In this issue:
- Ministry for Industry and Trade expanding the scope of subsidizing the pharmaceuticals clinical trials
- The Ministry of Healthcare is developing the draft law on pharmaceuticals’ sale in retail networks
- Federal Anti-Monopoly Service clarifies the maximum ED selling prices calculation
- The rules for determining maximum trade mark-ups for ED are set out
- Ministry of Healthcare developed the requirements to the user manual for pharmaceuticals’ medical use
- Ministry for Industry and Trade proposes exempting low-cost pharmaceuticals from pricing regulation
- Federal Anti-Monopoly Service proposed ED prices adjustment
- Methodology established for calculating the fee for GMP audit of foreign producers
Ministry for Industry and Trade expanding the scope of subsidizing the pharmaceuticals clinical trials
The Ministry for Industry and Trade prepared the Draft Government Resolution “On Amendments to the Rules for Granting Subsidies from the Federal Budget to Russian Companies for Compensating a Part of Expenses under the Projects Associated with Pharmaceuticals’ Clinical Trials in Course of the Subprogram “Pharmaceuticals Manufacturing Development”.
It is envisaged to expand the list of priority areas for research and development activities in the field of healthcare innovative growth, in particular, to add to the list the pharmaceuticals intended for:
- early detection and treatment of digestive tract diseases and metabolic disorders;
- treatment of hematological, oncohematological and congenital hereditary diseases;
- early detection and treatment of respiratory diseases;
- pain syndrome therapy;
- treatment of rare (orphan) diseases.
The Draft Law also proposes to:
- increase the maximum period of pharmaceuticals’ introduction into the civil circulation from 3 to 4 years;
- increase the maximum subsidy amount from RUB 200 to 400 milion in respect of all the agreements concluded with a Russian company in accordance with the Rules.
The Ministry of Healthcare is developing the draft law on pharmaceuticals’ sale in retail networks
Public discussions have conducted in respect of the notification on amendments to the Federal Law № 61-FZ of April 12, 2010 “On Circulation of Pharmaceuticals” and the Federal Law № 99-FZ “On Licensing Certain Types of Activities”.
The Document will address the possibilities of selling a limited list of pharmaceuticals types in the retail food stores.
Federal Anti-Monopoly Service clarifies the maximum ED selling prices calculation
The Federal Anti-Monopoly Service in its Letter # АК/10724/16 dd. February 2, 2016 “On registration of prices for generic drugs (points 16 and 17 of the Rules for maximum selling prices registration”) has clarified the procedure for calculating the maximum selling prices for generics:
- should the dosages of a generic and a reference drug be equal, the price for the purposes of state registration shall be calculated based on the average of all the registered prices for the reference drugs with this dosage, per one dosage form;
- should the dosages of a generic and a reference drug differ, the price for the purposes of the state registration shall be calculated based on the average of all the registered prices for the reference drugs with any dosages, per one unit of the API, with account to the three-year period of reference drugs prices registration;
- should there be no reference drugs for a pharmaceutical, the calculation shall be based on the maximum registered price for the similar drug (based on the INN or, in its absence, on the chemical or grouping name, the pharmaceutical form and its dosage (concentration, activity in units), calculated based on the maximum value of one dosage form disregarding the primary and secondary packaging.
The Federal Anti-Monopoly Service also clarified the rules for identifying reference drugs.
The rules for determining maximum trade mark-ups for ED are set out
The Government of Russia issued the Resolution #58 dd. February 03, 2016 “On Amending the Government Resolution # 865 dd. October 29, 2010 and Invalidating Certain Provisions of the Government Acts’” and established the rules for determining maximum wholesale and retail mark-ups to ED selling prices.
A draft resolution of the corresponding regional executive body on establishment and / or adjustment of the maximum wholesale and retail mark-ups for ED selling prices should be submitted to the Federal Anti-Monopoly Service for approval.
Further, such a draft resolution should be either approved or rejected by the Federal Anti-Monopoly Service within 30 business days from the date of its registration. The list of possible grounds for the rejection is envisaged by the Resolution.
