Insights
New Regulation on Medical Device Clinical Trials Published
On 8 July 2022, the Regulation on Medical Device Clinical Trials (Turkish language) (Regulation) was published in the Official Gazette numbered 31890, repealing the former regulation dated 6 September 2014. The Regulation, which came into force on its day of publication, introduces amendments to ensure clinical trials comply with the Turkish Medical Device Regulation. The Regulation sets rules in connection with the functionality date of the European Database on Medical… »
Decision on Pricing of Medicinal Products For Human Use Amended
On 8 July 2022, the Decision Amending the Decision on Pricing of Medicinal Products for Human Use (Turkish language) was published on the Official Gazette numbered 31890. The Decision on Pricing of Medicinal Products for Human Use (Decision) is the legislation which set the rules on pricing of the human medicinal products. The amendments to the Decision include: An increase in pharmacist profit rates to be applied when determining the retail sale price of the products. A new… »
Regulation on Clinical Trials of Medicines and Biological Products Amended
On 6 July 2022, amendments (Turkish language) made by the Turkish Medicines and Medical Devices Agency to the Regulation on Clinical Trials of Medicines and Biological Products were published in the Official Gazette numbered 31888. The amendments: Introduce new provisions regarding the clinical trial application procedure, exceptional trials and the Agency's authority to obtain scientific opinion from a scientific consultancy committee while evaluating clinical trial… »
What Is Non-Fungible Token (NFT) and What Is Not?
Non-Fungible Token (NFT), which we have heard about more often since the beginning of 2021, is a digital asset that uses blockchain technology and primarily operates within Ethereum. NFT is a digital token that cannot be exchanged or replaced and may represent many tangible objects in the real world, such as songs, artworks, GIFs, virtual game items, videos, and cartoons. NFT is technically not the work itself, whereas it is a metadata file that contains the unique… »
Liability of the Hosting Providers for Copyright Infringement
One of the most violated rights on the internet is copyright, and nowadays, works such as music, movies and cartoons are published by third parties on various websites, social media accounts, video watching and file-sharing platforms without the owners’ permission. In fact, recently, the unauthorised sharing of cartoons by famous cartoonists on specific internet sites and the legal actions initiated by the authors of these works have created quite a stir; and the issue of… »
Compensation Liability for Copyright Infringement
The author or the owner of a work is entitled to claim compensation in the case of violation of economic and moral rights arising from the ownership of the work protected under Law No. 5846, the Intellectual and Artistic Works (the “LIAW”), in addition to other legal remedies. Article 70 of the LIAW regulates compensation that may be claimed based on violation of economic and moral rights, separately. Accordingly, the author whose moral rights have been infringed, is… »
Ownership of the On-Demand Works
The General Assembly of the Civil Court of Cassation (GACoC) made important determinations with its decision dated 16.01.2020 and numbered E. 2019 / 11-474, K. 2020/26, concerning the scope of the ordering party’s use of the work created within on-demand work agreements, and whether a separate contract is required for the transfer of the economic rights of the author in terms of related uses. In this case, the plaintiff was working as the purchasing manager in the defendant… »
Does Technical Function Impede Copyright?
The question of whether appearance features of utilitarian objects with technical functions can benefit from copyright protection has become a debated issue in recent years, and it has also started to find a place in the decisions of the Court of Justice of the European Union (CJEU). In the decision of the CJEU, dated June 11, 2020, and numbered C-833/18, it was evaluated how appearance features of products with technical functions can benefit from copyright protection. The… »
Data Protection Law in General
On April 7, 2016, a new law on the protection of personal data came into force in Turkey: The Law on the Protection of Personal Data numbered 6698 (“Data Protection Law”). It is the first law of its kind in Turkey, specifically regulating the protection of personal data. The Data Protection Law is a step towards harmonizing Turkish legislation with EU legislation, and it was prepared based on Directive 95/46/EC on data protection (“Data Protection Directive”). The Data… »
Application of the Data Protection Law
The Data Protection Law applies to data controllers who process and transfer personal data. In the situation where data controllers utilise the services of third-party data processors for these processes, the law holds them jointly liable for taking all of the technical and administrative measures required to ensure the safeguarding of personal data and to prevent any unlawful access or processing. The Data Protection Law does not envisage the scope of its application in… »
Lawful Data Processing
Processing Personal Data Personal data can be processed based on the below specified legal grounds: If explicit consent of the data subject is obtained; If processing is clearly proposed under the laws; 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… »
Transfer of Personal Data to Third Party
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 Data Protection 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… »