Question: How have medical device patents contributed to periods of market exclusivity on drug-device combinations?

Findings: In this cohort study of 331 drug-device combinations approved by the Food and Drug Administration (FDA) from 1986 to 2023, 1751 of 3241 individual patent listings were on the delivery devices of these products. Medical device patents extended periods of protection for 180 products (54.4%) by a median (IQR) of 7.5 (2.8-13.9) years, with most device patents failing to mention the active pharmaceutical ingredients in their claims.

Meaning: Patenting strategies on drug-device combinations may impede generic entry and keep prices high for patients and payers.

Background: The Global Fund to Fight AIDS, Tuberculosis, and Malaria is one of the world’s largest global health donor agencies, playing a key role by filling recipient countries’ domestic health financing gaps; however, little is known about how well it achieves value for money. Given the current uncertainty regarding global health development assistance, it is critical to understand how to prioritize external donor funding allocations in an effort to maximize health impact.

Methods: In this study, we evaluated 66 recipient countries’ efficiency relative to peers in achieving improvement in health outcomes for TB, malaria, and HIV given their 2017–2019 Global Fund expenditures for (1) health products, (2) program activities, and (3) program management. Using a combination of frontier analysis, linear regression, and cluster analysis, we examined how macroeconomic conditions, epidemiological context, health system factors, and Global Fund spending decisions explain variation in country program performance.

Results: For malaria and HIV, we found a negative relationship between Global Fund spending on program activity and health product costs respectively and countries’ efficiency at translating funds to health impact. For malaria and HIV, there was also significant variation in efficiency across countries according to their economic capacity, disease burden, and most prominent spending area.

Conclusions: Our results suggest possible structural inefficiencies in country program management, dampening the health impact of frontline programs. The lack of broad patterns to predict performance signals the importance of tailoring spending strategies to country-specific contexts.

Question: How did obstetric-related Emergency Medical Treatment and Labor Act (EMTALA) violations change in association with state-level abortion policy?

Findings: In this difference-in-differences analysis of EMTALA violations from 2018 to the first quarter of 2023, states with no health exceptions saw a substantial rise in obstetric-related violations that were associated with policies adopted by Texas. There was a concurrent rise in emergency department utilization, and screening failures suggest that violations may have increasingly occurred on arrival before treatment.

Meaning: The study results suggest that state abortion laws may undermine federally protected care in obstetric emergencies.

Medicare is often regarded as a universal benefit for most US citizens and legal permanent residents. The program is financed through payroll tax contributions during individuals’ working lives with the expectation of coverage at age 65 years for most people. However, those who die prematurely are unable to realize the benefits they helped fund—raising equity concerns for populations with lower life expectancies.

In 2022, the mean life expectancy in the US was 77.5 years, down from 78.9 years in 2014,2 partly due to rising mortality among working-age adults and widening disparities across racial and socioeconomic groups.3-5 As health declines begin earlier—especially for Black individuals—a growing number may not reach Medicare eligibility. This inequity in unrealized Medicare benefits underscores the need to understand how premature mortality before age 65 years has varied over time and by race.

Federal health spending plays a central role in the nation’s long-term fiscal outlook. In 2024, Medicare, Medicaid, and the Children’s Health Insurance Program accounted for 31 percent of all federal program spending—$1.8 trillion—and this total is projected to rise significantly over the next 30 years. At the same time, private health insurance spending per enrollee is expected to grow by over 50 percent by 2032. These unsustainable trends—occurring without commensurate improvements in population health— create a burning need for reform: Without meaningful change, rising health care costs will increasingly strain household budgets, crowd out other federal and state priorities, and undermine the nation’s long-term fiscal stability.

Against this urgent backdrop, the United States Government Accountability Office issued its 2024 report, “Highlights of a Forum: Reducing Spending and Enhancing Value in the U.S. Health Care System”. The report summarizes the discussions of an expert forum convened in October 2024. The forum brought together participants from government, academia, and industry to explore persistent challenges in United States (US) health care spending and identify opportunities to improve value. The report’s recommendations were structured around five pre-identified areas of potential reform: strengthening primary care; expanding the health care workforce; reforming pricing to better align with high value care; revising Medicare physician payments; and mitigating anticompetitive actions and practices. As two of the forum participants, we highlight below the areas we believe are most critical for policymakers to consider and offer new insights that have gained salience given shifts in the policy landscape since the forum was conducted.

Introduction: By 2050, antimicrobial resistance (AMR) could lead to over 10 million deaths annually and $100 trillion in healthcare costs, making it one of the most urgent public health threats. The WHO recommends AMR National Action Plans (AMR NAPs) to address this threat, but the effectiveness of these plans is unknown.

