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BRAZIL CONSULTS ON DRUG PACKAGING, DEFENDS PRICE CONTROLS

December 14, 2005

Brazilian drug regulator Anvisa has launched a public consultation on changes in drug advertising, ending in January 2006. The move follows a series of meetings with industry representatives on the future of market regulations.

Regulators expect several changes to packaging rules, especially for OTC products, such as new warnings on risks associated with consumption of drugs and alcohol. In the prescription sector, it could become compulsory for all drugs distributed free of charge to contain the same quantities as normal packets. Further, unit dose dispensing is set to come into effect after January, and regulators recently published a new national formulary.

Meanwhile, a survey by IMS Health claims that Brazil's drug prices are the world's fifth cheapest, at just US$0.18 per standard dose -- roughly a quarter of the US average. Industry representatives have blamed falling drug prices for shrinking foreign investment in recent years, but regulators have defended Brazil's tough controls. One official claims that during the period of price liberalisation between 1992 and 2000, foreign investment in pharmaceuticals was minimal but imports soared from US$100mn to US$2.2bn.