22 June 2022

Healthcare Professionals in Russia: Legal Status and Liability

June 22, 2022

The state guarantees citizens the availability and quality of medical care. This principle is achieved largely through the availability of a sufficient number of healthcare professional (specialists, HCP) and their qualifications. This article examines who qualifies as a healthcare specialist, the rights granted to them, and the obligations and restrictions imposed upon them.

Healthcare Professionals (Specialists): Who Are They?

Current legislation does not contain a specific definition of "healthcare specialists." However, Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law on Health Protection") identifies several categories of specialists whose activities relate to the protection of public health. These include medical workers, pharmaceutical workers, and other employees permitted by law to carry out medical activities.

We shall consider each of these categories in more detail.

Pharmaceutical Workers: Definition and Educational Requirements

According to Article 2 of the Law on Health Protection, a pharmaceutical worker is "a physical person who has a pharmaceutical education, works in a pharmaceutical organization, and whose labor duties include the wholesale trade of medicinal products, their storage, transport, and (or) the retail trade of medicinal products for medical use, their manufacturing, dispensing, storage, and transport."

As seen from this definition, one of the primary requirements for a pharmaceutical worker is the possession of specialized education. Current legislation provides for two types of pharmaceutical education: higher and secondary.

Higher education may be obtained in the following four specialties:[1]

Name of Specialty	Level of Professional Education	Positions Held
Pharmacy	Specialist degree in Pharmacy	Pharmacist, pharmacist-technologist
Pharmaceutical Technology	Specialist degree in Pharmacy; Internship/Residency training in Pharmaceutical Technology	Pharmacist-technologist, head of a structural unit (department) of a pharmacy organization
Pharmaceutical Chemistry and Pharmacognosy	Specialist degree in Pharmacy; Internship/Residency training in Pharmaceutical Chemistry and Pharmacognosy	Pharmacist-analyst, head of a structural unit of a pharmacy organization
Management and Economics of Pharmacy	Specialist degree in Pharmacy; Internship/Residency training or professional retraining in Management and Economics of Pharmacy	Director (manager, head) of a pharmacy organization, deputy director, head of a structural unit of a pharmacy organization

A specialty in Pharmacy can be obtained through specialist programs, while other specialties require additional completion of an internship or residency in the chosen field.

Regarding secondary professional education, the Ministry of Health and Social Development of Russia approved the list of specialties in its Order No. 176n dated April 16, 2008.[2] Only one specialty may be obtained.[3]

Name of Specialty	Level of Professional Education	Positions Held
Pharmacy	Secondary professional education	Pharmacy technician, junior pharmacy technician, senior pharmacy technician

Medical Workers: Definition and Educational Requirements

Pursuant to Article 2 of the Law on Health Protection, a medical worker is "a person who has a medical or other education, works in a medical organization, and whose labor (job) duties include the performance of medical activity, or an individual entrepreneur directly performing medical activity."

As with pharmaceutical workers, specialized education is a core requirement. However, in this case, it may involve education other than medical education. The Nomenclature of Positions of Medical Workers identifies five categories of medical workers:[4]

Managers (chief physician, deputy, head of a structural unit, chief nurse, etc.);
Specialists with higher medical education (physicians of various specialties);
Specialists with higher non-medical education (biologist, instructor-methodologist in physical therapy, medical psychologist, forensic expert, etc.);
Specialists with secondary medical education (nurses of various designations, midwives, paramedics, X-ray laboratory technicians, etc.);
Junior medical personnel (orderlies, nurse-housekeepers, etc.).

This article does not focus on the last category, as they do not actually perform medical activities as a general rule.

The Qualification Requirements determine the list of specialties and levels of training for physicians and secondary medical personnel in a manner similar to that of pharmaceutical workers. Notably, the list of specialties for physicians and secondary medical personnel is much broader. Currently, only a few medical specialties can be obtained after completing a specialist degree (e.g., "Medical and Preventive Care," granting the right to hold the position of an epidemiologist, or "General Medicine," granting the right to hold the position of a primary care physician or emergency room physician). In the vast majority of cases, an individual must additionally complete an internship/residency and, in some instances, undergo retraining.

