Brazil Drug Regulator Urged to Resist Government Pressure

Drug industry groups in Brazil have urged national regulator Anvisa to implement effective drug regulation, despite government pressure to ensure the provision of so-called similar medicines at the lowest possible cost.

Industry groups at least credit Anvisa with some progress in protecting public safety, even if intellectual property controls remain highly flawed. A significant reform introduced in 2003 enabled the agency to oblige drugmakers to submit clinical trial data supporting bioequivalence with branded products. Basic manufacturing standards were also introduced, along with tougher regulations on quality and bioavailability, which have reportedly led to increased takeup by prescribers.

Nevertheless, drug industry federation Febrafarma continues to cite long delays to Anvisa's clinical trials and the glacial pace of new product approvals. The association claims that Anvisa's main activity continues to be the relatively inexpensive business of issuing regulations, rather than actively enforcing industry standards.

According to Febrafarma, political interference and red tape -- especially visible in Brazil's failure to align national and municipal legislation -- is starving the industry of much-needed investment. Further, unwieldy price controls implemented in 2000 have failed to improve universal access to medicines, as existing measures have proved widely unenforceable.