Methods: We estimate the impact of AMR NAPs on retail sales of all antibiotics across 68 countries from 2014 to 2023 using IQVIAs Multinational Integrated Data Analysis System dataset. We further examine the effect of AMR NAP adoption on the proportion of antibiotic sales by WHO AWaRe (Access, Watch, Reserve) classification. To account for differences in the quality of the AMR NAP, we also examine if countries with a better NAP have differential use of antibiotics following its adoption. Finally, we explore whether countries with higher quality NAPs make differential use of azithromycin during the COVID-19 pandemic.

Results: The adoption of an AMR NAP did not have a significant impact on total retail antibiotic sales. But when accounting for the quality of the AMR NAP, as identified from an evaluation of NAP plans, we find that high-scoring AMR NAPs significantly increased the proportion of retail sales from Access-class agents (0.031; 95% CI 0.003 to 0.06), and significantly decreased the proportion of Watch-class antibiotics (−0.03; 95% CI −0.055 to −0.005) as compared with those with lower scoring or no NAPs. Countries with high-scoring NAPs also exhibited lower retail azithromycin sales per 1000 persons during the COVID-19 pandemic (−49.08; 95% CI −89 to −9.16).

Conclusions: Countries with higher quality AMR NAPs exhibit more appropriate use of essential antibiotics overall and less inappropriate utilisation of azithromycin during the COVID-19 pandemic compared with those with no or low-scoring plans. Well-developed AMR NAPs may be a useful policy tool to promote more judicious antibiotic use globally.

Life expectancy in the USA is considerably lower than in most high-income countries, with many deaths considered preventable. The extent by which poor performance on prevention measures and public health policies in the USA could be contributing to this issue is not well understood. To address this issue, we compared publicly available population-based indicators of health care across different levels of prevention in the USA and six high-income countries (ie, Australia, Canada, Germany, France, Sweden, and the UK) and Organisation for Economic Co-operation and Development countries between 2010 and 2023. Relative to comparator countries, the USA had a younger population and lower smoking rates, but it had higher obesity prevalence, calorie intake, illicit drug use, and gun and vehicle ownership. Regarding public health policies that lie largely outside the health-care system, the USA compared unfavourably to comparator countries. For measures dependent on the health-care system, the USA performed well across several measures of clinical prevention, including screening rates and diagnosis and control of chronic conditions. However, the USA was worse on measures of access to health care and coverage. While the USA performs well in prevention efforts within the health-care system compared with other countries for people with access to the system, it faces greater risk from external factors, generally worse dietary intake, and implements weaker public health prevention and regulation against harmful products that might exacerbate these issues. To improve population health, policy makers should prioritise multi-sectoral investments in prevention policies and improve access to health care.

The Inflation Reduction Act (IRA) requires Medicare to negotiate prices for certain brand-name drugs with gross annual Medicare spending exceeding $200 million. Small-molecule drugs are exempt from negotiation for 9 years following US Food and Drug Administration approval and biologics for 13 years. The pharmaceutical industry, some members of Congress, and the Trump administration have argued that this difference prioritizes the development of biologics over small-molecule drugs and have proposed aligning the initial eligibility periods for both at 13 years.1,2 To inform these policy discussions, we compared the revenues earned by manufacturers after 9 vs 13 years on negotiation-eligible products from 2012 to 2022.

The COVID-19 pandemic has underscored the importance of resilient health systems that can manage and adapt to large-scale health crises. However, the relationship between resilience and health system performance remains unclear. While some view performance as a feature of resilience, others conflate the two. Excess mortality—defined as the difference between observed and expected deaths during a given period—is often used to assess resilience, but may introduce bias. In particular, countries with stronger pre-pandemic performance and lower baseline mortality may appear to have worse resilience simply because they had less “room” for mortality to rise under normal conditions.

Trade-related tensions between the United States and China have escalated dramatically in recent months. Despite a tentative agreement in May 2025 (extended in August 2025) to reduce the size of newly imposed tariffs on both sides, geopolitical frictions remain. Among other implications, these tensions threaten the cross-border trade of medicines. China has long been a major global supplier of generic drugs and active pharmaceutical ingredients. In recent years, it has also emerged as an important player in new drug development — a field traditionally dominated by the United States and European countries. This shift has implications for global access to promising new medicines and presents challenges for U.S. regulators and policymakers.

More than 75% of cancer drugs are approved by the US Food and Drug Administration (FDA) through expedited regulatory programs,(1) the use of which often leaves clinical uncertainties that may arise from issues related to trial design, conduct, analysis, or reporting—such as unvalidated end points, limited long-term data, or approval based on a single trial—about drug efficacy and safety.(2) Communicating these uncertainties is important, as clinicians may otherwise be unaware and overestimate a drug’s benefits and underestimate its risks.(3)

Although the FDA describes these uncertainties in detail in its benefit-risk assessments,(2) these documents are not widely read by clinicians. Instead, clinicians often rely on journal publications and guidelines. It is unclear whether clinical trial uncertainties about newly approved cancer drugs are reported in these sources.

