KPMG Pharma Bulletin Issue #7, 2017 (July)
KPMG Pharma Bulletin Issue #7, 2017 (July)
The Ministry for Industry and Trade wishes to change the rules for supporting pharmaceutical producers. The new concept envisages an additional pricing preference for drugs produced in Russia from API originating from Russia or other EEU member states, as an element of the “three is a crowd” rule.
Should there be no supply offers from full-cycle manufacturers, the bidders will be subject to the “three is a crowd” rule. According to the Ministry, this approach will allow accommodate the interests of finished dosage manufacturers who have invested into production facilities in Russia.
As per the Minitsry’s press service, if the state auction is won by a domestic full-cycle supplier who offered the minimum price, this supplier will be contracted applying the pricing preference.
According to market experts, the purpose is to enhance the "three is a crowd" concept by introducing an additional price preference of 25% for full-cycle manufacturers.
The Ministry of Healthcare approved the procedure of the pharmaceutical registration dossier formation and requirements to its content. On August 08, 2017 the Ministry of Justice registered the departmental Order # 409н of 12.07.2017 which stipulates:
− requirements to the scope of information submitted as part of the registration dossier for certain types of pharmaceuticals;
− the procedure for submitting the documents included into the registration dossier for further state registration of the pharmaceutical.
The Order applies to registration dossiers submitted to the Ministry of Healthcare of Russia along with applications for pharmaceuticals registration after the Order is entered into force.
The Russian President signed the Law # 189-FZ of 26.07.2017 "On Amendments to the Russian Code of Administrative Offences in Part of Establishing Administrative Sanctions for State Customer’s Officials for Violating the Terms and Procedures of Payment for Goods (Works, Services) Procured for State and Municipal Needs", which states administrative fines from 30 to 50 kRUB (US$ 500-845) for violating terms and procedures of payment for goods (works, services) under public procurement, which includes failure to make prepayments provided for by a state or municipal purchase contract.
Those officials who have already been held liable for the same type of offense, may be disqualified for the term from one to two years.
The Ministry of Healthcare posted for public discussions the draft Order "On Amendments to the Order on Administration and Prescription of Pharmaceuticals, Approved by the Order of the Ministry of Healthcare dd. 20 December 2012 # 1175н", aimed at resolving the issue of applying pharmaceuticals for therapeutic indications differing from those indications set out by the medication guide.
The draft Order permits administration and prescription of a pharmaceutical to a specific patient for vital indications different from those contained in the medication guide for this pharmaceutical, under a decision of a medical commission of a healthcare provider and subject to the following conditions:
− no registered pharmaceuticals with the same INN are circulated in the Russian market;
− the therapy by other pharmaceuticals intended for treatment of the patient’s disease is assessed by the medical commission as ineffective;
− the quality and (or) efficiency of the pharmaceutical for treatment of the particular disease are supported by information about the clinical studies or the experience of applying this pharmaceutical, published in professional printed media, including foreign ones.
The President signed the Federal law # 278-FZ dd. 29.07.2017. "On Amendments to the Federal Law "On State Regulation of Production and Circulation of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products and on Restricting Consumption (Drinking) of Alcoholic Products" and to Certain Legislative Acts of the Russian Federation".
The law establishes measures to control the circulation of the pharmaceutical substance of ethyl alcohol (ethanol), including in course of production of alcohol-containing pharmaceuticals and medical devices. In particular, individual entrepreneurs and legal entities procuring and using the ethanol pharmaceutical substance as well as producing, manufacturing and (or) distributing (except for retail trade) of alcohol-containing pharmaceuticals, shall perform accounting and reporting of the corresponding products.
The Federal law also upgrades the administrative responsibility for offences in the sphere of production and circulation of ethyl alcohol, alcoholic and alcohol-containing products.
The Federation Council has ratified the Protocol on export of mandatorily licensed pharmaceuticals. Earlier, the corresponding draft Federal law "On Approval of the Protocol Amending the Agreement on Trade-Related Aspects of Intellectual Property Rights" was supported by the deputies of the State Duma.
The Protocol allows Russia supply generic drugs to the CIS states at affordable prices, in line with the WTO regulations. The Protocol supplements the Agreement on Trade-Related Aspects of Intellectual Property Rights with the article and the annex extending the scope of compulsory licensing mechanism applicable to production of generics for export sales.
For more details, please refer to KPMG Pharma Bulletin for May 2017.
The Russian Government introduced to the State Duma two bills relating to the state information system of monitoring pharmaceuticals circulation for medical use.
The draft law "On Amendments to the Federal law "On Circulation of Pharmaceuticals" envisages implementation of the federal state information system for monitoring circulation of pharmaceuticals for medical use from manufacturer to end user by means of control labels (serial numbers), to be used across the entire Russian territory.
The draft law "On Amendments to the Code of the Russian Federation on Administrative Offenses" establishes an administrative fine for manufacturing or sale of pharmaceuticals not bearing the control labels; for violating the established rules of labeling; for untimely or data submission to the system for pharmaceuticals monitoring:
─ RUB 5-10K (US$ 85-170) for a company’s management;
─ RUB 50-100K (US$ 845-1’700) for legal entities and individual entrepreneurs.
According to the Government’s Resolutions #801 dd. 05.07.2017 and #868 dd. 22.07.2017, Roszdravnadzor will apply the risk-based approach to statutory control in respect of legal entities and individual entrepreneurs engaged in medical activities and medical devices circulation.
In particular, the Resolutions define the criteria and procedure of classifying the objects of state control per risk categories and the corresponding frequency of scheduled inspections (depending on the risk category).
Roszdravnadzor is also obliged to keep the list of the objects of state control ranged by the category of risk, and to publish at its official web-site the information on those objects rated with the significant risk category.
The State Duma approved in the third reading the draft law "On Amendments to Article 149 of the Tax Code of the Russian Federation in Part of VAT Exemption for Financial Lease of Essential and Vital Medical Devices".
The bill proposes VAT exemption for financial lease-out of the corresponding medical devices.
It is expected that the amendments will come into force starting from October 1, 2017.
The State Duma unanimously adopted the bill on telemedicine in the third reading. The corresponding federal law comes into force from 2018.
The law provides for creating the unified statutory information system in healthcare area, outlines the structure of the information to be processed therein and the legal bases of its functioning. According to the law, the system will enable patients to obtain doctors’ consultations and get prescriptions for pharmaceuticals. The standard for electronic prescriptions will be introduced starting from 2019.
Physicians would be able to issue prescriptions for pharmaceuticals, including narcotic/psychotropic substances. The prescription shall be executed on special stationery and in the electronic form protected by an enhanced encrypted and certified electronic signature of the doctor the corresponding medical institution.
Telemedicine technologies may not be used for diagnosis and treatment.
The Russian Government submitted to the State Duma a draft law on personified accounting in area of obligatory medical insurance. The bill suggests improvements of controls over individuals’ rights to OMI.
The changes are supposed to rule out the obligatory medical insurance of citizens whose medical care is financed from the federal budget. Thus, the bill aims to preclude double funding of medical care.
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