INTRODUCED BY: Quy Ton

SCHOOL: University of Minnesota Medical School, Twin Cities

SUBJECT: University Research, Intellectual Property and Access to Essential Medicines in Resource-Poor Settings

TYPE: Principles

PREAMBLE:

It is beyond dispute that we are in the midst of a global health crisis: Millions of people around the world, the majority of them living in developing countries, are dying because they lack access to life-saving medications for diseases like AIDS, tuberculosis, and malaria. Life-saving antiretroviral therapy for HIV/AIDS is available, but unaffordable prices too often prevent safe and effective treatments from reaching the populations that need them. Clearly, the current patenting and licensing system, exacerbated by the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) Agreement, is not meeting the needs of the majority of the world's population because the world drug market is concentrated in the North.

Universities have played early and crucial roles in developing many HIV-related medicines, but still rely upon patents and licenses to private-sector pharmaceutical companies to develop and market final products. Because universities are "upstream", they often are in position to have early leverage over any drug that is developed and marketed. With intellectual property (IP) rights now recognized as key levers in determining prices, profits and access, universities face difficult questions about how best to manage their IP policies to further their mission of serving the public good. As yet, however, there are no best-practices models that define specific IP management strategies universities can adopt to promote access to medicines in developing countries.

Students, faculty and researchers can greatly influence university intellectual property practices and thus play an important role in increasing access to essential medicines worldwide. For example, students and faculty were influential in convincing Yale University and Bristol-Meyers Squibb to announce that they would allow generic production of stavudine (d4T, a widely-used antiretroviral drug patented by Yale and licensed to Bristol-Meyers Squibb) and sharply reduce prices in developing countries. The result was a rapid, thirty-fold price reduction of d4T in South Africa and a subsequent agreement signed with a generic company to make generic d4T in South Africa. This important change was made at Yale without any negative consequences to the University - financial or otherwise.1

THEREFORE BE IT RESOLVED that the PRINCIPLES REGARDING PHARMACEUTICALS AND MEDICAL DEVICES, BE AMENDED to include:

7. Regarding University research, intellectual property and access to essential medicines in resource-poor settings:

AMSA RECOGNIZES that Universities, as intellectual property holders, play a crucial role in the development of new medicines and medical technologies. How they patent and license these technologies can help determine whether individuals in developing countries have access to the end products of university research.

AMSA URGES Universities to utilize the following Principles, suggested by the institutional ethos of universities, when making patenting and licensing decisions that have potential impacts on access to essential medicines and medical technologies worldwide:

• University research is intended to advance the common public good, a primary element of which is the advancement of health.
• Global public health concerns need to be an important part of patenting and licensing decisions.
• The success of patenting and licensing programs should be measured according to their impact upon public health.
• University intellectual property policies should be implemented in a manner supportive of developing countries' right to protect public health and, in particular, to promote access to medicines for all.
• Technology transfer to develop capacity in developing countries is an important part of universities' mandate to advance knowledge and the social good.

AMSA URGES Universities to consider different strategies to implement these Principles, including not patenting or allowing their licensees to patent in developing countries, and issuing non-exclusive licenses for developing country markets.

AMSA RECOGNIZES that changes in University practices, with regards to intellectual property, will require collective action and leadership amongst Universities world-wide. Henceforth, AMSA URGES Universities to act together to establish norms and implement strategies and best practices to promote access to essential medicines in developing countries.

The Center for Interdisciplinary Research on AIDS. Workshop Report: Access to Essential Medicines and University Research: Building Best Practices. Yale University, September 25, 2002.
Also available online at:
http://cira.med.yale.edu/whats_new/Essential%20meds,%20final%20report.doc