Fifty days before the start or how to live after July 1?

Labeling of drugs starts on July 1, or again, for objective reasons, the start will be postponed? The issue of postponing the start of drug labeling is particularly acute in a pandemic when the uninterrupted and timely provision of drugs to patients is crucial. The pharmaceutical industry, while supporting and understanding the importance of introducing a labeling system, also notes the risks associated with the launch of a system that is not 100% ready. The world situation associated with the threat of the spread of coronavirus has led to quarantine restrictions, which negatively affects the ability to start the system on time.

50 days are left until the official start of the All-Russian labeling. Today, more than 60 thousand participants are registered in the informational system for Drug Movement Monitoring (IS DMM), more than 800 million packages of medicines are labeled. A serious technical malfunction that occurred during the implementation of the drug support program at 12 high cost nosologies showed the vulnerability of the system, becoming the first test that entailed stopping the movement of drugs along the entire distribution chain. The accident confirmed the need to develop algorithms to fix such problems in the future, since each force majeure may cost a human life.

Recall, at the end of March, the Association of Russian Pharmaceutical Manufacturers sent a letter addressed to the Chairman of the State Duma Vyacheslav Volodin with a request to set a stop time for the implementation of the labeling system for the duration of the pandemic. The Chamber of Commerce and the Russian Union of Industrialists and Entrepreneurs also proposed postponing the introduction of mandatory labeling of medicines.

Many pharmaceutical manufacturers are in favor of postponement. Today, most of them have encountered problems when setting up equipment: foreign manufacturers cannot come to Russia to test production processes, and ours cannot go abroad for an internship, suppliers delay the manufacture of mechanical parts of equipment necessary for its modernization due to deficiencies identified during testing. According to Yuri Mochalin, Director of Corporate Relations at Sanofi Eurasia: “We consider it necessary to postpone the introduction of mandatory labeling until the end of the acute phase of the COVID-2019 pandemic in the world and the temporary restrictions introduced in our country. The extension period should include, inter alia, the time after the expiration of the period of increased preparedness and restrictions on the entry of foreign citizens into the Russian Federation. Since it is impossible to determine the deadline for removing restrictions and resolving situations in the short term, and the risks associated with the supply of drugs will increase significantly, we consider it necessary to postpone the implementation of mandatory labeling. ”

At the same time, a number of pharmaceutical companies declare their readiness to start labeling on July 1. Some large distributors prepared to work with labeled products. And what about pharmacies and hospitals? “In the current situation, they have an increased workload, and even with the equipment, not all employees have been trained to work in the system. And in this issue one link is not ready means the whole chain does not work. The existing inconsistency in the work of the involved regulatory bases may lead to an automatic suspension of the implementation of entire series of vital drugs as a result of system instability or a technical malfunction,” said Yaroslav Narcissov, Director General of Medical Research and Production Complex Biotiki.

Providing patients with vital drugs is one of the priorities of the health system. Therefore, when starting the DMM system, it is important not only to take into account all possible risks, but also the need to eliminate them before launch.

The Association of Russian Pharmaceutical Manufacturers agrees with the Ministry of Industry of the Russian Federation in a request for the transfer of information to the IS DMM by those manufacturers who are already ready to launch the system. This will allow testing of the performance of the system throughout the chain. “Their experience will make it possible to overcome possible difficulties in the future,” said Olga Klygina, general director of Velfarm LLC. At the same time, the ARPM emphasizes the need for the mandatory introduction of an unauthorized period (a period without fines) until July 1, 2021 for those who, due to objective reasons of the quarantine could not prepare on time. Most market participants support this position. According to the Director General of the ARPM Victor Dmitriev, “those who are already ready cannot be slowed down. And for those who, due to restrictive measures, cannot qualitatively prepare for the start on July 1, they must be given the opportunity to enter the system after easing the restrictions without interrupting the provision of patients, without receiving fines and continuing to develop the industry. ”

Alexei Repik, member of the Economic Council under the President of Russia, head of the public organization Delovaya Rossiya develops this initiative: “Now it is extremely important to do everything necessary to prevent the supply chain from breaking and the occurrence of lack of drugs, especially those used in therapy socially significant diseases. We must act in accordance with current circumstances. The introduced drug labeling system, which will be launched in July this year, is a very necessary tool for our economy to make the situation on the market more transparent and calculable, and to further protect patients. We must not forget that during the current crisis, many businesses are simply “bloodless”, we cannot demand from them the same as that required in the previous situation. However, this does not mean that the labeling system does not need to be launched on the appointed date — it must be launched in such a way that all those who are ready for this can take full advantage of its functionality. As for the companies who have some delays, there is no need to apply fines to them and organize additional checks. ”

He is supported by Servier, represented by Yana Kotukhova, Director for Work with Government Agencies and External Communications for the EAEU Countries: “We believe that a flexible mechanism for implementing drug movement monitoring should be envisaged without changing the overall term for introducing a drug movement monitoring system for medical application from July 1, 2020. An incentive measure for companies that would be ready to implement the labeling on time could be the establishment of a number of preferences, for example, when participating in public procurement. ”

According to Yaroslav Narcissov, “A transitional period is necessary for testing the system for possible failures and checking the stability of its functioning under increased load, during which the information in the code will be read, recorded and included in the generated data volume, but do not carry an overestimated regulatory load. Something similar happened in the 90s with barcodes. The goods came with a barcode, but there was a rather long period when scanners were used in some outlets and not in others. Over time, this has become a common norm, so will be the case with labeling. ”

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