“There will be no postponement of labeling unless force majeure occurs,” said Irina Golovina, Deputy Director General of the Federal State Budget Institution Information and methodological center for examination, accounting and analysis of circulation of medical devices of Federal Service for Surveillance in Healthcare (Roszdravnadzor), on the sidelines of the pharmaceutical industry digitalization forum on October 28 at the First Sechenov Moscow State Medical University. But at least three such cases have already occurred during the experiment. What the regulator calls force majeure is perceived by business as a hoax!
The first is the initiative to introduce additional crypto protection (Decree of the Government of the Russian Federation of April 28, 2018 No. 791-r). Pharmaceutical manufacturers who invested millions in the labeling project needed to increase funding to make changes to information and production processes. In addition, this innovation significantly complicated the process of introducing labeling, not to mention the fact that it contradicts international standards and runs counter to European experience.
Second, the Government of the Russian Federation approved a fee for “rendering services for the provision of marking codes … in the amount of 50 kopecks for 1 marking code excluding value added tax” (Decree of the Government of the Russian Federation of May 8, 2019 No. 577). At the start of the experiment, the fee was not supposed.
Third, manufacturers have long and hopefully waited for a government decision to change the number of signs. As a result, 88 characters were reduced to 44, instead of justified 20. Why did they leave just such a number is not clear ?!
Due to all these changes, the marking participants have repeatedly had to change and reconfigure equipment, retest, make adjustments to business processes and incur significant financial losses. And they will have to be compensated by the end consumer, that is, patients.
A new problem is ripening today. Pharmaceutical companies offer opening them access to product data in the drug labeling and movement system. The Federal Law of December 28, 2017 No. 425-FL “On Amendments to the Federal Law“ On the Circulation of Medicinal Products ”states:“ Pharmaceutical manufacturers receive information contained in the drug movement monitoring (DMM) system for medical use on series and batches of medicinal products, produced by them and in civil circulation in the Russian Federation, free of charge." Thus, it was initially assumed that the owner of the drug with the click of a button can trace its movement along the entire distribution chain to the final consumer. However, the Advanced Technology Development Center (ATDC) cannot provide information to companies today. The DMM system is owned by the state, and by-laws are required to permit the dissemination of this data.
Revaz Yusupov, Deputy General Director in Public Relations and Marketing of the ATDC, said that “The ATDC advocates that pharmaceutical and other manufacturers gain access to them and use them to optimize business processes and increase their efficiency. The idea of obtaining full traceability of its products by the manufacturer was laid in the basis of the system concept. If access to such data is open at the legislative level, we are ready to implement it. ”
The pharmaceutical industry notes that obtaining online information for each product item from the labeling system is essential. They will be able to replace marketing research to companies and will optimize the production plan, redistribute financial flows and reduce costs. In addition, increasing the transparency of the passage of a particular drug throughout the supply chain until the time of disposal will show the availability of drugs and help to avoid lacks in the drug market.
“The DMM system itself is a chic resource that allows to solve many problems, but you need to consolidate the amount of information that manufacturers will be able to get from the system,” Geropharm Director for Economic Security Andrei Akhantiev emphasized at a conference on the pharmaceutical industry.
Evgeny Nifantiev, General Director of Neofarm Group of Companies, has the same opinion: “Manufacturers should be able to receive information about wholesale solutions. That is why the market needs labeling, including for combating pouring out. If the manufacturer does not have information where the goods are resold at the wholesale link, then we won’t be able to destroy the pouring out. ”
Director General of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev said that “due to numerous changes and deviations from the launch project, in which the business believed and started to implement, today the degree of trust in the “labeling ”project is extremely low. He became a barricade between the federal organizations involved in it and business. Now we have a unique opportunity to bring our positions closer and increase our trust in each other, we need to do what is prescribed in the law, and in particular, to ensure that the manufacturer can monitor the movement of its products online for free. This is useful to everyone, not costly for the industry and will increase the rating of those in power. ”
Manufacturers are also supported by deputies of the State Duma. Following the results of the parliamentary hearings “On the implementation of the federal state information system for monitoring the movement of drugs for medical use” on October 15, the Government of the Russian Federation recommended: “Together with the State Duma, develop and introduce amendments to the legislation of the Russian Federation aimed at securing the rights of participants in the federal state information monitoring system of movement of drugs for medical use to receive information online about the presence of residues and the movement of medicinal products shipped by them to accurately form production plans, sales and management of drug residues and other possible necessary changes. "
It turns out that all participants are interested in this information and the technical capabilities allow it to be transmitted, we have to wait again and hope that in 2 months the necessary by-laws will be developed and all necessary approvals will be passed. In the meantime, the analytical capabilities of the DMM system will be used to a limited extent, which, as before, will not allow the Ministry of Health of Russia, manufacturers and distributors to have reliable information about the availability of specific drugs in the country as a whole, and in individual regions, which means that no one is insured from the occurrence of lack in certain drugs on the drug market.