Pharmaceutical Pricing and Reimbursement in Brazil

Pharmaceutical Pricing and Reimbursement in Brazil published by Decision Resources, Inc. in December, 2009. This report consists of 27 Pages and the price starts from US $ 4600.

Introduction

Abstract

Introduction

Brazil has unequivocally claimed its space in the global pharmaceutical market, with 2008 sales estimated at US$12.7 billion and an on-track goal of booking stronger growth for the future. The country' s growing affluence and increasing life expectancy as well as its highly privatized healthcare expenditure and brand-centric prescribing behavior will stimulate the expanding demand for pharmaceuticals. Further, the country is instating programs to increase drug access to people across the private and public health systems. However, Brazil' s dynamics also include barriers that may threaten its anticipated growth trajectory, including unfavorable coverage of medicines in the public healthcare system, stern intellectual property rules, and moderate use of generics. Nonetheless, an examination of pricing rules and reimbursement activities demonstrates Brazil' s ability to balance the growing need for pharmaceuticals with equitable distribution of medicines for its people.

Questions Answered in This Report

• The population of Brazil is forecast to increase 12.8% in 12 years, from 2008 to 2020. What factors are driving this growth? How is this growth reflected in the working-age population? What impact does an aging population have on Brazil' s economy and pharmaceutical potential?
• Twenty-five percent of Brazil' s population is covered by private health insurance, and the total private health expenditure accounts for more than half of the national health expenditure. How much of that spending is attributable to pharmaceuticals? What issues come into play when considering drug coverage in private and public health insurance?
• Many multinational companies are looking to expand their activities in Brazil because the potential rewards of success are substantial. What are the considerations for companies before they do business in Brazil? Before importing into Brazil, with which offices should companies be in compliance?
• The 1996 Lei de Propriedade Industrial (Law on Industrial Property) allows pipeline patents, facilitating opportunities for drug exclusivities and drug branding rights. However, the Brazilian government also has adopted stern policies that have resulted in granting of compulsory licenses of patents. How has the intellectual property landscape changed over the years in Brazil? Have these changes had a largely positive or negative impact on the international pharmaceutical industry?

Scope

• Market drivers and barriers: aging population, socioeconomic trends, public and private healthcare systems, intellectual property rights, branded drugs, and generics.
• Pricing and reimbursement data: autorizacao de internacao hospitalar (AIH; authorization for hospitalization), coeficiente de adequacao de precos (CAP; price adjustment coeffi cient), preco maximo de venda ao governo (PMVG; maximum government sale price), ENCPI, gross national income (GNI), and Relacao Nacional de Medicamentos Essenciais (RENAME; National List of Essential Medicines),
• International price comparison: a comparison of the prices of 39 widely prescribed drugs in Brazil with prices in other markets, including the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan.
• National programs and legislation: Programa da Saude Familiar (PSF; Family Health Program), Programa Nacional de Doencas Sexualmente Transmissiveis e Aids (National Program on Sexually Transmitted Diseases and AIDS), Programa Nacional do Sangue e Hemoderivados (National Program on Blood and Hemoderivatives), National System for Drug Control, Lei de Propriedade Industrial (LPI; Law on Industrial Property), Componente Estrategico da Assistencia Farmaceutica (Strategic Program for Pharmaceutical Assistance), Componente de Medicamentos de Dispensacao Excepcional (CMDE; Program for Medicines for Exceptional Dispensing), and Farmacia Popular do Brasil (People' s Pharmacy of Brazil)

Mentioned in This Report

• National Offices
• Agencia Nacional de Saude Suplementar (ANS; National Agency for Supplementary Health)
• Agencia Nacional de Vigilancia Sanitaria (ANVISA; National Health Surveillance Agency)
• Camara de Medicamentos (CAMED; Medicines Council)
• Camara de Regulacao do Mercado de Medicamentos (CMED; Pharmaceutical Market Regulation Council)
• Central de Medicamentos (CEME; Center for Medicines)
• Comissao Nacional de Etica em Pesquisa (CONEP; National Commission on Research Ethics)
• Comite de Etica em Pesquisa (CEP; Committee on Research Ethics)
• Comite Interministerial de Precos (CIP; Interministerial Committee on Prices)
• Componente Basico da Assistencia Farmaceutica (Basic Program for Pharmaceutical Assistance)
• Conselho Administrativo de Defesa Economica (CADE; Administrative Council for Economic Protection)
• Instituto Brasileiro de Geografi a e Estatistica (IBGE; Brazilian Institute of Geography and Statistics)
• Instituto Nacional de Assistencia Medica da Previdencia Social (INAMPS; National Institute for Social Security Medical Assistance)
• Instituto Nacional da Propriedade Industrial (INPI; National Institute of Industrial Property)
• Interministerial Group of Intellectual Property (GIPI)
• Ministry of Health
• National Committee of Piracy Combat (CNCP)
• Sistema Unico de Saude (SUS; National Health System)
• Secretariat de Acompanhamento Economico (SEAE; Secretariat for Economic Monitoring)
• Secretariat of Foreign Trade (SECEX), a division of the Ministry of Industry, Commerce, and Tourism
• Farmacia Popular do Brasil (People' s Pharmacy of Brazil)

Companies

• Aché
• Amil
• Aurobindo
• Banyu
• Boehringer Ingelheim
• Braseco
• Bristol-Myers Squibb
• EMS
• Eurofarma
• Gilead
• GlaxoSmithKline
• Golden Cross
• Medley
• Merck
• Merck Sharp & Dohme
• Neo Quimica
• Novartis
• Pfizer
• Ranbaxy
• Sanofi-Aventis
• Sul America

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Socioeconomic Trends
• Organization and Funding of the Healthcare System
  • Public Healthcare System
  • Private Healthcare System
• Regulation of Pharmaceuticals
• Intellectual Property Rights
• Pharmaceutical Pricing
  • Historical Price-Setting Procedures
  • Current Price-Setting Procedures
  • Annual Price Adjustments
  • International Price Comparison
• Pharmaceutical Reimbursement
  • Fully Reimbursed Government Programs
    • Basic Program for Pharmaceutical Assistance
    • Strategic Program for Pharmaceutical Assistance
    • Program for Medicines for Exceptional Dispensing
  • People' s Pharmacy of Brazil
  • Private Health Plans
• Use of Generics
• Outlook and Implications for the Pharmaceutical Industry

Tables

• 1. Main Types of Pharmaceuticals That Dodge the Regulatory System
• 2. Factors Influencing Access to Conventional Prescription Drugs in Brazil
• 3. Ex-Manufacturer Prices of Select Drugs in Brazil and Other Major Markets as a Percentage of U.S. Prices, 2008

Figures

• 1. Brazil Population Breakdown by Age and Sex, 2008-2018
• 2. Private Healthcare Expenditure in Brazil, 2000-2006
• 3. Public and Private Healthcare Delivery Network
• 4. Health System Organization in Brazil
• 5. Proportion of Physicians Accepting Patients from the National Healthcare System According to Clinical Specialty, Brazil, December 2008
• 6. Average Prices in Brazil and Major Markets of a Sample of International Brands as a Percentage of Average U.S. Prices, 2008

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