Vladimir Putin signed two anti-crisis laws aimed at stabilizing the Russian medical devices and pharmaceuticals markets:
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.
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:
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:
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:
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”.
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’.
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.
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:
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.