New Phase of Mandatory Drug Labeling in Russia

| By | Drug Label, Russian Pharma
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In Russia, a new phase of mandatory labeling of drugs begins. From July 1 to July 8, manufacturers, distributors, pharmacies are required to register in the Drug Movement Monitoring (DMM) system to work with high-cost nosologies.

The introduction of a unified automated database of monitoring drugs and the formation of a transparent system of quality control of drugs is necessary. The business fully supports the innovation, actively participates in the labeling experiment, but the application of cryptographic bar codes in accordance with the requirements of the Government Decree No. 1556 of December 14, 2014 is not possible. This is due to the fact that the percentage of defects is 20-30%, and in some cases reaches 89%, which is unacceptable, since it leads to large financial losses for producers. In addition, productivity decreases, the cost increases, and as a result, the final selling price of drugs rises.

The arguments of the manufacturers are not heard in the authorities responsible for the implementation of the project. In this regard, 6 unions sent a letter to the Prime Minister of the Russian Federation D.A. Medvedev. In the document, they expressed their concern about the low readiness of the industry and possible destabilization in the drug market.

The document states that “carried out testing of printing of means of identification with a cryptocode content in accordance with the parameters of the Decree of the Government of the Russian Federation No. 1556 of 12/14/18, show that the vast majority of drug manufacturers cannot print identification tools on the installed equipment while maintaining the required print quality of the identification means and without significant deterioration in the regulatory parameters of defects and productivity for the production, and without the need for significant modification or replacement of already installed hardware and software“.

Manufacturers ask to reduce the DataMatrix code to 20 characters and postpone the launch of the industrial exploitation of the drug labeling system to 2021 “given the availability of all necessary infrastructure.” Until now, there is no common position on the length of the “cryptotail”. According to current regulations, 88 characters are assigned. But on June 13, at a meeting at the Ministry of Industry and Trade, Deputy Minister Sergei Tsyb said that the government would accommodate pharmaceutical companies and reduce the crypto-security code to 44 characters to simplify the implementation procedure. The ministry prepared an interdepartmental draft document, it was assumed that the changes will be made before the end of June. But nothing happened. In addition there will be no postponing of the introduction of mandatory labeling, as requested by manufacturers. The ministry is confident that the participants in the experiment will have time to test the innovation, and the start will be successful. The same optimistic attitude is also expressed by Dmitry Alkhazov, the Executive Director of the Center for Development of Advanced Technologies. He stressed at the labeling conference on May 24: “a change in the requirements for the code does not require a total transformation of the marking process. Typing 2,20 or 44 characters is the same.” Although on December 18, 2018, the CDAT press office spread the information that “the CDAT supports the pharmaceutical industry initiative and confirms its readiness to reduce the length of the labeling code in order to accelerate the implementation of the system”.

Now 19,223 participants are registered in the DMM system, although it is assumed that about 350,000 should participate in the program. Recall that the drug labeling experiment began in 2017. Its goal is to increase the transparency of the movement and accounting of medical products, to exclude counterfeit products from circulation. According to the Government Decree No. 62 of January 24, 2017, “On Conducting an Experiment on Labeling with Control (Identification) Signs and Monitoring the Circulation of Certain Drugs for Medical Use”, from October 1, 2019, the first stage of mandatory labeling of high-cost nosologies begins, 2020 this initiative applies to all medicines and products.

During the two years of the project’s existence, the rules and the regulatory framework are constantly changing. So initially, the law said that data transfer was free, but after changing the data transfer operator, a sum of 50 kopecks appeared per code plus VAT, which is 3.5 billion rubles a year for the entire drug market.

According to General Director of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev, “only those drugs that are cheaper than 20 rubles do not fall under the obligatory payment of a code, but if the price is even 2 kopecks more, it will become more expensive by at least 60 kopecks, or even more. And these are the very drugs that are used daily by socially vulnerable segments of the population. Thereafter, such a measure would significantly hit the patients’ wallets.”

Victor Dmitriev stressed that “in order to change the current situation, it is necessary to fully implement 425 Fl of 12/28/2017“ On Amendments to the Federal Law “On Circulation of Medicines”.

The pharmaceutical industry is seriously concerned about the current situation, which could lead to a man-made collapse. In addition, the business does not understand how to start living from January 1, 2020 in a new way, and the results of the experiment will be summarized only a month later in February. Manufacturers still insist on holding parliamentary hearings, a detailed analysis of the already done work and the postponement of the start of mandatory labeling for an indefinite period until all acute problems are resolved.