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FAS Has Established

It turned out that prices for these products are generally 29% lower than minimum prices in 38 countries, while Russian prices are lowest for 58 items.

However, for 95 items lower prices were detected. Commenting on this situation, Timophey Nizhegorodtsev, Head of Social Sphere and Trade Control Administration, FAS of Russia  remarked, that for all cases of overstatement of approved maximum manufacturers’ prices in Russia over the minimum prices in reference countries, measures will be taken to decrease the prices.

In particular, it is suggested to oblige marketing authorization owners or holders for international drugs to review the approved prices for drugs if such prices are decreased in the reference countries. Besides, MA owners will have to review prices for generic drugs, if prices were decreased for the corresponding reference drugs. It is suggested to introduce the relationship between the price indexation level and the price group of products and introduce a differentiated decreasing coefficient for generic drugs depending on the price group of the reference drug, define prices for reference drugs, considering expenses for development and commercialization with limited breakeven level.

It is suggested to switch local generic drugs from the “cost-based” method of registration of prices to indicative  (based on comparison with prices for reference drugs and weighted mean sales prices), which will help avoid discrimination of local manufacturers relative to foreign manufacturers.

The list of reference countries will also be revised.

The state register of prices for drugs will be reviewed on an annual basis.

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