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Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Saint Louis University Journal of Health Law & Policy
Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …
Intellectual Property As A Determinant Of Health, Ana Santos Rutschman
Intellectual Property As A Determinant Of Health, Ana Santos Rutschman
All Faculty Scholarship
Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …