Recommendations of the Federal Anti-Monopoly Service of Russia on the development and application of commercial policies by businesses holding the dominant position in the pharmaceutical markets and medical devices markets have been approved by the General Committee of the Federal Anti-Monopoly Service of Russia.
The Recommendations contain detailed information on the process of defining the commodity market, on the selection procedure and criteria, on interaction with counterparties and termination thereof, on record-keeping management.
According to the Federal Anti-Monopoly Service, compliance with the Recommendations should help mitigate the risk of raising claims by anti-monopoly authorities against businesses with dominant position in course of their interaction with the existing or prospective contracting parties.
The Commission of the Russian Government in charge of law-drafting activities approved the Draft Federal Law “On Amendments to Articles 37 and 70 of the Federal Law “On Contractual System In the Sphere of Procurement of Goods, Work and Services for Governmental and Municipal Needs”, prepared by the Ministry of Economic Development of Russia.
Currently, the Federal Law (parts 9 and 10 of Article 37) provides that in case the participant of procurement of food goods, first-aid supplies, pharmaceuticals and fuel offers the contact price below the initial (maximum) contract price by 25 and more percent, this participant is obliged to justify the proposed price.
The Draft Law suggests invalidating the parts 9 and 10 of Article 37 of the Federal Law, in order to improve the pharmaceuticals procurement procedure.
At the same time, according to the principle of fair competition, the IMPC is calculated as the maximum value of manufacturers’ maximum ex-factory prices.
The actual manufacturer’s ex-factory price is determined as the price (net of VAT) which is stated by a Russian manufacturer in the shipping documents; in the case of a foreign this means the price stated in the shipping documents on which basis the customs cargo declaration is completed (including the costs associated with customs clearance).
While determining the IMPC, as well as while preparing the contract price proposal for ED procurement by a tender participant, VAT should be added on top of the registered maximum ex-factory price.
It is also mentioned that in course of ED procurements under federal or municipal contracts the ED price is taken net of the maximum trade mark-ups.
The Ministry of Healthcare placed for public debates the Draft The President of the Russian Federation signed Federal Law “On Amendments to the Federal Law “On Circulation of Pharmaceuticals” with the purpose to improve the system of state pricing regulation for pharmaceuticals.
The document anticipates amendments, according to which, draft resolutions of regional executive authorities on establishment and (or) changing the maximum trade mark-ups to ex-factory prices of Essential Drugs manufacturers shall be approved by an authorized federal executive body.
The approval procedure for the said draft resolutions is supposed to be established by the Government of the Russian Federation.
The Ministry for Industry and Trade developed the Draft Order “On Establishment of Administrative Regulation of the Ministry for Industry and Trade on Rendering the State Services on Issuing, Setting the Procedure for Issuing and Approving the Form of a Document Confirming that the Pharmaceutical Production Is Carried Out in Compliance with the Requirements of Good Manufacturing Practice, which is Subject to Submission at the Request of an Authorized Governmental Body of an Importing Country”.
The Draft Regulation envisages that the document confirming that the pharmaceutical production has been carried out in compliance with GMP standards, and which is subject to submission to an authorized governmental body of an importing country, shall be issued based on the results of the review of the set of documents submitted by the manufacturer to the Ministry for Industry and Trade.
The Document establishes the requirements for planning, conducting, documenting, presenting the results and control over clinical trials with respect to pharmaceuticals for medical use.
Compliance with these requirements in course of clinical trials should guarantee safety and well-being of the patients, and is in line with the principles established by the Declaration of Helsinki of the World Healthcare Organization.
The public debates of the Document are scheduled from July 22 to September 19, 2015.
The public debates on the Draft Federal Law "On Amendments to Certain Regulatory Acts of the Russian Federation" will last until 28 August 2015. The Law anticipated introduction of an automatized system monitoring the pharmaceuticals circulation from the manufacturer to the end-consumer.
According to the Draft Law, the market players carrying out manufacturing, production, storage, transportation, import and export, as well as release, sale, transfer, administration and destruction of pharmaceuticals should submit the corresponding data into the system by means of pharmaceuticals labels scanning and (or) data recording.
The Ministry of Justice registered the Order of the Ministry for According to the Government Resolution #608 of May 19, 2015, starting from July 1, 2015 the Ministry for Industry and Trade is entitled to participate in development and signing of special investment contracts on behalf of the Russian Federation and to supervise these contracts’ execution as well.
Special investment contracts will be concluded with companies constructing or modernizing industrial facilities, including those for pharmaceuticals manufacturing.
Investors having entered into special investment contracts would be eligible to tax benefits and the right to be the exclusive suppliers of certain goods to the state. To ensure concluding state procurement contracts, the Federal Law “On the Contractual System” has to be amended respectively. The draft documents have already been submitted to the State Duma. However, according to the draft law, the only company manufacturing the goods having no analogues in Russia could be entitled to become exclusive suppliers to the state.
The Ministry of Healthcare Order #303n of June 3, 2015 “On Amendments to the Ministry of Healthcare Order #1353n of December 21, 2012 “On Adopting the Procedure for Organizing and Conducting of Expertise of Quality, Effectiveness and Safety of Medical Devices” enters into force on June 17, 2015. The Order is supposed to simplify the state registration procedure for medical devices of first class risk.
Registration of the first class risk medical devices will be conducted in one step, provided that the set of documentation submitted for the registration contains the information confirming the clinical effectiveness and safety of a medical device. Inter alia, clinical data, analysis of scientific literature and (or) unpublished data and reports related to designated and intended use of the medical device should be available.
The simplified state registration procedure of first class risk medical devices will be applied for those medical devices, for which the registration applications are submitted to the Federal Service on Surveillance in Healthcare after the enactment of the above-said Order.
The Ministry of Healthcare Order #303n of June 3, 2015 “On Amendments to the Ministry of Healthcare Order #1353n of December 21, 2012 “On Adopting the Procedure for Organizing and Conducting of Expertise of Quality, Effectiveness and Safety of Medical Devices” established the following:
The Order contains the proforma for documenting the expert commission’s conclusion on the possibility (impossibility) of amending the documents for a medical device. Such a proforma is supplementing the Order of the Ministry of Healthcare #1353n of December 21, 2012 “On Adopting the Procedure for Organizing and Conducting the Expertize of Quality, Effectiveness and Safety of Medical Devices”.
The list of medical goods subject to 10% import VAT in accordance with the Foreign Economic Activity Commodity Nomenclature of the Customs Union has been revised by the Government Decree #655 of June 30, 2015 “On Amendments to the Government Decree #688 of September 15, 2008”.
The following items were included into the list:
For some of the items, the wording was revised, in particular, devices compensating an organ defect or disability.
The following items were excluded from the list:
The Federation Council approved the Federal Law “On Amendments to the Federal Law “On Contractual System In the Sphere of Procurement of Goods, Work and Services for Governmental and Municipal Needs” with regard to prohibition for offshore companies (i.e. those incorporated in ‘tax haven’ jurisdictions) from participation in state procurement.
The Law envisages:
The Law enters into force upon 30 days from the date of its official publication.
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Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.