Vaccine nationalism risks prolonging the global pandemic

While vaccination programmes are well underway in some richer nations, many poorer countries have yet to secure their supply, let alone begin administering jabs. Governments risk failing to contain the pandemic in the coming years unless they guarantee timely global access to COVID-19 vaccines. Olivier Wouters (LSE) looks at the growing global inequalities and how they could be addressed

Lobbying expenditures and campaign contributions by the pharmaceutical and health-product industry in the United States, 1999- 2018

Importance: Government efforts to lower drug costs and other legislative and regulatory initiatives may be counteracted by campaign donors and lobbyists in the pharmaceutical and health product industry. Objective: To review how much money the pharmaceutical and health product industry spent on campaign contributions and lobbying in the US from 1999 to 2018 at the federal and state levels. Design and Setting: Analysis of federal-level and state-level data obtained from the Center for Responsive Politics and the National Institute on Money in Politics, respectively. These nonprofit, nonpartisan organizations track federal and state campaign contributions and lobbying expenditures by individuals and groups. Exposures: Lobbying expenditures and contributions to political campaigns. Main Outcomes and Measures: Total spending, inflation adjusted to 2018 dollars using the US Consumer Price Index, on lobbying and campaign contributions by year, source, and state. Results: From 1999 to 2018, the pharmaceutical and health product industry recorded $4.7 billion- A n average of$233 million per year-in lobbying expenditures at the federal level, more than any other industry. Of the spending, the trade group Pharmaceutical Research and Manufacturers of America accounted for $422 million (9.0$2.2 billion (46.8%). The industry spent $414 million on contributions to candidates in presidential and congressional elections, national party committees, and outside spending groups. Of this amount,$22 million went to presidential candidates and $214 million went to congressional candidates. Of the 20 senators and 20 representatives who received the most contributions, 39 belonged to committees with jurisdiction over health-related legislative matters, 24 of them in senior positions. The industry contributed$877 million to state candidates and committees, of which $399 million (45.5$287 million (32.7%) went to recipients in 9 other states. In years in which key state referenda on reforms in drug pricing and regulation were being voted on, there were large spikes in contributions to groups that opposed or supported the reforms. Conclusions and Relevance: From 1999 to 2018, the pharmaceutical and health product industry spent large sums of money on lobbying and campaign contributions to influence legislative and election outcomes. These findings can inform discussions about how to temper the influence of industry on US health policy

Primary health care should play bigger role in treating chronic kidney disease

A new review article suggests that primary health care should play a bigger role in managing early-stage chronic kidney disease. Olivier J. Wouters and Dr. Panos G. Kanavos, two of the co-authors of the study, discuss these findings

Pharmaceutical policies in Cyprus: a review of the current system and future options

The pharmaceutical market in Cyprus is characterised by several country- and system specific peculiarities and challenges, including: • Small market size; • The system of external price referencing (ERP) does not enable the country to capitalise on transaction prices in reference countries; • The absence of a health insurance scheme and the resulting absence of a suitable reimbursement system does not allow the country to exercise any form of market power; this may lead to inequities in access and expose citizens to undue financial and health risks; • There are no mechanisms in place to monitor and control the prescribing behaviour of physicians; coupled with brand awareness, this likely encourages the over-prescribing of expensive, on-patent products; • There do not appear to be any limits on promotional activities by manufacturers and distributors or any self-regulating practices (such as a code of practice), potentially incentivising providers to induce demand; • The pharmacy remuneration structure and the absence of generic substitution favour the dispensing of expensive products; • For patients, there is little cost-sharing in the public sector, whereas drug costs are borne out-of-pocket in the private sector. A World Health Organization (WHO) mission to study the current system of pharmaceutical pricing and coverage decisions resulted in a series of recommendations. Chronologically, these have been divided into three categories: first, interventions for the short-term to refine the way the current system works, aiming to increase its efficiency and economise on resources; second, interventions aiming to address gaps in the organisation and delivery of health and pharmaceutical services in anticipation of the introduction of a general health insurance scheme (GeSY); and, third, interventions aiming to ensure the sustainability of health and pharmaceutical care provision following GeSY implementation

The challenges of regulating artificial intelligence in healthcare: comment on “clinical decision support and new regulatory frameworks for medical devices: are we ready for It? - A viewpoint paper”

