For two days, the platforms of Komsomolskaya Pravda and the Eurasian Pharmaceutical Forum became centers for discussion of the most acute and relevant topic today — drug labeling.
The participants of the discussion raised issues related to technical nuances, adjusting the system during the transition period, correcting errors and interacting with the DMM (Drug Movement Monitoring) system. These issues are resolved in one way or another thanks to the joint efforts of all subjects of circulation.
But the most acute issue, which sounded almost in all the speeches of the speakers, is the establishment at the legislative level of the responsibility of the ATDC operator to the participants of the circulation chain for failures in the DMM system.
Victor Dmitriev, general director of ARPM, acting as a moderator at both sites, focused on the fact that the responsibility enshrined in the framework of the concluded agreement on public private partnership refers to the regulation of legal relations between the state, represented by the Ministry of Industry and Trade and Operator ATDC LLC and does not apply to the relationship between the operator and the participants in the process, which are regulated by the model contract approved by order of the Ministry of Industry and Trade of Russia dated September 11, 2019 No. 3381.
“We suggested making changes and securing responsibility for the losses caused to the participant and / or third parties in the amount of 100% compensation for the loss due to non-fulfillment or improper fulfillment of the Operator’s obligations.
We sent these proposals on February 1 to the Ministry of Industry and Trade, on the recommendation of the Director of the Department of the Digital Labeling of Goods and Legalization of Product Turnover E.G. Priezzheva and proposed at a meeting of the Interfactional Working Group on improving legislation in the field of drug provision of citizens and circulation of drugs of the State Duma, which were also supported by the deputies.»
Alexander Petrov, deputy of the State Duma, participating in the discussion on the live broadcast of Komsomolskaya Pravda, emphasized the inadmissibility of a situation when drugs cannot be supplied to the hospital in a timely manner due to problems in the operation of the DMM system, and the operator does not answer in any way and does not bear any responsibility for supply disruptions.
“Implementing the state tasks of introducing labeling and creating a transparent market, we ourselves, without knowing it, created another regulator for the industry, on which not only all participants in the distribution chain now depend, but primarily patients undergoing the necessary treatment.
Labeling is a state program in the paradigm of the country’s drug safety and this function should be returned to the state structure,» the speaker also noted.
“One regulator should deal with the circulation of medicines, and not six, as it is now, including the ATDC, which really affects the market,” concluded Alexander Petrov.
As part of an interactive discussion at the Eurasian Pharmaceutical Forum, Yegor Zhavoronkov, head of the Pharma group of ATDC, noting that the DMM system now processes 94% of reports within 10 minutes, drew attention to the fact that it still needs to be stabilized and therefore everyone needs to be patient.
This once again confirmed the Russian proverb “Measure seven times, cut once”. It was necessary to initially fully adjust the system and ensure its guaranteed uninterrupted operation, and only after appropriate full-scale testing, launch it into industrial operation, taking into account the nuances of the pharmaceutical industry, and its structuredness and multiplicity.
The meeting participants also touched upon a number of issues in anticipation of July 1 and the transition to a new stage of the system. The new stage is of particular concern to medical organizations, for which the light mode will be canceled and all interaction schemes between the participants will become mandatory.
In turn, patient associations state that 42 INNs have disappeared from the market. Due to frequent failures in the operation of the DMM system, patients are faced with situations when, receiving a preferential drug, they find a hole on the package, due to the pharmacy, in order not to stop the process of dispensing drugs, cutting out label codes to enter this information into the DMM system later, when the system will come into working condition. The same often appears at vaccination points.
Despite the numerous difficulties and problems that the industry solves, in general, the participants in the discussions stated that drug labeling is necessary and using it, many issues can be resolved. They expressed the hope that the effectiveness of the system can be seen already in the medium term, but for that to happen it is necessary to work harmoniously and constructively, overcoming the emerging barriers.