The influence of representatives of foreign companies on decisions of the Eurasian Economic Commission on the design of the legislation framework was one of the main topics of the meeting of the Expert commission on development of biotechnologies of pharmaceutical and medical industry of the State Duma Committee on Industry.
During the meeting on “Development of rules of registration and examination of medicines and medical equipment using within the Eurasian Economic Union” ARPM Director General Victor Dmitriev spoke on the recent change to the Union documentation made by the working group. The changes were lobbied by representatives of the foreign companies. The agency, that did consulting while preparing the final decision was lately excluded from the working group.
“ORV is an effective and very sensitive mechanism. An unethical usage of that mechanism in a competition could not only misbalance the market but also discourage the idea of productive cooperation of business and the Government” said Victor Dmitriev. We were quite surprised when we saw the final evaluation of the Eurasian Economic Committee on “Registration and examination of medicines and medical equipment”. Everything came to place lately when we saw the list of the expert involved in the work.
“In order for the working group to work productively we need to come up with particular criteria to who can be involved as an expert. It is important to determine the level of responsibility for expert’s decisions,” concluded Mr. Dmitriev.
The position of the Association was supported by other members of the pharmaceutical community. A deputy director on cooperation with state authorities of “Bicard”, Aleksey Torgov said that their company was faced with a similar challenge. A regulation base on examination of biological medicines within the EAEU, which Russian pharmaceutical companies were involved in creation of, were completely changed after the ORV revision, and had ended up providing more support to foreign companies. “There should be no foreign companies involved in making a decision of the Russian party,” said Mr. Torgov.
A first deeply chairmen on the State Duma Committee on Industry, Vladimir Gutenev supported the position of the speakers. It was decided to appeal to the state official to defend the position of Russia.