Política industrial farmacéutica, un requisito clave para la autonomía sanitaria de Colombia

Colombia depende de la importación de medicamentos, así como de gran parte de los materiales (principios activos y excipientes) requeridos para su elaboración; problemática que genera consecuencias sanitarias y macroeconómicas, las cuales se agudizan en el contexto de desindustrialización nacional y de disrupción tecnológica. De esta manera, se acepta que la disponibilidad y acceso a medicamentos y otras tecnologías sanitarias esenciales son un requisito fundamental para alcanzar la autonomía sanitaria de un país. Por lo tanto, resulta imprescindible coordinar esfuerzos entre diversos sectores sociales para desarrollar una agenda pública enfocada a la creación de condiciones que fortalezcan las capacidades científicas y tecnológicas de la industria farmacéutica local, y con ello, mejorar el suministro farmacéutico del país. En el presente documento se presentan conceptos teóricos y prácticos que deberían ser considerados en la definición y materialización de una política pública encaminada a fortalecer la industria farmacéutica y favorecer la autonomía sanitaria de Colombia.

Colombia has a notorious dependency on the importation of medicines, as well as a large part of the materials (active ingredients and excipients) required for their manufacture. This problem generates health and macroeconomic consequences, which are exacerbated in the context of national deindustrialization and technological disruption. In this way, it is accepted that the availability and access to medicines and other essential health technologies are a fundamental requirement to achieve the health autonomy of a country. Therefore, it is crucial to coordinate efforts between several social sectors to develop a public agenda focused on creating conditions that allow strengthening the scientific and technological capabilities of the local pharmaceutical industry, thereby, improving the country's pharmaceutical supply. This document presents conceptual and practical topics that should be considered to defining and materializing a public policy aimed at strengthening the local pharmaceutical industry and favoring Colombia's sanitary autonomy.

Regulação sanitária e desenvolvimento tecnológico: estratégias inovadoras para o acesso a medicamentos no SUS / Health regulation and technological development: innovative strategies for accessing medicines in the SUS

Resumo A ciência regulatória é o campo de articulação de saberes que visa estabelecer as bases científicas para a definição de mecanismos e práticas regulatórias adequadas e eficientes. Com base na análise documental, foram estudadas as interfaces entre as políticas sistêmicas e setoriais no campo do desenvolvimento tecnológico e da saúde, especialmente a partir da Política Nacional de Assistência Farmacêutica (PNAF), com impactos no campo regulatório sanitário e no estímulo à produção de medicamentos de interesse do Sistema Único de Saúde (SUS). As iniciativas para a produção nacionalizada do medicamento antirretroviral "efavirenz", objeto de licença compulsória em 2007, bem como o estabelecimento das Parcerias para o Desenvolvimento Produtivo (PDP), contribuíram para a definição de marcos e práticas regulatórias inovadoras, com destaque para os Comitês Técnico-Regulatórios (CTR) de acompanhamento das internalizações das tecnologias e registro sanitário dos produtos resultantes. Foi identificada a capacidade de permeação dos princípios e eixos estratégicos da PNAF no campo das políticas setoriais analisadas. A partir de 2014 não foram identificadas de macropolíticas ou políticas setoriais relacionadas à ampliação do acesso aos medicamentos no SUS com impactos no campo regulatório.

Abstract Regulatory science involves articulating knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. The interfaces between systemic and sectoral health and technological development policies were studied based on documentary analysis, especially from the National Pharmaceutical Policy (PNAF), with impacts on health regulation and stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of ARV "Efavirenz", which was the subject of a compulsory license in 2007, and the establishment of Partnerships for Productive Development (PDP), contributed to defining innovative regulatory frameworks and practices, emphasizing the Regulatory Technical Committees (CTR) for monitoring the internalization of technologies and health registration of the resulting products. The permeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies on expanding access to medicines in the SUS with impacts on regulations were identified.