Health systems globally face growing challenges, including ageing populations, increasing prevalence of chronic diseases, and limited resources to fund advances in health care. Emerging issues, such as climate change, infectious disease outbreaks, large-scale migration, and geopolitical instability, are placing additional strain on already burdened health systems. In Greece, many of these stressors have converged in the past 15 years, exposing structural vulnerabilities and testing health system resilience.(1–3)

Against this backdrop, Greece has implemented a series of reforms to improve service delivery and address public health challenges, but their long-term sustainability remains uncertain. The COVID-19 pandemic offered an illustrative example; the initial response was effective and driven by the prompt adoption of public health measures and interministerial coordination. However, as the pandemic progressed, persistent weaknesses and underdeveloped public health infrastructure exposed crucial vulnerabilities, ultimately undermining the health system's capacity to sustain an effective response.(4) Examining the Greek health system's adaptive capacity more broadly offers important insights for policy makers, in Greece and in other contexts facing comparable structural and fiscal constraints.

This Health Policy paper explores the key and emerging public health and health system challenges in Greece. The paper also provides an overview of recent reform efforts, identifying crucial gaps and opportunities for strengthening the health system to ensure its long-term sustainability.

People with schizophrenia are at heightened risk for physical multimorbidity and premature death. Semaglutide improves cardiometabolic outcomes, yet research is limited among individuals with schizophrenia. This study explored weight loss in Veterans with schizophrenia and physical multimorbidity (ie, heart failure and diabetes) prescribed semaglutide and compared weight changes to those in Veterans without schizophrenia. We hypothesized that those with schizophrenia would experience less weight loss compared to those without schizophrenia.

Competition between firms selling similar drugs is often fostered by policymakers as a means to curb pharmaceutical spending. While firms may compete within these specific drug markets, they also repeatedly encounter rival firms in different markets. This may shape competitive dynamics within and between markets. Yet, multimarket contacts, particularly relevant for multiproduct firms such as pharmaceutical companies, are often overlooked by pricing regulations. This paper investigates how multimarket contacts influence competition between pharmaceutical firms in off-patent markets. Using detailed product-level information on all retail pharmacy sales of generic statin drugs, we quantify the universe of multimarket contacts between firms in these off-patent markets, in Portugal, between 2015 and 2017. We then assess how multimarket contacts affect price competition. To do so, we explore the strict price regulation in Portuguese generic drug markets. Specifically, the Portuguese Internal Reference Pricing System (RPS) defines a price cap for each generic drug. Rather than examining absolute drug prices, we quantify the degree of price competition as the ratio between a firm's drug price and its regulatory price cap (price-to-cap ratio). We find that firms with more multimarket interactions set prices closer to price caps, consistent with the mutual forbearance hypothesis. This effect persists after controlling for brand status, lagged market share, and is not explained by common ownership. Our main results are consistent across alternative model specifications. However, due to limited within-firm variation over time, the effect is not significant in system generalized method of moment instrumental variable estimates. These results suggest that price caps may act as coordination anchors, thus lowering price competition between firms. Policymakers should consider targeted price cap adjustments as safeguards to preserve competition in off-patent drug markets.

Equitable access to essential medicines, which the World Health Organization (WHO) defines as those that meet the priority needs of the population,1 is key to achieving universal health care coverage.(2) However, it is estimated that essential medicines are unaffordable or unavailable to 1 in 4 people worldwide.(3) As governments strive to achieve universal access to essential medicines, it is important to understand how the prices and affordability of these medicines vary between countries. High drug prices strain both personal and government budgets, especially in low- and middle-income countries, where patients often face high out-of-pocket costs.

Although many national surveys of medicine prices and affordability have been conducted, fewer analyses have compared these variables internationally, with most research dating back to 2011 or earlier.(4-20) Many of these studies have focused on high-income countries. Of the studies that also included low- and middle-income nations, most compared the prices of 15 or fewer medicines or included a small number of countries, limiting the generalizability of those findings. Therefore, little is known about the relationship between national income and drug prices. The question remains whether some poor countries routinely pay more than rich countries for the same prescription drugs, possibly owing to weaker pharmaceutical pricing policies.

This cross-sectional study used global data on pharmaceutical sales to compare the list prices of 549 essential medicines in 72 high-, middle-, and low-income markets (covering 87 countries) in 2022, both in nominal and purchasing power–adjusted terms. We also evaluated the affordability of 8 essential medicines used to treat major causes of death and disability globally.

