Open Access. Powered by Scholars. Published by Universities.®

Health Law and Policy Commons

Open Access. Powered by Scholars. Published by Universities.®

Articles 1 - 4 of 4

Full-Text Articles in Health Law and Policy

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman Jan 2021

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

All Faculty Scholarship

We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.

While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new …


The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman Jan 2020

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

All Faculty Scholarship

This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …


Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman Jan 2020

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

All Faculty Scholarship

Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …


Layers Of Law: The Case Of E-Cigarettes, Eric A. Feldman Jan 2014

Layers Of Law: The Case Of E-Cigarettes, Eric A. Feldman

All Faculty Scholarship

This paper, written for a symposium on "Layers of Law and Social Order," connects the current debate over the regulation of electronic cigarettes with socio-legal scholarship on law, norms, and social control. Although almost every aspect of modern life that is subject to regulation can be seen through the framework ‘layers of law,’ e-cigarettes are distinguished by the rapid emergence of an unusually dense legal and regulatory web. In part, the dense fabric of e-cigarette law and regulation, both within and beyond the US, results from the lack of robust scientific and epidemiological data on the behavioral and health consequences …