Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US.

Importance: 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.

Low- And Middle-Income Countries Experienced Delays Accessing New Essential Medicines, 1982-2024.

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.

Sales Revenues for New Therapeutic Agents Approved by the United States Food and Drug Administration From 1995 to 2014.

Objectives: This study aimed to analyze worldwide sales of new therapeutic agents and to estimate the time it takes for product sales to exceed industry-wide average drug development costs.

Methods: Data obtained from company reports were analyzed to track worldwide sales of new medicines approved by the US Food and Drug Administration from 1995 to 2014. All sales figures were reported in 2019 US dollars.

Price benchmarks of drugs selected for Medicare price negotiation and their therapeutic alternatives.

Background: The Centers for Medicare and Medicaid Services (CMS) are currently negotiating prices with pharmaceutical manufacturers for the first 10 Part D drugs selected for Medicare drug price negotiation. Non-publicly available data, including the net prices of selected drugs and their therapeutic alternatives, will play a central role in the determination of the maximum fair prices (MFPs).

Objective: To estimate price benchmarks involved in the derivation of the starting point of the CMS initial price offer for the 10 drugs selected for Medicare price negotiation.

The launch of the EU Health Emergency Preparedness and Response Authority (HERA): Improving global pandemic preparedness?

The crowded global health landscape has been joined by the European Union Health Emergency Preparedness and Response Authority (HERA). HERA will assume four broad areas of responsibility: horizon scanning for major health threats; research and development; support for capacity to manufacture drugs, vaccines, and equipment; and procuring and stockpiling key medical countermeasures. In this Health Reform Monitor article, we outline the reform process and describe HERA's structure and responsibilities, explore issues that arise from the creation of this new organisation, and suggest options for collaboration with existing bodies in Europe and beyond.

Divergent COVID-19 vaccine policies: Policy mapping of ten European countries.

Background: The COVID-19 pandemic highlighted the fragmented nature of governmental policy decisions in Europe. However, the extent to which COVID-19 vaccination policies differed between European countries remains unclear. Here, we mapped the COVID-19 vaccination policies that were in effect in January 2022 as well as booster regulations in April 2022 in Austria, Denmark, England, France, Germany, Ireland, Italy, the Netherlands, Poland, and Spain.

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 modern-day technologies.

Association of Research and Development Investments With Treatment Costs for New Drugs Approved From 2009 to 2018.

Importance: Drug companies frequently claim that high prices are needed to recoup spending on research and development. If high research and development costs justified high drug prices, then an association between these 2 measures would be expected.

Objective: To examine the association between treatment costs and research and development investments for new therapeutic agents approved by the US Food and Drug Administration (FDA) from 2009 to 2018.

Measuring health science research and development in Africa: mapping the available data.

Background: In recent years there have been calls to strengthen health sciences research capacity in African countries. This capacity can contribute to improvements in health, social welfare and poverty reduction through domestic application of research findings; it is increasingly seen as critical to pandemic preparedness and response. Developing research infrastructure and performance may reduce national economies' reliance on primary commodity and agricultural production, as countries strive to develop knowledge-based economies to help drive macroeconomic growth.

Multi-country collaboration in responding to global infectious disease threats: lessons for Europe from the COVID-19 pandemic.

Since 2005, the world has faced several public health emergencies of international concern arising from infectious disease outbreaks. Of these, the COVID-19 pandemic has had by far the greatest health and economic consequences. During these emergencies, responses taken by one country often have an impact on other countries.

Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment.

The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities.

Association between provincial income levels and drug prices in China over the period 2010-2017.

In the past decade, the Chinese central government has made sweeping reforms to national pharmaceutical policies. However, provincial authorities have retained control over most drug procurement procedures, potentially leading to cross-province differences in drug prices. The objectives of this study were to (i) examine drug price trends in 31 Chinese provinces and municipalities between 2010 and 2017; (ii) evaluate the association between provincial income levels and drug prices over this period; and (iii) compare the results for Chinese state-owned, Chinese private, and multinational pharmaceutical firms.