RU 
ZH 
ES 
BRACE Law Firm presents its latest regulatory digest for the Russian life sciences and pharmaceutical industry covering February 2019.
This month witnessed a marked increase in legislative and regulatory activity, alongside the adoption of several critical legal amendments governing pharmaceutical operations.
The Collegium of the Eurasian Economic Commission approved the Guidelines on the Selection of Tests and Acceptance Criteria for Specifying Herbal Medicinal Materials, Herbal Pharmaceutical Substances (Herbal Drug Preparations), and Herbal Medicinal Products. The document establishes general principles for drafting specifications and methodologies for selecting acceptance criteria.
In February 2019, the Standard of Primary Health Care for Children with Systemic Juvenile Arthritis and the Procedure for Issuing Import Permits for Specific Batches of Unregistered Biomedical Cell Products (along with the corresponding permit forms) entered into force.
The Ministry of Health of the Russian Federation approved the criteria for compiling the list of alcohol-containing medicinal products included in the State Register of Medicines. Furthermore, the Ministry of Health proposed draft regulations establishing supplemental requirements for documents submitted for the marketing authorization of medicinal products and setting the monthly expenditure standard per citizen receiving state social assistance for prescription drugs.
Crucially, February also brought a landmark judicial precedent that significantly impacts the protection of pharmaceutical patent holders.
1. Laws, Regulations, and Legal Developments
1.1. The Collegium of the Eurasian Economic Commission Approved the Guidelines on the Selection of Tests and Acceptance Criteria for Specifying Herbal Medicinal Materials and Herbal Medicinal Products.
Recommendation of the Collegium of the Eurasian Economic Commission No. 6 dated February 12, 2019, “On the Guidelines on the Selection of Tests and Acceptance Criteria for Specifying Herbal Medicinal Materials, Herbal Pharmaceutical Substances (Herbal Drug Preparations), and Herbal Medicinal Products”
The Guidelines outline general principles for compiling specifications for herbal medicinal materials, herbal pharmaceutical substances (herbal drug preparations), and herbal medicinal products for registration purposes pursuant to the Rules for Registration and Examination of Medicinal Products for Human Use, approved by Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016.
The Recommendation advises member states of the Eurasian Economic Union (EAEU) to apply these guidelines upon the expiration of six months from the date of publication on the official EAEU website.
The document mandates that applicants establish and justify acceptance criteria in specifications based on data and results obtained from testing batches used in preclinical (clinical) studies, or derived from relevant published literature.
Specifications for herbal medicinal materials must include: the botanical characteristics of the medicinal plant; macro- and microscopic characteristics; phytochemical profiles; data on biological (geographical) variation; information on cultivation, harvesting, and drying conditions; data on pre- and post-harvest chemical treatments (pesticides, fumigants); and a description of the component profile and stability of the herbal material.
Specifications for finished dosage forms of herbal medicinal products must include: data on the quality of herbal medicinal materials and/or herbal pharmaceutical substances (herbal drug preparations); a description of the manufacturing process (temperature effects, residual solvents, etc.); the profile and stability of active components (composition) during packaging; and batch numbers used in preclinical (clinical) trials to evaluate safety and determine efficacy (where applicable).
Section 5 of the Guidelines details the principal tests and acceptance criteria. In addition to standard criteria, the document sets forth supplemental (specific) testing parameters and acceptance thresholds.
We anticipate that this document will significantly clarify the requisite compliance standards for selecting tests and acceptance criteria when drafting specifications.
1.2. The Procedure for Issuing Import Permits for Specific Batches of Unregistered Biomedical Cell Products Enters into Force on March 10, 2019.
