New labeling rules or who will pay for a broken system!

Failures in the labeling system lead to a shortage of drugs on the market. Hundreds of millions of packages of medicines have accumulated in warehouses and quarantine zones of the distribution chain. To avoid a collapse, the Government has simplified the procedure for working with the drug monitoring system. The new regime will operate until the full readiness of the industry participants. The changes apply to all drugs, both produced in the country and imported into the Russian Federation, with the exception of drugs from category 12 high-cost nosologies. The document contains simplified mechanisms and a notification character when working with the system. According to the regulator, the industry is to blame for the current situation, and not the operator, which did not prepare the system for work under load.

Victor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers, believes that these changes affect the goal-setting of the system. Now pharmacies will be able to dispense drugs without waiting for a response from the system. Of course, this will partially solve the problem of drug movement from the manufacturer to the patient, but where is the guarantee whether he will receive a quality medicine? Initially, the purpose of drug labeling was to combat counterfeit and substandard products.

“The amendments do not abolish the payment for the labeling code, which means that manufacturers, if the system is not working, will pay 50 kopecks to the operator and 10 kopecks VAT for each control identification mark. It turns out that regardless of want we it or not, the country has introduced a new tax on medicines. The system does not function, but you will have to pay. For what? It is necessary to exempt producers from paying until the system starts working in “combat mode,” said Victor Dmitriev.

 During the debugging of the system, penalties should not be applied to all participants in the distribution chain. There are cases when, due to failures in Drug Movement Monitoring (DMM), pharmacies were fined for lack of a minimum assortment. For the same reason, manufacturers run the risk of being included in the list of unscrupulous suppliers, since they cannot fulfill government contracts for the supply of drugs.

Victor Dmitriev ironically says that until now the DMM operator has identified four weak links: manufacturer, pharmacy, distributor and medicine. The amendments to the Government Decree No. 1556 remove only two: the distributor and the pharmacy. It remains to exclude the manufacturer and the drug, and the system will work without failures.

“Today the illusion is created that everything works. It is necessary not to make "cosmetic" adjustments to regulatory documents and point changes, but to make serious decisions. The system must be stopped and improved. After that, conduct full-scale testing with industry representatives. It is necessary to legislatively approve the criteria for the acceptance of the system and indicators of the quality of work,” summed up the head of the ARPM.

The association continues to insist on the introduction of financial liability for the operator. To ensure the uninterrupted operation of the drug supply system, in case of failures, determine alternative operators on a competitive basis. For example, SBER or FTS.

Пресс-служба АРФП