Legal & Regulatory > Russia > Regulatory, Pricing and Reimbursement Overview

An intro to the legal situation for regulatory, pricing and reimbursement in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The authorities responsible for applying and enforcing the regulatory framework shall be:

• concerning drugs and biologicals – the Ministry of Healthcare of the Russian Federation (the “Minzdrav”) and the Federal Service for Surveillance in Healthcare (the “RZN”);
• concerning medical devices – RZN.

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The regulatory framework for pricing and reimbursement of drugs and biologicals includes Federal Law dd 21.11.2011 No. 323-FZ “On Fundamental Healthcare Principles in the Russian Federation” (the “Law on Fundamental Healthcare Principles”), Federal Law dd 12.04.2010 No. 61-FZ “On Circulation of Drugs” (the “Law on Circulation of Drugs”), which provisions are supplemented with the regulations, adopted by the Government of the Russian Federation and Minzdrav.

Russia, being the member state of the Eurasian Economic Union (the “EAEU”), complies with the EAEU provisions regarding the formation of the Common Market of medicines and medical devices under Art. 30 and Art. 31 of the Eurasian Economic Union Treaty dd 29.05.2014. Starting from 2021, authorization (i.e. registration) of new medical drugs in Russia is performed under the regulations of the EAEU that include the Rules of registration and examination of medical drugs approved by the decision of the Council of the Eurasian Economic Commission dd 03.11.2016 No. 78 (the “EAEU Rules”) and other applicable regulations of the EAEU.

The are no specific requirements for the pricing of drugs in the private sector, except common antitrust regulations that shall be considered. As well there is no reimbursement in the private sector. As for the public sector and the drugs included in the list of vital essential and necessary drugs, please, refer to Question 12.

The regulatory framework for authorization, pricing and reimbursement of medical devices includes the Law on Fundamental Healthcare Principles, the provisions of which are supplemented with the regulations, adopted by the Government of the Russian Federation and Minzdrav. Starting from 2022, registration of new medical devices is to be performed under the applicable EAEU regulations. Before that registration of new medical devices can be performed under national laws.

Cl. 2 Art. 38 of the Law on Fundamental Healthcare Principles provides for the segregation of medical devices for classes, depending on the degree of the potential risk of use of medical devices, and types, depending on the nomenclature classification of medical devices (i.e. the purpose of their use), that is set forth by Decree of Minzdrav dd 06.06.2012 No. 4н. The class of the medical device affects its registration, i.e. procedure for obtaining marketing authorization (please, refer to Question 4 ), and post-registration control.

The classes of the medical devices include the following:

• class 1 – medical devices with a low degree of risk (for instance, medical gauze);
• class 2b – medical devices with an increased degree of risk (for instance, solution for lens);
• class 2a – medical devices with an average degree of risk (for instance, X-ray apparatus);
• class 3 – medical devices with a high degree of risk (for instance, coronary stent).

The are no specific requirements for the pricing of medical devices in the private sector, except common antitrust regulations that shall be considered. As well there is no reimbursement in the private sector. As for the public sector, please, refer to Question 12.

3. What are the steps to obtaining authorization to develop, test, and market a product?

The manufacturers or their authorized representatives in Russia shall obtain marketing authorization from Minzdrav for drugs and biologicals and from RZN – for medical devices. The registration procedures are outlined in Administrative regulations of Minzdrav on the provision of state services for the state registration of medical drugs intended for circulation in the EAEU common market of medical drugs under the EAEU Rules in respect of drugs, and by the Law on Fundamental Healthcare Principles and supplementary regulations of the Government of the Russian Federation and Minzdrav – in respect of medical devices.

3.A. DRUGS

The EAEU Rules provide for 2 different registration procedures:

1. Mutual recognition procedure
2. Decentralized procedure

A. Mutual recognition registration procedure

Within this procedure, the applicant chooses one of the EAEU member states as a reference state that will be responsible for a full-fledged cycle of procedures, including tests and inspections, resulting in an expert report. In other chosen member states (recognition states) only examination of the expert report from the reference state and particular modules of the registration dossier takes place. Registration in the reference state is first completed and then recognition in other EAEU member states (recognition states) follows. The applicant independently chooses the reference state and recognition state(s) between the EAEU member states.

