Aspek Hukum dalam Paten Farmasi dan Implikasinya terhadap Akses Obat di Negara Berkembang
DOI:
https://doi.org/10.38035/dhps.v2i4.1847Keywords:
Paten Farmasi, Akses Obat, Fleksibilitas TRIPS, Lisensi Wajib, Kesehatan MasyarakatAbstract
Penelitian ini menganalisis aspek hukum paten farmasi dan implikasinya terhadap akses obat di negara berkembang, dengan fokus khusus pada Indonesia. Penelitian menggunakan pendekatan yuridis normatif dengan analisis perbandingan hukum untuk mengkaji implementasi fleksibilitas Perjanjian TRIPS di negara berkembang. Hasil penelitian menunjukkan bahwa perlindungan paten berdampak signifikan terhadap harga obat, dengan rezim paten yang lebih kuat berkorelasi dengan harga obat yang lebih tinggi di negara berkembang. Analisis kasus lisensi wajib untuk obat antiretroviral di Indonesia mengungkapkan keberhasilan sekaligus tantangan implementasi. Penelitian mengidentifikasi empat strategi hukum utama untuk meningkatkan akses obat: lisensi wajib, importasi paralel, ketentuan Bolar, dan mekanisme oposisi paten. Penelitian menyimpulkan bahwa negara berkembang, termasuk Indonesia, belum memanfaatkan secara optimal fleksibilitas TRIPS untuk menyeimbangkan perlindungan paten dengan kebutuhan kesehatan masyarakat. Penelitian ini merekomendasikan reformasi hukum termasuk penguatan prosedur oposisi pra-pemberian paten, penerapan kriteria patentabilitas yang lebih ketat, dan pengembangan kebijakan komprehensif yang menyelaraskan perlindungan paten dengan tujuan kesehatan masyarakat.
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