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.

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.

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.

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.

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.

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.

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.

Article 85(3)/(c) of the Industrial Property Law No. 6769 regulates the Bolar Exemption, which stipulates the exclusion of experimental acts containing the invention subject to the patent from the scope of the patent right, including the licensing of pharmaceuticals and the necessary tests and experiments thereof.

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.

Standard-Essential Patents are the 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 innovation in the relevant market.

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.

On September 28, 2022, the Turkish Medicines and Medical Devices Agency published guidelines outlining the procedures and principles for donations of human medicinal products not approved in Turkey. Donations must align with the World Health Organization's medicine donation guidelines and be evaluated by the Ministry of Health based on their list of required medicines. In exceptional cases, the Agency may accept donations on a patient basis for medicines without a compassionate use program. The guidelines also detail customs clearance, storage, distribution, and delivery rules for donated medicines. The guidelines came into effect upon publication.