"Regulation of the pharmaceutical market" satellite discussion within the framework of the St. Petersburg International Legal Forum
On 17 of May in St. Petersburg, within the framework of the St. Petersburg International Legal Forum, a satellite discussion concerning "Regulation of the pharmaceutical market" took place.
The initiators of the discussion were the Ministry of Industry and Trade of the Russian Federation, the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union and the audit and consulting company EY.
In anticipation of the adoption of the Strategy for the Development of the Pharmaceutical Industry until 2030, the discussion was focused on the negotiation of the main issues and key tasks facing the industry, the implementation of which is necessary to ensure public access to medicines. Also, the task of the introduction of innovations and development of the industry was discussed. The second key topic was discussion of the directions of development of the state policy in the field of protection of intellectual property rights.
Sergei Movchan, the vice-governor of St. Petersburg, outlined the importance of the event in the view of the city's establishment as one of the centers of the pharmaceutical industry in Russia, indicating the need for cooperation with the leaders of the region, already localized their research and production facilities in St. Petersburg.
Alexey Alekhin, the director of the profile department of the Ministry of Industry and Trade of Russia, formulated the main directions of the Strategy for the development of the pharmaceutical industry until 2030, emphasizing separately the interdepartmental nature of the Strategy as a government document consolidating the efforts of all regulators in the industry, regardless of the scope of authority.
Dmitry Chagin, in his introduction to the substantiation of the key directions of the session on regulation of the pharmaceutical market, noted that the bulk of special regulatory acts was approved in the framework longstanding work to harmonize the single market of the Eurasian Economic Union.
However, the spheres of competitive, antimonopoly legislation, regulation of the issues of the contract system of the Russian Federation and legislation in the field of protection of intellectual property rights were not included in the scope of harmonized documents and would be of the greatest interest from the point of view of the development of the industry.
"High-tech industries are developed primarily on the basis of infrastructures of modern companies, it makes their integration inevitable in all significant segments of the industry development - first of all in the field of personnel training and the development of innovative infrastructure," said Zakhar Golant, one of the moderators of the discussion.
As direct proposals, the participants of the discussion noted the need to consistently tighten regulatory requirements for drug registration, quality control of production, tighten the examination of patent applications, in order to create uniform and equal conditions for the admission of medicines to the local market, and to create conditions for the export of pharmaceutical products.
Vladislav Shestakov separately stressed the importance of the priority of GMP standards execution, and not formal compliance with the requirements for licensing the production of medicines, otherwise there are different requirements for local and foreign production.
In the opinion of the deputy head of Rospatent, Lyubov Kirii needs to consolidate the industry position regarding the definition of innovation, and formalize approaches to patent examination in order to avoid risks associated with the "greening" of patents.
From specific proposals, the need to compensate the expenses related to registration and access to external markets, in particular, compensation of the costs of conducting clinical trials and the purchase of standard samples of comparison products, which is the largest amount of expenditure, was voiced.
Pyotr Rodionov, CEO of GEROPHARM, also noted the importance of establishing innovation criteria for the patenting of medicines. He stressed that the issuance of secondary patents that protect new modifications and compounds may adversely affect the development of the industry and the availability of drugs to the public.
To change the situation, it is necessary to amend the current legislation, as well as the introduction of the patent opposition procedure, which suggests involving a wide range of experts in the application.
A separate discussion developed with regard to the formation of the necessary competences in the field of training personnel for the successful development of the pharmaceutical industry. For all companies, personnel management is a priority, in particular Alexander Glazkov from Biocad confirmed the incredible dynamics of recruiting up to 500 specialists a year, with a very broad profile of competencies. Creation of profile academic departments and master's programs was once again supported by the development of the key profile educational institution in the country - the St. Petersburg Chemical and Pharmaceutical University. The rector of the University, Igor Narkevich, stressed the importance of developing joint competencies in the training of personnel and the integration of advanced industry competencies in the overall educational process.
Integration of international requirements for the registration of medicines and the passage of foreign inspections, including the fluency in foreign languages of basic regulatory systems, are also relevant requirements for the standards of modern pharmaceutical education.
Particular attention was paid to the special training of specialists in the field of intellectual property, as one of the most complex competencies in any high-tech industry. Taking into account the social significance, the volume of budget expenditures for pharmaceutical products, the development of the industry in the field of innovations.
Anna Kostyra, partner of EY, summarized tendencies and trends in the development of legislation on intellectual property, which has already been the subject of active discussion at the Legal Forum. In addition to the acute problems associated with the general trend of restricting the rights of rightholders (legalization of "parallel imports", granting the antimonopoly authority the power to enforce licensing, the actual reduction of data-exclusivity due to the insecurity of the results of clinical research as know-how), Anna outlined another legislative initiative of the antimonopoly authority within the framework of the "fifth antimonopoly package" - this is the "removal of immunities" with respect to the right holders of exclusive intellectual property rights by excluding from paragraph 4 of Article 10 of the Federal Law "On Protection of Competition" and paragraph 9 of Article 11 of this Law. Vitaly Kastalsky and Artemy Ivanyushin supported the discussion by illustrating the above tendencies with examples from the current law enforcement practice.
Anna Guseva, EY partner, outlined the main findings of the study of global companies' investment in the Russian market, noting that more than half of direct investments were directed to the construction or modernization of production facilities and the acquisition of companies, as well as prospective niches for public-private cooperation as part of the transition to the Strategy development of the pharmaceutical industry until 2030.
Elena Bushberg, CEO of Veropharm (a member of Abbott), stressed that their investments were largely directed to training and development programs for staff and partnership programs with universities. Elena also noted that government support for partnership programs with universities pharmaceutical manufacturers could enhance companies' efforts in this direction.
Ivan Glushkov (Stada) noted that in order to stimulate the attraction of global innovations and the withdrawal of innovative drugs, changes in the drug supply system are needed. The position of international pharmaceutical companies regarding the investment experience, future directions and possible measures of support and stimulation was indicated by the representatives of Pfizer, Takeda, and others.
Alexei Martynov, member of the Council of the Leaders Club, an expert of the Agency for Strategic Initiatives and CEO of the X-Biocell Company, supplemented the proposals of the discussion participants on the need to develop advanced technologies in the development of medicines, in particular the Biomedical Cellular Products segment, taking into account the perspective of the direction and the recently adopted federal law that eliminates the legal uncertainty of the BCP before it was adopted.
The result of the discussion was summed up by the vice-governor of St. Petersburg, Sergei Movchan, noting the most significant proposals from the participants of the session, which is extremely important not only for the formation of state policy in the regulation of the industry, but also for direct action to develop a pharmaceutical cluster in St. Petersburg.