Procurement of medicines for human use is no longer a monopoly right

Turkey

On 5 December 2018, the Law No. 7151 on Amendment of Certain Laws and Decree Laws related to Healthcare (“Law”) was published. This Law foresees some amendments to the provisions of Law No. 984 on Stores Selling Toxic and Active Chemical Substances Used in Pharmacies, Arts and Agriculture.

Background:

In recent years the discussion regarding the procurement of medicinal products (with prescription) from abroad has become more important. The monopoly right to procure the medicinal products belonged to the Turkish Pharmacists’ Association (Türkiye Eczacılar Birliği). While only the Turkish Pharmacists’ Association was authorised to procure medicines from abroad, some pharmacies were granted the same right by the Turkish Medicines and Medical Devices Agency (Türkiye İlaç ve Tıbbi Cihaz Kurumu) in 2013. In response the Turkish Pharmacists’ Association has appealed to the administrative court for a stay of execution. The Turkish State Council (Danıştay) granted a motion for such a stay. Following this, the Regulation on Pharmaceutical Warehouses and Products Stored in Pharmaceutical Warehouses (“Regulation”) was amended and would have allowed the pharmaceutical warehouses to procure medicinal products from abroad, which cannot be found in the Turkish market. However, this provision in the Regulation was recessed by the Turkish State Council earlier this year.[1] After this contentious process, the Law introduces some radical amendments, which may be summarised as follows:  

  • Human medicinal products not licensed in Turkey or those licensed but not available on the market for several reasons may be procured from abroad (with prescription) not only by the Turkish Pharmacists’ Association, but also by the Social Security Institution (“SGK”) and by the state institutions and organisations approved by the Ministry of Health. The Law means; therefore, it is no longer the monopoly right of Turkish Pharmacists’ Association to import the medicines specified under the Abroad Medicines List. Such procurement is not limited to the personal use (şahsi kullanım) of these medicines; the institutions mentioned above can directly provide these medicines to hospitals. In these terms, hospitals can also bulk-purchase medicinal products from abroad.
  • According to the abovementioned amendment, licence holders are obligated to apply for a licence in Turkey within three (3) years of the procured medicinal product entering the Abroad Medicines List. Following the date of application, it is obligatory to obtain the license within two (2) years. If there is no application for a licence or the licence could not be obtained, the President of the Republic of Turkey is authorised to decide whether the medicinal products may be procured further or not.
  • Owners of pharmacies or liable managers and sellers of toxic and active chemical substances in pharmaceutical and agricultural businesses who are not complying with the abovementioned provision or act contrary to the Law on Stores Selling Toxic and Active Chemical Substances Used in Pharmacies, Arts and Agriculture will face an administrative fine ranging from TRY 2,000 to TRY 20,000. The Turkish Medicines and Medical Devices Agency has the authority to impose these administrative fines.
  • If the purchase of these medicinal products poses a danger to public health, the business involved will be temporarily barred from operation until the situation is resolved.
  • The licence holders who did not apply for a licence for the procured medicinal products must apply for a license following the enforcement date of this Law.

Contact:

Please do not hesitate to contact us at done.yalcin@ybb-av.com or levent.bilgi@ybb-av.com for further details on the subject or with any specific questions.



[1] Danıştay, 15D., dated 23.01.2018, File No. 6856/350.