25 December 2022

Therapeutic Nutrition: Legal Regulation in Russia

December 25, 2022

BRACE Law Firm ©

Currently, therapeutic nutrition is an integral part of the treatment process and preventive measures. It can be both a complementary method, for example, in infectious diseases or in the postoperative period, contributing to increasing the body's defenses and restoring organs and tissues, and one of the main methods of treatment, as, for example, in diseases of the digestive system or diabetes.

The main regulatory documents regulating the requirements for the organization of therapeutic nutrition are:

Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Protection of the Health of Citizens in the Russian Federation (the "Law on Protection of Health of Citizens");
Order of the Ministry of Health of Russia No. 1008n dated September 23, 2020, On approval of the procedure for providing patients with therapeutic nutrition (the "Order of the Ministry of Health of the RF No. 1008n");
Order of the Ministry of Health of Russia No. 330 dated August 5, 2003, On measures to improve therapeutic nutrition in medical and preventive institutions of the Russian Federation (the "Order of the Ministry of Health of the RF No. 330").

In this article, we will consider what is understood by therapeutic nutrition, what its principles are, and what requirements are imposed on the organization of therapeutic nutrition.

What is Therapeutic Nutrition?

According to Part 1 of Article 39 of the Law on Protection of Health of Citizens, therapeutic nutrition is understood as nutrition ensuring the satisfaction of the physiological needs of the human body in nutrients and energy, taking into account the mechanisms of disease development, the peculiarities of the course of the underlying and concomitant diseases, and fulfilling prophylactic and therapeutic tasks.

In other words, therapeutic nutrition represents a food ration consisting of specific food products that have an established chemical composition and energy value, and contributes to the fastest recovery of the patient.

The main principles of the therapeutic nutrition ration are formulated in the Order of the Ministry of Health of the RF No. 1008n:

correction of body functions disturbed or lost as a result of the disease;
correspondence of energy value to the patient's energy expenditure, taking into account gender and age characteristics and the level of physical activity;
correspondence of the chemical composition to the physiological needs of a person in proteins, fats, carbohydrates, vitamins, mineral substances, and microelements;
provision of a varied dietary regime;
correspondence of culinary and technological processing of food products to the rapid assimilation of nutrients and the preservation of the nutritional value of products.

Products of Therapeutic Nutrition

Therapeutic nutrition uses both traditional food products (food products of animal, plant, microbiological, or mineral origin produced from food raw materials) and specialized products of therapeutic nutrition (composite mixtures, enteral nutrition products, dietary therapeutic nutrition food products obtained by modification of traditional products, etc.).

Let us dwell in more detail on specialized products of therapeutic nutrition. In accordance with Part 3 of Article 39 of the Law on Protection of Health of Citizens, specialized products of therapeutic nutrition are food products with established chemical composition, energy value, and physical properties, with a proven therapeutic effect, which have a specific impact on the restoration of body functions disturbed or lost as a result of a disease, the prevention of these disorders, as well as on increasing the adaptive capabilities of the body.

Specialized food products are used to replace ordinary products prohibited for consumption due to medical indications. For example, in case of disorders of the act of chewing and swallowing, in the postoperative period, for the nutrition of patients with hereditary metabolic disorders. They can be produced in various forms: ready-to-eat mixtures, gels, solutions, dry mixtures, etc.

The fundamental document regulating their turnover is the Technical Regulation of the Customs Union On Safety of Certain Types of Specialized Food Products, Including Dietary Therapeutic and Dietary Preventive Nutrition (the "TechRegulation", "TR CU 027/2012") [1].

The TechRegulation provides the following definitions of specialized therapeutic nutrition products:

food products of enteral nutrition – liquid or dry (reconstituted to ready-to-eat) food products intended for oral consumption directly or administration through a probe when it is impossible to provide the body with nutrients and energy in the usual way;
food products of diabetic nutrition – food products in which there are no or reduced content of easily digestible carbohydrates (monosaccharides – glucose, fructose, galactose, and disaccharides – sucrose, lactose) relative to their content in similar food products and (or) the carbohydrate composition is changed;
low-lactose (lactose-free) food products – food products produced on the basis of cow's milk or milk of other productive animals and (or) milk processing products, in which the lactose content is reduced compared to similar food products;
food products without or with low content of individual amino acids – food products obtained on the basis of protein hydrolysates freed (or with low content) from individual amino acids and (or) from a mixture of amino acids without phenylalanine, and (or) using components with a reduced content of phenylalanine.

