Intellectual property and Drug Discovery: Implications for Access, Quality, and Value
Expert Review Of Drug Patent Applications: Improving Health In The Developing World
Tahir Amin, Rahul Rajkumar, Priti Radhakrishnan, and Aaron S. Kesselheim
A Trade Agreement’s Impact On Access To Generic Drugs
Ellen R. Shaffer and Joseph E. Brenner
Global Drug Discovery: Europe Is Ahead
Donald W. Light
Expert Review of Drug Patent Applications: Improving Health In The Developing World
Tahir Amin 1, Rahul Rajkumar 2, Priti Radhakrishnan 3, Aaron S. Kesselheim 4*
1 Tahir Amin is a codirector of the Initiative for Medicines, Access, and Knowledge in
2 Priti Radhakrishnan is a codirector of the Initiative for Medicines, Access, and Knowledge in
3 Rahul Rajkumar is an associate physician at Brighamand Women's Hospital in
4 Aaron Kesselheim is an instructor in medicine at
Health Affairs, doi: 10.1377/hlthaff.28.5.w948
(Published online August 25, 2009)
Available online at: http://content.healthaffairs.org/cgi/content/full/hlthaff.28.5.w948/DC1
“…..Many developing countries have enacted intellectual property laws allowing patents on pharmaceutical products. These countries now must figure out how to provide legitimate protection of innovative discoveries while avoiding drug patents that do not conform to their laws. Using case-study examples, including the antiretroviral tenofovir disoproxil fumarate (TDF, or Viread), we demonstrate the importance of having outside experts participate in the review of drug patents. Vibrant patent review systems require sharing information among developing countries and active consultation with local public health authorities…..”
[Health Aff (Millwood). 2009;28(5):w948-56 (published online 25 August 2009; 10.1377/hlthaff.28.5.w948)]
Europe Expands Lead Over The
The study is one of three released by Health Affairs dealing with prescription drugs and intellectual property. In a second study, researchers document for the first time that trade rules reduce access to generic drugs in a low-income country. In Guatemala, some generics have been withdrawn from the market while others have been denied entry altogether due to intellectual property rules contained in the Central American Free Trade Agreement, say Ellen Shaffer and Joseph Brenner, co-directors of the Center for Policy Analysis on Trade and Health.
In a final study, researchers analyze the role outside experts can play in pre-grant and post-grant review of pharmaceutical patents in developing countries. Tahir Amin, a co-director of I-MAK, the Initiative for Medicines, Access, and Knowledge, and coauthors conclude that public health is best served by allowing outside experts - members of the public apart from the inventor and examiners in the patent office - to challenge patent applications before they are granted.
You can read the article by Amin and coauthors at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w948
You can read the article by Shaffer and Brenner at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w957
You can read the article by Light at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w969
Health Affairs is pleased to make this article freely accessible for two weeks.
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