Although scientific and technological innovation has contributed to significant improvements in health conditions, health crises, relating, in particular, to HIV/AIDS, malaria, tuberculosis, and, most recently, avian influenza, continue to create major problems in many parts of the world. In various national and international fora, solutions are sought in respect of the role of patents in pharmaceutical innovation and fair and affordable access to health care.
The patent system is designed to promote innovation and, at the same time, offer a mechanism ensuring that the fruits of that innovation are accessible to society. In the contexts of public health, the challenge for policy makers is to find an optimal balance between the rights of patent owners, who provide technological innovations to improve health conditions, and the needs of the general public.
In general, the development of new drugs requires heavy investment and long-term research, coupled with expensive clinical trials and regulatory approval procedures. The exclusive right conferred by a patent is one of the incentives for developers of new drugs to make the necessary investments into that research. Clearing issues, such as ownership and licensing policies for innovation derived from public research, would contribute to the promotion of a more effective deployment of public funds and public R&D programs. At the same time, the patent system also contributes to society by making available patent information, which is freely available to other researchers to further improve existing technologies. With a view to facilitating commercialization and ensuring access to patented technologies, the patent system is primarily based on conferring an exclusive right, in conjunction with a voluntary licensing mechanism. However, taking into account the public interest and policy objectives beyond the patent system, there are a number of flexible mechanisms built in the patent system, such as the possibility of issuing compulsory licenses, research exceptions and parallel imports.
On the other hand, some consider that the current patent system does not adequately address public health crises. It is argued that the commercial incentives provided by the patent system are not sufficient to ensure the development of new products in certain areas, for example, in respect of neglected diseases, and that patent rights, which are enforced on the basis of commercial and market-based considerations, prevent access to, or increase prices of, essential medicines. Some criticize that the safeguard mechanisms built in the patent system, such as compulsory licenses or research exceptions, are not sufficiently broad to cover existing needs. Further, the number and, at times, the broad scope of patents granted in the field of early fundamental research have raised concerns about patent thickets and royalty stacking. In particular, reach-through claims in respect of research tools are considered a potential obstacle to further research and development.
World Intellectual Property Organization
- Intellectual Property and Public Health
- Report on the International Patent System
- Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights
- Open Forum on the Draft Substantive Patent Law Treaty, March 1 to 3, 2006
- Striking a Balance: Patents and Access to Drugs and Health Care [PDF]
- Bibliographies of academic papers on the WIPO Worldwide Academy web site
Other International Organizations
- European Commission
- Commission communication on parallel importation of proprietary medicinal products for which marketing authorizations have already been granted, December 30, 2003 [COM(2003) 839 final] [PDF]
- Production of patented medicines for export to countries in need
- Access to essential medicines
- Organisation for Economic Co-operation and Development (OECD)
- South Centre
- World Health Organization (WHO)
- Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, December 4-8, 2006
- Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH)
- Combating Counterfeit Drugs: Building Effective International Collaboration, February 16 to 18, 2006
- World Trade Organization (WTO)
- The World Bank Group
- United Nations Conference on Trade and Development (UNCTAD)
- Q94: Implementation of Paragraph 6 of the Doha Declaration on TRIPS and Public Health (September 2004)
- Center for Medicines in the Public Interest
- Knowledge Ecology International (KEI)
- Essential Inventions Inc.
- European Generic Medicines Association (EGA)
- Health Action International (HAI)
- International Chamber of Commerce (ICC)
- International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
- International Intellectual Property Institute (IIPI)
- Médecins Sans Frontières (MSF)
- National Research Council of the National Academies
- Reaping the Benefits of Genomic and Protemic Research: Intellectual Property Rights, Innovation, and Public Health, Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation
- Oxfam International
- Quaker United Nations Office (QUNO)
- 3D -> Trade - Human Rights - Equitable Economy