The Amended Guidelines on Named Patient Program (“Guidelines”) has been published by the Turkish Medicines and Medical Devices Agency (“Agency”) on September 25, 2020.
The Guidelines explains the procedure on the supply from abroad of drugs that are not authorized in Turkey and/or not available on the Turkish market due to various reasons. This Guidelines was first published in 2014, amended in 2015 and 2017, and finally published in its most current version on September 25, 2020.
The Guidelines regulated a more detailed procedure for the supply. However, the authority of the Turkish Pharmacists’ Association (“TEB”), the Social Security Institution’s drug warehouse named İbn-i Sina Health Social Security Center (“SSI”) and Uluslararası Sağlık Hizmetleri A.Ş. (“USHAŞ”) to supply medicines from abroad is preserved. The most important amendments are made on the procedure of adding new drugs to the Foreign Drugs List (“List”), the countries where products shall be supplied and their supply conditions and the responsibility clause.
1. Applications for the Addition to the Foreign Drug List and the Supply Procedure
The Foreign Drug Evaluation Commission (“Commission”) is established with the Guidelines and the Commission is appointed to evaluate applications for the supply of drugs from abroad.
i. Addition of Active Ingredients to the List
The applications for patients, who exhausted all treatment options in Turkey, or who are not able to exhaust them, shall be filed by the treating physician of the patient by submitting a report of the relevant Health Committee in an Education and Research Hospital or a Medicine Faculty Hospital affiliated to the Ministry of Health. Within this scope, active ingredients that are deemed appropriate for usage shall be published in the “Active Ingredient List” section of the Foreign Drug List. All necessary information and documents that are required for the addition to the List of the drug having a listed active ingredient shall be supplied to the Agency by USHAŞ, TEB or SSI according to the Guidelines. Products deemed appropriate by the Commission will be added to the List.
ii. Supply of Drugs that are Included in the List
The applications filed by treating physicians to the Agency for the patients who exhausted all treatment options in Turkey, or who are not able to exhaust them shall be evaluated by the relevant scientific committee. Drugs that are deemed appropriate for usage shall be supplied by USHAŞ, TEB or SSI.
iii. Supply of Drugs from Abroad having the Active Ingredients of Drugs that are authorized in Turkey but are not Available on the Market
Applications made by treating physicians shall be published in the “Active Ingredients that Are Authorized but Not Available on the Market” section of the List if they are deemed appropriate by the Agency. The applications to be made for the supply of drugs containing published active ingredients in accordance with the Guidelines shall be examined by the Commission.
In addition to these rules, drugs included into the List are announced by the Agency 6 months before they fill 3 years from the date of entry to the List. Upon the evaluation by the Commission, the products deemed appropriate to remain in the List shall be submitted to the Presidency for approval to decide whether to remain on the List.
2. Countries Where Drugs shall be Supplied and Conditions of Supply
Priorly, the supply of drugs containing active ingredients listed in the List could be supplied from products licensed by the FDA / EMA, and if such product could not be found the supply was made from products licensed in the PIC/s member countries. However, this provision was amended; and now, products that meet one of these two conditions can be supplied, regardless of the priority relationship.
In applications for the supply of generic drugs which are not authorized by the PIC/s member countries or the FDA / EMA, if the Commission deems necessary, the document showing that a bioequivalence analysis has been made in accordance with the legislation of the Ministry of Health and the document showing the bioequivalence, shall be requested by the Agency from USHAŞ, TEB or SSI.
The products to be supplied shall be licensed for the same indication as the indication applied by the treating physician, or their use for the same indication shall be authorized by the competent official authorities of the respective country or countries.
Finally, it has been regulated that the 2D barcode procedure implemented for authorized drugs in Turkey shall also be applied to NPP products; and in this context, the 2D barcode procedures shall be carried out by USHAŞ, TEB or SSI.
3. New rules on the Responsibilities of USHAŞ, TEB and SSI
The article regulating the responsibility of USHAŞ, TEB and SSI on the quality, efficacy and safety of drugs supplied from abroad has been removed. A new provision has been introduced holding these organizations responsible for ensuring that the processes leading up to the delivery of the drug to patient are carried out in accordance with Good Distribution Practices.
The control over the drugs to be supplied has increased by means of the procedures of adding active substances to the List upon a Health Committee Report and the Commission’s approval. However, the deletion of the provisions governing the responsibility of the suppliers for the quality, efficacy and safety of products created an uncertainty.
First published by Practical Law, in 03.11.2020