KPMG Pharma Bulletin Issue #11, 2017 (November)
KPMG Pharma Bulletin Issue #11, 2017 (November)
The State Duma approved in the first reading amendments to the Federal Law # 61 “On Circulation of Pharmaceuticals”, which introduce mandatory drug labeling (serialization) starting from January 01, 2019.
The relevant Duma Committee is to hold a detailed round-table discussion of the draft prepared for the second reading.
The Russian Ministry for Industry and Trade and the Ministry of Healthcare posted for public discussion the draft Order # 1503 “On Amendments to the List of Bio-Targets for developing Improved Analogues of Innovative Pharmaceuticals having Similar and Pharmaco-Therapeutical Effect”, approved by the Order of the Ministry for Industry and Trade and the Ministry of Healthcare dd. 19.05.2016 # 1605/308н.
The list is supposed to be extended by adding 22 new bio-targets. The list is viewed as the basic document for companies applying for state subsidies under the Resolution of the Government dd. 30.12.2015 # 1503 in accordance with the federal program “Development of Pharmaceutical and Medical Industry” during 2013-2020.
The draft law enables foreign pharmaceutical manufacturers to submit for the purposes of a drug registration a copy of the resolution on a production site inspection, instead of the GMP compliance certificate.
It is also proposed to entitle the Ministry of Healthcare to suspend circulation of a pharmaceutical in case of investigating non-compliance with GMP rules or licensing requirements.
On 27.11.2017 the Ministry of Justice registered the Order of the Ministry of Healthcare dd. 26.10.2017 # 871n “On Approval of the Procedure for Setting the Starting (Maximum) Contract Price under a Public Procurement Contract for Pharmaceuticals for Medical Use Concluded with a Sole Supplier (Contractor)”.
The Order sets out the approach to calculating and justifying the starting (maximum) price under the contract concluded with a sole supplier. Prices are to be established per each pharmaceutical name, with account to equivalent dosage form and strength.
Reference price calculation shall be made automatically, using the data from the Uniform State Health Information System on the historical purchases of a pharmaceutical with the corresponding name as at 01 January, 01 July and 01 October of the current year.
The draft Federal Law “On Amendments to the Federal Law dd. 22.12.2014 # 429 “On Amendments to the Federal Law “On Circulation of Pharmaceuticals”” is submitted to the State Duma.
The draft proposes to cancel the deadlines for submitting applications for pharmaceuticals substitutability assessment. Currently, the assessment is to be performed by an expert commission before 31.12.2017, which precludes assessment of pharmaceuticals registered after 2017.
The Russian Ministry of Industry and Trade revised (i) the Regulations for rendering of a public service on issuance of a document setting out technological stages of pharmaceuticals production, and (ii) the Regulations on issuance of a document confirming GMP compliance.
The purpose of the amendments is to improve quality, speed and accessibility of public services rendered by the Ministry, ensuring comfortable terms for participants of pharmaceuticals licensing processes and structuring and scheduling administrative procedures.
The Federal Service on Surveillance in Healthcare and Social Development of Russia (Roszdravnadzor) approved the template checklist (the list of control-aimed questions) to be used during regular federal inspections on the matters of pharmaceuticals circulation.
The internal Order # 9438 dd. 09.11.2017 consists of 39 appendices, containing the control questions to be referred to by the state inspectors.
The Ministry of Healthcare prepared the data on weighted average prices for single-use PVC medical devices of foreign origin, which are subject to restrictions for public procurement purposes.
For the purposes of procuring the above products in 2017, the year of 2015 should be taken as the reference period, adjusted by the inflation rate of 3.8%.
The Russian Ministry for Industry and Trade developed localization coefficients for single-use PVC medical devices of foreign origin, which are subject to restrictions for public procurement purposes.
The coefficients and rules for their calculation are set forth in the Order dd. 31.10.2017 # ЦС-71651 “On Localization Coefficients for PVC Medical Devices in Accordance with the Schedule for Implementation of Projects on Expansion and (or) Localization of Manufacturing of Single-Use Polyvinylchloride Plastic Medical Devices”.
The coefficients vary from 0.98 to 0.999 per medical device types.
The Russian Ministry of Healthcare approved the nomenclature of medical services. The corresponding Order dd. 13.10.2017 #804n was registered by the Ministry of Justice on 07.11.2017. The objective is enabling the unified regulatory framework for healthcare services across the Russian Federation.
The Order shall enter into force from 01.01.2018.
The Russian Ministry of Healthcare posted for public discussion the draft Order “On Approval of the Procedure for Healthcare Standards Development” which sets out procedure based on the “Automated system for developing and maintaining of healthcare standards”.
A healthcare standard should be developed in accordance with the medical services nomenclature and include averaged target parameters for frequency and repeated number of:
− rendering medical services,
− applying pharmaceuticals duly registered in Russia (with average dosage indicated) in accordance with the application guideline and pharmaco-therapeutical group under anatomic-therapeutical-chemical classification as recommended by WHO,
− applying implantable medical devices,
− applying blood components,
− applying clinical nutrition (including specialized types),
− applying other therapeutical products, considering the specifics of a disease (condition).
The Government approved documents proposing the amendments to the rules of granting federal subsidies under the state program “Pharmaceutical and Medical industry development during 2013-2020”.
The subsidy amount is limited by RUB 200 MM for each contract throughout its validity period.
Companies owned by more than 50% by foreign shareholders registered in offshore zones are not eligible to subsidizing.
Further amendments are set out in detail in the following documents:
The Government Resolution dd. 01.11.2017 # 1321 amended the “Rules for Granting Subsidies from the State Budget to Producers of High Technology Products for Reimbursing Costs for Certification Incurred while Realizing Investment Projects”.
The deadline for achievement of KPIs on subsidies use is extended from 3 to 5 years.
The Resolution also provides for a new subsidy type, granted for participation in activities of international organizations developing voluntary technical standards under multi-national agreements on mutual acknowledgement of conformity assessment results.
The Government approved list of healthcare services which can be delivered in electronic form through the Public Services Portal of the Russian Federation, with support from the Unified Public Informational System for Healthcare. The corresponding Resolution #2521-р dd. 15.11.2017, coming into force from 01.01.2018, was signed by the Prime Minister.
The list of online medical services includes:
1) fixing a doctor appointment;
2) accepting requests for a doctor visit;
3) providing information for subscribing to a healthcare provider;
4) scheduling a medical check-up;
5) providing data on healthcare services delivered from an electronic medical record;
6) providing data on the obligatory medical insurance policy and the insurance provider;
7) providing access to electronic medical documents;
8) providing to an insured person the list of healthcare services delivered and their cost;
9) applying for selecting a health insurance provider.
Ministry of Healthcare intends to tighten requirements to health insurance providers
The Russian Ministry of Healthcare placed for public discussions the draft Order “On Amendments to the Model Contract on Financial Warranty for Obligatory Medical Insurance, Approved by the Order of the Ministry of Healthcare and Social Development of the Russian Federation dd. 09.09.2011 # 1030n’.
The draft order proposes to include into the template financial warranty contract KPIs for health insurance provider’s performance assessment. If these are not achieved, an insurance contract could be terminated.
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