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    Lawyers Dicle Doğan

    Dicle Doğan

    Gün + Partners
    [email protected]

    Dicle Doğan is a managing associate in Gün + Partners and she has been working for the firm since 2011.

    Dicle has been specialized on life sciences, data protection and privacy and intellectual property with a special focus on trademarks and designs.

    She advises corporate clients from life sciences sector, especially multinational pharmaceutical and medical device companies and industry associations. She advises and represents her clients on a wide range of issues including promotional activities, advertisement, labelling requirements, clinical trials, marketing authorization procedures, pricing and reimbursement regulations, and also assists clients in their day-to-day business activities. She is also experienced in cases of cancellation of administrative acts, including Regulations and Communiqués, issued by public institutions.

    Dicle also advises corporate healthcare companies on the protection of personal data and privacy issues.

    In the field of intellectual property, especially on trademarks and designs, in addition to counselling clients regarding their IP strategies and providing legal opinions, she has been involved in many litigation processes, where she represents the clients before the Courts in cancellation, invalidation, infringement, unfair competition actions and other types of actions. At the same time, she supervises and drafts oppositions and appeals on trademark and design applications before the Turkish Patent and Trademark Office.


    Practice Areas & Work Department

    Life Sciences

    Intellectual Property

    Trademarks and Designs

    Data Protection and Privacy


    Languages

    English

    Turkish

    French

    German

    Turkish Court of Cassation’s Comparison of Goods in Different Subclasses

    During 2022, the 11th Civil Chamber of the Turkish Court of Cassation (the CoC) issued several decisions regarding trade marks covering goods in class 5. The CoC formed its evaluation on the likelihood of confusion by comparing the subclasses of class 5. The details of the decisions are provided below:
    Dicle Doğan

    New Euro Fx Rate For Drug Prices

    The Turkish government has increased the euro exchange rate used to price medicinal products by 30.5%. The new exchange rate is TRY14.0387, up from TRY10.7577. The increase is effective from July 24, 2023.
    Dicle Doğan

    Decision on the Pricing of Drugs Has Been Amended

    The Presidential Decree 6932, issued on July 23, 2023, amends the Decision on Pricing of Medicinal Products for Human Use. Euro value in Turkish Lira for pricing increased by 30.5% to 14.0387 TRY in July 2023. Offsetting process won't apply during this change. Price thresholds are set at 48.41 TRY for price-protected products and 25.30 TRY for others. Previous increases up to 4 TRY aren't considered. The regulation, effective immediately, addresses the rapid exchange rate increase and ensures pharmaceutical availability.
    Dicle Doğan

    İlaç Fiyatlandırılmasına Dair Karar’da Değişiklik

    Beşerî Tıbbi Ürünlerin Fiyatlandırılmasına Dair Karar’da (“Karar”) Değişiklik Yapılması Hakkında 6932 sayılı Cumhurbaşkanı Kararı 23 Temmuz 2023 tarihli 32257 sayılı Resmi Gazete’de yayınlanmıştır. Karara eklenen geçici maddeler ile, Beşerî tıbbi ürünlerin fiyatlandırılmasında kullanılacak Türk lirası cinsinden 1 avro değerinin 2023 yılı temmuz ayında %30,5 oranında arttırılarak 14,0387 TL olması belirlenmiş, bu artış uygulanırken Karar’ın 3/3 maddesindeki mahsuplaşma işleminin uygulanmayacağı belirtilmiş,Kurdaki değişime paralel olarak Karar’da geçen fiyat baremleri güncellenerek, bu tutarlar fiyat korumalı ürünler için 48,41 TL, diğer ürünlerde 25,30 TL olarak belirlenmiştir. Dönemsel avro değeri güncellemesinde Karar’ın Geçici 7. maddesi kapsamında uygulanan 4 TL’ye kadar olan artışların dikkate alınmayacağı, güncelleme sonrasında 4 TL’ye kadar olan artışlar, TL değerinde değişiklik yapılmadan, ürünlerin depocuya satış fiyatları üzerine ekleneceği belirtilmiştir.Yeni düzenleme yayımı takip eden gün yürürlüğe girmiştir.
    Dicle Doğan

    Guidelines For Withdrawal and Recall of Medical Devices Published

    The Guidelines regulate the procedures to be implemented to prevent unsafe and non-conforming medical devices from being placed on the market and the responsibilities of the relevant parties pursuant to Law No 7223 on Product Safety and Technical Regulations. In this regard, the Guidelines indicate the procedure on withdrawal and recall of medical devices and in vitro diagnostic devices from the market, and duties, authorities and responsibilities of the Agency and the medical devices companies.
    Dicle Doğan

    Regulation on Licensing of Medicines Amended

    The Regulation Amending the Regulation on Licensing of Human Medicinal Products was published in the Official Gazette on 27 May 2023. The amended provisions introduce a new reason for license suspension related to license transfer applications. To avoid suspension, license holders must provide proof of Good Manufacturing Practice compliance and a Production Site Authorisation Certificate for the active substance production site in Turkey. License holders must now notify the Medicines and Medical Devices Agency of license application rejections or withdrawals in other countries. The deadline for submitting notified body opinions or CE certificates for medicinal products with integrated medical devices is extended to 31 December 2028.
    Dicle Doğan