To obtain a specialty at the secondary education level, completing an educational institution is sufficient in some cases (e.g., for "Midwifery"). In others, additional retraining is required (e.g., to obtain a specialty in "Physical Therapy," one must have secondary professional education in "General Medicine," "Midwifery," or "Nursing" and complete professional retraining in "Physical Therapy").

Concurrent Employment for Medical Workers

Current labor legislation of the Russian Federation permits concurrent employment (holding multiple positions) for medical workers. According to Article 60.2 of the Labor Code of the Russian Federation, an employer may, with the written consent of the employee, assign additional work in a different or the same profession (position) during the established working day (shift) for additional pay. This additional work may be carried out through the combination of professions (positions). Additional work in the same profession (position) may be performed by expanding service areas or increasing the volume of work. To fulfill the duties of a temporarily absent employee without relief from the duties specified in the employment contract, an employee may be assigned additional work in either a different or the same profession (position). Thus, medical workers may work through concurrent employment. Requirements for necessary training, accreditation, and continuing professional development at least once every five years also apply to these concurrent positions.

Accreditation of Pharmaceutical and Medical Workers

Possession of a specialized education is insufficient for admission to pharmaceutical and medical activities; one must also pass accreditation. Accreditation is a procedure for determining a person's compliance with the requirements for performing medical or pharmaceutical activities.

The Accreditation Regulations govern the procedure for specialist accreditation.[5] There are several types of accreditation:

Primary (after completing higher or secondary education programs);
Primary specialized (after completing residency, master's, or professional retraining programs);
Periodic (after completing additional professional development programs, at least once every five years).

Accreditation commissions, formed by healthcare management bodies, conduct these procedures separately for specialists with higher medical and non-medical education, secondary medical education, and pharmaceutical education. Testing and assessment of practical skills are used for primary and primary specialized accreditation. To pass periodic accreditation, a specialist must submit a portfolio. This portfolio includes a report on professional activities for the reporting period and information on training (professional development of at least 144 hours or at least 74 hours of professional development with the remainder completed through continuing medical education (CME)).

Information on persons who have passed accreditation is entered into the Unified State Health Information System in the Sphere of Healthcare (EGISZ). Upon request, a specialist receives an extract from the EGISZ and (or) an accreditation certificate in paper form. Due to the threat of COVID-19, the Ministry of Health of Russia extended the validity of specialist certificates and accreditation certificates by 12 months in 2021. In 2022, it permitted working without a specialist certificate or passing accreditation until July 1, 2022.[6] After this date, accreditation once again became mandatory.

Features of Admission to Medical and Pharmaceutical Activity for Certain Categories

Specific admission features apply to the following categories:

Persons with a career break;
Persons without a completed education;
Persons who received education in foreign states.

Medical and pharmaceutical workers with a career break of five years may be admitted only after professional development or retraining and accreditation.

Article 69 of the Law on Health Protection provides several exceptions allowing persons without a completed higher medical or pharmaceutical education to perform activities. Such persons may hold positions as secondary medical or pharmaceutical personnel. Ministry of Health Order No. 419n dated June 27, 2016, details the admission procedure, positions held, and the required volume of completed training.[7]

Special admission conditions apply to persons educated in foreign states. They may work only after the recognition of their education and (or) qualifications and passing accreditation. The Russian Federation recognizes foreign education and qualifications if international mutual recognition treaties are in place or if the education was obtained at foreign educational organizations listed in Government Decree No. 28r dated January 19, 2022. In other cases, Roszdravnadzor recognizes foreign education and qualifications based on an expert evaluation.

