Insights
Guidelines on Donation of Non-Approved Drugs
On 28 September 2022, the Turkish Medicines and Medical Devices Agency (Agency) published guidelines (Turkish language) on donation from abroad of human medicinal products that are not approved in Turkey on its official website. The guidelines have been prepared to determine the procedures and principles regarding donation from foreign companies within the scope of the Regulation on Licensing of Human Medicinal Products. The most significant provisions of the guidelines are… »
First Preliminary Injunction Issued by a Court in Turkey Regarding NFTs
Few issues in the world of intangible rights contain as many legal uncertainties as do non-fungible tokens. Kat friends Mutlu Yıldırım Köse and Havva Yıldız discuss a recent decision rendered in Turkey, representing the first foray by a Turkish court into these murky legal waters.Non-Fungible Tokens (NFTs), ranging from art and literature to fashion and cinema, remain among the hottest legal topics in the world of intangible rights, despite the lack of clear legal regulation.… »
New Regulations Expected For OTT Service Providers
With the bill known as ‘law against disinformation’, there are several provisions specifically related to the Law on the Regulation of Internet Broadcasts and Prevention of Crimes Committed through Such Broadcasts (“Law No. 5651”) and the Press Law. The amendment proposals related to the Law No. 5651 and the Press Law have been on the agenda for a while of the publication of the bill. In addition to these issues discussed widely, with the bill, ‘over the top’ (OTT) services… »
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… »