The IX St. Petersburg International Legal Forum discussed provisions of the Strategic Development of Pharmaceutics in the Russian Federation Through to 2030. The session referred to the goals of the document formulated by the Ministry of Trade and Industry of the Russian Federation, while industry representatives presented their opinions on further development of Russian pharmaceutics.
‘The key goal of our strategic document is to establish sustainable settings for the development of domestic pharmaceuticals market, including to eliminate dependency on import across roughly all segments of social significance and in the mean time to develop export-driven capacities of national pharmaceutics and intensively support export of medicines to international markets. These goals may seem to run in parallel, though they definitely do not contradict one another; quite the contrary, one is a follow-up to the other,’ Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation, claimed.
He noted that the initial Strategy until 2020 enacted in 2011 was bound to instill order in the industry, to modernize it as much as possible, as well implement international practices and advanced technologies. At present, according to Deputy Minister’s data, the amount of investment in national pharmaceutics has exceeded 200 bln. roubles. According to Sergey Tsyb, since the Strategy-2020 was launched, pharmaceuticals market in Russia has seen an economic growth of roughly 1.5 trillion roubles which is expected to grow exponentially in the next 10 years.
‘Smart public support enables you to overcome obstacles on your way towards international markets; it is important for us to ensure that local manufacturers expand their presence on the domestic market and thus gain opportunities to intensify investments in order to promote their products to foreign markets,’ Deputy Minister added.
Dmitriy Morozov, Chief Executive Officer of Biocad, named several reasons, why at present the chance for national medicines to reach international markets is indeed very slim. Firstly, he pointed, Russia has so far failed to join ICH and PIC/S international standards which establish requirements for manufacturing procedures and release of products to market in countries with a well-developed pharmaceutical industry. Secondly, Dmitriy Morozov believes, internal production standards and requirements to different manufacturing procedures followed by Russian pharmaceutical companies are not aligned or harmonized with international standards. More so, thirdly, as far as the Biocad CEO is concerned, national manufacturers do not have sufficient resources. ‘The more rapidly will stagnation take over our domestic market, the lower will the prices sink, and the more feasible the scenario of us staying within this market,’ he underscored.
On top of that, Dmitriy Morozov believes that Russian pharmacists need to think what products they can offer to international markets, as well as to accumulate technological savvy, scientific competencies, and develop innovative drugs.
In his turn, Sergey Tsyb reported that Russia’s joining ICH and PIC/S is meant by Strategy-2030 and included Ministry plans. Dmitry Morozov replied to the Deputy Minister that it is equally necessary to elevate the country’s standards in the development of medicines and harmonize them with the international ones in order to promote transformations in national industry.
Participants of the discussion also considered aspects of obtaining international certificates on pharmaceutical substances, as well as measures to support full lifecycle manufacturing – from substances to commercial medicines – and tools to promote competition both inside Russia and globally.
The discussion was participated by Sergey Klykov, Chief Executive Officer of Sintez JSC, Dmitriy Morozov, Chief Executive Officer of Biocad Ltd., Aleksandr Semenov, President of Acticomp JSC, Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation, and Elena Yakubova, Chief Executive Officer of ChemRar Pharma. The discussion was moderated by Zakhar Golant, Chairman of the Board, Union of Pharmaceutical and Biomedical Clusters of Russia.
St. Petersburg Legal Forum takes place 14 to 18 May, 2019 in the Eastern wing of the General Staff Building, State Hermitage. SPBILF is supported by the Russian Federation President and organized by the Ministry of Justice of Russian Federation.