Türkiye İlaç ve Tıbbi Cihaz Kurumu (“Kurum”) geçtiğimiz haftalarda, Türkiye İlaç ve Tıbbî Cihaz Kurumu Ulusal Kontrol Laboratuvarının Görev, Yetki ve Sorumlulukları ile Çalışma Usul ve Esasları Hakkında Yönetmelik, Farmakovijilans Sistemi Kılavuzu, (AB) 2022/2346 Sayılı ve (AB) 2022/2347 Sayılı Uygulama Tüzükleri hakkında duyuru ve Tıbbi Cihaz Klinik Araştırmaları Hakkında duyuru yayımladı.

Sağlık & Yaşam Bilimleri Bülteni

Can Sözer is a partner of IT/C practice group
and head of Healthcare industry group at Esin Attorney Partnership. His main
areas of practice are data privacy, healthcare law, IT/C law, consumer
protection law, commercial law, contracts law, marketing law, regulatory,
environmental law, media &amp; entertainment law and product liability law. Can Sözer represents local and foreign
companies regarding day-to-day commercial matters as well as administrative
regulations of different sectors. He is also an active member of AmCham Healthcare
and Life Sciences Committee and Digital Economy Committee since 2016. Practice Areas &amp; Work Department





Information Technology &amp; Communications

International Commercial &amp; Trade

Healthcare 

Languages

Turkish 

English 

German 



Memberships

Admitted to Istanbul Bar, 2012.

Esin Attorney Partnership

Partner

Yiğit is an associate at Esin Attorney
 Partnership. He specializes in pharmaceuticals and healthcare law. He also
 focuses his practice on data privacy, IT/C law, commercial law, contracts law
 and product liability law. 

&nbsp; Practice Areas &amp; Work Department

Information Technology &amp; Communications

International Commercial &amp; Trade

Healthcare

&nbsp; 

Languages

Turkish 

English 

&nbsp; 

Memberships

Admitted to Istanbul Bar, 2020.

Associate

Ayça Doğu is an associate at Esin
Attorney Partnership. Her main areas of practice are healthcare law,
regulatory, data privacy, media &amp; entertainment, IT/C, e-commerce,
commercial law and contracts law. Practice Areas &amp; Work Department

Information Technology &amp; Communications

Healthcare

International Commercial &amp; Trade

&nbsp; 

Languages

Turkish 

English 

French

&nbsp; 

Memberships

Admitted to Istanbul Bar, 2019.

Practice Areas &amp; Work DepartmentInformation Technology &amp; CommunicationsInternational Commercial &amp; TradeHealthcare EducationKoç University, Faculty of Law, Istanbul, 2021.Koç University, International Relations, Istanbul, 2021. Bar AdmissionAdmitted to Istanbul Bar, 2022. LanguagesTurkishEnglish

