Further Product Information

AUTHOR(S):

Claudia Patricia Vacca González is pharmacist and pharmaco-epidemiologist. She is also Assistant Professor at National University of Colombia and coordinator of Research group Network for Rational Use of Medicines (Net RUM). She is President of Drug Utilization Research Group (DURG-LA).

James F Fitzgerald is Consultant of Essential Drugs, Vaccines, and Health Technologies Unit at Pan-American Health Organization, Washington, DC.

Joan Rovira is Economist and Emerital Professor of Barcelona University. She is also Consultant for World Bank and External Consultant for Panamerican Health Organization.

ABSTRACT

The purpose of this study was to establish regulatory trends related to competing drugs in several Latin American and Caribbean countries and to review regulations and national policies on generic drugs in these countries. Furthermore, information on the incentives to register and produce competing drugs, the promotion of international non-proprietary name (INN) use, the regulation of bioequivalence studies and the substitution of drugs prescribed by lower price alternatives to the public was also obtained. The results showed three regulatory categories: those countries that favour financing of competing drugs and the extended promotion of INN use, without restricting the substitution of innovative drugs with competitors; those that have a scheme oriented to the demonstration of the therapeutic equivalence, that is, countries that restrict the substitution of the original drugs to some authorised competing drugs; and those that are in an incipient stage of their regulation process. This variety causes difficulties in the characterisation of the pharmaceutical markets and can generate fictitious segmentations. In conclusion, harmonisation efforts should take into account the possible relationship among the definitions adopted by the countries, the national pharmaceutical markets development and their incentive policies for competition.

ABOUT THE JOURNAL Journal of Generic Medicines ISSN: 1741-1343 The Journal of Generic Medicines is guided by its respected Editor Greg Perry (European Generic Medicines Association) and an international Editorial Board of leading practitioners and Association representatives from the generics industry. Journal of Generic Medicines is the major, international business journal written by and for expert analysis, briefings and legal updates on all aspects of business development, regulatory affairs, manufacturing and marketing affecting the generic pharmaceutical industry. Each quarterly issue publishes analyses, briefings and updates which are of direct relevance to practitioners and that meet the highest intellectual standards.