KPMG Pharma Bulletin, Issue #5, 2016 (May)
KPMG Pharma Bulletin, Issue #5, 2016 (May)
In this issue:
- The Ministry of Healthcare has developed a Regulation on state control over pharmaceuticals circulation
- Deputies propose canceling state registration of prices for implantable medical devices
- General safety and efficacy criteria for medical devices for EEC have been approved
- Labeling of medical devices in EEC member states
- Rules for technical trial of medical devices within the EEC have been adopted
- Rules for trials for assessing biological effect of medical devices have been adopted
The Ministry of Healthcare has developed a Regulation on state control over pharmaceuticals circulation
The Ministry of Healthcare has placed for public debates the following drafts of departmental orders:
- “On approval of the Administrative Regulation of the Federal Service on Healthcare Surveillance (Roszdravnadzor) for execution of the state function of the federal state control over pharmaceuticals circulation, via organizing and conducting audits of compliance with the requirements for pre-clinical trials, clinical trials, storage, transportation, delivery, shipment, sale, usage and the destruction of pharmaceuticals”;
- “On approval of the Administrative Regulation of the Federal Service on Healthcare Surveillance for execution of the state function of sample quality control of pharmaceuticals for medical use”;
- “On approval of the Administrative Regulation of the Federal Service on Healthcare Surveillance for execution of the state function of licensing control of pharmaceutical activities carried out by pharmaceutical wholesalers and pharmacies which are under the charge of federal executive bodies and national academies of sciences”.
The Administrative regulations envisage:
- liability of the executives of the Federal Service on Healthcare Surveillance (its regional bodies) for adopting the decisions and actions (inaction) in course of conducting their state functions;
- pre-trial (extra-curial) appeal procedure against actions (inaction) and decisions made in course of conducting the state functions;
- timeframes and sequence of administrative procedures and actions in course of the state functions execution;
- rights and responsibilities of the executives in course of executive the state functions;
- rights and responsibilities of persons subject to control and supervision measures.
Furthermore, the Regulations limit the duration of quality control procedures by 40 business days from the receipt by the expert of pharmaceuticals samples, standard samples and documents. In exceptional cases, the timeframe may be extended, but not more than for 30 business days.
Deputies propose canceling state registration of prices for implantable medical devices
Deputies submitted to the State Duma a draft Federal Law ‘On Amending Article 80 of the Federal Law "On Fundamentals of Public Healthсare Protection in Russia’, which proposes to abolish the state registration of prices for medical devices implanted into a human body and those used for fixation (temporary or permanent), delivery, extraction of implant devices, adhesion prevention, including devices used when preparing to implantation. Most of such medical devices are auxiliary and have a short life-cycle.
In addition, the draft law clarifies the rules of setting maximum wholesale and retail trade mark-ups to actual prices for medical devices implanted into a human body within under the programme of state guarantees for free medical aid to citizens.
General safety and efficacy criteria for medical devices for EEC have been approved
Additional requirements for medical devices circulated within the EEC were enacted by the EEC Council Resolution #27 dd. February 12, 2016 “On Approval of General Safety and Efficacy Criteria for Medical Devices, Requirements to their Labeling and Operational Documentation”. In accordance with the Resolution, medical devices shall be designed and manufactured in a way ensuring that they are safe for the patient and other persons when used as intended and based on the technical knowledge, experience, education or special training, considering the patient’s clinical and physical condition, assuming an acceptable risk as compared to the therapeutic effect for the patient.
The General criteria include also requirements to for labeling and operational documentation for medical devices circulating within the EEC.
Labeling of medical devices in EEC member states
In accordance with the EEC Council Resolution #26 dd. February 12, 2016 “On Special Label for Medical Devices Circulating in the EEC Market”, medical devices registered under the EEC rules and verified for compliance with the General Safety and Efficacy Criteria, shall be marked with a special market circulation mark.
Labeling of medical devices with the special market circulation mark shall be done by the manufacturer or its authorized representative before releasing of a medical device into circulation in the EEC territory.
Rules for technical trial of medical devices within the EEC have been adopted
The EEC Council Resolution # 28 dd. February 12, 2016 approved the Rules for technical trials of medical devices for assessment of compliance with the General Safety and Efficacy Criteria, as well as to requirements to their labeling and operational documentation.
Technical trials are performed by institutions, entities and enterprises entitled to carry out medical devices trials for registration purposes, based on applications of medical devices manufacturers or their representatives.
Rules for trials for assessing biological effect of medical devices have been adopted
The trials are carried out in order to assess the compliance of medical devices with the General Safety and Efficacy Criteria, as well as compliance with the labeling and operational documentation requirements.
The trials are performed by institutions, entities and enterprises listed in the unified register of authorized entities, based on applications of medical devices manufacturers or their representatives.
Draft law increases penalties for healthcare-related violations
The Law-drafting Commission has approved the Draft Federal Law “On Amendments to the Code of Administrative Offences of the Russian Federation in Part of Improving Administrative Liability in Healthcare Area”.
The draft proposes establishing administrative liability for violations detected by the Federal Service on Healthcare Surveillance (Roszdravnadzor) in course of control over the quality of the work of medical and pharmaceutical companies, including violations of:
- rules of due laboratory and clinical practice in course of clinical and pre-clinical trials of pharmaceuticals for medical use;
- delivery of medical aid in part of mandatory requirements,
- rules for medical examinations, inspections and check-ups, as well as procedure of pharmaceuticals administration and prescription.
Furthermore, the draft law proposes treating the following breaches as a separate administrative offense:
- violation of licensing requirements for pharmaceutical activities;
- violation of rules for determining maximum wholesale and retail trade mark-ups to actual ED selling prices.
In addition, the draft law proposes increasing fines for violation of rules for pharmaceuticals sale, including selling Rx drugs without a doctor’s prescription.
Roadmap on supporting fair competition in healthcare area has been developed
The Federal Anti-Monopoly Service of Russia prepared a draft Government Order on approval of an action plan (road map) on “Development of Fair Competition in Healthcare Area”, which includes the following activities:
- improving the state registration of pharmaceuticals;
- ensuring the enactment of pharmaceuticals interchangeability concept;
- improving the state regulation of EDL prices;
- improving the regulations of procurement of pharmaceuticals and medical devices for state and municipal needs;
- improving the legislation related to intellectual property protection;
- support of fair competition in pharmaceuticals retail segment;
- improving the legislation governing circulation of biologically active additives and medical devices;
- fixing the fee for expert examination of medical devices for the purpose of obtaining an act of primary (annual) assessment; extending the ST-1 certificate validity up to one year;
- implementing measures for extending medical devices accessibility for patients;
- improving the legislation on public healthcare protection;
- improving the legislation on obligatory medical insurance;
- improving the licensing regulations;
- developing and updating clinical practice guidelines (treatment protocols).
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector
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