The Ministry of industry and trade of the Russian Federation
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Vladislav Shestakov took part in a special session of the Legal Forum

On May 17, 2018, St. Petersburg hosted a special session of the Legal Forum dedicated to regulation of the pharmaceutical market.

The session welcomed recognized experts and leaders in the area, e.g. Ernst & Young, “Medico-Pharmaceutical Projects. XXI century” Association, and EAEU Pharmaceutical Manufacturers Association. Key pharmaceutical regulators and heads of major pharmaceutical companies took an active part in the discussion.
The program outline covered main trajectories of Pharma-2030 strategy, policy priorities in government support measures, as well as state policies aimed at protection of intellectual property, mandatory licensing and parallel imports, new drug supply models, prospects of budgetary maneuvering in healthcare, sanctions impeding development of the industry, and the substitution plan.

Vladislav Shestakov in his speech noted as unavoidable introduction of effective mechanisms to enhance control over pharmaceutical products circulation. He referred to Ukraine as an example. With no more than just two sites that were duly certified, most of Ukrainian producers ignored audits for compliance with the good manufacturing practices. Nevertheless, their turnover in Russia keeps growing as if nothing were wrong. In January-February of 2018 to continue the last year’s trend, Ukraine has significantly increased its drugs export to the Russian Federation, at the same time reducing imports of Russian pharmaceutical products. ‘The Ministry of Industry and Trade of the Russian Federation is actively working on this. In particular, mechanisms have been developed that will allow for action in the event of failure to undergo an inspection. These mechanisms will be reflected in updated Federal Law 61 of the Russian Federation, which is currently going through the third hearing in the State Duma,’ said Vladislav Shestakov, director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade.