Latin American pharmaceutical overview

Article type: Research Article

Authors: Valverde, José Luis

Affiliations: Chair Jean Monnet EU Law, Granada, Spain E-mail: [email protected]

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

DOI: 10.3233/PPL-140384

Journal: Pharmaceuticals, Policy and Law, vol. 16, no. 3-4, pp. 179-206, 2014