5.1. POST-REGISTRATION STUDIES

5.1.1. Post-registration studies, including post-registration clinical (interventional) studies, post-registration observation (non-interventional) studies, and epidemiological studies, should comply with the requirements of applicable Russian legislation and of this clause.

5.1.2. A post-registration study should have a rationale and a scientific purpose(s), which are to be reflected in the protocol of the study.

5.1.3. The medical department or the corresponding medical functional unit / employees of a pharmaceutical company should organize and supervise, and are responsible for, any post- registration studies.

5.1.4. The choice of investigators should be based solely on their professional qualifications and clinical experience and should never be linked in any way to the past, current, or possible future prescription or recommendation of the company’s pharmaceutical products.

5.1.5. The data obtained from post-registration studies should be statistically processed and analyzed.

5.1.6. Post-registration studies should be conducted in compliance with the laws, rules, and requirements applicable to personal data confidentiality (including, but not limited to, the collection and use of personal data).

5.1.7. The protocol of a post-registration study is subject to approval by the medical department or by the responsible medical functional units / employees. The medical department (or the corresponding medical functional units / employees) should coordinate and monitor the progress of the post-registration studies.

5.1.8. The documentation related to the post-registration studies (including the protocol, the individual registration card, patient information sheet, etc.) is at all times subject to obligatory ethical expert examination.

5.1.9. The employees of a company’s other departments may participate in the handling of only administrative tasks when acceptable (such as the transfer of documents related to post-registration studies from the medical department to and from the research center / investigators ). That participation should proceed under the control of the medical department which should ensure that the employees from the pharmaceutical company’s other departments are properly trained.

5.1.10. The participation of a healthcare professional in any post-registration study should not serve as an incentive for the recommendation / prescription, purchase, sale, or use of any specific pharmaceutical product.

5.1.11. The compensation provided to medical organizations during post-registration studies should be reasonable and should reflect the fair market value of the work performed.

5.1.12. It is prohibited to perform any post-registration study under the guise of a marketing study. If no clear distinction between marketing studies and post-registration studies as defined in sub-clause 5.1.1 above is present, the purposes of the marketing studies are subject to verification by the pharmaceutical company’s medical professionals.

5.2. MARKETING STUDIES

5.2.1. Marketing studies conducted directly by pharmaceutical companies or by pharmaceutical companies with the involvement of marketing agencies are only possible provided that applicable legislation is complied with.

Neither the pharmaceutical companies nor the agencies engaged in such cases may pay any compensation to any healthcare professionals for their participation in the marketing study. Exceptions may include cases where marketing studies require specialist scientific knowledge and substantial work inputs on the part of a healthcare professional provided that: (1) marketing studies are conducted with the involvement of independent agencies; (2) the healthcare professional is not informed on, and it is unclear from the materials of the study, which pharmaceutical company has ordered / sponsored the study; and (3) the pharmaceutical company is not involved in the selection of the persons to take part in the study and is unaware of which healthcare professionals will   be involved in the marketing study.

5.2.2. Marketing studies should not be used for the purposes of:

• promoting or selling of any pharmaceutical products or managing the opinions or conduct of the participants of the study. For that reason, it is necessary to avoid references to the trade name of the relevant pharmaceutical product unless the purpose of the study requires otherwise;
• gathering the personal data of patients;
• conducting the follow-up studies of the efficacy or safety of any pharmaceutical product;
• pre-registration promotion for any pharmaceutical product or the indications for its use that are subject to registration;
• obtaining confidential information about competitors;
• discrediting the pharmaceutical products of any competitor or otherwise causing detriment to any competitors.