In this issue:
- The Ministry of Healthcare developed the draft Federal Law “On circulation of medical devices”
- Procedure adopted for medical devices lists formation
- Roszdravnadzor proposes simplifying the registration of medical devices of the first risk group
- Unified registration of pharmaceuticals for companies of the Customs Union expected from 2016
- Draft law on enhancement of anesthetics’ accessibility passed the first reading
- The Government proposes Rx distribution of alcohol-containing pharmaceuticals
- Amendments to the Law "On circulation of pharmaceuticals" adopted in the first reading
- The application form for inclusion into the list of drugs purchased in accordance with proprietary names
The Ministry of Healthcare developed the draft Federal Law “On circulation of medical devices”
The Ministry of Healthcare provided a draft Federal Law “On circulation of medical devices” for a public debates. The draft stipulates the regulation of medical devices circulation throughout their life cycle and governs the associated legal relationships with the purpose of maintaining the quality, effectiveness and safety of medical devices.
The need for development the document was due to the lack of legislative framework in Russia in area of medical devices circulation, as well as to the adoption of advanced medical technologies. As a result, nowadays there is a room of contradiction between various regulatory acts governing medical devices’ circulation.
The key goal of the draft law adoption is to form the unified systemic industry-specific regulatory framework aligned with the international standards, as well as to harmonize the Russian regulations with the international legislation.
Main provisions of the draft law include:
- defining of the executive bodies’ powers with respect to medical devices’ circulation, including establishment of the stages and means of implementation of the statutory control (surveillance) over circulation of medical devices;
- determining the expert examination procedures which precede the registration of medical devices, in particular, technical, toxicological and clinical trials;
- stipulating the procedure, forms and methods for monitoring safety of medical devices’ circulation in Russia;
- outlining the restrictions applicable to persons engaged in medical devices’ circulation etc.
Procedure adopted for medical devices lists formation
Previously, formation of lists of medical devices, envisaged by the Russian legislation, was not subject to any unified regulatory procedure.
The Resolution establishes the Rules, which set out:
- The special order of forming through committees the list of medical devices implanted into human body, under the state guarantees program for free medical care, and the list of prescription medical devices in scope of the social services rendering;
- the criteria for the lists formation and frequency of their update.
The Ministry of Healthcare was assigned to enact a regulation on the Committee engaged in formation of the medical devices lists and the composition of the committee representatives.
The committee is supposed to include representatives of federal executive bodies, higher education and scientific organizations and the medical community.
The Rules establish a template for submitting suggestions to the Committee regarding the inclusion or exclusion of medical devices from the corresponding list.
Roszdravnadzor proposes simplifying the registration of medical devices of the first risk group
Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) initiated the work on a third package of changes to the Decree of the Russian Government #1416 dd. 27 December 2012 “On adopting the Rules on state registration of medical devices”.
According to Irina Borzik, the deputy director of Roszdravnadzor, it is planned, in particular, to envisage the simplification of registration procedure for medical devices of first risk group.
Currently, in accordance with point 5 of the Rules, the registration is performed on the basis of results of technical and clinical trials, toxicological studies that are deemed to be forms of medical devices’ assessment with respect to potential risk of their use.
Introduction of the said amendments should allow improving the registration procedure depending on the class of potential risk.
Along with the above, software is being developed which will enable electronic submission of documents for registration.
Unified registration of pharmaceuticals for companies of the Customs Union expected from 2016
Nowadays, pharmaceuticals are the only exception from the goods eligible for free circulation within the Eurasian Economic Community (EEC). Although logistical and economical barriers for pharmaceuticals are already removed, the drugs registration procedures are diverse for each country (Belorussia, Kazakhstan, Russia) due to being governed by local laws. The EEC task force is working on harmonization of the respective domestic regulations.
It is planned to create the unified registration certificate for pharmaceutical companies of the Customs Union, to set up an executive body responsible for pharmaceuticals registration. It is expected that pharmaceutical companies will be able to opt between applying to the local Ministry of Healthcare and register pharmaceuticals e.g. in Kazakhstan, or undergoing the multiple registration procedure with the Customs Union executive body and register the drug in all the three member countries simultaneously.
