ISSN: 2225-8329
Open access
Unequal access to vaccines between high-income and lower-income countries has highlighted the role of Intellectual Property rights as leverage or bargaining tool by pharmaceutical companies in procurement and distribution. India and South Africa 2020 initiated a proposal for Intellectual Property (IP) temporary waivers for Covid-19 patent vaccines to suspend the proprietary rights of the patent owner. This article aims to answer whether total or temporary dismantling of IP rights is the best response to a health emergency while ensuring the industry remains competitive. This article employs qualitative method works of literature through thematic analysis of secondary data. Academic literature on the justification of IP waivers and competition policies, oligopolistic pharmaceutical market structure, provisions of Malaysia Patent Act 1983, TRIPS Agreement, and Competition Policies. Our analysis proposes stakheolders' mutual benefits framework through harmonisation of IP rights and competition policy toward a holistic approach to ensure mutual benefit for all stakeholders. The novelty findings outcome would accelerate the pharmaceutical market development in Level 1 of the market structure, fair competition, efficient vaccine production, and allocation for future pandemics.
Adigwe, O. P., & Oturu, D. (2022). The Role of Patent Waivers and Compulsory Licensing in Facilitating Access to Covid-19 Vaccines: Findings from a Survey Among Healthcare Practitioners in Nigeria. PLOS Global Public Health, 2(7), e0000683. https://doi.org/10.1371/journal.pgph.0000683
Althabhawi, N. M., & Kashef Al-Ghetaa, A. A. (2023). The Covid-19 Vaccine Patent: A Right Without Rationale. Medical Humanities, 49(1), 128–133. https://doi.org/10.1136/medhum-2022-012386
Andrenelli, A., Lopez-Gonzalez, J., & Sorescu, S. (2021, February 11). Using Trade to Fight Covid-19: Manufacturing and Distributing Vaccines. OECD. https://www.oecd.org/coronavirus/policy-responses/using-trade-to-fight-covid-19-manufacturing-and-distributing-vaccines-dc0d37fc/
Balasubramaniam, K., & Sita, V. (2014). Access to Vaccines and the Vaccine Industry—An Analysis. Journal of Vaccines & Vaccination, 5(2). https://doi.org/10.4172/2157-7560.1000218
Barnes-Weise, J., Rutschman, A. S., & Adler, R. (2022). Assessment of the Proposed Intellectual Property Waiver as a Mechanism to Address the Covid-19 Vaccine Scarcity Problem. Journal of Epidemiol Community Health, 76(4), 317–318. https://doi.org/10.1136/jech-2021-218409
Braun, V., & Clarke, V. (2006). Using Thematic Analysis in Psychology. Qualitative Research in Psychology, 3(2), 77–101. https://doi.org/10.1191/1478088706qp063oa
Chade, J. (2021). Vaccine patent waiver push takes centre stage in Geneva. SWI Swissinfo.Ch. https://www.swissinfo.ch/eng/politics/vaccine-patent-waiver-push-takes-centre-stage-in-geneva/46491268
Choong, R., & Novakovic, D. (2021). COVAX ships 828,000 doses of COVID-19 vaccines to Malaysia. UNICEF Malaysia. https://www.unicef.org/malaysia/press-releases/covax-ships-828000-doses-covid-19-vaccines-malaysia
CodeBlue. (2021). Malaysia Co-Sponsors Covid-19 Vaccine Patent Waiver Proposal At WTO. CodeBlue. https://codeblue.galencentre.org/2021/09/17/malaysia-co-sponsors-covid-19-vaccine-patent-waiver-proposal-at-wto/
FMT Reporters. (2021). Support Waiver on Covid-19 Vaccine Patents, Putrajaya Told. Free Malaysia Today (FMT). https://www.freemalaysiatoday.com/category/nation/2021/05/15/support-waiver-on-covid-19-vaccine-patents-putrajaya-told/
GlobalData Healthcare. (2020). The impact Covid-19 on pharmaceutical companies worldwide. Pharmaceutical Technology. https://www.pharmaceutical-technology.com/comment/covid-19-pharmaceutical-companies-impact/
Goyal, Y., Malik, J., & Sharma, G. (2013). Essential Facilities Doctrine. CUTS Centre for Competition, Investment & Economic Regulation.