On May 12, 2025, the Trump administration issued an executive order to lower prescription drug costs by mandating that the US pay no more than prices in peer countries. The legality of implementing this so-called most favored nation (MFN) pricing through executive action is unclear. However, the idea of benchmarking US drug prices to prices in other countries is not new. The Trump administration unsuccessfully attempted a more limited MFN policy during its first term, and a 2019 bill passed by House Democrats used international prices as upper limits for Medicare price negotiations. Although lowering drug prices is a priority, achieving this by linking prices in the US to those in other countries is a misguided approach built on a misdiagnosis of the reason prices are higher in the US than in other countries.

The responses to our study on wealth and mortality in the United States and Europe raise important questions about causal inference, potential confounding, and the interpretation of cross-national differences. As noted by the correspondents, our findings reflect associations, not causal relationships. Although the patterns we observed were consistent across settings, more work is needed to disentangle the complex relationship between wealth and health.

Uncertainties about the benefits and harms of new drugs are common at the time of drugs’ approval. It is unclear to what extent the Food and Drug Administration (FDA) communicates these uncertainties in the FDA-approved prescribing information (the drug label), which is the primary channel of communication between the FDA and physicians. Although physicians might not regularly consult the drug label for prescribing decisions, other information sources used by physicians either index or incorporate information from the label. We searched FDA review documents for uncertainties identified by FDA reviewers with new cancer drugs. We considered the subset of uncertainties highlighted in the FDA’s Benefit-Risk Framework as important to the FDA’s approval decision. During the period 2019–22, the FDA approved fifty-two new cancer drugs. In review documents, FDA reviewers identified a total of 213 clinical trial uncertainties with new cancer drugs, 50 percent of which were considered to be important uncertainties to the FDA’s approval decision. Labels for physicians reported information on 26 percent of all uncertainties and 48 percent of uncertainties that were important to the FDA’s approval decision. Communicating uncertainties about the evidence of drugs in the label is essential for informing physicians about drugs’ safe and effective use.

Scholars express concern that general practitioner shortages and specialist surpluses induce overspecialization, with overuse of costly specialist services and underuse of cost-effective primary care services. Yet few studies directly assess the relationship between physician supply and patient utilization. Given this gap, this paper examines the associations between physician supply, care utilization, and patient need and whether patients use more specialists in areas with lower primary care supply.

We appreciate the responses to our Article, which suggest that the health cost of paying for new pharmaceuticals in the National Health Service (NHS), estimated at £1·25 million quality-adjusted life-years (QALYs) lost between 2000 and 2020, might be justified by the benefits of incentivising future innovation, attracting industry funding, or prioritising certain populations—we disagree.

Outcomes after a hip repair in the older adult population are highly dependent on patients’ characteristics. However, contextual factors such as the hospital of treatment may have an impact not sufficiently studied. We aimed to elicit the effect of hospital providers on all-cause-adjusted mortality rates after hip fracture repair. Observational study on virtually all potentially eligible hip fracture patients treated in 2240 hospitals from Ontario (Canada), Aragon (Spain), Finland, Sweden, and the USA (40 states). The primary endpoint was the risk-adjusted all-cause mortality after hip repair measured 30 days and 180 days after surgery. Following a federated approach, GAMM-logit models were run for each region. Median odds ratio (MOR) were estimated to elicit the variation at hospital level. The study included 535 519 hip repairs. The overall predicted 30-day adjusted mortality rate was 40.5 per 1000 hip repair episodes; 136.3 per 1000 hip repair episodes in the 180-day adjusted mortality rate. 30- and 180-day adjusted mortality rates were larger within the regions than across regions. Variance in patients’ mortality at the hospital provider accounted for MOR: 1.43 in 30-day mortality and MOR: 1.35 in 180-day mortality. Beyond differences in the individual risk of death, our study found wide systemic variations in mortality rates in older adult patients exposed to hip fracture repair attributable to the hospital of treatment. Our results call for a reorientation of care pathways after hip repair in frail patients, both in the short- and the long-term.

The English National Health Service (NHS) is a publicly funded system, however significant disparities in provision exist. Whereas the national picture of the distribution of Intensive Care Unit (ICU) beds has increased over time, less is understood about the regional variation in the rate of growth in ICU services and whether this is related to population growth. The aim of this study was to describe the national variation in the supply of ICU beds in England and evaluate whether there has been a narrowing of the regional disparities in providing ICU beds over time.