Draft law on enhancement of anesthetics’ accessibility passed the first reading
On 24 September 2014, the State Duma adopted in a first reading the draft law #454266-6 “On amendments to the Federal Law “On narcotic drugs and psychotropic substances” (in part of establishing the priority access to medical care for patients requiring drug and psychotropic anesthetics).
The draft law, in particular, proposes to extend the validity of prescription for narcotic anesthetics to thirty days (currently – five days), as well as to simplify the procedure for the destruction of the used drugs and psychotropic substances, and to remove the obligation to return the used transdermal therapeutic systems by the patients’ relatives.
The development of the draft law was due to the difficulties for patients to obtain such anesthetics. Usually such difficulties arise as a result of excessive bureaucracy in the process of prescription and further destruction of narcotic drugs and psychotropic substances.
The Government proposes Rx distribution of alcohol-containing pharmaceuticals
As a result of the governmental working session on measures for improving the regulation of production and circulation of fermentation alcohol, alcohol and alcohol-containing products, the Prime Minister Dmitry Medvedev entrusted the Ministry of Healthcare and other responsible federal executive bodies to elaborate on the changes to the Russian legislation. These changes encompass the imposition of the restrictions on container capacity of the produced alcohol-containing pharmaceuticals and its limits of their delivery. In addition, the changes envisage the introduction of procedures when alcohol-containing pharmaceuticals require the doctor’s prescription.
Additionally, the Federal Service for Alcohol Market Regulation was assigned to draft the proposed amendments to the Russian legislation envisaging the prohibition of manufacturing the alcohol-containing pharmaceuticals and medical devices from fermentation alcohol, which is not considered fermentation alcohol as per the corresponding pharmacopoeial classification.
Amendments to the Law "On circulation of pharmaceuticals" adopted in the first reading
The following changes are envisaged:
- specifying certain definitions and introducing new ones, such as “orphan pharmaceuticals”, “biological pharmaceuticals”, “biotechnological pharmaceuticals”, “gene-therapy pharmaceuticals”, “reference medicinal product”, “bio-accessibility”, “therapeutic equivalence”, “biosimilar pharmaceuticals (biosimilar)”, “standard samples’, “manufacturing site”.
- Extending the powers of federal executive authorities, e.g. by authority to adopt good laboratory and good clinical practice regulations, establish a procedure for registration dossier formation;
- enhancing the state control procedures over pharmaceutical circulation by selective control of pharmaceutical quality and determining the respective requirements;
- determining the specifics of pharmaceuticals registration process, including for pharmaceuticals for orphan diseases treatment and establishing special rules for registration of drugs intended for use in war-time conditions, emergency, prevention and treatment of diseases and injuries resulted from influence of chemical, biological and radioactive factors;
- specifying the rules for conduction of expert review of documents for obtaining a clinical trials permit and for quality inspection of certain pharmaceuticals groups;
- adopting the rules for confirming the substitutability of pharmaceuticals for medical aid, including outlining the substitutability criteria.
In addition, the draft law amends the rules for registration dossier formation, specialties of clinical trials conduction, peculiarities of production and labeling of pharmaceuticals, destruction of pharmaceuticals, state pricing regulation, monitoring of efficiency and safety of pharmaceuticals traded in Russia.
The deputies unanimously adopted the draft law in the first reading.
The application form for inclusion into the list of drugs purchased in accordance with proprietary names
From 14 October 2014, the application form for inclusion of pharmaceuticals into the list of those purchased in accordance with their proprietary names, entered into force. The reason for the inclusion into the list is the impossibility of substituting the drug within the same INN or, in the absence of INN, impossibility of substituting within the chemical or grouping name. Possibility of such substitution shall be the reason for exclusion of a pharmaceutical from the list.
Applications under the approved forms are to be sent for consideration by the Ministry of Healthcare in electronic or hard-copy format.