Análisis y reflexiones sobre la iniciativa de reforma a la Ley General de Salud de México 2019 / Analysis and reflections on the 2019 initiative that reforms Mexico's Ley General de Salud

Resumen: La iniciativa con Proyecto de Decreto por el que se reforma la Ley General de Salud de México presentada en 2019 ante el Congreso de la Unión propone la creación de un sistema de acceso universal y gratuito a los servicios de salud y a medicamentos asociados para la población sin seguridad social y la creación del Instituto de Salud para el Bienestar. Este artículo analiza algunos aspectos sustantivos del Proyecto de Decreto con el objetivo de motivar la reflexión sobre la reforma propuesta y sus componentes más importantes para contribuir a su propósito. Se concluye que los principales temas del proyecto requieren precisión en rubros relevantes, como la transformación del esquema de financiamiento para la atención, el fortalecimiento de la rectoría y gobernanza, la responsabilidad en la provisión de servicios y la regulación y acceso a medicamentos. Las aportaciones de académicos, tomadores de decisiones y organizaciones sociales serán indispensables para una política pública de salud basada en evidencia y con equidad social.

Abstract: The initiative including an Act Project for reforming the Ley General de Salud of Mexico, submitted in 2019 to the Congress of the Union, proposes the creation of a system of universal and free access to health services and associated medicines for the population lacking of social security benefits, and the creation of the Instituto de Salud para el Bienestar. This article analyzes the substantive aspects of the project, with the aim of motivating the reflection of the proposed reform and its most important components, to contribute to achieving its aim. The conclusion is that the main themes of the Project require precision in relevant areas, such as the transformation of the financing scheme for care, the strengthening of stewardship and governance, the responsibility in the provision of services, and the regulation and access to medicines. The contributions of academics, decision makers and social organizations will be essential to create a public health policy based on evidence and social equity.

Comparison of Approval Process for Nonprescription Drugs in Different Countries

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

Pharmaceutical pricing and reimbursement policy and its effect in China / 中国卫生政策研究

Background:In recent years, there has been rapid growth in pharmaceutical spending in China. In addition, the country faces many challenges with regards to the quality, pricing and affordability of drugs. Pricing and reimbursement are important aspects of pharmaceutical policy that must be prioritised in order to address the man-y challenges. Methods:This review draws on multiple sources of information. A review of the academic and grey lit-erature along with official government statistics were combined with informa-tion from seminars held by China's State Council Development Research Center to provide an overview of pharmaceutical pricing and reimbursement in China. Results:Pricing and reimbursement policy were analysed through a framework that incor-porates supply-side policies, proxy-demand policies and demand-side policies. China's current pharmaceutical policies interact in such a way to create dysfunction in the form of high prices, low drug quality, irrational prescribing and problems with access. Fi-nally, the country's fragmented regulatory environment hampers pharmaceutical policy reform. Conclusions:The pri-cing and reimbursement policy landscape can be improved through higher drug quality standards, greater market con-centration, an increase in government subsidies, quality-oriented tendering, wider implementation of the zero mark-up policy, through linking reimbursement with rational prescribing, and the promotion of health technology assess-ment and comparative effectiveness research. Addressing broader issues of regulatory fragmentation, the lack of trans-parency and corruption will help ensure that policies are created in a coherent, evidence-based fashion.

Analysis and prospect of status of orphan drug research / 国际药学研究杂志

Growing attention on the rare diseases promotes the work of the government legislation, so a series of rare diseases related policies have been introduced. However, under the conditions of economy, population, social security and so on, China’s rare disease medical care and drug development are still in the initial stage. This paper elaborates and analyzes the status and future development of rare disease drugs, and provides advice for the policy formation of rare diseases and industrial development.

Estructuración y formulación de la política pública farmacéutica regional y territorial en Colombia / Structuring and Development of Regional and Territorial Pharmaceutical Public Policy in Colombia / Estruturação e formulação da política pública farmacêutica regional e territorial na Colômbia

Problema: radica en la estructuración y formulación de la política pública farmacéutica regional y territorial en Colombia. Justificación: el documento Conpes 155 exige la definición del marco de política pública farmacéutica en Colombia, y por ende a escala departamental y territorial. Método: la fundamentación analítica de dicho Conpes, al igual que el uso de la metodología de marco lógico, fungen como herramientas metódicas para la postulación del trabajo. Marco de referencia: revisión en materia de definición u observancia de políticas públicas farmacéuticas internacionales. Principales resultados: el planteamiento de la respectiva política pública farmacéutica en el departamento de Antioquia y la postulación de dicho escenario en la ciudad capital de Medellín. Conclusiones: la construcción de la política pública farmacéutica nacional aún está en ciernes, obstáculo que impide registrarla en la política pública territorial.

