Vaccination against monopoly: the mechanism of registration of new vaccines is simplified

Foreign and domestic manufacturers of vaccines, immunomodulators, probiotics, interferons and other immunobiological medicines for medical purposes will breathe a sigh of relief in the near future. The state has fulfilled its promise to provide market participants with a new mechanism for quality control and licensing of drugs.

The promised, fortunately, had to wait not three years, as the saying goes, but only one. In August 2006, an order was issued by the Federal Service for Supervision of Healthcare and Social Development, which put an end to the long-term monopoly in this area of the State Research Institute for Standardization and Control of Medical Biological Preparations (GISK) named after L.A. Tarasevich.

And this week, the new authorized laboratories should complete the clarification of details and begin full-fledged work. According to Olga Solovyova, head of the department of registration of medicines of Roszdravnadzor, now market participants will be able to choose between GISK im. Tarasevich, N.F. Gamalei Research Institute of Epidemiology and Microbiology and I.I. Mechnikov Research Institute of Vaccines and Serums. The laboratories of these two institutes, subordinated to the Russian Academy of Medical Sciences, have already been recognized as meeting the state requirements for quality control bodies of immunobiological preparations. In addition, as reported by the "Time of News" in "Roszdravnadzor", negotiations on the conclusion of the contract have ended with the Research Hematology Institute.

In fact, the current leadership of the Ministry of Health and Social Development and Roszdravnadzor by its actions apologizes for almost a decade of silence that contributed to the emergence of a monopolist, whose actions were not satisfied with all market participants. The letter of the law "On Medicines" adopted in 1998 did not require a single control body and registration of immunobiological drugs. However, officials, contrary to the opinion of market participants, but in the best traditions of the Soviet healthcare management system, preferred to create one – in 1999, an order appeared "On improving the system of examination and testing of medical immunobiological drugs." This document provided for the creation of a Committee of Medical Immunobiological preparations. Despite the fact that the committee included representatives of several specialized research institutes, the technical side of the examination, conducted on a contractual basis, that is, paid for the manufacturer of drugs, was assigned to the GISK im. The deputy minister and chief sanitary doctor of the country Gennady Onishchenko became the curator of this whole system of control and registration.

The lion's share of the market of immunopreparations in price terms falls on vaccines. The volume of vaccines produced and put on the market only last year, according to the Center for marketing research "Pharmexpert", amounted to about 70-75 million euros. At the same time, no more than 26 million euros worth of imported vaccines were imported. All drugs, both domestic and foreign, received a "ticket" to the Russian market through GISK im. Tarasevich. And not all manufacturers were satisfied with the cooperation with the national control authority. In particular, there were questions about the discrepancy between the validity periods of certificates issued in this research institute with the expiration dates of manufactured drugs. Some market participants were not satisfied with the timing of the examination, which, in their opinion, delayed the promotion of the drug. At the same time, few people openly resented the actions of the monopolist for obvious reasons – it was still impossible to get past this instance. Last year, Roszdravnadzor considered that the situation requires a radical change, and issued a new administrative regulation demonopolizing the process of immunobiological examination. Theoretically, even a private company can now conduct it, if, of course, it has laboratories and personnel that meet the state standard.

However, private traders are not rushing into this sector yet, and well-known institutions, to which the state is ready to delegate the rights to conduct an examination, believe that historical justice has been restored. In particular, the I.I. Mechnikov Research Institute of Vaccines and Serums reminds that back in the Soviet years the institute was one of the leading ones in the process of registering new immunobiological drugs. In an interview with the correspondent of "Time of News", Natalia Mikhailova, Deputy director of the Mechnikov Research Institute for Science, stressed that there are quite a lot of highly qualified specialists working at the institute, so now you can be sure that "there will be plenty of customers from among manufacturers of immunobiological drugs and medical equipment." According to her, after the end of negotiations with Roszdravnadzor, a separate laboratory will be allocated for the examination and certification of new drugs. Director of the Institute Vitaly Zverev is convinced that the involvement of well-known academic institutions with modern equipment and competent specialists in the certification process "will improve the quality of expertise and speed up the process as a whole." A similar position is held by the N.F. Gamalei Research Institute of Epidemiology and Microbiology. Academician of the Russian Academy of Medical Sciences Felix Ershov, who works at this institute, emphasizes that "a new generation of drugs has appeared today, the examination of which requires additional and special conditions and qualifications."

But the optimism of the new partners of the state is not shared at all by the leadership of the Research Institute that has lost its monopoly. Tarasevich. Moreover, in an interview with the correspondent of "Time of News", representatives of the institute tried to prove that they resist demonopolization not for the sake of self-interest, but solely for the benefit of patients. "In such a matter as quality control and effectiveness of immunobiological drugs, monopoly is the only acceptable form, because we are also talking about state security. It is very dangerous to spray information about certain drugs or to entrust it to private companies," the director of the Research Institute told our newspaper. Tarasevich Nikolay Medunitsin. "Responsibility should be in one hand." According to him, only the laboratories of the institute entrusted to him can ensure objectivity and thoroughness of control. Mr. Medunitsin not only referred to the experience of his institute, but also quite transparently hinted at the possible interest of potential competitors, stating that GISK differs from other expert institutes in that it does not have its own production of immunobiological drugs and, therefore, can be as objective as possible.

It is noteworthy that in recent years there has been a full–fledged comparison with the FDA (Food and Drug Administration - a quality control body in the United States, known for its rigidity and exactingness regarding the quality of medicines. – Ed.) not a single structure subordinated to the Ministry of Health and Social Development and trying to gain the fame of the American department in the domestic market could stand it. It is not yet possible to fully protect the Russian consumer from low-quality drugs. The same "Rospotrebnadzor", which is in charge of the GISK im. It is necessary to periodically suspend the implementation of previously approved and certified vaccines in our country, or to conduct emergency inspections after high-profile scandals caused by information about complications in patients that came from nowhere. From the point of view of business, demonopolization and the involvement of additional state-authorized experts will only benefit, since it will allow more new immunobiological drugs to be brought to the end consumer faster. "We generally support the transfer of functions to new research institutes, since the departure from monopolization should lead to a positive result," the newly elected head of the Association of Russian Pharmaceutical Manufacturers (ARFP) commented on the changes in the market Victor Dmitriev. "The new order is more convenient for everyone, of course, except for those who have lost their monopoly," Alexander Kuzin, CEO of DSM Group, told Vremya Novosti. "Producers and consumers only benefit."

Galina Papernaya, "Time of News", 19.11.2007

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20.11.2007