Life Sciences Regulatory Digest: Key Developments in Pharmaceutical Law and Public Procurement

The Eurasian Economic Commission has established unified classification criteria to determine whether products qualify as medical devices within the Eurasian Economic Union (EAEU), with full implementation scheduled for 2019.

The Ministry of Healthcare has enacted comprehensive amendments to the official Procedure for Providing Adult Medical Care in Anesthesiology and Intensive Care.

The Ministry of Healthcare has approved updated statutory standards governing primary healthcare delivery for adults diagnosed with Human Immunodeficiency Virus (HIV).

Regulators have expanded the national admission requirements and restrictions applied to foreign-manufactured medicinal products included in the List of Vital and Essential Drugs (VED).

Proposed regulatory overhauls are set to significantly amend the Regulation on Licensing Medical Activities to align it with the updated nomenclature of medical and pharmaceutical positions, alongside modifying the supervision framework executed by territorial funds over Mandatory Medical Insurance (MMI) organizations.

The State Duma is reviewing a new draft bill that formally authorizes trained medical professionals to provide outpatient, day-hospital, and in-home palliative care.

The Supreme Court of the Russian Federation ruled that assessing fixed-amount contractual fines for minor delays in performance is legally improper when the underlying public contract lacks an express late-delivery penalty clause and limits fines exclusively to general breaches of contract terms.

1.         Statutory Acts, Regulatory Updates, and Legal Developments

1.1.     The Collegium of the Eurasian Economic Commission has enacted unified criteria defining the classification framework for medical devices within the Eurasian Economic Union.

Recommendation of the Collegium of the Eurasian Economic Commission No. 25 dated November 12, 2018

The specified Recommendation establishes that the intended use of a product constitutes the principal benchmark for its classification as a medical device. This intended medical purpose must be either exclusive or primary.

The regulatory text delineates distinct criteria to qualify commodities as medical devices across the following designated product groups:

• Perfumery, cosmetics, and personal hygiene products;

• Disinfectants and sterilization equipment;

• General-purpose industrial or commercial commodities;

• Assistive and rehabilitative products designed for individuals with disabilities;

• Sports gear and therapeutic physical culture equipment;

• Personal protective equipment (PPE);

• Standalone medical software;

• Specialized packaging and storage systems for medical and related supplies;

• Physiotherapy apparatus and consumer household appliances;

• Specialized medical furniture;

• Combination products containing medicinal substances or pharmaceuticals;

• In vitro diagnostic (IVD) reagents and equipment.

The Collegium of the Eurasian Economic Commission recommends that member states enforce these evaluation criteria effective May 16, 2019.

1.2.        The Collegium of the Eurasian Economic Commission has operationalized the formal process for compiling and maintaining the Unified Register of Eurasian Economic Union Pharmaceutical Inspectors.

Order of the Collegium of the Eurasian Economic Commission No. 175 dated November 12, 2018

Pursuant to the compliance requirements set forth in the Procedure for Accession to the Common Process "Compilation, Maintenance, and Utilization of the Unified Register of Eurasian Economic Union Pharmaceutical Inspectors" (approved by Decision of the Collegium of the Eurasian Economic Commission No. 127 dated November 25, 2016), the Commission issued this Order to implement the centralized registry framework. The document clarifies that new institutional participants must complete the standard accession protocols in strict accordance with the prescribed legal framework to integrate into the live data network.

1.3.        The Ministry of Healthcare has authorized substantive revisions to the official Procedure for Providing Adult Medical Care in Anesthesiology and Intensive Care.

Order of the Ministry of Healthcare of the Russian Federation No. 919n dated November 15, 2012 "On Approval of the Procedure for Providing Adult Medical Care in Anesthesiology and Intensive Care"

The new decree officially repeals Order of the Ministry of Healthcare and Social Development of the Russian Federation No. 315n dated April 13, 2011, "On Approval of the Procedure for Providing Anesthesiology and Intensive Care to Adults."

