NEWSLETTER-2019-metin
278 NEWSLETTER 2019 third-party service providers). Within that scope, the pharmaceutical companies should be defined under the word “company”. The pharmaceutical companies have legal responsibilities that in- clude the notification of suspicious adverse reactions. Accordingly, in order to provide the patient with safety and obey the laws, they collect this related data on a regular basis. The patient’s age/age group, sex, weight, height, medical his- tory and current situation should be noted for an efficient analysis of the safety data in the adverse reaction notifications. The initials, or a contact number and/or the date of birth of the patient, is important for providing followup notifications. Moreover, the reporting parties’ names and contact information should be taken in order to collect complete and accurate data. In that sense, the pharmacovigilance data may comprise personal data or sensitive data of the patient, as well as the personal data of the reporting party. Sensitive Data The conditions under which to process sensitive personal data have been set forth under Article 6 of the Law. According to Article 6 (1), personal data relating to race, ethnic origin, political opinion, philosophical belief, religion, sect or other beliefs, attire, memberships with associations, foundations or trade-unions, health, sexual orienta- tion, criminal convictions and security measures, and biometric and genetic data are deemed to be sensitive data. Pursuant to Article 6 (2), it is prohibited to process sensitive data without the explicit consent of the data subject. On the other hand, Article 6 (3) reads as follows: “Personal data, excluding that which is related to health and sexual orientation, as listed in the first paragraph, may be pro- cessed without seeking the explicit consent of the data subject, in the cases provided for by the law. Personal data relating to health and sexual orientation may only be processed without seeking the explicit consent of the data subject, by any person or authorized public institutions and organizations that have confidentiality obligation, for the purposes of the protection of the public health,
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