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BRAZIL APPROVES MANDATORY GENERIC DISPENSING PLAN

September 19, 2005

A legislative committee in Brazil has approved a draft law that could oblige pharmacies to stock a "minimum" amount of non-branded drugs on the national essential medicines list.

Industry sources had feared that the measure could force pharmacies to sell so-called "similar" drugs, or potential copies of patented medicines. Pharmacies will also not be obliged to stock the entire essential drugs list, as originally planned.

The proposals -- which have yet to receive final approval -- could be positive for branded drug manufacturers, as pharmacies will explicitly not be forced to stock copy medicines that have not been subjected to bioequivalence tests.

Further, any drugs made available under the proposals will have to be already available on the market. US associations recently acknowledged that the incidence of copying of patented drugs is relatively low in Brazil. However, the country has only 300 true generics on the market, despite strident government efforts to boost sales in order to improve access to medicines.