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

Year 2025, Volume: 7 Issue: 1, 41 - 57, 07.08.2025
https://doi.org/10.52675/jhesp.1587165

Abstract

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.

References

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  • Koçkaya, G., Atalay, S., Oğuzhan, G., Kurnaz, M., Ökçün, S., Sar Gedik, Ç., Şaylan, M., & Şencan, N. (2021). Analysis of patient access to orphan drugs in Turkey. Orphanet Journal of Rare Diseases, 16,1–8. https://doi.org/10.1186/s13023-021-01718-3
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  • Social Security Institution (SGK). (2024). Genel sağlık sigortası. https://www.sgk.gov.tr/gss
  • Turkish Statistical Institute (TURKSTAT). (2023). Sağlık harcamaları istatistikleri 2022. https://data.tuik.gov.tr/Bulten/Index?p=Saglik-Harcamalari-Istatistikleri-2022-49676
  • Turkish Medicines and Medical Devices Agency (TİTCK). (2021). RD/2021/12/2 Beşeri tıbbi ürünler ruhsatlandırma yönetmeliği. https://www.titck.gov.tr/duyuru/ruhsat-yonetmeligi-11122021202714
  • Turkish Medicines and Medical Devices Agency (TİTCK). (2024). Çeşitleme başvuruları ile varyasyon başvurularının sınıflandırmasına dair kılavuz. https://www.titck.gov.tr/mevzuat/cesitlemebasvurulari-ile-varyasyon-basvurularinin siniflandirmasina-dair-kilavuz-14042022112200
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  • World Health Organization [WHO]. (2018). Ensuring access to medicines: How to stimulate innovation to meet patients’ needs? (Policy Brief 29). https://iris.who.int/handle/10665/331971
  • Vural, E. H., Koçkaya, G., Tanyeri, P., Babacan, S., Vural, İ. M., Akbulat, A., Artıran, G., Akar, H., Tokaç, M., & Kerman, M. S. (2012). Compassionate medicine-use programs in Turkey: A report on current status. Journal of Pharmaceutical Health Services Research, 3(3), 129–134. https://doi.org/10.1111/j.1759-8893.2012.00090.x
  • Yüksel, G. H., & Topuzoğlu, A. (2019). Aşı redlerinin artması ve aşı karşıtlığını etkileyen faktörler. ESTÜDAM Halk Sağlığı Dergisi, 4(2), 244–258. https://doi.org/10.35232/estudamhsd.525983
Year 2025, Volume: 7 Issue: 1, 41 - 57, 07.08.2025
https://doi.org/10.52675/jhesp.1587165

