Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceutical products without marketing authorisation (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons.
Only the Turkish Pharmacists’ Association (“TEB”) and the İbn-i Sina Health Social Security Center, established under the SSI, were authorized to import NPP products until December 2018. An amendment in the law was introduced in December, 2018, stating that this special importation shall be made by the SSI and the TEB, as well as institutions / organizations deemed appropriate by the MoH. No criteria have been determined for the selection of such institutions/ organizations to date.
The 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 mandatory to obtain marketing authorization within two years from the date of application for marketing authorization. However, no sanction has been determined in the event this rule is breached. After the completion of the given durations, the President of the Republic is authorized to decide 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. For the products that had been supplied from abroad, prior to the entry into force of the Law, which was 5 December 2018, the application period for marketing authorization, and the products for which previous marketing authorization had been applied, the period to obtain marketing authorization commenced 5 December 2018.
In addition, without making any change in the Regulation on the market authorization, or NPP, and by only amending the legislation on pharmacies, the obligation to obtain market authorization within three years after being listed on the Foreign Drug List, and to obtain market authorization within two years after the application for the market authorization, has been established for the drugs that are included on the Foreign Drug List. As well, for the drug that has been prescribed for a patient by a physician, but for which no application for a market authorization has been filed, or which did not obtain market authorization within the specified periods, the decision to continue the supply from abroad is left to the President's discretion. Also, if the company who owns the product in question does not have any subsidiary or representative in Turkey, it is understood that the discretionary power on the decision to continue supplying that product has been also given to the President.
On 10 January 2020, the TITCK published the New “Guidelines on Named Patient Program (“Guidelines”). The Guideline includes some changes regarding the execution of the named patient program. Among the suppliers of the NPP, Uluslararası Sağlık Hizmetleri A.Ş. (“USHAŞ”), a public enterprise established by law, was added next to TEB and SSI.
In addition, only active ingredients that are supplied from abroad will be published; thus, the list of the products supplied from abroad will no longer be published. The responsibility for the risks that may arise in terms of patient health due to the supplied medicines is now clearly burdened on USHAŞ, TEB and/or SSI. In addition, the TITCK clearly regulated its right to conduct any kind of examination and research, including GMP inspection, on human medicinal products supplied from abroad by the NPP, if deemed necessary.
As of the publication of the Guidelines, the TITCK has ceased to share the list of the products supplied from abroad, and has already published new lists of active ingredients supplied from abroad.
Although it is not given in the legislation, there is a practice to grant some of the NPP with alternative reimbursement agreements in which 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. In addition, this agreement allows confidentiality between the parties; the prices, discounts, and other conditions are not publically available.