Counterfeit drugs and law n. 11.903/09: legal aspects and impacts

Abstract

The objective of this article is to describe federal regulations that regulate the pharmaceutical chain and existing mechanisms to prevent counterfeiting, to assess the number of counterfeit drugs during the period 2005 to 2009 and especially to describe the scope of Law n. 11.903/09 and major implications for the chain through literature review and a questionnaire completed by pharmaceutical industries' associations. The number of batches of counterfeit drugs increased during the period 2005 to 2009 in Brazil. The inclusion of an authenticity mechanism (security label) and traceability (two-dimensional code) in all drugs' packages stipulated by Law 11.902/09 can reduce the number of cases of counterfeit drugs; however, other measures must be carried out concurrently to prevent the illicit market, such as continuous monitoring and public awareness of the risks of counterfeit medicines. The implementation of the new system will lead to increase costs in the pharmaceutical chain, particularly in the pharmaceutical industry, especially if it is ratified the inclusion of the label. The challenges for implementation of the system include the system complexity and the number of parts involved - the country has about 3,800 distributors and over 79,000 prescription pharmacies and drugstores - as well as the deadlines defined by this law.