Autonomía farmacéutica y biotecnológica frente a emergencias sanitarias / Autonomous pharmaceutical and biotechnological capabilities during sanitary emergencies

La pandemia de COVID 19, ha puesto de presente la necesidad de contar con políticas de autonomía farmacéutica y biotecnológica para cada país. Esta autonomía es necesaria porque en eventos ocasionados por agentes de riesgo biológico, la afectación masiva de la población mundial hace imposible que se cubran las necesidades para todos los países. Muchos medicamentos de interés en salud pública no son producidos por la industria farmacéutica privada dado que los márgenes de ganancia no son importantes para ellos y se encuentran situaciones de desabastecimiento ante brotes de infecciones inusitados.

The COVID 19 pandemic has highlighted the need for pharmaceutical and biotechnology autonomy policies for each country. This autonomy is necessary because in events caused by biological risk agents, the massive involvement of the world population makes it impossible to cover the needs of all countries. Many drugs of public health interest are not produced by the private pharmaceutical industry because the profit margins are not important for them and there are situations of shortages in the event of outbreaks of unusual infections.

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.

Impact of the introduction of mandatory generic substitution in South Africa: private sector sales of generic and originator medicines for chronic diseases.

OBJECTIVE: To assess the impact of mandatory offer of generic substitution, introduced in South Africa in May 2003, on private sector sales of generic and originator medicines for chronic diseases. METHODS: Private sector sales data (June 2001 to May 2005) were obtained from IMS Health for proton pump inhibitors (PPIs; ATC code A02BC), HMG-CoA reductase inhibitors (statins; C10AA), dihydropyridine calcium antagonists (C08CA), angiotensin-converting enzyme inhibitors (ACE-I; C09AA) and selective serotonin reuptake inhibitors (SSRIs; N06AB). Monthly sales were expressed as defined daily doses per 1000 insured population per month (DDD/TIM). Interrupted time-series models were used to estimate the changes in slope and level of medicines use after the policy change. ARIMA models were used to correct for autocorrelation and stationarity. RESULTS: Only the SSRIs saw a significant rise in level of generic utilisation (0.2 DDD/TIM; P < 0.001) and a fall in originator usage (-0.1 DDD/TIM; P < 0.001) after the policy change. Utilisation of generic PPIs fell (level 0.06 DDD/TIM, P = 0.048; slope 0.01 DDD/TIM, P = 0.043), but utilisation of originator products also grew (level 0.05 DDD/TIM, P < 0.001; slope 0.003, P = 0.001). Generic calcium antagonists and ACE-I showed an increase in slope (0.01 DDD/TIM, P = 0.016; 0.02 DDD/TIM, P < 0.001), while the originators showed a decrease in slope (-0.003 DDD/TIM, P = 0.046; -0.01 DDD/TIM, P < 0.001). There were insufficient data on generic statin use before the policy change to allow for analysis. CONCLUSION: The mandatory offer of generic substitution appeared to have had a quantifiable effect on utilisation patterns in the 2 years after May 2003. Managed care interventions that were already in place before the intervention may have blunted the extent of the changes seen in this period. Generic policies are an important enabling provision for cost-containment efforts. However, decisions taken outside of official policy may anticipate or differ from that policy, with important consequences.

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.

Dispensación de medicamentos en farmacias y establecimientos asistenciales del sector público / Dispensing of medicines in pharmacies and public health-care institutions

INTRODUCCION: Existe un conjunto de variables que están asociadas a los resultados de la política nacional de medicamentos implementada en los últimos años.OBJETIVO: Identificar variables y nuevas estrategias que permitan mejorar el acceso de la población a los medicamentos y promuevan su uso racional.METODOS: Se utilizó un enfoque descriptivo y cuantitativo basado en encuestas realizadas sobre una muestra probabilística de etapas múltiples, que aseguró la selección aleatoria de la población relevada en todas las fases del proceso. La investigación contuvo dos módulos: a) encuestas en farmacias y b) encuestas en lugares de dispensación de medicamentos pertenecientes a establecimientos asistenciales del sector público de toda la Argentina. En ambos casos, se encuestó a los compradores y beneficiarios de medicamentos, así como a los vendedores y responsables de la dispensación.RESULTADOS: La proporción de recetas que incluyen el nombre genérico del medicamento ha disminuido en las farmacias, mientras que alcanza el 95% en los establecimientos públicos.CONCLUSIONES: Las características de la compra y la proporción de entrega sin receta de medicamentos éticos resultan preocupantes. Tanto el sector público como el privado requieren acciones de fortalecimiento para garantizar el acceso y el uso racional de medicamentos.

