In Russia, labeling of medicines is mandatory from July 1, 2020. It was introduced in order to prevent illegal circulation of medicines and the secondary sale of expensive medicines for the treatment of serious diseases, which the state purchases for hospitals.
The drug labeling experiment began in 2017. From October 1, 2019, the procedure has become mandatory for drugs from the list of high-cost nosologies (it includes expensive drugs intended, in particular, for patients with hemophilia, cystic fibrosis, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, etc.), and from July 1, 2020 - for everyone else.
Earlier, pharmaceutical associations have repeatedly stated the risk of significant price increases that may arise with the introduction of mandatory labeling of all drugs. In mid-July 2020, six associations of pharmaceutical manufacturers also asked Prime Minister Mikhail Mishustin to simplify the procedure for introducing unlabeled medicines into circulation, explaining that otherwise there may be drug outages in the coming months. Representatives of the associations drew attention to the fact that putting into circulation under the new rules can take several months - some regulations are not ready, moreover, it takes time to collect the necessary documents and register them in the information system.
Is it really worth being afraid of higher prices for medicines and their shortages in pharmacies?
According to the Minister of Industry and Trade of the Russian Federation Denis Manturov, labeling will not lead to an increase in their cost or a shortage of drugs. "By definition, labeling cannot cause a deficit, as well as a rise in prices," he said in an interview with TASS.
According to Manturov, the law on compulsory labeling of drugs is already yielding results. In particular, pharmacies began to identify drugs intended only for dispensing to patients in hospitals. According to the minister, many unscrupulous clinic workers resell hospital drugs to pharmaceutical outlets. Labeling reveals such patterns and makes the drug market transparent.
What measures have been taken to prevent drug shortages?
According to Manturov, a number of mechanisms are envisaged to prevent shortages, which should help companies that, for objective reasons, failed to label certain series of drugs after July 1.
Foreign manufacturers can apply means of identification to their drugs in customs warehouses licensed for pharmaceutical activities. There are seven such warehouses in Russia, the minister said.
Also, Russian and foreign manufacturers can apply to the interdepartmental commission under Roszdravnadzor to obtain approval for the import or introduction of drugs into circulation without applying identification means.
Such rules apply to medicines manufactured before October 1, 2020.
How much does drug labeling cost?
According to Manturov, the Center for the Development of Advanced Technologies (CRPT), which is the labeling operator, is obliged to provide labeling codes for drugs free of charge, at its own expense, no more than 20 rubles. The cost of labeling more expensive drugs is 50 kopecks.