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Disjointed campaign

Some reasons behind the failure to pass legislation came from former State Duma Deputy Sergei Kolesnikov, member of the presidium of the Russian Academy of Sciences. At the discussion stage, he said, many legislators felt that counterfeit medicine was already regulated under extant laws - on fraud, for example.

"This was the way that the several bills that were active - I wrote two of them - were buried, for this reason," Kolesnikov said.

Maximov offered another reason: the lack of a single enforcement body within the government.

"The Federal Service for Healthcare Supervision had significant authority during the formation of one body in 2004, and was moving toward increasing it, which would have allowed a more effective fight," he said.

A change of policy meant that the service's powers were split among different agencies, however, and the incipient Pharmaceutical Inspection Agency was shut down in favor of a system of fines for violators. Protests from the pharmaceutical industry meant that the fines were eventually dropped, too, Maximov said.

A third problem is transparency in state purchases, such as tenders for generic versions of medications.

The example cited in the report was an auction for the right to sell Imatinib, a generic version of Novartis's leukemia medication Glivec, to the Russian government for use in state healthcare facilities. Novartis holds the patent for Glivec in Russia through Apr. 1, 2013, but two separate tenders in August and September last year mean that generic producers are now selling their versions in Russia.

According to an inquiry submitted to ARPO's Public Council for Healthcare and Social Welfare, neither of the winners had secured permission from Novartis to sell them here.

The key question as a result of the auction is, Maximov said, "What Imatinib is found today in the medical facilities of our country?"

Under the Federal Anti-Monopoly Service, he said, consultations were already under way to require production of a documented agreement between a patent-holder and a generic producer, before sales of a generic version of a patented medicine could take place in Russia.

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