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www.fdanews.com/articles/68645-brazil-parliament-debates-decree-to-allow-split-drug-dispensing

Brazil Parliament Debates Decree to Allow Split Drug Dispensing

February 11, 2005

A presidential decree to authorise the sale of drugs at the exact prescribed dose, which would involve splitting packets into smaller batches, has been under recent discussion in Brazil's Congress. The plans have caused substantial controversy on grounds of safety, as the pills could be sorted incorrectly into new packets, and have attracted criticism due to likely effects on drug company sales.

Nevertheless, the current debate is understood to be nothing new. According to a former health official, the predecessor agency of national drug regulator Anvisa first issued the regulations in November 1993, which could even now be legally binding. The plans envisaged the separation of the drugs and their inclusion, with basic validity and active ingredient information, in new packets distributed by pharmacists.

Adding to the confusion, Anvisa's current chief insists that the original decree was revoked and, if passed, that the new measure will become the only one in force on the issue. However, the local multinational sector is unlikely to welcome the new measure, which may remove some of their few remaining protections against counterfeit drugs.