Journal of Health Politics Policy and Law最新文献

Context: The False Claims Act is the US federal government's primary tool for identifying and penalizing pharmaceutical fraud. The Department of Justice uses the False Claims Act to bring civil cases against drug manufacturers that allegedly obtain improper payment from federal programs.

Methods: The authors searched the Department of Justice website for press releases published between 2006 and 2022 that announced fraud actions brought against drug companies. They then used the World Health Organization's Anatomical Therapeutic Classification index to identify the classes of prescription drugs implicated in fraud actions.

Findings: During fiscal years 2006-2022, payments by six manufacturers amounted to more than 28% of total payments made as a result of federal False Claims Act actions. Nervous system and cardiovascular drugs were the classes of medications most commonly implicated in alleged fraud. Federal officials most frequently alleged that companies improperly promoted nervous system drugs and paid kickbacks to increase revenues from cardiovascular, antineoplastic and immunomodulating, and alimentary tract and metabolism drugs.

Conclusions: Despite frequent pharmaceutical fraud settlements and penalties, incidence of alleged fraud among drug companies remains high. Alternative methods for preventing and deterring fraud could help safeguard our health systems and promote public health, and policy makers should ensure that effective fraud enforcement complements preventive public health regulation.

The need to bolster Medicaid home and community-based services (HCBS) became more evident during the COVID-19 pandemic. This recognition stemmed from the challenges of keeping people safe in nursing homes and the acute workforce shortages in the HCBS sector. This article examines two major federal developments and state responses in HCBS options as a result of the pandemic. The first initiative entails a one-year increase of the federal Medicaid matching rate for HCBS included in the American Rescue Plan Act championed by the Biden administration. The second initiative encompasses administrative flexibilities that permitted states to temporarily expand and modify their existing Medicaid HCBS programs. The article concludes that the effects of the pandemic flexibilities and enhanced federal funding on most state HCBS programs will be limited without continued investment and leadership on the part of the federal government, which is a Biden administration priority. States that make the American Rescue Act and COVID-19 flexibilities initiatives permanent are states that have the fiscal resources and political commitment to expanding HCBS benefits that other states lack. States' different approaches to bolstering Medicaid HCBS during the pandemic may contribute to widening disparities in access and quality of HCBS across states and populations who depend on Medicaid HCBS.

Context: Wealthy countries vary considerably in terms of how well they have been able to inoculate their populations against COVID-19. In particular, democracies have been constrained in their abilities to implement vaccine mandates, given enshrined protections of civil liberties and individual freedom in such regimes. While scholars have begun addressing the democratic constraint on vaccine mandates, less attention has been paid to the additional challenges democracies face in constraining the spread of vaccine misinformation-particularly misinformation that spreads online.

Methods: This study combines large-N cross-country analysis with a case study of Germany to illustrate the "double bind" that democracies face when it comes to containing both the spread of disease and the spread of misinformation through social media.

Findings: The cross-national analysis confirms that democracies have been less likely to enact vaccine mandates, and they have also been relatively more hesitant to restrict what people can see and share online. The case study of Germany highlights the normative and the procedural constraints underlying such decisions.

Conclusions: These findings show that resources are often not the binding constraint on effective disease control, raising questions regarding the ability of high-income democracies to respond effectively to future public health emergencies.

This study investigates South Korea's trials and errors in procuring COVID-19 vaccines from abroad, amid the limitations of a multilateral scheme for global provision through the COVID-19 Vaccines Global Access (COVAX) program via the World Health Organization (WHO) and the discussions on COVID-19 vaccine patent waivers at the World Trade Organization. Using the framework of "self-help" in the international system and country categorization to explicate country behaviors by state-business relations and expertise to explain South Korea's COVID-19 vaccine procurement process, this study argues that in the absence of a global mechanism that guarantees adequate and timely vaccine provision, countries are left to the sole option of depending on their own capabilities: expertise, budget, and policy planning by consolidating public and private capacities to acquire vaccines for the public. To support the argument, an in-depth case investigation of South Korea's Vaccine Procurement Task Force is presented. The case study focuses on the policy assessment of critical elements in South Korea's vaccine procurement and rollout on facing obstacles to sufficient procurement through COVAX: decision-making impacting the timing and dosage of procurement, diplomatic and business channels to sign bilateral contracts, setup of a smart-factory vaccination hub, and indigenous vaccine development for WHO approval.

Context: To facilitate the manufacturing of COVID-19 medical products, in October 2020 India and South Africa proposed a waiver of certain intellectual property (IP) provisions of a World Trade Organization (WTO) agreement. After nearly two years, a narrow waiver agreement that did little for vaccine access passed the ministerial despite the pandemic's impact on global trade, which the WTO is mandated to safeguard.

Methods: The authors conducted a content analysis of WTO legal texts, key-actor statements, media reporting, and the WTO's procedural framework to explore legal, institutional, and ideational explanations for the delay.

