From October 1, drugs used in the treatment of rare diseases (7 High cost nosologies) should be labeled. On the eve the head of Roszdravnadzor Mikhail Murashko said: “The entire infrastructure is assembled, the final product is being accepted. All organizations and all manufacturers of 28 drugs are connected to the system, all are registered. ”
Drug labeling is the number one pharmaceutical industry topic. Manufacturers, distributors, pharmacies report their readiness, express concerns. The data of the regulator and the Center for development of advanced technologies are sometimes diametrically opposed to the participants in the process. So what is going on at the finish line?
More than two years ago, a decision was made on the mandatory labeling of all medicines. At the start of the project, many good goals were voiced. Manufacturers actively went into it. But the rules of the game have repeatedly changed. There was a marking fee. Plus VAT. And this is 3.5 billion rubles. “Most likely, the money will be taken from the patient’s pocket — there is no other source of financing,” said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers.
“Medicines are socially important products. The amount of fee for the cryptographic code should be absent or be reviewed. The cost cannot be the same for fur coats that cost several hundred rubles, and the same for medicines worth 10 rubles, for example iodine and Colloquial, ”Nadezhda Daragan, chairman of the Coordination Council of the National Association of AMP, drew attention.
The shape of the labeling sign has changed, cryptographic protection has appeared with a length of 88 characters, now it is 44. Although manufacturers still insist on 20. Unique additional protection has led to a drop in productivity, an increase in defects and an increase in the cost of drugs. Equipment and software for labeling is estimated at hundreds of billions of rubles, all these costs will put a burden on patients. Some manufacturers, reporting their readiness, point out problem points, and do not hide the fact that from the beginning of a New Year prices for medicines in the country will rise.
According to Sergey Zhikharev, Director for Corporate Development at AKRIKHIN, “investment in equipment is not limited only to hardware on the line, it is the cost of software licenses, connections and other technical issues, as well as a code fee — all this will go into the cost of our products . For each unit of our products, the minimum price increase will be 1 ruble 15 kopecks. ”
Margarita Mustafina, Project Management Manager, Teva LLC: “Unfortunately, within our company a sufficiently large number of products will have to revise the sizes of secondary packaging and, as a result, primary, and even further — the dimensions of transport boxes, sizes of areas in the warehouse, transport and other things. Because all this inevitably leads to a change not only in logistics processes, but also in production business processes. ”
In addition to the technical side, manufacturers point to the legal one. For proper operation, it is necessary to improve Drug Movement Monitoring (DMM), and to enter into the industry legislation: administrative, criminal, civil law. “The system can save money, it is effective, but there must be perfect law enforcement,” said Vladimir Akineev, Deputy Advisor to the General Director for Legal Affairs of Biocad.
Experts emphasize the low readiness of the industry. All market participants predict a serious increase in prices, and as a result, lack of the drugs on market. And this is one of the biggest fears of patients.
So, the Executive Director of Association of pharmacy institutions «SoyuzPharma» Dmitry Tselousov reported: “Today, pharmacies are on standby. They are ready to try. But the situation is complicated by the fact that UTII has been canceled since the new year. This is a serious measure of not supporting pharmacy organizations, which will lead to the closure of many points. Thus, 60% of registered pharmacies in the system after January 1 will turn into 100%. ” Describing the complexity of the work, he emphasized that an additional full-time unit is needed for work. And in solidarity with manufacturers and distributors, he drew attention to the fact that "prices will rise and significantly."
Yelena Kudryavtseva, Deputy Head of the Office for Organization of State Quality Control of Medical Products of Rozdravnadzor, summing up the results of the Labeling round table at the Komsomolskaya Pravda Publishing House, encouraged the participants in the pilot project: “All this has been developed for a long time, it works, everything is there. You do not work well in the sandbox, problems are solved there, you can calmly register, most of the voiced issues already have a solution and application, this also applies to regulatory documents and work processes. ”
Yuri Zhulev on behalf of the All-Russian Union of Patient Public Associations said that “by January 1, everything should work. It remains to wait a short time. I will not blame the authorities for optimism or pharmaceutical industry for pessimism. If a lack of drugs appears, who will be responsible? These are not nails, but vital medicines. ”
It was originally planned that the number of project participants would be 350 thousand. Now it is not clear how many of them will actually be. So Elena Kudryavtseva at the round table on the labeling named the number 125000, while clarifying that a little less than a quarter are already registered in the system. And during the marking session at the IV GMP conference, Deputy Head of Roszdravnadzor Valentina Kosenko called 240 thousand points of medical organizations and social institutions. But, according to regulators and the Center for development of advanced technologies, in general, the industry is ready to start.
Victor Dmitriev expressed the hope that there will still be a return to labeling issues and there will be big hearings where, perhaps, business’s position will be heard.
“We are not against labeling, its introduction will allow us to obtain serious economic and social benefits. We are for the labeling to serve the benefit of business and patients, and not be the mechanism that leads to problems, ”concluded the head of the ARPM.
A pilot drug labeling project was launched on February 1, 2017. According to the Law on the Circulation of Medicines, labeling of all medicines will become mandatory from January 1, 2020.
In Turkey, drug labeling has been used since 2012. All drugs produced in the country are subject to the procedure. Medicines manufactured in Turkey are labeled on automatic lines. For imported products, codes are printed using a printer and then manually pasted. Information is read by the scanner and transmitted to the general system in order to track the movement of goods to the pharmacy. It took about 4 years to eliminate the problems caused by the introduction of a separate labeling. The total duration of the project in Europe is already 7 years. In Russia, it is planned to achieve a solution in a short time.