KPMG Pharma Bulletin Issue #5, 2018 (May)
KPMG Pharma Bulletin Issue #5, 2018 (May)
The Federal Law dd. 04.06.2018 # 140-ФЗ “On Amendments to the Federal Law “On Circulation of Pharmaceuticals” is published, simplifying the procedure for pharmaceuticals state registration.
The law simplifies the registration of pharmaceuticals by foreign manufacturers, allowing start the registration procedures before GMP audit completion. The GMP audit, though, has to be finalized prior to the registration procedures completion.
Furthermore, the law enables registration of pharmaceuticals having the same international non-proprietary name and manufactured at the same production site but with different trade names.
It is also envisaged that the use of a pharmaceutical could be suspended is it had caused or could cause harm to life and health of citizens.
The Russian Government amended the Resolution # 1289 dd. 30.11.2015 which stipulated restrictions and conditions for admission of foreign-made EDL to public procurement. The corresponding Resolution dd. 12.05.2018 # 572 is signed by the Prime Minister.
Starting from January 1, 2019, in case of rejecting applications (final bids) according to the currently effective provisions of Clause 1 of the said Resolution (i.e. if upon rejecting bids for foreign-made pharmaceuticals supply not less than 2 bids for EAEU-made pharmaceuticals remain in the tender) there is at least one bid for supply of pharmaceuticals produced fully in the EAEU (including molecule synthesis), such a bid could be accepted for the procurement as per the rules set out by the Ministry of Finance.
That is, a tender could be viewed as executed and supplies can be conducted in case of receiving just one bid for a pharmaceutical, all production stages of which are realized in the EAEU territory.
At the same time, to confirm the compliance of the drug and the API with the specified requirements, the bidder has to include into the application submitted:
- data on the document confirming the manufacturer's compliance with EAEU GMP standards or the GMP standards approved by the Russian Ministry for Industry and Trade;
- data on the document issued by the Russian Ministry for Industry and Trade and containing information on stages of the technological process for the production of drugs in the EAEU, including the API molecule production stage.
The Resolution applies only for state and municipal procurement and does not cover drug supplies in the commercial segment.
The purpose of the above decisions is to support pharmaceutical manufacturers with a high degree of localization in Russia and other EAEU member states.
The Federal Law dd. 04.06.2018 # 127-ФЗ “On Measures of Influence (Counteraction) on Unfriendly Actions of the United States of America and (or) Other Foreign States” is published officially.
While considering the document in the State Duma it was suggested, inter alia, to ban or restrict importing in Russia pharmaceuticals originated from the US and (or) other foreign countries, as per the list set out by the Russian Government. The suggested restrictions should not have been applied to pharmaceuticals having no analogues produced in Russia and (or) foreign countries. By the second reading, the ban for importing drugs was removed from the bill. Thus, the final version of the law sets out framework regulations and does not impose prohibitions for pharmaceuticals import.
The original version of the document raised a lot of disputes and challenges from public, professional and patient communities. Introduction of restrictions was viewed as a threat primarily for Russian companies and for patients, rather than for foreign producers.
The Resolution of the EEC Collegium dd.10.05.2018 # 71 “On the Classifier of International Non-proprietary Names of Pharmaceuticals” was adopted (along with the “Passport of the Classifier of International Non-proprietary Names of Pharmaceuticals”).
The Classifier forms a part of the EAEU unified information system. Application of its codes shall be obligatorily while performing common EAEU processes in area of pharmaceuticals circulation.
The document was posted at the EAEU’s official website on 14.05.2018 and entered into force on 13.06.2018.
The Recommendation of the EEC Collegium dd. 10.05.2018 # 6 "On Guidelines on the Quality of Phyto-Pharmaceuticals" was approved.
The Guidelines systemizes rules for compiling a registration dossier module for phyto-pharmaceuticals and addresses questions related to quality of phyto-pharmaceuticals (including those containing vitamins and mineral components) in respect of distinguishing them from drugs containing only pharmaceutical substances with a pre-determined chemical structure. Pharmaceuticals containing individual components or a mixture of components with a pre-detemined chemical composition are not considered as phyto-pharmaceuticals.
The registration dossier contents and all other information mandatorily provided with respect to a phyto-pharmaceutical must comply with the established requirements.
The Resolution of the EEC Collegium dd. 10.05.2018 # 69 “On the Approval of Requirements to Studies of Stability of Drugs and Active Pharmaceutical Ingredients” is adopted.
The requirements are applicable when planning and conducting stability studies for API and pharmaceuticals based on these API as well as during formation of registration dossiers.
The purposes of the stability studies are obtaining data on changes in quality of an API or a drug over time under influence of various environmental factors (temperature, humidity and light), as well as identifying preferred storage conditions and the permissible period before re-studies, the shelf-life of low-resistant APis or drugs.
The Resolution is posted at the EAEU’s official website on 14.05.2018 and comes into force on 14.11.2018.
The Resolution of the EEC Collegium dd. 10.05.2018 # 70 “On the Classifier of Types of Work and Services Constituting Healthcare Activity” is approved.
The Classifier forms a part of the EAEU unified information system. Application of its codes shall be obligatorily while performing common EAEU processes in area of, inter alia, medical devices circulation.
The Resolution was posted at the EAEU’s official website on 14.05.2018 and came into force on 13.06.2018.
The Ministry of Health released clarifications on matters related to tele-health care delivery, stating, in particular, the following:
- delivering medical aid via tele-health technologies does not constitute a separate type of a medical service;
- tele-health tools are a technological component applied when rendering services which qualify for medical aid;
- delivering medical aid via tele-health technologies shall be carried out in full compliance with the licensing requirements and in line with the health care services guidelines (порядки);
- a unified identification and authentication system shall be used to identify and authenticate participants of the online communications in course of rendering services via tele-health channels;
- each tele-health consulting provider as well as each operator of another information system used shall provide the patient or his authorized representative (by any available means, including via internet) with the information on the ways to identify and authenticate the patient by means of the unified information system.
