Named Patient Program in Turkey

Named Patient Program (“NPP”) is one of the exceptional pharmaceutical importation regimes for products that are not authorized or authorized but unavailable in the Turkish market for various reasons.

After numerous allegations in the news that the drugs supplied from abroad and used in cancer treatment were only products containing painkillers and that the products were counterfeit, the Regulation on the Supply of Medicines from Abroad (“NPP Regulation”) was published on February 3, 2023. The roles of stakeholders in the procurement process have been defined more clearly:

  • Foreign companies that supply medicines from abroad have been identified as Foreign Supply Sources, and having a Representative in Turkey has become mandatory.
  • The qualifications of Foreign Supply Sources and where they should supply the product if they are not the manufacturer are regulated.
  • The Turkish Pharmacists Association, the Social Security Institution, and the public institutions that are deemed appropriate by the Ministry of Health to supply products from abroad are defined as Foreign Drug Suppliers.

The products procured through these means must be registered with the Drug Monitoring System, just like the authorized medicines, allowing them to be tracked via the QR code that must be sealed on the products.

In line with the new rules stipulated in the NPP Regulation, the Guidelines on the Supply of Pharmaceuticals from Abroad ("Guidelines"), which indicates the guiding provisions regarding the implementation of the NPP Regulation, has been updated several times. According to the Guidelines, the QR code process, which Foreign Drug Suppliers must perform, can also be conducted by the Foreign Supply Sources in the customs-free zone. Another option would be that the QR code process is handled by Foreign Drug Suppliers where the Representative meets the financial obligations attributed to the process.

On 13 February 2024, the Guidelines has been updated to include a new provision stating that upon the Ministry of Health’s evaluation, the pharmaceuticals imported via NPP may also be requested to be supplied within a Compassionate Use Program. Usually, the Compassionate Use Program is an exceptional pharmaceutical importation regime where a product for which at least Phase II of the clinical trials have been completed in the world or for which efficacy and safety data have been obtained in the adaptive design trials in which Phase II and III are conducted together, allowing for the advanced phase of the trial. The product is supplied free of charge, until the same or another product in the relevant therapeutic area obtains a marketing authorization in Türkiye.

Considering the economic conjuncture in Türkiye, products become harder to enter or be available on the market. Supplying products from abroad via NPP creates financial burdens for the Social Security Institution; therefore, new solutions are sought and implemented to create an alternative procurement model in which the product is supplied free of charge.

First published by Biolegis in Mar 18, 2024.

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