In the most recent National Health Expenditure (NHE) Projections, for 2024-33, Sean Keehan and colleagues at the Centers for Medicare and Medicaid Services (CMS) predict strong growth in health care expenditures in 2024, and average annual growth over the entire projection period that exceeds growth in GDP. According to their projections, health care is set to comprise 20.3 percent of GDP by 2033. This increase in health spending is expected despite declines in coverage, prompted by the continued unwinding of Medicaid pandemic policies and lower enrollment in private insurance stemming from the expiration of the IRA’s temporarily enhanced premium tax subsidies for Marketplace plans.

The past two decades have seen a surge in available patient safety metrics. However, the variability in how healthcare organizations choose and monitor these metrics remains unknown. We cataloged the metrics organizations chose and how actively they monitored them. We investigated factors influencing the monitoring of patient safety metrics using surveys and in-depth interviews with patient safety experts from 11 Harvard-affiliated organizations.

In this piece we examine three forms of coercive or otherwise involuntary care that can occur with patient consent. To do so, we examine: (1) uninformed consent, (2) contingency-based consent and (3) constrained-market consent, amongst female sterilization patients. While there is broad recognition that “coercion” in sterilization care can manifest beyond instances of overt force and clarity on what constitutes coercion within clinical care, this has not translated to accountability. The current practice of identifying coercion through discrete civil cases may facilitate a narrow understanding of its contemporary prevalence; one that does not align with definitions of coercion supported by international human rights entities. We use three acute, and widely recognized, examples—hysterectomies in ICE detention facilities, India’s sterilization camp deaths and birth control quotas for Uyghur women—as an entry point to highlight less overt contemporary forms of coercive sterilization care, pairing each example with data that explores prevalence at a broader population level. These data suggest less visible forms of coercion may persist relatively unchallenged—raising the ethical case for a functional approach to the measurement of coercion. In turn, we argue the relevant question may not be “when is coercion ethically justified in public health,” but rather, why is coercion already the status quo?

Worse health outcomes have been described for patients with sepsis from more deprived neighborhoods, but it is unclear if this disparity gap has narrowed. Moreover, the mechanisms by which neighborhood disadvantage influences sepsis outcomes are not fully understood. This study aims to understand the trajectory of mortality among patients with sepsis in England across varying levels of neighborhood deprivation, and to what extent do patterns of ICU admission and treatment explain the observed differences.

Fever is associated with brain injury after cardiac arrest. It is unknown whether fever management with a feedback-controlled device impacts patient-centered outcomes in cardiac arrest patients. This trial aims to investigate fever management with or without a temperature control device after out-of-hospital cardiac arrest. The TEMP-CARE trial will investigate if post-cardiac arrest management of fever with or without a temperature control device affects patient-important outcomes after cardiac arrest.

We performed a longitudinal, retrospective cohort study involving adults 50 to 85 years of age who were included in the Health and Retirement Study and the Survey of Health, Ageing, and Retirement in Europe between 2010 and 2022. Wealth quartiles were defined according to age group and country, with quartile 1 comprising the poorest participants and quartile 4 the wealthiest. Mortality and Kaplan–Meier curves were estimated for each wealth quartile across the United States and 16 countries in northern and western, southern, and eastern Europe. We used Cox proportional-hazards models that included adjustment for baseline covariates (age group, sex, marital status [ever or never married], educational level [any or no college education], residence [rural or nonrural], current smoking status [smoking or nonsmoking], and absence or presence of a previously diagnosed long-term condition) to quantify the association between wealth quartile and all-cause mortality from 2010 through 2022 (the primary outcome).

The volume-outcome relationship has been a commonly invoked policy initiative aimed at improving the quality of healthcare. This inverse relationship between the caseload volume of patients treated and patient mortality has been described across many health settings and in many countries. Despite the large body of literature demonstrating this favourable relationship, most studies have focused on differentiating the effects of selective referral and the true effects of volume. In comparison, there are few studies evaluating the underlying mechanism of the volume-outcome relationship, namely dynamic learning-by-doing or the static effect of economics of scale. Resolving this tension between policies that allow providers to accrue experience over time and policies that promote centralisation of services would make a more compelling argument for policies such as minimum volume standards to be firmly established.

In this retrospective study, between 2009 and 2021, avoidable mortality increased in all US states, primarily due to increases in preventable deaths, while it decreased in comparable high-income countries. Health spending was significantly negatively associated with avoidable mortality for other high-income countries but not across US states.

Americans have grown accustomed to direct-to-consumer pharmaceutical advertisements and the refrain, “If you think [this drug] is right for you, talk to your doctor.” But some recent online ads feature a new twist — a link to a clinician offering telehealth services. Several pharmaceutical companies have also launched online platforms that direct users to websites run by telehealth companies, where clinicians are available to prescribe medications after a virtual consultation.

