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Insights

We share our knowledge and expertise to update our community and clients about legal developments in Turkey.

Judicial Review of Board Decisions

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The Data Protection Law does not include an explicit provision concerning the appeal process of Board decisions imposing administrative fines; however, it is accepted that criminal courts of peace are the authorized courts pursuant to Law No. 5326 on Misdemeanours dated 30/3/2005 since the title of Article 18 of the Data Protection Law is “Misdemeanours,” and administrative fines are issued as per Article 18 of the Data Protection Law. Having this in mind, decisions imposing… »

Planned Amendments to the Data Protection Law

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Processing Sensitive Personal Data Proposed amendments to the Data Protection Law, which have been drafted by the DPA and which introduce some modifications to certain disputed provisions of the Data Protection Law, have been presented for the related institutions and organisation’s consideration. Articles proposed to be amended are Article 6, regulating the legal grounds for processing sensitive personal data and Article 9, regulation transfer of personal data abroad. Under… »

Draft Guidelines on Cookies Applications

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The DPA prepared draft guidelines (“Guidelines”) on January 11, 2022, explaining cookies and practical advice for data controllers who process personal data through cookies. The  Guidelines was published on the official website of the DPA on January 11, 2022, to gather views on the same. Within the scope of the Guidelines, which is still at the draft stage, cookies in general and their types are regulated. It also categorises cookies based on their timeframe, intended purpose… »

Pharmaceutical Licensing Regulation Harmonized with EU Legislation

The new Regulation on Licensing of the Human Medicinal Products (“Regulation”) prepared by Turkish Medicines and Medical Devices Agency (“Agency”) has entered into force following its publication in the official Gazette numbered 31686 and dated December 11, 2021. The purpose of the Regulation is reflecting processes already existing in the Agency’s practice which were not regulated under the Regulation on Licensing of the Human Medicinal Products dated 2005 (“previous… »

Guidelines on Licensing Allergen Products Published

On 9 March 2022, the Turkish Medicines and Medical Devices Agency (Agency) published on its official website the Guidelines on Licensing of Allergen Products (Turkish language). The Guidelines were prepared in accordance with the Regulation on Licensing of Human Medicinal Products (Regulation) which was recently published (see Legal update, New Regulation on licensing of medicinal products for human use (Turkey)). The Regulation divided the abridged marketing authorisation… »

New Guidelines on Authorisation and Packaging of Homeopathic Medicinal Products

On 24 December 2021, the Regulation on Licensing of Homeopathic Medicinal Products (Regulation) was published in the Official Gazette. Pursuant to the Regulation, on 15 March 2022 the Medicines and Medical Devices Agency published the Guidelines on Licensing of Homeopathic Medicinal Products (Turkish language) and the Guidelines on Packaging and Product Information, Readability and Tracking of Homeopathic Medicinal Products (Turkish language). The Guidelines regulate the… »

A Fairer Way to Determine Royalties in Turkish Compulsory Licensing

Compulsory licensing, which is regulated by both  Article 99 of the repealed Decree Law  551 and  Article 129 et seq of the Industrial Property Law, which follows Article 31 of the Trade-Related Aspect of Intellectual Property (TRIPs), is a fairly recent institution in Turkey. However, covid-19 has given new urgency to the debate on this issue.   Even though it has never actually been applied, compulsory licensing has been widely discussed, not only as a convenient tool to… »

How Should Turkish Private Sector Read the 2021 Corruption Index?

The term corruption is often defined as the abuse of entrusted power for private gain. Corruption does not only kill public trust, but also prevents countries from unleashing their potential. Many studies indicate the negative correlation between corruption and sustainable economic growth. Entrepreneurship, investment, and business expansion all depend on transparency and accountability and may only flourish in an environment where corruptive attempts are fought back… »

Amendments on the Communiqué Concerning the Mergers and Acquisitions Calling for the Authorization of the Competition Board

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Merger and Acquisitions of 2021 Being 309 merger and acquisition notifications were notified to and reviewed by the Turkish Competition Authority (“TCA”) in 2021. TCA has granted authorization to 277 of them, conditional authorization to 3 of them, and has found that 29 of them are not subject to an authorization at all. It is seen that 37 of the merger and acquisition notifications examined in 2021, were related to the chemical and mining sectors, 32 of them were related to… »

Recent Developments & Turkey’s Position on SEPs: Navigating The Technology-Driven World

Standard essential patent (SEP) appears to be the new buzzword of patent law considering the upward trend in patent litigation arising from SEPs. Indeed, the continuous technological advancement supports the creation of SEPs so this trend is likely to continue in the near future. Accordingly, SEPs is a concept arising from the interaction between patent rights, which provide exclusive use of an invention and ‘standards’ aimed at the widespread and mandatory use of this… »

Pricing of Pharmaceuticals and the Fixed Exchange Rate

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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… »

Market Access-Reimbursement Agreements

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For an extended period, the pharmaceuticals industry needed a unique model of reimbursement where its conditions could be set together through negotiation with the SSI, and the regular price and reimbursement rules did not apply for innovative products. With the enactment of the Social Security and General Health Insurance Law numbered 6552 in September 2014, alternative reimbursement models also became an essential topic in the Turkish healthcare industry. The complementary… »

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