6.1. DONATIONS AND GRANTS

6.1.1. Pharmaceutical companies may make donations to non-commercial organizations for publically beneficial purposes. Such donations may be in the form of educational grants made available to support medical education and ultimately intended to raise the quality of medical care provided to patients.

6.1.2. No in-kind donations to non-commercial organizations are permitted if intended, directly or indirectly, for specific healthcare professionals or made in their interests. This is why it is not permitted to donate any items which are generally seen as being intended for individual use rather than for use by the relevant non-commercial organization.

6.1.3. The provision of a donation may under no condition be made dependent, directly or indirectly, on the prescription or purchase of the company’s pharmaceutical products.

6.1.4. It is prohibited to make donations in the form of cash.

6.1.5. Pharmaceutical products may be provided to non-commercial medical organizations as donations unless such donations pursue any commercial purposes. The donating company must inform the donation recipient of the remaining shelf lives of the pharmaceutical products.

6.1.6. Donations may only be made on the basis of an appropriate written request from a noncommercial organization and a relevant donation agreement.

6.2. SAMPLES FOR NON-COMMERCIAL MEDICAL ORGANIZATIONS

6.2.1. Pharmaceutical companies may provide samples of pharmaceutical products only to non commercial medical organizations so that they can familiarize themselves with the use of, and gain experience in working with, such pharmaceutical products in accordance with the approved package leaflet.

6.2.2. A company must inform the recipient of such samples of the remaining shelf lives of the pharmaceutical products which is planned to provide.

6.2.3. Any samples may only be provided within the first two years of the pharmaceutical product’s launch on the market of the Russian Federation. It is permitted to provide sample of pharmaceutical product only in the smallest package in compliance with the dosage regime and indications as specified in package leaflet, available at the market. The number of samples made available to a medical organization should be reasonable but should not exceed four (4) packs (samples) per medical professional of that medical organization in the corresponding medical specialization per annum.

6.2.4. Pharmaceutical companies should keep record and control the transfer of samples of  a pharmaceutical product to a medical organization. The transfer of samples to a medical organization should be documented in writing. The documents must specify that the sample products are not intended for sale.

6.2.5. Samples may under no circumstances be provided as an incentive to the recommendation, prescription, purchase, supply, sale, or administration of the respective pharmaceutical product.

6.3. EDUCATIONAL ITEMS

6.3.1. Pharmaceutical companies may provide Educational Items only to non-commercial medical organizations meeting the following requirements:

• The frequency and the total number of transferred Educational Items should be justified and reasonable;
• Transfer of Educational Items should not serve as an incentive for healthcare professionals to recommend, prescribe, purchase, dispense or administer pharmaceutical products;
• The transfer of Educational Items should be documented in writing;
• It is prohibited to provide healthcare professionals with medical supplies / items that are necessary for their daily medical practice, such as stethoscopes, gloves, blood pressure monitors, needles, etc.

6.3.2. Educational Items:

• should not be entertaining and should not have any purposes other than educational and/or demonstration purposes;
• should not contain an active ingredient and should not have possibility to be used for therapeutic use;
• should not contain trade name and other elements of a brand of the pharmaceutical product, but may contain the company’s name;
• should indicate that they are intended only for educational and/or demonstration purposes.

6.3.3. Educational Items aimed at improving the quality of administration (use) of pharmaceutical products should also indicate that they:

• are not intended for therapeutic use;
• do not contain an active ingredient of the pharmaceutical product.

6.4. INTERACTIONS WITH PATIENT ORGANIZATIONS

6.4.1. The pharmaceutical companies share interests of patient organizations and respect their independence, including in relation to their procedures and activities. All interactions between patient organizations and companies should be based on mutual respect, with the views and decisions of each partner having equal value.

