The Brazilian private pharmaceutical market after the first ten years of the generics law

Andréa Dâmaso Bertoldi,Luisa Arueira Chaves,Anita K. Wagner,Peter Stephens,Isabel Cristina Martins Emmerick,Dennis Ross-Degnan

doi:10.1186/s40545-019-0179-9

Abstract

ObjectivesTo describe changes in the private market for selected originators, branded generics (‘similares’), and generic products during the 10 years following passage of the Brazilian Generics Law.MethodsWe analyzed longitudinal data collected by IQVIA® on quarterly sales by wholesalers to retail pharmacies in Brazil from 1998 through 2010, grouped by originators, branded generics, and generic products in three therapeutic classes (antibiotics, antidiabetics, and antihypertensives). Outcomes included market share (proportion of the total private market volume), sales volume per capita, prices and number of manufacturers by group.ResultsIn the private market share, generics became dominant in each therapeutic class but the speed of uptake varied. Originators consistently lost most market share while branded generics varied over time. By the end of the study period, generics were the most sold product type in all classes, followed by branded generics. The number of generic manufacturers increased in all classes, while branded generics increased just after the policy but then decreased slowly through the end of 2010. For approximately 50% of the antibiotics analyzed, branded generics and generics had lower prices than originators. For antidiabetics, branded generic and generic prices were quite similar during the period analyzed. Price trends for the various subclasses of antihypertensive exhibited very different patterns over time.ConclusionSales of branded generics and originators decreased substantially in the three therapeutic classes analysed following the introduction of the generics policy in Brazil, but the time to market dominance of generics varied by class.

Highlights

The World Health Organization considers equitable access to safe and affordable medicines as vital to the attainment of the highest possible standard of health by all [1, 2]
The Resolution 2 (2004) of the creation of the new Medicines Regulatory Board (CMED) provides that, at the time of registration of a generic product, its price must be at least 35% lower than the price of the pioneer branded drug to which it refers
This paper aims to describe the changes in the private market for selected originator products, branded generics, and generics during the first 10 years of the Brazilian generics policy

Summary

Introduction

The World Health Organization considers equitable access to safe and affordable medicines as vital to the attainment of the highest possible standard of health by all [1, 2]. Strategies aimed at improving access to essential medicines have been adopted in many countries. Of special relevance are strategies that aim to guarantee the availability of medicines [1]. Despite those initiatives, access to medicines remains an important issue to be addressed in low and middle-income. In Brazil, access to health care and medicines is recognized as a citizen’s constitutional right and the government’s responsibility [4]. The Unified Health System (SUS – ‘Sistema Único de Saúde’) provides free of charge all medicines, which are part of the national list of essential medicines (RENAME – ‘Relação Nacional de Medicamentos Essenciais’). Low availability in the public sector leads to high out-of-pocket expenditures for medicines in the private sector [5]. Data from the household expenditures survey shows that, with 47% of total household expenditures, health care accounts for the fourth most important group of expenses, with a greater

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