Order of the Ministry of Health of Russia No. 31n dated January 30, 2019, “On Approval of the Procedure for Issuing Import Permits for Specific Batches of Unregistered Biomedical Cell Products into the Russian Federation and the Import Permit Form for Specific Batches of Unregistered Biomedical Cell Products into the Russian Federation”
The regulation mandates that, to obtain the relevant permit, market participants in biomedical cell products must submit the following documents or information to the Ministry of Health of Russia:
• an application for permit issuance;
• a copy of the agreement (contract), including its appendices and/or amendments, or, in the absence of a contract, a copy of another document confirming the parties' intent;
• the manufacturer's certificate of the biomedical product, certifying compliance of the imported biomedical cell product with the product's regulatory documentation requirements;
• the specification for the biomedical cell product;
• the applicant's Primary State Registration Number (OGRN) and Taxpayer Identification Number (INN);
• where importing a specific batch of an unregistered biomedical cell product for biomedical evaluation and/or preclinical studies, a justification for the quantity of the imported product;
• where importing a specific batch of an unregistered biomedical cell product for clinical trials: a justification for the quantity of the imported product; information on the clinical trial authorization issued by the Ministry of Health of Russia; and copies of documents confirming proper product labeling that restricts its target use exclusively to clinical trials;
• where importing a specific batch of an unregistered biomedical cell product for providing medical assistance to a specific patient on compassionate grounds (life-saving indications): details on the full name and address of the federal medical institution treating the patient; and the findings of the federal institution’s medical board specifying the quantity of the biomedical cell product to be imported into the Russian Federation.
This legal act also approves the template for the corresponding permit. Notably, the validity period for the Procedure for Issuing Import Permits for Unregistered Biomedical Cell Products remains limited to April 30, 2019, pursuant to Paragraph 3 of Government Decree No. 1229 dated October 16, 2018, "On Introducing a Temporary Procedure for the Importation of Biomedical Cell Products into the Russian Federation."
1.3. A New Standard for Primary Pediatric Healthcare for Juvenile Arthritis Took Effect on February 5, 2019.
Order of the Ministry of Health of Russia No. 953n dated December 29, 2018, “On Approval of the Standard of Primary Health Care for Children with Systemic Juvenile Arthritis”
This document establishes an updated List of Medicinal Products Authorised in the Russian Federation, prescribing mean daily and course doses that differ from the list previously approved under the now-repealed Order of the Ministry of Health of Russia No. 777n dated November 9, 2012.
The standard underscores that medical practitioners may prescribe and administer medicinal products, medical devices, and specialized therapeutic nutritional products excluded from the standard care pathway under specific clinical indications (such as individual intolerance or life-saving circumstances), subject to approval by a formal medical commission.
1.4. Pharmaceutical Manufacturing Approved within the "Mendeleevsk" Territory of Advanced Social and Economic Development (TASED).
Decree of the Government of the Russian Federation No. 123 dated February 12, 2019, “On the Creation of the 'Mendeleevsk' Territory of Advanced Social and Economic Development”
This Government Decree explicitly designates the manufacture of medicines and medical materials as an approved economic activity within the "Mendeleevsk" Territory of Advanced Social and Economic Development.
During the first year following a corporate entity's entry into the TASED resident register, the resident must commit a minimum capital investment of 2.5 million rubles toward the designated economic activities under their investment project. Furthermore, the project must generate a minimum of 10 new permanent jobs.
1.5. The Ministry of Finance Clarified the Retention of Preferential VAT Rates for Certain Goods and Services.
Letter of the Ministry of Finance of the Russian Federation No. 03-01-11/7176 dated February 7, 2019
The Ministry clarified that although the standard VAT rate increased from 18% to 20% effective January 1, 2019, preferential VAT exemptions and the reduced 10% VAT rate remain intact. These special rates continue to apply to socially significant goods and services, specific food products, children's goods, medicinal products, and medical devices.
1.6. The Government Approved the Procedure for Compiling the Registry of Alcohol-Containing Medicines Exempt from General Alcohol Regulation.
Decree of the Government of the Russian Federation No. 201 dated February 28, 2019, “On Approval of the Rules for Compiling the Registry of Alcohol-Containing Medicines Exempt from Federal Law 'On State Regulation of Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products and on Limiting Consumption (Drinking) of Alcoholic Products'”
Competent authorities will compile the registry based on proposals to include or exclude specific alcohol-containing medicines. Market participants must submit these applications in hard copy along with an electronic copy to the Ministry of Health of the Russian Federation (for human medicinal products) or the Ministry of Agriculture of the Russian Federation (for veterinary drugs).
The regulation establishes that alcohol-containing medicines registered in Russia and listed in the State Register of Medicines qualify for inclusion if they meet one or more of the following criteria:
• the volume of the consumer packaging precludes its use as a substitute for alcoholic beverages;
• the retail price of the alcohol-containing medicinal product, evaluated in comparable volumes of packaging and ethyl alcohol content, exceeds the retail price of consumer alcoholic beverages;
• the therapeutic purpose of the alcohol-containing medicinal product, according to its patient information leaflet, excludes oral ingestion, save for medicines with the International Nonproprietary Name (INN) "ethanol" at the manufacturing stage across all liquid dosage forms and strengths.
Authorities will exclude medicines from the registry if they fail to meet the aforementioned criteria or if the State Register revokes their marketing authorization.
Although approved, the government has not yet officially published this document. The Government Decree will enter into force seven days following its official publication.
1.7. The Government Approved Amendments to the Licensing Regulations for Pharmaceutical Manufacturing Regarding Alcohol-Containing Medicines.
Decree of the Government of the Russian Federation No. 217 dated February 28, 2019, “On Amending the Regulation on Licensing the Manufacture of Medicines”
Applicants seeking a license to manufacture alcohol-containing medicines must comply with supplemental regulatory mandates, including:
• equipping storage tanks for receiving ethyl alcohol (ethanol) with automated measurement and accounting tools that track the concentration and volume of anhydrous alcohol, as well as total volume, in compliance with equipment configuration mapping approved by the Federal Service for Alcohol Market Regulation;
• equipping manufacturing infrastructure with technical tracking devices that record and transmit data regarding the production and turnover volume of ethyl alcohol and alcohol-containing products directly into the Unified State Automated Information System (EGAIS).
2. Draft Regulations and Legislative Initiatives
2.1. The Ministry of Health Proposed a Registry of Federal Budget-Funded Diagnostic Tools for HIV and Hepatitis B/C Monitoring.
Draft Order of the Ministry of Health of Russia “On Approval of the Registry of Diagnostic Tools Procured via Federal Budget Subsidies for the Detection and Treatment Monitoring of Individuals Infected with Human Immunodeficiency Viruses, Including Co-Infections with Hepatitis B and/or C, Across Subjects of the Russian Federation”
The proposed registry includes rapid, equipment-free enzyme immunoassay or chromatographic test kits designed to detect HIV-1/HIV-2 antibodies and the HIV-1 p24 antigen in human biological samples, along with standardized serum panels (both positive and negative for HIV-1/HIV-2 antibodies/antigens) for incoming quality control.
2.2. The Ministry of Health Proposed a Federal Subsidy Registry for Multi-Drug Resistant Tuberculosis (MDR-TB) Diagnostics.
Draft Order of the Ministry of Health of Russia “On Approval of the Registry of Diagnostic Tools Procured via Federal Budget Subsidies for the Detection, Drug Susceptibility Testing of Mycobacterium Tuberculosis, and Treatment Monitoring of Patients with Multi-Drug Resistant Tuberculosis Across Subjects of the Russian Federation”
The registry encompasses reagents used for the extraction and polymerase chain reaction (PCR) amplification of Mycobacterium tuberculosis complex DNA from human biological samples and cultures to identify gene mutations associated with resistance to second-line antituberculosis drugs.
2.3. The Ministry of Health Outlined Plans to Repeal the Tracking and Monitoring Procedure for High-Cost Orphan and Oncology Drugs.