6.4.2. The objectives and scope of any interactions with patient organizations must be transparent. Pharmaceutical companies may interact with patient organizations in the following fields:

• study of opinions of patients and persons taking care of them with respect to the impact of diseases on patients’ quality of life, career, family as well as to how medical care is provided and how medication or any other treatment may change the quality of their life and satisfy their needs. This can help to optimize pharmaceutical products’ clinical studies’ program and expedite efforts to develop pharmaceutical products that address patient needs in the best possible way;
• informational support for patient associations through responses to queries in accordance with the rules established in clause 4.5 of this Code for responses to patient queries;
• support for initiatives of patient organizations on creation and maintaining of patient registers subject to strict compliance with legislation on personal data protection and medical secrecy;
• the launch of campaigns to keep the general public informed about a disease;
• cooperation in providing medical organizations with a non-registered pharmaceutical product as required to provide medical care to specific patients in accordance with their vital needs;
• the provision of charitable aid; and
• in other cases, provided they are consistent with applicable legislation.

6.4.3. Pharmaceutical companies must not ask for the promotion of, and patient organizations must not promote specific pharmaceutical products.

6.4.4. A pharmaceutical company may not be the founder or participant of a patient organization.

6.4.5. A pharmaceutical company should explicitly disclose the fact, nature, value of its support of patient organization on companies website. A pharmaceutical company may be the sole source  of financing for any charitable and/or social project of the patient organization upon receiving an appropriate written request from the patient organization for assistance with its program to organize prophylactic measures, protect public health, promote a healthy way of life, and help socially vulnerable segments of the population in the Russian Federation. Financing should not  be aimed, directly or indirectly, at encouraging the patient organization to make decisions in favor of the pharmaceutical company / its products as it carries out its charter activities. In any case, the pharmaceutical company should not restrict the rights of other pharmaceutical companies to finance similar projects of the patient organization should they so wish.

In case of financial support of development or printing of patient organization’s materials pharmaceutical company must not influence the content of such materials in a manner favourable to its own commercial interests. This does not preclude pharmaceutical companies from correcting factual inaccuracies.

6.4.6. Any relations between pharmaceutical companies and patient organizations should be properly documented.

6.4.7. Pharmaceutical companies may provide financial support for events arranged by patient organizations provided that the primary purpose of such events is educational or scientific in nature or is otherwise of publicly beneficial purposes facilitating the performance of the mission pursued by the respective organizations. Where companies provide financing for an event arranged by a patient organization, they should ensure that the place and conditions of holding the event meet the requirements for limits on hospitality under sub-clause 3.3.4 of this Code.

6.5. SPECIFIC FEATURES OF INTERACTION WITH PHARMACIES/PHARMACY NETWORKS

6.5.1. Pharmaceutical companies’ representatives may visit pharmacy organizations to inform their pharmaceutical professionals and heads of pharmacy organizations on pharmaceutical products produced or sold by such companies.

6.5.2. A pharmaceutical company may enter into contracts for provision of services with a pharmacy organization, including such services as:

• the arrangement of a display ordered by the pharmaceutical company for over-the-counter pharmaceutical products;
• the placement of advertising for over-the-counter pharmaceutical products (provided it meets the requirements of the applicable legislation of the Russian Federation and of this Code), as well as information materials devoted to the prevention and treatment of various diseases, at the pharmacy organization and on its website;
• joint promotion for over-the-counter pharmaceutical products, including, but not limited to, customer surveys; and
• provision of incentive gifts, which may feature the company’s logo, or a logo of its over-the-counter pharmaceutical product, to customers buying certain product.

6.5.3. It is permitted to carry out programs to lower the cost of pharmaceutical products for end consumers. Should any such program be undertaken in respect of any prescription pharmaceutical products, pharmaceutical companies should make certain that the total number of such products’ dosages provided must not under any circumstances exceed their amount prescribed to a particular patient by a healthcare professional.

Pharmaceutical companies may not organize programs to award in-kind prizes to pharmaceutical professionals, to heads of pharmacy organizations, and to pharmacy organizations for the attainment of certain sales.