The transition period for the implementation of drug labeling will be extended by six months. “Medicinal products for medical use manufactured before July 1, 2020 are subject to storage, transportation, dispensing, sale, transfer, use without identification means until the expiration date,” the document says. The amendment adopted in the second reading allows participants in the process to register, test the system and debug business processes. In November, according to Elena Kudryavtseva, deputy head of the Office for Organization of State Quality Control of Medical Products of Federal Service for Surveillance in Healthcare (Roszdravnadzor), the industry’s readiness was 30%, even companies that participated in the experiment since the start of the project still have difficulties with equipment, data transfer and a product description in the a single directory-catalog of drugs (SDCD) reference book.
At the general annual meeting of member companies of the Association of Russian Pharmaceutical Manufacturers, labeling was given special attention. Leaders of leading pharmaceutical companies and pharmaceutical market experts were worried about the protracted approvals of the bill in the State Duma and were pessimistic about the situation.
“So far, we cannot speak with confidence about the prospects of how this will be realized. The third reading of the bill is scheduled for December 12, ”said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers.
The meeting participants discussed possible models of drug provision for the population. This is the number one topic not only for pharmaceutical manufacturers, but also for the state as a whole. According to business, the national drug policy should be structured in such a way that drugs developed and produced in Russia are in demand and really lead to a decrease in mortality, morbidity, and disability of citizens, and pharmaceutical manufacturers know the volume of the domestic market and can plan their capacities, while maintaining profitability and supporting the possibility of further development.
In accordance with the instructions of the President of the Russian Federation Vladimir Putin, the Ministry of Health is obliged to introduce a system of drug provision for the population in 2020. In late October, the department sent a request to the regions about their readiness for pilot projects to develop models of drug provision. We are talking about free medications for patients who have had acute cardiovascular disease. This will effectively deal with relapses of acute vascular disorders. Now there is a selection of the proposed schemes, development of all mechanisms and preparation for the implementation of the drug supply system in the regions.
“It was planned that an additional 43.5 billion rubles will be allocated for the treatment of acute cardiovascular diseases over the next three years. — 14.5 billion annually. However, only 10.15 billion rubles are included in the draft federal budget for next year for the program on co-financing of drug provision, ”Victor Dmitriev explained.
Recall that today in the Kirov region a pilot drug reimbursement project is being implemented. Over 10 months of work, he showed his effectiveness. Its essence is that the patient, on the basis of the prescribed prescription, chooses the drug in the pharmacy for any trade name, but in strict accordance with the approved list of international nonproprietary names (INN), formed as part of the VED list. The patient pays only half the cost of the medicine, and the pharmacy receives the remaining funds in the form of subsidies from the state. In order to avoid duplication of benefits, a rule has been introduced: if a patient received this drug by INN for regional or federal benefits, then a prescription for drug reimbursement is not issued to him. In the first six months of testing the project, more than 16 thousand recipes were stocked.
The pharmaceutical industry is also concerned about the upcoming reform of control and supervision activities, the so-called “regulatory guillotine”. The topic is complex, important. The Association of Russian Pharmaceutical Manufacturers is actively involved in the formation of a new system of control and regulatory legislation. She must start working from January 1, 2021.
“The process is gaining momentum. This is really a large-scale and very difficult task. We analyze the current legislation. We find out which acts are hopelessly outdated and become barriers. The guillotine implies the complete cancellation of a document: if the document contains important rules for both business and the regulator, then they remain, if not, the document is canceled completely, ”Victor Dmitriev explained to the audience.
During the meeting, they discussed the proposal to create a single register of patented pharmacologically active ingredients. It is assumed that Rospatent, Federal service for intellectual property will lead him. Under the new rules, the originator can file information on an existing patent for an active substance for inclusion in the register. An expert opinion will be issued to him after Rospatent checks the documents, correlates the characteristics of the active substance in the patent and registration certificate. If the characteristics match, the information is entered into a single register. In addition, the current legislation does not prohibit the registration of a generic with a valid patent, but limits the introduction of a generic into circulation. The leaders of the pharmaceutical market are careful in introducing amendments to 61-FL “On circulation of medicines” and note that these amendments will negatively affect the possibility of bringing a generic drug to the market after the patent for the original drug is over. And this will preserve the monopoly of the originator and lead to an increase in the burden on the budget. Therefore, experts of the Association are preparing proposals on linking the “capabilities” of the registry with the introduction of the generic into civil circulation.
Since January 2021, pharmaceutical manufacturers are required to register their products only according to union requirements. By the end of 2025, all medicines registered under the rules of national legislation should be brought into line with the EAEU standards. Members of the Association were able to get answers from representatives of the federal executive bodies participating in the meeting to answers to questions about the registration of drugs according to the unified rules of the Eurasian Economic Union (EAEU), according to the requirements for certification of authorized persons of companies. Following the meeting, it was decided at the beginning of next year to organize an expanded meeting with the participation of all interested parties, including the Ministry of Education of the Russian Federation.
Elena Denisova, Deputy Director of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia, presented the meeting participants with a new financial support mechanism for the pharmaceutical and medical industries. Since 2020, co-financing of innovative projects of companies is provided. Currently, a list of competitive selection is being approved. It is planned that 4.5 billion rubles will be allocated for new developments from the venture capital fund. Companies can apply now.
In addition to discussing relevant topics, the tasks and directions of the ARPM for the next year were defined. The Director of the Biotiki medical research and production complex Yaroslav Narcissov was elected to the Association’s Supervisory Board, and Denis Chetverikov, President of Akrikhin, was elected Chairman.
Victor Dmitriev thanked everyone for their productive work and active participation in the activities of the Association and emphasized that the ARPM will continue to work for the good of the health of Russians, taking into account the interests of Russian industry.