Reed F. Beall

Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis

Reed Beall and Randall Kuhn describe their findings from an analysis of use of compulsory licenses for pharmaceutical products by World Trade Organization members since 1995.

The time for pharmaceutical compulsory licensing has expired

The compulsory license mechanism is broken and will not bring drug access to the worlds poorest nations. Its time to consider another option—a tax levied on patents—to fund drugs for developing countries, rather than the erratic compulsory licensing mechanism.

Modes of delivery in preventive intervention studies: a rapid review

This review was commissioned to generate broad discussion about how to select intervention delivery modes when designing a complex, preventive intervention aimed at chronic disease through the promotion of physical activity, healthy diet and/or medication adherence. In this context, we asked, what are the delivery modes? What are the important design considerations? And how do these compare (e.g. strengths, limitations)?

Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?

Background Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as “evergreening”, can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. Materials and Methods We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration’s Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product’s device patents and medicine patents. Results Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3–15.2 years). Conclusion Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes “evergreening” depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic improvements in the standard of care, which is highly debatable.

Upstream solutions for price-gouging on critical generic medicines

Exorbitant price increases for critical off-patent medicines have received considerable media attention in recent months, leading to an investigation by the U.S. Senate. However, much of this attention has focused upon the companies that initiated the price increases, all of whom had recently acquired the drugs in question. Overlooked are upstream interventions with the originators of these drugs to prevent generics trolling in the first place. Using the particular example of Eli Lilly and Company’s efforts to divest itself of cycloserine, a flawed process that paved the way for the recent price hike by Rodelis Therapeutics, this article highlights the responsibilities of drug originators, and safeguards to ensure similar rights transfers do not affect ongoing affordable access.

Comparing alternative design options for chronic disease prevention interventions

While the randomized clinical trial is considered to provide the highest level of evidence in clinical medicine, its superiority to other study designs in the context of prevention studies is debated. The purpose of this review was (i) to gather evidence about challenges facing both randomized controlled trials and observational designs for the conduct of population‐based chronic disease prevention interventions and (ii) to consider the suitability of recently proposed hybrid designs for population‐based prevention intervention studies.

Effectiveness of individual-focused interventions to prevent chronic disease.

The burden of chronic disease is projected to assume crisis proportions in most parts of the world by the middle of the century, focusing attention on the need for preventive interventions. We identify and review published research on primary prevention individual‐level interventions in current practice and describe and discuss the limitations of the current evidence. The report facilitates prioritizing a research agenda for potential interventions that might be investigated within cohort studies.

Exploring Contingent Inequalities: Building the Theoretical Health Inequality Model

There is considerable controversy whether a population’s extent of income inequality (not just individual income levels) affects a population’s health. Very provocative evidence is provided by a comparison of Canadian and US cities. There is a clear correlation in the US between city-level income inequality and working age mortality. But highly comparable data for Canada show no correlation. One hypothesis is that this major observed difference is due to greater income segregation (in turn highly correlated with racial segregation) in US cities compared to Canada. In this chapter, we develop and present an agent-based model called the Theoretical Health Inequality Model (THIM). THIM embodies a theory of this correlation wherein it is contingent on a range of factors that are plausibly important, and that differ between Canada and the US in empirically verifiable ways. Drawing on both empirical evidence and various social science theoretical work, we posit a formal algorithmic structure for THIM, and then a set of parameters reflecting the “stylized facts” for Canada and the US. The focus of this chapter is on the development of THIM as an agent-based model, including its conceptualization, and the realization of these concepts as a virtual in silico laboratory for simulation experiments and hypothesis exploration.

Will inter partes review speed US generic drug entry

A new extra-judicial pathway for challenging pharmaceutical patents has intensified patent challenges and helped to clear the way for earlier generic entry.

Which patent and where? Why international patent transparency by companies is needed for medicines

A common method for determining the patent status of medicines internationally is highly imprecise and complicates medicine access by obscuring the true medicine patent landscape for policymakers and procurement officers.