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- W2000587495 abstract "The Commission on Intellectual Property, Innovation and Public Health (CIPIH) was given the task of reviewing existing research and development (R&D) efforts, examining the role of intellectual property (IP) in stimulating innovation, and to make concrete proposals for action by national and international stakeholders, both public and private, to encourage R&D for diseases that disproportionately affect developing The Commission focussed exclusively on the application of IP to pharmaceuticals, and did not address the public health implications of copyright law, or genomic patents, which are covered elsewhere in this issue. The report (1) presents a wealth of evidence and analysis in support of the view that the current system of drug development is fundamentally flawed and leaves huge health needs unmet, because of its reliance on patents and commercial incentives for the priority-setting and financing of medical R&D. The report calls for improved mechanisms that promote research that responds to patients' needs, and that ensure access to innovations for all. However, it fails to provide alternatives and concrete new proposals. Many of the data presented in the report illustrate the urgent need for change. I will discuss some of the Commissions more salient conclusions, on intellectual property rights, international trade, access to medicines, and global frameworks. Intellectual property rights The report recognizes that IP is a means and not an end. It concludes that IP is irrelevant in stimulating innovation in developing countries where markets have limited purchasing power, confirming the same finding by the UK Commission on Intellectual Property Rights in September 2002. (2) The report says: There is no evidence that the implementation of the TRIPS Agreement in developing countries will significantly boost R&D in pharmaceuticals on Type II and particularly Type III diseases. Insufficient market incentives are the decisive factor. (1) The report also points out that even in regions with strong IP protection, innovation results are declining. In the USA for example, medical R&D spending has doubled between 1995 and 2002, while in the same period, the registration of new products has declined, as well as the therapeutic significance of products reaching the market. In other words, although worldwide patent standards have been strengthened since 1995 as a result of the TRIPS Agreement, and global spending on medical R&D has increased, pharmaceutical innovation has declined both in quantity and quality. Furthermore, the report draws attention to the fact that patents can actually hamper innovation, by blocking follow-on research or access to research tools. The CIPIH identifies patent pools, compulsory licensing, and the application for research exemptions as potential solutions to overcome barriers caused by patenting. International trade and competition The report warns against trade agreements that include so-called measures. The Commission concludes: Bilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries. (Recommendation 4.21). (1) Data is one example of a TRIPS-plus provision often included in bilateral trade agreements with the US. The report offers much awaited clarity on issues related to the protection of data submitted by companies to obtain marketing approval for new medicines. WTO Members are obliged to protect undisclosed test or other data against unfair commercial use. But this does not imply property rights, nor a right to prevent others from using the data, or from relying on the data for the marketing approval of the same product by a third party--except where unfair, dishonest commercial practices are involved. Developing countries have been pressured during bilateral talks to accept TRIPS-plus provisions including data exclusivity rules that would delay the introduction of generic medicines. …" @default.
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- W2000587495 date "2006-05-01" @default.
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- W2000587495 title "Report of the Commission on Intellectual Property Rights, Innovation and Public Health: a call to governments" @default.
- W2000587495 doi "https://doi.org/10.2471/blt.06.032391" @default.
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