SavedAdd your journal

Journals / Fiscaoeconomia / 2026 / Volume: 10 Issue: 2

The Intersection of Artificial Intelligence and Intellectual Property: The Impact of Data Exclusivity Policies on Pharmaceutical Production in Africa

Yapay Zekâ-Fikri Mülkiyet Bağlantısı: Afrika’da İlaç İnovasyonu Üzerinde Patent Muafiyetleri ve Veri Münhasırlığının Etkisinin Değerlendirilmesi

Klemens Katterbauer(Euclid University)0000-0001-5513-4418
Sema Yılmaz(YILDIZ TEKNİK ÜNİVERSİTESİ)0000-0002-3138-1622
Rahmi Deniz Özbay(İSTANBUL TİCARET ÜNİVERSİTESİ)0000-0002-3927-8216
Hassan Syed(Euclid University)0000-0003-2114-2473
Pages
—
Publication Date
2026-09-26
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

We conclude that the regulatory choice regarding IP is determinative of whether Africa becomes a mere market for finished goods or a strategic node in the global generic value chain.

📌 3 Key Takeaways

🎯
Objective & Hypothesis:The intersection of artificial intelligence (AI), intellectual property (IP) regimes, and pharmaceutical manufacturing capacity represents a critical frontier in global health governance.
📊
Key Findings & Data:A central friction point in this ambition is the bifurcated IP strategy employed by the People's Republic of China in its bilateral engagements with African nations.
💡
Conclusion & Impact:We conclude that the regulatory choice regarding IP is determinative of whether Africa becomes a mere market for finished goods or a strategic node in the global generic value chain.
🔬Design:Modeling & Simulation
📍Scope:2018–2025 Verileri
⚙️Variables:Intellectual Property · Artificial Intelligence · Pharmaceutical Manufacturing

Abstract

The intersection of artificial intelligence (AI), intellectual property (IP) regimes, and pharmaceutical manufacturing capacity represents a critical frontier in global health governance. Nowhere is this nexus more contested than in Africa, where the African Medicines Agency (AMA) seeks to build a robust generic manufacturing base to mitigate historical dependency on imported medicines. A central friction point in this ambition is the bifurcated IP strategy employed by the People's Republic of China in its bilateral engagements with African nations. China simultaneously deploys compulsory licensing mechanisms in some contexts while enforcing stringent data exclusivity and patent linkage rules to protect its burgeoning domestic innovators in others. This paper empirically assesses how this variegated IP regime—mediated by AI-driven drug discovery and manufacturing processes—affects local generic manufacturing capacity. Utilizing a firm-level panel dataset of 142 pharmaceutical manufacturers operating in Chinese-financed industrial parks across Ethiopia, Kenya, and Nigeria (2018–2025), we employ a fixed-effects model to estimate the association between IP enforcement clauses embedded in bilateral investment treaties and firm output and R&D expenditure. Our findings challenge the binary "access vs. innovation" dichotomy. We demonstrate that strict data exclusivity clauses, when paired with AI-enabled manufacturing infrastructure, are associated with higher local generic output but lower price elasticity—indicating reduced market competition. Conversely, flexible regimes correlate with greater price elasticity but fail to attract the advanced technology transfer necessary for complex generic production. We conclude that the regulatory choice regarding IP is determinative of whether Africa becomes a mere market for finished goods or a strategic node in the global generic value chain.