Gurgula, O. (2021). Compulsory Licensing V the IP Waiver: What Is the Best Way to End the COVID-19 Pandemic? South Center, Policy brief 104. https://doi.org/10.2139/ssrn.3944192
Hosseini, M. (2021). A Covid Competition Dilemma: Legal and Ethical Challenges Regarding the Covid-19 Vaccine Policies during and after the Crisis. Public Governance, Administration and Finances Law Review, 6(1), 51–63. https://doi.org/10.53116/pgaflr.2021.1.5
Hovenkamp, H., Wong-Ervin, K., & Vinje, T. (2019). Licensing of IP rights and competition law—OECD. OECD. https://www.oecd.org/daf/competition/licensing-of-ip-rights-and-competition-law.htm
Jecker, N. S., Wightman, A. G., & Diekema, D. S. (2021). Vaccine ethics: An ethical framework for global distribution of COVID-19 vaccines. Journal of Medical Ethics, 47(5), 308–317. https://doi.org/10.1136/medethics-2020-107036
Jomo, K. S. (2021). COMMENT | Us Support for Vaccine Waiver Welcome, but More Needed. Malaysiakini. https://www.malaysiakini.com/news/574354
Kharel, A. (2018). Doctrinal Legal Research. SSRN Electronic Journal. https://doi.org/10.2139/ssrn.3130525
Lindsey, B. (2021). Why intellectual property and pandemics don’t mix. Brookings. https://www.brookings.edu/articles/why-intellectual-property-and-pandemics-dont-mix/
Lobo, F. (2021). Restructuring the Global Vaccine Industry. South Center, 134(1). https://doi.org/10.2139/ssrn.4083058
Lyn, A. L. K. (2021). Patented Vaccines: Is Waiving The Way Forward? Mondaq: Connecting Knowledge and People. https://www.mondaq.com/patent/1090224/patented-vaccines-is-waiving-the-way-forward
Marcowitz-Bitton, M., & Kaplan, Y. (2021). Recalibrating Patent Protection for COVID-19 Vaccines: A Path to Affordable Access and Equitable Distribution. Bar Ilan University Faculty of Law Research Paper, 21–26. https://doi.org/10.2139/ssrn.3855033
Marquardt, P. D., & Leddy, M. (2003). The Essential Facilities Doctrine and Intellectual Property Rights: A Response to Pitofsky, Patterson, and Hooks. Antitrust Law Journal, 70(3), 847–873.
Mbaye, F. D., & Sardjono, A. (2022). The Patent System During Global Pandemic and the Access to Medications and Vaccines. Sriwijaya Law Review, 6(1), Article 1. https://doi.org/10.28946/slrev.Vol6.Iss1.1233.pp55-69
Mrdecins Sans Frontirres. (2021). Countries obstructing COVID-19 patent waiver must allow negotiations. Médecins Sans Frontières. https://www.msf.org/countries-obstructing-covid-19-patent-waiver-must-allow-negotiations
Ministry of Finance Malaysia. (2021). Budget Speech 2022: Keluarga Malaysia, Makmur Sejahtera. Nasional Malaysia Berhad. https://budget.mof.gov.my/pdf/2022/ucapan/bs22.pdf
Nathan, L. (2022). Malaysia Aspires to Be a Global Vaccine Manufacturing Hub. Free Malaysia Today (FMT). https://www.freemalaysiatoday.com/category/nation/2022/04/27/malaysia-aspires-to-be-a-global-vaccine-manufacturing-hub/
Nature Editorial. (2021). A Patent Waiver on Covid Vaccines Is Right and Fair. Nature, 593(7860), 478–478. https://doi.org/10.1038/d41586-021-01242-1
Ngakhusi, L. P. (2021). Covid Vaccines: Widening Inequality and Millions Vulnerable. UN News. https://news.un.org/en/story/2021/09/1100192
Okonjo-Iweala, N. (2021). Trade in the Time of Pandemics. SWI Swissinfo.Ch. https://www.swissinfo.ch/eng/business/trade-in-the-time-of-pandemics/46371248