Only products complying with the requirements of this TechRegulation are allowed for circulation on the market (Article 5 of TR CU 027/2012).

Safety requirements for specialized therapeutic nutrition products are established in Chapter 6 of TR CU 027/2012:

it must satisfy the physiological needs of the human body in necessary nutrients and energy, taking into account risk factors and the pathogenesis of diseases;
comply with established hygienic requirements for the permissible content of contaminants and biologically active substances and compounds, microorganisms, and other biological organisms;
it is not allowed to use poultry meat for its production, except for chilled poultry meat, mechanically deboned poultry meat, and collagen-containing raw materials from poultry meat, as well as the use of raw materials containing GMOs and (or) components;
the nutritional value of certain types of products must comply with the requirements set forth in Annex 3 to the TechRegulation;
the composition of salt substitutes must correspond to those set forth in Annex 2 to the TechRegulation;
requirements for the level of gluten for gluten-free or low-gluten food products must be observed.

TR CU 027/2012 also imposes specific requirements for the packaging and labeling of specialized food products:

labeling must contain information on the purpose of the product, the category of persons for whom it is intended, and (or) information on the change in the composition of such products, recommendations for their use;
instructions for storing food products after opening the package must be given in the labeling. If the product cannot be stored after opening the package or cannot be stored in the package, a corresponding warning must be contained;
labeling of products with low sodium content must contain an indication of the presence of salt substitutes (if any); when adding a salt substitute consisting entirely or partially of potassium salts – the total potassium content per 100 grams of the product;
products must be packaged and packed in a way that ensures their safety and the consumer properties declared in the labeling throughout the shelf life;
perishable food products must be released only in packaged form in small-piece packaging for single consumption.

Conformity assessment of therapeutic nutrition to the requirements of the TechRegulation is carried out in the form of state registration (Article 10 of TR CU 027/2012). It is carried out by the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor). For the state registration of therapeutic nutrition, the applicant provides documents confirming the declared therapeutic properties of the products.

Information on therapeutic food products that have passed state registration is entered into the Unified Register of Specialized Food Products. Registration can be checked on the website of the Eurasian Economic Commission. State registration is indefinite; it is terminated or suspended in cases of non-compliance with the requirements of the TechRegulation based on the results of state control or a decision of judicial bodies.

In case of detection of products in circulation that have not passed state registration, administrative liability is involved under Article 14.43 of the Code of Administrative Offenses of the RF "Violation by the manufacturer, executor (person performing the functions of a foreign manufacturer), seller of the requirements of technical regulations". The maximum penalty for an official is 40,000 rubles, for an individual entrepreneur – 50,000 rubles or administrative suspension of activity for a period of up to 90 days with confiscation of the subjects of the administrative offense; for legal entities – 1,000,000 rubles or administrative suspension of activity for a period of up to 90 days with confiscation of the subjects of the administrative offense. Let's consider an example from judicial practice.

As an example, we can cite a case in which the territorial administration of Rospotrebnadzor, during a planned inspection of the Company's activities, discovered specialized products for dietetic nutrition that had not passed mandatory state registration. A protocol on an administrative offense under Part 2 of Article 14.43 of the Code of Administrative Offenses of the RF was drawn up. The court established the fact of non-compliance with the requirements of the TechRegulation, expressed in storage for the purpose of further sale of specialized food products that had not passed state registration. These violations create a threat of harm to the life and health of citizens. The Company was held administratively liable, and a penalty was imposed in the form of an administrative fine in the amount of 300,000 rubles with confiscation of the products [2].

Despite the fact that specialized products of therapeutic nutrition are used in the provision of medical care and in some cases, such as enteral nutrition, are administered to the patient by doctors, they are not medicinal products (drugs). Key differences:

the quality of specialized therapeutic nutrition products must comply with TR CU 027/2012, while the requirements for the quality of medicinal products are established in the State Pharmacopoeia;
registration of specialized therapeutic nutrition products is carried out by the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor), medicinal products – by the Ministry of Health of the RF;
the turnover of specialized therapeutic nutrition products (production, trade, storage, transportation, etc.) is not subject to licensing.