Draft Order of the Ministry of Health of Russia “On Repealing Order of the Ministry of Health of the Russian Federation No. 983n dated December 21, 2016 'On Approving the Procedure for Monitoring the Distribution and Accounting within Subjects of the Russian Federation of Medicines Intended for the Supply of Individuals with Hemophilia, Cystic Fibrosis, Pituitary Dwarfism, Gaucher Disease, Malignant Neoplasms of Lymphoid, Hematopoietic and Related Tissues, Multiple Sclerosis, and Post-Organ or Tissue Transplant Recipients...'”
The Ministry justified this initiative by pointing to the expiration of Government Decree No. 1155 dated December 26, 2011, effective January 1, 2019, under which the original monitoring order had been promulgated.
2.4. The Ministry of Health Proposed Revisions to the Procedure for Calculating the Initial Maximum Contract Price (IMCP) for Pharmaceutical Procurement.
Draft Order of the Ministry of Health of Russia “On Amending the Procedure for Determining the Initial Maximum Contract Price (IMCP) and the Price of a Contract Concluded with a Single Supplier (Contractor, Performer) for Public Procurements of Medicinal Products for Human Use, Approved by Order of the Ministry of Health of the Russian Federation No. 871n dated October 26, 2017”
The draft regulation mandates that public procurers utilize reference pricing models provided the relevant benchmark data is published in the Unified Information System (EIS). This aligns with the planned 2019 transition to calculated reference prices for interchangeable human medicines.
2.5. The Ministry of Industry and Trade Proposed GMP Compliance Certificates for Active Pharmaceutical Ingredients (APIs) Destined for Export.
Draft Federal Law “On Amending Article 5 of the Federal Law ‘On the Circulation of Medicines’”
The bill establishes a legal framework enabling competent authorities to issue Good Manufacturing Practice (GMP) compliance certificates for active pharmaceutical ingredients (APIs) upon the request of importing countries. This initiative aims to streamline export-import operations and align domestic legal frameworks with EAEU law.
2.6. The Ministry of Health Proposed Enhanced IP Protection Requirements for Marketing Authorization Applications.
Draft Federal Law “On Amending Article 18 of the Federal Law ‘On the Circulation of Medicines’”
The bill tackles patent linkage and IP infringement during the state registration process. It requires applicants to disclose information regarding valid patent rights for inventions or registered trademarks associated with the medicinal product.
Upon enactment, applicants must submit a formal written declaration certifying that the marketing authorization does not infringe upon third-party intellectual property rights, supported by copies of relevant patents and trademark certificates.
2.7. The Ministry of Health Proposed the 2019 Monthly Financial Allowance Standard for Social Welfare Drug Coverage.
Draft Decree of the Government of the Russian Federation “On Establishing the 2019 Monthly Financial Allowance Standard per Citizen Entitled to State Social Assistance in the Form of Prescription Medicines, Medical Devices, and Specialized Therapeutic Nutrition for Disabled Children”
This draft Government Decree fixes the monthly financial baseline for subsidized medical care and therapeutic nutrition at 861.8 rubles per eligible beneficiary for 2019.
3. Judicial Precedents and Enforcement Landscape
3.1. The Intellectual Property Rights Court Upheld a Mandatory Injunction Requiring a Patent Infringer to Revoke its Generic Marketing Authorization for Gefitinib.
Ruling of the Intellectual Property Rights Court dated February 28, 2019, in Case No. A40-106405/2018
The Court ruled in favor of AstraZeneca UK LIMITED, affirming the decision of the Ninth Arbitration Appeal Court. The ruling orders Jodas Expoim LLC to petition the Ministry of Health to cancel its marketing authorization for the generic drug Gefitinib and remove its maximum manufacturer selling price from the Essential Drugs List (EDL) registry. Furthermore, the injunction bars the corporate entity from undertaking any actions to register generic Gefitinib or its pricing structures in the Russian Federation until the underlying patent expires.
This landmark case reshapes the enforcement landscape for innovative pharmaceutical companies. Previously, courts routinely issued unfavorable rulings to patent holders, holding that registering a generic before patent expiration merely constituted legitimate preparatory work to enter the commercial market post-expiration.
