In this issue:
- The list of medical devices restricted for state procurement is adopted
- Federal hospitals executives are obliged to report on medical devices pricing weekly
- The Ministry of Healthcare is preparing the order of state price regulation with respect to Essential Drugs
- The President ordered to curb the pharmaceuticals prices inflation
- Ministry of Healthcare developed the approach for identifying drugs substitutability
- The Ministry of Healthcare develops the pharmacovigilance rules
- Ministry of Healthcare published the rules for drugs manufacturing and distribution by pharmacies
- The law combating new psychoactive substances circulation has been signed
- Ministry of Healthcare working on several documents ensuring the enforcement of amendments to the Federal Law “On Circulation of Pharmaceuticals”
The list of medical devices restricted for state procurement is adopted
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 application offers supply of one or more types of medical devices included into the List and originating from the Russian Federation, the Republic of Armenia, the Republic of Belarus or the Republic of Kazakhstan;
- the applications do not offer supply of the same type of medical device produced by the same manufacturer.
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.
Federal hospitals executives are obliged to report on medical devices pricing weekly
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:
- price fluctuations for medical devices procured;
- list of the procured medical devices which are implanted into a human’s body for over 30 days.
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 is preparing the order of state price regulation with respect to Essential Drugs
The Ministry of Healthcare informs on development of the Government Resolution “On the State Pricing Regulations for Essential Drugs”.
The draft Resolution approves:
- registration rules;
- standards for maintaining the state register;
- rules for the setting the maximum wholesale and retail trade mark-ups to actual prices for regions of Russia;
- methodology for setting maximum ex-factory prices by pharmaceuticals manufacturers.
The Resolution is expected to come into force on July 1, 2015.
The President ordered to curb the pharmaceuticals prices inflation
─ 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.
Ministry of Healthcare developed the approach for identifying drugs substitutability
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:
- reference drugs;
- homeopathic drugs;
- drugs approved for medical use in Russia for more than 20 years and for which bioequivalence assessment is not possible.
- The substitutability assessment of a drug for a medical use with a reference drug shall be performed in the following cases: state registration of the drug is conducted in Russia;
- introducing amendments to the documents included into the registration dossier of a drug registered in Russia, provided that the application for the substitutability assessment is submitted by the registration certificate holder/owner.
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 Ministry of Healthcare develops the pharmacovigilance rules
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.
Ministry of Healthcare published the rules for drugs manufacturing and distribution by pharmacies
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 combating new psychoactive substances circulation has been signed
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”:
- regulating the circulation of new potentially hazardous psychoactive substances of synthetic or natural origin; use and promotion of such substances are forbidden;
- introducing administrative liability for consumption of hazardous psychoactive substances and for involvement of the under-ages into the consumption;
- introducing criminal liability for illegal distribution of new hazardous psychoactive substances.
Ministry of Healthcare working on several documents ensuring the enforcement of amendments to the Federal Law “On Circulation of Pharmaceuticals”
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:
- Departmental Order “On Establishing the Rules of Selective Quality Control of Pharmaceuticals”;
- Departmental Order “On Establishing the Rules for Expert Assessment of Pharmaceuticals and Specifics of Assessing Certain Kinds of Pharmaceuticals (Reference Drugs, Generics, Biologic Drugs, Biosimilar Drugs, Homeopathic Drugs, Phyto-Pharmaceuticals, Pharmaceuticals Combinations), Forms of Expert Panel Resolutions”;
- Departmental Order “On Establishing the Proforma of the Document Containing the Results of Monitoring of the Pharmaceuticals Efficiency and Safety Conducted by the Registration Certificate Holder/Owner or by an Authorized Party, which shall be Enclosed to the Application for Confirmation the State Registration of a Pharmaceutical”;
- Departmental Order “On Amendments to the Rules for Monitoring Safety of Pharmaceuticals for medical use, Recording Side Effects, Major Adverse Reactions, Unexpected Adverse Reactions to Drugs used for Medical Purposes, Adopted by the Order of the Ministry of Healthcare and Social Development of the Russian Federation # 757n of August 26, 2010”;
- Departmental Order “On Establishing the List of Pharmaceutical Forms Terms”;
- Departmental Order “On Establishment the Rules for Good Laboratory Practice for Pharmaceuticals for Medical Use”;
- Departmental Order “On Establishment the Rules or Good Clinical Practice for Pharmaceuticals for Medical Use”;
- Departmental Order “On Establishing the Rules for Conducting Studies for Proving the Absence of Impact of Various Excipients or Auxiliary Devices on Safety and (or) Efficiency of Pharmaceuticals for Medical Use”;
- Departmental Order “On Establishing the Rules for a Pharmaceutical Registration Dossier Formation and Requirements to Documents Included therein”.
The above acts are expected to come into force in the 3rd quarter of 2015.
Requirements to the web placement of information about healthcare institutions approved by the Ministry of Healthcare
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:
- On availability of the license for medical activities (with the electronic images of the respective documents attached);
- On types of medical assistance;
- On availability of medical assistance under the program of state guaranties on provision of free medical aid to citizens;
- On the terms, procedures and results of standard medical examination of citizens;
- On the rules for registering for the first time visit / consultation / examination;
- On the rules for delivering medical assistance on a chargeable basis;
- On the prices for medical services (with the electronic images of the respective documents attached);
- On the medical staff (including time-table and attendance hours of the medical professionals);
- On patients’ feedbacks on the medical services received;
- On medical insurance companies contracted for delivery of medical services under the obligatory medical insurance system.
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.