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 Intellec
Overview of Human rights
Concept of Human rights
The concept of Human rights first appeared on the international agenda when the United Nations Charter declared in 1945 that the United Nations was determined 11
This statement reaffirms commitment to fundamental human rights, emphasizing the importance of respecting human dignity and the inherent worth of every individual It highlights the need for equality between men and women, as well as the importance of fostering mutual respect among nations of all sizes Upholding these principles is essential for promoting global peace, justice, and social cohesion.
The adoption of the Universal Declaration of Human Rights (UDHR) by the United Nations General Assembly on December 10, 1948, marked a significant milestone as the first legal document to establish universal protection of fundamental human rights The UDHR serves as the foundation for all international human rights laws, affirming that “all human beings are born free and equal in dignity and rights,” and are endowed with reason and inherent dignity.
11 Michael Freeman, Human Rights, Key Concepts Series, Fourth Edition (Fully Revised and Updated), 2022, page 10 - 15
12 Charter of the United Nations 1945, Preamble, Section 1
13 Michael Freeman (2022), Supra note 11, page 10 - 15
14 OHCHR, “What are human rights?”, https://www.ohchr.org/en/what-are-human-rights (Accessed on May 8,
Everyone is entitled to all the rights and freedoms outlined in the Declaration, regardless of race, color, sex, language, religion, political or other opinions, national or social origin, property, birth, or other status Furthermore, no distinctions should be made based on the political, jurisdictional, or international status of the country or territory to which a person belongs—for instance, whether it is independent, a trust, non-self-governing, or under any sovereignty limitations These principles emphasize acting towards one another in a spirit of brotherhood and uphold the importance of equality and non-discrimination.
Following the Declaration, the Office of the United Nations High Commissioner for Human Rights (OHCHR) defines human rights as inherent to every individual, emphasizing that all people are entitled to these rights without discrimination based on race, color, sex, language, religion, political beliefs, national or social origin, property, birth, or other status Human rights acknowledge the fundamental entitlement of each person to enjoy their rights universally and without prejudice.
Universal legal guarantees protect individuals and groups from actions and omissions that infringe upon fundamental freedoms, rights, and human dignity Human rights law obligates governments and duty-bearers to uphold these rights by taking positive actions and refraining from violations, ensuring the safeguarding and promotion of human dignity for all.
Human rights are founded on universal ethical principles that emphasize the equal value of every individual's life These principles ensure that all people, regardless of location or time, are entitled to dignity and respect Upholding human rights promotes fairness and justice worldwide, safeguarding individual freedoms consistently across diverse societies.
15 Universal Declaration of Human Rights 1948, Article 1
16 Universal Declaration of Human Rights 1948, Article 2
17 OHCHR, United Nations Staff College Project, Human Rights – A Basic Handbook for UN Staff, page 2
18 OHCHR, Frequently Asked Question On A Human Rights-based Approach To Development Cooperation,
19 Darren J O’Byrne, Human Rights – An introduction, Routledge, 2013, page 26, 27
Approached tendencies of Human rights
In traditional, there are two tendencies to approach HRs Based on the combination of those two tendencies, the last tendency appears They are detailed as follows:
Human rights are fundamentally rooted in the natural attribute of being human, meaning every individual inherently possesses these rights simply by virtue of their human nature These rights are universal and held equally by all people, regardless of cultural, traditional, or social differences As innate and inalienable, human rights do not depend on the will of any individual, community, or state, and cannot be granted or revoked by any entity, including governments.
The second perspective highlights the artificial nature of human rights, asserting that rights are established through agreements among people or defined by the State's laws Therefore, human rights are not innate or inherent but require regulation by the State According to this view, the scope, limitations, and even the validity period of human rights are determined by the ruling class and influenced by societal customs, practices, and cultural traditions.
The third tendency is a combination of the two approaches mentioned above
Accordingly, this approach holds that HRs have both a natural attribute, innate and
20 Vu Cong Giao et al., Question and Answer on Human Rights, Rights and Obligations of Citizens (Revised and
Supplemented Edition), National Political Publishing House, Hanoi, 2016, page 10
21 Jack Donnely, “Human Rights as Natural Rights”, Human Rights Quarterly, Vol 4 No.3, 1982, page 397
22 Vu Cong Giao et al (2016), Supra note 20, page 11
Human attributes are inherently individual but are also shaped by external factors such as legal systems, cultural influences, and political differences, which collectively influence personal development and societal dynamics.
