The Association of Russian Pharmaceutical Manufacturers held a round table “General preparedness for drug labeling” as part of the business program of the Pharmtech & Ingredients 2019 exhibition. The panelists once again discussed the degree of readiness of the industry to launch a drug movement monitoring system (DMM), gave an analysis of the first steps of labeling according to the program, 7 high-cost nosologies and identified problems that need to be addressed.
ARPM General Director Victor Dmitriev noted that "the light loomed at the end of the tunnel, but the tunnel does not end."
Deputies submitted a bill to the State Duma of the Russian Federation on the phased implementation of drug labeling until July 1, 2020. 64 deputies and 3 members of the Federation Council have already joined the initiative. “The deputies promised that by the second reading the law will fix the possibility for the manufacturer to receive information on the movement of products from the moment of production to the final consumer for free in real time,” said the head of the ARPM.
German Inozemtsev, Director General of the “Medicinal Ecosystem”, also spoke about the importance of this amendment: “The black box of Pandora, which has been formed on the Russian pharmaceutical market over the past 25 years, can be made transparent by the labeling. Indeed, now none of the manufacturers knows how his goods are moving on the market, and how they reach the consumer. Of course, to achieve transparency, full access to this data is needed. ”
Yelena Kudryavtseva, deputy head of the Office for Organization of State Quality Control of Medical Products of Federal Service for Surveillance in Healthcare (Roszdravnadzor), traditionally began her presentation with statistics: “Currently, about 40 thousand organizations are registered in the system, about 90 thousand places of activity, this is 30% of the total amount, moreover, about 15 thousand names of medicines, the movement of about 90 million packages is being monitored.”
The development director of RPC “Katren” JSC Anatoly Tenсer clarified the stated data: “90 million labeled manufactured packages were put into circulation. Of these, distributors got much less. And how many of them went to the pharmacy? Here you need to cut zeros from the original digit. 90 or 900 drugs in the most advanced pharmacy chains under the supervision of an IT department and management were shipped to a specially trained customer. To make a conclusion from this about readiness for real sales is bold! ”
Distributor is concerned about reverse logistics processes. “Now it’s completely not clear how to get the code out of circulation if it is not readable, the code is lost or found absolutely different one, and such cases will not be isolated. And at whose expense there will be these large write-offs, obviously not at the expense of the operator,” said Anatoly Tenсer.
Evgeny Nifantiev, Chairman of the Russian Association of Pharmacy Chains (RAPC) Coordination Council, noted: “In six months, the situation with labeling will not improve much. There will also be problems and will be not ready companies. ” He suggests adding a transition period to increase liability with warnings and fines.
“We have tested the purchase, transfer, disposal procedures, but at the same time we have not worked out the procedures for returning to the supplier, writing off due to flaws, inventory. These are important stages in the work of pharmacies, and how it will be in practice is not yet clear,” said Yevgeny Nifantiev.
In addition, pharmacies are also concerned about the fact that distance selling is starting simultaneously with labeling. “From July 1, absolutely uncontrolled sales of medicines in the territory of the Russian Federation will begin,” Evgeni Nifantiev drew attention.
Manufacturers today have much more problems. Representatives of companies that took part in the experiment on introducing labeling shared their practical experience. For example, the approval of 44 characters for cryptocode posed a difficult challenge for manufacturers, since they can only fit in a certain module size with a certain matrix code size. In this regard, the company "Teva" had to reconsider the size of secondary packaging in 30% of manufactured products.
According to Teva project manager Margarita Mustafina, the company faces technical difficulties in transferring information to DMM: “by mid-November it is impossible to test the system in combat mode, as it is constantly being updated. Today, SAP supports version 1.31, and in the sandbox, it is 1.34 already. Therefore, imagine how far we have to go forward. ”
The information systems of the experiment participants are under development. Their adaptation to the processes of each company and testing will take time. Ready-made IT solutions for the pharmaceutical industry and the DMM system will not appear until the second quarter of 2020.
Sergey Kholkin, Head of “Pharma” direction of Advanced Technology Development Center (ATDC), did not agree with a negative assessment of the industry’s readiness for labeling and the requirement to identify specific responsible people for the project and possible risks. The operator calls for collective responsibility and partly blames manufacturers. “Someone did not modify for a year and a half, because the experiment was going on. Was waiting for the legal framework for 88, believed in a miracle for 44" …"And someone from the very beginning bought expensive equipment. It did not come in handy, because the rules of the game have changed and are still changing, ”the head of the ARPM Victor Dmitriev was indignant. — Collective responsibility is the irresponsibility of those who intervened in this process and it is clear why! Today, the goal is not to look for the answer to the eternal Russian question: who is to blame and what to do, but to think about what needs to be changed for effective work. In the end, the patient will give an assessment to everything. ”
Meanwhile, the participants in the experiment create channels to prevent lack in the drug market and are waiting with hope for a phased introduction of the labeling before July 1, 2020.
Vladimir Shipkov, AIPM Executive Director: “6-month respite, which now looms for us, won’t be enough for the industry because the system is not ready, not tested, and the project management is to blame. We see how decisions are being prepared, how the ATDC is evading responsibility, how the Ministry of Industry and Trade is behaving and sending completely contradictory signals to management, the market, and the public, who have little contact with the real situation. ”
But the real situation is such that consideration of the expected amendments in the first reading has been postponed by the State Duma. Will there be an opportunity to release products without labeling before July 1? The question hung in the air. Everyone is waiting.