NEWSLETTER-2019-metin

277 PERSONAL DATA PROTECTION Healthcare Sector Publishes a Guideline on Data Protection* Att. Elif Mungan Introduction The Turkish Medicines and Medical Devices Agency (“TITCK”) published Guidelines on Protection of Personal Data in Pharmacovigi- lance Activities (“Guideline”) on 1 August 2019 1 . The Guideline aims to protect personal data that is processed during pharmacovigilance activities and, accordingly, to inform the data processors regarding their incumbencies and the relevant procedures and principles. The Guideline is based on Data Protection Law No. 6698 (“Law”) and the relevant secondary legislation. Pharmacovigilance Pharmacovigilance is defined as the activities and scientific stud- ies with regard to exploring the determination, understanding and pre- venting of adverse reactions and other problems related to medicines. “Adverse reactions” are the dangerous and undesirable responses that are developed to medicines. “Adverse incidents” are the medical cases in which an undesirable result that cannot be related to the prescribed treatment has occurred to the patient, or the clinical study volunteer that the medicine has been applied on. Pharmacovigilance Actions and Personal Data The Guideline defines the “company” as the license owner and/or the service institutions that provide services to the license owner (the * Article of September 2019 1 https://www.titck.gov.tr/mevzuat/farmakovijilans-faaliyetlerinde-kisisel-veriler- in-korunmasi-hakkinda-kilavuz-01082019183233 (Access date: 13.09.2019).