Patent protection legal facility for access and availability of pharmaceutical products
Keywords:
Legal Facilities, Patent Protection, Pharmaceutical Products, DrugsAbstract
Patent protection in the pharmaceutical sector plays a dual role: it provides incentives for innovation while simultaneously raising barriers to affordable access to essential medicines. This tension becomes particularly urgent in developing countries such as Indonesia, where high drug prices, unequal distribution, and limited insurance coverage constrain public health rights. This study aims to analyze the legal facilities available under international and national frameworks to balance patent protection with the right to health, focusing on compulsory licensing, government use of patents, parallel imports, and the bolar provision. The research adopts normative legal methods using statue, conceptual, and comparative approaches, with reference to the TRIPs Agreement, Indonesian Patent Law No. 13 of 2016, and relevant case studies. The findings demonstrate that while Indonesia has utilized TRIPs flexibilities such as government use of patents for HIV/AIDS and Covid-19 medicines, the implementation remains fragmented and hampered by weak regulation of parallel imports and data exclusivity. The comparative analysis highlights how other jurisdictions provide clearer safeguards to ensure accessibility while maintaining incentives for innovation. This study concludes that reform is required in Indonesian patent law to strengthen the balance between innovation incentives and public health needs. Clearer regulatory guidelines, transparent remuneration schemes, and stronger distribution mechanisms are essential to guarantee drug availability and affordability, especially during health crises.
References
A Ardagh, Globalization, Intellectual Properties and the Transfer of Technology Finding the Right Balance under the TRIPs Agreement (Charles Sturt University 2003)
[2] 'IC Agenda' (1 June 2023) <https://dgip.go.id/artikel/detail-artikel/Government-Prepare-obat-covid-19-murah?categori=Official Industrial Design News>
[3] Aktieva Tri Tjitrawati, 'The Just Drug Distribution In The Perspective Of Welfare State' (2013) 25, No. 3 Law Platforms 10
[4] Correa Carlos M., Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement (South Centre/WHO 2004)
[5] Correa CM, 'Implications Of The Doha Declaration On The Trips Agreement And Public Health'
[6] E. Bale H, 'The Conflict Between Parallel Trade and Product Access and Innovation: The Case of Pharmaceuticals' (2008) I Journal of International Economic Law <https://papers.ssrn.com/sol3/papers.cfm?abstract_id= 157027>
[7] German Velasquez and Pascale Boulet, 'Globalization and Acess to Drugs: Implication of the WTO/TRIPs Agreement', Globalization and Access to Drugs-Perspective on the WTO/TRIPs Agreement 2 , vol doc.WHO/DAP/98.9 (WHO 1998) < http://apps.who.int/iris/handle/10665/63905> accessed 26 June 2020
[8] Law and Technology Transfer (A Sociological Struggle) (Thafa Media 2013)
[9] John H. Barton, ', Intellectual Property Rights and Innovation' in Nicholas Imparato (ed), Capital for Our Time: The Economic, Legal and Management Challenges of Intellectual Capital (Hoover Institution Press 1999)
[10] John H. Barton, 'Different Pricing of Patented Products' (2001) No. WG4:2 Commission on Macroeconomics and Health Working Paper Series
[11] Ministry of Health, 'Report on the Development of HIV/AIDS and Sexually Transmitted Diseases (PIMS) Quarter I of 2021' (2022) <https://siha.kemkes.go.id/portal/files_upload/Laporan_TW_III_2021.pdf>
[12] Muis, L. S., & Hamid, S. N. C. (2024). State Responsibility in Guaranteeing Access to Essential Medicines for Public Health. Indonesian Journal of Law and Economics Review, 19 No. 3. https://doi.org/https://doi.org/10.21070/ijler.v19i3.1258
[13] Muis, L. S., Jened, R., Barizah, N., & Tjwan, G. C. (2023). State Responsibility for Access and Availability of Patented Drugs for Public Health. Yuridika, 38(2), 219–242. https://doi.org/10.20473/ydk.v38i2.43007
[14] Shery Muis, L. (2024). Accessibility of Pharmaceutical Product Patents for Public Health Through the TRIPs Waiver. Indonesian Journal of Law and Society, 5, 1–115. https://doi.org/10.19184/ijls.v5i1.38647
[15] Maskus KE, 'Intellectual Property Rights in the Global Economy'
[16] Maskus KE, 'Parallel Imports In Pharmaceuticals: Implications For Competition And Prices In Developing Countries'
[17] Maskus KE, 'Integrating Intellectual Property Rights and Development Policy' (2004) 62 Journal of International Economics 237 <https://linkinghub.elsevier.com/retrieve/pii/S0022199603000849>
[18] Mossinghoff GJ, 'Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process' (1999) 54 FOOD AND DRUG LAW JOURNAL
[19] Rajeev Dhavan LH and GJ, '“Conquest By Patent : The Paris Convention Revisited”' Vol. 32, N Journal of the Indian Law Institute 131 <http://14.139.60.116:8080/jspui/bitstream/123456789/17279/1/003_Conquest by Patent - The Paris Convention Revisited %28131-178%29.pdf>
[20] Rozek RP and Berkowitz R, 'The Effects of Patent Protection on the Prices of Pharmaceutical Products: Is Intellectual Property Protection Raising the Drug Bill in Developing Countries?' (2005) 1 The Journal of World Intellectual Property 179 <https://onlinelibrary.wiley.com/doi/10.1111/j.1747-1796.1998.tb00010.x>
[21] Russo P, 'China's Healthcare Reform: How Patent Laws and Generic Drugs Can Benefit China's Public Health' (2015) 15
[22] South-East Asia World Health Organization Regional Office, 'Data Exclusivity and Other “Trips-plus” Measures' [2017] World Health Organization <http://apps.who.int/iris/handle/10665/272979%0Ahttp:/ /apps.who.int/iris/bitstream/10665/272979/1/Data-exclusivity.pdf>
[23] Subramanian A, 'Putting Some Numbers on the TRIPS Pharmaceutical Debate' [2014] International Journal of Technology Management 10 252
[24] The Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (CIPR 2002)
[25] Thomas Founce; Tim Vines; Helen Gibbons, 'New Forms of Evergreening in Australia : Misleading Advertising, Enantiomers and Data Exclusivity : Apotex v Servier and Alphapharm v Lundbeck.' 16 Journal of Law and Medicine 220 <https://search.informit.org/doi/10.3316/agispt.20090483>
[26] Weschler C, 'Use Exception: University Research After' 79 New York University Law Review
[27] WHO, 'HIV/AIDS' ( WHO , 1 June 2022) <https://www.who.int/news-room/facts-in-pictures/detail/hiv-aids>
[28] Yuswanto S, Understanding Patents (Keni Media 2017)
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