Counterfeit Medicine

On February 1, an experiment on drug labeling began in Russia. And from the beginning of 2018, QR codes on drug packaging will become mandatory. This will help protect the pharmaceutical market from counterfeiting, the Federal Service for Surveillance in Healthcare explains. Market participants are afraid that the result will be a 20% rise in the price of drugs. Experts consider this forecast to be exaggerated.

Labeling experiment

As follows from the recently published decree of the government of the Russian Federation of January 24, 2016 No. 62 "On conducting an experiment on labeling with control (identification) marks and monitoring the circulation of certain types of drugs for medical use", at the initial stage, the total volume of labeled drugs will be about 10 % of the market. We are talking about more than 60 names of drugs, including 10 trade names of drugs intended for the treatment of high-cost nosologies, and more than 30 trade names of drugs from the list of vital and important drugs. Their manufacturers will begin to label medicines with control (identification) marks using a two-dimensional bar code. At the same time, there is no need to make changes to the registration dossier for the drug.

“The main goals of labeling drug packages with a two-dimensional barcode is to enable each buyer to check their legality using a smartphone or a publicly available scanner in a pharmacy, as well as to provide automated protection of legal circulation from substandard and counterfeit drugs,” the Roszdravnadzor explained.

The experiment is conducted on a voluntary basis. According to the ministry, 23 drug manufacturers, four largest pharmaceutical distributors, over 30 medical organizations and more than 250 retail trade organizations expressed their readiness to take part in it. Geography of the experiment: Moscow, Moscow region, St. Petersburg, Nizhny Novgorod region, Novgorod region and Belgorod region.

In the future, when labeling 100% of manufactured drugs, the monitoring system will track about six billion packages per year and will cover more than 350 thousand participants in the turnover, including about 1000 domestic and foreign drug manufacturers, over 100 thousand medical and 250 thousand pharmacy organizations.

From conveyor to counter

The obligation to label each package of medicinal products is spelled out in the concept of "Creation of the Federal State Information System for Monitoring the Movement of Medicinal Products from the Manufacturer to the End Consumer Using Labeling". Along with the transition to reference pricing in state purchases of drugs, labeling is included in one of the five development priorities identified by the Ministry of Health for the next three years.

According to Sergei Kalashnikov, First Deputy Chairman of the Federation Council Committee on Economic Policy, individual labeling is needed to monitor the movement of medicines from the manufacturer to the end consumer and can be considered an analogue of an excise stamp. Thanks to this, each package of a medicine that belongs to a certain batch can be tracked from the moment of release to the pharmacy counter. (Such a system is already working in Belarus). “After the drug passes all clinical trials (confirming its biological equivalence and other compliance with the original drug) and is registered, it is very important to ensure the quality of production. Here, as a rule, a failure occurs, - says Kalashnikov. - In Russia, since the year before last, the GMP system (Good Manufacturing Practice,international standard for production in pharmacology). But in itself this is a half-measure, it is also necessary to ensure maximum control over the production of each package of the drug. This is what individual labeling of the package is for."

Issue price

Earlier, the head of the Ministry of Industry and Trade Denis Manturov said that labeling drugs with QR codes would not affect their cost. According to him, the cost of applying a QR code on each package will not exceed 1 ruble.

Market participants give completely different numbers. In their opinion, the introduction of a monitoring system will require significant costs from pharmaceutical manufacturers for the automation of production, the purchase of additional equipment and software, and the maintenance of databases. As the executive director of the Russian Association of Pharmacy Chains (RAAS) Nelly Ignatieva said yesterday, mandatory labeling could lead to a 20% price increase.

“The Ministry of Industry and Trade estimated the segment of drugs, which was originally planned as a pilot project, at 14 billion. It is an open question to estimate all the costs of the entire drug market for the future, because today there is no clear understanding of what requirements for the system will be formed,” Ignatieva said. - “Pilot” started to answer the questions about the requirements for the system, who will finance it and whether these funds are worth the expediency of its large-scale implementation on the entire market."

According to the director of the Health Independent Monitoring Foundation Eduard Gavrilov, the fears of the head of the RAAS are somewhat exaggerated. Indeed, for the packaging of the cheapest medicinal product, such as activated carbon, this mark-up can be 10% or more. But for the vast majority of drugs, the difference in price will be imperceptible against the background of the usual range of prices in retail chains. “On the one hand, the cost of implementing two-dimensional marking devices on a production line is really high - from 50 to 250 thousand euros. But, on the other hand, pilot projects for the introduction of two-dimensional labeling at Russian pharmaceutical industries have shown that investments in equipment are paid off in a year, and the price of a drug package increases by less than a ruble,”said Gavrilov.

As for the cost of the equipment for reading the label, which must be installed in all pharmacies, it will also be included in the selling price of the drug for the consumer. But even these expenses will slightly affect the increase in the price of drugs, Gavrilov is sure.

Foreign experience

According to Gavrilov, two-dimensional drug labeling is not a Russian invention, and the supply of drugs without labeling to the European market will be prohibited in mid-2018. The developers of the experiment also say that the project was created taking into account international experience.

Meanwhile, in the European Union, the development of the concept of the first stage of creating a system for monitoring the movement of medicines (assigning individual numbers to individual packaging and the possibility of verifying the packaging when handed over to consumers in medical institutions or pharmacy chains), and preparing for its implementation (including conducting pilot projects) has been going on for ten years. And the market participants were familiarized with the main provisions of the system more than five years before the start of the first stage of the project. In the United States, the FDA's timetable for implementing such a system is 10 years.

However, in Russia it is customary to solve problems with a cavalry swoop, clarifying the strategy already "along the way." So, although officially the "pilot" has already started, according to Roszdravnadzor, the software and its installation will be finalized for another four months, and only after that the participants in the experiment will have access to the system.