The steps to obtain marketing authorization and approval timeframes through the mutual recognition procedure in the reference state shall be as follows:

• Step 1. Pre-registration stage

Preparation of documents to be filed with Minzdrav:

• • Application, confirmation of the fee payment, samples of drugs, and registration dossier that includes 5 modules:
    • Module 1: Administrative Information;
    • Module 2: Summaries of Common Technical Document;
    • Module 3: Quality;
    • Module 4: Non-clinical (preclinical) reports;
    • Module 5: Clinical reports.

• Step 2. Registration of a drug

• • Minzdrav verifies the completeness and accuracy of the documents submitted within the registration dossier within 14 working days from the date of filing an Application for registration;
  • Minzdrav appoints assessment of a medicinal product by an expert organization of a reference state, it is possible to appoint a pharmaceutical inspection (in parallel with the assessment, no more than 180 calendar days);
  • Minzdrav draws up the final expert report;
  • Within 10 working days after drawing up the final expert report:
    • Issuance of a registration certificate to the applicant;
    • Placement of information about a medicinal product in the Common Register.

The timeframes for Step 2 (the whole registration process in the reference state) shall be within 210 calendar days upon the receipt of the application and the relevant documents by Minzdrav.

The steps to obtain marketing authorization and approval timeframes through the mutual recognition procedure in the recognition state shall be as follows:

• Step 1. Pre-registration stage

Preparation of documents to be filed with the competent authorities (assessment organization) of such member states:

• • Application, Confirmation of the fee payment, and Module 1 of the registration dossier. Instructions for medical use and packaging layouts may also be required depending on the national legislation of the specific EAEU member state chosen as the recognition state.

• Step 2. Registration of a drug

• • The applicant submits a request to the authorized body of the reference state to open access to the Registration dossier and expert report;
  • The assessment of the drug includes:
    • Evaluation of the application and information provided in the registration dossier;
    • Evaluation of the expert report prepared in the reference state.
  • No later than 90 calendar days (in the absence of disagreements between the authorities of the relevant member state and the reference state) from the date of granting such access, the registration of the drug takes place;
  • Within 10 working days:
    • Issuance of a registration certificate to the applicant;
    • Placement of information about a medicinal product in the EAEU common register.

B. Decentralized registration procedure

Under decentralized procedure registration both in reference state and in recognition state(s) take place simultaneously.

• Step 1. Pre-registration stage.

• • Preparation of documents to be filed with Minzdrav (reference state): Application, Confirmation of the fee payment, samples of drugs, and registration dossier;
  • Preparation of documents to be filed with the competent authorities (assessment organization) of recognition state(s): Application, confirmation of the fee payment, and module 1 of the registration dossier. Additional documents may also be required depending on the national legislation of the specific EAEU member state chosen as the recognition state.

• Step 2. Registration of drug

• • The assessment of the drug by the competent authorities (assessment organization) of the reference state and the states of recognition:
  • Within 90 calendar days from the date of the beginning of the assessment, the competent authorities (assessment organization) of the reference state prepares a preliminary report and sends copies of this report with commentaries and a request to the applicant to the authorized bodies of the recognition state(s);
  • The authorized bodies of the recognition state, no later than 30 calendar days from the date of receipt of the preliminary report, shall send requests to the authorized body of the reference state;
  • The reference state, within 5 working days from the date of receipt of the request from the recognition state, prepares a single request and sends it to the applicant. The total term for the applicant to respond is within 180 calendar days;
  • Preparation of the final expert report and issuance of a registration certificate (205th calendar day from the date of applying for registration).

The timeframes for Step 2 should take not more than 210 calendar days. More time may be required for answering additional requests and in the case of other complications.

Generics

Applicants for marketing authorizations of generic drugs shall generally prove that their products are bioequivalent to the brand-name product under the EAEU regulations for conducting bioequivalence studies of drugs, and clinical trials are not conducted. Additionally, the EAEU Rules provide for specific requirements for the documents of the registration dossier of a generic drug accordingly.

Orphan drugs

According to the EAEU Rules, to orphan drugs, the main provisions of Part II (registration on conditions) may be applied. The applicant must justify in the preclinical and clinical summaries the reasons why it is not possible to provide complete information and provide a justification for the balance of benefits and risks for the orphan drugs in question.

Also, the submission of samples, specific reagents, and other materials is not required if it is impossible to conduct tests in an expert organization due to the inaccessibility of samples of medicinal products (if they are classified as an orphan), the impossibility of observing the conditions for transporting these samples to the territory of the member state and (or) their storage, lack of special equipment and consumables in an expert organization.

Biologicals

According to the EAEU Rules, there are special requirements for the documents of Module 3 of the registration dossier of biologicals.

