The paper describes the legal and regulatory mechanism in the United States pursuant to which generic versions of patented medicines may be approved for marketing by the Food and Drug Administration (FDA). The paper makes two basic points: (1) the system works reasonably well for the United...

The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic...

UNDP first drew attention to the utility of competition law in health care as a tool to facilitate and promote access to health technologies in 2014. It published ‘Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries’ (the...

This chapter reflects on the evolution of competition law jurisprudence regarding the excessive pricing of pharmaceutical products, and suggests areas where improvements might be considered. This includes, first, establishing per se rules regarding pricing increases that might be considered...

The WTO has just finished two and one half years of negotiations on the TRIPS Agreement and Public Health, with an additional tranche of negotiations scheduled to commence soon. These negotiations have been extraordinarily instructive on the subject of trade diplomacy and the means by which ends...

The wheel of the global medicines supply market is broken, but proposals for fixing it are at very early stages. The patent is an instrument designed to aggregate production capital, and for some product sectors the patent may be the best means for promoting the introduction of new products. But...

This article addresses NAFTA's environment-related dispute settlement mechanisms and how these might serve as a prototype for other regional integration efforts. The article focuses on a few critical issues with respect to NAFTA's environment-related dispute mechanisms. These are: (1) whether...