This article explores the relationship between EU internal market law and ambitious tobacco end-game policies, using the United Kingdom’s proposed smoke-free generation measure and its application to Northern Ireland under the Windsor Framework as a focal case. Responding to objections raised by EU Member States through the Technical Regulations Information System (TRIS), the article develops an interpretative framework that situates free movement rules within the EU’s broader constitutional commitment to public health protection. Drawing on a doctrinal analysis of EU primary law, the Tobacco Products Directive, EU Court of Justice case law, and the TRIS submissions themselves, the article challenges claims that generational sales bans are inherently incompatible with EU law. It argues that such claims rely on narrow and selective readings of internal market doctrine that overlook the extent to which health protection is embedded in EU market regulation. The analysis demonstrates that EU law leaves significant regulatory space for national authorities to pursue proportionate, evidence-based tobacco control measures, including end-game strategies. Beyond the immediate UK–Northern Ireland context, the findings have broader implications for innovative public health regulation within the EU, contributing to ongoing debates at the intersection of health policy, regulatory governance, and economic integration.

Competition regulation plays a key role in determining firm size, market structure, and what firms can do with their market power. In this paper, we explore how competition regulation in many countries has largely tolerated rising industry concentration and market power in harmful consumer product industries, which, in turn, has likely facilitated an increase in preventable death and disease associated with such industries (ie. industrial epidemics). One important reason for this tolerance has been the rise of the ‘consumer welfare’ standard, which contends that competition regulators should only focus on a narrow set of concerns mostly relating to consumer price and output. Yet, recent developments shed light on potential avenues through which competition regulation could work more synergistically with public health policies and programmes. While discussions on how to leverage competition regulation along these lines are invariably contested and complex, we argue that it is critical that public health advocates engage with these discussions.

In public healthcare systems, effectiveness is a central requirement for determining which services should be offered and reimbursed. Yet, due to its technical nature and to the need for specification through specialised bodies, the nature of this principle remains underexplored. This article bridges the gap by conducting a comparative analysis of effectiveness’ operation in three distinct healthcare systems: Germany, France, and England. We argue that effectiveness can be recognised as a foundational legal principle governing reimbursement decisions, revealing a substantive and a formal dimension. Substantively, effectiveness requires a consideration of an intervention’s ability to bring about a clinical benefit, accounting both for its desired outcomes and its risks. The applied evidentiary standard calls for a careful scrutiny of the available scientific evidence, as well as the state of medical knowledge. The exceptions to this standard are extremely limited and do not undermine the validity of the wider principle. Formally, the article emphasises the central role that administrative authorities conducting Health Technology Assessment (HTA) play, with delegated decisions ranging from the definition of the applicable evidentiary standards to the issuing of binding guidelines. It is argued that mechanisms must be put in place to ensure these bodies’ expertise, independence, and transparency.

This study aimed to compare reimbursement prices for new, innovative non-orphan drugs in Germany based on price negotiation and cost-effectiveness analysis, using the efficiency frontier (EF) approach and cost-utility analysis (CUA). For the EF, the next effective intervention and no intervention were used as comparators. Three pairwise comparisons were conducted: negotiation vs EF, CUA vs EF and negotiation vs CUA. For the comparison between negotiation and EF, relative risk reductions for a given added health benefit were assigned, and resulting price premiums were determined using an empirical estimate from the literature and a conceptual model. The difference between CUA vs EF was determined based on an aggregation rule and thresholds for CUA based on the average and marginal cost-effectiveness of the health care system. The difference between negotiation and CUA was determined through an indirect comparison. Price premiums based on negotiation are approximately 10–40 per cent higher than those based on EF using no intervention as a comparator. Furthermore, price premiums based on CUA (threshold at system-average cost-effectiveness) are approximately 25–50 per cent higher than those based on EF using no intervention as a comparator. The indirect comparison predicts that price premiums based on CUA (threshold at system-average cost-effectiveness) are approximately 10–15 per cent higher than those based on negotiation. For a threshold set at system-marginal cost-effectiveness, price premiums based on CUA are more than threefold higher than those based on negotiation. In the German health care system, CUA with a threshold set at system-average or system-marginal cost-effectiveness is predicted to yield higher reimbursement prices than price negotiations or the EF approach based on no intervention as a comparator.

Reforms to the means tests in England for state-financed long-term care were planned for implementation in 2025. They included a lifetime limit (cap) on how much an individual must contribute to their care, with the state meeting subsequent care costs. We present projections of the costs and distributional impacts of these reforms for older people, using two linked simulation models which draw on a wide range of data. We project that by 2038 public spending on long-term care for older people in England would be about 14% higher than without the reforms. While the main direct beneficiaries of the lifetime cap would have been the better off who currently receive no state help with their care costs, the reforms also treated capital assets more generously than the current system, helping people with more modest incomes and wealth. When analysing the impacts of the reforms it is therefore important to consider the whole reform package. Our results depend on a range of assumptions, and the impacts of the reforms would be sensitive to the levels of the cap and other reformed parameters of the means test on implementation.

