threatens overall economic performance. Access to pharmaceuticals, technology, blood, and organs for transplant is jeopardised. Information used for international comparisons is threatened, as is service delivery, especially in Northern Ireland. Governance concerns relate to public health, competition and trade law, and research. However, we identified a few potential opportunities for improvement in areas such as competition law and flexibility of training, should the UK Government take them. Overall, a soft version of Brexit would minimise health threats whereas failed Brexit would be the riskiest outcome. Effective parliamentary scrutiny of policy and legal changes will be essential, but the scale of the task risks overwhelming parliament and the civil service.

Legalism and tobacco control in the EU.

Tobacco control policies rely heavily on law and are steeped in litigation. Examining the creation of tobacco control laws in the European Union, this article lays out the potential costs and benefits of legalism for public health practitioners and advocates. Legalism is a form of governance that relies heavily on the authority of law to settle political disputes, with consequences for the ways in which governments make, and advocates push for, public health policies. To the extent that legalism creates procedural problems and distortions in the content of public health policy, then the content of law and its making is a public health problem. On the other hand, litigation can also be a public health tool, and an enforceable, justiciable right to health is a powerful political and legal weapon in its own right.

The New Political Economy of Health Care in the European Union: The Impact of Fiscal Governance.

We argue that the political economy of health care in the European Union is being changed by the creation of a substantial new apparatus of European fiscal governance. A series of treaties and legal changes since 2008 have given the European Union new powers and duties to enforce budgetary austerity in the member states, and this apparatus of fiscal governance has already extended to include detailed and sometimes coercive policy recommendations to member states about the governance of their health care systems. We map the structures of this new fiscal governance and the way it purports to affect health care decision making.

When trade law meets public health evidence: the World Trade Organization and clove cigarettes.

A recent trade dispute between the USA and Indonesia, overseen by the World Trade Organization, challenges piecemeal approaches to tobacco regulation.

Centralizing and decentralizing governance in the COVID-19 pandemic: The politics of credit and blame.

COVID-19 led to significant and dynamic shifts in power relations within and between governments, teaching us how governments make health policies and how health crises affect government. We focus on centralization and decentralization within and between governments: within government, meaning the extent to which the head of government controls policy; and between governments, meaning the extent to which the central government pre-empts or controls local and regional government. Political science literature suggests that shifting patterns of centralization and decentralization can be explained by leading politicians' efforts to gain credit for popular actions and outcomes and deflect blame for unpopular ones. We test this hypothesis in two ways: by coding the Health Systems Response Monitor's data on government responses, and through case studies of the governance of COVID-19 in Austria, Czechia and France. We find that credit and blame do substantially explain the timing and direction of changes in centralization and decentralization. In the first wave, spring 2020, heads of government centralized and raised their profile in order to gain credit for decisive action, but they subsequently tried to decentralize in order to avoid blame for repeated restrictions on life or surges of infection. These findings should shape advice on governance for pandemic response.

Defining and analyzing health system resilience in rural jurisdictions.

Rural areas face well known and distinctive health care challenges that can limit their resilience in the face of health emergencies such as the COVID-19 pandemic. These include problems of sparsity and consequent limited health care provisioning; poverty, inequalities, and distinctive economic structures that limit access to health care; and underlying population health risks and inequalities that can increase vulnerability. Nonetheless, not all rural areas face the same problems, and non-rural areas can have challenges. To be useful in influencing policy, a tool to identify more and less resilient areas is necessary. This Commentary reviews key forms of risk and constructs a county-level index of resilience for the United States which helps to identify countries with limited resilience. Further, it argues that health care resilience should be conceptualized in terms of broader regions than counties since health care facilities' referral regions are larger than individual counties; resilience needs to be understood at that level. The index, read at the level of counties and referral regions, can contribute to identification of immediate problems as well as targets for longer term investment and policy response.

Impact on the NHS and health of the UK's trade and cooperation relationship with the EU, and beyond.

The UK's relationship with the European Union (EU) is now embodied in two principal legal instruments: the EU-UK Trade and Cooperation Agreement, which formally entered into force on 1 May 2021; and the Withdrawal Agreement, with its Protocol on Ireland/Northern Ireland, which continues to apply. Using a 'building blocks' framework for analysis of national health systems derived from the World Health Organisation, this article examines the likely impacts in the UK of this legal settlement on the National Health Service (NHS), health and social care. Specifically, we determine the extent to which the trade, cooperation and regulatory aspects of those legal measures support positive impacts for the NHS and social care. We show that, as there is clear support for positive health and care outcomes in only one of the 17 NHS 'building blocks', unless mitigating action is taken, the likely outcomes will be detrimental. However, as the legal settlement gives the UK a great deal of regulatory freedom, especially in Great Britain, we argue that it is crucial to track the effects of proposed new health and social care-related policy choices in the months and years ahead.

Neither protective nor harmonized: the crossborder regulation of medical devices in the EU.

To what extent does inadequate market regulation contribute to poor health outcomes? A series of prominent scandals involving harmful medical devices has made improving the regulation of these devices an urgent problem for the European Union (EU). This is, however, a specific example of a general phenomenon. The EU remains first and foremost a large and integrated market within which the EU institutions have considerable regulatory authority. Even if there is little EU commitment to a health or social policy agenda, its use of that regulatory authority shapes health care cost and quality and should be understood as health policy. We use data from EU-level and national policy documents to analyse the EU's current regulatory framework for medical devices and assess its likely future efficacy. Despite revising the medical devices directive to require more stringent pre-authorization requirements for high-risk medical devices and improvements in post-market surveillance, the key underlying problems of market fragmentation and patient safety persist. Without strong and consistent support for the implementation of the new directive, the likely result is the status quo, with significant consequences for health in Europe.

Perspectives in the study of the political economy of COVID-19 vaccine regulation.

Vaccines against SARS-CoV-2 continue to be developed at an astonishingly quick speed and the early ones, like Pfizer and Moderna, have been shown to be more effective than many public health scientists had dared to hope. As COVID-19 vaccine research continues to progress, the world's eyes are turning toward medicine regulators. COVID-19 vaccines need to be authorized for use in each country in which the pharmaceutical industry intends to commercialize its product. This results in a patchwork of regulations that can influence the speed at which products are launched and the standards that govern them. In this research forum article, we discuss several key questions about COVID-19 vaccine regulations that should shape research on the next stage of the pandemic response. We call for a research agenda that looks into the political economy of pharmaceutical regulation, particularly from a comparative perspective, including Global South countries.

Assessing the potential impact on health of the UK's future relationship agreement with the EU: analysis of the negotiating positions.

While policy attention is understandably diverted to COVID-19, the end of the UK's post-Brexit 'transition period' remains 31 December 2020. All forms of future EU-UK relationship are worse for health than EU membership, but analysis of the negotiating texts shows some forms are better than others. The likely outcomes involve major negative effects for NHS staffing, funding for health and social care, and capital financing for the NHS; and for UK global leadership and influence. We expect minor negative effects for cross border healthcare (except in Northern Ireland); research collaboration; and data sharing, such as the Early Warning and Response System for health threats. Despite political narratives, the legal texts show that the UK seeks de facto continuity in selected key areas for pharmaceuticals, medical devices, and equipment [including personal protective equipment (PPE)], especially clinical trials, pharmacovigilance, and batch-testing. The UK will be excluded from economies of scale of EU membership, e.g. joint procurement programmes as used recently for PPE. Above all, there is a major risk of reaching an agreement with significant adverse effects for health, without meaningful oversight by or input from the UK Parliament, or other health policy stakeholders.