Attestation of Medical and Pharmaceutical Workers

Attestation should not be confused with accreditation. Unlike accreditation, attestation is voluntary and serves to obtain qualification categories as an indicator of worker qualification. A qualification category allows a worker to claim a higher pay scale.

A new Procedure for the Attestation of Medical and Pharmaceutical Workers took effect in 2022.[8] Attestation occurs every five years, except when a worker seeks a higher category. In that case, attestation may occur no earlier than two years (previously three years) from the date the previous category was assigned.

Healthcare management bodies create attestation commissions. Based on the results, workers receive the Second, First, or Highest category. The category is valid throughout the Russian Federation for five years from the date the assignment act is issued.

Due to the spread of coronavirus, attestation is temporarily suspended until January 1, 2023.[9] This suspension does not apply to medical and pharmaceutical workers applying for a category for the first time or for a higher category. For other workers whose categories expire in 2022, the categories are extended by 12 months. This rule also applies to categories that were previously extended until January 1 of the current year.

Legal Status of Pharmaceutical and Medical Workers

In legal science, "legal status" refers to the set of rights, freedoms, obligations, and restrictions, as well as the liability of a legal subject. The Law on Health Protection regulates the primary rights, obligations, and restrictions imposed on pharmaceutical and medical workers.

According to Article 72 of the Law on Health Protection, pharmaceutical and medical workers have the right to:

The creation of appropriate conditions for the performance of labor duties, including the provision of necessary equipment;
Professional training, retraining, and professional development at the employer's expense, including retraining if unable to perform duties due to health reasons or upon dismissal due to staff reduction or organization liquidation;
Passing attestation to obtain a qualification category and differentiated pay based on attestation results;
Labor incentives based on qualification level, the specific nature and complexity of the work, and the volume, quality, and specific results of activities;
The creation of professional non-profit organizations;
Insurance for professional liability risks.

These rights are formulated generally and primarily concern the labor activities of workers.

Regarding professional liability risk insurance, despite the declared right, a law on mandatory professional liability insurance has not yet been adopted. The Russian Government established a list of medical workers subject to mandatory insurance.[10] However, this was developed to implement a now-defunct regulation and only covers workers in the state and municipal healthcare systems. Consequently, only voluntary professional liability insurance is currently feasible.

Obligations of medical and pharmaceutical workers are specified in Article 73 of the Law on Health Protection. Medical workers must:

Provide medical care in accordance with their qualifications and job duties;
Maintain medical secrecy and adhere to the principles of ethics and deontology;
Improve professional knowledge and skills through additional professional programs;
Prescribe medicinal products in the established manner;
Inform the authorized official of the medical organization about side effects, adverse reactions, and other facts or circumstances threatening life or health at all stages of medicinal product circulation.

Due to the nature of their activities, pharmaceutical workers have a narrower range of obligations. The duties to provide medical care and prescribe medicine do not apply to them.

Focusing on the obligation to improve knowledge, professional development at least once every five years is a licensing requirement for both pharmaceutical and medical activities and an obligation for those admitted to perform them. Ministry of Health Order No. 66n dated August 3, 2012, regulates the procedure and timelines for professional development and retraining.

The Law on Health Protection sets forth restrictions imposed on medical and pharmaceutical workers in Article 74.

Medical workers and heads of medical organizations may not:

Accept gifts or funds from organizations holding rights to a medicinal product's trade name, wholesale organizations, or pharmacy organizations (the "Company"), including payment for entertainment, recreation, or travel, or participate in entertainment events funded by Companies (except for clinical trials and testing);
Enter into agreements with a Company to prescribe or recommend medicinal products or medical devices to patients (except for clinical trials);
Receive samples of medicinal products or medical devices from a Company to give to patients (except for clinical trials);
Provide inaccurate and (or) incomplete information about medicinal products or medical devices when prescribing treatment, including concealing information about interchangeable medicinal products or medical devices;
Receive representatives of Companies, except for clinical trials, meetings of medical workers, or events aimed at professional development or providing information related to safety monitoring;
Issue prescriptions for medicinal products or medical devices on forms containing advertising or on prescription forms where the name of the product is pre-printed.