Characteristics and features of Human rights
All HRs are universal, indivisible and interdependent and interrelated 25 and inalienable 26 These are the most essential characteristics and features of HRs In particular, these characteristics are demonstrated below:
First, human rights are universal as mentioned in the first approach in Section
1.1.1.b International HRs law is based upon the principle of universality of HRs 27 They are with us irrespective of ethnicity, race, gender, sexuality, age, religion, political beliefs, or government type 28
Second, human rights are inalienable The preamble of the Universal
The Declaration of Human Rights affirms that the recognition of inherent dignity and the equal, inalienable rights of all human beings is the foundation of freedom, justice, and peace worldwide It emphasizes that, except in specific circumstances or following due process, no individual's human rights can be waived or revoked.
Third, human rights are indivisible, interdependent and interrelated No human right is inherently inferior to another, according to the principle of their indivisibility
On an equal footing with civil and political rights, economic, social, and cultural rights must be respected, protected, and realized The interdependence principle
24 Ho Chi Minh City University of Law, Monograph Book of Human Rights in International and Vietnamese law, Hong Duc Publishing House - Vietnam Bar Association, Ho Chi Minh City, 2014, page 20
25 Vienna Declaration and Programme of Action 1993, Part I, paragraph 5
26 Universal Declaration of Human Rights 1948, Preamble, Section 1
27 OHCHR, Supra note 14 (Accessed on May 8, 2022)
28 Darren J O’Byrne (2013), Supra note 19, page 27
29 OHCHR, Supra note 14 (Accessed on May 8, 2022); See also OHCHR, Supra note 17, page 2
Achieving a single human right in isolation is often difficult or impossible, as highlighted by OHCHR (2006) This underscores that no set of rights can be fully enjoyed without the support of others, emphasizing the interdependence and interconnectedness of human rights.
Access to COVID-19 vaccines as a human right
Right to health
According to the WHO, health is defined as a state of complete physical, mental, and social well-being, not merely the absence of disease or infirmity The organization emphasizes that enjoying the highest attainable standard of health is a fundamental human right for everyone, regardless of race, religion, political beliefs, economic status, or social condition Prioritizing holistic well-being and equitable access to healthcare is essential for promoting global health and human rights.
32 OHCHR, Supra note 14 (Accessed on May 8, 2022)
33 Oxford Vaccine Group, “What is a vaccine, and how do vaccines work?”, January 03, 2019, https://vk.ovg.ox.ac.uk/vk/how-do-vaccines-work (Accessed on May 17, 2022)
In this thesis, the terms “medication,” “medicine,” and “drug” are used interchangeably, referring to substances used for medical treatment According to the National Cancer Institute's NCI Dictionaries, “medication” is defined as a substance used to diagnose, treat, or prevent disease (National Cancer Institute, NCI Dictionaries, “Medication,” accessed May 17, 2022) This terminology ensures clarity and consistency throughout the discussion on pharmaceutical treatments.
35 Constitution of the World Health Organization 1946, Preambles, Section 1
36 Constitution of the World Health Organization 1946, Preambles, Section 2
Health and Human Resources (HRs) are rarely linked explicitly, but their connection aims to enhance human well-being beyond what separate health or human rights-based approaches can achieve There are three key relationships between health and HRs that highlight this interdependence, emphasizing the importance of integrating these areas to promote comprehensive human development.
Public health policies, programs, and practices significantly influence human rights, both positively and negatively, through the use of state power Key functions of public health—assessing health needs, formulating policies, and implementing programs—directly impact human rights benefits and obligations The core challenge is balancing public health promotion with the protection of human rights, requiring governments to align their health policies and practices with both national and international human rights standards This alignment ensures that health initiatives effectively address priority health issues while safeguarding individual rights.
HR breaches, particularly severe, pervasive, and long-term violations, can have significant health consequences affecting individuals’ physical, mental, and social well-being Recognizing and examining these health impacts is essential, using health expertise and methodology to better understand the role of HR violations in harm Documenting the health effects of HR breaches can raise social awareness about the need for human rights promotion and protection, emphasizing that violations or non-fulfillment of rights negatively impact overall well-being.
