On January 1, the drug labeling system in Russia will become mandatory for all market participants, without exception. Every day there is less and less time left until the start, and more questions arise. At round tables, meetings and forums the progress of the experiment and the readiness to implement the system are being discussed. Problems and forecasts were discussed at the international conference “What is happening on the pharmaceutical market”.
The Director General of the Association of Russian Pharmaceutical Manufacturers, Viсtor Dmitriev, in his opening speech noted: “Today, the system is not completely ready, on each of its stages: be it a manufacturer, distributor, pharmacy, regulator, operator. We cannot talk about 100% readiness — everywhere there are some flaws. And this means that there is a risk of disruptions in drug provision. ”
So is it worth the delay? Who will take responsibility for the implementation of the Drug movement monitoring (DMM) system? And what difficulties were encountered in the testing process all participants reported: from manufacturers to the operator. Estimates are different, forecasts too.
According to Andrei Akhantiev, Director for Economic Security at Geropharm, the company is ready, but not 100%. “We are testing signs, an emission recorder, internal processes, all the barriers in our path are surmountable, but this takes time. We have one drug in the experiment, tried to register the others for half a month, and nothing came of it. The Advanced Technology Development Center (ATDC) in manual mode helped us do this. And what to do when a mass of such situations will arise, ”the manufacturer emphasized.
In turn, the director of health economics at R-Farm, Alexander Bykov, reported on the readiness for launch and explained that the manufacturer solves the difficulties in the testing process privately with the ATDC. Maksim Stetsyuk, executive director of Nanolek, is also in agreement with colleagues, and they have developed a strategic plan for the introduction of markings within the company. “We’ll see how the system handles when the product roll starts on January 1. Now we must stop all production processes for 2 weeks to enable us to test everything in the new conditions. This is a difficult and painstaking work, ”said Maxim Stetsyuk.
A risk management plan for working with labeled products was developed at implementation center Protek. The company is trying to foresee any emergency situations. A special department has been created that monitors all changes in the system, helps in resolving issues related to DMM. “New business processes affect the entire company. Restructuring is required both in logistics and in terms of paperwork, ”said Victor Gorbunov, Deputy General Director for IT Technologies at Protek. He emphasized that the company’s acceptance rate of boxes dropped 2–2.5 times lower, and the internal scanning system did not fit in with DMM, so they would have to refuse it. “It will be difficult, but within the first six months the problems will resolve and normal work will begin,” said a distributor representative.
Representatives of the pharmacy segment suggested that the cost of training personnel, preparing software, introducing a new job and canceling UTII will seriously affect business. On the one hand, small pharmacies, especially in remote regions, will be closed or sold to large players, on the other hand, the final price of drugs will increase and this will negatively affect the consumer. On average, the cost of drugs that are not included in the list of vital drugs, will increase by 20%.
“Keep putting one foot in front of the other. Any pharmacy organization that is involved in the process — adapts to this work. Everyone knew that January will be, so choose any deadline, there still will be those who are not ready, ”Neofarm CEO Evgeni Nifantiev summed up his speech.
In the three years that the project lasts a lot of work has been done. But just as much remains to be done. The regulator needs to interview all participants of the labeling for readiness and compile a register of errors that participants encounter during the testing process. Based on the data received, issue an instruction: a step-by-step plan for solving the problem. And this is the first priority. It is necessary to fix the information about the substance in the composition data, in addition to the number and series of the drug. To deal with overflows, manufacturers need to be able to receive information about bulk movements. The regulatory framework should spell out the responsibility of companies for late data entry into the system. It is necessary to develop a mechanism, how this will happen in practice, how the regulator will decide that this operation was not performed in accordance with the recommendations. Law regulations are needed to explain when an operator is liable for the lost profits by companies.
But while Russia is actively preparing for labeling, the EurAsEC countries are considering this measure as a restriction on their products.
“Labeling will be considered in relation to goods manufactured in the Republic of Armenia, Belarus, Kazakhstan and Kyrgyzstan as a barrier in the domestic market. The Department of Control of Domestic Markets will be forced to launch a procedure to remove the barrier, and if this issue is resolved, the goods of manufacturers from 4 countries will be treated without taking into account this barrier, ”said Dmitry Rozhdestvensky, head of the coordination of work in the field of drug circulation and medical products of the Department of Technical Regulation and accreditation of the Eurasian Economic Commission. And what is the meaning of labeling then? “The issue of introducing labeling should be addressed comprehensively taking into account the interests of all states, otherwise, according to the adopted documents in the Eurasian Union, this measure will be a barrier from Russia to other members of the union,” the expert emphasized.
“Based on this, the person who will take responsibility should determine whether or not to introduce the DMM system. If, in his or her opinion, after the introduction of mandatory labeling, the situation will not only not worsen, but even improve, then in this case you can start. But if at least some minimal percentage is retained that patients will suffer, then labeling cannot be started, ”concluded the head of the ARPM Victor Dmitriev.