The Law on Health Protection imposes the following prohibitions on pharmaceutical workers and heads of pharmacy organizations:

Accepting gifts or funds, including payment for entertainment, recreation, or travel, or participating in entertainment events funded by Companies;
Receiving samples of medicinal products or medical devices from a Company to give to the public;
Entering into agreements with a Company to offer specific medicinal products or medical devices to the public;
Providing inaccurate and (or) incomplete information to the public regarding the availability of medicinal products, including those with the same International Nonproprietary Name (INN), or medical devices, including concealing information on lower-priced products.

These restrictions aim to prevent corruption. Roszdravnadzor monitors compliance with these restrictions. For instance, quality and safety control checklists include verifying the absence of Company souvenirs, drug samples, or promotional forms among medical workers, and ensuring supply contracts do not mandate the recommendation of specific drugs.

Currently, the CAO RF does not contain norms establishing liability for these violations, though such drafts have been developed repeatedly.

A situation where a medical or pharmaceutical worker has a personal interest in obtaining a material benefit or other advantage that influences or could influence the proper performance of professional duties due to a contradiction between personal interest and patient interests is called a conflict of interest.

If such a conflict arises, the law mandates its resolution. The worker must inform the head of the organization in writing. Within seven days of becoming aware, the head must notify the authorized executive body (the Ministry of Health of Russia) in writing. A Conflict of Interest Resolution Commission is then formed to confirm or deny the conflict.

Failure to report a conflict of interest results in administrative liability under Article 6.29 of the CAO RF, with fines ranging from 3,000 to 5,000 rubles for workers and 5,000 to 10,000 rubles for heads. Repeated violations carry fines of 10,000 to 20,000 rubles or disqualification for up to six months.

In one case, a prosecutor's office found that a relative of a head of a forensic medical examination bureau was providing funeral services on the bureau's premises. Roszdravnadzor identified a conflict of interest and held the head liable under Part 1 of Article 6.29 of the CAO RF; the court upheld the decision.[11] Similarly, a court qualified the presence of pharmaceutical drugs not purchased by the hospital and bags with pharma logos in a department head's office as a violation.[12]

Medical workers are subject to other anti-corruption restrictions under Federal Law No. 273-FZ dated December 25, 2008, On Countering Corruption. Medical workers may be subjects of the following crimes under the Criminal Code:

Receiving a bribe, giving a bribe, mediation in bribery, or petty bribery (Articles 290–291.2). These apply only if the subject performs the functions of an official. Officials include those performing organizational, administrative, or economic functions in state or municipal institutions. Thus, only medical workers with such functions in state or municipal healthcare are subjects of these crimes.
Commercial bribery (Article 204). Subjects may include medical workers performing managerial functions in commercial or other organizations.
Abuse of office (using official powers contrary to the interests of the service for personal gain, resulting in a substantial violation of rights).

To comply with restrictions and prevent conflicts of interest, the head of an organization must take measures, such as developing local regulations. On a practical level, organizations often develop a package of documents, including:

An order on organizing work to comply with restrictions;
Regulations on interaction with Company representatives;
Regulations on the prevention, detection, and resolution of conflicts of interest;
Amendments to job descriptions.

Workers must be familiarized with this legislation under personal signature, and regular explanatory work should be conducted.

Regulation of Healthcare Specialists in the Code of Marketing Practice of the Association of International Pharmaceutical Manufacturers

According to the Code of Practice of the Association of International Pharmaceutical Manufacturers (the "AIPM Code"), healthcare specialists include physicians, other medical workers, heads of medical organizations, pharmaceutical workers, and other experts whose professional activities involve pharmaceutical products and who have the right to prescribe, recommend, receive, or apply them. This definition is broader than the Russian legal definitions of "medical worker" and "pharmaceutical worker." Consequently, the AIPM Code norms apply to all categories of healthcare specialists.