INTRODUCTION: There are several variables related to the results of the national drug policy, implemented by health authorities in Argentina during the last years.OBJECTIVE: To identify variables and new strategies that help to improve the access to the medicines and promote its rational use.METHODS: A descriptive and quantitative approach was used. The surveys were conducted through a multistage probabilistic sample, ensuring a random selection of the population during the whole process. The research included two modules: a) surveys in pharmacies, and b) surveys in public health-care institutions dispensing medicines all around the country. In both cases the people surveyed were, on one side, buyers and beneficiaries, and on the other, sellers and persons in charge of the dispensing.RESULTS: The proportion of prescriptions including the generic name of the drug has been reduced in pharmacies, while it reaches 95% in public health-care institutions.CONCLUSIONS: The features of the purchase and the rate of delivery of ethical drugs without prescription are distressing. Both public and private sectors require appropriate actions in order to guarantee access to and rational use of medicines.

Dispensación de medicamentos en farmacias y establecimientos asistenciales del sector público / Dispensing of medicines in pharmacies and public health-care institutions

INTRODUCCION: Existe un conjunto de variables que están asociadas a los resultados de la política nacional de medicamentos implementada en los últimos años.OBJETIVO: Identificar variables y nuevas estrategias que permitan mejorar el acceso de la población a los medicamentos y promuevan su uso racional.METODOS: Se utilizó un enfoque descriptivo y cuantitativo basado en encuestas realizadas sobre una muestra probabilística de etapas múltiples, que aseguró la selección aleatoria de la población relevada en todas las fases del proceso. La investigación contuvo dos módulos: a) encuestas en farmacias y b) encuestas en lugares de dispensación de medicamentos pertenecientes a establecimientos asistenciales del sector público de toda la Argentina. En ambos casos, se encuestó a los compradores y beneficiarios de medicamentos, así como a los vendedores y responsables de la dispensación.RESULTADOS: La proporción de recetas que incluyen el nombre genérico del medicamento ha disminuido en las farmacias, mientras que alcanza el 95% en los establecimientos públicos.CONCLUSIONES: Las características de la compra y la proporción de entrega sin receta de medicamentos éticos resultan preocupantes. Tanto el sector público como el privado requieren acciones de fortalecimiento para garantizar el acceso y el uso racional de medicamentos.

INTRODUCTION: There are several variables related to the results of the national drug policy, implemented by health authorities in Argentina during the last years.OBJECTIVE: To identify variables and new strategies that help to improve the access to the medicines and promote its rational use.METHODS: A descriptive and quantitative approach was used. The surveys were conducted through a multistage probabilistic sample, ensuring a random selection of the population during the whole process. The research included two modules: a) surveys in pharmacies, and b) surveys in public health-care institutions dispensing medicines all around the country. In both cases the people surveyed were, on one side, buyers and beneficiaries, and on the other, sellers and persons in charge of the dispensing.RESULTS: The proportion of prescriptions including the generic name of the drug has been reduced in pharmacies, while it reaches 95% in public health-care institutions.CONCLUSIONS: The features of the purchase and the rate of delivery of ethical drugs without prescription are distressing. Both public and private sectors require appropriate actions in order to guarantee access to and rational use of medicines.

Política farmacéutica saludable / Healthy pharmaceutical policy

Hoy en día, la industria farmacéutica se encuentra en una transición profunda. La globalización y el avance tecnológico representan las principales presiones de cambio para un mercado mundial de medicamentos donde a este tipo de industria le resulta cada vez más difícil recuperar de forma eficiente los costos crecientes de la innovación. México debe analizar las implicaciones en el ámbito político de estos factores de cambio y promover, en el mercado de medicamentos, una política que incremente al máximo las ganancias de salud de los recursos invertidos. La política de medicamentos ofrece un raro ejemplo de complementariedad entre una buena política de salud y una política económica eficiente, es decir, una "política farmacéutica saludable".

