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. 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. 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. 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. Overview of Human rights.
Concept of Human rights. Approached tendencies of Human rights. Characteristics and features of Human rights. Access to COVID-19 vaccines as a human right.
Right to health. Right to enjoy the benefits of scientific progress and its applications. International practice regarding access to COVID-19 vaccines. Introduction to COVID-19 Vaccines Global Access.
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. The interface between Intellectual Property rights and Human rights.
Approaches to the interface between Intellectual Property rights and Human rights. Intellectual Property rights, right to health and right to enjoy the benefits of scientific progress and its applications. Waiver of Intellectual Property rights on COVID-19 vaccines.1 Legal framework for waiving Intellectual Property rights for COVID-19 vaccines. The insufficiency of compulsory licensing and voluntary licensing.
Global reaction regarding the waiver of Intellectual Property rights on COVID-19 vaccines. Recommendations for Vietnam. Utilizing the Decision on TRIPS Agreement to issue compulsory licenses 62 2. 64 SUBCONCLUSION OF CHAPTER II.
68 CONCLUSION OF THESIS. 72 LIST OF ABBREVIATIONS ACT-A Access to COVID-19 Tools Accelerator CEPI Coalition for Epidemic Preparedness Innovations CESCR Committee on Economic, Social and Cultural Rights COVAX COVID-19 Vaccines Global Access COVID-19 Coronavirus disease Council for TRIPS Council for Trade-Related Aspects of Intellectual Property Rights DOHA Declaration Declaration on the TRIPS agreement and public health C-TAP COVID-19 Technology Access Pool GAVI Global Alliance for Vaccines and Immunization HRs Human rights ICESCR 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 Non-governmental organizations OHCHR 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 World Trade Organization UDHR Universal Declaration of Human Rights 1 INTRODUCTION 1. 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. 1 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 3 clinical trials. More than 40 other vaccines are also in phase 1/2 clinical trials and show promising outcomes. 2 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 1 WHO, “WHO Director-General’s opening remarks at the media briefing on COVID-19 - 11 March 2020”, March 11, 2020, https://www.int/director-general/speeches/detail/who-director-general-s-opening-remarks- at-the-media-briefing-on-covid-19---11-march-2020 (Accessed on June 10, 2022) 2 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 1 3 WHO, “COVID-19 vaccines”, https://www.int/emergencies/diseases/novel-coronavirus-2019/covid-19- vaccines (Accessed on June 10, 2022) 2 protection is characterized by general IP law, which is territorial. However, the Covid- 19 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 COVID- 19 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.
5 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. 6 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 Covid- 19 vaccines is necessary because IP holders have many opportunities to reap economic 4 Nguyen Van Quan, Vu Thanh Cu, “The right to access vaccines to prevent Covid-19 in the current context”, Journal of Legislative Studies, Vol.vn/Pages/TinTuc/211029/Quyen-tiep- can-vac-xin-phong-ngua-Covid-19-trong-boi-canh-hien-nay.html, (Accessed on June 13, 2022) 5 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 4 6 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 1 3 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. 7 Furthermore, with the vaccination policy for children 5-12 years old8 and the plan for vaccinating the 2 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 7 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.vn/Pages/tintuc/tinchitiet.aspx?tintucid=211080 (Accessed on June 29, 2022) 8 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 5 to 12 years old 9 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 3 4 practice shows that COVID-19 vaccination is taking place inequitably and the world is struggling and having difficulty in enhancing fair10 access to COVID-19 vaccines, the appearance of the proposal of the waiver as a legal instrument that allows countries to temporarily refrain from WTO’s obligations related to the protection of IP rights in the TRIPS Agreement raise another interesting concern. Approaching this topic with the above issues, the author has referenced the following works: 2.
Domestic Studies: Nguyen Ho Bich Hang, “COVID-19 and Challenges to Intellectual Property Rights”, Vietnamese Journal of Legal Science, Vol. 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. Nguyen Van Quan, Vu Thanh Cu, “The right to access vaccines to prevent Covid- 19 in the current context”, Journal of Legislative Studies, Vol. International Studies: De Menezes, Henrique Zeferino, The TRIPS waiver proposal: An urgent measure to expand access to the COVID-19 vaccines, Research Paper No.
129, South Centre, Geneva, 2021. International AIDS Society and Desmond M Tutu Endowment in Public Health and Human Rights at the Johns Hopkins University, “Human rights and fair access to COVID-19 vaccines: the International AIDS Society–Lancet Commission on Health and Human Rights”, The Lancet, Vol. Philip Loft, Waiving intellectual property rights for Covid-19 vaccines, Research Briefing No. 9417, House of Commons Library, 2022.
10 Within this thesis, the word “fair” and “equitable” shall be used in the same manner without any important differences, indicating that they are interchangeable. 5 Prabhash Ranjan, The Case for Waiving Intellectual Property Protection for COVID-19 Vaccines, Issue Brief, Issue No. 456, Observer Research Foundation, 2021. Along with a number of other domestic and international research works related to either the issue of access to COVID-19 vaccines as a Human right or the waiver of IP rights or both.
Considering from beginning of the COVID-19 pandemic to the present, the author finds that, there are very few domestic studies connecting both the issues of access to COVID-19 vaccines as a Human right and the waiver of IP rights and there is no research work, to the extent of the author’s research, on accessing to COVID -19 vaccines for children and 2 nd booster shot for those who are appropriate. In addition, the author finds that the most recent international research works are likely to focus more on the issue of waiving IP rights. Therefore, through reference from domestic and international studies, the author wishes to inherit previous studies to develop deep research on both issues at the same time.
