In this issue:
- Ministry for Industry and Trade developed rules for subsidizing drug manufacturers
- The Government established rules for Essential Drugs price control in regions
- Ministry for Industry and Trade prepared amendments to the licensing procedure for drugs manufacturing
- Ministry of Healthcare developed rules for drugs manufacturing and distribution by pharmacies
- The Code of Conduct for pharmaceuticals producers is under development
Ministry for Industry and Trade developed rules for subsidizing drug manufacturers
Ministry for Industry and Trade prepared the Draft Government Resolution “On Adoption of Rules for Subsidizing to Russian Companies in order to Compensate Part of Expenses for Projects Associated with Manufacturing of Pharmaceuticals and (or) Pharmaceuticals Substances under the Subprogram “Development of Pharmaceuticals Production” of the State program “Development of Pharmaceutical and Medical Industry for 2013 – 2020”.
The document proposes subsidizing the expenses of Russian institutions associated with manufacturing of pharmaceuticals and (or) pharmaceuticals substances, assumed that these costs are duly justified.
It is suggested to grant subsidies at request of a manufacturer, provided that the manufacturer complies with the regulatory requirements and commits to achieve certain socio-economic targets.
The Government established rules for Essential Drugs price control in regions
The Government approved the Procedure for State Control over Essential Drugs Pricing in Regions of Russia. The corresponding Resolution #434 of May 6, 2015 has been signed by the Prime Minister Dmitry Medvedev.
The Procedure establishes the approach to controlling the Essential Drugs pricing at the regional level – namely, in rural settlements where there are no pharmacies. The control shall be executed by the regional executive bodies.
Ministry for Industry and Trade prepared amendments to the licensing procedure for drugs manufacturing
The Draft Administrative Regulation “On Amendments to the Ministry for Industry and Trade Order #877 of June 7, 2013 “On Adopting the Administrative Regulation of the Ministry for Industry and Trade on Rendering the State Service for Pharmaceuticals Manufacturing Licensing” is undergoing the anti-corruption expertise.
The document specifies, inter alia, the list of documents required for obtaining the license, stamp duty payment schedule, procedure of appealing against the decisions of the Ministry for Industry and Trade.
Anti-corruption expertise is carried out from May 17, 2015 through July 17, 2015.
Ministry of Healthcare developed rules for drugs manufacturing and distribution by pharmacies
Ministry of Healthcare has placed for public debates the Draft Departmental Order “On Establishing the Rules for Manufacturing and Distribution of Pharmaceuticals for Medical Use by Pharmacies and Entrepreneurs Licensed for Pharmaceutical Activities”.
The draft Order establishes the specific rules for manufacturing different pharmaceutical forms, such as powders, homeopathic triturations, granules, concentrated solutions, drops, homeopathic solutions, ointments, suppositories, pharmaceutical forms with antibiotics, etc.
All the manufactured products are subject to mandatory written organoleptic control at distribution.
The labelling requirements for manufactured pharmaceuticals have also been established.
The rules envisaged by the draft shall apply to manufacturing and distribution of pharmaceuticals produced “in-house” by pharmacies and individual entrepreneurs, i.e. Rx drugs and drugs at requests of medical institutions.
The document is expected to enter into force in July 2016.
Under the draft Code, the following activities are supposed to be prohibited: unjustified refusal from supply, exclusive agreements between dominating manufacturers and distributors, pharmaceuticals overpricing, etc. Any breach shall be subject to consideration by a committee of AEB members and FAS representatives.
As stipulated by the draft Code, market players are free to agree upon a minimum amount of one-time product shipment and a minimum procurement amount (in monetary or physical terms) for the period. To mitigate financial risks, manufacturers will be able to set a credit limit for distributors and to stop shipments in case of exceeding thereof. The Code would also oblige market players to disclose in their commercial policies the terms of providing bonuses under supply arrangements.
The previous Pharma Bulletin issues are accessible our website.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.