Labeling — a step forward or stagnation?

There is a threat of a lack of drugs in Russia, said experts of the round table "Labeling of Medicines" on the air of the radio "Komsomolskaya Pravda". Since July 1, the mandatory labeling of drugs has started, but manufacturers will soon be able to obtain permission from the interdepartmental commission and produce drugs without labeling until October 1. While some companies are waiting for permission, others are faced with technical failures and many hours of downtime when using the system under load. The lack of a clear understanding of the situation and jointly developed actions and solutions in a particular situation between government agencies and the pharmaceutical industry does not give positive results.

Victor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers, warned of possible disruptions in drug supply. Problems may arise not only because manufacturers were unable to finalize the commissioning of production lines due to the coronavirus pandemic, but also because the Drug movement monitoring (DMM) system itself was not ready. Over the past two weeks, massive connections have destabilized it. Manufacturers are forced to stop production at times for several days due to the lack of feedback. Thus, productivity decreases and the cost of production increases, which will affect the consumer’s wallet.

The head of ARPM did not rule out an increase in prices or withdrawal from production of drugs in the low price segment. In addition to the costs of labeling and packaging, the price is influenced by the cost of substances that are purchased abroad. Alexey Alekhin, director of the Department of Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade, disagrees with the arguments of the manufacturers. “Prices can increase slightly only in the unregulated segment, in regulated segment, and this is more than half of the entire drug market, the price is strictly regulated by the state. The prices for these drugs will not rise from the introduction of labeling,” he stressed.

“In the case of unprofitable production, manufacturers have two ways: either to compensate for the costs at the expense of drugs not included in the VED (vital and essential drugs) list, or to withdraw from production. We already went through this in the low price segment: Mezaton and a number of other drugs were withdrawn. The prime cost of the drugs will definitely pull the final price with it, and that worries us,” noted Victor Dmitriev.

For international manufacturers, in addition to failures in the system, the issue of importing unlabeled drugs manufactured in accordance with the legislation of the Russian Federation before July 1, 2020 is critical. “At the moment, millions of such packages of drugs have already been stored in industrial, customs warehouses, temporary storage warehouses in the Russian Federation and transits, many of which are included in the list of vital and essential drugs and must be supplied under government contracts. This situation, together with the existing technical failures in the industrial circuit of the drug movement monitoring system, as well as the unsettled interaction between this system and the customs authorities, creates the preconditions for limiting new drug supplies,” says Vladimir Shipkov, executive director of AIPM. The Association calls not to build any additional bureaucratic barriers that are not beneficial to patients and costly for manufacturers, but to introduce a notification procedure. Instead of solving the problem and ensuring the availability of medicines to the population, the new government decree creates an unreasonably cumbersome, technically difficult to implement, corruption-intensive bureaucratic “permissive” import procedure. AIPM sent a letter to the Deputy Prime Minister of Russia Tatyana Golikova with a request to draw attention to this problem.

The introduction of drug labeling has affected not only manufacturers, but also hospitals and pharmacies. Acceptance and release of labeled products have significantly slowed down the usual pace of work. In addition, being at the forefront of the fight against coronavirus infection, they were unable to install the necessary software and train employees.

“It is necessary to teach how to work with the labeling pharmacies in the most remote cities and villages. — noted the executive director of the Union of Professional Pharmaceutical Organizations Lilia Titova. — A video instruction is needed, which will explain all the work in detail and step by step and will be widely available”.

Medicines prices and availability are of concern not only to the industry, but also to patients. According to the co-chairman of the All-Russian Union of Patients, Yuri Zhulev, the population has already encountered a paradoxical situation in a number of regions when there are medicines in the pharmacy, but they cannot be sold, and even worse, they are issued with violations of the integrity of the packaging.

“For us, this is a real threat, because the patient’s life depends on the pill taken on time,” Zhulev said. "There should be a phased, organic, safe for patients labeling implementation."

According to the all-Russian poll " VCIOM (Russian Public Opinion Research Center) — Sputnik", only every second Russian citizen supports the labeling of drugs. More than half of the respondents believe that labeling will increase the protection of consumers from the purchase of illegal goods and increase the responsibility of manufacturers. The majority of respondents (92%) believe that counterfeit manufacturers should be held administratively and criminally liable, and 94% support liability for state authorities that have allowed the sale of illegal products. Industry experts also insist on legislative approval of the personal responsibility of not only those who make the decision, but also the operator, which is Advanced Technology Development Center (ATDC). “Today it is not clear who will be responsible for the disruptions in the country’s drug supply, and even worse if people suffer as a result of technical errors and lack of prompt response,” concluded Victor Dmitriev.

Recall that the leading industry associations asked the country’s leadership to analyze the possible consequences and postpone the start. However, that did not happen. On the eve of the start, the Government issued Decree No. 955 "On the Specifics of Putting Medicines for Medical Use into Civil Circulation", which provides for a number of exemptions until October 1. However, the industry has many questions about the document.

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