&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;strong>Yeni Gelişme&lt;/strong>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">Cumhurbaşkanlığı, 14 Mart 2023 tarihinde Beşeri Tıbbi Ürünlerin Fiyatlandırılmasına Dair Kararda Değişiklik Yapılması Hakkında Karar'ı ("Karar") yayımladı. Karar kapsamında getirilen gerçek kaynak fiyat hesaplanmasına ilişkin düzenlemeler 9 Kasım 2022 tarihinde, diğer değişiklikler ise Karar'ın yayımı tarihinde yürürlüğe girecektir. Karar'a&nbsp;&lt;/span>&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;a href="https://www.resmigazete.gov.tr/eskiler/2023/03/20230314-1.pdf" target="_blank" style="color: rgb(3, 102, 132);">buradan&lt;/a>&lt;/span>&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&nbsp;ulaşabilirsiniz.&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;strong>Ne Değişecek?&lt;/strong>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">Karar ile yapılan başlıca değişiklikler aşağıdaki gibidir:&lt;/span>&lt;/p>&lt;ul style="list-style-type: square;">&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">Türkiye'de halihazırda perakende satışı bulunan veya perakende satış fiyatı talep edecek olan ithal ürünlerin, kaynak ürününün tespit edilemediği durumlarda, herhangi bir ülkede perakende satışı olmayan ve sadece hastane kanalıyla satışa sunulan ürünün depocuya satış fiyatı, gerçek kaynak fiyat hesaplamasında dikkate alınacaktır.&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">Türkiye'de referans ürünü bulunmayan veya Türkiye'de bulunan referans ürünü kaynak ürün olarak alınamayan imal eşdeğer ürünler için kaynak ülke araştırması yapılmayacaktır. Halihazırda maliyet kartı ile fiyatlandırılmış olup Türkiye'de referans ürünü bulunmayan imal eşdeğer ürünler için TİTCK tarafından yeniden referans ürün araştırması yapılmayacak, veya kaynak ülkelerde kaynak fiyat tespit edilmesi halinde bu fiyat hesaplamalarda dikkate alınmayacaktır.&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">İlaçlar haricindeki ürünlerin perakende satış fiyatı belirlenirken uygulanacak eczacı kar oranları aşağıdaki şekilde değiştirilmiştir;&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">328 TL'ye kadar olan kısım için (328 TL dahil) %28,&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">328-657 TL arasında kalan kısım için (657 TL dahil) %18,&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">657 TL üstünde kalan kısım için %13&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">Geri ödemesiz ürünler hariç olmak kaydıyla, Detaylı İlaç Fiyat Listesinde yer alan ve Depocuya Satış Fiyatı (DSP) 55,90 TL (55,90 TL dâhil değil) altında olan ürünler için Depocuya Satış Fiyatına;&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">mevcutta Depocuya Satış Fiyatı (DSF) 37,10 TL ve altında olan ürünlere 37,10 TL'yi aşmayacak şekilde,&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">mevcutta Depocuya Satış Fiyatı (DSF) 37,11 TL (dahil) ile 55,89 TL arasında olan ürünlere 55,89 TL’yi aşmayacak şekilde,&nbsp;&lt;/span>&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">4 TL'ye kadar artış verilecektir.&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">Fiyat korumalı ürünlerde 37,10 TL ve altında, diğer ürünlerde 19,39 TL altında olan ürünlere verilen bu artış mahsuplaşma işleminden muaf tutulmuştur. Fiyat korumalı ürünlerde 37,11 TL ile 55,89 TL arasında, diğer ürünlerde 19,39 TL ile 55,89 TL arasında olan ürünlere verilen bu artış gerçek kaynak fiyat değişiklik döneminde mahsuplaşma işleminden muaf değildir.&lt;/span>&lt;/li>&lt;/ul>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;strong>Sonuç&lt;/strong>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">Karar'da yapılan değişiklikler ile beşeri tıbbi ürünlerin fiyatlandırılmasına ilişkin yeni düzenlemeler ve eşikler getirilmiş, kaynak ürünün ya da referans ürününün tespit edilemediği haller için alternatif bir hesaplama yöntemi düzenlenmiştir. Türkiye'de ilaçların piyasa arzında, ithalatında veya dağıtımında faaliyet gösteren tüm şirketler, fiyatlandırma düzenlemelerinde yapılan değişiklikleri yakından takip etmeli ve mevzuatta yer alan yükümlülüklerini yerine getirmelidir.&lt;/span>&lt;/p>

Cumhurbaşkanlığı, 14 Mart 2023 tarihinde Beşeri Tıbbi Ürünlerin Fiyatlandırılmasına Dair Kararda Değişiklik Yapılması Hakkında Karar'ı yayımladı. Karar kapsamında getirilen gerçek kaynak fiyat hesaplanmasına ilişkin düzenlemeler 9 Kasım 2022 tarihinde, diğer değişiklikler ise Karar'ın yayımı tarihinde yürürlüğe girecektir.

