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Thought Leadership

COVID-19 HUB

COVID-19 HUB

Our COVID-19 HUB is designed to keep our stakeholders updated and help them understand the legal effects of COVID-19 outbreak, and take steps to maintain their businesses in Turkey.

Trademark Law in Turkey Key Developments and Predictions - 2021

Trademark Law in Turkey Key Developments and Predictions - 2021

We have compiled our articles on various topics of trademark law that we deem important for brand owners, which we have developed over the course of the last year.

Patent Law in Turkey Key Developments and Predictions - 2021

Patent Law in Turkey Key Developments and Predictions - 2021

We focus on the key aspects of patent litigation in Turkey, and the most important or challenging issues in Turkish Patent Law.

Life Sciences Law in Turkey Key Developments and Predictions - 2021

Life Sciences Law in Turkey Key Developments and Predictions - 2021

We focus on the key aspects of life sciences in Turkey, the most important and challenging issues in Turkey’s life sciences industry.

Data Protection and Privacy Law in Turkey Key Developments and Predictions 2021

Data Protection and Privacy Law in Turkey Key Developments and Predictions 2021

We focus on the key aspects of data privacy matters and developments in Turkey, and the most important or challenging issues regarding the same.

Copyright Law in Turkey Key Development and Predictions 2021

Copyright Law in Turkey Key Development and Predictions 2021

In the report, we outline seven controversial issues that we often encounter in Turkish copyright Law.

Commercial Dispute Resolution Under Turkish Law Rules, Developments and Insights - 2020

Commercial Dispute Resolution Under Turkish Law Rules, Developments and Insights - 2020

We focus on the four main topics of commercial dispute resolution under Turkish law, and the most important and challenging issues in commercial dispute resolution under Turkish law.

Media and Advertising Law in Turkey Key Developments and Predictions - 2020

Media and Advertising Law in Turkey Key Developments and Predictions - 2020

We focus on the key aspects of media and advertising law in Turkey, and the most important or challenging issues in Turkish media and advertising Law.

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Monthly Newsletters

January 2022

January 2022

We are pleased to publish our monthly newsletters to update our community and clients about legal developments in Turkey.

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Transfers of Value

Articles -
Life Sciences || Gün + Partners

There is no public disclosure rule for value transfers made by pharmaceutical companies. However, according to the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated 3 July 2015, the pharmaceutical companies shall notify TITCK of any value transfers that exceed 10% of the current monthly gross minimum wage, to health institutions, organizations, universities, health professionals, and members of professional associ...»

Interactions with HCPs

Articles -
Life Sciences || Gün + Partners

Promotional activities of human medicinal products, enteral nutrition products, and infant formulas for special medical purposes, are regulated under the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated 3 July 2015. Pursuant to the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet, i...»

Named Patient Programs

Articles -
Life Sciences || Gün + Partners

Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceuticals without marketing authorization (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons. In cases where a pharmaceutical does not have an MA in Turkey, or has an MA, but cannot be found on the market, and patients are in need the pharmaceutical in question, it is possible to procure the pharmaceutical via this special m...»

Localization of Imported Products

Articles -
Life Sciences || Gün + Partners

Following the announcement of the Structural Transformation Program Action Plan for Healthcare Industries on 7 November 2014, Turkey commenced adopting measures to localize the production of a substantial number of pharmaceutical products sold in Turkey. On 10 December 2015, the 64th Government announced the 2016 Action Plan (64th Government Action Plan), which included a statement that measures would be taken to prioritize domestically produced medical supplies and medical d...»

Market Access-Reimbursement Agreements

Articles -
Life Sciences || Gün + Partners

For a long period of time, the pharmaceuticals industry needed a special model of reimbursement where the reimbursement conditions could be set, together through negotiation with the SSI, and the normal price and reimbursement rules did not apply for innovative products. With the enactment of Law of the Social Security and General Health Insurance Law numbered 6552, in September, 2014, alternative reimbursement models also became an important topic in the Turkish healthcare i...»

Pricing of Pharmaceuticals and the Fixed Exchange Rate

Articles -
Life Sciences || Gün + Partners

Pharmaceutical prices in Turkey have always been one of the most controversial issues. The prices of medicines that are to be marketed are set in accordance with the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of 29 September 2017, issued by the Ministry of Health (“MoH”), which is vested with the competencies to regulate this area. The Decision provides for a reference pricing syste...»

Commercialisation of Healthcare 2021 in Turkey

Guides -
Life Sciences || Özge Atılgan Karakulak and Dicle Doğan

A Q&A guide to the commercialisation of healthcare in Turkey. This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Turkey. It covers the key requirements for manufacturing, marketing and advertising medicines, medical devices, biological products and natural health products. Medicines 1.What is the definition of medicine (or equivalent) in your jurisdiction? Under the Law on Pharmaceuticals and Medical Preparations...»

New Guidelines Published For Promoting Medical Devices

Articles -
Life Sciences || Dicle Doğan and Fatma Sevde Tan

On 12 February 2021, the Turkish Medicines and Medical Devices Agency published new guidelines (Turkish language) for the implementation of regulation on sales, advertising and promotion of medical devices. The new guidelines introduce detailed provisions on implementing some of the significant amendments that were made to the Regulation on Sales, Advertising and Promotion of Medical Devices on 2 September 2020. Under the guidelines, in addition to advertising and promotional...»

Developments on Signature Specimen and Signature Circular

Articles -
Corporate and M&A || Görkem Bilgin and Yalçın Umut Talay

Amendments Related to Signature Specimen The Amending Law Related to the Technology Development Zones and Certain Other Laws (the "Law No. 7263") was published in the Official Gazette on February 3, 2021 and entered into force on the same date. Article 22 of the Law No. 7263 amended Article 40 of the Turkish Commercial Code with respect to issue of signature specimen. In this regard, the amendment provides that signature samples of real person merchants and authorized signato...»

Impact of EPO Proceedings and EPC Provisions on National Actions

Articles -
IP Prosecution, Patent and Utility Models and Intellectual Property || Gün + Partners

Since Turkey’s inclusion as a member of the EPC, a hot topic has been the enforcement or invalidity of Turkish validation of European Patent(s) (“EP”) while proceedings before the European Patent Office (the “EPO”) are pending. Once an EP is validated in Turkey, it becomes a national patent. For EPs, the Turkish Patent and Trademark Office (the “TPMO”) seems to have transferred its powers and duties to the European Patent Office; therefore, it functions as an institution that...»

Discovery of Evidence Requests and the Scope of Bolar Exemption

Articles -
IP Prosecution, Patent and Utility Models and Intellectual Property || Gün + Partners

Discovery of evidence requests are specially regulated under Civil Procedural Law No. 6100. Discovery of evidence serves the purpose of determining a fact that has not yet been examined in an ongoing action or a fact that will be put forward in a future action. It must be emphasised that unlike the US and UK systems, there is no full and frank disclosure procedure under Turkish civil law. In other words, the parties may decide, at their discretion, which documents they will o...»

Arbitration Proceedings Regarding Determination of Reasonable Amount for Employee’s Invention

Articles -
IP Prosecution, Patent and Utility Models and Intellectual Property || Gün + Partners

In 2020, an arbitration judgment was held in accordance with the ISTAC serial arbitration procedure regarding the compensation request for employee invention and, as far as it is known, this is the first and pilot file in which the Regulation on Employee Inventions, Inventions in Higher Education Institutions and Public Funded Projects, will determine the price tariff for employees’ inventions and the arbitration procedure to be followed in case of dispute. Within the scope o...»