Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceuticals without marketing authorization (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons.
In cases where a pharmaceutical does not have an MA in Turkey, or has an MA, but cannot be found on the market, and patients are in need the pharmaceutical in question, it is possible to procure the pharmaceutical via this special method upon the request of a physician. Institutions authorized to import pharmaceuticals within the scope of the supply of pharmaceuticals from abroad are Uluslararası Sağlık Hizmetleri A.Ş. (“USHAŞ”), Turkish Pharmacists' Association (“TEB”) and /or the İbn-i Sina Health Social Security Center (“İbn-i Sina”), within the Social Security Institution (“SSI”).
If the product is approved for the NPP, the products are added to the list of the Foreign Drugs List of the Turkish Medicines and Medical Devices Institution (“TITCK”), and imported from abroad by authorized institutions. If it is decided to reimburse the relevant product by the SSI, the product is published in the Annex-4/C list of the SSI's Communique on the Implementation of Healthcare.
The Law on Amending Certain Laws and Decree Laws Concerning Health dated 5 December 2018 (“Law”) now foresees that for foreign products imported, it is mandatory to apply for marketing authorization within three years from the date of entry onto the Foreign Drug List, and it is also required to obtain marketing authorization within two years from the date of application for marketing authorization. After the completion of the given durations, the decision on the continuation of the supply of drugs that has not obtained a marketing authorization, or for which no marketing authorization application has been filed, will be at the discretion of the President of the Republic.
The Guidelines on Drug Supply from Abroad (“Guidelines”) has also been updated several times within a short period of time.
With the last amendment dated 25 September 2020, the Foreign Drug Supply Commission was established to evaluate the applications for drugs to be supplied from abroad, and it is clearly regulated that medicinal products for human use added to the Foreign Drug List will be announced by the Authority six months prior to the completion of 3 years from the date of their entry onto the list, and the products deemed appropriate to remain on the list after these products are evaluated by the Foreign Drug Supply Commission, will be submitted for Presidential approval.
In addition, contrary to the regulation in the previous Guidelines, it is regulated that products registered in PIC/S member countries or licensed by the FDA / EMA can be supplied, without considering any priority relationship between PIC/S membership and FDA / EMA.
In addition, the drugs to be supplied from abroad will need to be licensed with the same indication, or allowed to be used by the competent official authorities of the relevant country or countries with the same indication, for which the treating physician requests usage of the product in Turkey. The Article regulating the responsibility of USHAŞ, TEB and SGK for the quality, effectiveness, and safety of medicinal products for human use supplied from abroad was removed, and it was regulated that these institutions would only be responsible for ensuring the processes until the delivery of the drug.
There is a practice to grant some of the NPP with alternative reimbursement agreements in which the SSI signs an agreement with foreign suppliers or their Turkish representatives. The alternative reimbursement agreements may guarantee that the products of a company that do or do not have an affiliate in Turkey, or which did or did not apply for an MA, will be reimbursed. This agreement allows confidentiality between the parties, but he prices, discounts, and other conditions are not publicly available.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.