Pharmaceutical Market Access in Türkiye: Processes, Challenges, and Opportunities

The primary objective of this study is to provide an analysis of pharmaceutical market access processes in Turkey by examining approval, pricing, reimbursement, and entry barriers. It addresses the roles of the Turkish Medicines and Medical Devices Agency (TİTCK) and the Social Security Institution (SGK) in access to medicines, presenting recommendations for solutions to encountered challenges. Access to pharmaceuticals in Turkey involves a multi-stage and challenging process, including approval, pricing, and reimbursement steps. Key obstacles include bureaucratic delays, lack of transparency in pricing processes, and the complexity of reimbursement procedures. Additionally, incentives for local production, alternative reimbursement agreements, and early access programs present significant opportunities to overcome existing limitations. It is crucial for pharmaceutical companies to understand Turkey’s regulatory framework and to develop strategic plans. Policymakers might also consider reforms to improve transparency and expedite processes. Such improvements could lead to expansion in Turkey’s pharmaceutical market, quicker patient access to innovative treatments, increased local production, and enhanced independence. This study concludes that if the proposed recommendations are considered, Turkey’s regulatory and reimbursement policies can facilitate faster market access for new drugs, making the Turkish pharmaceutical sector more attractive to local and global companies.