A law aimed at improving Russians' access to innovative medicines has backfired badly.
'On the circulation of medicines', a law that came into effect in September 2010, was intended to streamline the bureaucratic system for testing and registering new drugs in Russia. There were high hopes that it would also boost the nascent domestic pharmaceutical industry and attract foreign companies to run trials there. The law set a maximum cost and time limit for drug registrations, for example; mandated compensation for those injured during trials; and declared that drugs manufactured in Russia solely for export did not need to undergo registration.
But the law has actually hampered clinical trials and limited the number of drug approvals over the past year, according to a report from the Association of Clinical Trials Organizations (ACTO) in Moscow, which represents companies conducting clinical trials in Russia.