Repeated Supreme Court cases suggest uninformed sterilization care is a persistent and contemporary issue in India. This article examines patient satisfaction ratings as a potential accountability mechanism to assess normalized forms of coercion. With a sample of over 180,000 sterilized women in India, it identifies a statistically significant relationship between exposure to coercive care and odds of reporting low quality. However, over 95 percent of women who underwent a tubal ligation procedure rated their care highly even when provided with inadequate information (a recognized form of coercion), with more pronounced discordance when a patient belonged to a historically marginalized caste. System-modifiable factors, such as conditional cash transfers (CCT) to the patient and postpartum procedure timing increased reporting discordance. Using a reproductive justice lens and building on Amartya Sen’s capabilities approach, this work examines how to identify human rights violations in the routine delivery of care.

Repeated Supreme Court cases suggest uninformed sterilization care is a persistent and contemporary issue in India. This article examines patient satisfaction ratings as a potential accountability mechanism to assess normalized forms of coercion. With a sample of over 180,000 sterilized women in India, it identifies a statistically significant relationship between exposure to coercive care and odds of reporting low quality. However, over 95 percent of women who underwent a tubal ligation procedure rated their care highly even when provided with inadequate information (a recognized form of coercion), with more pronounced discordance when a patient belonged to a historically marginalized caste. System-modifiable factors, such as conditional cash transfers (CCT) to the patient and postpartum procedure timing increased reporting discordance. Using a reproductive justice lens and building on Amartya Sen’s capabilities approach, this work examines how to identify human rights violations in the routine delivery of care.

The aim of this report from the Expert Group (see Box 1) on Health Systems Performance Assessment (HSPA) is to establish a comprehensive definition of low-value care in line with the concept of valuebased healthcare and from a health system perspective, and to identify low-value care indicators and measures to facilitate the reduction of low-value care for national HSPA practices. To achieve this aim, a “value-based healthcare” working group was established as a subgroup of the Expert Group with country representatives from Belgium, Czechia, Estonia, France, Germany, Hungary, Italy, Poland, Portugal, Romania and Slovenia as well as the European Observatory on Health Systems and Policies, the Organisation for Economic Co-operation and Development (OECD) and the DirectorateGeneral for Health and Food Safety (DG SANTE)

Total knee arthroplasty (TKA) is an effective treatment for patients with end-stage knee osteoarthritis but some patients exhibit a discrepancy between patient-reported outcomes (PROs) and patient satisfaction (PS). This study aims to identify predictors for patients reporting unfavorable PROs but high PS and vice versa.

Patient harm remains an important concern in hospital care,1 urging a reprioritisation of patient safety and healthcare quality.2 The past 20 years have been characterised by indispensable quality developments,3 including accreditation and public reporting providing foundations for monitoring and promoting healthcare organisation performance.4 Yet, the quality progress appears unsustainable in the long term, as indicated by, for example, nosocomial infections rising in the aftermath of the COVID-19 pandemic,5 6 or mortality reductions being abolished weeks after accreditation survey visits.7 A resilient safety culture with quality truly embedded into everyday practice can only occur after increased awareness of hospital-wide safety risks.3 8

In Belgium, the setting of this study, there is a lack of systematic hospital-wide quality monitoring, despite indications of important differences in patient outcomes between hospitals persisting over time.9 It has been shown for urology patients10 that outcomes such as mortality, readmissions and prolonged length of stay vary to a great extent between hospitals, largely impacting healthcare equity and patient safety.11 12 No data exist on variation in patient outcomes across all patient service lines and across multiple patient outcomes. By recognising which patient service lines are most prone to between-hospital variation and by identifying which hospitals have the highest potential for quality improvement (QI), targeted initiatives can be established. Such focused efforts are highly required in times of scarce financial and human resources and poor outcome prevalence.

The primary aim of this study was to examine inter-hospital variability in in-hospital mortality, unplanned 30-day readmissions and prolonged length of hospital stay (pLOS) across all Major Diagnostic Categories (MDCs) for all Belgian acute-care hospitals. Second, we aimed to estimate the number of outcomes potentially avoidable if successful QI policies could be established. Finally, we aimed to identify a set of high-impact-opportunity hospitals where policymakers can stimulate QI initiatives set to improve patient outcomes.

Health systems experience difficult trade-offs when paying for new drugs. In England, funding recommendations by the National Institute for Health and Care Excellence (NICE) for new drugs might generate health gains but inevitably result in forgone health as the funds cannot be used for alternative treatments and services. We aimed to evaluate the population health impact of NICE recommendations for new drugs during 2000–20.

