European support for improving global health systems and policies

The European Union (EU) is one of the world’s largest markets, aid donors, health care innovators and tradingpowers. As such, many of its policies affect global health. EU policies affect global health directly, as with overseas aid, trade policy or support for the World Health Organization (WHO). They also affect global health indirectly, as with the many internally focused policies which affect health and health policy options in other countries, such as research priorities or medicines regulation. The extensive range of policy areas that touch global health mean that the EU has a wide range of policy tools which inevitably shape global health, and which the EU can use intentionally to shape health governance and outcomes worldwide.The broad shape of any coherent strategy or approach to global health, in the complex institutional environment ofEurope, must align priorities with tools, identifying what the EU wants to achieve in the global health sphere andwhich policy tools will be best suited to have the desired effects. Alignment requires consideration of the differentways in which countries near the EU already relate to it (e.g. accession candidates) and should include anappreciation of which actors should use the different policy tools, with respect to subsidiarity as well as the advantages of joint action in some areas. The review of EU instruments clearly shows the immense scale of the impact of existing EU policies on global health, and the potential that a coherent approach could have to strengthen global health governance and improve global health policies and outcomes. The EU affects global health through many different policies; the question is how, when and by whom these policies will be used for global health.

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.

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.

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.

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.

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.

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.

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 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.

It’s the governance, stupid! TAPIC: a governance framework to strengthen decision making and implementation

This policy brief’s key messages are: governance is a broad and complex topic with many overlapping definitions, frameworks and recommendations, but governance concepts and ideas found in the literature can broadly be grouped into five key domains: Transparency, Accountability, Participation, Integrity and Capacity (TAPIC); governance is crucial to successful policy-making and implementation. It affects the likelihood that workable policies are adopted, that they are implemented, and that they produce intended results. At the same time, governance may be the cause of policy problems. But it is only one potential cause of problems, alongside other causes of failure such as inadequate finance.; each of the five domains of the TAPIC framework contains many different techniques for policy and procedural change. Rigorous and context-sensitive analysis is required to work out which domains contain governance problems and what those problems might be.

Everything you always wanted to know about European Union health policies but were afraid to ask

What does the European Union (EU) mean for health? What can it mean for health? This comprehensively revised second edition answers these questions. It provides a broad review and analysis of EU public health policies to mid-2019. It begins by explaining the basic politics of European integration and European policy-making in health, including the basic question of how the EU came to have a health policy and what that policy does. Thereafter, it moves on to the three faces of EU health policy. The first face is explicit health policy, both public health policy and policies to strengthen health services and systems in areas such as cancer, and communicable diseases. The second face is internal market building policies, which are often more consequential for health services, but are not made with health as a core objective. These include professional and patient mobility, regulation of insurers and health care providers, and competition in health care. They also include some of the policies through which the EU has had dramatic and positive health effects, namely environmental regulation, consumer protection and labour law. The third face is fiscal governance, in which the EU institutions police member state decisions, including relating to health. Each face has different politics, law, policy and health effects. The book provides a synthesis of the different faces and the different ways in which they have been used to strengthen or weaken public health and health systems in Europe. It shows the many, often unappreciated, ways that the EU has worked for health, as well as the opportunities to further strengthen the EU's positive impact on health. This book is aimed at policy-makers and students of health systems in the EU who seek to understand how the influence of the EU on health policy affects those systems and their patients. To ensure that the EU’s impact on health is wholly positive, the wider health community must understand and engage with the EU in the future – something this book aims to encourage.

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.

Trade policy governance: What health policymakers and advocates need to know.

Trade policies affect determinants of health as well as the options and resources available to health policymakers. There is therefore a need for health policymakers and related stakeholders in all contexts to understand and connect with the trade policymaking process. This paper uses the TAPIC (transparency, accountability, participation, integrity, capacity) governance framework to analyze how trade policy is commonly governed. I conclude that the health sector is likely to benefit when transparency in trade policymaking is increased, since trade negotiations to date have often left out health advocates and policymakers. Trade policymakers and negotiators also tend to be accountable to economic and trade ministries, which are in turn accountable to economic and business interests. Neither tend to appreciate the health consequences of trade and trade policies. Greater accountability to health ministries and interests, and greater participation by them, could improve the health effects of trade negotiations. Trade policies are complex, requiring considerable policy capacity to understand and influence. Nevertheless, investing in understanding trade can pay off in terms of managing future legal risks.

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.