3.B. MEDICAL DEVICES

The steps to obtain marketing authorization and approval timeframes for medical devices shall be as follows:

• Step 1. Pre-registration stage: Preparation of documents, which include:

• • Testing of medical devices:
    • Technical;
    • Toxicological;
    • Approval of measuring instruments (if applicable).
  • Preparation of documents for state registration of medical devices

• Step 2. Registration of medical devices (Stage I)

• • RZN reviews the documents submitted;
  • RZN appoints the examination with the state institution and such institution examines the quality, effectiveness, and safety of medical devices based on the documents submitted;
  • RZN permits to conduct clinical trials.

• Step 3. Clinical trials of medical devices, that are conducted by the applicant (state registration shall be suspended)

• Step 4. Registration of medical devices (Stage II):

• • RZN reviews the documents submitted;
  • RZN appoints the examination with the state institution and such institution examines the completeness and the results of trials;
  • RZN approves state registration and issues marketing authorization.

The timeframes for Stage I (Step 2) and Stage II (Step 4) shall be 88 business days (58 days for registration activity exercised by RZN and 30 business days for examination conducted by budgetary institution reported to RZN). The term for clinical trials is not included.

4. What are the approximate fees for each authorization?

According to Art. 333.32.1 – 333.32.2 of the Tax Code of the Russian Federation, government fees shall be as follows:

• for drugs and biologicals:
  • for issuing of marketing authorization – around USD 135 (RUB 10 000);
  • for examination of a drug at its registration – around USD 4 370 (RUB 325 000).

• for medical devices:
  • for issuing of marketing authorization – around USD 95 (RUB 7 000)
  • for quality, efficiency, and safety examination of a medical device at its state registration (dependent on the class of potential risk):
    • class 1 – around USD 605 (RUB 45 000);
    • class 2a – around USD 875 (RUB 65 000);
    • class 2b – around USD 1 145 (RUB 85 000);
    • class 3 – around USD 1 550 (RUB 115 000).

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Under Cl. 18 of the EAEU Rules, marketing authorization validity for a drug to be registered for the first time is 5 years. Upon the expiration of this 5-year term the marketing authorization can be renewed for an indefinite term subject to confirmation of its registration (re-registration). In some cases (due to pharmacovigilance issues), a renewed marketing authorization can be issued for 5 years.

Marketing authorizations of those drugs that (A) were registered under national rules (under Russian laws) before 2021; and (B) have valid Russian marketing authorization, are valid until their expiration date, but no later than December 31, 2025. For these drugs, the procedures for making changes and confirming their registration in compliance with the EAEU regulations will be available until December 31, 2025.

According to Cl. 6 of Regulation of the Government of the Russian Federation dd 27.12.2012 No. 1416 marketing authorization for a medical device shall be issued for an indefinite term.

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The differences between the brand-name and generic product authorization process are covered in Question 3. In general, the differences are that for brand-name products it is necessary to demonstrate safety and efficiency, and for generic products it is required to demonstrate bioequivalence.

There are no differences for local manufacturers versus foreign-owned manufacturers in terms of marketing authorization.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated

Combination products shall be subject to marketing authorization. Combination products may be classified either as drugs or medical devices depending on the product’s basic purpose and effects on the human body. Separate elements of such products can be registered as a separate drug or medical device as the case may be.

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

RZN has a permanent pharmacovigilance program, that is based on information on possible adverse effects of the drugs submitted, among others, by manufacturers, distributors, drug stores, healthcare institutions. Moreover, according to Cl. 22 of Art. 18 of the Law on Circulation of Drugs the holder of the marketing authorization shall submit a pharmacovigilance report to RZN on the registered drug regularly, as specified by the law.

Besides, the EAEU member states cooperate with respect to the registered drugs under the EAEU Good Pharmacovigilance Practice.

RZN as well monitors the registered medical devices based on notices submitted by the persons specified above and by individuals, as well.

Generally, RZN supervises pharmaceutical activities, supervision of production, manufacture, quality, efficiency, safety, turnover, and procedures for the use of medicinal products, which include the abovementioned pharmacovigilance activities. The regulatory regime in Russia is comparable to those conducted by U.S. Food and Drug Administration or the European Medicines Agency.

9. What is the potential range of penalties for noncompliance?

RZN is authorized to make on-site visits at any time to inspect premises and verify such compliance and may indicate ex officio legal proceedings to sanction non-compliance. Ultimately these legal proceedings may result in sanctions ranging from administrative fines up to revocation of the marketing authorizations and suspension of circulation of the medical product.

