Enhance fair access to covid 19 vaccines through the waiver of intellectual property rights recommendations for vietnam

HO CHI MINH CITY UNIVERSITY OF LAW FACULTY OF INTERNATIONAL LAW -*** LE THANH THAO Student ID: 1751101030139 ENHANCE FAIR ACCESS TO COVID-19 VACCINES THROUGH THE WAIVER OF INTELLECTUAL PROPERTY RIGHTS – RECOMMENDATIONS FOR VIETNAM BACHELOR’S THESIS School Year: 2017 - 2022 Supervisor: LL.M Ngo Kim Hoang Nguyen Ho Chi Minh City – Year 2022 HO CHI MINH CITY UNIVERSITY OF LAW FACULTY OF INTERNATIONAL LAW -*** LE THANH THAO Student ID: 1751101030139 ENHANCE FAIR ACCESS TO COVID-19 VACCINES THROUGH THE WAIVER OF INTELLECTUAL PROPERTY RIGHTS – RECOMMENDATIONS FOR VIETNAM BACHELOR’S THESIS School Year: 2017 - 2022 Supervisor: LL.M Ngo Kim Hoang Nguyen Ho Chi Minh City – Year 2022 DECLARATION I, hereinafter, declare that the bachelor thesis of “Enhance fair access to COVID-19 vaccines through the waiver of Intellectual Property rights - Recommendations for Vietnam”, which has been carried out under the supervision of LL.M Ngo Kim Hoang Nguyen, represents my own research work unless otherwise cited or acknowledged by means of complete references Therefore, I take full responsibility for this declaration Ho Chi Minh City, June 29, 2022 Le Thanh Thao TABLE OF CONTENTS INTRODUCTION 01 CHAPTER I: ACCESS TO COVID-19 VACCINES AS THE FOUNDATION OF HUMAN RIGHT 09 1.1 Overview of Human rights 09 1.1.1 Concept of Human rights 09 1.1.2 Approached tendencies of Human rights 11 1.1.3 Characteristics and features of Human rights 12 1.2 Access to COVID-19 vaccines as a human right 13 1.2.1 Right to health 13 1.2.2 Right to enjoy the benefits of scientific progress and its applications 22 1.2.3 Conclusion 24 1.3 International practice regarding access to COVID-19 vaccines 26 1.3.1 Introduction to COVID-19 Vaccines Global Access 26 1.3.2 International vaccination and distribution of COVID-19 vaccines 28 SUBCONCLUSION OF CHAPTER I 31 CHAPTER II: WAIVER OF INTELLECTUAL PROPERTY RIGHTS ON COVID-19 VACCINES – RECOMMENDATIONS FOR VIETNAM 33 2.1 The interface between Intellectual Property rights and Human rights 36 2.1.1 Approaches to the interface between Intellectual Property rights and Human rights 36 2.1.2 Intellectual Property rights, right to health and right to enjoy the benefits of scientific progress and its applications 37 2.2 Waiver of Intellectual Property rights on COVID-19 vaccines 39 2.2.1 Legal framework for waiving Intellectual Property rights for COVID-19 vaccines 40 2.2.2 The insufficiency of compulsory licensing and voluntary licensing 49 2.2.3 Global reaction regarding the waiver of Intellectual Property rights on COVID-19 vaccines 56 2.3 Recommendations for Vietnam 62 2.3.1 Utilizing the Decision on TRIPS Agreement to issue compulsory licenses 62 2.3.2 Other recommendations 64 SUBCONCLUSION OF CHAPTER II 68 CONCLUSION OF THESIS 70 BIBLIOGRAPHY 72 LIST OF ABBREVIATIONS ACT-A CEPI CESCR Access to COVID-19 Tools Accelerator Coalition for Epidemic Preparedness Innovations Committee on Economic, Social and Cultural Rights COVAX COVID-19 Council for TRIPS COVID-19 Vaccines Global Access Coronavirus disease Council for Trade-Related Aspects of Intellectual Property Rights DOHA Declaration Declaration on the TRIPS agreement and public health C-TAP GAVI HRs ICESCR COVID-19 Technology Access Pool Global Alliance for Vaccines and Immunization Human rights International Covenant on Economic, Social and Cultural Rights IP Intellectual Property LDCs Least-developed countries LOIP Law on Intellectual Property Marrakesh Agreement Marrakesh Agreement Establishing the World Trade Organization NGOs OHCHR Non-governmental organizations Office of the United Nations High Commissioner for Human Rights TRIPS Agreement Agreement on Trade-Related Aspects of Intellectual Property Rights WHO World Health Organization WTO UDHR World Trade Organization Universal Declaration of Human Rights INTRODUCTION Imperativeness of the study With deep concern both of the alarming levels of spread and severity and of the alarming levels of inaction, on March 11, 2020, the World Health Organization has declared the coronavirus disease (“COVID-19”) caused by the SARS-CoV-2 virus outbreak a global pandemic Since then the world has been in a race to develop vaccines that can control the COVID-19 pandemic In 2021, more than 250 projects have been initiated for this purpose, but only 14 of them have been authorized for use, despite being in phase clinical trials More than 40 other vaccines are also in phase 1/2 clinical trials and show promising outcomes However, as WHO especially emphazies “it’s not vaccines that will stop the pandemic, it’s vaccination”3 On the other hand, the current situation of COVID-19 vaccination in the world has shown that COVID-19 vaccines have not been distributed and accessed equitably leading to the failure of States to comply with their obligation to ensure access to COVID-19 vaccines for everyone, everywhere since such access is realized to be a Human right One of the main reasons leading to the above problem is the protection of Intellectual Property (“IP”) rights for COVID-19 vaccines Even though, IP protection has a strong and positive impact on socio-economic development, it also has certain negative effects, especially in the current context of COVID-19 pandemic IP rights WHO, “WHO Director-General’s opening remarks at the media briefing on COVID-19 - 11 March 2020”, March 11, 