Decision on Pricing of Human Medicinal Products Has Been Amended
On 14 March 2023, the Presidential Decree numbered 6932 Amending the Decision on Pricing of Medicinal Products for Human Use (“Decision”) was published in the Official Gazette numbered 32132. With the Decision, a new rule have been introduced on the real source price calculation completing the rule introduced in November 2022. With the prior amendment in the Decision in November 2022, a rule had been introduced stating that products that do not have a retail sale in the… »
Overlapping Intellectual Property Rights - 2nd Edition
While intellectual property rights are mostly studied in isolation, in practice the legal categories created to protect these rights provide only partial legal coverage of the broader context in which such rights are created, used, and enforced. Consequently, often multiple IP rights overlap with respect to the same underlying subject matter. Contributed by our partners Uğur Aktekin and Mutlu Yıldırım Köse, Overlapping Intellectual Property Rights (Second Editon) published… »
Corporate Governance in Turkey 2023
What are the primary sources of law, regulation and practice relating to corporate governance? Is it mandatory for listed companies to comply with listing rules or do they apply on a ‘comply or explain’ basis? The Turkish Commercial Code (TCC) dated 13 January 2011 (Law No. 6102) entered into force on 1 July 2012. The TCC has important objectives, such as ensuring transparency, adopting corporate governance standards and introducing internationally accepted auditing and… »
Alternative Reimbursement Regulation published
As a consequence of lawsuits filed against provisions of the Alternative Reimbursement Regulation dated 10 February 2016, due to the regulation being published without obtaining the Ministry of Health’s opinion, the articles subject to the lawsuits were cancelled based on formal deficiency. On 12 May 2023, a Alternative Reimbursement Regulation (Regulation) was published in the Official Gazette numbered 32188 and entered into force on the date of publication. While the… »
Evaluating ChatGPT and AI Applications from the Personal Data Protection Perspective
AI Applications Under the Radar of Data Protection Authorities Concerns about how artificial intelligence (AI) systems use and store data collected from users have been frequently debated by data protection authorities and professionals dealing with data security and privacy issues lately. These discussions are kept in the public eye through decisions, publications, and press releases related to the subject. The Italian Data Protection Authority, Garante per la Protezione dei… »
Personal Data Protection Board Decisions on Commercial Electronic Messages
Along with the progress in information technologies, the fact that even the smallest daily needs are met through electronic commerce has resulted in the advertisement and marketing of goods and services mainly through telecommunication networks. With the effect of the Covid-19 pandemic, the sales of goods and services in electronic environment, which have reached a serious potential in recent years, have also caused an increase in the personal data processing activities of… »
New Guidelines on Named Patient Program was Published
The pharmaceuticals not authorized in Turkey or those not available in the market, despite being authorized, shall be procured from abroad upon the request of a physician and special authorization in cases where patients require such pharmaceuticals. Until recently, this exceptional import regime for pharmaceuticals was regulated by the Guidelines on the Supply of Pharmaceuticals from Abroad published by the Turkish Medicines and Medical Devices Agency ("TİTCK"). In line with… »
Turkish MDR and IVDR Amended
On 2 April 2023, regulations amending the Turkish Medical Device Regulation (Turkish language) and the Turkish In Vitro Medical Device Regulation (Turkish language) were published in the Official Gazette numbered 32151. They amend he transitional provisions stipulated in the which was published in the Official Gazette numbered 31499 to be in line with the transitional provisions applicable to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The… »
Communiqué on Electronic Instructions For Use of Medical Devices Published (Turkey)
On 6 April 2023, the Turkish Medicines and Medical Devices Agency (Agency) published a new Communiqué on Electronic Instructions for Use of Medical Devices (Turkish language) (Communiqué) in the Official Gazette numbered 32155. The Communiqué replaced the version dated 2 April 2015 numbered 29314 and entered into force on the day of its publication. The Communiqué has been updated in line with Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for… »
A Glance at the Concept of Plagiarism
Although plagiarism is not clearly defined in Law No. 5846 on Intellectual and Artistic Works (LIAW), it is one of the most common acts of infringement. Plagiarism, which is defined as “pilferage” by the Turkish Language Association under the law on intellectual and artistic works, is used to “present someone else’s work as your own, taking a piece from someone else’s work without citing the source”. While there is no definition for plagiarism, “Freedom of quotation” is… »
The Protection of Cinematographic Works in Türkiye
LIAW which entered into force in 1952, has been amended in 1995, 2001, 2004, 2006, 2008, 2012, and 2014. The amendments in 1995 and 2001 were major amendments which changed the legal regime for rights to cinematographic works and created legal uncertainty as to the ownership and protection term for rights to cinematographic works. The initial text of the LIAW (dated 1952) recognized the Producer of a cinematographic work as the author and provided for a protection term of 20… »
Non-Fungible Tokens (“NFTs”) and Copyright Law
NFTs have been one of the most popular topics for copyright law during 2022. Discussions were widely held about whether NFTs could be considered copyrightable works, whether purchase of an NFT grants authorship rights to the buyer, which formal requirements are relevant for a valid copyright assignment for an NFT, and which particular rights associated with copyright could be infringed by unauthorized use. Although we are yet to see legislation concerning these issues, many… »