In this issue:
- Russian Government is back to the idea of selling pharmaceuticals in retail chains
- The Government accepts amendments to the Federal Law “On Circulation of Pharmaceuticals”
- President endorses the law allowing non-specialized media to advertise medical services
- Amendments to the Law on the State Procurement Contracting System
- The draft Document defining standards for formation of the lists of pharmaceuticals directed to the Government
- Patent protection period for original pharmaceuticals in Russia may be reduced
- Procedure of state registration of medical with Roszdravnadzoris updated
Russian Government is back to the idea of selling pharmaceuticals in retail chains
The Ministry of Healthcare, the Ministry for Industry and Trade, the Ministry for Economic Development and the Russian Federal Service on Customers' Rights Protection and Human Well-Being Surveillance will prepare a list of OTC drugs to be traded in retail chains.
The idea of permitting retail chains to sell certain pharmaceuticals has been discussed by the Government of the Russian Federation since the autumn of 2012. The Ministry of Healthcare did not back the idea due to the potential risk of increase in low-quality and counterfeit medicines on sale.
In 2013 the Ministry of Healthcare permitted the sale of care products for patients, personal-care products, child nutrition and food additives not only in pharmacies. The Ministry offered the possibility of selling OTC drugs in accordance with the list developed by the Ministry for Industry and Trade. The final version of the list should include vitamins, anti-cold, anti-febrile, gastrointestinal and absorbing medicines, diagnostic devices and products for external use.
The Government accepts amendments to the Federal Law “On Circulation of Pharmaceuticals”
At the Government session held on June 26 the draft federal law on introducing amendments to the Federal Law “On Circulation of Pharmaceuticals” was endorsed in respect of adjustment of conceptual framework, addition of new terms, including terms covering interchangeable, orphan, biologic, innovative drugs and reference drugs.
The draft law envisages the following:
- Establishing the procedure for monitoring compliance of pharmaceuticals production with the rules of medicines manufacturing and quality control;
- Changing the list of documents composing the registration dossier;
determining the conditions under which no bioequivalence study for generic drugs is required;
- Procedure for confirming the interchangeability of pharmaceuticals for medical use;
- Empowering the federal executive bodies to adopt “good practices” in the field of clinical and pre-clinical trials and sales of pharmaceuticals.
The document is to enter into force on the 1st of January 2015.
President endorses the law allowing non-specialized media to advertise medical services
The Russian President Vladimir Putin signed the draft Federal Law “On Amendments to Article 24 of the Federal Law “On Advertising””, which allowed advertising of medical services in non-specialized media. The State Duma has adopted the law on 20th of June and the Federation Council approved the law on 25th of June.
The Federal Law is intended to eliminate the differences between points 7 and 8 of Article 24 of the Federal Law “On Advertising” setting out requirements for advertising of medical services.
The new Law allows placement of information on medical services in non-specialized media, provided that the notice of contra-indications, necessity of familiarizing the patient with administration instructions or consultation with specialist are in place. The Law entered into force on the 3rd of July 2014.
Amendments to the Law on the State Procurement Contracting System
The Russian President Vladimir Putin signed the draft of the Federal Law “On Amendments to the Federal Law “On the Contracting System in the Area of Procurement of Goods, Work, Services for Governmental and Municipal Needs””. The State Duma has adopted the Law on the 23rd of May and the Federation Council has approved the Law on the 28th of May.
The document envisages the following changes:
- Specification of the conceptual framework currently in use;
- Introduction of the definition of total annual amount of procurements, and specification of the procedures in order to apply the substantiation methods with respect to the contract price and procurements’ execution from the small enterprises;
- Definition of specifics of procurements’ for customer’s activities in foreign jurisdictions;
- Possibility of low-scale procurements amounting up to RUB 2,000 thousand or up to 5 percent of total annual volume of procurements, not exceeding RUB 50,000 thousand in total, from the sole supplier;
- Lifting of the documentary evidence on the impossibility to use other methods to determine the supplier (except for procurement execution from the sole supplier (contractor), as well as the price and other substantial contractual terms in certain cases;
- Extension of the list of cases when procurement is allowed from the sole supplier (contractor);
- Extension of the list of cases when customers should be allowed to carry out the expertise of the delivered goods (work, services) without experts involvement.
The draft Document defining standards for formation of the lists of pharmaceuticals directed to the Government
The Draft Government Resolution “On Establishing the Standards for Formation of the Lists of Pharmaceuticals Provided for by the Laws of Russia” was directed to the Cabinet of Ministers on the 1st of June.
- The document was developed by the Ministry of Healthcare for the purpose to simplify and to clear up the procedure of formation of the lists of pharmaceuticals, procured in course of state tenders. The rules will define the order of formation of the following lists:
Essential and Vital Drugs (EDL) list;
- Minimal assortment of pharmaceuticals for medical use, which are necessary for medical treatment;
- List of drugs which procurement is financed from the federal budget and intended for drug coverage of the patients suffering from hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher's disease, malignant neoplasm of lymphoid tissue, blood-forming tissue and other related tissues, multiple sclerosis and persons after transplantation of organs or tissues;
- List of drugs for medical use including drugs prescribed by the medical panels of healthcare organizations and which are provided in accordance with health care standards on prescription of the doctor (paramedic) in course of state social care provision in the form of composition of social services.
Patent protection period for original pharmaceuticals in Russia may be reduced
The Ministry of Healthcare developed amendments to the Federal Law “On Circulation of Pharmaceuticals” intended at reduction of the patent protection period for original pharmaceuticals. The Draft has already passed by the interdepartmental review and was submitted to the Russian Government for consideration.
Producers of generics (analogues of the original drugs) could be allowed to file an application for registering a pharmaceutical in 4 years after the market access of the original drug, and biosimilars’ (a drug, which is similar to the original drug in terms of safety, quality and efficiency) producers – in 3 years.
Amendments may allow the pharmaceuticals companies get an earlier access to the data on trials results for the original drugs, which, in view of the Ministry of the Healthcare could accelerate the market access for generics and biosimilars in Russia.
Procedure of state registration of medical with Roszdravnadzoris updated
The Order No.737н of the Ministry of Healthcare dated the 14th of October 2013 “On Establishing of the Administrative Regulation of the Federal Service for Supervision in the Area of Health Care about Provision of the Government Service in Respect of the Government Registration of the Medical Devices” introduced updates to the procedure of state registration of medical devices performed by Roszdravnadzor.
For the purpose of the state registration the producer of medical devices should file to Roszdravnadzor an application with all the necessary documents.
The Regulation updates and specifies the structure, terms and sequence of Roszdravnadzor’s administrative actions in course of rendering the state registration service. Also the list of persons entitled for filing the registration application and the list of required documents were adjusted.
The new Regulation contains a more detailed list of administrative procedures with a step-by-step description, including the pre-trial appeal against Roszdravnadzor’s decisions and actions in course of the state registration of medical devices.
The maximal period established for the state registration of a medical device comprises 50 business days (which does not include the timing required for clinical trials).
The Order enters into force within 10 days after the day of its official publication
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.