Beşeri Tıbbi Ürünlerin Fiyatlandırılmasına Dair Karar'da Değişiklik

&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;strong>Recent Development&lt;/strong>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">On 14 March 2023, the Presidency of Republic of Türkiye amended the Decree on the Pricing of Pharmaceuticals (“&lt;/span>&lt;strong style="font-size: 14px;">Decree&lt;/strong>&lt;span style="font-size: 14px;">“). The amendments regarding the calculation of real source price will enter into force as of 9 November 2022, whereas the other amendments to the Decree will enter into force as of the date of publication. The Decree is available online&nbsp;&lt;/span>&lt;span style="font-size: 14px;">&lt;a href="https://www.resmigazete.gov.tr/eskiler/2023/03/20230314-1.pdf" target="_blank" rel="nofollow" style="color: rgb(3, 102, 132);">here&lt;/a>&lt;/span>&lt;span style="font-size: 14px;">&nbsp;(in Turkish).&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;strong>What’s New?&lt;/strong>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">The main amendments to the Decree are as follows:&lt;/span>&lt;/span>&lt;/p>&lt;ul style="list-style-type: square;">&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">In cases where the source product the following imported products cannot be determined, the warehouse sale price of the product that does not have retail sales in any country and is only offered for sale through hospital channels will be taken into account in the real source price calculation:&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Products that already have retail sales in Türkiye, or&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Products for which a retail sales price will be requested.&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">A source country search will not be conducted for the following manufactured generic products:&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Products without a reference product&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Products whose reference product cannot be considered as a source product.&lt;/span>&lt;/span>&lt;/li>&lt;/ul>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">For manufactured generic products that are already priced with the cost card and for which there is no reference product in Türkiye, the Turkish Pharmaceuticals and Medical Devices Authority (“&lt;/span>&lt;strong>TİTCK&lt;/strong>&lt;span style="font-size: 14px;">”) will not conduct a reference product search again, or if a reference price is determined in the source countries, this price will not be taken into account in the calculations.&lt;/span>&lt;/span>&lt;/span>&lt;/p>&lt;ul style="list-style-type: square;">&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">The following pharmacist profit rates will apply when determining the retail price of products other than pharmaceuticals:&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">28% for amounts up to TRY 328 (including TRY 328),&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">18% for amounts between TRY 328-657 (including TRY 657),&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">13% for amounts over TRY 657.&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">Except for non-reimbursable products, for products included in the Detailed Pharmaceutical Price List with a Warehouse Sale Price below TRY 55.90 (not including TRY 55.90), the Warehouse Sale Price will be increased up to TRY 4 for:&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">products with a current Warehouse Sale Price of TRY 37.10 and below, and&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">products with a current Warehouse Sale Price between TRY 37.11 (included) and TRY 55.89.&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">The foregoing increase applied to price-protected products that are priced at or below TRY 37.10 and other products priced below TRY 19.39 is exempt from offsetting. The increase applied to price-protected products between TRY 37.11 and TRY 55.89 and other products priced between TRY 19.39 and TRY 55.89 is not exempt from offsetting during the real source price change period.&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;/ul>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">&lt;strong>Conclusion&lt;/strong>&lt;/span>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">Amendments to the Decree introduced new regulations and thresholds in relation to the pricing of pharmaceuticals and set out an alternative pricing regime for cases where the source product or reference product cannot be identified. Companies that are involved in the placement on the market, importation or distribution of pharmaceuticals in Türkiye must review the amendments to the pricing regulations carefully and take the necessary actions to ensure compliance with the legislation.&lt;/span>&lt;/span>&lt;/span>&lt;/p>

Recent Development On 14 March 2023, the Presidency of Republic of Türkiye amended the Decree on the Pricing of Pharmaceuticals.

Amendments on Decree on the Pricing of Pharmaceutical

Vergi alacakları da dahil olmak üzere çeşitli kamu alacaklarının yeniden yapılandırılması, matrah artırımı, işletme kayıtlarının düzeltilmesi ve bazı kurumlar vergisi mükelleflerine ek vergi ihdas edilmesine dair hükümleri içeren 7440 sayılı Bazı Alacakların Yeniden Yapılandırılması ile Bazı Kanunlarda Değişiklik Yapılmasına İlişkin Kanun 12 Mart 2023 tarihli Resmi Gazete'de yayımlanarak yürürlüğe girdi.

