7.1. DISCLOSURE OBLIGATION

7.1.1. Each pharmaceutical company shall document and disclose transfers of value it makes, directly or indirectly, to or for the benefit of any healthcare professional or healthcare organization being a recipient, as described in more detail in clause 7.3.

7.1.2. Without limitation, transfers of value that (i) are solely related to over-the-counter pharmaceutical products; (ii) are not listed in clause 7.3 of this Code, such as items of medical utility, meals and drinks, samples to the extent they are not restricted by applicable legislation and this Code; or (iii) are part of ordinary course purchases and sales of pharmaceutical products by and between a pharmaceutical company and an healthcare professional or a healthcare organization, as relevant, do not fall within the scope of the disclosure obligation described in sub-clause 7.1.1.

7.1.3. For the avoidance of doubt, in the setting of a group of companies, the primary responsibility to make a disclosure is borne by a legal entity, which enters into a contract with the healthcare professional or healthcare organization under which the transfer of value is performed.

7.2. FORM OF DISCLOSURE

7.2.1. Disclosures shall be made on an annual basis and each reporting period shall cover a full calendar year. Pharmaceutical companies, which became subject to the provisions of this Code in the course of the reporting period, should make disclosures after the end of the relevant reporting period as set forth in sub-clause 7.2.2 below and should cover only the relevant part of the calendar year.

7.2.2. Disclosures shall be made by each pharmaceutical company within 6 months after the end of the relevant reporting period and the information disclosed shall be required to remain in the public domain for a minimum of 3 years after the time such information is first disclosed in accordance with sub-clause 7.2.4, unless, in each case, (i) a shorter period is required under applicable national data privacy or other laws or regulations, or (ii) the recipient’s consent relating to a specific disclosure has been revoked.

7.2.3. For consistency purposes, disclosures pursuant to this Code will be made using a structure set forth in Appendix 2, reflecting the requirements of this Code.

7.2.4. Disclosures are made in accordance with sub- clause 7.2.5 of this Code on the relevant pharmaceutical company’s website, provided that it is unrestricted and publicly available.

7.2.5. Disclosures shall be made pursuant to the code governing disclosure of the transfers of value to the recipients enacted in the country where the recipient has its physical address, e.g., as it is set forth in the contract, covering transfer of value. If a pharmaceutical company is not resident or does not have a subsidiary, an affiliate or any other presence in a county, defined in accordance with the above rule, this pharmaceutical company shall disclose such transfer of value in a manner consistent with the code governing disclosure of the transfers of value to the recipients enacted in the country of registration of a legal entity, which enters into a contract with the healthcare professional or healthcare organization under which the transfer of value is performed, or, if no such code is enacted in that county, any other similar code applicable to a pharmaceutical company should govern.

7.2.6. Disclosures shall be made in Russian language. A pharmaceutical company can make disclosures in English in addition to the mandatory disclosures in Russian language.

7.2.7. Each pharmaceutical company shall document all transfers of value required to be disclosed pursuant to sub-clause 7.1.1 and maintain the relevant records of the disclosures made under this Code for a minimum of 5 years after the end of the relevant reporting period, unless a shorter period is required under applicable Russian laws or regulations.

7.3. INDIVIDUAL AND AGGREGATE DISCLOSURE

7.3.1. Except as expressly provided by this Code, transfers of value shall be disclosed on an individual basis, provided that applicable personal data protection rules are complied with. Each pharmaceutical company shall disclose, on an individual basis for each clearly identifiable recipient, the amounts attributable to transfers of value to such recipient in each reporting period which can be reasonably allocated to one of the categories set out below. Such transfers of value may be aggregated on a category-by-category basis, provided that itemized disclosure shall be made available upon request to (i) the relevant recipient, and/or (ii) the relevant authorities.

7.3.2. Categories for transfers of value to a healthcare organization include:

Donations and grants. Donations and grants to healthcare organizations that support healthcare, including donations and grants (either cash or benefits in kind) to institutions, organizations or associations that are comprised of healthcare professionals and/or that provide healthcare.

Contribution to costs related to events. Contribution to costs related to events, through healthcare organizations or third parties such as:

• Registration fees;
• Sponsorship agreements with healthcare organizations or with third parties appointed by a healthcare organization to manage an event; and
• Travel and accommodation.

Fees for service and consultancy. Transfers of value resulting from or related to contracts between pharmaceutical companies and healthcare organizations under which such healthcare organizations provide any type of services to a pharmaceutical company or any other type of funding not covered in the previous categories. Fees, on the one hand, and on the other hand transfers of value relating to expenses agreed in the written agreement covering the activity will be disclosed as two separate amounts.

7.3.3. Categories for transfers of value to a healthcare professional include:

Contribution to costs related to events. Contribution to costs related to events when it is not prohibited by the applicable legislation, such as:

• Registration fees;
• Travel and accommodation.

Fees for service and consultancy. Transfers of value resulting from or related to contracts between pharmaceutical companies and healthcare professionals under which such healthcare professionals provide any lawful type of services to a pharmaceutical company or any other type of funding not covered in the previous categories. Fees, on the one hand, and on the other hand transfers of value relating to expenses agreed in the written agreement covering the activity will be disclosed as two separate amounts.

7.3.4. For transfers of value where certain information, which can be otherwise reasonably allocated to one of the categories set forth in sub-clauses 7.3.2 and 7.3.3, cannot be disclosed on an individual basis for legal reasons, a pharmaceutical company shall disclose the amounts attributable to such transfers of value in each reporting period on an aggregate basis. Such aggregate disclosure shall identify, for each category,

the number of recipients covered by such disclosure, on an absolute basis and as a percentage of all recipients, and 

the aggregate amount attributable to transfers of value to such recipients.

7.3.5. Where a transfer of value required to be disclosed pursuant to sub-clauses 7.3.1 - 7.3.4  is made to an individual healthcare professional indirectly via a healthcare organization, such transfer of value shall only be required to be disclosed once. To the extent possible, such disclosure shall be made on an individual healthcare professional named basis pursuant to sub-clause 7.3.3.

7.3.6. Research and development transfers of value in each reporting period shall be disclosed by each pharmaceutical company on an aggregate basis. Costs related to events that are clearly related to activities covered in this section can be included in the aggregate amount under the “Research and Development Transfers of Value” category.

7.3.7. Each pharmaceutical company shall publish a note summarizing the methodologies used by it in preparing the disclosures and identifying transfers of value for each category described in sub- clauses 7.3.2 and 7.3.3. The note, including a general summary and/or country specific considerations, shall describe the recognition methodologies applied, and should include the treatment of multi- year contracts, VAT and other tax aspects, currency aspects and other issues related to the timing and amount of transfers of value for purposes of this Code, as applicable.