• NSN Law Bulletin

New Announcement on Value Transfer Notifications

Within the scope of the new Covid-19 measures, the Turkish Medicines and Medical Devices Agency (“TMMDA”) issued an announcement to be sent to the relevant associations and unions on May 6, 2021.

Previously, all kinds of scientific, cultural, artistic and similar meetings or activities to be held in open or closed areas at national and international level had been postponed until the end of April with the Presidential Decree dated March 20, 2020, within the scope of the measures taken regarding the COVID-19 pandemic. In this context, the scientific and product promotional meetings for which an application was made or preliminary approval was obtained before March 20, 2020 have been either cancelled or postponed.

In latter announcement of TMDDA on April 27, 2020, it was indicated that the requests of healthcare institutions/organizations and healthcare professionals from MA holders for in-kind/cash donation due to the Covid-19 pandemic were also evaluated and that such donations must be made in accordance with the specified points in the previous announcement. TMMDA states that notifications were received from the MA holders and the associations/trade unions to which the MA holders are member on how to make the value transfer notifications of donations within the scope of the mentioned letter and for the value transfer notifications for the meetings for which the MA holders have made a payment, but eventually did not take place due to the above explained cancellation or postponement.

In the latest announcement, TMMDA provides the below considerations on the subject matter by also referring to the “Guideline on Value Transfers to be Made within the Scope of the Regulation on Promotion Activities of Medicinal Products for Human Use” regulating the procedures and principles concerning value transfers:

a. In case a payment (including deduction, penalty, agency/organization firm service fee, etc.) was made for scientific meetings/product promotional meetings that are cancelled or postponed, although they were granted preliminary approval; i- the payments made for healthcare professionals (registration, accommodation, transportation and relevant deduction/penalty/service fee) will be notified as ‘value transfer made to the healthcare professional’, ii- the other payments related to carrying out of the meeting (satellite symposium, booth participation, general sponsorship and relevant deduction/penalty/service fee) will be notified as ‘value transfer made to the health institution/organization’.

b. In-kind/cash donations made directly to the Provincial Health Directorates will be notified as ‘value transfer made to the relevant Provincial Health Directorate’. The donations made to a healthcare centre in accordance with the reference of the Provincial Directorate of Health, will be reported as ‘value transfer to the relevant health institution’.

c. In-kind/in-cash donations made to the centers providing health services through the Association/Union to which the MA holders are affiliated, will be reported as ‘value transfer made by MA holders to the Association/Union’.

TMMDA requests a list from the Associations/Unions in a specific format for the donations have been made within this framework until 31.12.2020, until 31.12.2021.

TMMDA continues to make announcement for providing further regulations or clarifying the previous ones in order to take the necessary measures and avoid any possible aggrieves during the Covid-19 pandemic

Author: Duygu Beyazo, Gözde Şahin