In this issue:
- The draft resolution on the restrictions for foreign producers of medical devices to participate in state tenders is at the final stage of approval
- No requirement to enclose the registration certificates for medical devices to a VAT return
- Principles of state pricing regulation for pharmaceuticals can be changed
- Changes to the Federal Law “On Circulation of Pharmaceuticals” signed by the President
- Ministry of Healthcare develops changes to the procedure of authorization for conducting clinical trials of pharmaceuticals
- Regulations adopted on the Commission in charge of the pharmaceuticals’ lists formation
The draft resolution on the restrictions for foreign producers of medical devices to participate in state tenders is at the final stage of approval
According to Julia Totrova, Chief advisor of the Department of Economics and Finance of the Russian Government, the draft Resolution of the Ministry of Industry and Trade of Russia on restricting foreign medical devices producers’ participation in state tenders is at the final stage of approval and will be adopted in the near future.
The considered version of the List of restricted medical devices types is not publicly available. It is expected that about 40 types of medical devices would be affected.
No requirement to enclose the registration certificates for medical devices to a VAT return
According to the clarification of the Ministry of Finance and the Federal Tax Service of Russia, when submitting a VAT return to the tax authority, it is not obligatory to enclose the registration certificates for medical devices which are VAT-exempt.
However, in course of desk tax audits the tax authorities are entitled to request for review the registration certificates, along with other documents validating the VAT exemption.
Principles of state pricing regulation for pharmaceuticals can be changed
A new chapter, introducing the state pricing regulation for pharmaceuticals not included into the Essential Drugs List, may be added to the Draft Law "On Introducing Changes to the Federal Law "On Circulation of Pharmaceuticals", which second reading in the Parliament is scheduled for November. These amendments are under development by the State Duma Committee on Health Protection and by the Russian Government. Should the amendments be adopted, the Government is supposed to analyze prices for pharmaceuticals in foreign markets and set price limits for pharmaceuticals in the Russian domestic market with account to such studies’ results. This approach is supposed to preclude inflating prices for certain pharmaceuticals in Russia.
The Federal Law would include only general principles of state price regulation, while the methodology for determining the price limits would be further developed by the Government based on the two basic approaches most commonly used internationally:
- using reference prices, calculated based on the benchmarking against prices for particular pharmaceuticals in a certain group of countries;
- setting the price limit for each particular pharmaceutical, exceeding of which would result non-admission of the supplier to the Russian market.
Currently, the Russian law regulates only the prices for Essential Drugs (as per the list formed by the Government), the share of which does not exceed 30% of the entire pharmaceuticals market. Prices for the other 70% pharmaceuticals are not the subject to state regulation.
Changes to the Federal Law “On Circulation of Pharmaceuticals” signed by the President
The law inter alia imposes certain restrictions for conducting clinical trials at children. According to the new provisions, children may potentially be the clinical trial patients only if such a trial is vital for their health improvement or is necessary for prevention of childhood contagious diseases, or if the aim of the trial is identifying the optimal dosage of a pharmaceutical for treatment of children. In the said cases, the trial should be preceded by the clinical trials of the pharmaceutical at adults (except for instances when the pharmaceutical is intended for pediatric use only and cannot be tested at adults).
The amendments also address the circulation of veterinary pharmaceuticals, namely:
- The procedure of submission and processing of applications for state registration of veterinary pharmaceuticals (Article 18);
- The procedure of veterinary pharmaceuticals quality assurance and the expert assessment of the expected benefits vs. possible risk correlation of veterinary pharmaceuticals (Article 24), etc.
Article 58 is supplemented by a provision, permitting the storage of veterinary pharmaceuticals without obtaining a pharmaceutical license provided that the pharmaceuticals are used solely in breeding, farming (raising), keeping and curing of animals.
Ministry of Healthcare develops changes to the procedure of authorization for conducting clinical trials of pharmaceuticals
The Russian Ministry of Healthcare placed for the public discussion the departmental Order “On Changes to the Procedure of Authorization for Conducting Clinical Trials of Pharmaceuticals for Medical Use, Adopted by Order #748n of the Ministry of Health and Social Development of Russia on August 26, 2010”.
The proposed changes lift the requirement to re-apply for the authorization to conduct an international multicentre clinical trial and/or a post-registration clinical trial of pharmaceuticals for medical use after their expert examination.
The order is expected to come into force on December 8, 2014.
Regulations adopted on the Commission in charge of the pharmaceuticals’ lists formation
The Regulation on the Commission of the Ministry of Healthcare in charge of formation of the pharmaceuticals’ lists and the minimum range of pharmaceuticals for medical aid has been approved. The respective departmental Order № 498n of September 9, 2014 was published by “Rossiyskaya Gazeta” on October 22, 2014.
The Commission is created to develope the following lists:
- The Essential Drugs List;
- The list of pharmaceuticals intended for treatment of patients suffering from hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, some types of cancer, multiple sclerosis, as well as patients undergone transplantations of organs or tissues;
- The list of pharmaceuticals for medical use, including those prescribed by the medical commissions’ resolutions;
- The minimum assortment of pharmaceuticals for medical use, required for medical aid delivery.
The Commission is composed of the representatives of the Ministry of Health, the Ministry for Industry and Trade, the Ministry of Finance, the Ministry of Labor, the Ministry of Regional Development, the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), the Federal Service on Surveillance for Consumers Rights Protection and Human Welfare (Rospotrebnadzor), the Federal Anti-Monopoly Service (FAS), the Federal Medical-Biological Agency (FMBA), the Federal Agency of Scientific Organizations (FANO) and other federal authorities, federal state educational institutions of higher medical and pharmaceutical education, federal state medical and pharmaceutical scientific institutions.
The organizational support of the Commission’s activity is ensured by the Department of pharmaceuticals coverage and regulation of medical devices’ circulation of the Ministry of Healthcare.
Ministry of Healthcare developed criteria for medical institutions performance assessment
The Draft Order of the Ministry of Healthcare introducing the new methodology of assessing medical institutions quality performance has passed public discussions.
Specific assessment criteria were developed for in-patient medical facilities and for day hospitals. The criteria include:
- transparency and accessibility of information related on the medical institution,
- comfortable conditions and affordability of medical services,
- queuing time when receiving medical aid,
- amiability of medical personnel,
- politeness and professionalism of medical personnel,
- satisfaction with the quality of medical services provided.
Performance quality will be assessed also taking into account such factors as the medical institution’s rating published at http://www.bus.gov.ru; completeness, relevancy and clarity of the information provided at the medical institution’s official web-site; efficiency of getting feedback, etc.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.