Pharmaceuticals that are not authorized in Türkiye or
authorized but not available on the market shall be procured from
abroad as per a special authorization and on a case by case basis
(Named Patient Program-NPP). This supply can be conducted by public
institutions approved by the Ministry of
Health that are defined as Foreign Pharmaceutical Suppliers
(Suppliers) and currently constitute the
Social Security Institution and the Turkish Pharmacists
Association. The Suppliers can procure the product
from a foreign entity defined as the Pharmaceutical Drug Source,
which shall have a Representative
based in Türkiye.
On April 17, 2024, the Guidelines on Supply of Pharmaceuticals from Abroad (Guidelines), which contains the guiding provisions regarding the implementation of the Regulation on Supply of Pharmaceuticals from Abroad (Regulation) was amended.
The applications for first-time use of a pharmaceutical are made
by the treating physician before the
Medicines and Medical Devices Agency (Agency), based on the
reasoned decision of a council consisting of at least three
specialist physicians related to the patient's illness.
Pursuant to the new amendments, in the first-time use applications,
the Commission for the Evaluation of the Use of Medicinal Products
in Personal Treatment (Commission) shall further evaluate the
authorities by which the pharmaceutical is authorized, its
availability in the market, and its compliance with regulatory
requirements. The first-time use applications approved by the
Commission shall be submitted to the Foreign Medicines Evaluation
Board (Board) of the Agency. After the Board's approval, the
pharmaceutical containing the relevant active ingredient and form
may be supplied by Suppliers.
Another change stipulates that in cases where the authorized
product is included in the reimbursement
list of the Social Security Institution but is not available on the
market or is not available in sufficient quantity, the procurement
of the pharmaceutical containing the relevant active ingredient can
be supplied through NPP upon the decision of the Pharmaceutical
Supply Planning Commission of the Agency and the Board. Therefore,
in the event that the pharmaceuticals that are currently supplied
to patients through the NPP obtains a marketing authorization in
Türkiye, their supply from abroad may be continued until the
product becomes accessible on the market.
Given Türkiye's current economic situation, it is more
difficult for products to reach or be available
on the market. The Social Security Institution faces financial
difficulties when it supplies goods from overseas through NPP; as a
result, innovative ideas are developed and put into practice to
establish a different kind of procurement where the goods are
provided free of charge.
First published by LIR Turkiye Edition 5 N°2 in Jun 07, 2024.
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.