The problem lies on the structuring and development of regional and territorial public drug policy in Colombia. Justification: The document Conpes 155 requires the definition of the public pharmaceutical policy framework in Colombia, and therefore defining it at the departmental and local level. Method: the analytical foundation of the Conpes like the use of the logical framework methodology, serve as methodical tools for the application of the project. Framework: review of the definition or compliance of international drug policies. Main results: the approach of the public pharmaceutical policy in the department of Antioquia and the application of such a scenario in the capital city of Medellin. Conclusions: the construction of a public national drug policy is still in its infancy, fact that hinders the establishment of a territorial public policy.

Problema: reside na estruturação e formulação da política pública farmacêutica regional e territorial na Colômbia. Justificação: o documento Conpes 155 exige a definição do quadro de política pública farmacêutica na Colômbia, e, portanto, na escala departamental e territorial. Método: a fundamentação analítica de tal Conpes, mesmo que o uso da metodologia de quadro lógico, agem como ferramentas metódicas para a execução do trabalho. Quadro de referência: revisão em matéria de definição ou observância de políticas públicas farmacêuticas internacionais. Principais resultados: a colocação da respetiva política pública farmacêutica no departamento de Antioquia e a proposição de tal cenário na cidade capital de Medellín. Conclusões: a construção da política pública farmacêutica nacional ainda está na infância, obstáculo que impede cadastrá-la na política pública territorial.

Antiretroviral purchasing and prescription practices in Mexico: constraints, challenges and opportunities / Compras y prescripciones de medicamentos antirretrovirales en México: restricciones, retos y oportunidades

Objective. This study examines the antiretroviral (ARV) market characteristics for drugs procured and prescribed to Mexico's Social Protection System in Health beneficiaries between 2008 and 2013, and compares them with international data. Materials and methods. Procurement information from the National Center for the Prevention and the Control of HIV/AIDS was analyzed to estimate volumes and prices of key ARV. Annual costs were compared with data from the World Health Organization's Global Price Reporting Mechanism for similar countries. Finally, regimens reported in the ARV Drug Management, Logistics and Surveillance System database were reviewed to identify prescription trends and model ARV expenditures until 2018. Results. Results show that the first-line ARV market is concentrated among a small number of patented treatments, in which prescription is clinically adequate, but which prices are higher than those paid by similar countries. The current set of legal and structural options available to policy makers to bring prices down is extremely limited. Conclusions. Different negotiation policies were not successful to decrease ARV high prices in the public health market. The closed list approach had a good impact on prescription quality but was ineffective in reducing prices. The Coordinating Commission for Negotiating the Price of Medicines and other Health Supplies also failed to obtain adequate prices. To maximize purchase efficiency, policy makers should focus on finding long-term legal and political safeguards to counter the high prices imposed by pharmaceutical companies.

Objetivo. Este estudio analiza el mercado de los medicamentos antiretrovirales (ARV) adquiridos y prescritos a los beneficiarios del Seguro Popular entre 2008 y 2013, en México, comparándolo con información internacional. Material y métodos. Se analiza información sobre la compra de medicamentos por parte del Centro para la Prevención y el Control del VIH y el Sida (Censida) para estimar precios y volúmenes de compra de los principales ARV. Los costos anuales de tratamiento estimados fueron comparados con información del Global Price Reporting Mechanism (GPRM) de la Organización Mundial de la Salud, para países similares. Finalmente se revisaron los esquemas reportados en el Sistema de Administración, Logística y Vigilancia de ARV para identificar tendencias y proyectar el gasto en ARV hasta 2018. Resultados. El mercado mexicano de ARV está concentrado en pocos esquemas de primera línea y, aunque la prescripción es clínicamente adecuada, los precios son más altos que en otros países similares. El conjunto actual de opciones legales y estructurales disponibles para los formuladores de políticas para reducir los precios es muy limitado. Conclusiones. Las políticas de negociación han sido poco exitosas para disminuir los precios de los ARV en México. La Coordinating Commission for Negotiating the Price of Medicines and other Health Supplies y la integración de las guías de tratamiento han tenido impacto significativo en la calidad de la prescripción, pero moderado en la reducción de precios. Por ello es necesario buscar garantías jurídicas y políticas a largo plazo para hacer frente a los altos precios de los ARV.