Abstract

References

  • Alanay, Y., & Özbek, U. (2019, November 8). Nadir hastalıklar: Ülkemizde güncel durum ve ACURARE. Acıbadem University. https://www.acibadem.edu.tr/en/node/1662
  • Awad, A., Trenfield, S. J., Pollard, T. D., Ong, J. J., Elbadawi, M., McCoubrey, L. E., Goyanes, A., Gaisford, S., & Basit, A. W. (2021). Connected healthcare: Improving patient care using digital health technologies. Advanced Drug Delivery Reviews, 178, 113958. https://doi.org/10.1016/j.addr.2021.113958
  • Costello Medical Consulting Ltd. (2017). ISPOR US 2017 report: 22nd Annual International Meeting Boston MA, USA. https://www.costellomedical.com/wp-content/uploads/2018/10/ISPOR-US-2017-Report.pdf
  • Doğuç, E. (2021). Türkiye’de sağlık harcamaları ve çözüm önerisi olarak davranışsal iktisat. Uluslararası Sağlık Yönetimi ve Stratejileri Araştırma Dergisi, 7(3), 647–664.
  • Econix. (2024). 2023 yılı detaylı ilaç listesi analizi. https://econalix.net/media/files/publications/Detayl%C4%B1_%C4%B0la%C3%A7_Listesi_Analizi-29.12.2023_sunum_compressed.pdf
  • IQVIA. (2024). Türkiye ilaç sektörü raporu 2024. https://www.aifd.org.tr/wp-content/uploads/2024/10/IQVIA_Turkiye-ilac-Sektoru-Raporu-2024.pdf
  • Koçkaya, G., & Wertheimer, A. (2016). Pharmaceutical market access in emerging markets. SEEd.
  • Koçkaya, G., Atalay, S., Oğuzhan, G., Kurnaz, M., Ökçün, S., Sar Gedik, Ç., Şaylan, M., & Şencan, N. (2021). Analysis of patient access to orphan drugs in Turkey. Orphanet Journal of Rare Diseases, 16,1–8. https://doi.org/10.1186/s13023-021-01718-3
  • Kwon, I.-W. G., Kim, S.-H., & Martin, D. G. (2016). Healthcare supply chain management; strategic areas for quality and financial improvement. Technological Forecasting and Social Change, 113(B), 422–428. https://doi.org/10.1016/j.techfore.2016.07.014
  • Newton, M., Stoddart, K., Travaglio, M., & Troein, P. (2024a). EFPIA Patients W.A.I.T. Indicator 2023 Survey. European Federation of Pharmaceutical Industries and Associations (EFPIA). http://efpia.eu/media/vtapbere/efpia-patient-wait-indicator-2024.pdf
  • Newton, M., Stoddart, K., Travaglio, M., & Troein, P. (2024b). EFPIA 2023 W.A.I.T. araştırması: Hastaların yenilikçi tedavilere erişim süresi göstergeleri (EFPIA Patients W.A.I.T. Indicator 2023 Survey). European Federation of Pharmaceutical Industries and Associations (EFPIA). https://www.aifd.org.tr/wp-content/uploads/2024/07/EFPIA-Patient-WAIT-Anketi-2024-turkce.pdf
  • Organization for Economic Co-operation and Development (OECD). (2021). OECD Health Working Paper No. 124. Skills for the future health workfoce: Preparing health professionals for people-centeredcare. https://one.oecd.org/document/delsa/hea/wd/hwp(2021)1/en/pdf
  • Presidency of Türkiye, Presidency of Strategy and Budget. (2023). 2023 yılı merkezi yönetim bütçe gerçekleşmeleri ve beklentiler raporu. https://www.sbb.gov.tr/wp-content/uploads/2023/07/2023-Merkezi-Yonetim-Butce-Gerceklesmeleri-ve-Beklentiler-Raporu_31072023.pdf
  • Republic of Türkiye Legal Gazette. (2024, October 20). Beşeri tıbbi ürünlerin fiyatlandırılmasına dair karar (Karar Sayısı: 9063), 2024. https://www.resmigazete.gov.tr/eskiler/2024/10/20241020.pdf
  • Sciascia, S., Roccatello, D., Salvatore, M., Carta, C., Cellai, L. L., Ferrari, G., Lumaka, A., Groft, S., Alanay, Y., Azam, M., Baynam, G., Cederroth, H., Cutiongco-de la Paz, E. M., Weerabaddana Dissanayake, V. H., Giugliani, R., Gonzaga-Jauregui, C., Hettiarachchi, D., Kvlividze, O., Landoure, G., … Taruscio, D. (2023). Unmet needs in countries participating in the undiagnosed diseases network international: An international survey considering national health care and economic indicators. Frontiers in Public Health, 11, 1248260. https://doi.org/10.3389/fpubh.2023.1248260
  • Social Security Institution (SGK). (2024). Genel sağlık sigortası. https://www.sgk.gov.tr/gss
  • Turkish Statistical Institute (TURKSTAT). (2023). Sağlık harcamaları istatistikleri 2022. https://data.tuik.gov.tr/Bulten/Index?p=Saglik-Harcamalari-Istatistikleri-2022-49676
  • Turkish Medicines and Medical Devices Agency (TİTCK). (2021). RD/2021/12/2 Beşeri tıbbi ürünler ruhsatlandırma yönetmeliği. https://www.titck.gov.tr/duyuru/ruhsat-yonetmeligi-11122021202714
  • Turkish Medicines and Medical Devices Agency (TİTCK). (2024). Çeşitleme başvuruları ile varyasyon başvurularının sınıflandırmasına dair kılavuz. https://www.titck.gov.tr/mevzuat/cesitlemebasvurulari-ile-varyasyon-basvurularinin siniflandirmasina-dair-kilavuz-14042022112200
  • UNESCO Institute for Statistics. (2019). Data for the sustainable development goals [data set]. http://uis.unesco.org
  • World Health Organization [WHO]. (2018). Ensuring access to medicines: How to stimulate innovation to meet patients’ needs? (Policy Brief 29). https://iris.who.int/handle/10665/331971
  • Vural, E. H., Koçkaya, G., Tanyeri, P., Babacan, S., Vural, İ. M., Akbulat, A., Artıran, G., Akar, H., Tokaç, M., & Kerman, M. S. (2012). Compassionate medicine-use programs in Turkey: A report on current status. Journal of Pharmaceutical Health Services Research, 3(3), 129–134. https://doi.org/10.1111/j.1759-8893.2012.00090.x
  • Yüksel, G. H., & Topuzoğlu, A. (2019). Aşı redlerinin artması ve aşı karşıtlığını etkileyen faktörler. ESTÜDAM Halk Sağlığı Dergisi, 4(2), 244–258. https://doi.org/10.35232/estudamhsd.525983
There are 23 citations in total.

Details

Primary Language English
Subjects Health Policy
Journal Section Review Articles
Authors

Öznur Seyhun 0009-0009-9871-0986

Publication Date August 7, 2025
Submission Date November 18, 2024
Acceptance Date December 17, 2024
Published in Issue Year 2025 Volume: 7 Issue: 1

Cite

APA Seyhun, Ö. (2025). Pharmaceutical Market Access in Türkiye: Processes, Challenges, and Opportunities. Journal of Health Systems and Policies, 7(1), 41-57. https://doi.org/10.52675/jhesp.1587165

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Contents of the Journal of Health Systems and Policies (JHESP) is licensed under a Creative Commons Attribution 4.0 International License.