37 Jonathan M Mann et al., “Health and Human Rights”, Health and Human Rights, Vol 1 No.1, 1994, page 12
The link between health and human rights is fundamental and remains crucial during both peace and conflict, as highlighted by the Pan American Health Organization and WHO According to WHO’s publication, this relationship is evident across various contexts, emphasizing that respect for human rights is essential for achieving optimal health outcomes worldwide Ensuring human rights safeguards individual well-being, supports health equity, and is vital at all times, including periods of political repression and conflict.
The third relationship emphasizes that the promotion and protection of human rights (HRs) are deeply interconnected with the safeguarding and enhancement of health This fundamental link has significant strategic implications and can lead to impactful practical outcomes in both areas, surpassing the influence of previous associations Access to good health is essential for the effective exercise of human rights, and conversely, the realization of human rights promotes better health outcomes, highlighting their mutually reinforcing nature.
Exploring the intersection of health and human resources (HRs) offers significant potential to rejuvenate the healthcare industry and expand HR practices Integrating health perspectives into HR strategies opens new avenues for enhancing employee well-being and organizational performance This interdisciplinary approach creates opportunities for innovative solutions in managing human capital, thereby improving overall societal health and productivity Embracing the connection between health and HRs can lead to more holistic and effective approaches to promoting human well-being in modern society.
International HR law outlines two essential health-related norms: the protection of public health, which justifies restricting human rights when necessary, and the recognition of individuals' right to health, creating corresponding government obligations While limitations on human rights are historically rooted in public health measures, recent developments emphasize applying human rights principles to such policies Ultimately, public health concerns are prioritized when governments establish obligations related to the human right to health, ensuring a balanced approach that respects both individual rights and collective health needs.
NGOs and scholars are increasingly taking the lead in advancing human rights initiatives, following the significant efforts by the World Health Organization (WHO), the United Nations General Assembly, the Commission on Human Rights, and the Sub-Commission on the Promotion and Protection of Human Rights Their collaborative efforts are critical in shaping effective policies that promote global health and human rights.
41 Pan American Health Organization, Supra note 39 (Accessed on May 08, 2022)
42 Jonathan M Mann et al (1994), Supra note 37, page 22
43 Asbjorn Eide et al., Economic, Social and Cultural Rights – A Textbook, Martinus Nijhoff Publishers,
The Committee on Economic, Social, and Cultural Rights (CESCR), the United Nations High Commissioner for Human Rights, and the Special Rapporteurs on Globalization assert the existence of a legal right to access medicine, particularly COVID-19 vaccines Although this right is not explicitly outlined in any formal agreement, it is primarily derived from the fundamental right to health.
Health is a fundamental human right essential for the exercise of all other human rights Various international agreements recognize the right to health, emphasizing its importance According to Article 25.1 of the Universal Declaration of Human Rights (UDHR), "Everyone has the right to an adequate standard of living for their health and that of their family, including food, clothing, housing, medical care, and social services."
Every human being has the right to enjoy the highest attainable standard of health, which is essential for leading a life of dignity The World Health Organization (WHO) initially recognized this fundamental right in its 1946 Constitution, emphasizing its importance as a primary goal of the organization International human rights laws, particularly Article 12 of the International Covenant on Economic, Social, and Cultural Rights (ICESCR) of 1966, explicitly acknowledge that everyone has the right to the highest achievable standard of physical and mental health.
44 Holger Hestermeyer, “Access to Medicine as a Human Right”, Human Rights and the WTO – The Casse of Patents and Access to Medicine, Oxford, 2007, page 78
45 OHCHR, CESCR General Comment No 14: The Right to the Highest Attainable Standard of Health (Art 12),
The 2021 Lancet article titled "Human rights and fair access to COVID-19 vaccines" highlights the crucial role of human rights in ensuring equitable vaccine distribution It emphasizes that addressing disparities requires a commitment to health and human rights principles, particularly in vulnerable populations The report, supported by the International AIDS Society and the Desmond M Tutu Endowment at Johns Hopkins University, advocates for global solidarity and fair access strategies to overcome vaccine inequality amid the COVID-19 pandemic.
