Multisource drug policies in Latin America: survey of 10 countries

Bulletin of the World Health Organization | January 2005, 83 (1)
Núria Homedes & Antonio Ugalde

Abstract Essential drug lists and generic drug policies have been promoted as strategies to improve access to pharmaceuticals and control their rapidly escalating costs. This article reports the results of a preliminary survey conducted in 10 Latin American countries. The study aimed to document the experiences of different countries in defining and implementing generic drug policies, determine the cost of registering different types of pharmaceutical products and the time needed to register them, and uncover the incentives governments have developed to promote the use of multisource drugs. The survey instrument was administered in person in Chile, Ecuador and Peru and by email in Argentina, Brazil, Bolivia, Colombia, Costa Rica, Nicaragua and Uruguay. There was a total of 22 respondents. Survey responses indicated that countries use the terms generic and bioequivalence differently. We suggest there is a need to harmonize definitions and technical concepts.

An increasing number of pharmaceuticals are available in the world market and yet many people in developing countries do not have access to medicines that can save lives and/or reduce suffering. Financial affordability is the main barrier to access (1–5). In Latin America the cost of medicines has increased at a rate faster than inflation. The number of pharmaceutical units sold in many countries in the region decreased despite increased drug expenditures, confirming that access to medicines has become more difficult (3, 6, 7). To ensure that countries have access to needed medicines at an affordable price, WHO has recommended the use of essential drug lists to guide drug selection, registration and procurement by governments; it has also recommended the implementation of policies to promote the use of generic drugs (4, 8–10). The need to increase the availability of and access to generic drugs has gained visibility with the failure of antiretroviral therapy to reach patients in the developing world (1). In response to these problems and recommendations, many countries in Latin America have recently taken steps to increase the use of cheaper off-patent drugs.
This article reports the result of a survey conducted in June 2003 in several Latin American countries. The aim was to document their pharmaceutical policies. In this paper we present data on the existence of generic or multisource drug policies, the cost and time needed to register the different types of pharmaceuticals, and the incentives used to promote the use of generic or multisource drugs.

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