The Inflation Reduction Act instructs Medicare to negotiate prices of top-selling drugs and sets statutory upper limits (“ceilings”) on negotiated prices. Medicare can negotiate prices below the ceilings based on how prices and clinical benefits of these drugs compare with those of therapeutic alternatives. In August 2024, Medicare published the negotiated prices for the first 10 drugs selected for negotiation; these prices will come into effect in 2026 and will apply to all Medicare Part D plans. We analyzed how negotiated prices in the US compared with net prices before negotiation, ceiling prices, and list prices in 6 other high-income countries.

Biologics approved by the US Food and Drug Administration (FDA) receive 12 years of guaranteed protection from biosimilar competition compared with 5 years of protection from generic competition for new small-molecule drugs. Under the 2022 Inflation Reduction Act, biologics are exempt from selection for Medicare price negotiation for 11 years compared with 7 years for small-molecule drugs. Congress codified these differing legal protections on the premise that biologics require more time and resources to develop and have weaker patent protection, necessitating additional protections for manufacturers to recoup their development costs and generate adequate returns on investment.

Launching Lifelong Health by Improving Health Care for Children, Youth, And Families presents a vision for transforming the child and adolescent health care system. This report also examines how the health care system can be better positioned to equitably address the needs of all children and families and leverage community supports. This requires transforming key components, such as health care financing, public health investment, community partnerships, and accountability strategies, to encourage team-based care delivery models and attention to and health promotion, prevention, and root causes of health disparities.

In contrast to bilateral aid, aid disbursed from multilateral institutions increased significantly at the onset of the COVID-19 pandemic. Yet, at a time when a coherent and effective multilateral response is needed most, the COVID-19 pandemic revealed a shifting landscape of donor agencies that struggle with basic functions, such as cross-national coordination. While multilaterals are uniquely positioned to transcend national priorities and respond to pandemics, functionally we find official development assistance (ODA) from these entities may increasingly mimic the attributes of bilateral aid. We explore three important, but not comprehensive, attributes of aid leading up to and during the COVID-19 pandemic: (1) earmarking, (2) donor concentration and (3) aid modality.

While the effectiveness of patient-reported outcome measures (PROMs) as an intervention to impact patient pathways has been established for cancer care, it is unknown for other indications. We assessed the cost-effectiveness of a PROM-based monitoring and alert intervention for early detection of critical recovery paths following hip and knee replacement.

The intervention significantly improved patient outcomes at lower costs in patients with hip replacements when compared with standard care. Further it showed a nonsignificant cost reduction in knee replacement patients. This reinforces the notion that PROMs can be utilised as a cost-effective instrument for remote monitoring in standard care settings.

The study underscores the importance of understanding and addressing variation in acute care utilization for mental health conditions, including the differential effect of COVID-19, across different health care systems. Further research is needed to elucidate the extent to which factors such as workforce capacity, access barriers, financial incentives, COVID-19 preparedness, and community-based care may contribute to these variations.

In this study we investigated the epidemiology, clinical presentation, and outcomes of the mpox outbreak related to clade IIb in the EMR. We raise concerns about the accuracy and completeness of the data, given that the number of cases reported to the WHO from EMR countries appears to be significantly lower than the number of cases documented within the region. This discrepancy could impact the reliability of the reported figures and the region's response strategies. Despite these challenges, collaborative efforts across EMR countries have laid the groundwork for effective outbreak response, underscoring the importance of ongoing regional cooperation to enhance future preparedness strategies.

Little is known about how long it takes for new medicines to reach countries with different income levels. We analyzed data, sourced from IQVIA, on the timing of new drug launches in seventy-five low-, middle-, and high-income markets from 1982 to 2024. The sample captured the majority of essential medicines (as designated by the World Health Organization in the twenty-third Model List of Essential Medicines) that first came into medical use anywhere globally from 1982 onward. Kaplan-Meier estimates were used to quantify delays in launches across countries. Our analysis comprised 119 medicines with 6,871 observed launches. Nearly three-quarters (74 percent) of first launches occurred in just eight countries (in order of the most first launches, the US, the Netherlands, Sweden, Switzerland, the United Kingdom, France, Germany, and Japan). From the first launch globally, the median time to availability was 2.7 years for high-income countries, 4.5 years for upper-middle-income countries, 6.9 years for lower-middle-income countries, and 8.0 years for low-income countries. The gap between richer (high- and upper-middle-income) and poorer (lower-middle- and low-income) countries remained largely unchanged over time. Strategies to address the disparities highlighted by this analysis are urgently needed.

Over the last two decades, comparative health systems research has gained significant traction as policymakers and researchers seek to better understand how to improve the effectiveness and efficiency of health-care systems worldwide. While most studies undertaken to achieve these goals continue to be predominantly at the national or sub-national levels, the role and importance of cross-country comparison research is increasingly being acknowledged. Recent challenges such as the COVID-19 pandemic, inflationary pressures, rising health-care costs globally, climate change, and decreasing life expectancy among several high-income countries have increased the importance and urgency of this work. Collaborative research efforts across disciplines and countries are therefore needed to identify focused solutions that health systems can apply to the challenges they currently face, and those that may arise in the future.

