In this issue:
- The Ministry of Healthcare amends the nomenclature classification of medical devices
- Production and sale of medical devices becomes subject to obligatory notification requirement
- Agreements on common principles for medical devices and pharmaceuticals circulation within the Eurasian Economic Union are signed
- Essential Drugs Priced will be increased
- Federal Law "On Circulation of Pharmaceuticals” amended
- Ministry for Industry and Trade is considering additional preferences for full-cycle drug manufacturers
- Regulations on import/export of pharmaceuticals and API into/from the Customs Union amended
- Ministry for Industry and Trade developed the proforma of GMP compliance certificate for pharmaceutical manufacturers
The Ministry of Healthcare amends the nomenclature classification of medical devices
On December 26, 2014 “Rossiskaya Gazeta” published the Order of the Ministry of Healthcare #557 dated September 25, 2014 “On amendments to Appendix #1 to the Order of the Ministry of Healthcare dated June 6, 2012 #4n “On establishment of the nomenclature classification of medical devices”.
According to the Order, nomenclature classification of medical devices per their types, as established by the Order of the Ministry of Healthcare #4n dated June 6, 2012 and as amended by the above-mentioned Order, applies to those medical devices for which an application for state registration, or an application for amending the registration certificate are submitted to the Federal Service on Surveillance for Healthcare and Social Development (Roszdravnadzor) after enactment of the date said Order # 557.
Production and sale of medical devices becomes subject to obligatory notification requirement
Under the Resolution of the Russian Government #1385 dated December 17, 2014 “On amendments to the Rules of filing notifications on commencing certain types of business activities and recording of such notifications”, activities of manufacturing, storage, transportation, sale, import and export of medical devices in and from Russia, their destruction, disposal, technical tests and toxicity tests are included into the list of activities, commencement of which requires submitting a written notification to the regulators.
The notification shall be completed by the applicant as per the approved proforma and submitted to the Federal Service on Surveillance for Healthcare and Social Development (Roszdravnadzor) via its subdivision in the location where the activity is commenced. Failure to submit the notification of submitting incorrect information entails an administrative fine.
Agreements on common principles for medical devices and pharmaceuticals circulation within the Eurasian Economic Union are signed
On December 23, 2014, the Supreme Eurasian Economic Council approved and signed the Agreement on Common Principles and Rules for Circulation of Pharmaceuticals within the Eurasian Economic Union and the Agreement on Common Principles and Rules for Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union.
The key purpose of the Agreements is to create the legal framework for functioning of the common market of pharmaceuticals and medical devices within the Eurasian Economic Union. The Agreements are entering into force on January 1, 2016. The secondary-level legislative acts required for the operation of the common market are to be developed before January 1, 2016.
However, not all the aspects of pharmaceuticals circulation will be unified in 2016; domestic regulatory standards will remain in force with respect to retail sales of pharmaceuticals and medical devices, pricing regulations and advertising of pharmaceuticals and medical devices.
Essential Drugs Prices will be increased
Price inflation for essential drugs is now at a low pace, though, the Ministry of Healthcare is planning to adjust them.
According to Mrs. Veronica Skvortsova, the Russian Minister of Healthcare, in November 2014 prices for essential drugs have risen by 0,3% as compared to January 01, 2014. Price inflation in the hospital segment did not exceed 4%.
Prices for essential drugs have to be increased, as there is a probability of significant gap between the registered ED prices and their actual cost of production / purchase. This may lead to substitution of low-priced pharmaceuticals by more expensive ones. The decision on prices adjustment has been made for lower- and medium-cost segments (up to 50 RUB and from 50 to 500 RUB per pack correspondingly).
Federal Law "On Circulation of Pharmaceuticals” amended
Amendments to the Federal Law "On Circulation of Pharmaceuticals” dated April 12, 2010 #61-FZ were adopted. The corresponding Federal Law #429-FZ was signed by the President of Russia on December 22, 2014.
In particular, the amendments relate to:
- Separation of registration procedures of pharmaceuticals and procedures for obtaining the permission for clinical trials;
- Replacing the “innovative pharmaceutical” term to “reference pharmaceutical”;
- Definition of the term “pharmacovigilance”;
- Approval of the list of pharmaceutical forms’ names;
- Development of standard operating procedures for medical use of interchangeable pharmaceuticals;
- Pre-trial ban of web-sites containing information on on-line sales of pharmaceuticals, narcotic drugs, psychotropic substances and their precursors (ban procedures shall be defined by the Russian Government separately);
- Possibility to dispute the decision / conclusion of an expert commission (an expert).