Procedure for Providing Therapeutic Nutrition to Inpatient Patients

Article 19 of the Law on Protection of Health of Citizens guarantees the right to receive therapeutic nutrition for patients undergoing inpatient treatment. When providing medical care within the framework of the Program of State Guarantees of Free Provision of Medical Care to Citizens, therapeutic nutrition products are not subject to payment at the expense of citizens (Part 3 of Article 80 of the Law on Protection of Health of Citizens).

The procedure for providing therapeutic nutrition is regulated in detail in the Order of the Ministry of Health of the RF No. 1008n and the Order of the Ministry of Health of the RF No. 330. Let's consider their main provisions in more detail.

Therapeutic nutrition is prescribed to patients upon admission to a medical organization by the attending or on-duty doctor of the medical organization no later than 4 hours from the moment of the patient's admission to the hospital in accordance with the nosological form of diseases according to the main and (or) concomitant diagnosis. If the diagnosis changes, requiring a change in therapeutic nutrition, it is adjusted no later than 48 hours from the moment of the diagnosis change. Upon discharge of the patient from the medical organization, the attending doctor gives recommendations on therapeutic nutrition in the discharge epicrisis.

Nutrition of adult patients is organized in accordance with the nomenclature of standard diets given in Annex No. 2 to the Order of the Ministry of Health of the RF No. 1008n, depending on the disease. Approved diets can be individualized by selecting dishes available in the card file of therapeutic nutrition, increasing or decreasing the amount of buffet products (bread, sugar, butter) or excluding products not recommended for these diseases, as well as by using specialized food products and products for enteral nutrition.

Nutrition of children, pregnant and lactating women is organized in accordance with the nomenclature of standard diets for organizing nutrition for children over 1 year old, given in Annex No. 3 to the Order of the Ministry of Health of the RF No. 1008n. In baby food, smoked meats, hot spices, seasonings (vinegar, horseradish, mustard, ketchup, mayonnaise), radish, garden radish, marinades, nuts, mushrooms, carbonated drinks, coffee, caviar, pates, curd mass, cakes, sweets, sausages are not used.

Order of the Ministry of Health of the RF No. 330, along with the main standard diet, establishes special diet options: surgical diets, high-protein diet, unloading diets, special rations (potassium, magnesium, probe diets, diets for myocardial infarction, rations for unloading-dietary therapy, vegetarian diet, etc.). It also regulates:

the ratio of natural food products and specialized food products in the patient's daily ration;
average daily sets of products for health resort institutions of various profiles;
interchangeability of products in the preparation of dietary dishes;
interchangeability of proteins and carbohydrates (Tables 1-7 to Annex No. 4 to the Order of the Ministry of Health of the RF No. 330).

Also, the Order of the Ministry of Health of the RF No. 330 regulates indications and contraindications for the use of enteral nutrition, as well as criteria for selecting mixtures depending on the disease. The organization of enteral nutrition is carried out by anesthesiologists-resuscitators, gastroenterologists, therapists, surgeons, phthisiatricians who have undergone special training in enteral nutrition.

The nomenclature of permanent diets in each medical institution is established in accordance with its profile and approved by the Council on Therapeutic Nutrition. In all medical organizations, at least a four-time meal regime is established; according to indications – for certain categories of patients (duodenal ulcer, operated stomach disease, diabetes mellitus, etc.), more frequent meals are used.

Provision of therapeutic nutrition is carried out in accordance with the norms. Norms of therapeutic nutrition were approved by the Order of the Ministry of Health of Russia dated June 21, 2013 No. 395n "On approval of norms of therapeutic nutrition". It regulates the quantity of various types of products in grams per person per day separately depending on various types of diets: standard, sparing, high-protein, low-protein, low-calorie, high-calorie.

For violation of the principles and norms of therapeutic nutrition, medical organizations are held administratively liable under Part 1 of Article 6.3 of the Code of Administrative Offenses of the RF for violation of legislation in the field of ensuring the sanitary and epidemiological well-being of the population. The fine for officials is from 500 to 1000 rubles; for legal entities – from 10,000 to 20,000 rubles or administrative suspension of activity for a period of up to 90 days.

