The Code adopted in Russian and English versions. The Russian version will be given preference in any disputes regarding the interpretation of the Code’s provisions.

If any contradictions are discovered between the provisions of this Code and the existing legislation of the Russian Federation and Eurasian Economic Union (EAEU), the existing legislation of the Russian Federation and EAEU shall apply. 

1.1. PURPOSE

The purpose of this Code is to establish the minimum requirements to be observed by the pharmaceutical companies who are AIPM members in their R&D, educational, informational, charitable, and marketing activities in the Russian Federation.

1.2. BASIC TERMS

Marketing study - a study designed to obtain information about the market and to explore the behavior and perceptions of consumers and interested parties in said market;

Medical representative - any representative of a pharmaceutical company, regardless of the title he or she holds within the company and irrespective of whether or not he or she is an employee of the company, who directly contacts healthcare professionals;

Events - all professional, promotional, scientific, educational meetings, congresses, conferences, symposia, and other similar events (including, but not limited to, expert advisory board meetings, visits to research or manufacturing facilities, and planning, training or investigator meetings for clinical trials and noninterventional studies) (each, an “Event”) organized or sponsored by or on behalf of a pharmaceutical company;

Samples of pharmaceutical products - pharmaceutical products which are gratuitously transferred to non-commercial medical organizations so that they can familiarize themselves with the use of such pharmaceutical products, and gain experience in working with them, in accordance with the approved package leaflet;

Educational items aimed at improving the quality of administration (use) of pharmaceutical products and/or raising the disease awareness (the “Educational Items”) constitute inexpensive items aimed at the education of healthcare professionals with a view to enhancing the level of medical and patient care, as well as inexpensive items of educational content which help to demonstrate the process of the disease development process to a patient. Examples of Educational items aimed at improving the quality of administration (use) of pharmaceutical products may include inhalers without active ingredient, devices which allow a patient to make himself/herself an injection, etc. Examples of Educational items aimed at raising the disease awareness may include layouts of human organs and tissues with affected area and other;

Healthcare organization (for the purposes of chapter VII of this Code) - any legal entity irrespective of the legal or organizational form, individual entrepreneur (i) that is a healthcare, medical, pharmaceutical or scientific association or organization, such as a hospital, clinic, foundation, university or other teaching institution (except for patient organizations), whose business address, location of legal entity or primary place of operation is in Russia or (ii) which provides services through one or more healthcare professionals; 

Patient organization - a non-commercial organization representing the interests and needs of patients, their families, and/or persons taking care of patients and/or disabled persons;

Patient organization representative - a person authorized to represent the interests and express the position of a patient organization on a specific issue or disease;

Transfers of value (for the purposes of chapter VII of this Code) - direct and indirect transfers of value, whether in cash, in kind or otherwise, made for the purposes allowed by the applicable legislation and by this Code in connection with the development and sale of prescription-only pharmaceutical products exclusively for human use. Direct transfers of value are those made directly by a pharmaceutical company for the benefit of a recipient. Indirect transfers of value are those made on behalf of a pharmaceutical company for the benefit of a recipient, or transfers of value made through an intermediate and where the pharmaceutical company knows or can identify the healthcare professional/healthcare organization that will benefit from the transfer of value;

Research and development transfers of value (for the purposes of chapter VII of this Code) - transfers of value to healthcare professionals or healthcare organizations related to the planning or conduct of (i) pre-clinical studies; (ii) clinical trials; or (iii) post-registration observation (non-interventional) studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, healthcare professionals specifically for the study;

Post-registration clinical (interventional) study - a study of a pharmaceutical product conducted  in the Russian Federation by its developer or manufacturer, including with the involvement of a contracted research organization, for the purpose of gathering additional data on the efficacy, safety, and tolerability of the relevant pharmaceutical product after its state registration, in the course of which the studied pharmaceutical product is prescribed according to the terms of its registration in the country, while the specific therapy, diagnostic and monitoring procedures are conducted in strict compliance with the relevant study protocol;

Post-registration observation (non-interventional) study - a post-registration study of a pharmaceutical product in the Russian Federation by its developer or manufacturer, including with the involvement of a contract research organization, during which the pharmaceutical product and/or specific therapy is prescribed for a patient as part of usual clinical practice, according to the terms of the relevant pharmaceutical product’s registration in the country in the course of which the decision to prescribe the product is separated from the decision to include the patient in the study and patients should not be subjected to any additional diagnostic or monitoring procedures beyond usual clinical practice in the treatment of the corresponding disease;

Promotion - any activity which is conducted, organized, or sponsored by or at a request of a pharmaceutical company, and which aims to facilitate the prescription, recommendation, dispensing, sale or administration of the pharmaceutical company’s pharmaceutical product;

Healthcare professionals - doctors and other medical professionals, heads of medical organizations, pharmaceutical professionals (including pharmacists), heads of pharmacy organizations, and other specialists the professional activity of which is concerned with pharmaceutical products and who in the process of their professional activity have the right to prescribe, recommend, purchase, supply, or administer pharmaceutical products;

Pharmaceutical product - any medicinal preparation, including both pharmaceutical and biological products (irrespective of the existence of a patent and/or registered trademark), which is intended to be used for the purpose of diagnosis, treatment, or prevention of a human disease; for rehabilitation; or for the maintenance, prevention, or termination of pregnancy; or exerting an effect on the structure or function of the human body;

Expert council - a group of outside experts (such as healthcare professionals and/or representatives of patient organizations) competent in the relevant field of knowledge, whose joint meeting is arranged by a pharmaceutical company so as to have a discussion and receive consultation on topics or questions determined in advance, on matters related to clinical or scientific aspects, as well as on issues related to patient access to innovative methods of therapy that cannot be properly examined by relying only on the company’s own resources;

Epidemiological study - a study of the spread, incidence, and intensity of various diseases or medical indicators of the state of health for the purposes of identifying the causes of their development, the factors of risk and their mutual interaction in different groups of the population;

1.3. SCOPE OF APPLICATION

This Code is applicable to:

• the advertising of pharmaceutical products to the general public;
• the advertising of pharmaceutical products to healthcare professionals;
• the activities of pharmaceutical companies’ representatives;
• interaction with healthcare professionals;
• interaction with patient organizations;
• post-registration clinical (interventional) studies, observational (non-interventional) studies, and epidemiological studies;
• marketing studies;
• the distribution by pharmaceutical companies, or organizations representing their interests,
• of information related to human health or diseases, and the making of donations and grants;
• support for continuous medical education;
• handling inquiries from patients and healthcare professionals;
• measures to promote pharmaceutical products to healthcare professionals;
• the sponsorship of scientific events in which healthcare professionals participate;
• the use of the Internet and other digital communication channels to promote pharmaceutical products;
• other methods to promote pharmaceutical products.

This Code is not applicable to:

• the labeling of pharmaceutical products, the package leaflet, and other information placed on a product or its packaging;
• factual and information announcements and references, e.g. regarding changes in packaging or warnings on adverse reactions, as part of general measures to monitor safety;
• setting prices and other commercial terms of supply of pharmaceutical products, including trade catalogues and price lists, provided that they do not include any specific advertising statements about a pharmaceutical product;
• pre-registration and registration clinical studies; and
• pharmaceutical companies’ relations with state and municipal bodies, state and municipal servants.