2004 Pan American Health Organization.... Curso Lideres en Salud Publica Internacional (CLSPI) OPS-Washington Octubre Intellectual Property and public health. The accommodation of needs, rights and constraints. Jaume Vidal Associate Expert HHS-MT Washington

2004 Pan American Health Organization Introduction How did Intellectual property became a factor in public health policy making decisions? How intellectual property rules might impact on public health policies? It is possible to accommodate public health demands with trade priorities and economic constraints? How has the interpretation of intellectual property rules evolved in the last 15 years? Innovation, access and intellectual property. Colliding titans? How did Intellectual property became a factor in public health policy making decisions? How intellectual property rules might impact on public health policies? It is possible to accommodate public health demands with trade priorities and economic constraints? How has the interpretation of intellectual property rules evolved in the last 15 years? Innovation, access and intellectual property. Colliding titans?

2004 Pan American Health Organization Intellectual Property and access to drugs. Patents awarded on a national basis. Most countries excluded pharmaceutical products of the patentability scope. Inclusion of pharmaceutical products and other sanitary products in the Trade Related Aspects of Intellectual Property (TRIPS). Since 2001 intellectual property has becomme a matter of interest for public health decision makers and an issue of controversy among various stakeholders Report of the CIPIH consolidates WHO position on the debate and discussions. IGWG. Two-year negotiations to achieve a global Strategy and Plan of Action on Public Helalth, Innovation and Intellectual Property. Patents awarded on a national basis. Most countries excluded pharmaceutical products of the patentability scope. Inclusion of pharmaceutical products and other sanitary products in the Trade Related Aspects of Intellectual Property (TRIPS). Since 2001 intellectual property has becomme a matter of interest for public health decision makers and an issue of controversy among various stakeholders Report of the CIPIH consolidates WHO position on the debate and discussions. IGWG. Two-year negotiations to achieve a global Strategy and Plan of Action on Public Helalth, Innovation and Intellectual Property. CLSI Oct. 10

2004 Pan American Health Organization Impact of IP rules on Public Health Patent protection. Guarantees monopolistic privileges to patent holder (innovator) shaping prices and competition policies. Consolidates an R&D landscape determined by eventual market revenues not sanitary needs. Trade and economic decisions might affect public health policy making decisions regardless public health officials input or participation Set of rules growingly complex and interrelated affecting different public health sectors (regulatory/health systems/…) Patent protection. Guarantees monopolistic privileges to patent holder (innovator) shaping prices and competition policies. Consolidates an R&D landscape determined by eventual market revenues not sanitary needs. Trade and economic decisions might affect public health policy making decisions regardless public health officials input or participation Set of rules growingly complex and interrelated affecting different public health sectors (regulatory/health systems/…) CLSI Oct. 10

2004 Pan American Health Organization Trade and health. Constraints and challenges. Doha declaration. Materialization of concerns by developing and least developed countries on the impact of TRIPS rules. Discussions from paragraph 6 of the Doha declaration embodies the contradictions and concerns raising from the situation of countries with no pharmaceutical manufacturing capabilities (Mechanism para. 6) WTO fora sidelidelined in favour of bilateral/sub- regional/regional agreements. Flexibilities often not included or explicitly rejected. Trade negotiations transformed into a bargain between strategic priorirites and goals. Publich Health one of them. Doha declaration. Materialization of concerns by developing and least developed countries on the impact of TRIPS rules. Discussions from paragraph 6 of the Doha declaration embodies the contradictions and concerns raising from the situation of countries with no pharmaceutical manufacturing capabilities (Mechanism para. 6) WTO fora sidelidelined in favour of bilateral/sub- regional/regional agreements. Flexibilities often not included or explicitly rejected. Trade negotiations transformed into a bargain between strategic priorirites and goals. Publich Health one of them. 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 instittuional coherent frameworl. Appropiation 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. Interinstitutional 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 instittuional coherent frameworl. Appropiation 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. Interinstitutional cooperation Empowerment and self responsibility Sub-regional leaderships CLSI Oct. 10

2004 Pan American Health Organization Mapa Conceptual. Legal e Institucional (I) Objetivos generales Compilar de forma coherente el marco legal y aparto regulatorio vigente en el ámbito de la gestión de DPI y Salud Publica que incide en el acceso a medicamentos para la población de los Estados de América Latina. Sugerir posibles reformas, mejoras y modificaciones en la normativa legal y regulatoria que permita una reducción de gasto público y una mejora de los índices de eficiencia y efectividad de las acciones públicas en el ámbito del acceso a medicamentos y tecnologías sanitarias. Identificar los diferentes agentes con incidencia (directa e indirecta) en el acceso a medicamentos y tecnologías sanitarias. Así como sus interacciones (coordinación, subordinación y supervisión) Establecer patrones comparables, tanto en el marco legal como en el ordenamiento institucional entre países y agrupaciones sub.-regionales.

2004 Pan American Health Organization Mapa Conceptual. Legal e Institucional (II) Objetivos específicos-secundarios Establecer un diagnostico que permita establecer programas y acciones de apoyo técnico en el medio y largo plazo. Identificar un conjunto de individualidades dentro de las instituciones estatales que puedan ser como recursos multiplicadoras. Fortalecer las capacidades de las autoridades publicas del sector salud en la comprensión y utilización de los mecanismos de protección de la PI, tanto en el ámbito nacional como sub-regional y regional Ofrecer una herramienta de coordinación para agencias técnicas especializadas, donantes y organizaciones no gubernamentales activas en la capacitación de funcionarios/as públicos Crear una base de datos legal/institucional que sea fácilmente actualizable,sostenible y combinable otros proyectos de diseminación y capacitación.

2004 Pan American Health Organization Aplicación y gestión de DPI como factor estratégico de políticas sanitarias Proveer apoyo técnico, incluyendo acompañamiento institucional, a procesos de reforma normativa, y promover la aplicación y gestión del régimen de protección de propiedad intelectual desde una perspectiva de salud publica a todos los niveles haciendo uso de las disposiciones y flexibilidades contenidas en el acuerdo ADPIC para contribuir a la innovación y promoción de salud pública. Apoyar la producción e introducción de genéricos, a través de políticas como la “cláusula bolar” en implementación del elemento 6.3 f de la EGPA. Dar seguimiento a las repercusiones que pudieran tener los derechos de propiedad intelectual sobre el desarrollo de tecnologías sanitarias. Introducir y recalcar la importancia de la gestión de DPI de productos biotecnológicos y la regulación de los mismos desde una perspectiva de salud publica.

2004 Pan American Health Organization Salud Pública y Propiedad Intelectual. Nunca más sin nosotros! Muchas gracias