The Turkish Ministry of Health (“Ministry”) and Social Security Institute (“Institute”) announced that according to a new cost savings action plan, pharmaceuticals imported under named-patient sales will occur through the Institute, rather that the Turkish Pharmacists Association (“Association”) from 2 May 2017.
Currently, specific conditions must be met in order to import pharmaceuticals to Turkey for named patient sales. First of all, the pharmaceutical to be imported (whether licensed in Turkey or not), should not be available in the Turkish market due to problems obtaining licenses, pricing, or reimbursement by the Institute. The named patient sales approach allows patients in Turkey to access these medicines, at their physician’s responsibility. A Ministry Guideline outlines import principles for pharmaceutical products. It states that the Association is the only organization authorized to import products which are registered in the “Imported Pharmaceuticals Provision System”. The Guideline also states that the Association will deliver the product to the treatment site or patient (as necessary and allowed).
In recent years, the named patient supply method has grown enormously. The market has developed to be worth approximately TRY 1.2 billion (USD 450 million) annually, with the Association receiving a 3.9% commission on the pharmaceuticals’ price.
According to officials from the Ministry and Institute, removing the Association from the named patient sales process is intended to economize the Association’s 3.9% profit. Under the new system, the Institute will directly import the prescribed pharmaceuticals and deliver them to patients or the relevant hospital’s pharmacy (where the patient is being treated). The Institute has signed an agreement with the Turkish post office for transporting imported pharmaceuticals to patients.
The Association and other groups (such as the Pharmacist Employees Union (“TEIS”)) have heavily criticized the change. The objections state that pharmaceuticals should only be obtained by patients through and under the care of pharmacists. Another criticism notes that give the varied and complicated conditions for storing pharmaceuticals, sending them via courier is both unacceptable and contrary to public health. TEIS declared that it has already challenged the legitimacy of the proposed system before the Council of State through a pending action.
In view of the Association’s established practice and connections for obtaining orphan pharmaceuticals, as well as TEIS’ objections, the success and effectiveness of the new system remains uncertain. Many aspects of the new system are yet to be regulated in detail. Moreover, the Council of State may also postpone the new system until the end of TEIS’ action via a preliminary injunction. In such an event, the conditions for importing pharmaceuticals through named patient sales will become even more complicated and unclear.