Translated material
Therapy without shock
Tatyana Golikova is preparing the pharmaceutical market for new rules of the game
The distribution of functions between the Ministry of Health and Social Development and the federal services subordinate to it - Roszdravnadzor and Rospotrebnadzor - will change noticeably from the beginning of next month. From September 1, in accordance with the law “On the Circulation of Medicines” that comes into force, virtually all licensing powers related to the regulation of the pharmaceutical market will transfer directly to the parent department. To address all questions from market participants, before the start of the “new era of regulation,” Minister of Health and Social Development Tatyana Golikova invited representatives of all the largest Russian and international pharmaceutical companies, as well as heads of trade unions, at the end of last week.Ms. Golikova noted that, according to employees of her department, the current system of distribution of powers in this area is not built ideally and not entirely logically. For example, Roszdravnadzor itself issues permits for the release of medicines into circulation, based on the conclusion (independent examination) prepared by the structure subordinate to it. And then he himself controls the legality of issuing such a permit and the circulation of the drug on the market. Considering that even the name of the federal service speaks of “supervision,” officials of the Ministry of Health and Social Development believe, it is quite natural to limit ourselves to this function, giving everything else up the administrative vertical.
For now, however, we are only talking about transferring the authority to register medicines to the ministry. “We have taken away the functions of registering medicines,” said Tatyana Golikova. “We have created a separate department in the ministry.” According to the minister, the function of licensing any medical and pharmaceutical activities will remain with the federal service for another two years as an atavism, which itself will then “fall off.” “Starting from 2013, we must switch to a notification procedure for carrying out this activity,” she recalled.
As very important, Ms. Golikova noted the moment of reassignment directly to the ministry of two expert institutions that were previously under the wing of Roszdravnadzor and Rospotrebnadzor. These are the Federal State Institution “Scientific Center for Expertise of Medical Products of Roszdravnadzor” (FGU NTs ESMP) and the FGU “State Research Institute for Standardization and Control of Medical Biological Preparations named after. L.A. Tarasevich", engaged in testing and examination of immunobiological drugs. It is worth noting that the director of the Federal State Institution NC ESMP Sergei Budanov was removed from his position several months ago.
From September 1, not only the subordination of expert institutions changes, but also the form of interaction of market participants with them. For many years, the Federal State Institution Scientific Center ESMP was the main object of criticism of businesses, which had to not only pay for the services of this government agency at a completely commercial rate (the amount was agreed upon in the contract), but also wait for months for expert work to be completed. Now there will be no direct contacts between Federal State Institutions and market participants, just as there will be no contracts for the provision of expert services. To reduce the corruption component, the new law provides for the introduction of a single state duty for the provision of expert services. Manufacturers will submit paid receipts along with a package of documents for registration of pharmaceuticals to the relevant department of the ministry, and not to an expert institution, as before. Only officials from Ms. Golikova’s ministry will have contact with the experts, thus taking on the role of customer of expert work. This, according to officials, is a kind of anti-corruption buffer.
The meeting with the minister on the eve of the entry into force of the new law seemed to fully satisfy both Russian and foreign participants in the pharmaceutical market. “We received answers to all our questions. The impression left is that the ministry is ready for dialogue and ready to work together with business to prevent any disruptions in the supply of medicines,” Viktor Dmitriev, general director of the Association of Domestic Pharmaceutical Manufacturers (ARPP), told Vremya Novostei. As it turned out, the biggest concern for Russian pharma is the procedure for importing substances from which drugs are made from abroad and entering them into the register. Ministry specialists, according to Mr. Dmitriev, have already explained that after September 1, the procedure will remain virtually unchanged. At the same time, all technical details must be spelled out in by-laws, and not all of them are ready yet.
Foreign companies clearly needed the minister’s advice on the organization and conduct of clinical trials of drugs - now they are the only ones conducting them on the territory of our country. Representatives of the transnational giants Pfizer and Nicomed asked Ms. Golikova several questions regarding the mutual recognition of the results of clinical trials by Russia and European countries. It was previously reported that representatives of the Ministry of Health and Social Development are conducting active negotiations on this matter with colleagues from the European Union, but there are no definite practical results yet. It is worth recalling that such agreements do not yet exist, and large foreign manufacturers have to conduct the entire “clinic” in our country from scratch. This slows down the access of new highly effective drugs to Russian patients. The fact that mutual recognition of test results would greatly help Russian drug manufacturers is also recognized by the ARPM. We should not forget that in the next two years, in accordance with the concept of industry development, many import substitution projects should be implemented in our country, and creating new production facilities targeting only one domestic market is obviously unprofitable.