Özet

Yapay zeka (AI), fikri mülkiyet (IP) rejimleri ve ilaç üretim kapasitesinin kesişim noktası, küresel sağlık yönetişiminde kritik bir sınırı temsil etmektedir. Bu bağlantının en çok tartışıldığı yer, Afrika İlaç Ajansı’nın (AMA) ithal ilaçlara olan tarihsel bağımlılığı azaltmak amacıyla sağlam bir jenerik ilaç üretim altyapısı kurmaya çalıştığı Afrika’dır. Bu hedefin önündeki temel engel, Çin Halk Cumhuriyeti'nin Afrika ülkeleriyle ikili ilişkilerinde uyguladığı ikili fikri mülkiyet stratejisidir. Çin, bazı durumlarda zorunlu lisans mekanizmalarını devreye sokarken, diğer durumlarda ise hızla gelişen yerli inovasyoncularını korumak için sıkı veri münhasırlığı ve patent bağlantısı kuralları uygulamaktadır. Bu makale, yapay zekâ destekli ilaç keşfi ve üretim süreçlerinin aracılık ettiği bu çeşitlilik arz eden fikri mülkiyet rejiminin yerel jenerik üretim kapasitesini nasıl etkilediğini ampirik olarak değerlendirmektedir. Etiyopya, Kenya ve Nijerya'da Çin tarafından finanse edilen sanayi parklarında faaliyet gösteren ilaç üreticilerinin firma düzeyindeki panel veri setini (2018–2025) kullanarak, ikili yatırım anlaşmalarına (BIT) dahil edilen fikri mülkiyet uygulama hükümlerindeki değişikliklere karşı firma üretimini ve Ar-Ge harcamalarını regresyon analizine tabi tutmak için sabit etkiler modeli kullanıyoruz. Bulgularımız, “erişim ve inovasyon” arasındaki ikili karşıtlığı sorgulamaktadır. Sıkı veri münhasırlığı hükümlerinin, yapay zekâ destekli üretim altyapısıyla birleştiğinde, paradoksal bir şekilde daha yüksek yerel jenerik üretimle, ancak daha düşük Ar-Ge çeşitliliği ile ilişkili olduğunu göstermekteyiz. Tersine, esnek rejimler fiyat esnekliğini teşvik etmekte, ancak karmaşık jenerik üretim için gerekli olan ileri teknoloji transferini çekememektedir. Sonuç olarak, fikri mülkiyet ile ilgili düzenleyici tercihlerin, Afrika’nın sadece bitmiş ürünler için bir pazar mı, yoksa küresel jenerik değer zincirinde stratejik bir düğüm noktası mı olacağını belirlediğini ortaya koymaktayız.

🔖

Cite This Article

Katterbauer, K., Yılmaz, S., Özbay, R. D., Syed, H. (2026). The Intersection of Artificial Intelligence and Intellectual Property: The Impact of Data Exclusivity Policies on Pharmaceutical Production in Africa. Fiscaoeconomia, Volume: 10 Issue: 2. https://doi.org/10.25295/fsecon.1929269

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (27)

