Pharmaceutical Market Access in Latin America
With its top eight markets valued at more than $30 billion in 2009, Latin America represents shining hope for an industry in flux.
Strong, steady growth, resiliency in the face of global downturn, positive regulatory frameworks and a motivated public all translate into one of the world’s leading emerging markets.
Yet, with seven cultural groups, an estimated population of 568 million and every political philosophy from left to right, the region also poses significant barriers. In some countries, such as Columbia, Mexico and Chile, right-of-centre politics mean a favorable regulatory environment and government support. In Venezuela, Ecuador, Bolivia and Nicaragua, however, left-leaning administrations can pose challenges.
And while country members of the Mercosur and Andean groups have joined forces to combine regulations and approval processes, there have been delays along the way. Regulatory frameworks overall have improved as a result of free trade and intellectual property agreements. Yet many administrations—intentionally or not—have promoted the generic industry.
Navigating such a diverse, colourful and dynamic region requires local knowledge, expert insight and up-to-date reporting. In Pharmaceutical Market Access in Latin America, FirstWord offers the roadmap the industry needs to tap into Latin America’s possibilities. The report, which features extensive interviews with industry and government leaders, explains the regulatory, legal and geo-political environment, country by country. The dossier offers up-to-date insights into the use of market access consultants, five case studies of major firms’ experiences and an in-depth breakdown of inter-governmental pharmaceutical agreements, by institution or country.
The report offers insights into:
Key features
Companies profiled in the case studies
Strong, steady growth, resiliency in the face of global downturn, positive regulatory frameworks and a motivated public all translate into one of the world’s leading emerging markets.
Yet, with seven cultural groups, an estimated population of 568 million and every political philosophy from left to right, the region also poses significant barriers. In some countries, such as Columbia, Mexico and Chile, right-of-centre politics mean a favorable regulatory environment and government support. In Venezuela, Ecuador, Bolivia and Nicaragua, however, left-leaning administrations can pose challenges.
And while country members of the Mercosur and Andean groups have joined forces to combine regulations and approval processes, there have been delays along the way. Regulatory frameworks overall have improved as a result of free trade and intellectual property agreements. Yet many administrations—intentionally or not—have promoted the generic industry.
Navigating such a diverse, colourful and dynamic region requires local knowledge, expert insight and up-to-date reporting. In Pharmaceutical Market Access in Latin America, FirstWord offers the roadmap the industry needs to tap into Latin America’s possibilities. The report, which features extensive interviews with industry and government leaders, explains the regulatory, legal and geo-political environment, country by country. The dossier offers up-to-date insights into the use of market access consultants, five case studies of major firms’ experiences and an in-depth breakdown of inter-governmental pharmaceutical agreements, by institution or country.
The report offers insights into:
- The regulatory, geo-political and economic environment of 10 Latin American regions
- The increasing use of market access consultants by major pharmaceutical firms
Key features
- A country-by-country breakdown of major players, newcomers, infrastructure and industry operations
- Five case studies of major pharmaceutical companies
- Charts on inter-governmental agreements, legal and national public policy environments
- Description of attempts to standardize regulations and policy approval processes
Companies profiled in the case studies
- GSK in Argentina
- Ranbaxy in six regions
- Frensenius Medical Care in Columbia
- Pfizer in Venezuela
- Bristol-Myers Squibb in Latin America
EXECUTIVE SUMMARY
THE LATIN AMERICAN PHARMACEUTICAL MARKET
THE REGULATORY ENVIRONMENT
IN LATIN AMERICA
THE INCREASING USE OF MARKET ACCESS
CONSULTANTS BY BIG PHARMA FIRMS
DRUG REGISTRATION
LEGAL, REGULATORY, AND GEO-POLITICAL CLIMATES
Latin America overall
Inter-governmental pharmaceutical agreements
The pharmaceutical legal environment
National public policy environments
Argentina
Brazil
Central America
Chile
Colombia
Cuba
Ecuador
Mexico
Peru
Venezuela
Case studies of market entry strategies
GSK in Argentina
Ranbaxy across Latin America
Ranbaxy in Peru
Ranbaxy in Central America
Ranbaxy in Venezuela, Ecuador and Colombia
Ranbaxy in Brazil
Ranbaxy in Mexico
Fresenius Medical Care in Colombia
Pfizer in Venezuela
Bristol-Myers Squibb in Latin America
INDEX
THE LATIN AMERICAN PHARMACEUTICAL MARKET
THE REGULATORY ENVIRONMENT
IN LATIN AMERICA
THE INCREASING USE OF MARKET ACCESS
CONSULTANTS BY BIG PHARMA FIRMS
DRUG REGISTRATION
LEGAL, REGULATORY, AND GEO-POLITICAL CLIMATES
Latin America overall
Inter-governmental pharmaceutical agreements
The pharmaceutical legal environment
National public policy environments
Argentina
Brazil
Central America
Chile
Colombia
Cuba
Ecuador
Mexico
Peru
Venezuela
Case studies of market entry strategies
GSK in Argentina
Ranbaxy across Latin America
Ranbaxy in Peru
Ranbaxy in Central America
Ranbaxy in Venezuela, Ecuador and Colombia
Ranbaxy in Brazil
Ranbaxy in Mexico
Fresenius Medical Care in Colombia
Pfizer in Venezuela
Bristol-Myers Squibb in Latin America
INDEX