48 Asbjorn Eide et al (1995), Supra note 43, page 128 while Article 12.2 outlines the procedures that States Parties must take to fully realize this right 49
Article 12.2 of the ICESCR demonstrates how the medication is included It specifies that States Parties must take actions to realize the right to health, including those required for 50 (i) the prevention, treatment and control of epidemic, endemic, occupational and other diseases 51 and for (ii) the creation of conditions which would assure to all medical service and medical attention in the event of sickness 52
Right to enjoy the benefits of scientific progress and its applications
Every individual has the right to enjoy the benefits of scientific progress and its applications, in addition to the right to the highest attainable standard of physical and mental health as outlined in Article 12 of the ICESCR and Article 25 of the UDHR This fundamental right was first internationally recognized in the 1948 Universal Declaration of Human Rights under Article 27 and later reinforced as legally binding in Article 15(1) of the International Covenant on Economic, Social and Cultural Rights.
Scientific progress enables advanced medical applications, such as vaccines, that prevent and improve disease treatment Ensuring the right to participate in and benefit from scientific advancements is essential for realizing the right to health Therefore, States Parties should actively promote and support scientific progress to enhance public health outcomes globally.
72 OHCHR, Human Rights and Access to COVID-19 Vaccines, COVID-19 Response, 2020, page 1
73 United Nations, Economic and Social Council, CESCR Statement on universal and equitable access to vaccines for the coronavirus disease (COVID-19), Document E/C.12/2020/2, 2020, page 2, paragraph 4
74 Particularly, Article 15.1.b ICESCR provides that the States Parties to the present Covenant recognize the right of everyone “To enjoy the benefits of scientific progress and its applications”
The right to benefit from scientific progress is fundamental, with international agreements emphasizing the responsibility of States to ensure these benefits are accessible and applicable to all, especially vulnerable populations According to Article 2.2 of the ICESCR, countries must make scientific developments available without discrimination, ensuring that medicines and medical treatments are evidence-based, with risks transparently communicated to obtain informed consent Utilizing all available resources, including international aid and cooperation as outlined in Article 2.1 of the ICESCR, States have an obligation to promote health and uphold economic, social, and cultural rights through science and innovation.
Effective distribution and prioritization of vaccines require coordinated international cooperation and assistance This approach ensures equitable access and benefits from scientific advancements, emphasizing the importance of sharing the benefits of scientific progress globally.
The United Nations Economic and Social Council's CESCR General Comment No 25 (2020) emphasizes the crucial role of science in advancing economic, social, and cultural rights under Article 15 of the International Covenant on Economic, Social and Cultural Rights This document highlights that access to scientific progress and its benefits is fundamental for the realization of these rights, reinforcing the state obligations to promote and facilitate scientific development for all.
Under Article 2.2 of the ICESCR, states are committed to ensuring that the rights outlined in the Covenant are exercised without discrimination This includes protections against discrimination based on race, color, gender, language, religion, political or other opinions, national or social origin, property, birth, or other status Upholding these principles promotes equality and non-discrimination in the realization of economic, social, and cultural rights globally.
78 United Nations, Economic and Social Council (2020), Supra note 76, page 15, paragraph 69, 71
Under Article 2.1 of the ICESCR, each State Party commits to taking all necessary steps, both individually and through international assistance and cooperation, especially economic and technical support, to progressively realize the rights outlined in the Covenant This includes utilizing the maximum of their available resources and adopting legislative measures to ensure the full realization of these rights for all.
80 United Nations, Economic and Social Council (2020), Supra note 76, page 11, paragraph 52 and page 15, paragraph 70
81 United Nations, Economic and Social Council (2020), Supra note 73, page 4, paragraph 11
While certain applications of scientific progress are protected under Intellectual Property (IP) regimes, it is essential to balance these rights with the right to health and the benefit from scientific advancements States have a duty to ensure that IP rights do not compromise access to health and the enjoyment of scientific benefits The interplay between IP rights, the right to health, and the right to benefit from scientific progress will be examined further in Section 2.1.2 of Chapter II.
Conclusion
According to Articles 2, 12, and 15 of the ICESCR and Articles 25 and 27 of the UDHR, many international bodies affirm that access to COVID-19 vaccines is a fundamental human right This right is rooted in the principles of enjoying the highest attainable standard of physical and mental health, as well as benefiting from scientific progress and its applications Therefore, every individual is entitled to access a safe, effective COVID-19 vaccine, developed based on the latest scientific advancements, without discrimination.