  1. Abdulwahab, A. A., Okafor, U. G., Adesuyi, D. S., Miranda, A. V., Yusuf, R. O., & Eliseo Lucero-Prisno, D. (2024). The African Medicines Agency and medicines regulation: Progress, challenges, and recommendations. Health Care Science, 3(5), 350–359. https://doi.org/10.1002/hcs2.117
  2. Ahen, F., & Salo-Ahen, O. M. H. (2018). Governing pharmaceutical innovations in Africa: Inclusive models for accelerating access to quality medicines. Cogent Medicine, 5(1), 1500196. https://doi.org/10.1080/2331205X.2018.1500196
  3. Aniche, E. T. (2023). African Continental Free Trade Area and African Union Agenda 2063: The roads to Addis Ababa and Kigali. Journal of Contemporary African Studies, 41(4), 377–392. https://doi.org/10.1080/02589001.2020.1775184
  4. Bhatt, P., Singh, S., Kumar, V., Nagarajan, K., Mishra, S. K., Kumar Dixit, P., Kumar, V., & Kumar, S. (2024). Artificial intelligence in pharmaceutical industry: Revolutionizing drug development and delivery. Current Artificial Intelligence, 2, e051223224198. https://doi.org/10.2174/0129503752250813231124092946
  5. Bontadini, F. (2021). Trade specialization and performance in global value chains. Industrial and Corporate Change, 30(6), 1557–1590.
  6. Cai, X. (2025). Multidimensional governance path of intellectual property protection for Chinese overseas enterprises under the CPTPP framework. Academic Journal of Business & Management, 7(9), 42–50.
  7. Capri, A. (2024). Techno-nationalism: How it’s reshaping trade, geopolitics and society. John Wiley & Sons.
  8. Cieślik, E., & Zamojska, A. (2025). Techno-nationalism in global value chains in the technology sector. European Review, 1–20.
  9. Gangwal, A., Ansari, A., Ahmad, I., Azad, A. K., Kumarasamy, V., Subramaniyan, V., & Wong, L. S. (2024). Generative artificial intelligence in drug discovery: Basic framework, recent advances, challenges, and opportunities. Frontiers in Pharmacology, 15, 1331062. https://doi.org/10.3389/fphar.2024.1331062
  10. Grabowski, H., Long, G., & Mortimer, R. (2011). Data exclusivity for biologics. Nature Reviews Drug Discovery, 10(1), 15–16. https://doi.org/10.1038/nrd3327
  11. Habibi, N., & Zhu, H. Y. (2021). The Health Silk Road as a new direction in China’s Belt and Road strategy in Africa. Center for Global Development and Sustainability, Brandeis University.
  12. Han, Y., Fan, L. L., & Xue, Y. (2024). A sustainable balance between innovation and risk: How the “right to science” affects China’s medical biotechnology regulatory policy. Computational and Structural Biotechnology Journal, 24, 306–313. https://doi.org/10.1016/j.csbj.2023.12.021
  13. Katterbauer, K., & Cleenewerck, L. (2024). Artificial intelligence and its impact on healthcare financing in China: A legal analysis. Financial Law Review, 33(1), 62–81. https://doi.org/10.4467/22996834FLR.24.004.18686
  14. Katterbauer, K., Genc, S. Y., Syed, H., & Cleenewerck, L. (2024). Examining investor protection in the South China Sea through an Islamic large language model legal analysis. Journal of Islamic Finance, 13(1), 57–69.
  15. Katterbauer, K., Syed, H., Bingül, B. A., & Yılmaz, S. (2025). Navigating base erosion and profit shifting between China and Africa: Regulatory hurdles and the promise of AI-driven tax enforcement. JOEEP: Journal of Emerging Economies and Policy, Advance online publication, 323–329.
  16. Li, Y. (2010). Imitation to innovation in China: The role of patents in biotechnology and pharmaceutical industries. Edward Elgar Publishing.
  17. Li, Z., Lai, Q., & He, J. (2024). Does digital technology enhance the global value chain position? Borsa Istanbul Review, 24(4), 856–868. https://doi.org/10.1016/j.bir.2024.03.002
  18. Liu, C. (2023). Deepening the disciplinary cognition and constructing the theoretical system of socialist political economy with Chinese characteristics. China Political Economy, 6(2), 62–73.
  19. Mak, K.-K., Wong, Y.-H., & Pichika, M. R. (2024). Artificial intelligence in drug discovery and development. In F. J. Hock & M. K. Pugsley (Eds.), Drug discovery and evaluation: Safety and pharmacokinetic assays (pp. 1461–1498). Springer. https://doi.org/10.1007/978-3-031-35529-5_92
  20. Motari, M., Nikiema, J.-B., Kasilo, O. M. J., Kniazkov, S., Loua, A., Sougou, A., & Tumusiime, P. (2021). The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement. BMC Public Health, 21(1), 490. https://doi.org/10.1186/s12889-021-10374-y
  21. Owoyemi, A., Owoyemi, J., Osiyemi, A., & Boyd, A. (2020). Artificial intelligence for healthcare in Africa. Frontiers in Digital Health, 2, 6. https://doi.org/10.3389/fdgth.2020.00006
  22. Patel, V., & Shah, M. (2022). Artificial intelligence and machine learning in drug discovery and development. Intelligent Medicine, 2(3), 134–140. https://doi.org/10.1016/j.imed.2021.12.001
  23. Strange, M., & Tucker, J. (2023). AI and the everyday political economy of global health. In Handbook of critical studies of artificial intelligence (pp. 367–377). Edward Elgar Publishing.
  24. Tambo, E., Khayeka-Wandabwa, C., Muchiri, G. W., Liu, Y.-N., Tang, S., & Zhou, X.-N. (2019). China’s Belt and Road Initiative: Incorporating public health measures toward global economic growth and shared prosperity. Global Health Journal, 3(2), 46–49.
  25. Tzeng, L. (2010). Follow-on biologics, data exclusivity, and the FDA. Berkeley Technology Law Journal, 25, 135–156.
  26. Zekos, G. I. (2022). Political, economic and legal effects of artificial intelligence: Governance, digital economy and society. Springer. https://doi.org/10.1007/978-3-030-94736-1
  27. Zhuang, W., Fan, Z., Chu, Y., Wang, H., Yang, Y., Wu, L., Sun, N., Sun, G., Shen, Y., & Lin, X. (2020). Chinese patent medicines in the treatment of coronavirus disease 2019 (COVID-19) in China. Frontiers in Pharmacology, 11, 1066. https://doi.org/10.3389/fphar.2020.01066