Roman Shabrov, Partner at BRACE Law Firm, participated in the 4th International Practical Conference "Market Access for Pharmaceuticals in Russia and the CIS," which took place in Moscow.

The conference sessions addressed the harmonization of the Eurasian Economic Union (EAEU) legal and regulatory frameworks, pharmaceutical registration procedures, and specific challenges surrounding market access for orphan drugs. Participants also evaluated the regulatory outlook for national pharmaceutical markets, overarching EAEU life sciences industry developments, and best practices for the successful launch of high-cost orphan drugs. Key technical discussions focused on practical aspects of pharmacovigilance, the legal status of the Authorized Person, public procurement of medicines, the unified EAEU regulatory regime, and the harmonization of regulatory pathways for biological molecules and biostructures within the EAEU.

Mr. Shabrov’s presentation examined market access complexities within the public procurement sector for pharmaceuticals across the Eurasian Economic Union. Specifically, the presentation analyzed Annex No. 25 (“Protocol on the Procedure for Procurement Regulation”) to the Treaty on the Eurasian Economic Union, alongside ex-ante and ex-post regulatory mechanisms governing pharmaceutical public procurement. Additionally, Mr. Shabrov evaluated the interaction between the 15% price preference framework, the “third-party exclusion” rule, and the three-tiered preference system.

The complete presentation is available for review here.