3.1. GENERAL PRINCIPLES OF INTERACTION WITH HEALTHCARE PROFESSIONALS

3.1.1. Interaction between pharmaceutical companies and healthcare professionals should be designed to benefit patients and enhance the practice of medicine. The purpose of this interaction should be to provide healthcare professionals with new information about pharmaceutical products, supply them with scientific and educational data, and support scientific and clinical research.

3.1.2. Cooperation between pharmaceutical companies and healthcare professionals should not result in a conflict of interest for healthcare professionals, in particular, a conflict between their professional duties and personal interests. In particular, no such conflict should arise when a doctor prescribes a pharmaceutical product or a pharmaceutical professional recommends and sells a pharmaceutical product.

3.1.3. It is prohibited to offer, promise, provide, or transfer remuneration in any form to healthcare professionals for the prescription or recommendation of a particular pharmaceutical product to patients. It is prohibited to enter into agreements with healthcare professionals for the prescription or recommendation of any pharmaceutical product to patients (other than agreements for the clinical studies of pharmaceutical products).

3.1.4. Personal data of healthcare professionals may only be included into databases subject to their duly obtained consent and compliance with the other requirements of legislation governing protection of personal data.

3.2. PRINTED ADVERTISING MATERIALS

3.2.1. Printed advertising materials, except for those described in sub-clause 3.2.2, should contain the following minimum information:

• the name of the pharmaceutical product (normally the trade name);
• the common names of the active substances (if the product contains no more than three active substances);
• the name and address of the pharmaceutical company or the organization representing its interests in the Russian Federation;
• the date of production of the advertisement; and
• “abbreviated prescribing information” which should include approved indications for use and, if necessary, the dosage and method of administration, and a succinct statement of the contraindications, precautions, side effects, links to the instructions for medical use, contacts of the pharmaceutical company for sending a request for instructions for medical use. "Abbreviated prescribing information" can be provided by using «digital» forms of access to an expanded amount of information (for example, QR codes, links, etc.).

If, when using “digital” forms of access to an expanded amount of information (for example, QR codes, links, etc.), in addition to the “abbreviated prescribing information” or instructions for medical use, any additional information is provided, it should be balanced and fully comply with the requirements of the current legislation of the Russian Federation and this Code. 

3.2.2. «Reminder» advertising is brief advertising containing only the trade name of a pharmaceutical product and the product’s therapeutic group.

3.3. EVENTS

3.3.1. The purpose of all the events should be to inform healthcare professionals about pharmaceutical products and/or to provide them with scientific or educational information in the fields of healthcare or pharmaceutics.

3.3.2. Companies should not organize or finance events for healthcare professionals outside their country of residence and practice unless it is justified in terms of logistics or security. International scientific congresses and symposia that attract participants from many countries are therefore justified and permitted.

3.3.3. The information distributed to participants of international scientific congresses and symposia may relate to pharmaceutical products that are not registered in the country where the event takes place or are registered on different terms, provided that the following requirements are satisfied:

• the distribution of said information is permitted by the laws of the country where the event is held;
• the event should be a truly international scientific event with a significant number of healthcare professionals from other countries taking part (as speakers or attendees);
• materials related to a pharmaceutical product not registered in the country where the event takes place should be accompanied by a clear indication that the product is not registered in said country;
• materials containing information related to a pharmaceutical product’s use (indications, warnings, etc.), which has been approved in another country/countries where the product is registered, should be accompanied by a statement that conditions of registration may differ in various countries.

3.3.4. An event should be held in an appropriated place and under conditions that will facilitate achievement of its scientific and educational objectives. Places and venues that are known for their entertainment and / or activities or are extravagant should be avoided. The use of facilities that the public would associate with entertainment, luxury, or exclusivity, regardless of their class, is prohibited. It is recommended to organize events at business centers, educational institutions, hotels, and other venues intended for business and educational events. A company may hold an event in a public place only if it is held in an isolated room or the place is closed to the public for the duration of the event.

The use of any entertainment or sporting events to attract healthcare professionals to promotional or scientific events is prohibited.

3.3.5. The pharmaceutical company must explicitly ensure that the fact of the support by the pharmaceutical company of an event held by third parties is always and initially indicated and obvious.

3.3.6. It is permitted to provide stationery (pens, writing pads, and pencils) of insignificant value for the purpose of taking notes or keeping records.

3.3.7. It is permitted to serve soft drinks, tea/coffee, snacks, and/or hot dishes in a buffet style at an event, provided that the refreshments are justified by the duration of the event, are unequivocally secondary to the purpose of the event, and are only available:

• to event participants rather than to persons accompanying them; 
• within reasonable limits.

