Recent Changes in the Named Patient Program

Pharmaceuticals not authorized in Turkey or authorized pharmaceuticals not available in the market, shall be procured from abroad as per a special authorization (named patient program) in cases where patients require such pharmaceuticals.

While this exceptional import regime for pharmaceuticals was until recently regulated by the Medicines and Medical Devices Agency ("Agency") through guideline, the Regulation on Supply of Pharmaceuticals from Abroad ("Regulation") was published in the Official Gazette dated 3 February 2023 and numbered 32093. The Guideline on Supply of Pharmaceuticals from Abroad ("Guideline"), which contains the guiding provisions regarding the implementation of the Regulation, was once again updated on 22 September 2023, after being updated in April.

Pursuant to the new revisions, in order to initiate the process of supplying products from abroad, instead of the Health Board Report to be obtained from tertiary healthcare service providers and prepared with the signatures of 3 physicians, at least 1 of them being from the relevant branch, the requirement of a reasoned decision of the council consisting of at least 3 specialised physicians related to the primary disease of the patient has been introduced. Thus, it is seen that the provision regarding the expertise of the physicians who will prescribe the products to be procured from abroad has been amended in order to strengthen the conditions required for the procurement of the product.

In addition, the Regulation and the Guideline stipulate that the authorisation document to be obtained by the foreign suppling company (the source) from the manufacturer or licensor providing the product, must be either wet signed or electronically signed. However, no additional explanation is provided regarding how electronic signature of such authorisation document can be conducted.

For medicinal products for human use that are approved to be procured from abroad before the effective date of the Guideline, the above-mentioned wet or electronic signature requirement must be completed and submitted to the Agency by 31 December 2023.

In addition, with the latest amendment to the Guideline, the draft patient consent form that the physician must obtain from the patient to be included in the programme has been added to the Guideline.

** First published by Gün + Partners in 18.12.2023