In this editorial, we summarize the current state of cross-country comparison work at a high level, outline research gaps that remain, and discuss the contribution to this literature of research contained in this special section on international comparisons.

This is a descriptive study using time-series analyses to quantify the annual effect of the COVID-19 pandemic on non-COVID-19 hospitalizations for 20 diagnostic categories and 15 surgical procedures. We compared expected hospitalizations had the pandemic never occurred in 2020–2021, estimated using autoregressive integrated moving average modeling with data from 2010 to 2019, with observed hospitalizations. Observed-to-expected ratios and missed hospitalizations were computed as measures of COVID-19 impact. Mixed linear models were employed to examine associations between hospitalization observed-to-expected ratios and covariates. There was marked cross-country variability in disruptions to hospitalizations and ambulatory care. Certain health system characteristics appeared to be more protective, such as insurance coverage, and number of inputs including healthcare workforce and beds.

Health systems should be designed to withstand emerging shocks and challenges such as the COVID-19 pandemic, and economic and social crises. The ability for a health system to sustain its performance, or even improve it, in the face of a shock can inform policymakers as to how resilient it is. The WHO’s Health System Performance Assessment (HSPA) Framework for Universal Health Coverage (UHC) offers policymakers a conceptual tool for a comprehensive assessment of health system performance. Specifically, it provides a framework from which to examine the performance of the health system itself, but also of the four health system functions - governance, resource generation, financing and service delivery - that make up health systems. The HSPA framework can thus aid policymakers and researchers in examining health systems and considering how shocks may influence the outcomes they produce, as well as the necessary structures that are required for it to produce and sustain performance. In this chapter, we present in detail how the framework can be used to examine how resilient health system performance is to different types of shocks. We consider through a series of case studies both how to use the framework to assess the vulnerabilities of the four key health system functions to different shocks and also how this may translate into changes in performance.

Many studies have documented differences in maternal health outcomes across high-income countries, noting higher and growing maternal mortality in the US. However, few studies have detailed the journeys of care that may underlie or influence differences in outcomes. This study explores how maternity care entitlements and experiences vary among the US and five high-income countries, to study variations in child delivery care practices. Health systems with different organizational structure, insurance coverage and with known differences in maternal care delivery and maternal health outcomes were selected. Data was collected using a structured questionnaire, comparison of secondary data, and literature scan. We find that, while prenatal care approaches were broadly similar across all six countries, there were some important differences in maternity care provision among the comparator countries: (1) the US has more fragmented coverage during pregnancy than comparator countries (2) there were differences with regards to the main provider delivering care, the US relied primarily on physician specialists rather than midwives for prenatal care and delivery which was more common in other countries, (3) the intensity of labor and delivery care varied, particularly with regards to rates of epidural use which were highest in the US and France and lowest in Japan, and (4), there was large variation in the use of postnatal home visits to assess health and wellbeing, notably lacking in the US. The US’ greater use of specialists and more intensive labor and delivery care may partially explain higher costs of care than in comparator countries. Moreover, US maternal mortality is concentrated in the pre- and postnatal periods and thus may be related to poorer access to prenatal care and the lack of an organized, community-based approach to postnatal care. Given the increase in maternal mortality across countries, policy makers should look across countries to identify promising models of care delivery, and should consider investing in more comprehensive coverage in pre- and postnatal care.

More than two decades ago, the Agency for Healthcare Research and Quality developed its Patient Safety Indicators (PSIs) to monitor potentially preventable and severe adverse events within hospitals. Application of PSIs outside the US was explored more than a decade ago, but it is uncertain whether they remain relevant within Europe, as no up-to-date assessments of overall PSI-associated adverse event rates or interhospital variability can be found in the literature. This article assesses the nationwide occurrence and variability of thirteen adverse events for a case study of Belgium. We studied 4,765,850 patient stays across all 101 hospitals for 2016–18. We established that although adverse event rates were generally low, with an adverse event observed in 0.1 percent of medical hospital stays and in 1.2 percent of surgical hospital stays, they were higher than equivalent US rates and were prone to considerable between-hospital variability. Failure-to-rescue rates, for example, equaled 23 percent, whereas some hospitals exceeded nationwide central line–associated bloodstream infection rates by a factor of 8. Policy makers and hospital managers can prioritize PSIs that have high adverse event rates or large variability, such as failure to rescue or central line–associated bloodstream infections, to improve the quality of care in Belgian hospitals.