The experts developed trial rules for bio-analogues
Experts of Russian and Kazakhstani pharmaceutical companies developed the Unified Rules for bio-analogous pharmaceuticals’ trials. The document was submitted to Veronika Skvortsova, the Russian Minister of Healthcare, on the 10th of September.
The Rules are based on the analysis of the current requirements to bio-analogous pharmaceuticals’ trials developed by the EU, the US and the WHO regulators. During past two years, the corresponding regulations were under discussion with foreign experts within the framework of top international conferences dedicated to the regulation of bio-analogous pharmaceuticals circulation.
The new Rules contain requirements to the volume of information to be provided with respect to the process of bio-analogous pharmaceuticals development and the results of its comparative physicochemical, biological, pre-clinical and clinical trials, as well as specification of many characteristics so that not to admit the possibility of manipulation and underestimation of regulatory requirements.
Maximum granulation and formalization of requirements to bio-analogues should ensure appearance of effective, safe, advanced and easy-to-access biological pharmaceuticals in the Russian market.
The powers of Ministry of Healthcare and Roszdravnadzor extended
It is envisaged that the Russian Ministry of Healthcare, besides adopting other normative documents, should determine:
- the medical examination procedure of an individual raising sufficient grounds to suspect drug-addiction drug intoxication or use of drugs or psychoactive substances without a medical prescription;
- dispensary observation procedure of an individual suffering from chronic and lingering mental illness with severe manifestations or exacerbation;
- a template of documentary evidencing absence of diseases precluding a person from being employed as a judge;
- the rules for preventive inoculation procedure;
- list of infectious diseases, which are virulent for the public and constitute grounds for refusal or annulment, including, but not limited to, a patent (comes into force starting from 1 January 2016);
In its turn, Roszdravnadzor is authorized to:
- issue the binding order and prosecute in case of detecting a breach of the Russian legislation in respect of pharmaceuticals’ circulation and healthcare legislation;
- create a committee for the purpose of clearing a conflict of interest while conducting medical and pharmaceutical activities;
- place at the official website of Roszdravnadzor the information on the resolutions adopted with respect to the results of medical devices’ safety monitoring.
The list of documents to be submitted when customs clearance is shortened
From 8 September 2014, due to enactment of the Orders of the Federal Customs Services of Russia #1188, 1189 dd. 23 June 2014 “On shortening the list of documents submitted for customs authorities upon customs clearance of goods”, certain documents will not be required anymore by the customs authorities while clearing the goods at customs in electronic form, in particular:
- licenses (granted by the Ministry for Industry and Trade of Russia) for export and import operations with goods included into the Unified list;
- resolutions (approvals granted by Roszdravnadzor) for importation into / exportation from the customs territory of the Customs Union of blood-forming stem cells and bone marrow for the purposes of direct transplantation, as included in paragraph 2.21 of the Unified list.
The Fourth Anti-Trust pack adopted by the Government
On 4 September 2014, the Government of Russia approved the Draft Federal Law “On introduction of changes in the Federal Law “On Protection of Fair Competition” and separate legislative acts of the Russian Federation”, also known as “the Fourth Anti-Trust Pack”.
The proposed Draft Law envisages significant reduction of administrative barriers for the business and simultaneous reduction of the state’s involvement in the economic activities.
The main provisions of the draft include:
- Enhancement of the concept of forestalling and its extension over the activities of federal and local government bodies (Article 15), unfair competition (except for cases of exclusive rights violations) and other forms of misuse of dominant position (points 6 and 8 of part 1 of Article 10);
- Empowering the Russian Government to determine the rules for non-discriminating access to goods on highly concentrated goods markets in case of antimonopoly law breaches in such markets;
- Elimination of the possibility to apply the prohibition for misuse of dominant position in case such actions impair the interests only of persons not engaged in entrepreneurial activity;
- Clarifying part 1 of Article 11 of the Federal Law “On Protection of Fair Competition” in part of viewing the agreements between customers as cartel ones;
- Empowering the Federal Antimonopoly Service of Russia to reconsider the territorial antimonopoly authorities’ resolutions;
- Elimination of the notification control of transaction closed by natural monopolies.
The draft will be submitted for the first reading to the State Duma.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.