The human right to medicines

This article considers the component of the right to the highest standard of health that relates to medicines, including essential medicines. Using the right-to-health analytical framework that has been developed in recent years, the first section focuses on the responsibilities of States. The second section provides a brief introduction to the responsibilities of pharmaceutical companies

Health Care Costs and the Arc of Innovation

Health care costs continue their inexorable rise, threatening America’s long-term fiscal stability, competitiveness, and standard of living. Over the past half-century, efforts to rein in spending have uniformly failed. In this Article, we explain why, breaking with standard accounts of regulatory and market dysfunction. We point instead to the nexus of economics, mutual empathy, and social expectations that drives medical innovation and locks in low-value technologies. We show how law reflects and reinforces this nexus and how and why health-policy-makers avert their gaze. Next, we propose to circumvent these barriers instead of surmounting them. Rather than targeting today’s excessive spending, we seek to leverage available legal tools to bend the arc of innovation, away from marginally-beneficial technology and toward high-value advances. To this end, we set forth a novel, value-based approach to pricing and patent protection—one that departs sharply from current practice by rewarding innovators in proportion to the therapeutic benefits new tests and treatments yield. Using cancer therapy as an example, we explain how emerging information technology and large troves of electronic clinical data are opening the way to near-real-time assessment of efficacy. We then show how such assessment can power ongoing adjustment of pricing and patent terms. Finally, we offer a blueprint for how laws governing health care payment and intellectual property can be tailored to realize this value-focused vision. For the reasons we lay out, the transformation of incentives we urge will both slow clinical spending growth and greatly enhance the social value that this spending yields

Social rights and economics : claims to health care and education in developing countries

The author analyzes contemporary rights-based and economic approaches to health care and education in developing countries. He assesses the foundations and uses of social rights in development, outlines an economic approach to improving health and education services, and then highlights the differences, similarities, and the hard questions that the economic critique poses for rights. The author argues that the policy consequences of rights overlap considerably with a modern economic approach. Both the rights-based and the economic approaches are skeptical that electoral politics and de facto market rules provide sufficient accountability for the effective and equitable provision of health and education services, and that further intrasectoral reforms in governance, particularly those that strengthen the hand of service recipients, are needed. There remain differences between the two approaches. Whether procedures for service delivery are ends in themselves, the degree of disaggregation at which outcomes should be assessed, the consequences of long-term deprivation, metrics used for making tradeoffs, and the behavioral distortions that result from subsidies are all areas where the approaches diverge. Even here, however, the differences are not irreconcilable, and advocates of the approaches need not regard each other as antagonists.Health Monitoring&Evaluation,Health Systems Development&Reform,Decentralization,Public Health Promotion,Early Child and Children's Health,Health Monitoring&Evaluation,Health Economics&Finance,Poverty Assessment,Agricultural Knowledge&Information Systems,Gender and Education

Depoliticisation, Resilience and the Herceptin Post-code Lottery Crisis: Holding Back the Tide

This article: Covers new empirical terrain in the study of depoliticisation, with an in-depth case study of health technology regulation; Analyses depoliticisation from a novel analytical perspective, examining how depoliticised institutions are resilient to external pressure for politicisation; Posits a distinctive framework for analysing resilience, drawing on cognate literatures on policy networks and agencification; Raises interesting and distinctive questions about the nature of depoliticisation in advanced liberal democracies, arguing it is more contested than commonly acknowledged. Depoliticisation as a concept offers distinctive insights into how governments attempt to relieve political pressures in liberal democracies. Analysis has examined the effects of depoliticisation tactics on the public, but not how those tactics are sustained during moments of political tension. Drawing on policy networks and agencification literatures, this article examines how these tactics are resilient against pressure for politicisation. Using an in-depth case study of the controversial appraisal of cancer drug Herceptin in 2005/6 by the National Institute for Health and Clinical Excellence (NICE), the article examines how ‘resilient’ NICE was to external politicisation. It is argued that NICE was resilient because it was effectively ‘insulated’ by formal procedures and informal norms of deference to scientific expertise. This mechanism is termed ‘institutional double glazing’. The conclusion suggests developments to the conceptual and methodological framework of depoliticisation, and highlights theoretical insights into the nature of ‘anti-politics’ in contemporary democracies

Concomitant alcohol and alcohol-interactive medication use by older New Zealanders : investigating the prevalence, and potential associations with health, healthcare utilization, and depression : a thesis presented in partial fulfillment of the requirements for the degree of Doctor of Clinical Psychology at Massey University, Manawatū, New Zealand

