Insights Life Sciences & Healthcare

Türkiye İlaç ve Tıbbi Cihaz Kurumu (“TİTCK”), Tıbbi Cihaz Onaylanmış Kuruluş ve Klinik Araştırmalar Daire Başkanlığı tarafından hazırlanan “Tıbbi Cihaz Yönetmelikleri Kapsamında Değerlendirilmeyen Ürünler Hakkında Duyuruyu (“Duyuru”) 30 Ekim 2023 tarihinde yayımladı.

The Turkish Medicines and Medical Devices Agency (“TİTCK“) published the “Announcement on Products Not Evaluated under Medical Device Regulations” (“Announcement“) prepared by the Medical Devices Approved Organization and Clinical Research Department on October 30, 2023.

Türkiye İlaç ve Tıbbi Cihaz Kurumu (“Kurum”) geçtiğimiz haftalarda Ruhsatlı Beşeri Tıbbi Ürünlerde Yeniden Ruhsat Düzenlenmesini Gerektiren Hallere İlişkin Kılavuz ve Beşeri Tıbbi Ürünlerin Ruhsatlandırma Başvurularının Takvimlendirme Süreçlerine İlişkin Kılavuz’u yayımladı. Kurum, ayrıca (i) Beşeri Tıbbi Ürünler İçin Bilimsel Tavsiye Kılavuzu, (ii) Yurt Dışı Üretim Tesislerinin GMP Denetimleri için Yapılacak Müracaatlara Dair Kılavuz, (iii) Tıbbi Cihaz Yönetmeliğinin Ek XVI’sında Listelenen Tıbbi Amaçlı Olmayan Ürün Gruplarına Yönelik Ortak Spesifikasyonları Belirleyen Kılavuz’da değişiklik yaptı.

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Guideline on the Conditions Requiring the Renewal of Marketing Authorization for Pharmaceuticals and the Guideline on the Scheduling Processes of Applications for Marketing Authorization of Pharmaceuticals. The TİTCK also amended (i) the Guideline on Scientific Advice for Pharmaceuticals, (ii) the Guideline on Applications for GMP Audits of Foreign Production Facilities and (iii) the Guideline on Common Specifications for Nonmedical Product Groups Listed in Annex XVI of the Medical Device Regulation.

In this article, Altuğ and İdil explore the legal and ethical dimensions of Türkiye's booming medical tourism industry. Covering topics from accreditation and government support to legal challenges and dispute resolution, the article delves into the complexities of this dynamic sector.

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Guideline on Scientific Advice for Pharmaceuticals. The TİTCK also amended (i) the Regulation on Pharmacists and Pharmacies, (ii) the Regulation on Bespoke Prosthetic and Orthotic Centers and Hearing Aid Centers, (iii) the Regulation on Opticianry Establishments, (iv) the Guideline on Scientific Meetings and Educational Activities to be Held within the Scope of the Regulation on Sale, Advertising and Promotion of Medical Devices, and (v) the Regulation on the Use of Health Claims for Food and Food Supplements. It also announced the Second Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products as well as the Second Quarter Results for 2015 on Market Surveillance and Inspection of Cosmetic and Medical Devices.

On 22 August 2023, the Turkish Medicines and Medical Devices Agency (Agency) announced an updated Guideline on Scientific Meetings and Educational Activities to be Held in Accordance with the Regulation on Sales, Advertising and Promotion of Medical Devices (Turkish language) (Guideline) on its official website. The Guideline replaced the previous version dated 15 November 2022.

Türkiye İlaç ve Tıbbi Cihaz Kurumu (“Kurum”) geçtiğimiz haftalarda Sağlık Hizmetlerinde Tanıtım ve Bilgilendirme Faaliyetleri Hakkında Yönetmelik’i yayımladı. Kurum ayrıca Faz 1 Klinik Araştırma Merkezleri Hakkında Kılavuz ve İyi Klinik Uygulamaları Denetimleri İçin Başvuru Kılavuzu’nda değişiklik yaptı. Ek olarak, Cumhurbaşkanlığı Beşeri Tıbbi Ürünlerin Fiyatlandırılmasına Dair Karar’da değişiklik yaptı.

