Esin / Healthcare & Life Sciences - March 2023

Recent Developments in the Healthcare Sector

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) has recently amended the Decree on the Pricing of Pharmaceuticals and the Regulation on Pharmacists and Pharmacies.

Amendments on Decree on the Pricing of Pharmaceuticals

On 14 March 2023, the Presidency of Republic of Türkiye amended the Decree on the Pricing of Pharmaceuticals. 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 main amendments to the Decree are as follows:

• 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:
• Products that already have retail sales in Türkiye, or
• Products for which a retail sales price will be requested.
• A source country search will not be conducted for the following manufactured generic products:
• Products without a reference product,
• Products whose reference product cannot be considered as a source product.

For manufactured generic products that are already priced with the cost card and for which there is no reference product in Türkiye, the TİTCK 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.

• The following pharmacist profit rates will apply when determining the retail price of products other than pharmaceuticals:
• 28% for amounts up to TRY 328 (including TRY 328),
• 18% for amounts between TRY 328-657 (including TRY 657),
• 13% for amounts over TRY 657.
• 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
• products with a current Warehouse Sale Price of TRY 37.10 and below, and
• products with a current Warehouse Sale Price between TRY 37.11 (included) and TRY 55.89.
• 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 priceprotected 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.

The Decree is available here (in Turkish).

Amendments on the Regulation on Pharmacists and Pharmacies

On 14 March 2023, the TİTCK published the Regulation Amending the Regulation on Pharmacists and Pharmacies. The main amendments introduced by the Regulation are as follows:

• If the scores of the pharmacists that apply for the places announced for the opening of a pharmacy are equal, the TİTCK shall draw lots in the presence of a public notary and the placement shall be made according to the result of the lot.
• The opinion of the chamber of pharmacists is no longer required for approval procedures for modifications that will constitute changes in the existing sketches of pharmacies.
• The chamber of pharmacists or its representative shall determine the days and hours of vacation for pharmacies according to the conditions of the settlements in the regions.
• The TİTCK shall determine the necessity of on-duty pharmacies in order to meet the needs of the public. The chamber of pharmacists or its representative will determine the pharmacies that will be on duty in the amount determined by the TİTCK, and it will prepare the duty lists of the pharmacies and submit them for the approval of the district and provincial health directorate in a timely manner without disrupting the service. The duty lists shall be implemented with the acceptance and approval of the provincial health directorate.
• If the duty lists are not prepared by the chamber of pharmacists or its representative in a way that meets the need determined by the TİTCK, the provincial health directorate shall return the lists for a revision. If the rearranged lists are also unable to meet the needs, the duty lists shall be arranged by the provincial or district health directorate. In addition, if the chamber of pharmacists or its representative fails to prepare the duty lists of pharmacies and submit them for the approval of the provincial and district health directorate in a timely manner, the duty lists shall be prepared by the provincial or district health directorate.
• The request of a pharmacist to be exempted from the duty service based on illness or other excuses shall be evaluated by the regional chamber of pharmacists and implemented with the acceptance and approval of the provincial health directorate.
• In places with more than one pharmacy, a pharmacy can be kept closed upon the request of the pharmacist based on illness or other excuses, provided that the total period of closure does not exceed two years during the pharmacist’s career.

The Regulation is available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK’s announcements and take necessary actions to ensure compliance.

Tagged with: Esin Attorney Partnership, Can Sözer, Yiğit Acar, Ayça Doğu Öztürk, Gizem Nur Giacomini, Berk Furkan Derici, Life Sciences, Healthcare