Acceso a Medicamentos Esenciales: Perspectiva regional . . Acceso a Medicamentos Esenciales: Perspectiva regional President of the Subcommittee on Planning and Programming, distinguished Members of the Subcommittee, members of the PAHO Secretariat….. My name is James Fitzgerald and I am Regional Advisor in Health Supplies Management Systems, working in the Unit of Essential Medicines, Vaccines and Health Technologies, it self located in the Area of Technology and Health Services Delivery. This afternoon, I have the pleasure in presenting to the Subcommittee provisional agenda item no. 7, Access to Essential Public Health Supplies. Presentación en Seminario Internacional: Propiedad Intelectual y Acceso a Medicamentos, Lima-Perú, Julio 5 – 7 2004

Acciones llevadas a cabo por OPS Reunión del 133avo Comité Ejecutivo, Septiembre 2003: Se resuelve considerar el tema acceso a medicamentos en el 38 avo Subcomité de Planeamiento y Programación. 38 avo Subcomité de Planeamiento y Programación, Marzo 2004, se presenta el tema y se recomienda ser llevado al 45avo Consejo Directivo. Taller en Nicaragua Grupo de trabajo en Acceso a Medicamentos, Washington DC Reunión del 134avo Comité Ejecutivo, Junio 2004, se aprueba el documento y resoluciones para el 45avo Consejo Directivo. The third line of action proposed is in Supply Management. We have little information with regard to the characteristics of the supply management systems in operation in countries throughout the region, their respective strengths and weakness. We need to map and assess the systems and examine the lessons that have been learnt in the development of centralized or decentralized systems. This need has become all the more apparent given the major emphasis that financing sources are placing in commodity supply management, including the Global Fund, PEPFAR, the World Bank and the IDB, in support of priority health programs, and in particular HIV/AIDS, TB and malaria. The importance of support is further highlighted in framework WHO and partnership initiatives such as the 3 by 5, Roll Back Malaria and Stop TB. Pillar 3 of the 3 by 5 Initiative specifically speaks to the development of systems for the effective, reliable supply of medicines, diagnostics and other commodities. Improved capacity in the definition of the supply model, planning and programming of supplies, as well as their management and distribution will facilitate the continued availability of essential products and the delivery of comprehensive care, reduce ever increasing multi-drug resistance, and build sustainability in the response of the health system.

El marco para el tema acceso Selección POLITICAS ACCESO REGULACION Financiamiento Precios The conceptual framework for presenting the determinants of access can be viewed in a number of ways. Irrespective of the preferred model, Access to Essential Public Health Supplies will depend on choices made in the selection of products, price and factors governing pricing, the supply management of commodities, and the availability of adequate financing, as well as the financing system. We would however be limiting our analysis and understanding of access if we considered that these were the only factors governing the discussion. Indeed the options and decisions available in each of these areas are often guided and directed by options and decisions at other levels, specifically in the policy development process, the regulation of the sector, standards of quality, and the rational use of the product. In addition we cannot ignore the impact of global, regional and national economies, that ultimately influence the amount of resources that can be brought to bear in tackling the problem of inequitable access to public health supplies, nor can we ignore the impact of market conditions that may directly or indirectly affect the supply of available products on the market. CALIDAD USO RACIONAL Gestión de Suministros

Líneas estratégicas de la OPS en el tema Acceso a Medicamentos Políticas de Genéricos coherentes Estrategias para la Contención de Costos Sistemas de Suministro Mecanismos de Compra The strategic lines presented in the WHO Medicines policy 2004 – 2007 available on the WHO website as a working draft, will follow the four principle areas of developed and implemented with some degree of success during the implementation cycle 2000 – 2003. These areas are, Policy, Quality and Safety, Access and Rational Use. Building on the elements of the WHO proposal outlined for Access, and adapting the strategy to the regional context, the document being put forward here for the consideration of the Subcommittee proposes that four principal lines of work are developed at the regional level. Within the context of the strengthening of medicines policy in the region, the development and support to the implementation of coherent generic medicines policy; the assessment and development of cost containment strategies promoting access to essential public health supplies, technical support in the strengthening of national and regional commodity supply mechanisms, and the development of capacity in procurement of supplies at the national level as well as through regional procurement mechanisms.