The amendments affecting 44 articles of the Federal Law come into force from July 1, 2015, except for the provisions of Articles # 5, 18, 29, 30 and 34, coming into force in 2016 – 2017.
Ministry for Industry and Trade is considering additional preferences for full-cycle drug manufacturers
By June 1, 2015 the Ministry for Industry and Trade will develop the document outlining the manufacturing process stages which will serve as the basis for establishing the preferences for manufacturers. The incentives would be available not only for Russia-origin manufacturers but also for those international companies, which localize the pharmaceuticals production in Russia.
Additional preferences may be granted to manufacturers of innovative patented pharmaceuticals (including foreign manufacturers), entering into long-term agreements and running production in Russia. The Ministry for Industry and Trade will develop the specific incentive measures during 2015.
Regulations on import/export of pharmaceuticals and API into/from the Customs Union amended
The Resolution of the Board of the Eurasian Economic Commission envisages that no special resolutions (approvals) of the authorized body are required when placing the following pharmaceuticals under the regimes of customs transit, customs storage, processing in the customs territory, temporary import, destruction, free customs zone and free customs warehouse:
- Non-registered pharmaceuticals subject to clinical trials, expert review, state registration, use for delivery of medical treatment due to a vital necessity of a particular patient or delivery of medical aid to a limited number of patients suffering from rare or a severe pathologies;
- Registered pharmaceuticals subject to clinical trials;
- Registered or non-registered pharmaceuticals delivered as humanitarian aid or emergency aid.
The Resolution enters into force upon 30 days after its official publication.
Ministry for Industry and Trade developed the proforma of GMP compliance certificate for pharmaceutical manufacturers
Mr. Sergey Tsyb, the Deputy Minister for Industry and Trade, is empowered for signing the orders on issuance of GMP compliance certificate for pharmaceutical manufacturers and the orders on rejecting the issuance of such a certificate.
The certificate is valid within 3 years from the date of completing the statutory GMP assessment.
The information on the issued certificates is to be published at the official web-site of the Ministry for Industry and Trade.
Offshore companies to be banned from the government procurement
At the session held on December 25, 2014 the Russian Government has approved the draft Federal Law “On Amendments to the Federal Law “On the contract system for the goods, works and services procurement for the federal and municipal needs”. The draft envisages the prohibition for offshore companies from entering into supply contracts for federal and municipal needs.
The Procurement Committee will be obliged to verify potential participants’ compliance with the new requirements. Tender applications submitted by companies incorporated in offshore jurisdictions will be rejected.
Ministry of Healthcare produced the long-term Strategy of Russian healthcare system development
On December 19, 2014 the Ministry of Healthcare has published at its web-site the draft “Strategy of Russian Healthcare System Development in the Long-Term Perspective from 2015 till 2030”. The relevant federal executive bodies and Russian Academy of Sciences participated in the development of this document, which was submitted to consideration by the Government.
The essential chapter of the Strategy is Section IV which sets out the main trends of developing the National Healthcare System and the corresponding goals, which include:
- improvement of the State Guarantees Program;
- development of the obligatory medical insurance (OMI) system based on the principles of solidarity, social equality and extended insurance;
- development of supplemental medical insurance system (in addition to the OMI), which should be available to insured persons in course of delivery of supplemental medical care not covered by the Program of State Guarantees to Deliver Free Medical Aid;
- development of public private partnership in the healthcare sector;
- development of public medical organizations established based on geographical and professional criteria;
- introduction of compulsory accreditation of healthcare professionals;
- informational support for healthcare services;
- building up the vertical system of control and surveillance in healthcare;
- supply of drugs and medical equipment;
- accelerated innovative development of healthcare system based on the results of biomedical and pharmacological trials.
The strategy also presumes development of international relationships in healthcare area, including the increased importance of Russia’s role in the global healthcare sphere.
Changes of stamp duties for registration of pharmaceuticals in 2015
According to the Federal Laws # 221-FZ dated 21 July 2014 and # 480-FZ dated 29 December 2014, amendments are introduced into Chapter 25.3 of the Russian Tax Code in respect of stamp duties imposed for the actions of a federal executive body in area of pharmaceuticals registration.
- Some of the duties are increased up to 1.5 times starting from 1 January 2015,
- Some of the duties are abolished and replaced by newly introduced ones, or the basis for imposing the duties is changed starting from 1 July 2015.
The duties which were in effect before 1 January 2015 and the corresponding changes are listed at KPMG’s web-site.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.