Regulation of health technologies must be rigorous, instilling trust among both healthcare providers and patients. This is especially important for the control and supervision of the growing use of artificial intelligence in healthcare. In this commentary on the accompanying piece by Van Laere and colleagues, we set out the scope for applying artificial intelligence in the healthcare sector and outline five key challenges that regulators face in dealing with these modernday technologies. Addressing these challenges will not be easy. While artificial intelligence applications in healthcare have already made rapid progress and benefitted patients, these applications clearly hold even more potential for future developments. Yet it is vital that the regulatory environment keep up with this fast-evolving space of healthcare in order to anticipate and, to the extent possible, prevent the risks that may arise

Transitioning to a national health system in Cyprus: a stakeholder analysis of pharmaceutical policy reform

Objective To review the pharmaceutical sector in Cyprus in terms of the availability and affordability of medicines and to explore pharmaceutical policy options for the national health system finance reform expected to be introduced in 2016. Methods We conducted semi-structured interviews in April 2014 with senior representatives from seven key national organizations involved in pharmaceutical care. The captured data were coded and analysed using the predetermined themes of pricing, reimbursement, prescribing, dispensing and cost sharing. We also examined secondary data provided by the Cypriot Ministry of Health; these data included the prices and volumes of prescription medicines in 2013 Findings We identified several key issues, including high medicine prices, underuse of generic medicines and high out-of-pocket drug spending. Most stakeholders recommended the national government review existing pricing policies to ensure medicines within the forthcoming national health system are affordable and available, introduce a national reimbursement system and incentivize the prescribing and dispensing of generic medicines. There were disagreements over how to (i) allocate responsibilities to governmental agencies in the national health system, (ii) reconcile differences in opinion between stakeholders and (iii) raise awareness among patients, physicians and pharmacists about the benefits of greater generic drug use. Conclusion In Cyprus, if the national health system is going to provide universal health coverage in a sustainable fashion, then the national government must address the current issues in the pharmaceutical sector. Importantly, the country will need to increase the market share of generic medicines to contain drug spending

A comparison of generic drug prices in seven European countries: a methodological analysis

Background Policymakers and researchers frequently compare the prices of medicines between countries. Such comparisons often serve as barometers of how pricing and reimbursement policies are performing. The aim of this study was to examine methodological challenges to comparing generic drug prices. Methods We calculated all commonly used price indices based on 2013 IMS Health data on sales of 3156 generic drugs in seven European countries. Results There were large differences in generic drug prices between countries. However, the results varied depending on the choice of index, base country, unit of volume, method of currency conversion, and therapeutic category. The results also differed depending on whether one looked at the prices charged by manufacturers or those charged by pharmacists. Conclusions Price indices are a useful statistical approach for comparing drug prices across countries, but researchers and policymakers should interpret price indices with caution given their limitations. Price-index results are highly sensitive to the choice of method and sample. More research is needed to determine the drivers of price differences between countries. The data suggest that some governments should aim to reduce distribution costs for generic drugs

QALYs in cost-effectiveness analysis: an overview for cardiologists

In recent years, cost-effectiveness data have strongly influenced clinical practice guidelines for several cardiovascular treatments. Economic considerations are increasingly common as health systems are under mounting pressure to maximise value for money. The quality-adjusted life year (QALY)—an outcome measure that expresses the duration and quality of life—is the main pillar of cost-effectiveness analyses. It is widely used in assessments of the clinical and economic value of new cardiovascular treatments, but how the QALY is derived is often unclear to clinicians. In this article, we first explain how QALYs are defined and calculated. We then review a selected set of cost-effectiveness analyses of recently introduced cardiovascular treatments and outline how these studies derived their QALYs. Finally, we discuss the limitations of the QALY and how the presentation of the measure could be improved in cost-effectiveness studies

Investments in Research and Development for Supplemental Drug Indications—Implications for Drug Price Negotiations

This Viewpoint compares the research and development costs for a drug’s first indication with supplemental indications to demonstrate that the cost of approval for supplemental indications may be substantially lower

Incentivizing nutrition: how to apply incentive mechanisms to accelerate improved nutrition outcomes: a practitioner’s compendium

Malnutrition is a driver of poverty. Reducing malnutrition is essential to achieving the World Bank’s goals of eliminating extreme poverty and enhancing shared prosperity. This compendium offers practical information on how to plan, implement, and monitor incentivized operations for improving nutrition results for World Bank client countries. For more detailed background information, see the World Bank report Incentivizing Nutrition: Incentive Mechanisms to Accelerate Improved Nutrition Outcomes