Lawyers Fatma Sevde Tan

    Practice Areas & Work Department

    Life Sciences

    Intellectual Property

    Patent and Utility Models





    Istanbul Bar Association

    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.
    Fatma Sevde Tan

    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.
    Fatma Sevde Tan

    The Need for an Injunction in Cases Where the EPO Proceeding is held as a Pending Issue

    Although there is no explicit provision in Turkish Law for the acceptance of the ongoing opposition or appeal proceedings before the European Patent Office as a “pending issue” due to the principle of procedural economy, in practice, pending issue decisions may be given by the Civil Courts of Intellectual and Industrial Property Rights according to the particular circumstances.
    Fatma Sevde Tan

    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.
    Fatma Sevde Tan

    Regional Court of Appeals: The Decision of the TMMDA of Refusal of the Applications of the Original Medicine Owners to Obtain Information on Reference Product is Unlawful

    As per article 9 of the Regulation on Authorization, which regulates “Abridged Application”, if a pharmaceutical has been authorized before, it is not necessary to repeat the tests and research, and the data of these tests doesn’t have to be submitted for authorizing again, …
    Fatma Sevde Tan

    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.
    Fatma Sevde Tan

    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").
    Fatma Sevde Tan

    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.
    Fatma Sevde Tan

    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.
    Fatma Sevde Tan