Brazilian generics market change after Farmácia Popular program

ABSTRACT OBJECTIVE To evaluate trends in the use of generic and non-generic medicines to treat hypertension and diabetes under the Farmácia Popular Program (FP) and its impact on generic medicines sales volume and market share in the Brazilian pharmaceutical market. METHODS This longitudinal, retrospective study used interrupted time series design to analyze changes in monthly sales volume and proportion of medicines sales (market share) for oral antidiabetic and antihypertensive medicines for generic versus non-generic products. Analyses were conducted in a combined dataset that aggregate monthly sales volumes from the Farmácia Popular program and from the QuintilesIMS™ (IQVIA) national market sales data from January 2007 to December 2012. The Farmácia Popular program phases analyzed included: a) 2009 reductions in medicines reference prices (AFP-II) and b) 2011 implementation of free medicines program for hypertension and diabetes, the Saúde não tem preço (SNTP - Health has no price). RESULTS Patterns of use for FP-covered antidiabetic and antihypertensive medicines were similar to their use in the market in general. After one year of the decreases in government subsidies in April 2010, market share of antidiabetic and antihypertensive medicines experienced relative declines of -54.5% and -59.9%, respectively. However, when FP-covered medicines were made free to patients, overall market volume for antidiabetic and antihypertensive generics increased dramatically, with 242.6% and 277.0% relative increases by February 2012, as well as non-generics with relative increase of 209.7% and 279% for antidiabetic and antihypertensive medicines, respectively. CONCLUSIONS Ministry of Health policies on the amount of patient cost sharing and on the choice of medicines on coverage lists have substantial impacts on overall generic sales volume in retail pharmacies.

Utilização de medicamentos genéricos no município de São Paulo em 2003: estudo de base populacional / Uso de medicamentos genéricos en San Paulo, Brasil, en 2003: estudio de base poblacional / Use of generic drugs in São Paulo city, Brazil, in 2003: a population-based study

OBJETIVO: analisar a utilização e a percepção sobre medicamentos genéricos pela população com diabetes e hipertensão na cidade de São Paulo, considerando-se a Política de Medicamentos Genéricos no Brasil. MÉTODOS: estudo transversal com dados do Inquérito de Saúde do Município de São Paulo (ISA-Capital), coletados em 2003; foi analisado o conhecimento sobre medicamentos genéricos e a associação entre utilização desses medicamentos e características sociodemográficas e socioeconômicas. RESULTADOS: foram incluídos 603 participantes; entre hipertensos e diabéticos, foi encontrada baixa utilização de medicamento genérico (33,3% e 26,3%, respectivamente) e a principal vantagem atribuída ao medicamento genérico foi o baixo custo (71,0% e 71,1%, respectivamente); não houve diferença estatisticamente significativa entre uso de medicamento genérico e idade, sexo ou escolaridade. CONCLUSÃO: o baixo custo e não haver diferença entre uso do genérico e escolaridade reforçam a importância do medicamento genérico para a promoção da equidade e do acesso universal a medicamentos.

OBJETIVO: analizar el uso de medicamentos genéricos en la población con diabetes e hipertensión en São Paulo, Brasil, considerando la política de medicamentos genéricos en Brasil. MÉTODOS: estudio transversal con datos de la Encuesta en Salud del municipio de São Paulo (ISA-Capital), colectados en 2003; se analizó el conocimiento sobre medicamentos genéricos y la asociación entre el uso de estos y las características sociodemográficas y socioeconómicas de la población. RESULTADOS: incluimos 603 participantes, entre hipertensos y diabéticos se encontró un uso escaso de genéricos (33,3% y 26,3%, respectivamente) y la principal ventaja atribuida al medicamento genérico fue el bajo costo (71,0% y 71,1%, respectivamente); no hubo diferencia entre el uso de medicación genérica y la edad, sexo o educación. CONCLUSIÓN: el bajo costo y ninguna diferencia entre el uso de genérico y educación refuerza la importancia de los genéricos para la promoción de la equidad y el acceso universal a los medicamentos.

