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What Does the Labeling Keep in Store for Us?

Yesterday, on February 1, a pilot project was launched  for labeling of drugs, intended to protect the pharmaceutical market from counterfeit products.

It should be reminded that 60 drugs are involved in the experiment. Ten of them are included into the state program for treatment of orphan diseases, 30 are included into the VEDL. As of 2018 it is planned to make drug labeling compulsory for all manufacturers in Russia. Mikhail Murashko, head of Roszdravnadzor, believes that the price for medicinal drugs will increase minimum by 50 kopecks as a result of this measure. Arkadiy Dvorkovich, Vice Premier Minister of the RF is of the same opinion.

The experiment will continue for one year, its first results will be summarized on December 1. The first labeled drugs within the project will be available in Russian pharmacies in summer. According to Nickolay Demidov, Director of IMS Health Russia and CIS, the stepwise implementation plan suggests that at first the experiment will relate to drugs within state programs. Labeled drugs will appear in pharmacies not earlier than in May-June this year. Then readers will be installed in pharmacies. Actual functioning of the system is suggested to begin in H2 2018. According to Demidov, the price increase will be insignificant, around 1 – 1.5%. It will happen gradually within one to three years.

However, pharma market representatives are not so optimistic. According to a study performed by experts of the Russian Association of Pharmaceutical Networks (RAAS) the labeling of drugs will certainly lead to increased prices: the mechanism of 2D datamatrix application will require additional costs for equipment. It will require purchase of QR-code readers, additional personnel, software. According to preliminary calculation, according to the Executive Director of the Russian Association of Pharmacy Networks, Nelly Ignatieva, prices for drugs will increase by 15-20% on the average.

But the experiment is intended to find answers to questions, weight pro’s and con’s, specify requirements to the system, sources of financing, the need for large-scale implementation.

Eurasia Economic Commission also reviewed the advisability of implementation of labeling. The issue of labeling standard compatibility within the union was discussed, its members remarked, that the pilot project of labeling, planned for implementation in Kazakhstan, is quite interesting, but will require detailed review. A representative of the Republic of Belarus supported labeling, but voiced concerns over increased retail price for patients or decreased profit of manufacturers. Representatives of Armenia were of the same opinion.

The Eurasia Commission has not yet taken any specific decisions.

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