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Full-Text Articles in Law
Legal Movements In Intellectual Property: Trips, Unilateral Action, Bilateral Agreements, And Hiv/Aids, Margo A. Bagley
Legal Movements In Intellectual Property: Trips, Unilateral Action, Bilateral Agreements, And Hiv/Aids, Margo A. Bagley
Faculty Articles
This Article begins with an overview of the relationship between the Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") and the HIV/AIDS pandemic which created the need for the Doha Declaration. It then discusses two trade-related movements, unilateral action and TRIPS-plus bilateral agreements, that call into question the long-term effectiveness of the TRIPS Agreement process, generally, and the benefits of the Doha Declaration, in particular, in addressing multiple facets of the access to essential medicines problem. This Article concludes that a consideration of these issues should be included in the development of any further TRIPS-related solutions to …
New Drug Research, The Extraterritorial Application Of Fda Regulations, And The Need For International Cooperation, William Dubois
New Drug Research, The Extraterritorial Application Of Fda Regulations, And The Need For International Cooperation, William Dubois
Vanderbilt Journal of Transnational Law
In recent years, U.S. pharmaceutical companies have expanded their new drug trials beyond the borders of the United States. While the companies have a variety of reasons for making this move, among them may be a desire to avoid Food and Drug Administration (FDA) regulation and monitoring. Lack of adequate supervision of drug trials conducted in the developing world endangers both the subjects of the tests and the consumers in the United States. It is unclear whether the FDA can execute regulatory and supervisory authority abroad. The FDA statute does not clearly authorize the agency to regulate extraterritorially. Applying the …