The updated framework mandates that healthcare organizations may administer medical care in anesthesiology and intensive care across the following distinct legal environments:

• Outside a healthcare facility (at the physical dispatch site of an emergency response medical team, or within transit vehicles during urgent medical evacuation procedures);

• On an outpatient basis (in clinical settings that do not structurally require round-the-clock medical observation and therapeutic treatment);

• Within a day hospital (in clinical units providing daytime medical observation and therapeutic care that fall short of requiring comprehensive 24-hour monitoring);

• On an inpatient basis (in dedicated hospital facilities properly equipped for continuous, 24-hour medical observation and intensive therapy).

The regulation further specifies that emergency and specialized emergency medical services within this clinical profile are available in both acute and urgent forms outside medical institutions, as well as across standard outpatient and inpatient departments.

The Ministry establishes a recommended operational time-allocation model for practicing anesthesiologists and intensive care specialists, prescribing that clinicians dedicate 70% of working hours directly to administering anesthesia and 30% to conducting pre- and post-operative patient examinations and clinical consultations across outpatient and inpatient units.

To optimize the governance and efficiency of emergency adult healthcare via real-time data exchange—specifically through remote tele-consultations and multi-disciplinary medical boards utilizing advanced telemedicine technologies—constituent entities of the Russian Federation shall establish specialized remote consultative centers for anesthesiology and intensive care.

1.4.        A new Order of the Ministry of Healthcare has taken effect, officially repealing the former decree on palliative care organization for HIV-infected patients, while concurrently introducing updated clinical primary healthcare standards for adults undergoing antiretroviral therapy.

Order of the Ministry of Healthcare of the Russian Federation No. 719 dated October 22, 2018 "On Repealing Order of the Ministry of Healthcare and Social Development of the Russian Federation No. 610 dated September 17, 2007 'On Measures to Organize Palliative Care for HIV-Infected Patients'"; Order of the Ministry of Healthcare of the Russian Federation No. 802n dated November 20, 2018 "On Approval of the Standard of Primary Healthcare for Adults with Human Immunodeficiency Virus (HIV) Infection (Third-Line Antiretroviral Therapy)"; Order of the Ministry of Healthcare of the Russian Federation No. 798n dated November 20, 2018 "On Approval of the Standard of Primary Healthcare for Adults with Human Immunodeficiency Virus (HIV) Infection (Alternative First-Line Antiretroviral Therapy)"; Order of the Ministry of Healthcare of the Russian Federation No. 799n dated November 20, 2018 "On Approval of the Standard of Primary Healthcare for Adults with Human Immunodeficiency Virus (HIV) Infection (Special Cases of First-Line Antiretroviral Therapy)"

On November 15, 2018, the Ministry of Justice of the Russian Federation officially registered the decree that invalidates the historical regulation "On Measures to Organize Palliative Care for HIV-Infected Patients."

These newly enacted standards explicitly supersede Ministry of Healthcare Order No. 1511n dated December 24, 2012, "On Approval of the Primary Healthcare Standard for Human Immunodeficiency Virus (HIV-Infection)," defining an updated, mandatory suite of diagnostic and therapeutic services alongside an exhaustive schedule of required pharmaceutical products and their strict daily dosages.

1.5.        Regulatory authorities have expanded the specific admission conditions and restrictions applied to foreign-manufactured medicinal products included in the national List of Vital and Essential Drugs (VED).

Order of the Ministry of Finance of the Russian Federation No. 126n dated June 4, 2018 "On Admission Conditions for Goods Originating from Foreign States or Groups of Foreign States for the Purpose of Procuring Goods to Meet State and Municipal Needs"

As a general rule, during public procurement tenders under Federal Law No. 44-FZ targeting VED-listed medicinal products bundled within a single state contract, the contracting authority must reject all foreign-source bids, provided that the procurement panel receives at least two compliant, competing bids that satisfy the tender notice and simultaneously meet the following criteria:

• Propose the supply of medicinal products strictly originating from Eurasian Economic Union member states;

• Contain no overlapping proposals for pharmaceuticals from the exact same manufacturer or corporate entities belonging to the same affiliate group.