2020, https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarksat-the-media-briefing-on-covid-19 -11-march-2020 (Accessed on June 10, 2022) Zainalabideen A Abdulla et al., “A Summary of the SARS-CoV-2 Vaccines and Technologies Available or under Development”, Pathogens, No 10(7):788, 2021, page WHO, “COVID-19 vaccines”, https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19- vaccines (Accessed on June 10, 2022) protection is characterized by general IP law, which is territorial However, the Covid19 pandemic did not stop within the territory of any one country, but created a global crisis.4 It has become a big deal for countries when they have to fulfill strict obligations imposed by the TRIPS agreement Therefore, the first pioneers such as India and South Africa and then fellow countries have proposed a waiver of IP rights toward COVID19 health products and technologies, including vaccines Such waiver presents an important opportunity for all States to unite and protect public health, global solidarity, and fair access through a concrete step at the international level that can provide an automatic and expedited solution to collectively address IP and technology challenges In this context, the TRIPS waiver is a critical legal instrument for enabling a significant increase in COVID-19 vaccine manufacturing capacity and thus supply, paving the way for global equitable production and access In terms of the balance between economic and social benefits, there is no absolute balance between economic benefits or social benefits, and to resolve the conflict between Human rights (“HRs”) and IP rights, it requires a long time of research with the adjustment of a synchronous and appropriate IP legal system It should be emphasized that waiver of IP rights for Covid19 vaccines is necessary because IP holders have many opportunities to reap economic Nguyen Van Quan, Vu Thanh Cu, “The right to access vaccines to prevent Covid-19 in the current context”, Journal of Legislative Studies, Vol 02+03 (450+451), 2022, http://lapphap.vn/Pages/TinTuc/211029/Quyen-tiepcan-vac-xin-phong-ngua-Covid-19-trong-boi-canh-hien-nay.html, (Accessed on June 13, 2022) Médecins Sans Frontières, India and South Africa proposal for WTO waiver from intellectual property protections for COVID-19-related medical technologies, Briefing Document, 2020, page Siva Thambisetty et al., The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentitives in Patent Law and Politics to end the COVID-19 Pandemic, Society and Economy Working Papers, LSE Legal Studies Working Paper No.06/2021, 2021, page profits while less than one year, the COVID-19 pandemic have claimed the lives of millions of people due to the barriers from the IP system itself Furthermore, with the vaccination policy for children 5-12 years old8 and the plan for vaccinating the nd booster shot (4th and other future dose) for those who need to be vaccinated, including the elderly (60 years old and older), people with background diseases, workers in industrial zones or crowded areas 9, Vietnam, at the present, still has a high demand for COVID-19 vaccines In other words, Vietnam still need to enhance the access of our children to COVID-19 vaccination and our poupulation in general to the 4th and other future dose vaccination and the waiver of IP rights shall act as a necessary legal instrument that will assist Vietnam in this regard With the desire to study in detail, specifically and thoroughly about the access vaccines from the perspective of HRs and the waiver of IP rights toward CVOID-19 vaccines, the author decided to choose the topic “Enhance fair access to COVID-19 vaccines through the waiver of Intellectual Property rights – Recommendations for Vietnam” as the topic of Bachelor of Law thesis Literature review Generally, access to medicines is not a new topic However, when placed in the context of the COVID-19 pandemic affecting the health of all mankind and causing the death of millions of people, the issue of access to medicines, specifically in this thesis, is the access to COVID-19 vaccines is of greater concern than ever While global Nguyen Van Phuc, “Waiver of Intellectual Property rights for COVID-19 vaccines to access the community's entitlement to health care”, Journal of Legislative Studies, Vol 08 (456), 2022 http://www.lapphap.vn/Pages/tintuc/tinchitiet.aspx?tintucid=211080 (Accessed on June 29, 2022) Resolution No 55/NQ-CP dated April 14, 2022 of the Government Office of Socialist Republic of Vietnam on COVID-19 vaccination for children from to 12 years old Notification No 114/TB-VPCP dated April 15, 2022 of the Government Office of Socialist Republic of Vietnam on the Conclusion of Prime Minister Pham Minh Chinh at the 14th online meeting of the National Steering Committee for COVID-19 prevention and control with localities, paragraph 5, page 74 Bolivia, Egypt, Eswatini, Fiji, India, Indonesia, Kenya, the LDC Group, Maldives, Mozambique, Mongolia, Namibia, Pakistan, South Africa, Vanuatu, the Bolivarian Republic of Venezuela and Zimbabwe”, IP/C/W/669/Rev.1, 2021 24 WTO, “Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19, Communication from the African Group, the Plurinational State of Bolivia, Egypt, Eswatini, Fiji, India, Indonesia, Jordan, Kenya, the LDC Group, Malaysia, Maldives, Mozambique, Mongolia, Namibia, Pakistan, South Africa, Vanuatu, the Bolivarian Republic of Venezuela and Zimbabwe”, IP/C/W/684, 2021 25 II Vienna Declaration and Programme of 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