The ICESCR imposes extraterritorial obligations on states for international assistance and collaboration, including equitable global vaccine distribution The CESCR and UN Human Rights Experts remind States Parties of their responsibilities under the ICESCR to ensure fair access to vaccines during the pandemic Emphasizing the importance of preventing discrimination and inequality, they advocate for proactive efforts to promote justice in global vaccination efforts amid COVID-19.
82 United Nations, Economic and Social Council (2020), Supra note 76, page 15, paragraph 69
83 United Nations, Economic and Social Council (2020), Supra note 73, page 1, paragraph 2, 3
84 International AIDS Society and Desmond M Tutu Endowment in Public Health and Human Rights at the Johns Hopkins University (2021), Supra note 47, page 1525; See also OHCHR, “Statement by UN Human Rights
Universal access to COVID-19 vaccines is crucial for effective prevention and containment of the pandemic worldwide, as emphasized by UN human rights experts Ensuring equitable vaccine distribution not only saves lives but also supports global health security and economic recovery The United Nations highlights that overcoming vaccine inequality is essential to ending the pandemic globally and upholding the right to health for all.
COVID-19 vaccinations are vital for public health, but any restrictions on economic, social, or cultural rights during the pandemic must comply with Article 4 of the ICESCR This means that limitations should only be enacted when legally justified, compatible with the nature of these rights, and aimed at promoting the general welfare within a democratic society Adhering to these principles ensures that measures taken during COVID-19 respect human rights while addressing public health needs.
The CESCR urges states to ensure equitable and universal access to COVID-19 vaccines by eliminating discrimination based on religion, nationality, gender, race, age, disability, migration status, and socioeconomic factors They should guarantee physical access to vaccines for marginalized groups and remote populations through both public and private channels, while strengthening healthcare systems Vaccines must be made affordable or free for low-income and underprivileged populations Additionally, governments should provide accurate scientific information about vaccine safety and efficacy through public awareness campaigns, combating misinformation and pseudoscience spread via the internet and social media.
85 United Nations, Economic and Social Council (2020), Supra note 73, page 1, paragraph 1
86 United Nations, Economic and Social Council (2020), Supra note 73, page 4, paragraph 12
87 United Nations, Economic and Social Council (2020), Supra note 73, page 2, paragraph 4
International practice regarding access to COVID-19 vaccines
Introduction to COVID-19 Vaccines Global Access
The Access to COVID-19 Tools Accelerator (“ACT-A”) was launched in April
In 2020, WHO and its partners—including CEPI, GAVI, the Global Fund, Unitaid, the Foundation for Innovative New Diagnostics, the Welcome Trust, the World Bank Group, and the Bill & Melinda Gates Foundation—launched ACT-A to combat the COVID-19 pandemic According to WHO, ACT-A is the world’s most comprehensive end-to-end solution for ending the pandemic's acute phase, involving collaboration among governments, health organizations, scientists, businesses, civil society, and philanthropists to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines The ACT Accelerator serves as a framework for coordination and collaboration but is not a decision-making body or a new organization.
The four pillars of ACT-A are diagnostics, therapeutics, vaccines, and strengthening the health system The vaccine pillar is managed by CEPI and GAVI through the COVID-19 Vaccines Global Access (COVAX) initiative, which aims to ensure fair and equitable access to COVID-19 vaccines worldwide COVAX is a multilateral, voluntary agreement that allows countries to pool resources and share risks by investing collectively in vaccine development while establishing the necessary political and logistical infrastructure for vaccine distribution.
