175935 Humanitarian Licensing in Universities: Circumventing the Politics of International Trade Enforcement

Tuesday, October 28, 2008: 9:00 AM

Branden Pfefferkorn, MD, MPH , University of Wisconsin School of Medicine and Public Health, Madison, WI
Universities play a pivotal role as innovators of new pharmaceutical products. The model by which these technologies are developed and eventually distributed is based on the Bayh-Dole Act, passed by Congress in 1980, and influenced by international instruments such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and the Doha Declaration. However, universities and individual technology transfer offices (TTO's) through their membership in organizations such as the Association of University Technology Managers (AUTM) and the Biotechnology Industry Organization (BIO), also mold these frameworks.

While many TTO's at universities espouse missions to widely disseminate the fruits of their research, economic forces, concerns of protecting intellectual property rights and the organizations in which they hold membership, constrict these missions. AUTM, for example, advocates for a restrictive intellectual property framework while BIO advocates for policies seen by health advocates as harmful to the citizens of low- and middle-income (LMI) countries.

The Wisconsin Alumni Research Foundation (WARF) is the oldest technology transfer office in the nation and supports research from the University of Wisconsin. Through its involvement in AUTM and BIO, WARF has the as yet unrealized opportunity to advocate for proactive solutions, such as Humanitarian Licensing (HL), that would help to ensure access to university pharmaceutical technologies, particularly in LMI nations.

Adoption of innovative solutions such as HL by universities would: 1) ensure access prospectively rather than requiring case-by-case activism by advocacy groups and; 2) sidestep larger barriers to access created by organizations such as BIO.

Learning Objectives:
1. Define key terms in intellectual property law, including the Bayh-Dole Act, TRIPS agreement, Doha Declaration, Humanitarian Licensing, the Stanford White Paper and 301 Watch List. 2. Discuss the role universities, through their technology transfer offices, can play in developing policies that ensure global access to medicines developed by their researchers. 3. Apply the example of the Wisconsin Alumni Research Foundation to universities more broadly 4. Identify ways universities can contribute to influencing national and international policies.

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have been actively involved in learning about these topics as a member of the national coordinating committee for Universities Allied for Essential Medicines. I have also studied these topics in elective courses as part of my MD degree.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.