Programs: Science and Policy
Humanitarian Licensing Working Group
In July 2004, SIPPI established a working group to develop practices for humanitarian licensing of essential biotechnologies.
Increasing intellectual property protections covering both research inputs and outputs have made the development of pharmaceuticals and agricultural products appropriate to the needs of developing regions more difficult, and have restricted the transfer of existing technologies to less developed countries. Overcoming these problems will require novel approaches for managing intellectual property, approaches which reconcile greater access to research inputs and new technologies with proprietors' ability to maintain control and receive a return on their investment in more profitable markets. This may be accomplished through developing humanitarian licensing practices.
A humanitarian license reservation is a provision in a license whereby inventors and technology suppliers protect in advance the possibility of sharing their proprietary technology with third parties for the benefit of people in need. This enables people who are unable to pay market prices to benefit from increased access to the technology, typically through a separate later license with a non-profit, public-sector, or developing-world entity, either public or private.
Many organizations have already made humanitarian needs a priority in their licensing activities. However, the lack of standardized practices for humanitarian licensing can complicate negotiations and discourage some institutions from pursuing it.
Exploring a Humanitarian Use Exemption to Intellectual Property Protections outlines issues involved in developing a humanitarian use exemption. This short report, prepared entirely by SIPPI, draws on presentations and discussions from the first working group meeting, held July 13-14, 2004.
Journal Article: "Facilitating humanitarian access to pharmaceutical and agricultural innovation." This article, published by SIPPI and based on the activities of the working group, examines intellectual property approaches that can assist low-income countries and members of disadvantaged groups in accessing health and agricultural innovations.
Nalini Anand, Fogarty International Center, NIH
Usha Balakrishnan, University of Iowa
John Barton, Stanford Law School
Alan Bennett, University of California, Davis; PIPRA
Steven Caltrider, Eli Lilly and Company
Cathy Garner, MIHR
Robert Horsch, Monsanto Company
Amy Kapczynski, Yale University
Anatole Krattiger, Arizona State University; BioDevelopments, LLC
Richard Mahoney, Arizona State University; MIHR
Duncan Matthews, Queen Mary Intellectual Property Institute, University of London
Luis Salicrup, Office of Technology Transfer, NIH
Joelle Tanguy, Global Alliance for TB Drug Development
Jacob Werksman, Rockefeller Foundation
The working group finished a statement of principles and practices for humanitarian licensing. SIPPI sought comments from a variety of stakeholder groups. SIPPI also compiled case studies illustrating situations in which organizations have used humanitarian licensing effectively, culminating in "Facilitating humanitarian access to pharmaceutical and agricultural innovation."
Atkinson RC, RN Beachy, G Conway, et. al. 2003. Public Sector Collaboration for Agricultural IP Management. Science 301: 174-175.
Commission on Intellectual Property Rights. 2002. Integrating Intellectual Property Rights and Development Policy.
Grace, Cheri. 2004. The Effect of Changing Intellectual Property on Pharmaceutical Industry Prospects in India and China: Considerations for Access to Medicines. DFID Health Systems Resource Centre.
Graff G and D Zilberman. 2001. Towards and Intellectual Property Clearinghouse for Ag-Biotechnology. IP Strategy Today. No. 3-2001.
Kapczynski A, ET Crone, MH Meyerson. 2003. Global Health and University Patents. CIRA Notes, Yale Center for Interdisciplinary Research on AIDS 3(2).
Kapczynski, Amy. 2003. Access to Essential Medicines and University Research: Building Best Practices.
Krattiger, Anatole. Financing the Bioindustry and Facilitating Technology Transfer. 2004. IP Strategy Today. No. 8-2004.
Matthews, Duncan. 2004. WTO Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: A Solution to the Access to Essential Medicines Problem?. JIEL 7(1). 73-107. (Abstract Only)
NIH. Best Practices for the Licensing of Genomic Inventions: Notices of Proposed Best Practices for the Licensing of Genomic Inventions; Request for Comments. Federal Register Nov. 19, 2004.
Nottenburg C, PG Pardey, BD Wright. 2003. Accessing Other People's Technology. IFPRI Brief 4.
Pardey PG, BD Wright, C Nottenburg, E Binenbaum, P Zambrano. 2003. Intellectual Property and Developing Countries: Freedom to Operate in Agricultural Biotechnoloy. IFPRI Brief 3. /biotechbr3.pdf
Taubman, Anthony. 2004. Public-Private Management of Intellectual Property for Public Health Outcomes in the Developing World: The Lessons of Access Conditions in Research and Development Agreements. Geneva: The Initiative on Public-Private Partnerships for Health.
Collection of Publications by MIHR (Centre for the Management of Intellectual Property for Health Research and Development).
The following publications are available from the MIHR website:
- C Gardner and C Garner. 2004. Technology Licensing to Nontraditional Partners
- L Salicrup et. al. 2004. Developing Health R&D Systems: Partnerships for Capacity Building in International Technology Transfer.
- C Garner and R Harris . 2004. Africa Programme for Health Innovation (APHI): A Joint Initiative of MIHR and the Medical Research Council, South Africa.
- R Mahoney (ed). 2003. MIHR Best Practice Manual
- MIHR Overview. 2002.
- MIHR Strategic Plan (2002 - 2006)
- First International Meeting for the Management of IP in Health R and D: Italy, Bellagio .2001.
- Management of Intellectual Property in Health R&D: An Interim Report and Discussion Document. 2001.
- Review of findings from survey of research institutions in developing countries. 2001.
- Management of IPR for Research in Health: MIHR Discussion Paper. 2001.
WTO TRIPS Agreement
TRIPS Section 5, Patents
WTO Decision: Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, August 30, 2003.