The specified Order dictates that if the contracting authority rejects bids on the aforementioned grounds, it shall award the contract to the qualifying domestic bidder at their proposed price, subject to the collective satisfaction of the following compliance thresholds:

• The participant's bid conclusively demonstrates that all manufacturing stages of the medicinal product—including active pharmaceutical ingredient (API) molecular synthesis—occur within EAEU territories, with the relevant API details properly recorded in the State Register of Medicines (GRLS);

• The bidder's proposal fully conforms to all technical and legal specifications outlined in the procurement documentation;

• The participant offers a contract price that is the lowest among all non-disqualified competing bidders;

• The participant's proposed price does not exceed the lowest non-rejected bid by more than 25%.

These specialized localization preferences remain unapplied if no single participant satisfies the aforementioned strict compounding criteria.

2.           Draft Legislation and Regulatory Proposals

2.1.        Legislative proposals introduce substantive modifications to the compliance framework governing audits of health insurance companies and healthcare organizations within the Mandatory Medical Insurance system.

Draft Order of the Federal Mandatory Medical Insurance Fund "On Amending Appendices No. 1 and No. 2 to Order of the Federal Mandatory Medical Insurance Fund No. 73 dated April 16, 2012 'On Approval of Regulations Concerning the Control of Health Insurance Providers and Healthcare Organizations in Mandatory Medical Insurance by Territorial Mandatory Medical Insurance Funds'"

The draft rules delineate the scope of compliance audits executed by territorial funds regarding the volume, timelines, quality, and terms of MMI-funded healthcare services as follows:

• Adherence to strict statutory timelines for executing control checks over the volume, speed, quality, and conditions of medical care delivery;

• Verification that health insurance organizations fulfill target metrics for medical-economic controls, medical-economic expertise, and formal clinical quality reviews;

• Compliance of active medical experts and insurance auditors with the professional eligibility standards set forth by the supervisory framework;

• Accountability, data integrity, and prompt submission of official summary reports detailing audit outcomes.

Additionally, the draft provisions establish that if a medical organization operates in the MMI sector outside its home constituent entity, the territorial fund situated at the actual place of operational execution holds full jurisdiction to conduct audits.

2.2.        The Ministry of Healthcare proposes a significant restructuring of the list of medical works and services subject to mandatory state licensing.

Draft Resolution of the Government of the Russian Federation "On Amending the Regulation on Licensing Medical Activities (Excluding Activities Conducted by Private Healthcare Systems Within the Skolkovo Innovation Center)"

The draft resolution separates physical therapy from sports medicine services into distinct regulatory categories, a structural shift expected to reduce unnecessary operational overhead and compliance costs for license applicants.

The legislative text expands the specific definitions of forensic medical examination services to encompass:

• Forensic medical examinations, physical assessments of victims, defendants, or other involved parties, alongside associated case-material legal reviews;

• Post-mortem forensic examinations, autopsies, and accompanying case-file evaluations.

Concurrently, the Ministry marks a large volume of operational activities for complete exclusion from the licensable medical works list. These revisions aim primarily to align the licensing framework with modern legislation, particularly the official nomenclature of medical and pharmaceutical positions. For example, the draft eliminates standalone licensing requirements for the following services:

• Aviation and aerospace medicine, splitting the discipline into separate, functional tracks: medical evaluations for flight crews, and medical clearance alongside clinical support for astronauts;

• Diabetology, clinical mycology, laboratory mycology, general laboratory practice, genetics, intensive care, and abdominal surgery;

• Bacteriology, virology, disinfectology, narcology, and surgical nursing;

• Urgent medical care. The explanatory note clarifies that since diverse, specialized clinicians deliver these urgent services, licensing will map directly to the specific qualification of the physician or mid-level practitioner instead of a broad service label;

• General nursing practice, given that a family medicine or general practice nurse must hold a secondary professional degree in General Medicine, Midwifery, or Nursing combined with specialized general practice retraining;

• General dentistry, because the current nomenclature of positions does not recognize a general dentist role, thereby eliminating the need for separate licensing.

2.3.        Proposed Bill Seeks to Expand Palliative Care Access Across Outpatient, Day-Hospital, and In-Home Settings.

Draft Federal Law "On Amending the Federal Law 'On the Basics of Health Protection of Citizens in the Russian Federation' on Matters Concerning Palliative Medical Care"

The draft bill permits trained medical professionals to provide palliative care across flexible outpatient, in-home, day-hospital, and traditional inpatient environments. It mandates close coordination with social services providers and other supporting entities. The enactment of these statutory changes will likely accelerate delivery timelines and improve patient access to specialized palliative support.