    Regulation on Technical Services For Medical Devices Published

    On 26 May 2023, the Turkish Medicines and Medical Devices Agency (Agency) published the Regulation on Technical Services for Medical Devices Used for Provision of Healthcare Services (Turkish language) (Regulation) in the Official Gazette numbered 32202. The Regulation has been prepared by the Agency to regulate the qualifications, authorisation, supervision and training of technical services that will support activities such as installation, updates, upgrades, modification, maintenance or repair of medical devices used in healthcare services. It will also regulate the qualifications and training of the relevant personnel working in these technical services and determine the obligations of technical services and healthcare service providers.
    Dicle Doğan

    Gıda ve Takviye Edici Gıdalarda Sağlık Beyanı ve Beslenme Beyanı Kullanımı

    20 Nisan 2023 tarihli ve 32169 sayılı Resmi Gazetede yayımlanan düzenlemelerle gıda ve takviye edici gıdalarda sağlık beyanının kullanımına ilişkin mevzuat ile beslenme beyanlarına ilişkin mevzuatta kapsamlı değişiklikler yapıldı. Söz konusu değişikliklerle birlikte; beslenme beyanlarına ilişkin yeni düzenleme olan Türk Gıda Kodeksi Beslenme Beyanları Yönetmeliği ile gıda ve takviye edici gıdalarda sağlık beyanlarına ilişkin yeni düzenleme olan Gıda ve Takviye Edici Gıdalarda Sağlık Beyanı Kullanımı Hakkında Yönetmelik (“Yönetmelik”) yürürlüğe girmiştir ve 20 Nisan 2023 tarihine kadar sağlık beyanları ve beslenme beyanlarına ilişkin düzenlemelerin birlikte yer aldığı Türk Gıda Kodeksi Beslenme ve Sağlık Beyanları Yönetmeliği yürürlükten kaldırılmıştır.
    Dicle Doğan

    New Regulations on Nutrition and Health Claims for Food and Food Supplements / June 2023

    The Turkish Food Codex Regulation on Nutrition Claims and the Regulation on Health Claims for Food and Food Supplements have replaced the previous regulations. The Turkish Pharmaceuticals and Medical Devices Authority has drafted the Guideline on Health Claims for Food and Food Supplements. Under the new system, health claims listed in the Guideline can be used without official permission, provided they comply with the Regulation and Guideline. The Authority has monitoring and supervising powers. Companies must ensure compliance and provide requested information.
    Dicle Doğan

    Sosyal Güvenlik Kurumu Alternatif Geri Ödeme Yönetmeliği Yayınlandı

    Alternatif Geri Ödeme Yönetmeliği ile ilgili olarak yapılan yeni düzenlemeler, Yönetmeliğin 2016'daki hükümlerine benzerlik göstermektedir. Öne çıkan değişiklikler şunlardır: Alternatif geri ödeme modellerinin tanımında, yurtdışından temin edilen ürünlerin yerli üretime geçmesi veya piyasada bulunurluğunun sağlanması gibi unsurlara yer verilmemiş, bunun yerine iskonto oranlarının belirlenebileceği ve alım garantisi verilerek sağlık hizmetlerinin ödeme kapsamına alınabileceği belirtilmiştir. Ayrıca Komisyon toplantılarına ilişkin takvim belirlenmiş ve gizlilik hükümleri yeniden yürürlüğe konulmuştur. Yeni düzenlemeler, firmaların ihtiyaçlarına hizmet etmek amacıyla alternatif geri ödeme modellerinin geliştirilmesine odaklanmaktadır. Ruhsat sahiplerinin başvurularını güncellemeleri ve sözleşme süresi biten sağlık hizmeti geri ödemeleri için başvuruda bulunmaları gerekmektedir.
    Dicle Doğan

    Social Security Institution Alternative Reimbursement Regulation Has Been Published

    As a result of lawsuits filed against the provisions of the Alternative Reimbursement Regulation, certain articles were canceled due to a formal deficiency. The new Social Security Institution Alternative Reimbursement Regulation has been published, and notable developments include the explicit definition of alternative reimbursement models and the establishment of a meeting schedule for the Alternative Reimbursement Commission. The regulation also reinstates provisions regarding confidentiality. The new regulation aims to serve the needs of companies by providing predictability and confidentiality in the development of alternative reimbursement models. Marketing authorization holders have been instructed to update their applications, and reimbursement applications must comply with the new regulation.
    Dicle Doğan