88 WHO, “The ACT-Accelerator frequently asked questions”, https://www.who.int/initiatives/act-accelerator/faq (Accessed on May 22, 2022)
89 Matthew Rimmer, “The People’s Vaccines: Intellectual Property, Access to Essential Medicines, and COVID- 19”, Journal of Intellectual Property Studies, Vol 5 Issue 1, 2022 page 14, 15
90 Lisa M Herzog et al., “Covax must go beyond proportional allocation of COVID vaccines to ensure fair and equitable access”, BMJ Clinical Research 2021:372m4853, 2021, page 1
COVAX was launched as an unprecedented initiative to promote equitable COVID-19 vaccine distribution, offering a self-financing option for middle- and high-income countries and subsidized vaccines for the 92 lowest-income nations However, despite its ambitious goals, COVAX's implementation has significantly lagged behind its initial rhetoric The initiative has faced ongoing challenges in securing vaccine purchasing agreements from the start, undermining its ability to deliver on promises of equitable access WHO has highlighted these difficulties, emphasizing the need for stronger commitments to ensure global vaccine equity.
In 2021, global vaccine equity efforts through COVAX were significantly undermined by vaccine nationalism, leading to unreliable supply, delays, and limited visibility that hampered vaccination campaigns and eroded public confidence The WHO Director-General described this situation as "a handful of rich countries gobbling up the anticipated supply as manufacturers sell to the highest bidder, while the rest of the world scrambles for the scraps." Additionally, COVAX was exposed as an insecure mechanism, heavily dependent on developed country sponsors holding exclusive vaccine rights and providing non-binding commitments, which often resulted in persistent vaccine shortages.
COVAX has faced criticism for being more of an aid initiative for low- and middle-income countries rather than a genuine global effort to control the pandemic Critics argue that it does not leverage its purchasing power to encourage vaccine-producing corporations to share science, knowledge, and technology, which could enhance global vaccine production Additionally, COVAX has been criticized for a lack of transparency regarding its deals and agreements.
91 WHO, “COVAX Allocation”, https://www.who.int/initiatives/act-accelerator/covax/allocation (Accessed on May 22, 2022)
92 Nguyen Van Phuc (2022), Supra note 7 (Accessed on June 29, 2022)
Karen Hussman (2021) highlights the lack of transparency in global COVID-19 vaccine access, emphasizing the need for greater accountability from pharmaceutical companies She critiques the ongoing collaboration with pharmaceutical firms that often results in monopolistic practices, while governments remain silent on strategies to address these market dominance issues This opacity hampers efforts to ensure equitable vaccine distribution worldwide and underscores the importance of implementing mechanisms to prevent monopolies in the pharmaceutical industry Addressing these challenges is crucial for achieving fair and widespread access to COVID-19 vaccines globally.
International vaccination and distribution of COVID-19 vaccines
COVID-19 vaccine equality emphasizes fair distribution based on need, regardless of a country’s economic status, rooted in the human right to the highest attainable health Ensuring equitable vaccine access should transcend factors such as ethnicity, religion, political beliefs, or social circumstances However, political, economic, social, diplomatic, and health-related challenges influence global vaccine distribution Therefore, reliable, up-to-date data is essential for guiding international efforts, identifying gaps, and achieving true vaccine equity in the final stages of distribution.
Global access to COVID-19 vaccines remains highly unequal, with low-income countries vaccinating only 12% of their populations with at least two doses or a single dose of a one-dose vaccine as of April 4, 2022, compared to 74% in high-income countries Africa continues to face the lowest vaccination rates among all continents, with less than 15% of its population vaccinated by March 2022.
94 The People’s Vaccine, “Frequently Asked Question”, March 10, 2022, https://peoplesvaccine.org/faq/ (Accessed on May 22, 2022)
According to the United Nations Development Programme’s "Global Dashboard for Vaccine Equity," ensuring equitable access to vaccines remains a critical global challenge The report highlights disparities in vaccine distribution across different regions, emphasizing the urgent need for international cooperation to bridge these gaps Addressing vaccine inequity is essential for achieving global health security and ending the pandemic, as highlighted in the UNDP's data on vaccine distribution.
96 Philip Loft, Waiving intellectual property rights for COVID-19 vaccines, Research Briefing No 9417, House of Commons Library, 2022, page 1
As of May 21, 2022, 65.7% of the global population has received at least one COVID-19 vaccine dose, with over 11.76 billion doses administered worldwide Daily, approximately 7.13 million doses are being given However, only 15.9% of people in low-income countries have been vaccinated at least once, highlighting disparities in vaccine access Several countries, including Portugal, Singapore, and the United Arab Emirates, have achieved vaccination rates of at least 75%, whereas many African nations have vaccinated only a small percentage of their populations, underscoring significant global vaccination gaps.
