The supply of pharmaceutical products to Turkey via the named patient programme (the “NPP”) is one of the exceptional importation regimes for pharmaceutical products. Where a pharmaceutical product is not granted marketing authorisation in Turkey, or it is granted marketing authorisation but not found in the market, but patients need it, it can be supplied via this special route by physician request. The entities that are authorised to import pharmaceuticals within the scope of the NPP are the International Health Services Inc. (the “USHAS”), the Turkish Pharmacists’ Association’s Economic Enterprise (the “TEB”) and/or the Ibn-i Sina Health Social Security Centre, established under the Social Security Institution (the “SSI”).
If the product is approved for the NPP, it is added to the Foreign Drug List of the Turkish Medicines and Medical Devices Agency (the “TMMDA”), and nowadays, is mostly imported by the TEB and SSI on a named-patient basis. If the reimbursement of the relevant product is decided by the SSI, the product is published in the Annex-4/C list of the Health Practices Communiqué of the SSI.
This exceptional supply method causes some problems for the protection and enforcement of patent rights in Turkey. The patent owner, who also supplies the patented product via the NPP, is made aware of the competitor product by its inclusion on the foreign drug list.
In cases where the existence of a patent infringement is suspicious or unavoidable, the patent owner intends to exercise its legal rights, but cannot access supplier information that is not publicly shared. The only known party to the patent owner who is causing the infringement would be either the TEB or the SSI, as the importer of the infringing products. The Courts of Appeal have ruled that in cases of the supply of an infringing product via the NPP, the buyer of product in Turkey, the TEB, may be one of the potential named parties of the patent infringement action, as the importer of the infringing products. However, since the relevant institutions are the solution partners of the patent owner for supply of its patented product via the NPP, it may not be preferred to bring an action against these institutions. In practice, the TMMDA, the TEB and the SSI do not share information about the supplier of the product that would create the risk of infringement. In order to ensure that patent rights are used effectively in this field, the foreign drug supply and reimbursement processes should be carried out more transparently.