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Ensuring drug safety in the EAEU

A round table was held at the Eurasian Economic Commission (EEC)

“The development of integration is the basis for increasing the level of security Pharmaceutical Products of the EAEU Member States”, the main topics of which were the development of import substitution and ensuring drug safety in the Eurasian Economic Union.

The event, chaired by the Minister for Industry and Agro-Industrial Complex of the Eurasian Economic Commission Artak Kamalyan, was attended by the heads of the largest drug manufacturers of the Union, industry clusters and associations, as well as innovative pharmaceutical and biotechnology companies.

The moderator of the meeting, Deputy Director of the Industrial Policy Department of the Commission Georgy Arzumanyan, noted the critical importance of ensuring the stability of the pharmaceutical industry in the current crisis situation, associated not only with the limitation of the supply of pharmaceutical substances and medicines, but also with the disruption of supply chains in general.

At the same time, it was noted that, despite the restrictions and problems caused, in particular, by the pandemic, the process of forming a common EAEU drug market has achieved noticeable results. For example, the formation of a system for ensuring and controlling the quality of medicines circulating on the single union pharmaceutical market has been completed. The Pharmacopoeia of the Union was adopted, which became the second operating regional pharmacopoeia in the world.

The key topics raised by representatives of the business community at the round table were the expansion of production and the formation of cooperation chains within the Union, the application of support measures for manufacturers of medicines and pharmaceutical substances, the formation of pharmaceutical clusters as points of growth in drug supply. In addition, the pharmaceutical companies stressed the importance of addressing issues related to improving the regulatory framework of the Union in the field of healthcare.

The head of the export department of GEROPHARM, Alexander Nesterenko, drew attention to the need for the soonest harmonization of the laws of the member countries of the Eurasian Union. Under the current conditions, this is necessary to ensure drug safety and the development of an independent pharmaceutical industry. Alexander Nesterenko noted:

Manufacturers need incentives to expand their activities. One of the main ones is the opportunity to gain market share. Within the framework of the EAEU, we are faced with the fact that in a number of cases the texts of technical specifications for auctions and lots are not harmonized. This leads to restrictions on bringing drugs to the market. For example, if in a country access is based on trade names, or bidding organizers indicate the possibility of participating in procurement only if the product is confirmed registered in accordance with European law, or FDA rules, then this becomes a problem for a number of companies. I would like to see uniform principles for compiling documentation for auctions formed within the EAEU. In this case, all participants will have equal access.

In order to support producers in the current conditions, tools that have been developed at the state level in recent years are useful. Yulia Shmakova, a representative of the BIOCAD company, told about this. Thus, special investment contracts (SPIC) proposed by the Ministry of Industry and Trade of Russia are aimed at concluding agreements between the investor and the state, according to which the investor undertakes to implement a project with the right to receive incentive measures, including: tax benefits, subsidies, simplified access to government orders, accelerated depreciation, special conditions for the lease of land plots and the creation of infrastructure facilities.

Under the sanctions, a decision was made to expand the possibilities for SPIC. On March 14, 2022, amendments to the Federal Law “On Industrial Policy in the Russian Federation” were approved regarding the regulation of special investment contracts. The purpose of this initiative is to attract investment in projects to create new industrial production, as well as leveling the negative impact of sanctions for investors who signed SPIC 1.0 in the period from 2016 to 2019.

Alexander Semenov, President of Active Component, spoke about the importance of creating the Russian Pharmacopoeia and the EAEU Pharmacopoeia and introducing their own institute of reference materials. Alexander Semyonov said:

The existence of our own Pharmacopoeia became especially important when there were certain problems with the supply of reference materials from the EU countries and the USA. To stabilize the situation, we need our own institute of reference materials. Today it is a matter of drug safety. Since 2018, our company has been cooperating with the SID and NP of the Ministry of Industry and Trade of Russia, and today with the National Center for Reference Materials. "Active Component" has already declared itself as a developer. We are ready to take on the development of a total of 270 samples and additives for active substances with the appropriate equipment and funding. In the next 9 months, it is necessary to launch the development and standardization of samples in Russia and the EAEU. Our common goal is to meet the needs for all drugs from the Vital and Essential Drug List.

Another advantage of introducing a reference material institute is the price. Own samples, according to Alexander Semenov, will cost 8-10 times cheaper today compared to American and European ones.

The participants of the event expressed their readiness to take an active part in the implementation of the action plan approved at the level of the heads of government of the Union countries to increase the level of their provision with strategically important drugs and pharmaceutical substances for medical use, the production of which should be ensured in the EAEU until 2024. The implementation of this document, as noted by the participants in the discussion, can become the basis for qualitative transformations not only in pharmaceuticals, but also in industries directly related to it - chemical, agro-industrial and a number of others.

Artak Kamalyan emphasized:

Summing up the results of the event, I would like to note the high social significance of our work and the need to combine the production, scientific and technical potentials of the EAEU countries. As practice shows, only by joint efforts can we achieve the necessary results to effectively counter all possible challenges.

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