3.3.8. Pharmaceutical companies should not provide or pay for any entertainment, either within or outside the scope of an event.

3.4. ENGAGING HEALTHCARE PROFESSIONALS TO PROVIDE SERVICES

3.4.1. Pharmaceutical companies may engage healthcare professionals, other than pharmaceutical professionals and heads of pharmacy organizations, to provide scientific and pedagogic services and services in the course of performance of clinical studies of pharmaceutical products. Pharmaceutical companies may pay fees to these healthcare professionals for the provision of these services.

3.4.2. The following requirements should be observed while engaging healthcare professionals to provide services:

• there should be a written contract describing the substance of the services to be rendered and the terms of payment for these services;
• compensation for the services should be reasonable and consistent with their fair market value; there should be a reasonable need for the services;
• there should be a direct connection between the criteria used to select the healthcare professionals to render services and the purpose to be achieved when these services are rendered;
• the number of the healthcare professionals engaged to render services should correspond to the number actually needed to achieve the relevant purpose;
• the fact of involving a healthcare professional for the provision of services must be disclosed by a healthcare professional, including when providing scientific and educational information at an event;
• the existence of the services contract should not directly or indirectly oblige the healthcare professional to recommend or prescribe any pharmaceutical product.

3.4.3. Expenses incurred by a healthcare professional directly relating to the services rendered may be paid for or reimbursed, including the costs for travel to the place where the services are rendered, lodging, and meals.

3.4.4. The following requirements must be observed when paying for or reimbursing the expenses:

• the use of hotels or other facilities associated by the public with luxury or exclusivity, regardless of their class, is prohibited;
• meals should be reasonable;
• economy class plane tickets should be acquired for trips of healthcare professionals that do not exceed four daylight hours;
• reimbursement of any of the costs incurred by accompanying persons is not permitted. In exceptional cases of identified medical needs requiring accompaniment (for example, if a participating healthcare professional has a disability or injury), travel, food, accommodation and registration fees for the accompanying person may be reimbursed within the same parameters as and for the healthcare professional.

Any exceptions must be justified by an objective need and approved by the company’s management.

3.5. GIFTS PROHIBITION TO HEALTHCARE PROFESSIONALS

3.5.1. Pharmaceutical companies are prohibited, either directly or indirectly, to give or offer gifts to healthcare professionals, including cash, cash equivalents or personal work / services. For the purposes of this clause, personal works / services are understood as any services related and not related to professional activities and bringing benefit to the recipient.

3.5.2. Pharmaceutical companies are prohibited to give or offer to healthcare professionals any items promoting pharmaceutical products, except advertising materials. 

3.6. BASIC RULES AND STANDARDS OF ACTIVITIES OF MEDICAL REPRESENTATIVES

3.6.1. The purpose of medical representatives’ activities should be to improve the professional level of healthcare professionals and to perform the duty to monitor the safety of pharmaceutical products imposed on the pharmaceutical companies.

3.6.2. In order to achieve the purposes specified in sub-clause 3.6.1 of this Code, medical representatives may take part in meetings and other events organized for healthcare professionals at medical organizations in accordance with the procedure established by the relevant organization. Individual visits by medical representatives to healthcare professionals are possible if allowed by this procedure.

3.6.3. In the course of these events medical representatives may provide healthcare professionals with printed promotional materials and informational materials of “inexpensive cost” such as partial reprints of individual chapters and sections of specialized publications, scientific treatises, and reference books; research articles; reports, and other printed materials provided that these printed materials improve the professional level of the healthcare professionals. Such information may be provided on CD-ROMs and memory cards, provided that these electronic devices are not intended for personal use. Moreover, any materials, including promotional materials, should improve the professional level of healthcare professionals and should not pursue solely advertising purposes.

3.6.4. Medical representatives of pharmaceutical companies should have sufficient training and knowledge to provide healthcare professionals with full, objective, accurate, and current information about pharmaceutical products. This information should improve the professional level of healthcare professionals. A pharmaceutical company is responsible for the substance and form of any information provided to healthcare professionals by its medical representatives.

3.6.5. A medical representative should provide a healthcare professional upon request with the leaflet for each pharmaceutical product that the representative reports on, with information on the conditions under which the product is dispensed by a pharmacy (prescription product, over- the-counter product or a product provided to groups of citizens entitled to social benefits, etc.), and information on the pharmaceutical product’s availability at pharmacies.

