Early Access System in Turkey - Part 1

Early Access System in Turkey – Part I

Early access or compassionate use is a treatment option that allows the use of an unauthorised medicine in Turkey. Products authorized by either FDA, EMA or health authorities of countries which are a member of PIC/s but not authorized yet in Turkey can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials, but only under strict conditions.

Early access programmes are coordinated and implemented by different stakeholders in Turkey, which are Turkish Medicines and Medical Devices Agency (TITCK, hereafter), Social Security Institute (SGK, hereafter) and Turkish Pharmacists Association (TEB, hereafter). Each institution handles one aspect of the demand for an unauthorized therapy coming from the medical community. The demand for the therapy can be initiated by a physician based on named patient prescription or a hospital based on a formal written request.

The legislative basis of these programmes is based on article 27 and 40 of the decree on the Organization and Duties of the Ministry of Health and its Affiliates dated 11/10/2011 with number 663 and additional article 7 of the law on pharmaceuticals and medical preparations dated 14/5/1928 with number 1262. Based on the legislation described above, there is a guideline published by TITCK describing the details of the process (http://www.titck.gov.tr/Mevzuat/MevzuatGetir?id=2968 ).

Two actions trigger the process: either a named-patient prescription by a physician who would like to use the novel and unauthorized therapy or by a request of a hospital (either a public hospital or a private hospital) for bulk purchasing for their prospective use in patients who are eligible for the novel and unauthorized therapy.

  • Early Access Programme Based on a Physician’s Named-Patient Prescription (NPP): A physician who would like to use the novel and unauthorized therapy to her/his patient who is eligible for the therapy submits the named-patient prescription filled in according to the guideline with accompanying supportive medical and administrative documentation to the TITCK for approval. Then, an approval procedure takes place and different stakeholders involve until the product in question can be imported for the patient.
  • Early Access Programme Based on a Hospital’s Request for Bulk Purchasing: This time a hospital management which would like to use the novel and unauthorized therapy prospectively to its patients who are eligible for the therapy submits an official request to the TITCK for the approval of a bulk purchase. A similar approval procedure takes place and different stakeholders involve until the product in question can be imported for the hospital.

The medicines that are imported under early access programmes are priced and reimbursed by a different system than the medicines that are authorised by marketing authorisation approval. The pricing system, the current and future aspect of the system will be written in part 2.