Medical Care Standards and Clinical Guidelines in Russia

Anna Ivanova, Attorney at BRACE Law Firm

June 1, 2022

According to Article 2 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ" or the "Law on Health Protection"), clinical guidelines are "documents containing evidence-based structured information on the prevention, diagnosis, treatment, and rehabilitation, including patient management protocols (treatment protocols), medical intervention options, and a description of the sequence of actions of a medical professional, taking into account the course of the disease, the presence of complications and comorbidities, and other factors affecting the results of medical care."

Medical care standards are technological maps developed based on clinical guidelines. They represent a list of services, medicines, medical devices, and other treatment components that may be used for a specific disease. Physicians do not use these standards directly; instead, they are intended for planning and economic calculations when providing free medical care to citizens.[1]

The Law does not directly regulate the relationship between clinical guidelines and medical care standards at the legislative level. This article attempts to clarify this issue.

Pursuant to Article 10 of the Law on Health Protection, the application of medical care delivery procedures, clinical guidelines, and medical care standards ensures the accessibility and quality of medical care. This regulatory act does not define medical care standards. In practice, standards represent averaged indicators of the frequency of provision and rate of application of:

• medical services;
• medicinal products;
• medical devices implanted into the human body;
• blood components;
• types of therapeutic nutrition, including specialized products.[2]

Currently, various medical standards approved by orders of the Ministry of Health of Russia exist, including:

• palliative medical care standards;
• primary healthcare standards;
• emergency medical care standards.

The Ministry of Health of Russia also approves clinical guidelines for various diseases.

According to Article 37 of the Law on Health Protection, medical care standards are developed based on clinical guidelines.

At the same time, the prescription and use of medicinal products, medical devices, and specialized therapeutic nutrition products not included in the relevant medical care standard or not provided for by the relevant clinical guideline are permitted by a decision of a medical commission in cases of medical necessity (individual intolerance or life-saving indications).

To ensure the uniform application of medical care delivery procedures, clinical guidelines, and medical care standards, the authorized federal executive body may issue relevant clarifications as needed.

Under Article 80 of Law No. 323-FZ, when providing medical care within the framework of the state guarantee program for the free provision of medical care to citizens and territorial programs, certain items are not subject to payment from the personal funds of citizens. These include medical services, prescriptions, and the use of medicinal products included in the VED List, medical devices included in the list of medical devices implanted into the human body, blood components, and therapeutic nutrition (including specialized products) based on clinical guidelines and taking into account medical care standards.

In its Letter No. 3175/25-2 dated December 17, 2019, the Ministry of Health of Russia indicated that when analyzing medicinal products to establish dosage equivalence, customers should use information from the instructions for medical use of the drugs, clinical guidelines, and medical care standards.¹

Thus, clinical guidelines form the basis of medical care standards and are mandatory for the organization of free treatment, while standards are taken into account when providing such care. Furthermore, both document²s are used to establish the equivalence of medicines purchased within the framework of state and municipal procurement.

In June 2019, the Ministry of Health of Russia issued Order No. 472n, which amended the Procedure for Developing Medical Care Standards (approved by Order No. 53n dated February 8, 2018), confirming that standards must be developed based on clinical guidelines.

Medical organizations are transitioning to providing medical care based on clinical guidelines in stages, as established by the Government of the Russian Federation, but no later than January 1, 2024. A medical care standard based on relevant clinical guidelines must be developed within six months after the guidelines are posted on the official website of the Ministry of Health of Russia.

The rules for the phased transition of medical organizations to providing medical care based on clinical guidelines were approved by Government Decree No. 1968 dated November 17, 2021. According to this document:

• Clinical guidelines posted on the Ministry of Health official website before September 1, 2021, apply from January 1, 2022.
• Clinical guidelines posted before June 1, 2022, apply from January 1, 2023.
• Clinical guidelines posted after June 1, 2022, apply from January 1, 2024.

Additionally, the Ministry of Health provided clarifications on its official website regarding the difference between medical care standards and clinical guidelines. Clinical guidelines are documents that establish the algorithm for patient management, diagnosis, and treatment, and contain the logical structure of a physician's actions. These guidelines are mandatory for the physician.