Evaluación de Tecnología Sanitaria y su impacto en políticas de tarificación y cobertura de medicamentos / Health technology assessment and its impact on pharmaceutical pricing and reimbursement policies

The article conceptualizes the pharmaceutical pricing and reimbursement policies related to financial coverage in the context of health systems. It introduces the pharmaceutical market as an imperfect one, in which appropriate regulation is required. Moreover, the basis that guide the pricing and reimbursement processes are defined and described in order to generate a categorization based on whether they are intended to assess the 'added value' and if the evaluation is based on cost-effectiveness criteria. This framework is used to review different types of these policies applied in the international context, discussing the role of the Health Technology Assessment in these processes. Finally, it briefly discusses the potential role of these types of policies in the Chilean context.

Retos y oportunidades para el desarrollo de la política farmacéutica nacional en México / Challenges and opportunities for the development of a national pharmaceutical policy in México

A diferencia de otros países de América Latina, México no tiene una política farmacéutica nacional (PFN) coherente y explícita. Otros retos que enfrenta el país son el alto gasto de bolsillo en medicamentos, a pesar de la implementación del acceso universal a través del Seguro Popular; los precios altos de medicamentos en el sector privado, ajustados por nivel de ingreso y en comparación con otros países; y la falta de una estrategia clara para mejorar el uso seguro y eficiente de los medicamentos con intervenciones dirigidas a los médicos, a las farmacias y a los consumidores. El objetivo de este trabajo es, con base en las recomendaciones hechas en la literatura, describir los retos y oportunidades para 1) consolidar la formulación de una PFN, junto con un plan de implementación y evaluación, y 2) definir el contenido de las políticas en términos del uso de los medicamentos y el acceso a los mismos.

Unlike many other Latin American countries Mexico has no coherent and explicit national pharmaceutical policy (NPP). Other national challenges are: high out-of-pocket expenditure on medicines despite the implementation of universal health care coverage through Seguro Popular, high prices of medicines in the private sector in comparison to other countries when adjusted for income level, and the lack of clear strategies to improve safety and efficiency in the use of medicines, in particular interventions aimed at private physicians, pharmacies and consumers. The aim of this paper is to describe the challenges and opportunities to (1) consolidate the processes of formulating, implementing and evaluating NPP, and (2) define the policy content with regard to access and use of medicines.

Dilemas da política de distribuição de medicamentos antirretrovirais no Brasil / Policy dilemmas in providing antiretroviral treatment in Brazil

Este artigo trata dos constrangimentos institucionais que têm afetado a política brasileira de provisão de medicamentos contra a Aids. É analisado o conflito normativo observado na política de Aids entre as regras internacionais da propriedade intelectual, em especial a proteção de patentes, e a orientação de acesso universal e gratuito a medicamentos, que norteia a política brasileira. Esses constrangimentos não têm tido sucesso em alterar a configuração distributiva da política pública brasileira; contudo, vêm alterando as condições de sustentabilidade da política pública. Considerando que a principal barreira para a produção de medicamentos protegidos por patente é institucional e não tecnológica, o governo brasileiro tem enfrentado o dilema da tomada de decisão entre a manutenção da regra de monopólio ou o incentivo à competitividade que permita o posicionamento eficiente dos produtores nacionais e dos países emergentes.

This paper addresses institutional constraints that have affected Brazilian politics regarding provision of anti-retroviral treatment (ART) to HIV/Aids patients. We analyzed the normative conflict resulting from international agreements on intellectual property rights, especially patent protection, and the constitutional rights of Brazilian patients to universal and free access to ART. These constraints have not substantially changed the Brazilian public policy yet, but they may impact the future sustainability of this policy. As the main barrier to the production of patented drugs is not technological but institutional, Brazilian government faces a dilemma. It may either abide by existing monopolistic restrictions or it may incite competitiveness of domestic industries and developing countries in the pharmaceutical market.

Medicamentos e saúde pública em tempos de AIDS: metamorfoses de uma política dependente: [revisão] / Drugs, health policy and AIDS: changes in a dependent policy: [review]

Desde os anos 1970, o Brasil vem tentando pôr em prática uma política de medicamentos que, apesar do mercado predominantemente oligopolizado e dominado pelas empresas farmacêuticas multinacionais, garanta à população o acesso a medicamentos essenciais. Foi nesse contexto que se deu a aprovação da lei de medicamentos genéricos, em 1999. O objetivo deste trabalho é analisar os elementos que interferiram no processo de implantação dessa lei. Com base na bibliografia especializada, na análise dos debates publicados em jornais brasileiros (1990 a 2002) e em entrevistas realizadas com membros da indústria, bem como com médicos, políticos, ativistas e funcionários públicos, procura-se mostrar que a efetiva implantação dos genéricos no Brasil está fortemente relacionada ao advento da AIDS. Mais precisamente, à implantação de uma política bem-sucedida de saúde pública no combate a essa doença, envolvendo a ação de diferentes atores e a combinação de diversos elementos também analisados neste artigo, tais como a política de cópia industrial de medicamentos, a lei de acesso universal aos medicamentos anti-AIDS, o movimento de luta contra a AIDS, a burocracia governamental constituída na luta contra essa epidemia e a forte mobilização da mídia.

