Benchmarking Progress in Tackling the Challenges of Intellectual Property, and Access to Medicines in Developing countries/Amelioration Des Criteres Permettant D'evaluer Les Solutions Aux Difficultes Pour Preserver a la Fois Les Droits De Propriete Intellectuelle et L'acces Aux Medicaments Pour Les Pays En developpement/Criterios Para Determinar Los Progresos De la Respuesta a Los Retos Que Plantea la Propiedad Intelectual

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Introduction

In January 2004 the Commission on Intellectual Property, Innovation and Public Health (CIPIH) (1) was established at WHO pursuant to the World Health Assembly (WHA) Resolution on Intellectual Property, Innovation and Public Health (Resolution WHA56.27) which requested WHO's Director-General to establish the terms of reference for a time-limited body to: "Collect data and proposals from different actors involved and produce an analysis of intellectual property rights, innovation, and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries." (2)

Resolution WHA56.27, signaled the emerging global consensus on the relationship between intellectual property rights and public health in accordance with, and partly building on the World Trade Organization's (WTO) Doha Declaration. (3) (Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health).

Resolution WHA56.27, however, acted beyond the confines of the intellectual property system focussing attention on eliminating the 10/90 gap, i.e. developed countries that account for nearly 90% of the global pharmaceutical sales represent only 10% of the 14 million or more deaths that occur globally every year due to infectious diseases, while developing countries which represent 90% of the 14 million deaths account for only 10% of the global pharmaceutical sales. (4) Thus the current system for innovation has failed to ensure that research and development (R&D) priorities reflect health needs in developing countries. Although non-communicable diseases now contribute to a large proportion of deaths in developing countries, the current challenge is primarily related to access to existing medicines as opposed to lack of relevant R&D. Also, since infectious diseases, unlike noncommunicable diseases, predominantly affect only developing countries the focus on infectious diseases and the 10/90 gap is justifiable.

In this regard, the work of the CIPIH represents considerable progress in tackling the intellectual property-related challenges to R&D, as well as accessibility of essential medicines, particularly those relevant for treating and managing diseases that disproportionately affect the populations of developing countries. The required action to address the interplay between intellectual property rights, innovation and public health was outlined fairly clearly in Resolution WHA56.27. The WHA in response to the 10/90 gap sought action at two levels. First, the WHA "Urged Member States to seek to establish conditions conducive to R&D that spur development of new medicines for diseases that affect developing countries"; and second, for the CIPIH (a time-limited body) to analyse intellectual property rights, innovation, and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products for diseases affecting developing countries.

There are two central issues with regard to diseases affecting developing countries. All countries need to take action to establish conducive conditions for R&D and rethink intellectual property rights and innovation approaches in the context of funding and incentives.

The work of the CIPIH, which is now completed, was mainly directed at the second issue though it also addressed important aspects of the first issue. However, the usefulness of the work of the CIPIH can only be assessed by follow-up. If there is no agreement about the value of the CIPIH findings and other similar reports in a situation where we have no objective criteria for thinking about value, then follow-up action will be very difficult, if not impossible.

There are two primary challenges regarding follow-up: (1) what is required to implement the findings of the CIPIH as well as continue research on these issues? …