Yeni Vergi Affı Yürürlüğe Girdi

&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;strong>Yeni Gelişmeler&lt;/strong>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">12 Mart 2023 tarihli Resmi Gazete’de yayımlanan 7440 sayılı Bazı Alacakların Yeniden Yapılandırılması ile Bazı Kanunlarda Değişiklik Yapılmasına Dair Kanun (“&lt;/span>&lt;strong>7440 Sayılı Kanun&lt;/strong>&lt;span style="font-size: 14px;">“) ile kurum kazancının tespitinde istisna ve indirimden yararlanan kurumlar vergisi mükelleflerine yönelik tek seferlik bir ek vergi getirildi. Tek seferlik ek vergi ile Kahramanmaraş ve Hatay merkezli depremlerden etkilenen depremzedelerin acil ihtiyaçlarının karşılanması ve bölgenin yeniden inşası için kaynak oluşturulması hedefleniyor. Deprem vergisi olarak da anılan ek verginin yirmi iki bin civarında kurumlar vergisi mükellefini etkilemesi bekleniyor.&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;strong>Tek Seferlik Ek Vergi Ne Anlama Geliyor?&lt;/strong>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">7440 Sayılı Kanun’un 10. maddesi ile bazı kurumlar vergisi mükelleflerine getirilen tek seferlik ek vergiye yönelik detaylar aşağıdaki şekilde:&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;u>Ek Verginin Kapsamı&lt;/u>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">7440 Sayılı Kanun’un 10. maddesi kapsamında 2022 yılı kurumlar vergisi hesabında;&lt;/span>&lt;/span>&lt;/p>&lt;ul style="list-style-type: square;">&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">Kurumlar Vergisi Kanunu ve diğer kanunlarda yer alan düzenlemeler uyarınca kurum kazancından indirim konusu yapılan istisna ve indirim tutarları ile Kurumlar Vergisi Kanunu’nun 32/A maddesi kapsamında indirimli kurumlar vergisine tabi matrahlar üzerinden,&nbsp;&lt;/span>&lt;strong style="">dönem kazancıyla ilişkilendirilmeksizin %10 oranında&lt;/strong>&lt;span style="font-size: 14px;">,&lt;/span>&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">Kurumlar Vergisi Kanunu’nun 5/1-a maddesinde düzenlenen iştirak kazancı istisnasına konu kazançlar ile yurt dışından elde edilip en az %15 oranında vergi yükü taşıdığı tevsik edilen istisna kazanç üzerinden&nbsp;&lt;/span>&lt;strong style="">%5 oranında&lt;/strong>&lt;/span>&lt;/span>&lt;/li>&lt;/ul>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">tek seferlik ek vergi uygulanacak. Afet bölgesi ilan edilen il ve ilçelerdeki kurumlar vergisi mükellefleri ise getirilen tek seferlik ek vergiden muaf tutuldu. Aynı zamanda aşağıda sayılan istisna ve indirimler üzerinden ek vergi hesaplanmayacak:&lt;/span>&lt;/span>&lt;/p>&lt;ul style="list-style-type: square;">&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Kurumlar Vergisi Kanunu’nun;&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">5/1-d maddesi kapsamında belirli yatırım fonlarından elde edilen kazançlara yönelik istisna,&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">5/1-i maddesi kapsamında kooperatiflerde harcanmayarak ortaklara iade edilen tutarlara ilişkin istisna ile tüketim kooperatiflerine yönelik risturn istisnası,&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">5/1-j