The Russian Government adopted a number of resolutions setting the rules for funding of Russian companies from the federal budget in order to partially compensate their costs for manufacturing and clinical trials of pharmaceuticals, API, and medical devices.
The Resolution provides a declarative procedure for costs funding, provided that the declarant meets all the applicable criteria and commits to achieve certain social-economic targets. One of the conditions for the subsidy is the availability of a business-plan, envisaging the release of the API and/or a medical devices into market circulation not later than in three years after the subsidy agreement signing.
The Resolutions envisage:
The documents are aimed at realizing the import substitution measures in medical and pharmaceutical industries, motivating the Russian companies’ investment activity, increase of the share of locally produced pharmaceuticals and medical devices in the total amount of consumption, creating and modernizing highly-efficient workplaces in healthcare and pharmaceutical industries.
The Ministry of Healthcare has notified on the work on the draft Order “On Approving the Application Proforma for Registration and Re-registration of Maximal Sales Price of a Manufacturer on Pharmaceuticals Included into the Essential Drugs List, Annually Adopted by the Government of the Russian Federation”.
The draft Order includes requirements to contents to be indicated in the application for registration and re-registration of an ED maximal selling price, as stipulated by the Resolution of the Government # 979 dd. September 15, 2015.
The Procedure for Selective Quality Control of Ppharmaceuticals for Medical Use, adopted by the Order of the Federal Service on Surveillance for Healthcare and Social Development (Roszdravnadzor) # 5539 dd. August 07, 2015, entered into force.
The selective quality control is performed either by Roszdravnadzor or by its regional bodies based on the data provided by manufacturers and importers of pharmaceuticals in Russia, and includes the following steps:
Following the Rules, substitutability of a pharmaceutical shall be determined in course of its state registration by comparing its parameters with the ones of the reference drug, according to part 1 Article 27.1 of the Federal Law # 61-FZ “On Circulation of Pharmaceuticals” dd. April 12, 2010.
When assessing the substitutability of a biosimilar drug, one shall consider the the data received during the drug’s clinical trials, including the data on absence of clinically significant safety differences, its efficiency and immunogenicity as compared to the reference drug.
The conclusion on substitutability (non-substitutobility) of a pharmaceutical shall be documented as an appendix to the statement of the expert panel as per the template adopted by the Ministry of Healthcare.
Additionally, certain types of pharmaceuticals are exempt from the above Rules, in particular, reference drugs, phyto-pharmaceuticals, homeopathic drugs and drugs approved for medical use in Russia for more than 20 years and for which bioequivalence assessment may not be performed.
The Resolution of the Government # 1042 dd. September 30, 2015 adopted the unified List of medical goods exempt from VAT when importing into and selling within Russia.
The Resolution was adoption for the purposes of:
- Harmonizing the terminology used in the Russian Tax Code and in the Federal Law “On Fundamentals of Public Healthсare Protection in Russia”;
- Uniforming the list of medical goods subject to point 1 clause 2 Article 150 of the Tax Code of the Russian Federation.
The document entered into force on October 13, 2015 and replaced a number of the previously effective Government Resolutions which stipulated different Lists of medical goods, not subject to VAT in Russia.
The Russian Government has developed the draft Resolution “On Adopting the Rules for Funding from the Federal Budget Provided to Residents of Industrial Clusters for Partial Reimbursement of Costs Incurred during Joint Projects on Manufacturing of Industrial Products for Import Substitution Purposes”.
The draft Resolution defines the industrial cluster as a system of entities operating in a particular industrial branch and interconnected while running activities in this branch due to the territorial proximity and functional inter-dependence.
It is supposed to provide funding for partial reimbursement of costs during joint projects in the following areas:
The non-budget financing should comprise not less than 70% of the total costs of such projects. At the moment of applying for the subsidy, not less than 30% of the non-budget financing should be available.
In addition, the project applying for the state subsidy shall meet the following criteria:
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.