Estrategias para lograr un Mercado maduro de Genéricos Estrategias nacionales de Genéricos Legislación y regulación Garantía de calidad Aceptabilidad de profesionales y público Incentivos económicos Porcentaje de las nuevas prescripciones en USA However the development of coherent generic medicines policies and their implementation in the market place are not without challenge. It is important for example to arrive at a consensus and understanding of what we mean by the term generic, and thereafter to develop appropriate legislation and regulations. The quality assurance system must ensure that the quality standards conform with those presented in national legislation, and that national authorities have the appropriate tools to assess the quality of products. Additionally, the system must ensure that manufacturers conform to the requirements of GMP, and that wholesalers and other points of distribution ensure that the quality of the product is undermined within the supply chain. Public acceptance of generics remains key to the success of a generics policy, and can only be built by a coalition of partners from the public and private sector. Finally, governments can develop a framework of economic incentives to promote the manufacture, registration, prescription and use of generics. In its support through Pan American Network for Drug Regulatory Harmonization, PAHO remains well placed to assist countries in the regulation of generic medicines. The work being directed by this network can be complemented by other areas of work, in exchanges between countries in the development and implementation of policy, with focus on acceptance and incentives to promote the rational use. Fuente: OMS, Rockefeller

Contención de Costos Entender como se fijan los precios Opciones de licitaciones Negociaciones Control de Precios Opciones regulatorias de Propiedad Intelectual provistas por ADPIC Licencias Voluntarias / Obligatorias Importaciones paralelas Protección de la Información Monitoreo de los impactos de los Acuerdos Globales, Regionales y Bilaterales de Comercio sobre Acceso y Precios The term cost containment is a relatively new term that is being applied for the most part, to well established processes. Numerous studies have shown that the most effective method of reducing costs of medicines and public health supplies is through the promotion of competition. In order to promote competition, it is important that those who are involved in the regulation and procurement of products have adequate information available to them on factors governing competition, including pricing information, an understanding of factors that influence price, tendering methodologies, as well as options in price negotiation. In addition TRIPS provides for a number of options in Intellectual Property Regulation that can facilitate access to an increased number of sources of medicines and supplies. As countries move towards January 2005 deadline and introduce legislation that conforms to the requirements of TRIPS, it will be important to develop the know-how and capacity in monitoring the impact of this global trade agreement, as well as other multi-lateral and bilateral trade agreements in the region, on access to medicines and prices

Ejemplo de Contención de Costos: Resultados de las negociaciones de Precios de ARVs por los países de la Comunidad Andina As just one example of cost containment in the region, we consider the price reductions achieved by the Andean countries, and Argentina, Mexico, Paraguay and Uruguay during regional Antiretroviral price negotiations in Lima Peru, June 2003. The negotiation which was based on principles of prequalification of source, and regional price, resulted in reductions in the order of 30 – 92%, from US$ 1,000 to US$ 400 per patient per year for the first line regimen AZT/3TC + NVP, and more significantly from a US$ 5,000 to US$ 700 using AZT/3TC + EFV. Based on estimations determined by the countries participating in this meeting, the cost reductions achieved would permit the provision of ARV treatment to an additional 150,000 persons living with HIV/AIDS in the region. REMSAA, Junio 2003, ORAS/OPS

Gestión de Suministros Mapeo de los Sistemas Por fuente de los recursos Por función (selección, financiamiento, compra, gestión, distribución) Herramientas de Planificación y Programación Capacitación en Gestión de Insumos Sostenibilidad The third line of action proposed is in Supply Management. We have little information with regard to the characteristics of the supply management systems in operation in countries throughout the region, their respective strengths and weakness. We need to map and assess the systems and examine the lessons that have been learnt in the development of centralized or decentralized systems. This need has become all the more apparent given the major emphasis that financing sources are placing in commodity supply management, including the Global Fund, PEPFAR, the World Bank and the IDB, in support of priority health programs, and in particular HIV/AIDS, TB and malaria. The importance of support is further highlighted in framework WHO and partnership initiatives such as the 3 by 5, Roll Back Malaria and Stop TB. Pillar 3 of the 3 by 5 Initiative specifically speaks to the development of systems for the effective, reliable supply of medicines, diagnostics and other commodities. Improved capacity in the definition of the supply model, planning and programming of supplies, as well as their management and distribution will facilitate the continued availability of essential products and the delivery of comprehensive care, reduce ever increasing multi-drug resistance, and build sustainability in the response of the health system.

