On January 12, 2018, the Prime Minister of the Russian Federation issued Directive No. 9-r, approving the "Development of Competition in Healthcare" action plan (roadmap). This initiative aims to expand access to novel pharmaceuticals, improve competitive conditions, and prevent anti-competitive practices within the Russian pharmaceutical market.

The core initiatives designed to achieve these objectives include:

• Standardizing requirements for interchangeable drug labeling by establishing a registry of model product inserts.

• Auditing the dietary supplement sector and prohibiting the registration of pharmaceutical products as dietary supplements.

• Imposing professional liability on healthcare professionals for non-compliance with pharmaceutical circulation laws.

• Introducing administrative penalties for misrepresenting data in product inserts and for exceeding maximum price caps on vital and essential medicines.

• Admitting pharmaceuticals into the Russian market based on foreign clinical trials, subject to mandatory disclosure regarding the absence of local clinical trials within the Russian Federation.

• Reforming pharmaceutical price-control mechanisms by restructuring the rules for calculating markups on actual manufacturer baseline prices.

• Enhancing public and professional transparency regarding data on interchangeable pharmaceuticals.

• Amending public procurement legislation governing pharmaceutical procurement, which includes developing model contracts and defining strict criteria for sole-source procurement.

Furthermore, the roadmap outlines comprehensive legislative amendments to existing regulations governing pharmaceutical circulation, public health protection, and intellectual property rights protection during drug patenting.