3.6.6. Medical representatives must inform the head of the corresponding division of a company engaging him or her regarding the practical application of their company’s pharmaceutical products, including information received from healthcare professionals on adverse reactions, etc.

3.7. SAMPLES AND EDUCATIONAL ITEMS

3.7.1. Pharmaceutical companies may not provide samples of pharmaceutical products and/ or Educational Items, either for subsequent transfer to patients or for personal use, directly to healthcare professionals.

3.7.2. It is possible to demonstrate Educational Items, without their further transfer, in venues of conduct of medical or pharmaceutical exhibitions, seminars, conferences and other events intended for healthcare professionals.

3.8. EXPERT COUNCILS

3.8.1. The purpose of an expert council is to discuss and receive consultations from external experts on a predetermined scientific question which cannot be resolved by relying on the relevant company’s internal expertise and experience alone and which cannot be resolved by any other method.

3.8.2. No expert council may be used as a vehicle for the distribution of any information or for the promotion of pharmaceutical products.

3.8.3. Pharmaceutical companies may pay healthcare professionals (except for pharmaceutical professionals and heads of pharmacy organizations) serving as experts for their work on the expert council (including reimbursing expenses incurred in connection with participating in the expert council), provided that the experts’ work on the expert council is scientific in nature. The requirements of sub-clause 3.4.4 above should be observed when reimbursing expenses.

3.8.4. In all cases, the main operating principle of any expert council is the independence and impartiality of the experts.

3.8.5. An expert council may only be established where there is a reasonable scientific need for doing so and should not be intended to finance the events of professional communities.

3.8.6. The frequency of an expert council’s meetings should be reasonable.

3.8.7. The choice of experts to serve on an expert council should be based exclusively on their professional competence and qualifications and should not be connected in any way to past, current, or potential future prescriptions or recommendations of the respective company’s pharmaceutical products. The employees of commercial departments should not influence the selection of experts or the expert council’s work.

3.8.8. The number of engaged healthcare professionals should correspond to the number actually needed to achieve the specified objective.

3.8.9. The total number of a company’s employees attending an expert council meeting should not exceed one-third of the independent, outside experts participating in the meeting. Specifically, none of the employees may use their participation in the expert council’s work for the promotion of the company’s pharmaceutical products in any manner whatsoever.

3.9. RESPONSES TO REQUESTS FOR MEDICAL INFORMATION

3.9.1. A company should be attentive to each request from a healthcare professional. Each request should be registered and a response should be provided to it, regardless of how the request was received (by e-mail, regular mail, fax, or telephone).

3.9.2. The information provided to healthcare professionals in response to a request should be in full compliance with applicable local legislation, the package leaflet approved for a particular pharmaceutical product, and this Code.

3.9.3. No response to a request from a healthcare professional should serve the purpose of promoting pharmaceutical products. It should only be limited to a reply to the corresponding question.

3.9.4. Any information given about the pharmaceutical products of any other companies should be objective.

3.9.5. All responses should be provided in a polite and understandable form corresponding to the knowledge and level of training of the person making the request.

3.9.6. No employees of a pharmaceutical company may initiate any discussion of any non-registered pharmaceutical products and/or of any non-registered indications for their use with any healthcare professionals or other third persons.

3.9.7. Information about any non-registered pharmaceutical products and/or about any non- registered indications for use may be disclosed only to healthcare professionals exclusively upon  a request submitted to the pharmaceutical company.

3.9.8. The medical information service or the personnel of any other duly authorized medical / regulatory department should provide responses to all requests from healthcare professionals so as to ensure that the information is of proper quality and is objective. All telephone calls on weekends and public holidays, as well as during off-hours, are to be accepted and registered by the personnel of the call center, voicemail machine, or otherwise, with information about the queries received to be subsequently passed on to the medical / regulatory department.

3.9.9. The employees of sales and marketing departments may only answer questions received in the course of interaction with healthcare professionals within the limits of the package leaflet approved for a pharmaceutical product. The employees of sales and marketing departments should forward any questions received that go beyond the limits of the duly approved information to the medical / regulatory department for a response.

3.9.10. The response to a healthcare professional should include exhaustive and scientifically proven information on the question. All statements and facts given in written replies should be supported by appropriate references identifying the name of the author, giving the full heading of the respective article or treatise, and indicating the place of publication (customary abbreviations are permitted), the year of publication, and the volume, issue, and page numbers.

3.9.11. The personal data of healthcare professionals and other persons may be included into the databases of pharmaceutical companies only when the relevant person has given his or her consent in the form established by law and in compliance with the other applicable requirements of the legislation on personal data protection.