Starting from 2015, the pharmaceutical companies - EFPIA members shall comply with the requirements regarding the disclosure of information on the transfer of value to Healthcare Professionals and Healthcare Organizations

On requirements set by EFPIA

In June 2013 the EFPIA General Assembly adopted the Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations.

As required by this Code, pharmaceutical companies shall be required to document and disclose information about values transferred directly or indirectly to Healthcare Professionals and Healthcare Organizations within the categories of values set forth below:

1) categories of values transferred to health care organizations:

• Donations and Grants;
• Contributions to costs related to Events (including registration fees; sponsorship agreements; travel and accommodation);
• Fees for Service and Consultancy (in particular, the values transferred under contracts for the provision of various types of services, or any other type of funding not covered in the previous categories.).

2) categories of values transferred to Healthcare Professionals:

• Contributions to costs related to Events (including registration fees; travel and accommodation);
• Fees for Service and Consultancy (in particular, the values transferred under contracts for the provision of various types of services, or any other type of funding not covered in the previous categories.).

The exception to this general obligation of disclosure is the transfer of the following values, without limitations:

• The values relating exclusively to pharmaceutical products sold without medical prescription;
• the medical products, food and beverages, as well as samples of pharmaceutical products, if it does not contradict the applicable laws and this Code;
• the values emerging in the ordinary course of operations of purchase and sale of pharmaceutical products, carried out between pharmaceutical companies and Healthcare Professionals or healthcare organizations, respectively.

The relevant information shall be disclosed by pharmaceutical companies annually within 6 months after theend of a full calendar year (Reporting Period) in compliance with the approved uniform framework by any ofthe following methods, provided that the information disclosed does not have access restrictions:

• on the website of a pharmaceutical company; or
• on the central platform of a public authority or association of pharmaceutical companies.

In addition, the information on the transfer of value within each category shall be disclosed on individual basis (i.e. with identification of each relevant Recipient). At the same time, the respective amounts of the transferred values may be summed on a category-by-category basis, given that the information on each type of transferred values shall be disclosed by a pharmaceutical company upon request of the relevant Recipient of values and/or relevant public authority.

In cases where the information may not be disclosed by a pharmaceutical company on an individual basis under law, pharmaceutical companies shall make a general disclosure of information, in particular, disclose information for each category of value transferred regarding:

• the number of Recipients within the respective category in absolute terms and as a percentage of the total number of Recipients;
• the total amount of payments within the respective category.

Disclosure of information about the values transferred to Healthcare Professionals and Healthcare Organizations by pharmaceutical companies will be launched in 2016 for the first Reporting Period – full calendar year of 2015.

On the requirements of the law of Ukraine on protection of personal data and the procedure

In Ukraine the legal relations associated with protection and processing of personal data are regulated by the Law of Ukraine “On Personal Data Protection”[1].

Under the said Law the personal data shall be interpreted as the information or aggregate information about an individual who is identified or can be specifically identified,[2] and its processing shall be interpreted as any activity or a set of activities, such as collection, registration, accumulation, storage, adaptation, change, recovery, use, dissemination (sale or transfer), depersonalization, destruction of personal data, including with the use of information (automated) systems[3].

In view of the above, the information on Healthcare Professionals (surname, first name, etc.) required for a public placement by pharmaceutical companies in compliance with the above EFPIA requirements, shall be qualified as personal data, and its public placement in the Internet shall be regarded as personal data processing.

At that, as required by Article 14 of the Law of Ukraine “On Personal Data Protection”, in order to disseminate personal data, the personal data subject’s consent, i.e. his/her voluntary expression of willingness to permit public placement of his/her data on the Internet with a specific purpose shall be obtained.

Dissemination of personal data without the appropriate consent is possible in the cases determined by law and only (if necessary) for the benefit of national security, economic prosperity and human rights.

General conclusions:

Given the above requirements of the EFPIA Code and Ukrainian legislation, the disclosure of information by pharmaceutical companies on the transfer of value to Healthcare Professionals on individual basis (i.e. with the identification of each relevant Recipient) is possible only in case of obtaining the consent of the relevant Healthcare Professionals on the appropriate dissemination of personal data. In the absence of such consent, the pharmaceutical companies shall be required to disclose exclusively general information(without indication of the specific information of the relevant Healthcare Professionals as Recipients of values).

[1] The Law of Ukraine "On Personal Data Protection", Article 1, Part 1.

[2] The Law of Ukraine "On Personal Data Protection", Article 2, Part 1, paragraph 10.

[3] The Law of Ukraine "On Personal Data Protection", Article 2, Part 1, paragraph 8.