Let's consider an example from judicial practice. During a planned inspection carried out by Rospotrebnadzor in the central district hospital, violations in the organization of therapeutic nutrition for patients were revealed: a summer version of the consolidated seven-day menu was not developed, individualization of the chemical composition and caloric content of standard diets through the use of biologically active food supplements and ready-made specialized mixtures was not carried out, vitamin-mineral complexes were not included in the therapeutic nutrition ration, nutrition norms were not observed, control of the compliance of diets received by patients (in terms of the set of products and dishes, cooking technology, chemical composition, and energy value) was not carried out. The supervisory authority issued a resolution on holding the medical organization administratively liable provided for by Part 1 of Article 6.3 of the Code of Administrative Offenses of the RF with the imposition of a fine in the amount of 10,000 rubles. The hospital's attempt to challenge the resolution in court was unsuccessful. The courts indicated that according to SanPiN 2.1.3.2630-10 "Sanitary and epidemiological requirements for organizations carrying out medical activities" [3], when compiling menu layouts, the main principles of therapeutic nutrition and nutrition norms per patient must be taken into account. Thus, non-compliance with the requirements of the orders of the Ministry of Health of the RF on therapeutic nutrition is a violation of current sanitary rules, which, in turn, forms the objective side of the administrative offense provided for by Article 6.3 of the Code of Administrative Offenses of the RF. The reference to the absence in the actions of the medical organization of a threat of harm to the life and health of people, the emergence and spread of infectious diseases, in the opinion of the court, did not affect the qualification of the committed offense [4].

The person responsible for the organization of therapeutic nutrition in a medical organization is a dietitian doctor, and in his absence – a dietary nurse. In addition, a Council on Therapeutic Nutrition is created in the organization, which hears and resolves issues related to the organization of therapeutic nutrition at least once a quarter. Control of ready meals before issuing them to the departments is carried out by the doctor on duty and once a month – by the chief physician or his deputy, as well as regularly – by the dietitian doctor, dietary nurse, and production manager.

Often, medical and health resort organizations outsource activities for the organization of therapeutic nutrition to specialized companies. It should be noted that the transfer of such works to outsourcing does not exempt the organization from liability for violations of requirements for the organization of therapeutic nutrition. Thus, in one of the cases, the Rospotrebnadzor Administration found a boarding house guilty of committing an administrative offense provided for by Article 6.6 of the Code of Administrative Offenses of the RF "Violation of sanitary and epidemiological requirements for the organization of public catering" and imposed a fine in the amount of 30,000 rubles. The argument that the boarding house concluded an outsourcing agreement for catering and is not a subject of an administrative offense was rejected by the court. By virtue of the Order of the Ministry of Health of the RF No. 330, the organization of therapeutic nutrition is an integral part of the treatment process and is included in the number of main therapeutic measures. The presence of the above agreement does not exempt the boarding house from compliance with legislation in the field of sanitary and epidemiological well-being of the population, since it provides medical services [5].

Provision of Therapeutic Nutrition to Outpatient Patients

By virtue of Article 29 of the Law on the Fundamentals of Health Protection, provision of therapeutic nutrition at the expense of budget funds for certain categories of citizens within the framework of providing outpatient medical care is provided.

In particular, disabled children have the right to receive specialized therapeutic nutrition products as part of the set of social services provided for by Federal Law No. 178-FZ dated July 17, 1999 "On State Social Assistance". The list of specialized therapeutic nutrition products for disabled children for 2023 was approved by Order of the Government of Russia No. 3731-r dated December 5, 2022. For 2023, this list was expanded. It includes 103 items, not 94 as in 2022. The updated list includes such items as dry mixtures "Nonphenic", liquid mixture "Mavalia PKU Motion", dry powders "Nutrien Elemental", etc.

Also, Article 44 of the Law on Protection of Health of Citizens provides for the provision of specialized therapeutic nutrition to citizens suffering from rare (orphan) diseases.