    Yeni Yurt Dışından İlaç Temini Kılavuzu Yayınlandı

    Türkiye'de ruhsatı olmayan veya piyasada bulunmayan ilaçlar, hasta talebi ve özel izinle yurt dışından tedarik edilebilir. Yeni Yurt Dışından İlaç Temin Yönetmeliği'ne göre, Yurt Dışından İlaç Temin Kılavuzu güncellenmiştir. Kılavuz, yurt dışı ilaç temin kaynağının kriterlerini ve temsilci yükümlülüklerini belirtir. İlaçlar, yetkili kuruluşlara beşeri tıbbi ürün tedariki yapan yurt dışındaki kuruluşlardan temin edilmelidir. İlaç temin kaynağı, üretici/ruhsat sahibi, yetkili ilaç otoriteleri tarafından ruhsatlandırılmış ecza deposu veya lisans verilen firma olmalıdır. Temsilci, yazılı olarak yetkilendirilmiş yerli bir kişi veya kuruluş olmalıdır. Kaynak ve temsilcinin yükümlülükleri Kılavuzda ayrıntılı olarak belirtilmiştir. Yönetmelik ve Kılavuz, ilaç temini sürecini düzenlemekte olup mali yükümlülükler anlaşmaya bağlıdır.
    Dicle Doğan

    New Guidelines on Named Patient Program was Published

    The Regulation on Supply of Pharmaceuticals from Abroad, recently published in Turkey, introduces new rules for procuring pharmaceuticals not authorized or available in the domestic market. The Guidelines accompanying the Regulation have been updated to reflect these changes. The Guidelines outline criteria for foreign pharmaceutical supply sources, specifying requirements for manufacturers/license holders, pharmaceutical warehouses, and authorized companies. The Regulation emphasizes obtaining products directly from authorized sources and ensuring quality and safety. The Guidelines also address the obligations of the representative appointed by the foreign pharmaceutical supply source, including pharmacovigilance and encoding processes. The Guidelines provide further details and examples not fully covered in the Regulation. The named patient program aims to charge costs to foreign companies, but it could be argued that the state should cover these expenses as part of its responsibility to provide healthcare services to citizens.
    Dicle Doğan

    Gıda ve Takviye Edici Gıdalarda Sağlık Beyanı ve Beslenme Beyanlarına İlişkin Yeni Düzenlemeler

    "Gıda ve Takviye Edici Gıdalarda Sağlık Beyanı Kullanımı Hakkında Yönetmelik" Resmi Gazete'de yayımlanarak yürürlüğe girdi. Türk Gıda Kodeksi Beslenme Beyanları Yönetmeliği ile birlikte yürürlüğe giren yönetmelik, beslenme ve sağlık beyanları için önceki izin ve onay sürecini tamamen kaldırdı. Sağlık Bakanlığı Türkiye İlaç ve Tıbbi Cihaz Kurumu tarafından hazırlanan kılavuzda, gıda ve takviye edici gıdalarda kullanılabilecek sağlık beyanları ve kurallar ayrıntılı olarak yer alıyor. Kayıtlı veya onaylı işletmeler tarafından üretilen veya ithal edilen ürünler, yönetmelik ve kılavuz hükümlerine uygunsa izin başvurusu yapmadan sağlık beyanları kullanılabilecek. Kurum, kamu sağlığı açısından gerekli gördüğü durumlarda sağlık beyanı kullanımını sınırlayabilir ve denetim mekanizmalarını işletebilir.
    Dicle Doğan

    New Regulations on Nutrition and Health Claims for Food and Food Supplements

    Turkey's Regulation on Health Claims for Food and Food Supplements has come into force, alongside the Turkish Food Codex Regulation on Nutrition Claims, repealing the previous Turkish Food Codex Regulation on Nutrition and Health Claims. The new regulations abolish the permission requirement for competent administrative authorities before making health claims for food and food supplements, introducing fundamental changes. A Guideline for Health Claims for Food and Food Supplements has been drafted by the Ministry of Health Turkish Pharmaceuticals and Medical Devices Authority, listing permitted health claims and detailed provisions. Health claims can be used without official permission, subject to certain conditions, and the Authority may limit their use to protect public health.
    Dicle Doğan

    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).
    Dicle Doğan

    Communiqué on Electronic Instructions for Use of Medical Devices Published (Turkey)

    On 6 April 2023, the Turkish Medicines and Medical Devices Agency published a new Communiqué on Electronic Instructions for Use of Medical Devices (Turkish language) in the Official Gazette numbered 32155.
    Dicle Doğan

    Decision on Pricing of Human Medicinal Products Amended with New Price Calculation

    On 14 March 2023, the Presidential Decree numbered 6932 Amending the Decision on Pricing of Medicinal Products for Human Use was published in the Official Gazette numbered 32132.
    Dicle Doğan

    Legislative Proposal on the Amendment of the Law on Pharmaceuticals and Medical Preparations No. 1262 and Certain Laws

    The Legislative Proposal on the Amendment of the Law on Pharmaceuticals and Medical Preparations No. 1262, Certain Laws and Decree Law No. 663 dated March 20, 2023, and numbered 2/5006 is an omnibus bill having some amendment offers regarding the regulating legislation of the health sector.
    Dicle Doğan

    Pricing of Pharmaceuticals and the Fixed Exchange Rate

    Pharmaceutical prices in Turkey have always been one of the most controversial issues. The prices of medicines that are to be marketed are set under the Decision on Pricing of Human Medicinal Products and the Communiqué on the Pricing of Human Medicinal Products of September 29, 2017, issued by the Ministry, which is vested with the competencies to regulate this area.
    Dicle Doğan