Russia considers making market access for generic drugs more difficult

Yesterday’s business daily reported that the Russian Ministry of Health considers amending the existing law on pharmaceuticals in a way that will make it much more difficult for generic drugs to access the market. The Ministry of Health defined the criteria for substitution of the original drugs with their generic counterparts, requiring the latter to have a “full therapeutic equivalent” with the originals – something that can only be established by performing a full range of clinical tests lasting approximately one year and involving a minimum of 150 patients. Clinical tests for oncological drugs can take up to five years. The current law requires the generic drugs to be accompanied only with a proof of bio-equivalence and toxicological data, which can be provided within three months, with the participation of a minimum of 18 patients. Testing required to prove full therapeutic equivalence is approximately ten times more expensive than the testing for bio-equivalence.

One of the industry experts provided the example of the eptacog alfa enzyme (a blood coagulation factor), for which the Russian Ministry of Health spent 763 million rubles (USD 25.3 million) in 2008; a year later, a supplier of a generic competitor participated in the tender and the cost went down to 438 million rubles (USD 14.55 million). Hence, experts argue, it is obvious that the drug expenditures will go up should the Government introduce stricter market access requirements for generic drugs, which is contrary to the Government’s plan outlined in its “Pharma-2020” strategy.


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