The Ministry of Health prepared the draft Federal Law “On Amendments to the Article 228 of the Criminal Code of the Russian Federation” which proposes de-criminalize those actions of medical and pharmaceutical professionals associated with violation of rules for narcotic drugs or psychotropic substances circulation, which do not entail high degree of public danger.
The amendments have been awaited for quite a time: in particular, there are cases of criminal prosecution against doctors for prescribing narcotic drugs to patients (including those under charge of other doctors/health providers) with the purpose to relieve their suffering.
The proposed changes are expected to ensure 100% availability of painkillers already in 2018.
The Ministry of Health updated the list of indicators for medical services quality assessment. The new list provides for three indicators for each of the following criteria:
- openness and availability of information about the healthcare provider;
- comfortability of health services rendering, including waiting time;
- availability of health services for disabled patient;
- friendliness and courtesy of the staff;
- patients’ satisfaction with the health services received.
The previous version of the assessment indicators lost their force since 03.06.2018 (the Order of the Ministry of Health of Russia dd. 28.11.2014 # 787н).
The public & private initiative of creating the universal system for tracking and tracing goods circulation is now enacted at the federal level. The Order of the Government dd. 28.04.2018 # 791-р established the model of digital serialization and labeling of goods. The Ministry of Industry and Trade shall become the coordinating regulatory body for the system, while the system’s operator is to provide data on the serialized goods’ circulation to state authorities, supply chain participants and customers/consumers.
The track & trace model embodies the following basic principles:
- each item of goods is identified by assigning a unique code;
- the universal information system is created;
- the universal catalog of goods circulating in Russia is created.
Further, one-time fee is charged for a unit of the serial code at the moment of its generation by the information system. This fees (to be set by law) is supposed to, inter alia, cover the cost of registering all the goods’ circulation stages in the system.
The serial codes are to be protected using Russian cryptographic technologies. The Ministry of Finance shall ensure legislative governance of the relations related to goods labeling. The control over the information system functioning and over its operator activities shall be the responsibility of the Ministry of Communications.
Furthermore, the Order of the Government dd. 28.04.2018 # 792-р stipulates the list of goods subject to mandatory serialization starting from 2019, which includes, in particular, tobacco products, perfumes and eau-de-toilet, clothes, shoes, cameras. Pharmaceuticals are not enlisted.
On 25 May 2018, the Russian Ministry of Justice has registered the Order of the Ministry of Health dd. 13.02.2018 # 67н, approving the Administrative Regulations of the Ministry of Health of Russia setting out the rules for rendering a public service on accreditation of healthcare organizations entitled to conduct clinical trials of pharmaceuticals for medical use.
The document governs the procedure of granting public service on issuance of a permit for clinical study of a pharmaceutical for medical use and the appeal procedure against actions (inactions) and decisions made while rendering the said public service.
The amendments were introduced to the Regulation “On the Accreditation of Pharmaceutical and Medical Professionals”, approved by the Order of the Ministry of Health dd. 02.06.2016 # 334н. The corresponding Order of the Ministry of Health dd. 26.04.2018 # 192н was registered by the Ministry of Justice on the 23rd of May.
The document stipulates, in particular, that for professionals with higher medical or pharmaceutical education, assessment of practical skills in simulated environment, including use of simulating equipment (simulators and (or) dummies) and (or) involving standardized patients, shall be based on evaluating correctness and consistency of performance of at least 5 practical tasks; and for professionals with the secondary medical or pharmaceutical education – by evaluating 1 practical task.
One practical task is to be completed within 10 minutes by a professional having the higher education degree, and within 30 minutes – by one having the secondary medical or pharmaceutical education.
Should a professional who fails to pass the accreditation not apply for a repeated accreditation within 5 business days after his first accreditation attempt, such a professional is deemed to be not accredited.
A group of deputies submitted to the State Duma the draft Federal Law "On Amendments to the Criminal Code of the Russian Federation Related to Upgrading the Liability for Violations in Area of the State Monopoly for Production and Circulation of Ethyl Alcohol and/or Alcoholic Products Manufactured Using Ethyl Alcohol (Vodka)".
The draft proposes to amend the Criminal Code, introducing liability for major criminal offenses related to production, purchase (including import), delivery (including export), storage, transportation and (or) retail sale of ethyl alcohol, alcohol and alcohol-containing products without an appropriate license in case when it is required mandatorily.
Persons committing such crimes by using benefits of their official positions may face imprisonment for 5 up to 10 years with a fine of up to 2 million rubles. Additional sanctions/punishments may also apply.
“A number of factories producing active pharmaceutical ingredient of ethyl alcohol (ethanol) are set up on the basis of facilities which were formerly producing ethyl alcohol but lost their manufacturing licenses for various reasons. In cases when a license for production of ethanol from food raw materials expired (and the producer failed to renew it), a former distillery becomes a branch of a pharmaceutical company and in fact continues manufacturing ethanol, presenting it as the ethyl alcohol API”, – the Explanatory note to the draft law clarifies.
The authors of the draft believe that, given negative trends in the alcohol market, as well as the need to sustain the state monopoly for production and distribution of ethyl alcohol and (or) ethanol-based alcohol products, increasing the liability should, to certain extent, help combat illegal production and circulation of ethyl alcohol and its supplies to producers of counterfeit and poor quality alcoholic drinks.
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