11 pharmaceutical industry organizations uniting drug manufacturers, distributors, pharmacy organizations, the patient community wrote a collective letter addressed to President of the Russian Federation Vladimir Putin, in which draw attention of the head of state to the unpreparedness to launch industrial operation of the drug movement monitoring (DMM) system and give arguments why it is necessary to postpone the start scheduled for July 1, 2020.
The situation surrounding COVID-19 required drug manufacturers and the entire supply chain to the patient to focus unprecedented efforts primarily on the development of drugs against COVID-19 and ensuring the uninterrupted supply of drugs for the healthcare system and the population of the Russian Federation.
“It is for the reasons of global force majeure that the current degree of readiness of the drug labeling system and the entire supply chain, according to our professional estimates, now does not guarantee the uninterrupted supply of drugs as one of the key factors of social stability in the current conditions,” the letter says.
The pharmaceutical industry draws attention to the fact that this is due to the impossibility of setting up equipment for labeling in a continuous production environment, limiting the availability of freight transportation, the inevitable increase in the delivery time of equipment, the inability to move technical specialists, breaking logistics and production chains, compliance with quarantine measures, workload of medical facilities and pharmacy organizations providing direct assistance to patients with coronavirus infection and its complications.
In addition, a number of unresolved issues of an organizational and technological nature with the functioning of the drug labeling system remain: changes to the Government Decision No. 1556 of December 14, 2018 in accordance with Federal Law No. 449 were not approved and in order to optimize the business processes necessary for the system, standard forms of contracts for the provision of labeling codes and device for registration of emissions for drug circulation entities have not been approved, which correspond to the current provisions of the Government of the Russian Federation Decree of March 20, 2020 No. 311, problems of numerous errors in the description of medicines related to the Unified Directory of medicines remain, there is no integrated implementation of the necessary software solutions by global IT providers and integrating serialization data companies, constant updating of information systems is required for sharing data with a marking system, and much more.
All this can create risks of interruptions in the drug supply of the population of the Russian Federation.
“Today, manufacturers do not have 100% readiness to launch the system, which means that there are high risks of lack of drugs. This is actually not about whether or not to start labeling, but to increase or not increase the risks of drug defects. Of course, there are companies that are ready to start, so they need to be given the opportunity to start. They can serve as a good example, and fill the market with labeled packages that are needed to test the system throughout the chain. Today, all tests take place in a virtual space without specific products. Therefore, the one who is ready — should start on July 1, and who is not ready — should be able to prepare properly without penalties,” said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers.
“As representatives of a socially responsible industry, deeply understanding all the potential risks associated with any disruptions in the availability of medicines, we consider it our professional duty to help make the only right decision in order to maintain uninterrupted drug supply for the population of the Russian Federation,” says Vladimir Shipkov, executive Director of the Association of International Pharmaceutical Manufacturers (AIPM).
Victoria Presnyakova, executive director of the SRO Association of Independent Pharmacies, drew attention to the fact that “in today’s situation, which is already not simple, it can not be allowed that the introduction of mandatory labeling will negatively affecti the market as a whole and lead to limited drug availability for the population. The readiness of pharmacies is less than 70%. The staff is not trained, issues with testing are not resolved, the DMM system fails and the risks are too great. And I am reminding you, it’s about medicines and the health of the people. ”
The All-Russian Union of Patients has supported the industry and is seriously concerned about the situation arising from the introduction of drug labeling. If manufacturers are not able to prepare for the start of mandatory labeling, then medicines may even disappear from pharmacies and public procurements.
“Already today there is a lack in many groups of drugs, the price of drugs in the lower price segment has risen to 150 rubles. And the introduction of mandatory labeling in times of crisis can not only exacerbate problems, but also lead to collapse, ”said Victoria Presnyakova.
Back in March, the Association of Russian Pharmaceutical Manufacturers sent a letter to the Chairman of the State Duma Vyacheslav Volodin with a request to postpone the launch of mandatory labeling of drugs due to the inability to carry out commissioning. For two and a half months, the situation has not changed.
The Association of International Pharmaceutical Manufacturers (AIPM) on May 27 sent a letter to deputies Andrei Isaev, Alexandr Petrov, Dmitry Morozov, as well as the heads of the Ministry of Health, the Ministry of Industry and Trade, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and the Ministry of Economic Development with a request to postpone the launch of mandatory labeling of drugs until the situation with the COVID-19 pandemic normalizes.
On April 24, Deputy Aleksandr Petrov on the air of Komsomolskaya Pravda radio reported that the draft law on the postponing of mandatory labeling to January 1, 2021 was drafted and is being prepared for submission to the State Duma.
On June 3, the State Duma at a meeting of the inter-factional group will consider a proposal to extend the transition period for the introduction of the drug labeling system until January 1, 2021.