maddesi kapsamında sat-kirala-geri al işlemlerinden doğan kazanç istisnası,&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">5/1-k maddesi kapsamında kira sertifikası ihracı amacıyla varlık ve hakların satışından doğan kazançlara ilişkin istisna,&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Geçici 14. maddesi kapsamında kur korumalı mevduat hesaplarına sağlanan istisna,&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">10/1-b maddesinde düzenlenen sponsorluk harcamaları indirimi,&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 40px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">10. maddesinde düzenlenen belirli bağış ve yardımlar ile ilgili kanunlarında düzenlenen bağış ve yardımlar kapsamındaki indirimler,&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Gelir Vergisi Kanunu’nun Geçici 63. maddesinde düzenlenen tevkifata tabi yatırım indirimi istisnası,&lt;/span>&lt;/span>&lt;/li>&lt;li style="margin-left: 20px; text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Mikro ve küçük ölçekli işletmelerin teknoloji geliştirme bölgeleri ile ar-ge ve tasarım merkezlerinden elde ettikleri istisna ve indirime konu kazançlar.&lt;/span>&lt;/span>&lt;/li>&lt;/ul>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Ek vergi kapsamında yapılacak ödemeler, gider ve indirim olarak dikkate alınamayacağı gibi herhangi bir vergiden mahsup da edilemeyecek.&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;u>Ek Verginin Beyanı ve Ödenmesi&lt;/u>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">7440 Sayılı Kanun ile getirilen tek seferlik ek vergi 2022 hesap dönemi kurumlar vergisi beyannamesi ile beyan edilecek. Kurumlar vergisi ödeme süresi olan nisan ayı içerisinde ek verginin ilk taksiti, ilk taksitin ödenmesini takip eden dördüncü ay olan ağustos ayında ise ikinci taksiti ödenecek.&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Özel hesap dönemine tabi mükellefler için ise ek vergi 2023 yılı içinde sona eren hesap dönemi bakımından uygulanacak. Bu kapsamda özel hesap dönemine tabi mükellefler, hesap dönemlerinin kapandığı ayı izleyen dördüncü ayda kurumlar vergisi beyannamesi ile ek vergiyi beyan edip ilk taksitini ödeyecek, ikinci taksiti ise ilk taksiti takip eden dördüncü ayda ödeyecek.&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;strong>Sonuç&lt;/strong>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">Afet bölgesindeki depremzedelerin acil ihtiyaçlarının karşılanması ve depremden etkilenen bölgenin yeniden inşası için kaynak oluşturulması amacıyla getirilen tek seferlik ek verginin uygulanmasına ilişkin usul ve esasların Maliye ve Hazine Bakanlığı’nca yayımlanacak bir tebliğ ile belirlenmesini bekliyoruz. Bununla birlikte, söz konusu ek vergi kanunların geriye yürümezliği, vergilendirmede öngörülebilirlik ve eşitlik ilkeleri gibi Anayasal ilkeler yönünden çeşitli tartışmaları da beraberinde getirdiğinden, kapsama giren kurumlar vergisi mükelleflerinin bu tartışmaları dikkate almalarında ve ek vergiyi ihtirazi kayıtla beyan ederek dava konusu etmelerinde fayda görüyoruz.&lt;/span>&lt;/span>&lt;/p>

