Anticounterfeiting Committee Update: Survey Sheds Light on Health Care Counterfeits in Latin America and the Caribbean

Published: November 15, 2019

A new survey conducted by INTA’s Anti-Counterfeiting Committee (ACC), Latin America Subcommittee revealed a substantial need for greater awareness regarding the problem of anticounterfeit health care products. The Gap Analysis of Anticounterfeiting Efforts in the Pharma Industry in Latin America survey analyzed the structural framework of this crucial issue, as well as legislative and enforcement authorities, applicable sanctions, and current consumer awareness, on a per-country basis.

Purpose of the Study

Counterfeit health care products have unfortunately become all too common throughout Latin America, as have other pirated and counterfeit goods. This phenomenon encompasses many types of medicine and medical devices-whether over-the-counter remedies, controlled substances, or highly specialized medications-increasing the risk to vulnerable consumers.

This issue is consistent throughout the region, raising its importance as a ubiquitous problem. While brand owners seek to address this issue through currently available legal actions, these efforts can have limited effectiveness. Therefore, there is a need for a more in-depth look at other contributing factors.

The Subcommittee’s goal was to create a comparative study of several aspects that impact the effectiveness of enforcement in each country. The Subcommittee started by listing all of the enforcement authorities, including the judiciary, as well as sanitary and health-related authorities, and the enforcement actions available in every country, whether related to intellectual property infringement or other causes, and also asked if the country has implemented the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), and if and how all the authorities interact to address counterfeiting.

To gain a full picture of the enforcement environment, the Subcommittee also gathered information about available statistics, education, and organizations that spread consumer awareness, such as trade associations, media campaigns, and news addressing cases of counterfeit pharmaceutical and/or medical devices.

Scope of Study

The survey was conducted in 11 countries of the region, and the gap analysis was further created by dividing the region into groups based on affinity or relationship between countries, grouped as South America (Argentina, Brazil, and Chile); Caribbean and Central America (Costa Rica, Dominican Republic, Mexico, and Panama); and the first four members of the Andean Pact (Colombia, Ecuador, Peru, and Venezuela). Representatives of each country provided information on enforcement authorities, legal actions available against counterfeiting, and positions on education and awareness in each jurisdiction. The results were analyzed and summarized in charts delineating where countries were successful and where there were challenges. Based on the information gathered, the goal is to be able to determine the countries or areas on which to focus for an advocacy plan.


Among the results, findings showed a clear need for raising awareness and training of authorities in almost all countries surveyed. Certain countries showed a lack of effective application of regulations or legislation; and moreover, almost all were found to lack a sufficiently proactive approach to action by the authorities. Almost one third of the countries were found to require lengthy proceedings before taking actions, or proceedings in which sanctions did not always reach infringers.

All this concentrated data clearly shows that there is no ideal situation in any country, but some clearly show more room for improvement, such as Brazil and Mexico, countries which, due to their large populations and business volume, have a significant relevance in the region.

As a next step, the findings of this study can help to provide the countries that do not have effective legislations and/or active authorities with the foundation to help them fight against counterfeit products that threaten people’s health and safety, as well as to develop the appropriate mechanisms and tools that have been implemented in other countries where the same have functioned efficiently. It is necessary to encourage the authorities of these countries to adopt the suggested effective measures in order to drastically diminish or eradicate the problem of counterfeit medicines and safety products in Latin America.

Promoting consumer awareness and education regarding the serious damages caused by these products, modifications to current legislation, and other proactive initiatives need to be delivered to the target countries. To this end, roundtables, conferences, and trainings should be conducted based on the experience of the countries with good results to date and with the participation of trademark holders of the products of interest.

Although every effort has been made to verify the accuracy of items in the INTA Bulletin, readers are urged to check independently on matters of specific concern or interest.

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