While the literature has largely focused on legal challenges to public healthcare rationing decisions, claims against private insurance companies in voluntary health insurance (VHI) schemes have received less attention. This paper aims to fill this gap by analysing a representative sample of 1,547 court of appeal decisions related to treatment funding claims filed against private insurance companies in Brazil from 2018 to 2021. Courts decided 83.6% of cases in favour of patients, ordering VHI companies to fully fund the claimed treatment. Patients´ rate of success is even higher (96%) in the cases in which insurance companies denied coverage on the grounds that the claimed treatment was not listed in the benefits package mandated by regulation. Court decisions present additional challenges to setting priorities through health technology assessment and explicit packages in the VHI sector. This has broader implications for health care equality and access in Brazil.

The standard analytical framework of insurance markets by Einav and Finkelstein (EF) focuses on the problem of welfare loss for low-risk individuals. A key assumption of this framework is that demand and cost curves are tightly linked, meaning that people are willing to pay a price equal to their expected cost plus a risk premium. Using data from the German risk-adjustment system we show that the distribution of expected health care costs is extremely skewed. We show that incorporating the extreme skewness of predictable individual health care expenses in the EF framework has important welfare consequences, which are typically overlooked when using this framework for analysing the negative welfare effects of voluntary health insurance markets with asymmetric information. Rather than the welfare loss of low-risk individuals due to underinsurance, the main problem of voluntary health insurance markets is the welfare loss of high-risk individuals not getting access to health insurance and affordable health care. We discuss that among the policy approaches to reduce this problem, mandatory health insurance with mandatory cross subsidies is likely to be the most effective, which is typically not recognised when focusing primarily on the welfare loss for low-risk individuals.

Despite the tremendous waste due to Medicaid fraud and abuse, not much scholarly attention has been paid to state variation in the investigations. This study explores the factors influencing variations in Medicaid fraud and abuse investigations across U.S. states, with a focus on the role of All-Payer Claims Databases (APCDs) and state political context. To test the impacts of price transparency and political factors, we built a dataset spanning eight years (2014 to 2021) and covering 49 states, excluding North Dakota. We then conducted a fixed-effects panel data analysis based on the results of a Hausman test. The impact of APCDs is statistically significant, suggesting its association with more fraud and abuse detection. A Democratic governor tends to be associated with fewer Medicaid fraud investigations. The findings of this research demonstrate that the operation of APCDs can influence the number of Medicaid fraud investigations conducted by Medicaid Fraud Control Units (MFCUs). Moreover, political discretion plays a role in the number of state investigations into Medicaid fraud and abuse.

The European Union (EU) is currently overhauling its pharmaceutical regulations, seeking to mature a single market for medicines as part of a ‘European Health Union’. We reflect on the interactions between regulations and markets in these reforms and investigate what this single market for medicines may mean in practice. We note how the proposed reforms aim to ensure equitable access to innovative treatments, yet at the same time, tie this access directly to regulatory exclusivities, limiting price competition. The reforms also do not seek full pricing transparency: prices will remain largely opaque and be set at the national levels rather than created through market exchange and open competition at the EU level. The envisioned single market for medicines thus remains a market that operates without direct reference to price − a situation not addressed head-on by the proposed reforms.

The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market medical devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to (i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; (ii) draw policy recommendations for governments and health organisations and identify a research agenda for scholars.

A systematic review was undertaken until February 2024 following the PRISMA guidelines. Original peer-reviewed articles in English and incorporating RWE/RWD into any sort of post-market assessment strategy for an MD were included and their reference lists manually checked. A narrative synthesis was employed to describe evidence retrieved.

Totally, 145 research articles were identified. Administrative databases were mostly utilised; clinical and/or economic evidence gathered in a short/medium time horizon the most frequently reported; other evidence types (e.g., organisational) underreported; patient perspectives rarely incorporated; the innovation complexity of MDs relatively low.

To our knowledge, this study is the first in its kind to provide a comprehensive picture of how non-randomised evidence has been used when assessing MDs working in real-life conditions. The implications of this review might help health policy scholars in addressing the avenues for research in RWE for MDs and policy-makers to better understand the risks and benefits of medium and long-term use of MDs alongside clinical practice and make more informed decisions about adoption and use.

In health care systems based upon the principles of managed competition, health insurers are expected to act as prudent buyers of care. Consumers are expected to switch between insurers based upon the performance of insurers in this role. Yet, the Dutch experience shows that trust of consumers in health insurers is low and that switching consumers focus primarily on price. The question arises if consumers do in fact perceive and trust insurers as prudent buyers of care. We addressed this question by using a mixed-method approach. The results show that most people know that insurers buy health care and feel that the purchasing tasks suit their role. They even have reasonable, though fragile, trust in the purchasing competencies of the insurer. However, the results also revealed that consumers have insufficient information to cast a judgement about insurers as purchasers and incorrectly think that insurers are commercial organisations. Hence, improving the public information about insurers and their purchasing role seems to be crucial. Given the inherent complexity in the system, it remains to be seen if this objective can be reached in the (near) future. For that reason, policymakers should also consider additional measures to encourage that insurers will take integral purchasing responsibility.

