The COVID-19 pandemic and war in Ukraine have highlighted the dependence of the European Union (EU) on individual trading partners. One of the tasks of the European Commission’s new Directorate-General, the Health Emergency Preparedness and Response Authority (HERA), established in 2021, will...

We examine the relationship between patent protection for pharmaceuticals and investment in development of new drugs. Patent protection has increased around the world as a consequence of the TRIPS Agreement, which specifies minimum levels of intellectual property protection for members of the...

Under Articles 31 and 31bis of the TRIPS Agreement, WTO members may validly sanction the use of a patented invention without the patent owner's authorization by issuing a compulsory license (CL). In the pharmaceuticals space, governments have historically employed compulsory licenses to compel...

Markush structures are molecular skeletons containing not only specific atoms but also placeholders to represent broad sets of chemical (sub)structures. As genus claims, they allow a vast number of compounds to be claimed in a patent application without having to specify every single chemical...

In the context of a health emergency like the COVID-19 pandemic, the global availability of and access to vaccines are imperative. This research paper provides an analysis from the perspective of international political economy, of the financing of COVID-19 vaccines and of the market strategies...

Should the intellectual property rights on the first Covid-19 vaccines be temporarily lifted in applying the Trade-Related Aspect of Intellectual Property (TRIPS) flexibility? Is it right to grant the first generation of Covid-19 vaccines a special treatment from an IPR perspective? On what...

The major bone of contention between the developed and developing countries in the TRIPS negotiations was patents for pharmaceuticals. The US-led developed countries bloc argued in favour of patents for pharmaceuticals amidst opposition from Brazil, India and other countries. Ample evidence,...

We analyze the weaknesses of meta-analyses (MAs) in management research using as benchmark a scientific field where this technique shows a longer tradition: clinical research. We suggest four areas in which management research MA practices should improve: (1) availability of information and...

Recent work linking the adoption of key organizational practices to productivity raises an important question: if adoption increases productivity so dramatically, why does adoption across an industry take so long? This paper explores this question in the context of one particularly interesting...

This Article makes the case that pharmaceutical companies, along with other powerful corporate actors in the pharmaceutical industry, are in effect designing their own markets, often at the expense of, rather than in pursuit of, public health. The influence exerted by these corporate actors...

The debate on whether COVID-19 vaccine patents are slowing down the pace of vaccination and the recovery from the crisis has brought the optimal design of pharmaceutical patent policy to the fore. In this paper we evaluate patent policy in the US pharmaceutical industry. We estimate the effect...

The role of the patent system in the pharmaceutical sector is highly debated also due to its strong public health implications. In this paper we develop an evolutionary, agent-based model of the pharmaceutical industry to explore the impact of different configurations of the patent system upon...

Die Corona-Pandemie hat die deutsche Pharmaindustrie mehr denn je in den Fokus politischer und gesellschaftlicher Diskussionen gestellt. In einer nie dagewesenen Geschwindigkeit haben pharmazeutische Unternehmen mittlerweile vier in Europa zugelassene Impfstoffe entwickelt und auf den Markt...

Wir berechnen einen neuartigen internationalen Maßstab für pharmazeutische Innovationskraft, indem wir uns auf die weltweiten medizinischen Durchbrüche und die dort zitierten Patente konzentrieren. Diese Berechnungsweise ist (über den Bereich der Lebenswissenschaften hinaus) bedeutsam, weil...

The debate about the lack of access to COVID-19 vaccines for the countries of the Global South joins a long history of struggle for effective and affordable treatments for those several dozen diseases for which the World Health Organisation (WHO) uses the telling adjective "neglected". Empirical...

Despite multilateral commitments and political statements of solidarity and cooperation to guarantee the availability and access to COVID-19 vaccines (and other relevant technologies for control and treatment), the scenario after the beginning of vaccination is marked by the deepening of vaccine...

In a simple representative consumer model, vaccines and drug treatments yield the same revenue for a pharmaceutical manufacturer, implying that the firm would have the same incentive to develop either ceteris paribus. We provide more realistic models in which the revenue equivalence breaks down...

The incentives of pharmaceutical companies to innovate and how competition affects these incentives has been topical in recent years: for the general public, as evidenced by a patent race at an unprecedented pace during the ongoing COVID-19 pandemic; and more specifically for competition...

Rapid technological progress has been a defining feature of the medical sector over the last century, yet we know little about the determinants of the development of these new technologies. This paper examines whether and to what extent the demand-side incentives embodied in health policy affect...

In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with speeding new medical innovations to market. These two missions create an inherent tension within the...

The introduction of Medicare in 1965 was the single largest change in health insurance coverage in U.S. history. Many economists and commentators have conjectured that the introduction of Medicare may have also been an important impetus for the development of new drugs that are now commonly used...

We model how risk-neutral firms’ ability to obtain substantial private returns on marginal new technologies causes them to "reach for mediocrity" by investing in socially suboptimal projects, even in the presence of competition and new entrants. Focusing primarily on pharmaceutical innovation,...

We perform an econometric investigation of the contribution of pharmaceutical innovation to mortality reduction and growth in lifetime per capita income. In both of the periods studied (1970-80 and 1980-91), there is a highly significant positive relationship across diseases between the increase...

Background: The COVID-19 or Coronavirus has impacted the world in an unprecedented way. More than 200 countries have been affected because of this novel coronavirus. Global public health, economy and society have all faced near breakdown. There is a surge for identifying vaccine or repurposing...

The discovery and development of new medicines classically involves a linear process of basic biomedical research to uncover potential targets for drug action, followed by applied, or translational, research to identify candidate products and establish their effectiveness and safety. This...

The patent laws of many countries have ''research exemption'' provisions that exempt certain research-related uses of proprietary materials from patent infringement. By limiting the rights of existing patent holders, such rules are meant to facilitate follow-on innovation and benefit latecomer...

"Capitalizing a Cure takes us into the struggle over accessing a medical breakthrough to investigate the power of finance over business, biomedicine, and public health. When sofosbuvir-based medicines launched in 2013, they promised a cure for millions of patients worldwide with hepatitis C. But...

Using the Food and Drug Administration Amendments Act of 2007 (FDAAA) that requires drug developers to disclose detailed clinical study results publicly, we examine the effect of information disclosure on drug development. We find significantly more suspensions of new drug projects after the...

In the midst of epidemics such as COVID-19, therapeutic candidates are unlikely to be able to complete the usual multiyear clinical trial and regulatory approval process within the course of an outbreak. We apply a Bayesian adaptive patient-centered model—which minimizes the expected harm of...

Current business models have struggled to support early-stage drug development. In this paper, we study an alternative financing model, the mega-fund structure, to fund drug discovery. We extend the framework proposed in previous studies to account for correlation between phase transitions in...

Die Corona-Pandemie und die damit einhergehenden Einschränkungen in fast allen gesellschaftlichen und wirtschaftlichen Bereichen beeinflussen seit einigen Wochen das Leben der Menschen weltweit. Neben der möglichen Strategie, eine Herdenimmunität durch Infizierung von 60 bis 70 Prozent der...