10. Is there a national healthcare system? If so, how is it administered and funded?

Following Art. 29 of the Law on Fundamental Healthcare Principles, the national healthcare system includes state (incl. federal and regional) and municipal healthcare systems, which respectively consist of relevant state and municipal authorities, operating administration, and healthcare institutions. The healthcare system is funded with respective national budgetary (federal and regional) and state non-budgetary funds.

Out-patient pharmaceutical care programs are financed via several different public sources: the federal budget, regional budgets, and compulsory health insurance.

Compulsory health insurance (via the Federal Fund for Mandatory Medical Insurance, FFOMS) funds the reimbursement of medicines provided for in-patient and emergency care. The government maintains the list of vital essential and necessary drugs (the “EDL”) outlining which drugs should be made available in the in-patient setting, and which is also used as the basis for several out-patient reimbursement schemes.

11. How does the government (or public) healthcare system function with private sector healthcare?

Public and private health sectors operate separately, and there is no interaction between one and another.

Private health insurance is voluntary, but quite common and is generally provided by the employer.

The public health sector normally faces financial issues and implements measures to limit costs, for instance, by pressing for price reductions in public bids and encouraging competition.

12. Are prices of drugs and devices regulated and, if so, how?

Prices for drugs are regulated in terms of public procurement: Cl. 2 Art. 80 of the Law on Fundamental Healthcare Principles, Art. 60 of the Law on Circulation of Drugs, Regulation of the Government of the Russian Federation dd 28.08.2014 No. 871, Regulation of the Government of the Russian Federation dd 29.10.2010 No. 865 provide for EDL, which prices are regulated by state authorities, and for the relevant procedures. Such maximum sale prices shall be submitted by the manufacturers or their authorized representatives and shall be subject to state registration with Minzdrav. Purchasing price in the public procurement sector shall not exceed the price calculated based on such registered price considering the relevant maximum wholesale mark-up.

Prices for medical devices are regulated in terms of public procurement as well: Cl. 2 Art. 80 of the Law on Fundamental Healthcare Principles and Regulation of the Government of the Russian Federation dd 22.09.2014 No. 968 provide for the list of medical devices, which prices are regulated by state authorities. Such maximum sale prices shall be submitted by the manufacturers or their authorized representatives and shall be subject to state registration with RZN. Purchasing price in the public procurement sector shall not exceed the price calculated based on such registered price considering the relevant maximum wholesale mark-up.

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

In the private sector, most payments are made on an out-of-pocket basis. Private insurers are improving the level of pharmaceutical coverage since the private market in medicines has grown considerably. Subject to Cl. 2 Art. 80 of the Law on Fundamental Healthcare Principles vital essential and necessary drugs are provided by the budgetary healthcare institutions within the framework of Medicare, that is subject to the following reimbursement with compulsory medical insurance funds (for more details, please, refer to Question 14).

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Commonly, budgetary healthcare institutions dispense medical products prescribed by their healthcare professionals. Products are prescribed from EDL and the same list for medical devices, that is annually approved by the Government, and as stated by standards of care, that are approved by Minzdrav. Public healthcare institutions directly procure such medical products mostly by public tender process and provide Medicare, that is subject to the following reimbursement with the funds of public insurers.

At present, in-patients (including patients in day hospitals) and patients to whom emergency care is provided are fully reimbursed for the cost of medicines used as part of their treatment.

In the out-patient setting, however, only certain population groups are eligible to receive either free or partially subsidized prescription medicines. Eligibility for these benefits is determined by the federal government – although the regional authorities have the right to extend reimbursement to additional groups, provided that such coverage is funded by the regional (rather than federal) budget. The prescribed medical product shall be sold to welfare beneficiaries in a drug store, whether it is private or not, free of charge or with a 50% discount, as provided by Art. 6.1 of Federal Law dd 17.07.1999 No. 178-FZ “On state social assistance”. The cost of such medical products shall be reimbursed by public healthcare institutions, which prescribed the medical product.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

The Government provides for EDL and medical devices which may be procured by public healthcare institutions and therefore dispensed by their healthcare professionals.

RZN exercises complex control over the circulation of medical products, including the public sector, and monitors the indicia of preferential drug provision, and conducts inspections in medical institutions and drug stores, as well as in authorities of the subjects of the Russian Federation related to the healthcare sector.