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    Lawyers Dicle Doğan

    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

    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

    Market Access - Alternative Reimbursement Models

    For an extended period, the pharmaceutical 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 to innovative products.
    Dicle Doğan

    Named Patient Program

    Named Patient Programs is one of the exceptional importation regimes of pharmaceuticals without marketing authorization in Turkey or with marketing authorization, but which are unavailable in the Turkish market for various reasons.
    Dicle Doğan

    Developments in the field of Medical Devices

    After the long-awaited Regulation on Medical Devices numbered 2017/745, prepared by the EU Commission, has entered into force, Medical Device Regulation, which was designed following MDR, was published in the Official Gazette numbered 31499 on June 2, 2020.
    Dicle Doğan

    Food Supplements, Food for Special Medical Purposes and Other Products

    The Regulation on the Importation, Production, Processing and Supply of Food Supplements was published by the Ministry of Food and Forestry on May 2, 2013, in the Official Gazette and came into force on August 2, 2013.
    Dicle Doğan

    Development of Telemedicine Activities in Turkey

    Telemedicine is one of the areas that are not explicitly regulated under Turkish law. Within the scope of the existing legal framework, the Medical Deontology By-law and Ethical Principles for Physicians prohibit remote examination, diagnosis, and treatment of patients.
    Dicle Doğan

    Yurt Dışından İlaç Temini Yeni Yönetmelik ile Düzenlendi

    Türkiye’de ruhsatlandırılmamış veya ruhsatlı olmakla birlikte piyasada bulunmayan ilaçlara hastaların ihtiyaç duyduğu durumlarda; söz konusu ilaç, hekimlerin talebi ve özel izinle yurt dışından tedarik edilebilmektedir. İlaçlar için öngörülen bu istisnai ithalat rejimi, yakın bir zamana kadar Türkiye İlaç ve Tıbbi Cihaz Kurumu (“TİTCK”) tarafından yayınlanmış olan Yurt Dışından İlaç Temini Kılavuzu ile düzenlenmekteydi. 3 Şubat 2023 tarihli 32093 sayılı Resmî Gazete’de Yurt Dışından İlaç Temin Yönetmeliği (“Yönetmelik”) yayınlanarak eski kılavuz yürürlükten kaldırılmıştır.
    Dicle Doğan

    New Regulation on Named Patient Programs is Published

    Pharmaceuticals that are not authorized in Turkey and/or not available in the market despite being authorized, shall be procured from abroad upon request of physicians and special authorization in cases where patients require such pharmaceuticals. Until recently, this exceptional import regime for pharmaceuticals was regulated by the Guideline on the Supply of Pharmaceuticals from Abroad published by the Turkish Medicines and Medical Devices Agency ("Agency").
    Dicle Doğan

    The Euro Value Applied to Pharmaceutical Prices was increased by 36.77%

    On 14 December 2022, the presidential decree numbered 6546 (“Decree”) amending the Decision on Pricing of Medicinal Products for Human Use was published in the Official Gazette numbered 32043.
    Dicle Doğan

    Life Sciences 2023 in Turkey

    The healthcare system is governed principally by the Fundamental Law on Healthcare Services No. 3,359 and dated 15 May 1987, which furnishes the Ministry of Health (MoH) with the authority to issue healthcare-related regulations and establish a healthcare system enabling each and every person living in Turkey to have equal and equitable access to the healthcare system. The regulatory authority is the MoH and its subsidiaries.
    Dicle Doğan

    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.
    Dicle Doğan

    New Provision Introduced to Decision on Drug Pricing

    On 9 November 2022, the Presidential Decree numbered 6365 Amending the Decree on Pricing of Medicinal Products for Human Use (Turkish language) (Decision) was published in the Official Gazette numbered 32008.
    Dicle Doğan