12 Mart 2023 tarihli Resmi Gazete’de yayımlanan 7440 sayılı Bazı Alacakların Yeniden Yapılandırılması ile Bazı Kanunlarda Değişiklik Yapılmasına Dair Kanun ile kurum kazancının tespitinde istisna ve indirimden yararlanan kurumlar vergisi mükelleflerine yönelik tek seferlik bir ek vergi getirildi.

Bazı Kurumlar Vergisi Mükelleflerine Tek Seferlik Ek Vergi Getirildi!

Law No. 7440 on Restructuring of Certain Receivables and Amending Certain Laws, which includes provisions regarding the restructuring of various public receivables, including tax receivables, tax base increase and business records correction and imposes additional tax on certain corporate taxpayers, has come into effect by being published in the Official Gazette dated 12 March 2023.

New Tax Amnesty Comes Into Effect

&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">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 (“&lt;/span>&lt;strong style="font-size: 14px;">Decision&lt;/strong>&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">”) and the Communiqué on the Pricing of Human Medicinal Products (“&lt;/span>&lt;strong>Communiqué&lt;/strong>&lt;span style="font-size: 14px;">”) of September 29, 2017, issued by the Ministry, which is vested with the competencies to regulate this area.&lt;/span>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">The Decision provides a reference pricing system, whereby the least-expensive ex-factory price in one of the listed EU countries for the relevant product is taken as the ex-factory price in Turkey. The currency is then converted into Turkish liras; however, this transaction is done at a fixed value every year so that it is not affected by fluctuations in the exchange rates. Thus, the exchange rate applied to the reference price taken from the respective EU country is fixed for one year, and the price reached is considerably lower than the current exchange rate.&lt;/span>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">With the Decision entered into force in 2017, the rate was determined as 60% of the average euro value of the previous year. Accordingly, the main rule is that the Price Evaluation Commission gathers in the first 45 days of each year and announces the value of euro 1 based on a calculation of 60% of the average value in the previous year.&lt;/span>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">According to this rule, on February 14, 2022, the exchange rate to be used in the pricing of medicines was set as TL 6.2925. However, due to the rapid change in the exchange rate in 2022, with the provisional article added to the Decision, on July 8, 2022, the value of 1 Euro was increased by 25%, and the new exchange rate was set as TRY 7.8656. Subsequently, on December 14, 2022, the value of 1 Euro in Turkish Lira to be used in the pricing of pharmaceutical products for human use was increased by 36.77% to TL 10.7577 in December 2022.&lt;/span>&lt;/span>&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">&lt;span style="font-size: 14px;">&lt;span style="font-size: 14px;">For 2023, it was stated that this last amount would continue to be applied and that the Price Evaluation Commission would not announce a new value in the first 45 days of the year. However, although it has not been regulated in the legislation yet, one can expect an increase to be made again in 2023 due to the fluctuations in the current exchange rate.&lt;/span>&lt;/span>&lt;/span>&lt;/p>

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.

Pricing of Pharmaceuticals and the Fixed Exchange Rate

&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">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.&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">With the enactment of the Social Security and General Health Insurance Law numbered 6552 in September 2014, alternative reimbursement models also became an essential topic in the Turkish healthcare industry. The complementary provisions introduced with the Regulation on the Alternative Reimbursement of Pharmaceuticals, published in February 2016, allowed companies and the SSI to benefit from discussing the terms and conditions of an alternative reimbursement model for particular products. It was expected that alternative reimbursement models, in which the SSI will enter a direct contractual relationship with pharmaceutical companies, will ultimately allow patients to access innovative pharmaceuticals faster. However, nowadays, these models also appear to control pharmaceutical prices.&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">In addition, with the conclusion of one of the actions filed against specific provisions of the Regulation on the Alternative Reimbursement of Pharmaceuticals, some articles were annulled on the grounds of procedural deficiency, as the SSI issued the regulation without receiving the opinion of the Ministry. Since the entire text is not the subject of the action, only some of the provisions were brought before the court, and essentially the entire Regulation is still in force, including the article of the law on which the alternative reimbursement models are based.&lt;/span>&lt;/p>&lt;p style="text-align: justify;">&lt;span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;">Following the annulment decision, the SSI was expected to update the Regulation on the Alternative Reimbursement of Pharmaceuticals by duly re-publishing the annulled articles. Instead, the SSI published the new Regulation on the Reimbursement of Pharmaceuticals, including the articles that will update the principle of confidentiality of the discount rates applied in these alternative models. In this context, the rule regarding confidentiality, implemented with the Alternative Reimbursement Regulation, has been re-introduced with the amendment made in the Pharmaceutical Reimbursement Regulation. However, it is unclear whether the Alternative Reimbursement Commission will be convened or the pharmaceutical companies will make new reimbursement agreements with the SSI with confidential and special discounted prices. It is thought that the elections, to be held in 2023, also play a role in how the implementation will continue in this issue, which is highly critical for the country’s economy and companies.&lt;/span>&lt;/p>

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.

Market Access - Alternative Reimbursement Models

Türkiye İlaç ve Tıbbi Cihaz Kurumu geçtiğimiz haftalarda, (AB) 2017/745 sayılı Tüzük hakkında duyuru, Özel Tıbbi Amaçlı Gıdalar Ruhsatlandırma Yönetmeliği ve Geleneksel Bitkisel Tıbbi Ürünler Ruhsatlandırma Yönetmeliği’ni yayımladı.

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