It is worth noting that patients do not always receive the specialized products due to them in a timely manner and in full. There are cases when rights have to be enforced in court. Thus, in one of the cases, the prosecutor appealed to the court with a lawsuit in the interests of a minor against the Ministry of Health of the region and the Central City Hospital regarding the obligation to provide a disabled child with specialized nutrition. The court established that the child needs specialized nutrition due to weight deficiency, which is confirmed by the discharge epicrisis from the medical record and the conclusion of the Moscow Regional Consultative and Diagnostic Center. According to the submitted medical documentation, this therapy is vital for the child and cannot be replaced. The head physician of the hospital sent requests to the Ministry of Health of the region with a request to provide the disabled child with the necessary nutrition. The Ministry of Health reported that there is no possibility of using this nutrition in conditions of outpatient polyclinic care due to the fact that the instructions for the use of specialized nutrition lack the nosology "cystic fibrosis", which the child suffers from. Due to the refusal to provide, the child's mother purchased this drug at her own expense, which is confirmed by the sales receipts submitted by her. The court decided that the Ministry of Health evaded the duty assigned to it to provide the plaintiff with the necessary specialized nutrition, given his right to its free provision. References to the instructions for use were deemed unfounded. The lawsuit was satisfied in full, obliging to provide the disabled child until a medical decision on the absence of need for specialized nutrition [6].

In accordance with Article 80 of the Law on Protection of Health of Citizens, the use of therapeutic nutrition is carried out on the basis of clinical guidelines and taking into account medical care standards. In cases where specialized therapeutic nutrition products are not included in the relevant standard of medical care or are not provided for by the relevant clinical recommendation, their prescription is allowed in the presence of medical indications (individual intolerance, for vital indications) by decision of the medical commission of the medical organization (Part 15 Article 37 of the Law on Protection of Health of Citizens).

In practice, there are refusals to provide therapeutic nutrition in cases where it is not included in the list approved by the order of the Government of Russia. Thus, in one of the cases, the prosecutor appealed to the court in defense of the rights of a minor with a lawsuit against the Health Committee of the region, the open joint-stock company "Pharmacy" regarding the imposition of the obligation to provide medicines, medical devices, and therapeutic nutrition. During the consideration of the case, the Health Committee of the region explained that the refusal to provide therapeutic nutrition "Nutridrink" was caused by the fact that it is not included in the list approved by the order of the Government of Russia. At the same time, there was a conclusion of the medical commission on the need of the disabled child for the specified therapeutic nutrition for vital indications, and a prescription was issued. However, nutrition was not dispensed according to the issued prescription. The court of first instance supported the position of the Health Committee. The courts of appeal and cassation instances did not agree with the specified decision, indicating the right to receive therapeutic nutrition for vital indications by decision of the medical commission, and obliged the Health Committee of the region to provide the disabled child with therapeutic nutrition "Nutridrink" until the adoption by the medical commission of a decision on their cancellation [7].

Prescription of specialized therapeutic nutrition is produced in the same order as medicinal products dispensed for outpatient treatment free of charge at the expense of budget funds, by issuing a special preferential prescription. To write a prescription, it is necessary to contact the polyclinic institution at the place of attachment for medical service.

In conclusion, we note that therapeutic nutrition plays a significant role in the complex therapy of patients. In this regard, strict compliance with all requirements for quality, safety of products used, as well as the organization of therapeutic nutrition is important. In turn, ignoring the norms of legislation can entail adverse consequences for all participants in the turnover, ranging from the imposition of a fine to the suspension of activity and confiscation of low-quality products.

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[1] Decision of the Council of the Eurasian Economic Commission dated June 15, 2012 No. 34, On adoption of the technical regulation of the Customs Union 'On Safety of Certain Types of Specialized Food Products, Including Dietary Therapeutic and Dietary Preventive Nutrition'.

[2] Determination of the Supreme Court of the RF dated May 18, 2021 No. 304-ES21-5643.

[3] Currently, similar norms are contained in SP 2.1.3678-20, Sanitary and epidemiological requirements for the operation of premises, buildings, structures, equipment and transport, as well as the conditions of activity of economic entities selling goods, performing work or providing services.

[4] Resolution of the Supreme Court of the RF dated November 19, 2019 No. 11-AD19-30.

[5] Resolution of the Sixth Cassation Court of General Jurisdiction dated March 1, 2021 No. 16-546/2021.

[6] Determination of the Fourth Cassation Court of General Jurisdiction dated July 14, 2020 in case No. 88-9654/2020.

[7] Resolution of the Sixth Cassation Court of General Jurisdiction dated March 1, 2021 No. 16-546/2021.