Significant increase in pharmaceutical substances imports this year in Russia

Print 05 September 2017
Remedium

Russian drugmakers and foreign companies operating in the country have significantly increased the volume of pharmaceutical substances imports this year, a spokesman for Veronika Skvortsova, Russia’s Minister of Health, recently said, reports The Pharma Letter’s local correspondent.

For the six months of 2017, 6,500 tonnes of substances were imported to Russia with a total value of 28.8 billion roubles (~$485 million). This is 16% more than in the same period of last year in value and almost 26% higher in volume terms.
The main reason for this is the decline of the US dollar, compared to the Russian rouble, as well as the growth of local production, including at the facilities of global drugmakers.

The Russian government has long insisted on the production of drugs in Russia on the full cycle basis, but the production of substances is not part of this.

According to an earlier order of Dmitry Medvedev, Russia’s Prime Minister, 90% of drugs from the list of vital and most important must be produced in Russia by 2019. Currently these figures are estimated at only 60%. Prices for such drugs are regulated by the state: they cannot cost more than the manufacturer's price registered with the Ministry of Health, plus wholesale and retail charges, which are set in the Russian regions.

In the meantime, representatives of the Russian Ministry of Health believe the increase of substances’ imports is a logical step in the development of localization projects in the field of pharmaceutics in Russia.

According to them, companies start with the packaging of drugs, after which they switch to full production cycle. In public procurements, the conduction of packaging operations in Russia is insufficient for the obtaining of preferences from the state.

Russia may permit use of unregistered domestic drugs for treatment of local patients

Also, the Russian Ministry of Health may permit the use of unregistered drugs for the treatment of Russian patients, due to the ever growing calls from domestic producers, according to press-service of the Russian government.

According to Russian drugmakers, it is important to allow domestic patients to use innovative domestic drugs that have already undergone all the necessary studies, but have not yet been registered in relevant state registers. Such a problem, however, does not exist in the case of global drugmakers.

In accordance with the current Russian legislation, imports of unregistered drugs for early access by local patients is only permitted to global drugmakers operating in Russia. The latter is considered as discrimination by local pharmaceutical producers.

Currently the permission for the imports of unregistered drugs into Russia is issued by the Russian government in the shortest possible time, not exceeding five days.

In addition, Russia currently has one of the shortest terms of examination of drugs, which are assessed in terms of quality, effectiveness and the ratio of the expected benefit to the possible risk of use. The period for such examination does not exceed 110 working days. 

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