2004 Pan American Health Organization.... Curso Lideres en Salud Publica Internacional. Modulo Medicamentos, Comercio y Propiedad Intelectual. Washington DC. 19 Octubre 2010 Intellectual Property and public health. The accommodation of needs, rights and constraints. Jaume Vidal Associate Expert THR-EV Washington

2004 Pan American Health Organization Introduction Intellectual property and public health. General concepts. IP and pharmaceutical products. Constraints and opportunities. Recent developments on IP, Innovation and Public Health. National/Regional/Global levels. Road ahead. Intellectual property and public health. General concepts. IP and pharmaceutical products. Constraints and opportunities. Recent developments on IP, Innovation and Public Health. National/Regional/Global levels. Road ahead. CLSI Oct. 10

2004 Pan American Health Organization Intellectual property and public health. General concepts (I) International Legal Framework. Paris ( ) Berne ( ) ADPIC (1994) Evolution of Intellectual Property parallel to growing of global knowledge-centered market. Inclusion of Pharmaceutical products (and processes!) at later stage of other industrial products. Dynamic framework. Not written in stone Innovation, access and intellectual property. Colliding titans? International Legal Framework. Paris ( ) Berne ( ) ADPIC (1994) Evolution of Intellectual Property parallel to growing of global knowledge-centered market. Inclusion of Pharmaceutical products (and processes!) at later stage of other industrial products. Dynamic framework. Not written in stone Innovation, access and intellectual property. Colliding titans? CLSI Oct. 10

2004 Pan American Health Organization Intellectual property and public health. General concepts (II) Patent: Domestic attribution based upon national legislation (international binding conventions and treaties). Legal integration. Regulatory issues and other legal areas. Limited duration. Extendable… and revocable. Patent grants monopolistic rights for a limited period of time Patent: Domestic attribution based upon national legislation (international binding conventions and treaties). Legal integration. Regulatory issues and other legal areas. Limited duration. Extendable… and revocable. Patent grants monopolistic rights for a limited period of time CLSI Oct. 10

2004 Pan American Health Organization Public Health perspective on Intellectual Property Rights management The Public Health Perspective of Management of Intellectual Property Rights can be understood as the set of measures, actions and collaborations that originating from the health sector can facilitate access without constituting an obstacle to innovation. Taking properly into account eventual health implications of changes and amendments both in policy and legal frameworks of protection of intellectual property rights; including the use of flexibilities and regulatory exceptions The Public Health Perspective of Management of Intellectual Property Rights can be understood as the set of measures, actions and collaborations that originating from the health sector can facilitate access without constituting an obstacle to innovation. Taking properly into account eventual health implications of changes and amendments both in policy and legal frameworks of protection of intellectual property rights; including the use of flexibilities and regulatory exceptions CLSI Oct. 10

2004 Pan American Health Organization Constraints and opportunities. Monopolistic period. Ability to fix prices. Capacity to limit production. Obstacle to greater access? Flexibilities- ADPIC and Doha Declaration Parallel Imports Voluntary License Compulsory License Bolar Exception Paragraph 6 Mechanism (Art.31.bis). Monopolistic period. Ability to fix prices. Capacity to limit production. Obstacle to greater access? Flexibilities- ADPIC and Doha Declaration Parallel Imports Voluntary License Compulsory License Bolar Exception Paragraph 6 Mechanism (Art.31.bis). CLSI Oct. 10

2004 Pan American Health Organization Recent developments Use of flexibilities. Thailand. Brazil. Ecuador Consolidation of a Public Health discussion forum CIPIPH. EWG. CEWG. Global strategy and Plan of Action on Public Health, Intellectual Property and Innovation (GSPA)/ Regional Perspective. Regional contribution to global discussions and sub-regional initiatives (UNASUR) Use of flexibilities. Thailand. Brazil. Ecuador Consolidation of a Public Health discussion forum CIPIPH. EWG. CEWG. Global strategy and Plan of Action on Public Health, Intellectual Property and Innovation (GSPA)/ Regional Perspective. Regional contribution to global discussions and sub-regional initiatives (UNASUR) CLSI Oct. 10