Findings: IP waivers are neither legally complex nor unprecedented within WTO law, yet these waiver negotiations exceeded their mandated 90-day negotiation period by approximately 18 months. Waiver opponents and supporters engaged in escalating strategic framing that justified and eventually secured political attention at head-of-state level, sidelining other pandemic solutions. The frames deployed discouraged consensus on a meaningful waiver, which ultimately favored the status quo that opponents preferred. WTO institutional design encouraged drawn-out negotiation while limiting legitimate players in the debate to trade ministers, empowering narrow interest group politics.

Conclusions: Despite global political attention, the WTO process contributed little to emergency vaccine production, suggesting a pressing need for reforms aimed at more efficient and equitable multilateral processes.

Context: A key task for countries around the world facing the COVID-19 pandemic was to achieve high vaccination coverage of the population. To overcome "vaccination inertia," governments adopted a variety of policy instruments. These instruments can be placed along a "ladder of intrusiveness" based on their degree of constraint of individual freedoms. The aim of this study is to investigate how the governments of three European countries moved along the ladder of intrusiveness and how the choice of policy instruments was influenced by contextual factors.

Methods: The study draws on secondary data sources, including academic and gray literature, policy documents, and opinion polls, over an observation period from December 2020 to summer 2022. The study employs inductive logic to analyze data and identify the factors explaining similarities and differences across England, Germany, and Italy.

Findings: The study identifies similarities and differences in how the three countries advanced along the ladder of intrusiveness. Contextual factors such as policy legacy, social acceptability, and ideological orientation contribute to explain the observations.

Conclusions: Country-specific contextual factors play an important role in understanding the choice of policy instruments adopted by the three countries. Policy makers should carefully consider these factors when planning immunization strategies.

Context: Regulatory approaches to COVID-19 vaccine authorizations varied substantially across countries. Facing a common public health threat, what accounts for regulatory variation? This study focuses on emergency pharmaceutical and vaccine regulatory procedures and whether and how regulators' emergency pharmaceutical regulatory procedures going into the pandemic shaped regulatory processes and decisions during the pandemic.

Methods: The authors conducted an analysis of seven high-impact national and international pharmaceutical regulators with case studies from Brazil, China, India, Russia, the United Kingdom, the United States, and the European Medicines Agency. The authors analyzed evidence from primary source executive and legislative branch regulations and statutes as well as national and international scientific and general press reporting; they also drew on the secondary analysis of scholars, practitioners, and international organizations.

Findings: Inherited emergency pharmaceutical and vaccine regulatory procedures substantially shaped COVID-19 vaccine regulation during the pandemic. Variation in the presence and content of emergency regulatory procedures affected the quality of pandemic regulatory processes, outcomes, and procedural updates and differentially empowered policy-making experts and elected politicians.

Conclusions: Emergency regulatory procedures affect key features of regulatory political economy and public health practices during crises. To improve future public health crisis responses, the authors provide policy recommendations for (1) establishing clear emergency pharmaceutical regulatory procedures, and (2) international collaboration.

What motivates state-sponsored vaccine misinformation campaigns, given clear scientific evidence of vaccines' efficacy? The authors explored this issue through the lens of state-owned presses in mainland China and in Hong Kong. They first collected an original database of media reports on both Western and Chinese vaccines from 16 Chinese-language media publications based in mainland China, Hong Kong, and Taiwan. They found the quantity of coverage of Western vaccines by mainland state-owned media outlets to be much less than their coverage of Chinese vaccines, reflecting the unavailability of Western vaccines in mainland China. However, applying a dictionary-based sentiment analysis, the authors found that state-owned presses in mainland China still portrayed Western vaccines negatively. In Hong Kong, where there is direct competition between Chinese and Western vaccines, they found that state-owned presses gave high coverage of both Western and Chinese vaccines but greater negative coverage of Western vaccines. These findings are consistent with a Chinese producer-oriented "vaccine nationalism" policy designed to nurture the domestic biotechnology sector.

Context: Much of the existing work on the political economy of vaccine access has focused on how intellectual property rights agreements contribute to inequitable COVID-19 vaccine access between high-income and low- and middle-income countries (LMICs). The two solutions that emerged to scale up access in LMICs involved either voluntary arrangements under COVAX or a waiver of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) to allow immediate access to intellectual property. However, an additional constraint on access is weak and ineffective supply chains within LMICs that have eroded over several decades of health-sector reform.

Methods: This article reviews the literature on the political economy of supply chain strengthening in LMICs and identifies key challenges to equitable access to emergent vaccines and other medicines emanating from market and state failures in internal supply chains.

Findings: Over the past century, supply chain policies in LMICs have alternated among an emphasis on addressing market failures contributing to unaffordability of vaccines/medicines, an emphasis on state failures contributing to unavailability of vaccines/medicines, and a more recent move toward public-private hybrid arrangements to strengthen supply chains.

Conclusions: In addition to reshoring production capacity through a TRIPs waiver, the international community must address chronic weakness in internal supply chains in LMICs to ensure access to novel vaccines/medicines.