Affiliations: Chair Jean Monnet EU Law, Granada, Spain E-mail: jlvalver@ugr.es
Abstract: Latin America is a diverse, multi-coloured and dynamic region; boast
the highest life expectancy among developing regions. In Latin America
persistent social exclusion and inequities in wealth distribution and in access
and use of services are reflected in health outcomes. With its population
reaching 600 million people in 2011, Latin American pharmaceutical sales were
at $62.9 billion. LA's pharmaceutical market represents approximately 25%
of global pharmaceutical sales. As a developing market, Latin America is quite
complicated and diverse in terms of regulatory, reimbursement, market,
demographic, and political characteristics. The harmonization of pharmaceutical
regulation has been initiated in conjunction with the creation of regional free
trade zones. Five main free trade zones are developing: North American
Free Trade Agreement (NAFTA); MERCOSUR; Central America;
Andean Area; and The Caribbean Community. Regulatory frameworks overall have improved as a result of free trade and intellectual property
agreements. Regulatory enforcement bodies, quality investigators, proactive
Good Clinical Practice (GCP) and policy development, have been cited as
contributing to Latin America's explosive growth. Latin American countries are currently moving policies to support productive development and
innovation. The local biotechnology industry is developing rapidly.
Keywords: Latin America, health care, pharmaceuticals, free trade, pharmaceuticals law, health policy