Mixed markets can enhance welfare compared to full public or private provision. However, this welfare gain depends on the extent to which market distortions exist. Recent literature demonstrates distortions in mixed long-term care markets worldwide. Our study explores potential distortions in the Dutch institutional market. While all Dutch residential nursing homes are non-profit, for-profit organisations, including private equity (PE) firms, have increasingly entered the market, offering round-the-clock care provided in home-like settings as an alternative to non-profit residential care.

We analysed claims data from 2017–2021 for dementia patients aged 70 and older using multinomial logit and Cox Proportional Hazards models. Specifically, we compared risk selection, upgrading, and care quality (measured by avoidable hospitalisations and mortality) between for-profit and non-profit providers.

Our findings do not suggest increased risk selection, higher upgrading, or lower care quality by for-profit (PE-owned) providers compared to non-profit providers. Consequently, we did not find evidence of strong market distortions in the Dutch institutional long-term care market. These results contrast with the existing international literature, suggesting that adverse incentives in the Netherlands may be influenced more by the way care is provided (in home-like settings versus in residential nursing homes) and financing structures rather than ownership type alone.

How the role of health technology assessment (HTA) agencies in relation to medical technologies (MedTech) is framed in the literature reflects and influences governance, shaping perceptions and guiding decisions. We identify different academic discourses to advance MedTech policy debates, in light of several factors potentially influencing this role. This is the first time that discourse on the role of HTA agencies in relation to MedTech has been reviewed. We conducted a comprehensive search, screened for eligibility, and synthesised findings using discourse analysis. 119 articles were included, from which 5 discourses were constructed. The first discourse describes the HTA agency as an independent evaluator of appropriate evidence for all health technologies. The second discourse explicitly categorises MedTech as separate from pharmaceuticals and expands the role of evaluator to include encouraging evidence generation for MedTech. The third discourse moves away from the role of independent evaluator and describes the HTA agency as a convenor of all stakeholder perspectives, using an experimental approach. The fourth and fifth discourses critically reflect on the role of HTA agencies, the fourth on their level of normative reflection and the fifth on their level of nuanced, clinical expertise. We conclude with recommendations for policy and research.

Health policy reforms often fail due to design flaws, implementation gaps, and political barriers. This paper examines the role of government stewardship in addressing these barriers drawing on lessons from healthcare reforms in Sanming, China, a city that has become a nationally recognised model for comprehensive health system reform. Employing a qualitative approach, the analysis traces how six core stewardship functions – strategic visioning, institutional alignment, instrument design, partnership management, accountability reinforcement, and learning facilitation – enabled Sanming’s government to control costs and improve service delivery and health outcomes. Sanming’s experience illustrates the potential for local government stewardship to catalyse reform in the face of constraints. Interviews indicated that strengthened stewardship enabled the government to set strategic direction for the health system, mobilise stakeholders, formulate workable policies, and adapt to changing needs during implementation. However, participants identified persistent challenges, including uneven distribution of capacity across agencies, changes in the external policy environment, and deficient stakeholder feedback loops. While specific to the local context, the core stewardship competencies identified in the paper offer a generalisable framework for strengthening reform governance in other settings. As countries seek to build resilient and equitable health systems, the lessons from Sanming’s stewardship model provide a timely contribution to the global health reform discourse.

Pre-exposure prophylaxis (PrEP) is a critical intervention that greatly reduces the risk of HIV transmission, yet limited access to prescribing providers continues to constrain uptake in the United States. This study examines how geographic access to PrEP providers changed between 2020 and 2023 and identifies areas with limited access, referred to as PrEP deserts. Using the Integrated two-step floating catchment area method, this study finds that despite widespread gains in PrEP access, five states experienced increases in the total population living in PrEP deserts. Additionally, more than 5 million residents in states designated as priority jurisdictions under the Ending the HIV epidemic initiative gained geographic access to PrEP providers between 2020 and 2023. However, improvements were uneven: in some states, communities of colour experienced declining access and remain disproportionately represented in PrEP deserts. These findings highlight persistent geographic and demographic disparities in HIV prevention infrastructure despite recent federal efforts to expand PrEP availability.

In the Dutch health care system of regulated competition, health insurers are assigned the crucial role of prudent purchasers and expected to critically contract providers based on the quality and prices of their services. Thus far, however, these organisations have struggled to fulfil this role. This study sheds new light on the purchasing behaviour of Dutch health insurers. We examine how insurers perceive the context in which the value-based purchasing of hospital care should take shape, and we draw on insights from institutional theory to frame our analysis. Our findings are based on a series of semi-structured interviews (n = 18) with employees and representatives of several insurer companies whose combined market shares add up to over 90 per cent of all premium payers. Our analysis highlights an environment in which market mechanisms are tangled up with historically rooted budgeting practices, where insurers are pressured to sustain rather than critique hospitals, and where self-regulating medical professionals are firmly supported by society’s deep-seated belief in the quality of their services. Like many other organisations, Dutch health insurers tend to conform to their institutional environment. While this conformity may aid them in organisational stability and survival, it also restricts their ability to purchase prudently.