Mecanismos de Compra Priorizar las necesidades de los países vs los requerimientos de las agencias financiadoras (PEPFAR, GFATM, Banco Mundial, BID) Opciones de fuentes de productos Precalificación y registro Opciones para compras consolidadastions in pooled procurement Opciones para compras via OPS (Fondo Rotatorio, Fondo Estratégico) Within the supply management system, the procurement of essential public health supplies is considered to warrant special consideration. With the multiple actors bringing resources to bear in region, there is a need to maintain a country focus, prioritizing the needs and requirements of the country as opposed to the obligations (either in the sourcing of medicines, procurement regulations, and reporting requirements) of the finance agency. Information on sourcing options for key supplies in the area of HIV/AIDS, TB and malaria remains an essential tool to guide the procurement process. Principles of prequalification or suppliers should be promoted to facilitate the procurement and product registration process, and options in pooling procurement within countries or throughout the region should be examined in order to achieve economies in scale, harmonize quality criteria in source selection, develop capacity in planning and programming, promote the use of supplies. The program of work also proposes to review the experiences of the PAHO Revolving Fund for Vaccine Procurement, or the EPI Fund, and take lessons learnt in the development of this Fund with a view to applying them in the development of other procurement mechanisms including the PAHO Strategic Fund.

Fondo Rotatorio de la OPS para Vacunas 1979 2002 El Consejo Directivo de la OPS establece el Fondo Fondo capitalizado con US$ 1 millón 19 países firman acuerdos y se realizan las primeras compras para 5 vacunas 35 países de las Américas participan > US$ 145 millones en órdenes anuales Capital del Fondo: US$ 24 millones Los contratos incluyen 12 vacunas The EPI Revolving Fund has come along way in the 25 years that it has been in operation. In 1979 the Fund was capitalized to the value of US$ 1 million dollars and 19 countries participated in procurement for 5 vaccines. 25 years later, 35 countries are participating in the Fund, which is capitalized to the value of 24 million dollars and currently purchasing 12 vaccines. The EPI Revolving Fund has contributed significantly to the achievement of priority objectives in immunization in the Americas, by supporting countries in commodity procurement, supply and use, as well as in the support systems required to ensure these tasks.

Fondo Estratégico de la OPS 2000 2004 Establecido por el Director con invitación formal a los países Un mecanismo de compra en apoyo a los países en la gestión de insumos de salud pública precalificados para TB, HIV-SIDA y malaria 12 Países han firmado acuerdos para participar >US$ 14 millones en órdenes de compras para tres países Revisión del marco estratégico del Fondo a través de los Cuerpos Directivos y Grupo de Trabajo By contrast the PAHO Strategic Fund, which was established to support countries in the procurement and management of HIV, TB and malaria has been in operation for 4 years and although 11 countries have signed participation agreements in the Fund, it has only been used by a small number of countries. The Strategic Fund is considered to remain an important option for countries in the region in the procurement of supplies in HIV/AIDS TB and Malaria. Its objectives are coherent with the 3 by 5 Initiative, as well as with national and sub regional Global Fund projects in the Americas, amongst others. To build the Fund it will be necessary to reaffirm and build political commitment, redirect the technical cooperation package in support of the Fund, review the administrative procedures governing operations, and develop lines of communication with the countries. With input from this subcommittee, as well as through future deliberations in a Working Group, it is expected that the development of the Fund can be guided to produce benefits for the counties in ensuring continuous supply of public health products while at the same time building capacity in supply management, programming and planning, and rational use. Procedures can be developed for a revolving Fund mechanism that is simple in concept and use, and that will generate capital in manner similar to the EPI Fund. The Strategic Fund can build on the principles of Pan Americanism, where the participation of large states in the Fund will facilitate the use of the Fund for smaller states.

Procesos en camino Taller sobre ADPIC y Acceso a Medicinas, Abril 2004, Nicaragua. Recomendaciones a los gobiernos, sociedad civil y organismos internacionales. The strategic lines that have been presented to the Subcommittee today are proposed as key areas for a future program of work. They are not intended to be presented as exclusive of current areas of PAHO work, to be developed isolated from ongoing activities. The strategic lines presented are however intended to complement existing programs of work, contributing to the achievement of the agenda in priority health programs and the development of health service delivery in disease treatment and prevention. By its nature, the work program is interprogrammatic and will draw on resources that exist with the Secretariat and particularly within the HIV/AIDS, TB and malaria Units as well as within the essential medicines, vaccines and technologies unit. The discussion and proposed action lines will be brought forward into a Working Group to meet most probably in May 2004 here in Washington DC, with input from PAHO country offices as well as other key external partners. It will build on the current financial resources currently being made available by the financing partners, as well as technical resources through WHO lead initiatives. Its implementation can be supported by drawing on the knowledge and experiences of countries as well as the capacity and experiences of the WHO collaborating Centers in the region.

Grupo de Trabajo en Acceso, OPS, Junio 2004 Reunión de representantes de las Unidades Técnicas de OPS-OMS, Centros Colaboradores, Banco Mundial, Cuerpos Regionales (CAN, CARICOM) y ONGs especializadas (MSH, AIS y MSF) Revisión de las líneas estratégicas de la propuesta de OPS y desarrollo de un plan de trabajo Resultados: Endorse por los socios Desarrollo de elementos del plan de trabajo para: a) Genéricos, b) Contención de Costos y Propiedad Intelectual, y c) Gestión de Suministros Consideración para la implementación de las estrategias usando los recursos existentes y desarrollando nuevas alianzas y redes. The strategic lines that have been presented to the Subcommittee today are proposed as key areas for a future program of work. They are not intended to be presented as exclusive of current areas of PAHO work, to be developed isolated from ongoing activities. The strategic lines presented are however intended to complement existing programs of work, contributing to the achievement of the agenda in priority health programs and the development of health service delivery in disease treatment and prevention. By its nature, the work program is interprogrammatic and will draw on resources that exist with the Secretariat and particularly within the HIV/AIDS, TB and malaria Units as well as within the essential medicines, vaccines and technologies unit. The discussion and proposed action lines will be brought forward into a Working Group to meet most probably in May 2004 here in Washington DC, with input from PAHO country offices as well as other key external partners. It will build on the current financial resources currently being made available by the financing partners, as well as technical resources through WHO lead initiatives. Its implementation can be supported by drawing on the knowledge and experiences of countries as well as the capacity and experiences of the WHO collaborating Centers in the region.

Resolución del 134avo Comité Ejecutivo en Acceso a Medicamentos Instar a los Estados Miembros a que: asignen prioridad al problema del acceso a los medicamentos y los suministros esenciales de salud pública, abordando los factores determinantes del acceso en el ámbito nacional y prestando especial atención a las poblaciones pobres y marginadas; formulen políticas de medicamentos genéricos como un medio para aumentar la disponibilidad y la asequibilidad de los medicamentos esenciales, así como asegurar la calidad y la seguridad de los productos mediante la reglamentación eficaz y la promoción del uso racional mediante incentivos dirigidos tanto a los proveedores como a los consumidores;

sigan poniendo en práctica una amplia gama de estrategias de contención de los costos de los suministros esenciales de salud pública, al objeto de maximizar la eficiencia y utilización de los recursos así como de vigilar y evaluar la repercusión de tales estrategias en los precios y el acceso; apliquen en la Región de las Américas la resolución WHA57.14 de la 57.a Asamblea Mundial de la Salud, específicamente para adaptar la legislación nacional con el fin de aprovechar al máximo las flexibilidades previstas en el Acuerdo sobre los Derechos de Propiedad Intelectual Relacionados con el Comercio (ADPIC), de la Organización Mundial del Comercio, y promover que los acuerdos comerciales bilaterales tengan en cuenta la Declaración Ministerial de Doha relativa a los Acuerdos sobre los ADPIC y la salud pública;

reconozcan la importancia de la gestión de los suministros para mantener la continuidad del acceso a los medicamentos y los suministros esenciales de salud pública, y fortalecer en consecuencia los sistemas de gestión de suministros farmacéuticos. Solicitar a la Directora a que: apoye el establecimiento de redes y asociaciones o alianzas con la participación activa de los interesados directos clave, a fin de poner en práctica un programa de trabajo que promueva la formulación de políticas coherentes sobre medicamentos genéricos en la Región; la implantación y vigilancia de estrategias de contención de costos de acuerdo con las leyes y los tratados internacionales vigentes y el fortalecimiento de la capacidad de gestión de los suministros; continúe reforzando el Fondo Rotatorio Regional para Suministros Estratégicos de Salud Pública como un mecanismo de adquisiciones que apoye el programa técnico de trabajo promoviendo el acceso a los medicamentos en la Región.