Prior to amendment of the Guideline Regarding Procurement and Use of Medicinal Products from Abroad (the “Guideline”) published by the Ministry of Health in July 2014, the Turkish Pharmacists Association (“TEB”) was the only entity authorized to supply products which were not licensed or made commercially available in Turkey on the basis of named patient sales (“NPS”).  

With the amendment of the Guideline in July 2014, over twenty alternative warehouses were authorized to supply NPS products to Turkey in addition to TEB despite the fact that TEB subsequently challenged this amendment before the administrative courts.  As a result of the developments in these legal proceedings and also due to failure of the Social Security Institution to conclude reimbursement agreements with these alternative warehouses, the latest version of the Guideline which has been amended several times in the last two years revoked the authority granted to the alternative warehouses and authorised again only TEB for the NPS supplies.

In parallel with these legal proceedings and further amendments of the Guideline, one of the alternative warehouses filed a complaint to the Competition Authority at the beginning of 2015 claiming that TEB abuses its dominant position in NPS activities. The Competition Authority initiated an investigation on activities of TEB which has recently been completed.

According to the announcement of the Competition Authority published on its website on December 7, 2016, the Competition Board has decided during its meeting on December 6, 2016 that:

  • TEB holds dominant position in procurement of pharmaceuticals from abroad,
  • TEB abuses its dominant position in such market by way of concluding exclusive agreements with the suppliers of these products abroad,
  • An administrative monetary fine in the amount of 18,062,307.32 Turkish Lira (approximately 5,000,000 Euros) shall be imposed to TEB.

Finally, the announcement also indicates that the Competition Authority will be providing its opinion to the Ministry of Health and Social Security Institution with a recommendation of opening the NPS market to competition. Moreover, it has already been announced by the representatives of Social Security Institution that Social Security Institution is currently working on a system in which it will directly procure NPS products from abroad and replace TEB.

As TEB is legally entitled to challenge this decision before the administrative courts and the regulatory authorities are also planning further changes to the current system, the ongoing tension between TEB, Ministry of Health, Social Security Institution and alternative warehouses in relation to the NPS products may not settle in near future.