2.4.        The Ministry of Finance proposes empowering the Ministry of Healthcare to mandate price-calculation rules for medical device public procurement.

Draft Resolution of the Government of the Russian Federation "On the Federal Executive Body Authorized to Establish the Procedure for Determining the Initial (Maximum) Contract Price and the Price of a Contract Concluded with a Sole Supplier (Contractor, Performer) for the Procurement of Medical Devices"

Pursuant to Part 22 of Article 22 of the Contract System Law, the Government of the Russian Federation holds the authority to designate specific commercial sectors where standardized initial (maximum) contract price (IMCP) calculations apply, alongside appointing the executive authorities empowered to mandate such rules.

The proposed measure formally vests the Ministry of Healthcare of the Russian Federation with exclusive authority to establish rules for calculating the IMCP, as well as the price of contracts finalized with a sole source supplier, during the public procurement of medical devices.

3.           Judicial Precedent and Enforcement Landscape

3.1.        Commercial Court remands a dispute involving the allocation of Mandatory Medical Insurance funds for reassessment.

Decree of the Commercial Court of the West Siberian District dated November 8, 2018, in Case No. A81-10941/2017

The auditing authority concluded that utilizing Mandatory Medical Insurance (MMI) funds to settle outstanding tax liabilities and statutory fees was unlawful. However, the Commercial Court of the West Siberian District reversed this finding.

In this instance, a judicial freeze on the claimant’s bank accounts combined with non-voluntary, automatic tax deductions executed by the tax authority completely stripped the healthcare organization's local branch of its ability to process standard vendor payments—specifically for medical supplies and pharmaceuticals—from its primary accounts. The healthcare organization fully complied with all terms of the applicable tariff agreement. Demonstrating complete good faith, the branch uninterruptedly maintained adult medical care delivery despite the freezing of its specialized account.

The MMI Fund failed to establish that the healthcare organization engaged in an abuse of rights; the court found the fund's assertions unpersuasive.

3.2.        The Supreme Court reviews a public procurement case regarding duplicative financial penalties for supplier timeline delays.

Ruling of the Supreme Court of the Russian Federation No. 310-ЭС18-13489 dated November 20, 2018, in Case No. A08-2558/2017

The record indicates that a contracting authority assessed a fixed fine against a healthcare provider following delivery delays. In sustaining the fine, lower courts ruled that a buyer could concurrently recover both a fixed fine and late-payment penalties (liquidated damages), positing that the supplier's conduct constituted both a milestone delay and a comprehensive breach of contract terms.

The Supreme Court, however, determined that the lower courts misapplied substantive law, citing a clear violation of Article 34 of the Contract System Law and Section 6.7 of the underlying public contract. The Court clarified that where a party merely delays performance, the assessment of a fixed breach-of-contract fine is statutorily precluded. Furthermore, the delay spanned a negligible two days, whereas the assessed fine equaled 10% of the entire contract value.

3.3.        The Omsk Administration of the Federal Antitrust Service rules in favor of a bidder following improper auction disqualification over medical device registration certificates.

Decision of the Omsk Administration of the Federal Antitrust Service (UFAS) No. 03-08/93-2018 dated November 6, 2018

The evidentiary review revealed that a complex numbering system for registration certificates, combined with clerical variations in medical device titles between the initial bid components and the official certificates, misled the evaluation committee. Consequently, during the secondary review phase of the electronic auction, the committee erroneously disqualified bid number 226, claiming in the official protocol that the bidder failed to attach copies of the mandatory medical device registration certificates for line items 43, 44, 47, 48, 52, 53, 57, 58, 61–65, 69, 70, and 72–75.

Upon evaluating the detailed data in the initial filing alongside the physical copies of the medical device registration certificates supplied in the secondary submission, the regional UFAS concluded that the bidder's full packet strictly conformed to the requirements delineated in the auction documentation.

Corporate counsel should note that enforcement trends remain highly fact-specific; bid compliance evaluations require a case-by-case analysis. This underscores the paramount importance of meticulously preparing procurement applications, ensuring total elimination of structural ambiguities, contradictions, or clerical discrepancies.

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