Government trade ministers arrived at that the WTO Seattle Ministerial Conference in late November 1999 without preliminary agreement on the future course of multilateral trade negotiations, and they departed without reaching consensus on a new WTO agenda. There was ample warning that the WTO...

The Doha Declaration on the TRIPS Agreement and Public Health recognized that developing countries with insufficient, or no manufacturing capacity in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. The World Health...

The First Report on Parallel Imports approaches the exhaustion/parallel imports question in broad economic terms, asking whether there may be an economic and social welfare benefit to permitting IPRs holders to block parallel imports that outweighs the potential harm to liberal trade. The Report...

In connection with the run-up to the Cancun Ministerial Conference, the author was asked whether there are grounds for recommending amendment of WTO TRIPS Agreement rules addressing competition. The general conclusion of the study is that the TRIPS Agreement in its present form provides...

This chapter addresses the interface between health and intellectual property (IP). The chapter provides an introduction to the forms of IP principally as they relate to health products, and describes the international legal framework in which IP is situated. It addresses the ways in which IP...

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...