“Regulatory Guillotine” in the pharmaceutical industry: general approaches and implementation specifics

Regulatory Guillotine: definition and substantiation Presidential Address to the Federal Assembly of the Russian Federation dd. 20.02.2019 “Presidential Address to the Federal Assembly” Action plan (roadmap) for implementation of the Regulatory Guillotine, approved by the Chairman of the Government of the Russian Federation under No. 4714p-P36 dd. 29.05.2019 deliberate restriction of the monitoring (surveillance) subject by omitting some requirements that were previously mandatory for inspection by authorized bodies, on the basis provided in a dedicated legal act

Regulatory Guillotine patterns Simplified administrative procedures (Vietnam, France, Moldova) Inventory check and classification of effective regulatory base on the basis of Regulatory Guillotine projects implemented by Jacobs, Cordova & Associates (Croatia, Kyrgizistan) Justification of regulatory intervention (EU), involving quality regulation to be based on the best available evidence, including research and expert data Deregulation (UK)

Framework of the Federal Law draft “Mandatory requirements” One-time amendment, cancellation or introduction of new mandatory requirements on January 1, 2021 Prohibition of mandatory requirements, except for those set for statutory purposes Unified approaches to and procedures of mandatory requirement review, regulated at the legal level

Risks of the Regulatory Guillotine Approach to definition of “mandatory requirements” Complete deletion of regulations stating mandatory requirements Restricted approach of developers by cancelling bylaw requirements only Different detail content of mandatory requirements Risk as a basis of legal force of a mandatory requirement