Since the 1970s the Brazilian government has made efforts to implement a pharmaceutical policy that, in spite of a market predominantly oligopolized and dominated by multinational pharmaceutical industries, guarantees access to essential drugs for the population. In this context, in 1999, a law regarding generics was approved. This article aims at analyzing the elements that interfered in the implementation process of this law. Based on specialized bibliography, on the debate in the Brazilian press (1992-2002) and on interviews with industry members, physicians, politicians, activists and civil servants we try to show that the implementation of generics in Brazil is strongly related to the AIDS epidemic. More precisely, it is related to the successful health policy against this disease involving different actors and a variety of elements to be analyzed here, among them the policy of copycat versions of drugs, the law of universal access to anti-AIDS drugs, the struggle of organized social movements, the governmental bureaucracy implemented for fighting this epidemic and the strong mobilization of the media.

Medicines in Mexico, 1990-2004: systematic review of research on access and use: [review] / Medicamentos en México, 1990-2004: revisión de investigación sobre acceso y uso: [revisión]

OBJECTIVE: To review original research studies published between 1990 and 2004 on the access and use of medicines in Mexico to assess the knowledge base for reforming Mexico's pharmaceutical policy. MATERIAL AND METHODS: A literature review using electronic databases was conducted of original studies published in the last 15 years about access and use of medicines in Mexico. In addition, a manual search of six relevant journals was performed. Excluded were publications on herbal, complementary and alternative medicines. RESULTS: Were identified 108 original articles as being relevant, out of 2289 titles reviewed, highlighting four policy-related problems: irrational prescribing, harmful self-medication, inequitable access, and frequent drug stock shortage in public health centers. CONCLUSIONS: This review identified two priorities for Mexico's pharmaceutical policy and strategies: tackling the irrational use of medicines and the inadequate access of medicines. These are critical priorities for a new national pharmaceutical policy.

OBJETIVO: Revisar estudios de investigaciones originales publicados sobre el acceso y uso de los medicamentos en México de 1990 a 2004, con el fin de evaluar el conocimiento que existe para reformar la política farmacéutica nacional. MATERIAL Y MÉTODOS: Se condujo una revisión de la literatura sobre estudios originales publicados entre 1990 y 2004 sobre el acceso y uso de medicamentos en México. Además, se revisaron manualmente seis revistas relevantes. Se excluyeron publicaciones sobre herbolaria, medicamentos tradicionales y alternativos. RESULTADOS: Se revisaron 2 289 artículos e identificaron 108 como relevantes que destacan cuatro problemas importantes relacionados con las políticas farmacéuticas: prescripción inadecuada, automedicación dañina, acceso inequitativo y desabasto de medicamentos en servicios públicos de salud. CONCLUSIONES: Esta revisión identificó dos prioridades críticas para el desarrollo de una nueva política farmacéutica en México: actuar sobre el uso irracional de medicamentos y sobre el acceso inadecuado a medicamentos.

Discussion on the Pharmaceutical Policy Research / 中国药房

OBJECTIVE:To advocate the necessity of carrying out drug policy research in our country.METHODS:The concepts,contents,subject characteristics of drug policy and it trend of development were analyzed by transplanting the method of the public policy subject.RESULTS&CONCLUSIONS:It is of very great significance to carry out the study of drug policy,for it can not only improve the formulation system of drug policy but also provide valid theory and methods for the improvement to the quality of drug policy in our country.

Research on the Division of Drug Attribute / 中国药房

OBJECTIVE:To divided the attribute of drug and to promote the study of pharmaceutical policy.METHODS:Through adopt the methods of deductive,to analyze the character of drug,then divided the attribute of drug.RESULTS&CONCLUSIONS:Thinking the attribute of drug is complicated,with considering it’s fairness,consumption feature of drug and external feature of disease,it could divide into three kinds,private product,common resource and public product.