[Defining generic drugs: an end or a means? Analysis of regulations in 14 countries in the Region of the Americas].
OBJECTIVE
To characterize current regulatory practices and trends relating to competing medications in 14 Latin American and Caribbean countries.


METHODS
Between July 2004 and April 2005 we collected information on national regulations and policies that established or contained a definition of "generic drug" and related terms in 14 Latin American and Caribbean countries: Argentina, Barbados, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, Panama, Paraguay, Peru, and Venezuela. We also compiled information on the incentives to register and produce competing medications, promotion of the use of International Nonproprietary Names (INNs) for pharmaceutical substances, the regulation of bioequivalence studies, and the replacement of prescription medications with less expensive alternatives.


RESULTS
We noted three patterns in the regulations: (1) countries that encourage financial support for competing medications, extensively promote the use of INNs, and place no restrictions on the replacement of innovative (proprietary) medications with competing products (Argentina, Colombia, Costa Rica, Ecuador, and Paraguay); (2) countries with policies aimed at showing therapeutic equivalence, which limits substitutions to approved products from a list of authorized competing medications that must be prescribed by their INN and must use distinctive labeling (Brazil, Mexico, Panama, and Venezuela); and (3) countries at a beginning stage in the process of regulation (Barbados, Bolivia, Guatemala, Nicaragua, and Peru). This variety leads to difficulties in characterizing pharmaceutical markets, and can lead to misleading categorizations.


CONCLUSIONS
Efforts to harmonize policies should consider the possible relationship among definitions adopted in different countries, the development of national pharmaceutical markets, and national policies to stimulate competition.
Vacca González
Claudia Patricia
CP
Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Universidad Nacional de Colombia, Santa Fe de Bogotá, Colombia. cvacag@invima.gov.co
Fitzgerald
James F
JF
Bermúdez
Jorge A Z
JA
D001460:Barbados; D016568:Drugs, Generic / Q000592:standards*; D007843:Latin America; D009626:Terminology as Topic
D016568:Drugs, Generic