The Resolution also provides for the template of an ED pricing protocol.
The Government Resolution comes into force on March 1, 2016.
Ministry of Healthcare developed the requirements to the user manual for pharmaceuticals’ medical use
The requirements are applicable to manuals for the medical use of pharmaceuticals submitted for state registration after the enactment of the said Order.
The draft sets out the list of data to be included into the manual, as well as the requirements to the manual format.
is the manual shall form a part of the registration dossier for a pharmaceutical, shall be approved by Ministry of Healthcare in course of the state registration procedure, shall be issued simultaneously with the registration certificate for a pharmaceutical and shall contain the registration certificate number and the state registration date.
Ministry for Industry and Trade proposes exempting low-cost pharmaceuticals from pricing regulation
The Ministry refers to the statistical reports for April – December 2015 prepared by pharmaceutical companies producing low-cost (up to RUB 50) and medium-cost (from RUB 50 to RUB 500) essential drugs. The reports show that 26 companies have already suspended manufacturing of such pharmaceuticals. In total, 182 pharmaceuticals have been withdrawn from the market, 131 of them belonged to the low-cost segment and 51 to the medium-cost one.
The Ministry for Industry and Trade noted that non-profitability of manufacturing of low-cost essential drugs resulted from inability of re-registering their prices with account to "the increased manufacturing costs". Furthermore, subsidy support to production of those pharmaceuticals, as proposed by the anti-crisis plan, is a temporary measure that could lead to superseding the manufactures who receive no subsidies.
According to the Ministry’s letter, to deal the issue comprehensively, manufactures should be entitled to re-register prices for low-cost essential drugs "under a declarative procedure" in 2016. The price inflation could be controlled via ensuring the fair competition.
Federal Anti-Monopoly Service proposed ED prices adjustment
The letter states that the issue has been raised by the Government back in 2014. In the late 2014 the Ministry of Healthcare, the Federal Anti-Monopoly Service, the Ministry for Industry and Trade, the Federal Tariff Service, the Ministry for Economic Development and the Ministry of Finance prepared the Draft Government Resolution envisaging one-time indexation of prices for low-cost essential drugs by 30%. In March 2015, the Draft was submitted to the Government and was rejected due to “unreasonably high increase of prices”. Meanwhile, the Ministry for Industry and Trade, as well as the majority of the Russian pharmaceuticals manufacturers, supported 80% indexation or total abolition of the pricing control for low-cost essential drugs. In autumn 2015, the Ministry for Industry and Trade performed a market survey and determined that the low-cost essential products were being gradually withdrawn from the market.
Methodology established for calculating the fee for GMP audit of foreign producers
The Ministry for Industry and Trade by the Order # 9 dd. January 11, 2016 established the methodology for calculation and the maximum level of the fee for GMP audits of foreign producers of pharmaceuticals.
The maximum fee for the GMP audit service, excluding travel allowance, is RUB 1,708,345.12; the travel allowance directly related to the GMP audit is RUB 1,173,510; hence, the maximum total fee for a GMP audit is RUB 2,881,855.12 (including 18% VAT).
Medical waste excluded from the scope of the general waste handling regulation system
The Federal Service for Supervision of Consumer Rights Protection and Human Well-Being in its Letter # 09-1236-16-16 dd. February 02, 2016 "On consideration of the application" established a special procedure for medical waste handling.
According to the letter, medical waste is subject to collection, use, deactivation, placement, storage, transportation, accounting and destruction in accordance with the regulations in area of sanitary and epidemiological safety.
The medical waste classification is governed by part II of SanPiN 18.104.22.16890-10 that establishes the hazard class of all the types of waste generated by companies engaged in medical activities, regardless of the OKVED Classifier code.
The waste located in premises of the companies engaged in medical and / or pharmaceutical activities shall be transported by specialized providers to the location of the medical waste deactivation and/or placement, considering the unified centralized sanitation system for a particular administrative territory.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.