The Resolution of the Government of the Russian Federation # 102 of February 5, 2015 introduces the list of medical devices originating from foreign states subject to restrictions to access to the state and municipal procurements.
In particular, medical devices included into the List and originating from foreign states (other than the Republic of Armenia, the Republic of Belarus and the Republic of Kazakhstan) are restricted for access to public procurements in case of submission of two and more tender supply applications which meet the following requirements:
The Resolution also establishes exceptions to the said restrictions, in particular, for procurements for the needs of consular offices, diplomatic and other representations of the Russian Federation in foreign states and in some other instances.
In course of the project on pricing regulation for medical devices, the Ministry of Healthcare released the Letter # 25-0/10/2-849 dd. February 2, 2015 to the executives of federal hospitals reporting to the Ministry, requesting to provide the following information on a weekly basis:
Additionally, medical devices for which prices have increased for more than 15% since the beginning of 2015, must be reported separately.
The data must be reported by hospitals on a weekly basis starting from February 20, 2015.
The Ministry of Healthcare informs on development of the Government Resolution “On the State Pricing Regulations for Essential Drugs”.
The draft Resolution approves:
The Resolution is expected to come into force on July 1, 2015.
─ Dmitry Medvedev was requested by March 20, 2015 to present the report on retail prices for essential and non-essential drugs. Such a report shall further be presented monthly;
─ The Government of Russia together with regional executive bodies shall consider by April 15, 2015 the need for establishing state (municipal) pharmacies ensuring availability of pharmaceuticals (including low-price segment) strong painkillers to citizens, and measures to support such pharmacies;
─ The Ministry of the Healthcare was requested by December 1, 2015 to develop and gradually implement an automated system of monitoring circulation of pharmaceuticals from a manufacturer to an ultimate customer using a marking (coding) and identification of pharmaceutical packs, for ensuring effective control over the quality of pharmaceuticals circulating in the market and protection from counterfeit products.
The Ministry of Healthcare placed for public discussions the draft of the Government Resolution “On Establishing the Rules for Identifying the Substitutability of Pharmaceuticals for Medical Purposes”.
Substitutability shall be assessed for all for the pharmaceuticals registered in Russia for the first time and the pharmaceuticals registered in Russia before 1 July 2015,except for:
The substitutability assessment of a drug for medical use is conducted by the panel of experts of an expert institution based on an assignment of the Ministry of Healthcare by way of comparing the following parameters of the assessed drug and the reference one:
1) equivalence of qualitative and quantitative characteristics of pharmaceutical substances,
2) equivalence of the drug form,
3) equivalence or comparability of the composition of excipients of the drug for medical use,
4) identity of the means for administration and application,
5) absence of clinically significant differences while a bio-equivalence study,
6) the manufacturer’s compliance with GMP standards.
Public debates on the document are scheduled from February 12, 2015 to April 13, 2015.
The Order is aimed at the full implementation of the amendments introduced by the Federal Law #429-FZ dd. December 22, 2014 “On Amendments to the Federal Law “On Circulation of Pharmaceuticals”.
Thus, the new procedure of monitoring efficiency and safety of pharmaceuticals circulated in Russia (pharmacovigilance) is being implemented. The purpose of monitoring is to detect, assess and prevent adverse effects of pharmaceuticals administration and application.
The Order is expected to come into force in the 3rd quarter of 2015.
The Ministry of Healthcare has placed at its official web-site for public discussion purposes the draft of the departmental Order “On Establishing Rules for Manufacturing and Distribution of Pharmaceuticals for Medical Use by Pharmacies and Entrepreneurs Licensed for Pharmaceutical Activities”.
The draft Order is aimed to improve the standards of manufacturing pharmaceuticals for medical use prescribed by a physician (paramedic, obstetrician), ensuring their consistence with the medical institutions’ requirements, as well as at establishing the requirements for distribution of the drugs produced.
The Law aims to improve the Russian legislation in area of precluding circulation of new hazardous psychoactive substances.
For these purposes, the following amendments were introduced to the Federal Law “On Narcotic Drugs and Psychotropic Substances”:
The Ministry of Healthcare notified about development of a range of departmental Orders aimed at enforcement of amendments introduced by the Federal Law № 429-FZ of December 22, 2014 “On amendments to the Federal Law “On Circulation of Pharmaceuticals”, which include the following:
The above acts are expected to come into force in the 3rd quarter of 2015.
The Order of the Ministry of Healthcare # 956n dd. December 30, 2014 “On Information Required for Independent Quality Assessment of Services Rendered by Medical Institutions, on Requirements to the Content and Form of the Information about Medical Institutions’ Activities Placed at Official Websites of the Ministry of Healthcare of the Russian Federation, the Regional Executive Bodies of the Russian Federation, the Local Authorities and Medical Institutions in the Internet” defined the list of data subject to mandatory disclosing by medical institutions at their websites, for the purposes of independent quality assessment of the healthcare services provided.
Particularly, the following information is required:
Moreover, the requirements are set to the content and form of the information on medical institutions’ activities placed at their web-sites, and at the web-sites of the Ministry of Healthcare, and the regional and local authorities.
The web-sites should provide for the possibility for patients to post feedback on the quality of medical services rendered (a questionnaire survey).
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.