Importantly, the current legislation now includes legal norms confirming these clarifications.

Federal Law No. 482-FZ dated December 30, 2021, On Amending the Federal Law On the Fundamentals of Health Protection of Citizens in the Russian Federation, stipulates that when providing medical care to a minor, the attending physician must inform the minor (if aged 15 or older, or 16 or older for drug addiction patients) or their parent/legal representative about the medicinal product being used. This includes products used according to indications not specified in the instructions (off-label), their safety, expected efficacy, the degree of risk to the patient, and the patient's actions in case of unforeseen effects. It is permitted to include registered medicinal products used off-label in medical care standards for children and in clinical guidelines, provided such products meet the requirements established by the Russian Government.

Thus, this federal law effectively regulates the critical issue of off-label drug prescriptions, which was previously governed only by the general legal norms of the Law on Health Protection.

However, not all legal acts have been brought into line with the latest clarifications regarding the primacy of clinical guidelines. For example, according to Clause 4 of Government Decree No. 1416 dated November 26, 2018, On the Procedure for Organizing the Provision of Medicinal Products to Persons with Hemophilia, Cystic Fibrosis... [and other High-Cost Nosologies]: "The Federal Center organizes the provision of medicinal products to patients at the expense of federal budget funds, taking into account medical care standards, clinical guidelines (treatment protocols), and the average course dose of medicinal products." We anticipate that corresponding changes will eventually be made to previously adopted legal acts.

The rules for providing medical care to children with severe life-threatening or chronic diseases (including rare/orphan diseases) through the Circle of Kindness Foundation (the "Foundation"), approved by Government Decree No. 769 dated May 21, 2021, establish a specific procedure. Proposals to include medicinal products in procurement lists must be sent to the Center for Expertise and Quality Control of Medical Care of the Ministry of Health for a comprehensive assessment. The expert opinion must include an assessment of the economic and social consequences of including the medicinal product or medical device in medical care standards and clinical guidelines. Thus, this document does not explicitly prioritize clinical guidelines over medical care standards.

Notably, judicial practice regarding the application of clinical guidelines and medical care standards is not yet extensive. However, courts do consider compliance with clinical guidelines when hearing cases regarding compensation for poor-quality medical care.[3]

In one case, the Supreme Court of the Russian Federation ruled in favor of a patient, citing medical care standards: "According to the Standard for Specialized Medical Care for Degenerative Diseases of the Spine and Spinal Cord, diagnostic medical measures include examinations and consultations by the following specialists: anesthesiologist-resuscitator, neurologist, neurosurgeon, therapist, and urologist. Criteria for assessing the quality of medical care, according to Part 2 of Article 64 of the Law on Health Protection, are formed for groups of diseases or conditions based on the relevant medical care delivery procedures, medical care standards, and clinical guidelines (treatment protocols). Medical organizations and medical and pharmaceutical workers are liable under the legislation of the Russian Federation for violations of rights in the sphere of health protection and for causing harm to life and (or) health during the provision of medical care."[4]

This article has reviewed the fundamental issues related to the application of clinical guidelines and medical care standards. These documents directly affect numerous aspects of patient treatment, from diagnosis to the prescription and procurement of medicinal products. According to recent clarifications, clinical guidelines serve as the foundation for medical care standards and are mandatory for physicians when treating patients.

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References

[1] Ministry of Health of Russia: Standards should not be confused with clinical guidelines. Website of the Ministry of Health of the Russian Federation. September 5, 2017.

[2] Legislative support of state policy in the field of dietary therapeutic and dietary preventive nutrition. Practical work tools. Potemkina I.V. Expert of the National Association of Clinical Nutrition. Ministry of Health of the Republic of Crimea. 2016.

[3] Determination of the Civil Chamber of the Supreme Court of the Russian Federation dated June 24, 2019, No. 74-KG19-5.

[4] Determination of the Civil Chamber of the Supreme Court of the Russian Federation dated October 14, 2019, No. 80-KG19-13.