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KPMG Pharma bulletin, Issue #3, 2015 (March)
KPMG Pharma bulletin, Issue #3, 2015 (March)
Related content
In this issue:
Medical devices
- The President signed the laws on the state pricing regulations for medical devices and pharmaceuticals
- Ministry of Healthcare developed the methodology for determining the maximal manufacturer’s sales price for medical devices
Pharmaceuticals
- New Essential Drugs lists enter into force
- Ministry for Industry and Trade developed GMP inspection Rules
- Ministry of Healthcare developed the list of pharmaceutical forms
- Only localized foreign drugs to be included into the pharmaceuticals list
Other
Medical devices
The President signed the laws on the state pricing regulations for medical devices and pharmaceuticals
Vladimir Putin signed two anti-crisis laws aimed at stabilizing the Russian medical devices and pharmaceuticals markets:
- The Federal Law #33-FZ dd. March 8, 2015 “On Amendments to Article 80 of the Federal Law “On Fundamentals of Public Healthсare Protection in Russia”;
- The Federal Law #34-FZ dd. March 8, 2015 “On Amendments to the Article 61 of the Federal Law “On Circulation of Pharmaceuticals”.
The first Law introduces the state pricing regulations rules for medical devices implanted into a human’s body under the program of state guarantees on free medical care rendering to citizens.
The second one empowers the Russian Government to set the state pricing regulations with respect to maximal sales prices for essential drugs.
http://ria-ami.ru/read/9323
Ministry of Healthcare developed the methodology for determining the maximal manufacturer’s sales price for medical devices
The Ministry of Healthcare developed the Draft Government Resolution “On Adoption of Calculation Methodology for Determining the Maximal Manufacturer’s Sales Prices for Medical Devices, the Maximal Whole-sale and Retail Mark-ups for Medical Devices Included into the List of Medical Devices Implanted into a Human Body under the Program of State Guarantees of Free Medical Care Rendering”.
In accordance with the new methodology:
- The price is calculated based on the maximal sales price of one manufacturer and maximal sale prices of other manufactures for medical devices of the same type;
- The price calculation includes direct costs (associated with the production process) and overheads;
- While state registration of the maximal sales price, the maximal profitability level shall not exceed 30%;
- Re-registration of the manufacturer’s sales price is allowed in cases of (i) increase or decrease of prices for raw materials and components (used for the medical device production), (ii) increase or decrease of the overheads, and (iii) increase of the forecasted inflation rate.
http://ria-ami.ru/read/9812
Pharmaceuticals
New Essential Drugs lists enter into force
On March 1, 2015 the following lists adopted by the Decree of the Government of the Russian Federation #2782-r dd. December 30, 2014 came into force:
- Essential Drugs List (EDL);
- Drugs List covering pharmaceuticals intended for the supply of the patients under “7 Nosologies” program;
- The List of Pharmaceuticals for Medical Purposes, inter alia, prescribed by the decision of healthcare institutions’ medical panels (Essential Drugs Coverage);
- List envisaging the minimal assortment of pharmaceuticals.
http://ria-ami.ru/read/9054
Ministry for Industry and Trade developed GMP inspection Rules
The Ministry for Industry and Trade placed for public discussions the Draft Government Resolution “On Establishing the Rules for Organizing and (or) Performing the Audits of Pharmaceuticals Manufacturers for Medical Purposes with respect to GMP Standards Compliance”.
The Ministry for Industry and Trade is in charge for issuance of the audit resolutions, as well as their re-issuance and producing duplicates.
The maximal term for the issuance of a resolution should not exceed 160 business days.
The state service is to be financed at the applicant’s expense:
- fee for issuance of the resolution on a manufacturer’s GMP compliance: RUB 5,000;
- fee for the resolution re-issuance: RUB 2,500;
- fee for the issuance of the resolution duplicate: RUB 1,000.
http://ria-ami.ru/read/9678
Ministry of Healthcare developed the list of pharmaceutical forms
The Ministry of Healthcare developed the Draft Departmental Order “On Establishing the List of the Pharmaceutical Forms Names”. The List includes more than 30 types of pharmaceutical forms of drugs for medical purposes.
The document is aimed at implementation of the Federal Law #429-FZ dd. December 22, 2014 “On Amendments to the Federal Law “On Circulation of Pharmaceuticals”.
http://ria-ami.ru/read/9274
Only localized foreign drugs to be included into the pharmaceuticals list
The Ministry of Healthcare and the Ministry for Industry and Trade are assigned to develop proposals on introducing the amendments to the Russian Government Resolution #871 dd. August 28, 2014 “On Adopting Rules of Forming Lists of Pharmaceuticals for Medical Use and the Minimal Assortment of Pharmaceuticals Required for Providing Medical Care”.
The proposals are supposed to affect only foreign pharmaceuticals. The mandatory criterion for foreign pharmaceuticals to be included into the mentioned lists is ‘full localization’.
http://ria-ami.ru/read/9376
Other
Specifics of state contracts conclusion with governmental guarantees
The Draft Government Resolution «On Amendments to the Federal Law #44-FZ dd. April 5, 2013 “On Contractual System in the Sphere of Goods, Works and Services Procurement for State and Municipal Needs” has passed public discussions.
In particular, the Federal Law #44-FZ is supposed to be supplemented by the new Article 111.2, envisaging the possibility of granting guarantees by the Russian state to suppliers in relation to a particular purchase order for federal needs under the following conditions:
1) the initial (maximal) price of the contract concluded with the sole supplier (contractor) exceeds RUB 10 bn.;
2) the contract’s execution term exceeds three years, but does not exceed seven years;
3) the contract stipulates the obligation of the supplier (contractor) to make capital investments in Russia, including if required, technology transfer, equipment supply for the purposes of localizing in Russia the production of goods subject to the said state procurement contract.
Moscow city Law on additional guarantees to investors is drafted
The Moscow city authorities developed the Draft Moscow city Law “On Additional Guarantees to Investors Implementing Industrial and (or) High-Technology Projects in Priority Sectors in the Territory of Moscow”.
The guarantees could be provided for the projects with both Russian and foreign capitalinvestments.
Guarantees in the form of compensations are provided to investors in cases of occurrence of the events and (or) circumstances resulting in: (1) inability to implement the industrial and (or) high-technology project, or (2) the investor’s significant losses due to the increase of project’s implementation timeline by more than 18 months and (or) its payback period, or (3) more than 20% increase of the capital investments required.
The events and circumstances, occurrence of which may entitle the investor for the compensatory guarantees, include:
- nationalization or requisition of the investor’s property,
- termination of the investor’s title to real estate as a result of the city authorities’ actions,
- introduction of additional requirements, prohibitions and restrictions with regard to the investor’s business activity,
- actions or inactions of the authorities’ executives hindering the investment project implementation.
http://stroi.mos.ru/news/moskva-podgotovila-zakonoproekt-o-dopolnitelnyh-garantiyah-investoram
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.
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