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

Abstract

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.

Keywords

• Fikri Mülkiyet
• Yapay Zeka
• İlaç Üretimi
• Çin-Afrika İlişkileri
• Veri Münhasırlığı
• Jenerik İlaçlar
• Afrika İlaç Ajansı
• Zorunlu Lisanslama

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

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.

Keywords

• Intellectual Property
• Artificial Intelligence
• Pharmaceutical Manufacturing
• China-Africa Relations
• Data Exclusivity
• Generic Medicines
• African Medicines Agency

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