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Russia considers curbing imports of new medicines

It would take new foreign medications an additional five to seven years to reach the Russian market if the State Duma, the lower house of parliament, passes a revised medication-sales bill stipulating a new medication-registration procedure which is much longer than the current 18-to-24-month process.

Any pharmaceutical company failing to conduct clinical trials of its drugs in Russia can currently submit the relevant data from any foreign laboratory. This clause is vitally important for transnational manufacturers, said Baker & McKenzie lawyer Sergei Lomakin.

The above bill changes the registration process and states expressly that obtaining a clinical-trial permit is a mandatory registration step. "This may put off the sale of advanced drugs in Russia, and some of them may become unavailable for Russian consumers," Lomakin said.

All industrial nations accept the relevant data obtained during trials in accordance with international standards and regardless of the place of such research, said Svetlana Zavidova, director of the Association of Clinical Trials.

"It takes five to seven years to conduct clinical trials for one drug, and these trials may involve thousands of patients," Zavidova told the paper.

An industrial trade association employee and a federal government official said the government had discussed the need for local research at several meetings. They said the Trade and Industry and the Health and Social Development ministries had argued that Russia should not accept the research data conducted "in some banana republic."

It is permissible to register medications that did not undergo clinical trials in Russia, a spokesperson for the Ministry of Healthcare and Social Development said. He said the bill allows companies to submit data on foreign clinical trials for registration but does not bind them to do so.

The marketing of our drugs in Russia will be delayed indefinitely if the bill's clinical trial sections are not interpreted in favor of drug companies, said an official from a European pharmaceutical company.

A Pfizer official said the bill contained vague sections with regard to essential research parameters, including their scale and location. He said conflicting interpretations could lead to the creation of corruption.


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