Controversial Brazil Pharmacy Decree Awaits Regulation

March 22, 2005

Brazilian health regulatory agency Anvisa has announced that it has sent documentation to pharmacies, issuing guidance on a controversial new law allowing dispensers to split drug packets into new boxes. The measure has already attracted suspicions that it will encourage copy products, but Brazil's government insists that the plans will improve public access to healthcare and drug safety.

The measure establishes that only qualified pharmacists will be able to split drug packets into the quantities stipulated on prescriptions, and will be obliged to print details of the manufacturer, therapeutic type and other details on the new packets. Nevertheless, critics argue that there is already a severe shortage of adequately trained pharmacists, and that the authorities' reliance on the public to report infringements of the new regulations will amount to poor monitoring of drug dispensing. Further, it is unclear to what extent any penalties will be enforced.

Anvisa insists that the measure will prevent households from stockpiling expired medicines and reduce the risks inherent in self-medication. However, statements from other official agencies imply that the new law has more to do with containing the government's drugs bill. Notably, generic drugs will be subject to distinct regulations under the new dispensing system, and the government is counting on the sector to reverse last year's sharp 20% rise in spending to BRL3.5bn (US$1.28bn).