Background: Older adults are more vulnerable to the adverse effects of alcohol-medication interactions (AMIs) than younger populations, and are more likely to use medications capable of causing an AMI when used with alcohol (alcohol-interactive (AI) medications). Survey findings from the United States (US) and Europe indicate many older adults use alcohol and AI-medications concomitantly. However, the prevalence of this issue in New Zealand is currently unknown, and few observational studies have explored the impact of concomitant alcohol and AI-medication use (concomitant alcohol/AI-medication use) on health outcomes in community samples. Research exploring motivating factors underlying alcohol use by AI-medication users indicates having awareness of AMI risks often motivates reduced alcohol consumption. There is also evidence that depression may increase the likelihood of concomitant alcohol/AI-medication use, particularly when alcohol is used to ‘self-medicate’ depressive symptoms. However, the moderating effects of depression on alcohol use by AI-medication users have not been directly assessed in a large community sample. Design and Methods: Two studies were conducted, both involved secondary analysis of existing survey data and national pharmaceutical claims data. Samples were drawn from a representative sampling frame of older adults living in New Zealand. The first study (study 1) analysed data from a survey of adults aged 54-70 years, and the second study (study 2) analysed data from an augmented sample aged 49-83 years. The prevalence of concomitant alcohol/AI-medication use was explored in both study samples overall, and in subsamples of participants aged ≥65 years. Study 1 investigated the potential impact of concomitant alcohol/AI-medication use on general physical health and healthcare utilization. Study 2 assessed the potential relationships between alcohol use, AI-medication use, and depression. An evidence-based protocol was developed to inform methods of classifying AI-medications and measuring AI-medication use among survey participants using pharmaceutical dispensing records. Relationships between variables of interest were assessed using a series of hierarchical regression models and Chi-squared tests. Results: Alcohol and AI-medications were used concomitantly by approximately one-in-four participants aged 54-70 years, one-in-three participants aged 49-83 years, and two-in-five participants aged 65-83 years. Concomitant alcohol/AI-medication use was not significantly associated with physical health or healthcare utilization, although these non-significant findings may reflect limitations of the outcome measures used in the present research. Alcohol use was negatively associated with AI-medication use, with stronger associations being observed for medications associated with more severe AMIs. These findings are consistent with research and theory indicating AMI awareness may lead to reduced alcohol consumption by AI-medication users. Depression did not influence the relationship between AI-medication use and alcohol use. Conclusions: The present research findings indicate many New Zealand older adults are at risk of AMI. Providing relevant health warnings may help reduce the potential for AMI-related harm, although additional intervention may be needed for many older adults. Future research in this area should include longitudinal health outcome measures that are specific to the effects of AMI, and measures that assess drinking motives directly. The two studies presented in the present thesis were the first to explore the prevalence of concomitant alcohol/AI-medication use by older adults in New Zealand, which is a major contribution of this project overall. Another important contribution was the development of an evidence-based framework for measuring AI-medication use among survey participants

The Affordable Care Act and Beyond: Opportunities for Advancing Health Equity and Social Justice

In 2010, the most monumental health care legislation in forty-five years was enacted. The Patient Protection and Affordable Care Act ( ACA ) makes changes great and small in virtually every important component of the American health care system. The new law\u27s implications will not be known fully for many years because state governments and federal agencies are in the process of interpreting key provisions, drafting rules and devising general implementation strategies. And, uncertainty exists about the scope of the ACA because of the recent Supreme Court ruling in National Federal of Independent Business v. Sebelius. The court upheld nearly all of the provisions in the ACA, but it ruled that the federal government cannot withhold Medicaid funds from states that refuse to expand their Medicaid programs to cover individuals with incomes of as much as 133 percent of the federal poverty level. This article seeks to analyze the most significant changes that affect communities of color and to examine the resulting health equity and social justice implications. Part I explains the moral and economic case for eliminating racial and ethnic health care disparities. Part II analyzes provisions in the new law designed to expand access to health insurance. Part III focuses on the special access challenges communities of color face and how the ACA provisions attempt to address these. Part IV examines key ACA provisions that are explicitly intended to reduce health disparities and improve the health of racially and ethnically diverse populations. Part V argues that achieving health equity for racial and ethnic minority groups will require policy strategies focused outside of the health care arena. This article concludes with recommendations on how to leverage federal spending to advance racial and ethnic equality

Combating Antimicrobial Resistance: Regulatory Strategies and Institutional Capacity

Amnesia is a common, important, but rarely noted side effect of antibiotics. Apart from medical historians, few recall the severe morbidity and mortality once associated with acute bacterial infection. However, decades of antibiotic overuse and misuse have compromised the long-term availability and efficacy of these life-saving therapies. If designed and implemented appropriately, regulation can reduce the risk of bacterial infection, reserve antibiotics for circumstances where they are necessary, and rationalize the use of the most powerful agents. Regulation of antibiotic resistance can be justified, and should be guided, by both efficiency and fairness. A range of regulatory options are available--some information-based, some incentive-based, some command-and-control--each of which has indications, strengths, and weaknesses. A desired set of regulatory strategies must then be matched with the appropriate legal and regulatory institutions. A renewed focus on regulatory and institutional design has significant potential to reduce antibiotic-resistant bacterial infections and increase the effective life of existing and new antibiotics