OBJECTIVE: to analyze the use and perception of generic drugs by people with diabetes and hypertension in São Paulo City, Brazil, considering the Brazilian Generic Drug Policy. METHODS: this was a cross-sectional study using data from a household health survey (ISA-Capital) in 2003; analysis was performed on knowledge regarding generic drugs and on the association between their use and sociodemographic and socio-economic characteristics. RESULTS: 603 people with hypertension and diabetes were included in the study, low use of generic drugs was found (33.3% and 26.3, respectively) and low cost was the major reported advantage of generic drugs (71.0% and 71.1%, respectively); there was no statistically significant difference between the use of generic medication and age, sex or schooling. CONCLUSION: low cost and there being no difference between generic drug use and education level strengthen the importance of generic drugs for promoting equity and universal access to medication.

Relevance of variation in use of terminology to define generic pharmaceutical products / Relevancia de la variación en el uso de la terminología para definir los medicamentos genéricos

The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

La Organización Mundial de la Salud (OMS) promueve el uso de políticas de medicamentos genéricos para estimular la competencia en el sector farmacéutico, reducir los precios y aumentar el acceso a los medicamentos. Sin embargo, hay poca información sobre la aplicación de dichas políticas por parte de los países. Este artículo describe la terminología empleada por los organismos regulatorios nacionales para definir los medicamentos genéricos frente a las especialidades farmacéuticas de marca en los países en desarrollo, incluidos los de América Latina, así como las dificultades que se encuentran en la aplicación de las directrices de la OMS, como por ejemplo en el etiquetado. El autor llega a la conclusión de que la variación en la terminología de los medicamentos genéricos en estos países es resultado del contexto institucional (es decir, el sector público y el ordenamiento jurídico-administrativo del país) y de los legados de las políticas, como los regímenes de propiedad intelectual, y destaca la necesidad de analizar más a fondo los reglamentos farmacéuticos a fin de conocer mejor los obstáculos y las implicaciones de las políticas en materia de medicamentos genéricos.

Estudios de bioequivalencia: la necesidad de establecer la fiabilidad de los medicamentos genéricos / Bioequivalence studies: need for the reability of generic drugs

Un medicamento genérico es un medicamento que contiene un principio activo ya conocido y previamente desarrollado e inventado por otros. El coste de estos productos genéricos o multifuente debe ser menor que el de sus contrapartidasoriginales. Los efectos clínicos y el balance riesgo-beneficio de un medicamento no dependen exclusivamente de la actividadfarmacológica de la sustancia activa. La demostración de bioequivalencia de los medicamentos genéricos es de gran importancia. En Europa y en los Estados Unidos de Norteamérica la autorización de medicamentos genéricos descansa en la demostración de la bioequivalencia mediante estudios de biodisponibilidad comparada in vivo. Estos argumentos son imprescindibles para la autorización de la comercialización de los fármacos genéricos por parte de las autoridadessanitarias europeas y norteamericanas. Como medida de la cantidad de fármaco absorbido se utiliza el área bajo la curvaconcentración-tiempo (AUC), y como indicador de la velocidad de absorción se mide la concentración máxima (Cmax) alcanzada en la curva concentración-tiempo y el tiempo que tarda en alcanzarse (Tmax). Se entiende por bioequivalencia entre dos productos cuando presentan una biodisponibilidad comparable en condiciones experimentales apropiadas. El objetivo final de todo este proceso tiene como único sentido poner a disposición de la sociedad fármacos de calidad, que además puedan contribuir a una utilización más racional de los recursos económicos en el sistema sanitario.

A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. Theclinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the UnitedStates generic medicine approval is based in the demonstration of bioequivalence through comparative bioavailability studies in vivo. These arguments are required for marketing approval of generic medicines by the European and North American health authorities. As a measure of the amount of drug absorbed it is used the area under the curve concentrationtime (AUC), and as an indicator of the rate of absorption it is measured the peak concentration (Cmax) reached in the concentration-time curve and the time for its occurrence (Tmax). It is known as bioequivalence between two products when they have a comparable bioavailability in the appropriate experimental conditions. The ultimate goal of this process is to make quality drugs available to society and contribute to a more rational use of economic resources in the health system.