According to the AIPM Code, it is prohibited to offer or provide remuneration to healthcare specialists for prescribing or recommending a specific pharmaceutical product. Companies may, however, engage healthcare specialists (excluding pharmaceutical workers and heads of pharmacy organizations) for scientific or pedagogical services or clinical trials and pay them for these services.

Additional restrictions in the AIPM Code involve personal data protection (consent required) and events held outside a specialist's country of residence (unless justified by logistics). The Code also limits the reimbursement of expenses and requires companies to document and disclose transfers of value to healthcare specialists or organizations.

Liability of Medical and Pharmaceutical Workers

According to Article 98 of the Law on Health Protection, medical and pharmaceutical workers are liable for violations of health protection rights and for causing harm to life and (or) health during the provision of medical care.

Types of liability include:

Disciplinary;
Administrative;
Civil;
Criminal.

Civil liability (compensation for damages and moral harm) is infrequent in practice, as the employer generally compensates for the actions of employees performed in the line of duty. Other types of liability are common in law enforcement practice.

In summary, the Russian Federation has a complex system for training medical and pharmaceutical specialists, involving multi-stage education, mandatory accreditation, and regular professional development. However, frequent changes in requirements and contradictions in regulations, combined with insufficiently defined rights and obligations, create additional difficulties that do not encourage the inflow of specialists into the healthcare sector.

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References

[1] Ministry of Health Order No. 707n dated October 8, 2015, On Approval of Qualification Requirements for Medical and Pharmaceutical Workers with Higher Education in the Healthcare and Medical Sciences Field.

[2] Ministry of Health and Social Development Order No. 176n dated April 16, 2008, On the Nomenclature of Specialties for Specialists with Secondary Medical and Pharmaceutical Education in the Healthcare Sphere of the Russian Federation.

[3] Ministry of Health Order No. 83n dated February 10, 2016, On Approval of Qualification Requirements for Medical and Pharmaceutical Workers with Secondary Medical and Pharmaceutical Education.

[4] Ministry of Health Order No. 1183n dated December 20, 2012, On Approval of the Nomenclature of Positions of Medical Workers and Pharmaceutical Workers.

[5] Ministry of Health Order No. 1081n dated November 22, 2021, On Approval of the Regulations on the Accreditation of Specialists.

[6] Ministry of Health Order No. 1179n dated December 23, 2021, On Features of Admission of Physical Persons to Medical and (or) Pharmaceutical Activity without a Specialist Certificate or Passing Specialist Accreditation and (or) in Specialties Not Provided for by a Specialist Certificate or Specialist Accreditation.

[7] Ministry of Health Order No. 419n dated June 27, 2016, On Approval of the Procedure for Admission of Persons Who Have Not Completed Higher Medical or Higher Pharmaceutical Education Programs, as well as Persons with Higher Medical or Higher Pharmaceutical Education, to Medical or Pharmaceutical Activity in Positions of Secondary Medical or Secondary Pharmaceutical Personnel.

[8] Ministry of Health Order No. 1083n dated November 22, 2021, On the Procedure and Timelines for Medical and Pharmaceutical Workers to Pass Attestation for Obtaining Qualification Categories.

[9] Ministry of Health Order No. 59n dated February 7, 2022, On Features of Medical and Pharmaceutical Workers Passing Attestation for Obtaining a Qualification Category.

[10] Government Decree No. 191 dated April 3, 2006, On Approval of the List of Positions of Medical, Pharmaceutical, and Other Workers of the State and Municipal Healthcare Systems Subject to Mandatory Insurance, Whose Employment is Related to a Threat to the Life and Health of These Workers.

[11] Decision No. 12-113/2019 12-8/2020 dated February 18, 2020, in Case No. 12-113/2019.

[12] Decision No. 21-1120/2019 dated October 30, 2019, in Case No. 21-1120/2019.