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Pharmaceutical Pricing and Reimbursement in Brazil
Decision Resources, Inc, December 2009, Pages: 27
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 behaviour 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 unfavourable 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?
- Market drivers and barriers: aging population, socioeconomic trends, public and private healthcare systems, intellectual property rights, branded drugs, and generics.
- Pricing and reimbursement data: autorização de internação hospitalar (AIH; authorization for hospitalization), coefi ciente de adequação de preços (CAP; price adjustment coeffi cient), preço máximo de venda ao governo (PMVG; maximum government sale price), ENCPI, gross national income (GNI), and Relação 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 Saúde Familiar (PSF; Family Health Program), Programa Nacional de Doenças Sexualmente Transmissíveis 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 Estratégico da Assistência Farmacêutica (Strategic Program for Pharmaceutical Assistance), Componente de Medicamentos de Dispensação Excepcional (CMDE; Program for Medicines for Exceptional Dispensing), and Farmácia Popular do Brasil (People’s Pharmacy of Brazil)
Organization and Funding of the Healthcare System
Public Healthcare System
Private Healthcare System
Regulation of Pharmaceuticals
Intellectual Property Rights
Historical Price-Setting Procedures
Current Price-Setting Procedures
Annual Price Adjustments
International Price Comparison
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
1. Main Types of Pharmaceuticals That Dodge the Regulatory System
2. Factors Infl uencing 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
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
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Golden Cross
- Merck Sharp & Dohme
- Neo Química
- Pfi zer
- Sanofi -Aventis
- Sul America