Pitruzzella, G., & Arnaudo, L. (2017). On Vaccines, Pharmaceutical Markets, and a Role for Competition Law in Protecting (Also) Human Rights. European Competition Law Review, 38(8), 347–352. https://doi.org/10.2139/ssrn.3033879
Pluss, J. D., Uehara, A., & Turuban, P. (2021, March 4). Calls intensify for Big Pharma to break monopolies on Covid-19 vaccines. SWI Swissinfo.Ch. https://www.swissinfo.ch/eng/business/calls-intensify-for-big-pharma-to-break-monopolies-on-covid-19-vaccines/46414146
Rubin, H., & Saidel, N. (2021). Innovation beyond patent waivers: Achieving global vaccination goals through public-private partnerships. Brookings. https://www.brookings.edu/articles/innovation-beyond-patent-waivers-achieving-global-vaccination-goals-through-public-private-partnerships/
Rutschman, A. S., & Barnes-Weise, J. (2021). The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal. Bill of Health. https://blog.petrieflom.law.harvard.edu/2021/05/05/covid-vaccine-patent-waiver/, http://blog.petrieflom.law.harvard.edu/2021/05/05/covid-vaccine-patent-waiver/
Shulman, J., Ahsan, R., & O’Malley, K. (2021). Understanding Global Vaccine Economics and Research and Development. The Sabin-Aspen Vaccine Science & Policy Group. https://www.sabinaspengroup.org/understanding-global-vaccine-economics-and-research-and-development/
Sundaram, J., & Chowdhury, A. (2021). My Say: WTO is finished without a TRIPS waiver. The Edge Malaysia. https://theedgemalaysia.com/article/my-say-wto-finished-without-trips-waiver
Swagel, P. L. (2021). Research and Development in the Pharmaceutical Industry. Congressional Budget Office. https://www.cbo.gov/publication/57126
Thambisetty, S., McMahon, A., McDonagh, L., Kang, H. Y., & Dutfield, G. (2022). Addressing Vaccine Inequity During the Covid-19 Pandemic: The Trips Intellectual Property Waiver Proposal and Beyond. The Cambridge Law Journal, 81(2), 384–416. https://doi.org/10.1017/S0008197322000241
The Economic Times. (2021). BRICS backs India-South Africa’s COVID-19 vaccine patent waiver proposal. The Economic Times.
https://economictimes.indiatimes.com/news/india/brics-backs-india-south-africas-covid-19-vaccine-patent-waiver-proposal/articleshow/83149877.cms
Thomson Reuters Foundation. (2021). US vaccine patent waiver: A ‘game changer’ for the global south? Eco-Business. https://www.eco-business.com/news/us-vaccine-patent-waiver-a-game-changer-for-the-global-south/
Uddin, M. (2022). Intellectual Property Rights and Competition Law for Transfer of Environmentally Sound Technologies. Pace International Law Review, 34(2), 63. https://doi.org/10.58948/2331-3536.1419
In-Text Citation: (Amin & Zulfakar, 2023)
To Cite this Article: Amin, W. L. M., & Zulfakar, M. M. (2023). Waiving Pharmaceutical Intellectual Property Rights: Harmonizing Patent and Competition Policy. International Journal of Academic Research in Accounting Finance and Management Sciences, 13(2), 1045–1060.
Copyright: © 2023 The Author(s)
Published by HRMARS (www.hrmars.com)
This article is published under the Creative Commons Attribution (CC BY 4.0) license. Anyone may reproduce, distribute, translate and create derivative works of this article (for both commercial and non-commercial purposes), subject to full attribution to the original publication and authors. The full terms of this license may be seen at: http://creativecommons.org/licences/by/4.0/legalcode