2004 Pan American Health Organization Grupo Consultivo de Expertos sobre Financiación y Desarrollo Resolución Establecimiento de un grupo consultivo de expertos en investigación y desarrollo: financiación y coordinación (AMS 63.28) la OPS invitó a los Estados Miembros a que propusieran candidatos para formar parte del Grupo Consultivo de expertos en Investigación y Desarrollo: Financiamiento y Coordinación (CEWG) 13 expertos/as, 10 hombres y 3 mujeres, fueron propuestos por 9 países y una organización subregional (Unión de Naciones sudamericanas, UNASUR) representando la pluralidad del continente, con una variedad de conocimientos y experiencia qué incluye investigación científica, gestión de derechos de propiedad intelectual, economía de innovación, bioquímica y otros campos de trabajo La lista de los candidatos se remitirá formalmente a la Directora General de la OMS para la acción final, en la cual OPS se mantendrá involucrada. CLSI Oct. 10

2004 Pan American Health Organization Evolution of concepts and transformation of landscape IP rules can not be conceived as a fit-for-all model. Need for different approaches. New spaces of discussions have been created following States concerns involving trade requirements and public health needs. Growing consensus around the need to guarantee access while promoting innovation and respecting intellectual property. Innovation as a continuous cycle. 3D. IP rules can not be conceived as a fit-for-all model. Need for different approaches. New spaces of discussions have been created following States concerns involving trade requirements and public health needs. Growing consensus around the need to guarantee access while promoting innovation and respecting intellectual property. Innovation as a continuous cycle. 3D. CLSI Oct. 10

2004 Pan American Health Organization Technical cooperation Management of Intellectual Property Rights as a Public Health Tool Main Goal : Enhance the use and implementation of both TRIPS flexibilities and FTA (negotiation/implementation) in a legal and institutional coherent framework. Appropriation of the Doha declaration at the national, sub-regional and regional levels. Secondary Goals: Dissemination of information. From the region and on the region. Best practices sharing. Inter-institutional cooperation Empowerment and self responsibility Sub-regional leaderships Main Goal : Enhance the use and implementation of both TRIPS flexibilities and FTA (negotiation/implementation) in a legal and institutional coherent framework. Appropriation of the Doha declaration at the national, sub-regional and regional levels. Secondary Goals: Dissemination of information. From the region and on the region. Best practices sharing. Inter-institutional cooperation Empowerment and self responsibility Sub-regional leaderships CLSI Oct. 10

2004 Pan American Health Organization ECONMED Lista electrónica bilingüe (ESP/ENG) moderada y coordinada por OPS sobre regulación legal y económica del medicamento. Parte de las conclusiones en el primer seminario internacional regulación económica del medicamento (Brasilia Noviembre 09) y parte de la Perspectiva Regional de la EGPA. Objetivo construir espacios de dialogo y generar oportunidades para el intercambio de información entre actores nacionales a escala regional y sub- regional sobre precios de medicamentos, políticas farmacéuticas, evaluación tecnológica de nuevos productos sanitarios. ´Estrategia para la diseminación de informes, estudios, artículos y desarrollos sobre políticas farmacéuticas/sanitarias en la región. Incluyendo avances en la implementación de la EGPA por parte de OPS Flujo de información basado en las contribuciones de los/as participantes (socializando dudas/brindando información). En la actualidad 215 participantes en 25 países en Agencias reguladoras, Ministerios de Salud, Academia y sociedad civil. Para participar CLSI Oct. 10

2004 Pan American Health Organization Public Health and Intellectual Property. Never again without us! Thanks for your attention paho.org/econmed Public Health and Intellectual Property. Never again without us! Thanks for your attention paho.org/econmed CLSI Oct. 10