In this issue:
- The Russian Government adopted subsidizing rules for drug and medical devices manufacturers
- The Ministry of Healthcare is preparing the application proforma for registration and re-registration of ED prices
- The Procedure adopted for pharmaceuticals’ selective quality control
- Rules developed for determining pharmaceuticals substitutability
The Russian Government adopted subsidizing rules for drug and medical devices manufacturers
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.
- Resolution # 1045 sets the procedure and conditions for funding of pharmaceuticals’ clinical trials. It is envisaged to compensate the costs for purchase of raw materials, consumables, reference pharmaceuticals, third-party services on laboratory and clinic-diagnostic trials, processing of clinical data, transportation of pharmaceuticals samples, life and health insurance of the patients participating in the clinical trials.
- Resolution # 1046 sets the procedure and conditions for funding of clinical trials of medical devices included into the List of Medical Devices Implanted into a Human Body under the Program of State Guarantees of Free Medical Care Provision. The compensation is supposed not to exceed RUB 5 million per one medical device.
- Resolution # 1047 sets the procedure and conditions for funding of manufacturing of pharmaceuticals and (or) API included into the Essential Drugs List. It is envisaged to compensate the costs of equipment leasing (excluding the primary installment), third-parties’ fees for pre-commissioning activities for manufacturing equipment, consumables and reagents for manufacturing technology testing and other third-party services.
- Resolution # 1048 sets the procedure and conditions for funding of high-technology manufacturing of medical devices in the following areas:
a) medical devices implanted into a human body;
b) expendable medical devices;
c) consumable materials for medical devices;
d) tools for rehabilitation of the disabled and handicapped people;
e) equipment for highly-effective radiological therapy using the ion beam;
f) medical devices for patients’ personal distance monitoring;
g) ophthalmological 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:
- funding of the costs de-facto incurred not earlier than January 1, 2015 and properly documented;
- compensating not more than 50% of the actual costs incurred and not more than RUB 200 miliion per one legal entity (RUB 5 million in case of implanted medical devices’ clinical trials).
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 is preparing the application proforma for registration and re-registration of ED prices
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 adopted for pharmaceuticals’ selective quality control
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:
- processing of the data provided by companies engaged in circulation of pharmaceuticals;
- sample selection of pharmaceuticals;
- decision on further market circulation of a pharmaceutical;
- decision on performing recurring serial sample quality control of a pharmaceutical in case of its repeated quality incompliance with the established requirements.
Rules developed for determining pharmaceuticals substitutability
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.
Unified list of VAT-exempt medical devices adopted
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.
Residents of industrial clusters will receive funding for joint projects
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:
- development of technological infrastructure located within the industrial cluster;
- research and development activities related to industrial products manufacturing;
- development of training and education system for engineering personnel;
- carrying out of exhibition arrangements, participation of the industrial cluster’s representatives in exhibitions and similar events in Russia and abroad;
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:
- two or more non-affiliated residents of the industrial cluster shall be engaged in the project;
- the project participants’ costs should be confirmed annually;
- the project should be coordinated by a specialized company existing within the cluster;
- the project shall be included into the program approved by the general meeting of the industrial cluster residents, or individually approved by the general meeting of the industrial cluster residents.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.