KPMG Pharma Bulletin Issue #11, 2016 (November)
KPMG Pharma Bulletin Issue #11, 2016 (November)
In this issue
- The Federal Anti-Monopoly Service of Russia proposes to allow compulsory licensing of pharmaceuticals in the interests of national security
- The Draft Law that simplifies the procedure of pharmaceuticals' procurement introduced in the State Duma
- The Ministry of Healthcare has initiated the development of the information-analytical system for monitoring and control in the sphere of pharmaceuticals` procurement
- The priority project passport for the introduction of automatic system of monitoring the movement of pharmaceuticals was approved
- The procedure for the selection of recipients of subsidies for reimbursement of costs associated with patenting abroad was approved
- The Council of the Eurasian Economic Commission has approved a number of documents required to launch a unified market for pharmaceuticals
The Federal Anti-Monopoly Service of Russia proposed to deprive pharmaceutical companies of their exclusive rights to manufacture and sell patented pharmaceuticals if they refused to furnish them to Russia for economic or political reasons.
The relevant amendments to the Civil code of the Russian Federation and the Federal law "On protection of competition" state that the Russian Government is entitled to release invention, utility model or industrial design without the patent owner's consent with simultaneous prompt notification and commensurate compensation of the owner. This right is granted in the interests of national security, protection of life and health of citizens.
The Russian Government introduced the Draft law "On introducing amendments to the Federal law "On contract system in procurement of goods, works and services for state and municipal needs".
In accordance with part 9 of article 37 of the Federal law of April 5, 2013 # 44-FZ "On contract system in procurement of goods, works and services for state and municipal needs":
• in cases, where the contract is subject to a tender or an auction and is concluded for the supply of goods necessary for normal life support (food supplies, first aid equipment, including emergency medical aid, pharmaceuticals, fuel), procurement participant offering contract price that is less than 25 percent of the initial (maximum) contract price, has to submit the justification of the proposed price.
Justification may include a guarantee letter from the manufacturer, specifying the price and quantity of the delivered goods, documents confirming the availability of goods at the procurement participant, other documents and calculations supporting the ability of a procurement participant to supply at the proposed price.
The Draft Law provides that documents confirming the ability to execute the contract at the offered price with due execution of the obligations thereunder shall be submitted only in respect of fuel supplies. It is proposed that the Draft Law enables the Russian Government to establish a list of other types of goods in respect of which provision of relevant documents is required.
The Ministry of Healthcare has notified on development of procedures for operating of the information-analytical system (IAS) for monitoring and control of pharmaceuticals' procurement for state and municipal needs.
The aim of this system is an operational analysis of all the information submitted from each region of the Russian Federation on state and municipal procurement both at the stage of procurement planning and tendering procedures and online auctions.
It is planned to set up the system in testing mode starting from 1 March 2017.
A meeting of the Presidential Council Presidium for strategic development and priority projects was held on October, 25. Following the results, it was decided to approve a number of priority projects' passports, including the project for the "Introduction of automatic system of monitoring the movement of pharmaceuticals from the manufacturer to the end user in order to protect citizens from counterfeit pharmaceuticals and prompt removal of fraudulent, substandard medicines from circulation."
The project aims at protection of citizens from fraudulent, substandard and counterfeit pharmaceuticals and to grant the ability to check the legality of registered pharmaceuticals in civil circulation to public (citizens) by means of the automated system of monitoring the movement of marked pharmaceuticals from the manufacturer to the end user.
The planned project implementation period is from October 25, 2016 to March 01, 2019.
The procedure for the selection of recipients of subsidies for reimbursement of costs associated with patenting abroad was approved
The Ministry for Industry and Trade approved the Procedure for the selection of subsidies` recipients for Russian organizations in order to reimburse the expenses related to the payment of fees for patenting inventions of Russian producers and exporters abroad. The Ministry of Justice registered the respective Departmental Order N # 3685 of October 14, 2016, on the 7 of November.
The document prescribes the procedure and conditions for granting subsidies, as well as the general content of the agreement on granting a subsidy.
Subsidies will be granted to Russian organizations, which provide services related to foreign patenting of inventions and utility models to domestic producers and exporters with.
According to the Draft Law "On the amendments to Federal Law "On circulation of pharmaceuticals", foreign producers, who have not received the Russian conclusion on compliance with GMP, will be able to apply for registration of a pharmaceutical without this document.
However, the applicant has to possess of a decision of the Ministry for Industry and Trade concerning the inspection of the production site that will substitute a copy of a statement of compliance with GMP.
In case the producer does not have a copy of GMP certificate in the package of documents at the time of adoption of the decision on registration, the Ministry of Healthcare is obliged to send to the applicant a request for clarification of information with a maximal reply period of 180 days.
In accordance with the Draft Law, if the Ministry for Industry and Trade refuses to issue a statement on GMP, the Ministry of Healthcare will be entitled to reject the pharmaceutical's registration.
The list of documents adopted by the Council of the Eurasian Economic Commission:
− "On recognition of the results of inspection of production of pharmaceuticals";
− "On specific issues of circulation of pharmaceuticals";
− "On approving the Procedure of ensuring the joint pharmaceutical inspections";
− "On approval of the Procedure for the formation and maintenance of a register of pharmaceutical inspectors of the Eurasian Economic Union";
− "On approval of Rules for the studies of biological pharmaceuticals of the Eurasian Economic Union";
− "On approval of requirements to instructions for medical use of pharmaceuticals and general characteristics of pharmaceuticals for medical use";
− "On approval of Rules of good pharmaceutical vigilance practice of the Eurasian Economic Union";
− "On the Procedure of the Eurasian Economic Union member states interaction in order to identify falsified, counterfeit and (or) poor quality pharmaceuticals";
− "On approval of Rules for carrying out bioequivalence studies of pharmaceuticals within the Eurasian Economic Union";
− "On the order of formation and maintenance of the unified register of registered pharmaceuticals of the Eurasian Economic Union and information databases in the field of circulation of pharmaceuticals";
− "On approval of Rules of pharmaceutical inspections";
− "On approval of General requirements to a quality system for pharmaceutical inspectorates of the member States of the Eurasian Economic Union";
− "On approval of Rules of GLP of the Eurasian Economic Union in the sphere of circulation of pharmaceuticals";
− "On approval of Rules of GDP within the framework of the Eurasian Economic Union";
− "On approval of Rules of GCP of the Eurasian economic Union";
− "On the Rules of registration and examination of pharmaceuticals for medical use";
− "On approval of Rules of GMP of the Eurasian Economic Union";
− "On approval of Requirements to labeling of pharmaceuticals for medical use and veterinary medicinal products";
− "On approval of the establishment of Regulation of the Expert Committee of pharmaceuticals ";
− "On approval of the Procedure for the formation and maintenance of a register of authorized persons of pharmaceutical manufacturers of Eurasian Economic Union";
− "On the Procedure for attestation of the authorized manufacturers of pharmaceuticals".
The Ministry of Healthcare issued for public debates a Draft Departmental Order "On approval of Administrative regulations of the licensing control of pharmaceutical activities by Federal service on surveillance in healthcare."
The Administrative regulation prescribes the following:
− timing and sequence of administrative procedures and administrative actions to execute the state function;
− rights and obligations of the officials in course of licensing control;
−rights and obligations of the controlled persons;
−procedure and control forms over execution of the state functions.
An integral part of the Administrative regulations is the diagram, which clearly shows the sequence of actions for the execution of the state function as well as the list of territorial bodies of Roszdravnadzor, including their addresses and telephone numbers for reference.
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