IMPLEMENTASI COMPULSORY LICENSING TERHADAP OBAT-OBATAN DALAM BIDANG FARMASI DI INDONESIA (STUDI BERDASARKAN DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH)

Abstract

Kesehatan adalah hak dan investasi setiap warga negara, untuk itu diperlukan adanya peraturan yang memberikan izin kepada pemerintah Indonesia untuk mengakses obat-obatan essensial terutama obat Antiretroviral tanpa harus melanggar paten yang dimiliki oleh pemegang paten. Doha Declaration on the TRIPS Agreement and Public Health adalah deklarasi internasional yang mengatur tentang fleksibilitas atas pasal-pasal pada TRIPS Agreement dalam bentuk compulsory licensing. Atas dasar latar belakang tersebut, terdapat dua rumusan masalah yaitu bagaimana implementasi dari compulsory licensing terhadap obat-obatan dalam bidang farmasi berdasarkan Doha Declaration on the TRIPS Agreement and Public Health di Indonesia? Dan Apa hambatan-hambatan yang terjadi pada implementasi dari compulsory licensing atas obat-obatan berdasarkan Doha Declaration on the TRIPS Agreement and Public Health di Indonesia?. Tujuan penelitian ini yaitu untuk mengkaji dan menganalisis implementasi compulsory licensing atas obat-obatan berdasarkan Doha Declaration on the TRIPS Agreement and Public Health di Indonesia dan mengkaji serta menganalisis hambatan-hambatan yang terjadi. Metode penelitian yang digunakan adalah metode penelitian yuridis normatif (doctrinal legal research/ pure legal research) dengan pendekatan undang-undang (statute approach) sehingga penelitian ini bersandar pada bahan pustaka atau data sekunder. Penelitian ini dilakukan dengan mengidentifikasi prinsip-prinsip pelaksanaan compulsory licensing, khususnya berkaitan dengan akses terhadap obat-obatan di Indonesia. Implementasi compulsory licensing di Indonesia dilaksanakan untuk mengurangi jumlah pengidap HIV/AIDS di Indonesia melalui pelaksanaan paten oleh pemerintah terhadap obat Antiretroviral atas dasar Pasal 99 UU Paten diikuti dengan Peraturan Pemerintah No. 27 Tahun 2004 yang diperjelas dengan Peraturan presiden No. 76 Tahun 2012. Hambatan-hambatan yang terjadi dalam penelitian mengenai implementasi compulsory licensing di Indonesia ini terbagi atas dua kelompok, yaitu hambatan yuridis dan hambatan non-yuridis. Hambatan yuridis berkaitan dengan kekurangan dalam Undang-Undang Paten serta definisi dan batasan Paragraf 6 Doha Declaration on the TRIPS and Public Health dan Pasal 31 TRIPS Agreement yang masih terlalu luas. Hambatan non-yuridisnya adalah ekonomi Indonesia yang belum stabil mengakibatkan rendahnya tingkat pendapatan masyarakat serta pola distribusi obat Antiretroviral yang belum merata. Keywords: Implementasi, Compulsory Licensing, Obat-obatan, Farmasi, Doha Declaration on the TRIPS Agreement and Public Health Health is investment and right of every citizen, for that, it is necessary to have any regulation which permitted/allowed the Indonesian Government to access the essential medicines especially access Antiretroviral drugs without breached the rights of patent holder. Doha Delcaration on the TRIPS Agreement and Public Health is international declaration come up with the flexibilities which regulated about compulsory liensing as the flexibility of TRIPS Agreement. Against this background the thesis focused on two problem statements, those are how is the implementation of compulsory licensing toward access to medicines based on Doha Declaration on the TRIPS Agreement and Public Health? And what is the barriers that occur in implementing compulsory licensing toward access to medicines based on Doha Declaration on the TRIPS Agreement and Public Health. The objectives of this research are to observe and analyze the implementation of compulsory licensing concerning access to medicines in Indonesia based on Doha Declaration on the TRIPS Agreement and Public health and also to identify the barrier in implementation of compulsory licensing in Indonesia. The thesis is using doctrinal legal research or pure legal research to determine or to answering the problem statements which is related with Patent. For Doctrinal legal research or pure legal research type, statute approach is the compatible type of approach which focuses on literature research. The implementation of compulsory licensing in Indonesia has been implemented to reduce the number of sufferers HIV/AIDS in Indonesia through implementation of patent by the Government on Antiretroviral drugs under Article 99 Patent Act followed by President Regulation No. 76/2012. The obstacles/barriers that occur in implementing compulsory licensing in Indonesia was devided into two types, namely: legal barriers and non-legal barriers. Legal barriers related to deficiences in Patent Act, definition and scope of Paragraf 6 Doha Declaration on the TRIPS Agreement and Public Health, and also Article 31 TRIPS Agreement. Non legal barriers is related to the economics factor, and distribution of Antiretroviral drugs. Keywords: Implementation, Compulsory Licensing, Medicines, Pharmacy, Doha Declaration on the TRIPS Agreement and Public Health