In this issue:
- The Ministry of Healthcare initiates price regulation for medical devices from 2016
- Amendments to the Regulations for trade of medical devices
- The law tightening the punishment for counterfeit pharmaceuticals circulation enacted
- Ministry of Healthcare intends to reduce administrative obstacles for registration of pharmaceuticals prices
- Restrictions to importation of pharmaceuticals are underway
- The Ministry of Healthcare is developing regulations of good storage and transportation practice
- Criteria for selecting the regions to participate in the modernization program of the pharmaceutical coverage
The Ministry of Healthcare initiates price regulation for medical devices from 2016
Public debates on the Draft Government Resolution ”On adoption of calculation methodology for determining the manufacturer’s sale price limits for medical devices, the maximal whole-sale and retail mark-up on medical devices, included into the list of medical devices implanted into a human body under the state guarantees of free medical aid program” were started.
According to the document, certain medical devices of those implanted into a human body through free medical aid under the state guarantees will be regulated; activities of both sellers and buyers would be subject to regulation as well.
Introduction of the pricing control is supposed to solve the problem of market prices destabilization.
Amendments to the Regulations for trade of medical devices
The Prime Minister Dmitry Medvedev signed the Government Resolution #6 dated January 05, 2015, that provides amendments to the Regulations for trade of certain products:
- Prohibition for retail trade of medical devices out of stationary points-of-sale, in particular: from home, workplace or place of study, transport, in the street and other places;
- In paragraph VIII of the Regulations, terms “products intended for medical purpose” and “medical equipment” are replaced for the term “medical devices”, which includes devices “for preventive treatment, diagnostics, treatment and medical rehabilitations of diseases, monitoring of human body health, prevention or termination of pregnancy”.
The adopted guidance is aimed to protect consumers purchasing medical devices in accordance with the Russian legislation.
The law tightening the punishment for counterfeit pharmaceuticals circulation enacted
The Federal Law #532-FZ “On Amendments to Certain Legislative Acts of the Russian Federation on Counteraction of Circulation of Counterfeit, Poor-Quality and Unregistered Pharmaceuticals, Medical Devices and Counterfeit Biologically Active Additives” came into force on January 23, 2015.
The Federal Law envisages:
- Amendments to Criminal Code of Russian Federation and Code of administrative offences of Russian Federation;
- Introduction of the following terms: “counterfeit biologically active additives”, “counterfeit medical device”, “poor-quality medical device”; a number of prohibitions for circulation of such devices is stipulated. The respective amendments were introduced to the Federal Law “On Quality and Safety of Food Products” and to the Federal Law “On Fundamentals of Public Healthсare Protection in Russia”.
Ministry of Healthcare intends to reduce administrative obstacles for registration of pharmaceuticals prices
The Russian Ministry of Healthcare informs on the preparation of a draft Government Resolution “On Amendments to the Government Resolution #865 dated October 29, 2010 “On State Price Regulation of Pharmaceuticals Included into Essential Drugs List”.
The proposed changes include:
- exemption from the state registration of a maximal sale price for an essential drug by pharmaceuticals manufacturers in case of insignificant changes to the existing register record;
- clarification to the maximal sales price registration rules for pharmaceuticals manufacturers, eliminating the possibility of subsequent price increase for the drugs which were earlier excluded from the EDL.
The Resolution is aimed to reduce administrative obstacles in course of registration and re-registration of sales prices by Russian and foreign manufacturers, and also to optimize determining of the timeline and sequence of the applicable procedures.
The document should enter into force on May 01, 2015.
Restrictions to importation of pharmaceuticals are underway
According to the Anti-Crisis Plan posted at the website of the Russian Government, by February 15 the Ministry for Industry and Trade will prepare a document introducing restrictions to importation of pharmaceuticals in case of two and more supply offers from Russian manufacturers, and restrictions to access of certain types of medical devices originating from foreign states to the state and municipal procurements.
Furthermore, the Ministry of Healthcare, the Federal Tariff Service and the Ministry of Economic Development are to prepare the documents providing for the possibility of one-off price indexation for EDL pharmaceuticals of lower and middle price segment.
The plan envisages the improvement of pharmaceuticals insurance for individuals, including those entitled for the state social aid, and also the reimbursement of losses caused by exchange rate differences when purchasing imported pharmaceuticals, including those purchased within government guarantees program of free medical aid for citizens.
The Ministry of Healthcare is developing regulations of good storage and transportation practice
- Departmental Order “On adoption of regulations of good practice on storage and transportation of pharmaceuticals”;
- Departmental Order “On adoption of regulations of good distribution practice of pharmaceuticals”;
- Departmental Order “On adoption of regulations of good pharmacy practice of pharmaceuticals”.
Development of these regulations is aimed at implementation of the changes introduced by the Federal Law #429-FZ dated 22 December 2014 “On Amendments to the Federal Law “On Circulation of Pharmaceuticals”. The Orders will apply to all the participants engaged in pharmaceuticals circulation.
The Orders are expected to enter into force in the third quarter of 2015.
Criteria for selecting the regions to participate in the modernization program of the pharmaceutical coverage
Selection standards for participation of Russia’s regions in the trial programs on improving pharmaceutical coverage for individuals in 2015-2016 have been developed. The purpose of the projects is detailed elaboration of organization and regulatory aspects of implementation of the reference price system, elaboration of free (or discounted) pharmaceutical coverage system for individuals at the expense of federal and regional budgets. The corresponding Decree #136-р was signed by the Prime Minister Dmitry Medvedev on January 30, 2015.
The following criteria have to be met by the regions for participation in the trial program:
- the minimal level of availability of medical and pharmaceutical professionals in medical institutions and pharmacies is set at 75%;
- there shall be not less than 25 pharmacies in the region delivering pharmaceuticals for individuals entitled for benefits;
- an organized information system regarding pharmaceuticals coverage of individuals shall be set up between medical institutions and pharmacies.
According to the information posted on the website of the Cabinet of Ministers, the initiative is aimed at enhancement of the availability of high-quality, effective and safe pharmaceuticals based on the efficient and balanced system of pharmaceuticals coverage.
Regulation adopted on the Coordination Council of the Ministry of Healthcare for PPP development
According to the Regulation, the main duties of the Coordination Council include:
- Consideration of proposed ideas on developing public-private partnership (PPP) mechanisms in healthcare, aimed at infrastructure improvement and increase of the quality and availability of medical aid; consideration of proposals on improving the regulatory framework on PPP;
- Consideration of proposals on lifting the restrictions for private investments;
- Consideration of proposals on preparation for investment projects implementation;
- Monitoring of investments projects implementation.
The Minister of Healthcare is appointed as the Head of the Coordination Council which will include the representatives of federal executive bodies, regional state authorities, state academies of sciences, social and professional unions, governmental development institutions, credit institutions and healthcare businesses.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.