Today, the pharmaceutical industry is experiencing a profound transition. Globalization and technological advancement represent the principal pressures for change in the market, where it is increasingly more difficult for this type of industry to efficiently recoup the growing cost of innovation. Mexico needs to analyze the policy implications of these change factors and promote, in the pharmaceutical market, policies that maximize health gains on invested resources. Pharmaceutical policy offers a rare example for a complementary approach between a sound health policy and an efficient economic policy; that is, a "healthy pharmaceutical policy."

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.

Ampliação do acesso a medicamentos de alto custo uma análise da política brasileira / Enhancing acces to high cost pharmaceuticals analysing brazilian policies

INTRODUÇÃO: A assistência farmacêutica constitui parte fundamental dos serviços de atenção à saúde do cidadão. Em muitos casos, a estratégia terapêutica para a recuperação do paciente ou para redução dos riscos da doença e agravos somente é possível a partir da utilização de algum tipo de medicamento. Nessas situações, o medicamento é elemento essencial para a efetividade do processo de atenção à saúde. Nesse contexto, o direito constitucional à saúde só se materializa em sua plenitude mediante o acesso ao medicamento pelo paciente. Em pouco mais de uma década de construção do Sistema Único de Saúde (SUS), muitos avanços foram alcançados. Os problemas iniciais de sua implantação, inclusive os de ordem política e filosófica, foram superados e significativos avanços foram alcançados no tocante à sua organização e à descentralização de sua gestão nos âmbitos político-administrativo e financeiro. Vivemos, hoje, um período de consolidação do SUS onde a organização da atenção e assistência à saúde e a ampliação do acesso dos cidadãos aos serviços constituem o principal desafio para os seus gestores, nas três esferas de governo. É na área de assistência farmacêutica, no entanto, que o sistema de saúde brasileiro ainda se depara com grandes problemas e dificuldades. É aqui que ficam mais evidentes as distorções e problemas que são gerados pelas grandes desigualdades sociais e econômicas ainda existentes no país, e que determinam restrições ao pleno acesso a medicamentos. Esta situação é particularmente dramática em se tratando de medicamentos de uso ambulatorial continuado, quando o tratamento de doenças crônicas, muitas vezes com duração por toda uma vida, se torna inacessível para a maioria da população, quer pelo alto custo do medicamento quer pelo custo total do tratamento. Neste particular é fundamental a ação do poder público para combater a iniqüidade no acesso, na formulação de políticas de assistência farmacêutica de alto custo, na garantia do financiamento, na distribuição gratuita de medicamentos e na ampliação do acesso à população a estes tratamentos. OBJETIVO: O presente trabalho tem como objetivo analisar a política brasileira de medicamentos, aspectos relativos à assistência farmacêutica de alto custo no país, sua evolução, o comportamento do mercado farmacêutico, o processo de gerenciamento do chamado Programa de Medicamentos Excepcionais, a regulação da atividade, o processo de ampliação da capacidade gestora do Ministério da Saúde e dos estados nesta área e a ampliação do acesso da população a medicamentos de alto custo.

INTRODUCTION: Pharmaceutical assistance constitutes a fundamental part of the services to be provided to health care of the citizens. In many cases, the therapeutical strategy for the recovering of the patient, or to reduce the risk of the disease, is only possible when using some kind of specific pharmaceutical. In such situations pharmaceuticals are a key issue to the efectiveness of the process of health care. Constitutional Right to Health Care is only possible and feasible at its highest level upon access to pharmaceuticals by the patients. In a little over a decade of existence of the Unified Health System (SUS) many improvements have been achieved. The initial problems of its implementation, including political and phylosofical ones, were overcome and significant improvements were achieved in regards to its organization and decentralization in fields such as politicies, administration and financing. We currently live a period of consolidation of the SUS where the organization of the health care assistance and enhancing services to population represent the major challenge to its administrators in the three levels of power (federal, state and municipal levels). However, it is exactly in the pharmaceutical assistance field that the SUS is still facing major problems and difficulties. It is here that it becomes more evident the distortions and problems that are generated by the drastic social and economical disparities still existing in the country, which determine restrictions. OBJECTIVE: The present work is focused in analysing the brazilian policy of pharmaceuticals, aspects related to high cost ones, its evolution, market behaviour, management process of the so called Exceptional Pharmaceutical Program, regulating of the activity, enhancing management capacity of the Health Ministry and the states in this field and enhancing access of high cost pharmaceuticals to population. Key Wo rds: pharmaceutical assistance, pharmaceutical policies, pharmaceuticals, medicaments, high cost pharmaceuticals, exceptional medicaments