Geneva, 21 May 2003 — The United States proposal asserts that strengthening intellectual property (IP) protection is the best way to stimulate investments in R&D. This assertion disregards mounting evidence to the contrary: the emerging global consensus that the current system of IP protection is failing to stimulate R&D for diseases of the poor. Of the 1,393 new drugs approved between 1975 and 1999, only 16 (or just over 1%) were specifically developed for tropical diseases and tuberculosis, diseases that account for 11.4% of the global disease burden.
Patents that ensure IP protection are part of a complex system that can motivate investment in R&D under certain circumstances, in particular when a profitable return on investment can be expected. However, patents will not stimulate neglected diseases R&D precisely because the people who suffer from neglected diseases do not have substantive purchasing power, and cannot constitute a profitable market.
In 2002, the UK government commissioned an independent report – the Commission on Intellectual Property Rights (CIPR) Report – which concluded that "[a]ll the evidence we have examined suggests that [IP] hardly plays any role at all [in stimulating R&D], except for those diseases where there is a large market in the developed world...The heart of the problem is the lack of market demand sufficient to induce the private sector to commit resources to R&D...[The] presence or absence of IP protection in developing countries is of at best secondary importance in generating incentives for research directed to diseases prevalent in developing countries." However, IP protection is clearly recognized as a barrier to access to existing medicines because it increases drug prices and hampers generic competition.
The proposals contained in this draft are based on an almost blind belief in the IP system – without regard for the reality for patients in desperate need of newer, more effective health technologies and access to existing essential medicines. In view of the HIV/AIDS crisis, and the massive problems expressed by many WHA delegates in guaranteeing equitable and sustainable access to affordable antiretroviral medicines, this text gives the impression that the US has lost touch with reality.
It is incomprehensible that the proposal makes no reference to the WTO Ministerial Declaration on the TRIPS Agreement and Public Health (Doha Declaration), no reference to the need to find an economically viable, workable solution to the Paragraph 6 (production for export) problem that will, consistent with the Doha Declaration, ensure access to medicines for all. The US proposal suggests that WHO should refer Member States to the WTO and WIPO for technical assistance, when countries have clearly and repeatedly indicated that they want WHO to play a much stronger role in order to ensure pro-public health national legislation.
We urge WHO Member States to reject this proposal and work towards a resolution that makes the health needs of people in developing countries the central focus.
Leaked Text of Draft US Resolution
The 56th World Health Assembly
Intellectual Property Rights, Innovation and Public Health
s/ Tommy Thompson
United States of America
Recognizing that innovation has fuelled much of the substantial progress in health care achieved during the last century,
Recognizing that innovative medicines, vaccines and diagnostics account for 40 percent of the increase in life expectancy achieved between 1986 and 2000
Further recognizing and affirming the important link between the progress of biomedical innovation and protection of intellectual property rights,
Understanding that intellectual property rights provide a critical incentive for innovation,
Further understanding that patents disclose new and useful inventions to the world that provide the basis for new research and development in the field of public health,
Acknowledging that the process of research, development and clinical testing required to bring safe and effective medicines to market is both expensive and lengthy,
Aware of the urgent need for increased and continued efforts to prevent the marketing, sales and use of substandard and counterfeit drugs in many countries,
Nothing that basic science spurs innovation and that private enterprises are the principal entities developing and brining innovative health technologies to market,
Mindful of the need to secure future development of medicines for HIV/AIDS, tuberculosis and malaria and other diseases of developing and developed countries by ensuring that a legal and regulatory environment conducive to successful innovation is created, fostered and maintained through the protection of patents and clinical test data within the framework of TRIPS -- including the flexibilities contained therein.
Concerned about the rapid redundancy of existing antimicrobial products through drug resistance, especially products for treating HIV/AIDS, tuberculosis, and malaria,
Noting the need to rapidly develop medicines, vaccines, and diagnostics for re-emerging and emerging diseases such as Severe Acute Respiratory Syndrome (SARS),
Deeply concerned that medicines for infectious diseases affecting the developing world are not being developed at an acceptable pace,
1. URGES Member States:
To take all appropriate measures, nationally and through cooperation, to promote the development of new and more effective preventative and therapeutic medications, including through implementation of patent and data protection, in accordance with applicable international law, including international agreements acceded to;
To cooperate with non-governmental organizations and private enterprises to strengthen infrastructures and share best practices to enhance biomedical research, innovation and product development in developing countries;
To take appropriate surveillance and enforcement action to prevent substandard and counterfeit drugs from entering the market;
To adopt appropriate measure to protect against the diversion to other countries of medicines, whether donated or provided under differential pricing mechanisms;
To establish conditions conducive to research and development through legislative, fiscal and regulator incentives to spur development of new medicines for diseases affecting developing countries such as tax and orphan medicines type incentives, examining possibilities for innovative approaches such transferable market exclusivity;
To work with developing counties to increase their ability to contribute to such research and development, including helping to create a climate of incentive and to develop the necessary regulatory incentives to spur development of new medicines for diseases affecting developing countries such as tax and orphan medicines type incentives, examining possibilities for innovative approaches such a s transferable market exclusivity;
To work with developing countries to increase their ability to contribute to such research and development, including helping to create a climate of incentive and to develop the necessary regulatory systems to support ethical and safe clinical trials To take steps to eliminate tariffs and internal taxes that constrain effective access to pharmaceutical product or other goods.
REQUEST the Director General:
To ensure that WHO policy remains supportive of biomedical innovation for both developing and developed countries;
To refer Member States to the WTO and WIPO to obtain assistance on how best to develop a national technology and innovation strategy including effective IPR systems that respond to public policy objectives including compliance with TRIPS requirements and flexibilities therein;
To encourage Member States in their efforts to remove tariffs and taxes and to eliminate excessive mark ups at the wholesale and retail levels in their countries for medicines, especially for HIV/AIDS, tuberculosis and malaria;
To develop, jointly with Members States, non governmental organizations, public funded research centers, and private sector innovators, strategies to stimulate the research and development of medicines where research gaps have been identified and to best match the health needs of developing countries;
To promote innovation in the field of public health, through encouraging respect for strong intellectual property rights,
To enhance public private partnerships that include private sector innovators as well as non-governmental organizations with recognized field experience in order to benefit from the unique expertise of these entities in research and development, as well as supply and delivery, of innovative medicines.