The Ministry of Health (MoH) is the main body in charge of health services in Türkiye. It regulates all healthcare institutions in the country, which includes patient care facilities such as hospitals, clinics and diagnostic centres and the practice of medical and other health professions. The Turkish Medicines and Medical Devices Agency (Agency) is a regulatory agency of the government that acts as the highest sanitary authority in terms of medical safety on medicines, health products, cosmetics and personal care products.

Turkey's healthcare system, governed by the Fundamental Law on Healthcare Services No. 3359, falls under the Ministry of Health's purview. Social Security Institution (SSI) health insurance covers the active population, retirees, and dependents, while co-payments apply to certain services. The Health Services Pricing Commission regulates pricing, and the Regulation on Drug Reimbursement governs reimbursement. Licenses for private hospitals require Ministry of Health approval. Foreign companies cannot provide healthcare services. Competition law applies to private hospitals and clinics, subject to Turkish Competition Authority oversight.

Türkiye's role as a connecting point between leading European cosmetics companies and the high-demand markets of Asia and the Middle East cannot be overstated. With its geographical location, trade relations with neighboring countries, and a population of over 85 million, Türkiye has a competitive edge in cosmetics and huge market potential. In support of this, Türkiye, which is in the top 30 among the World Cosmetics Importers in 2023, also has an average growth rate of 10% annually in the cosmetics market.[1] While cosmetic products are primarily intended for non-medical purposes, their application to the human body necessitates regulatory oversight within the cosmetics industry. This is essential to safeguard human health and maintain ethical standards in commercial marketing and advertising practices.

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Regulation on Promotion and Information Activities in Healthcare Services. The TİTCK also amended the Guideline on Phase 1 Clinical Research Centers and the Guideline on Application for Good Clinical Practice Audits. In addition, the Presidency amended the Decree on the Pricing of Pharmaceuticals.

27.05.2023 tarihli ve 32203 sayılı Resmi Gazete’de yayımlanan ilgili yönetmelik (“Yönetmelik”) ile yapılan klinik araştırmaların yürütülmesi ve gönüllülerin haklarının korunmasına dair usul ve esaslar ile Klinik Araştırmalar Danışma Kurulu ve etik kurulların teşkili, görevleri, çalışma usul ve esasları tekrardan genel olarak belirlenmiştir.

A new regulation on clinical trials in Turkey has been published in the Official Gazette. The regulation aims to protect the rights of volunteers and ensure that clinical trials are conducted in accordance with international standards. The regulation abolishes the separation of duties determined according to the threshold of the disputable amount. This means that the amount in question will no longer have an effect on the determination of the arbitral tribunal. The regulation also includes provisions on the import of research products, insurance for volunteers, and the Agency's inspection powers.

Özel Tıbbi Amaçlı Gıdalar Ambalaj Bilgileri Kılavuzu yayımlandı. Kılavuz, Özel Tıbbi Amaçlı Gıdalar Ruhsatlandırma Yönetmeliği’ne göre hazırlanan ve ambalaj bilgilerinin kapsamını ve içeriğini açıklayan detaylı bir rehberdir. Kılavuz, ürün adlandırılması, bileşenler listesi, enerji ve besin ögeleri tablosu, kullanım amaçları, uyarılar, hazırlanma talimatı, kullanım şekli, saklama koşulları, son tüketim tarihi, raf ömrü, ruhsat sahibi, üretim yeri, ruhsat numarası ve seri numarası gibi bilgilerin ambalajda yer alması gerektiğini düzenlemektedir. Kılavuz, hastalar için yararlı olacak semboller ve resimli diyagramların da ambalajda yer almasına izin vermektedir.

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.

The Turkish Medicines and Medical Devices Agency has published a guide on the packaging information and readability of foods for special medical purposes. The guide provides detailed information on the information that must be included on the packaging, such as the name of the product, list of ingredients, intended use, and warnings. It also includes regulations on the design and technical details of the packaging information.

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 August 14, 2023, the Personal Data Protection Board ("Board") released two rulings pertaining to the activities of two separate entities in the healthcare sector, within the framework of the Personal Data Protection Law ("Law"). In the first decision, stemming from a complaint regarding the linkage of health service provision by a private healthcare institution to explicit consent, an evaluation led to the imposition of a fine amounting to 300,000 TL on the institution. Furthermore, a decision was made to modify the phrasing that signifies endorsement of the consent form yet creates the perception of aligning with the clarification text. Additionally, a decision has been made to further organize explicit consent texts pertaining to personal data processed within the scope of explicit consent, despite it not being obligatory.