Decision on Pricing of Human Medicinal Products Amended with New Price Calculation
On 14 March 2023, the Presidential Decree numbered 6932 Amending the Decision on Pricing of Medicinal Products for Human Use (Turkish Language) (Decision) was published in the Official Gazette numbered 32132. The Decision introduces a new calculation for the real source price of products where the source price cannot be determined with the Presidential Decree numbered 6365 Amending the Decree on Pricing of Medicinal Products for Human Use that was introduced in November 2022… »
Medicines and Medical Devices Agency Publishes Guideline on Co-Marketing
On 17 February 2023, the Turkish Medicines and Medical Devices Agency (Agency) made an announcement (Turkish language) on its official website that it had published a Guideline on Human Medicinal Products that are Co-marketed (Guideline). The Guideline came into force on the day of its publication. The Guideline aims to provide guidance on licensing of co-marketed human medicinal products, cancellation or suspension of the main product's marketing authorisation and… »
Law on the Protection of Personal Data and Its Application
On April 7, 2016, the Law on the Protection of Personal Data (“Law”) came into force in Turkey as a special law regarding the protection of personal data. The Law is a step towards harmonising Turkish legislation with EU legislation, and it was prepared based on Directive 95/46/EC on data protection (“Data Protection Directive”). Although the Law is very similar to the Data Protection Directive, certain principles of the General Data Protection Regulation (“GDPR”) were also… »
Lawful Personal Data Processing
Personal data can be processed based on the following legal grounds: If explicit consent of the data subject is obtained. If processing is clearly proposed. If processing is mandatory for the protection of life or to prevent the physical injury of a person in cases where that person cannot express consent or whose consent is legally invalid due to physical disabilities. If processing is necessary for and directly related to the establishment or performance of a contract and… »
Explicit Consent under Data Protection Law
Explicit consent has been defined as consent that relates to a specified issue, declared by free will, and based on information. As the definition suggest, the Law stipulates that no kind of “blanket consent” of not limited to a specific subject or transaction will be valid. For example, consent such as "I allow all kinds of data processing activities", will not suffice under the Law. The data subject must know for what s/he is giving consent and must clearly express his/her… »
Transfer of Personal Data to Third Parties
Sensitive and non-sensitive personal data may be transferred to third parties if the data subject’s explicit consent is obtained or if one of the additional legal grounds is applicable for such transfer. The Law does not define a third party; therefore, any individual or entity (other than the data controller and the data subject) may be considered a third party. This creates a problem, especially about transfers between data controllers and data processors, as there is no… »
Transfer of Data Abroad
Sensitive and non-sensitive personal data can be transferred abroad if the data subject’s explicit consent is obtained. Furthermore, other legal grounds will also apply to transferring personal data to a foreign country. However, the destination country must have “sufficient protection” to conclude the transfer abroad based on legal grounds (except for having obtained explicit consent). The Board will determine a list of jurisdictions that provide sufficient protection. The… »
Data Breach Notification
The Law requires data controllers to notify the relevant data subject and the Board as soon as possible after becoming aware of a data breach. In its decision dated January 24, 2019, and numbered 2019/9, the Board clarified the rules and procedures applicable to data breach incidents. The Board took the GDPR approach regarding the timing of breach notifications and clarified that “as soon as possible” within the Law must be interpreted as 72 hours from becoming aware of a… »
Turkish DPA Fines Meta and WhatsApp Try 5,3m For Failure to Fulfill Their Registration Obligation to the VERBIS
The Turkish Personal Data Protection Authority (the “Turkish DPA”),concerning the investigation initiated ex officio, into Meta and WhatsApp which processes the personal data of the data subjects in Turkey and is subject to the provisions of the Law on the Protection of Personal Data No. 6698 (“Law”) over imposed an administrative fine of TRY 2,665,000 (approx. EUR 128,560) separately for failure to fulfill their Data Controller’s Registry (VERBIS) registration and… »
Data Controllers’ Registry (VERBIS)
According to Article 16 of the Law, an obligation to register in the Data Controllers Registry (“VERBIS”) has been introduced for data controllers. In 2018, the Board issued decisions granting exemptions from the registration obligation to specific professional groups, associations, and political parties. The Board also granted a general exemption to data controllers residing in Turkey with less than 50 employees and less than TRY 25 million on their balance sheets. Data… »
Consequences of Data Breach
The Law provides for both administrative fines and criminal liability where data breaches have occurred. Regarding criminal penalties, the Law refers to the relevant provisions of the Turkish Criminal Code that details sanctions for the unlawful recording, disclosing, or transferring of personal data. In addition to criminal sanctions, the Law also contains provisions detailing administrative fines applicable in a breach. Four breaches have been defined under the Law: The… »
Judicial Review of Board Decisions
The Law does not include an explicit provision concerning the process for appealing Board decisions that impose administrative fines. However, it is accepted that criminal courts of peace are the authorised courts under Law No. 5326 on Misdemeanours dated 30/3/2005 since the title of Article 18 of the Law is “Misdemeanours,” and administrative fines are issued as per Article 18 of the Law. With this in mind, decisions imposing behavioural sanctions can be appealed before… »