KPMG Pharma Bulletin Issue #12, 2017 (December)
KPMG Pharma Bulletin Issue #12, 2017 (December)
The President signed the Federal Law # 425 dd. 28.12.2017 “On Amendments to the Federal law “On Circulation of Pharmaceuticals.”
The Law is enacted from 01.01.2018; however, the provisions on manufacturers’ obligations to label the package with the identification marks, to submit the data to the monitoring system as well as the clauses governing the liability for non-compliance will come in force from 01.01.2020.
With respect to Essential Drugs and pharmaceuticals included into the “7 Nosologies” program, the Law provides for a possibility of applying ‘special procedure’ for the monitoring implementation. As per the representatives of Roszdravnadzor, serialization of these product categories is likely to become mandatory already during 2018; the corresponding Resolution of the Government is being drafted.
The State Duma adopted in the first reading the draft Law on establishment of administrative liability for untimely or unreliable data submission to the pharmaceuticals monitoring system. It is proposed to set administrative fines of:
- RUB 5,000 – 10,000 for management;
- RUB 50,000 – 100,000 for companies and individual entrepreneurs.
The Law is to enter into force from 01.01.2019.
The Russian Ministry for Industry and Trade developed and placed for public discussions the draft Order “On Approval of the Rules for Providing Subsidies from the Federal Budget to the Federal Autonomous Public institution “Russian Technological Development Fund” to Support Projects on Drugs Serialization”.
The Industrial Development Fund would provide targeted loans to partially finance pharmaceutical companies’ expenses associated with serialization projects, for the purposes of speeding up the overall implementation of the serialization across the market.
The borrowers will not however be allowed to use these loans to cover R&D expenses.
During the start-up phase of using the new financing tool in 2018, it is expected to realize at least 40 serialization projects involving 3 billion Rubles of investments in total.
On 26 December 2017, the Federation Council approved the Federal Law “On Ratifying the Convention of the Council of Europe on Combating Counterfeit Medical Products and Similar Crimes which Involve Threats to Public Health”.
The ‘Medicrime’ Convention imposes criminal liability for circulating counterfeit medical products and similar crimes and introduces mechanisms of protecting affected persons’ rights and development national and supra-national cooperation in combating counterfeiting products.
The Federal Law proposes ratifying the Convention with three caveats:
1. The Russian state bodies will prosecute foreign citizens and stateless personal permanently residing in Russia only in cases specified by the Criminal Code of the Russian Federation;
2. In cases when no extradition treaty or mutual legal assistance treaty is in place, the Russian state will refer to the Medicrime Convention as the legal basis for cooperation with other Medicrime Parties;
3. Roszdravnadzor shall be the national central contact point responsible for transmisison/recept of requests for information and/or cooperation in area of combating the counterfeit medical products.
The Russian Ministry of Healthcare by its Order # 870n dd. 26.10.2017 approved the template public procurement contract for pharmaceuticals and the template Bid Data Sheet.
The Law enters into force from 01.01.2018 and applies only to those public procurements which were announced via the unified information system of public procurement after the said date.
The State Duma approved in the first reading the Draft Law “On Amendments to Certain Legislative Acts of the Russian Federation regarding Remote Retail Trade of Pharmaceuticals”.
The Draft Law specifies the definitions of “pharmaceutical activities”, “pharmacy”, “veterinary pharmacy” by adding remote retail sale of pharmaceuticals as the new activity type.
Under the Draft, a pharmacy (a veterinarian pharmacy) may sell via internet only OTC pharmaceuticals and only if a valid pharmaceutical license is in place Remote trade of prescription drugs is prohibited, and web-sites breaching this requirement shall be banned.
The Russian Ministry for Industry and Trade posted for public discussions the Draft Law “On Amendments to Certain Legislative Acts of the Russian Federation regarding Sale of Medicines by Retail Trade Organizations”. As per the Draft, retailers have to obtain a pharmaceutical license to be able to sell OTC drugs in stores and supermarkets.
The Draft Law # 623906-6 “On Amendments to the Federal Law dd. 05.04.2013 # 44-ФЗ “On Procurement Contract System for Goods, Works, Services for State and Municipal Needs” is approved by the State Duma in the third reading.
One of the Draft Law’s key provisions is affirming electronic format for all the currently open public procurement procedures.
The Draft Law submitted to the Duma’s consideration proposes to consider an API as included into the State Register of Pharmaceuticals if the finished dosage pharmaceutical containing such an API in already recorded in the Register.
This rule should apply only to APIs purchased and imported for the purpose of drugs manufacturing (i.e. not for further re-sale).
As per the clarifications posted in the Duma’s web database, the proposed changes are expected to help avoid duplication of controls used when maintaining the State Register of Pharmaceuticals.
The Ministry of Industry and Trade posted for public discussions the draft Government Resolution proposing to extend the List of medical devices restricted from access to public procurement by adding the following articles:
− gamma therapeutic devices, equipment and systems for contact radiation therapy of medium and high dose rate;
− ultrasonic scanning devices;
− intra-ocular lenses;
− micro-sources containing iodine-125;
− osteoplastic surgical materials;
− disposable sterile medical devices sets;
− test strips for glucometers for measuring blood glucose.
A medical device would be included into the restrictive list in case at least two Russian manufacturers produce an identical device (as per the classification code) under GOST ISO 13485-2011 standard and foreign-origin materials/goods used for the production do not exceed 50% of the end-consumer price of these local devices.
The Russian Government approved the State Program for Healthcare System Development. Under the Government’s Resolution #1640 dd. 26.12.2017, the Program shall be maintained according to project-based management approach starting from 2018.
The objectives of the Program are increasing life expectancy at birth; reducing mortality of working-age population; reducing mortality from circulatory diseases and tumors (including malignant ones); raising the medical care quality satisfaction rate.
The Program is to be realized during 2018-2025.
The Program’s planned funding for 2018-2025 is RUB 34,9 billion, including RUB 2,7 billion to be provided from the federal budget, RUB 19 billion from the Federal Obligatory Medical Insurance Fund, and RUB 0,1 billion from the Social Insurance Fund.
The previous Pharma Bulletin issues are accessible our site.
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