The ins and outs of localization in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for USD 99.
1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?
Localization is a developing and ongoing plan in Turkey. Increasing employment, attracting foreign investment, and maintaining the quality reached in the Turkish pharmaceutical industry encouraged localization in our Turkey. Thus, localization was first announced/proposed in the Action Plan of the 64th Government for the Year 2016 (“Action Plan”). In the meantime, follow-up announcements were also made within this framework by both the Turkish Medicines and Medical Devices Agency (“TMMDA”) and Social Security Institution (“SSI”) on their official websites.
Action 46 of the Action Plan is to enhance the medical equipment and the process of reimbursement, pricing, authorization of strategical and domestic drugs. It has been stated in the Action Plan that “The imported drugs, which will be removed from the list of reimbursement, will be determined, provided that the required security for providing a proper treatment is ensured.” In this regard, the number of sales of the products, which have an import license with more than one generic, has been reviewed as per this Action Plan.
In addition, TMMDA’s announcement mentions that, in light of the negotiations and discussions with the relevant association, union and firms, a time plan is prepared regarding localization of the products, whose rate in manufacturing is more than 50%, as a first step, in order to prevent any supply problem in the market. The announcement is available in Turkish on TMMDA’s website at https://www.titck.gov.tr/duyuru/2521.
Furthermore, within the scope of the localization, a new Commission on Transferring from Import to Produced has been established with the participation of the representatives of the TMMDA, SSI, Turkish Ministry of Development, Ministry of Finance, Ministry of Economy, Undersecreteriat of the Treasury. In this regard, all process in relation thereto will be followed by this commission accordingly.
2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?
3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
According to the announcement made by TMMDA and the time plan referred to above, it was planned to commence with the process of localization of the equivalent groups determined as of 4 April 2016. In this regard, it has been also stated in the abovementioned announcement that relevant firms shall provide their undertaking for the domestic production to the Directorate of Drug Licensing of the TMMDA as of 22 March 2016. If such firms cannot or did not provide the undertaking regarding localization for the products, then the reasoning in relation thereto shall be provided as of 22 March 2016.
In addition, it has been stated in the Action Plan that the drugs, which are applied to be produced in Turkey, will be licensed expeditiously by the MoH.
4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
The Action Plan states that the reimbursement policies of the drugs, which are applied to be produced in Turkey, will be considered and reviewed. The SSI shall accelerate the evaluation process in order to add the medical products produced in Turkey to the list of reimbursement and by making required regulations in the legislation. The imported drugs, which will be removed from the list of reimbursement, will also be determined, provided that the required security for providing a proper treatment is ensured.
In this regard, TMMDA’s announcement has mentioned that the Action Plan in relation thereto does not aim to remove the imported products from the list of reimbursement but aims to promote/encourage the domestic production within predictable time.
6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?
8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?
9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?