Graph No 1 Total COVID-19 Vaccines Administered per 100 people
(Source: Our World in Data)
The data mentioned above along with Graph No 1 demonstrate significant inequitable access to COVID-19 vaccinations around the world
97 Hannah Ritchie et al., “Coronavirus Pandemic (COVID-19)”, https://ourworldindata.org/covid-vaccinations (Accessed on May 22, 2022)
98 Claire Felter, “A Guide to Global COVID-19 Vaccine Efforts”, Council on Foreign Relations, April 01, 2022, https://www.cfr.org/backgrounder/guide-global-COVID-19-vaccine-efforts (Accessed on May 22, 2022)
Health and healthcare inequities are deeply rooted in broader structural inequalities, leading to increased risks for marginalized populations Indigenous peoples, racial minorities, the working poor, and detainees experience higher COVID-19 cases and deaths across various countries Migrant workers in some regions, such as Southeast Asia, are not prioritized for vaccination despite their heightened exposure due to poor living conditions COVID-19 vaccination efforts often overlook displaced individuals, leaving many unprotected Additionally, incomplete vaccine coverage and ongoing community transmission facilitate virus mutations, potentially reducing vaccine effectiveness, as observed in South Africa.
Inequity in COVID-19 vaccine distribution is primarily driven by high-income countries prioritizing bilateral agreements with vaccine manufacturers, which limits COVAX’s vaccine supply due to its voluntary nature Additionally, these nations have underestimated the threat of emerging variants, focusing on vaccinating their populations and expanding booster programs instead of donating vaccines to low- and middle-income countries Consequently, bilateral deals between wealthy nations and the pharmaceutical sector have undermined the global efforts of COVAX to ensure equitable vaccine access.
The World Health Organization (WHO) has highlighted concerns regarding access to COVID-19 vaccines, emphasizing that while secure and effective vaccinations were developed rapidly, the virus is still outpacing vaccine distribution globally Despite record-breaking progress in vaccine development, equitable distribution remains a significant challenge in controlling the pandemic Addressing these disparities is crucial to ensure timely protection for all populations and to curb the ongoing spread of COVID-19 worldwide.
99 International AIDS Society and Desmond M Tutu Endowment in Public Health and Human Rights at the Johns Hopkins University (2021), Supra note 47, page 1525
100 Yang Ye et al., “Equitable access to COVID-19 vaccines makes a life-saving difference to all countries”,
Nature Human Behaviour, Vol 6, 2022, page 207
Most COVID-19 vaccine doses were administered in high- and upper-middle-income countries, covering health workers and older adults globally When distributed evenly, these doses could have significantly prevented virus mutations and enhanced worldwide pandemic control.
The WHO aims to vaccinate at least 40% of each country's population by the end of this year and 70% by mid-next year, emphasizing equitable distribution of vaccine doses The organization urges governments and vaccine suppliers to prioritize COVAX for delivering donated and purchased vaccines, as ensuring global access is crucial to ending the pandemic WHO states, “The fastest way to end the pandemic is to ensure vaccines are available to everyone, everywhere,” highlighting that limited vaccine access in many countries allows the virus to continue mutating and spreading globally To achieve global herd immunity and curb the virus’s impact, facilitating equitable vaccine access through COVAX is essential.
According to the CESCR, states should prioritize global health rights over national isolationism and vaccine nationalism, emphasizing the importance of fulfilling their obligations to promote human rights for all They advocate for transparent and participatory mechanisms like COVAX to ensure equitable global distribution of vaccines, aligning with WHO's recommendations to foster international cooperation in health.
Pursuant to the right to enjoy the highest attainable standard of physical and mental health stated in Article 12.1 ICESCR and the right to enjoy the benefits of
102 WHO, “Vaccine Equity”, https://www.who.int/campaigns/vaccine- equity?fbclid=IwAR37IC6ynJFKGRRXkaFzov903guKWtTaDDGmvfgA-OQYRIKvJugdegm5JWM (Accessed on May 22, 2022)
Access to COVID-19 vaccines is recognized as a human right under Article 15.1.b of the ICESCR; however, the steps needed for States to realize this right remain complex According to Article 12.2, States are obligated to take measures for disease prevention, treatment, and control, and to ensure access to medical services in case of sickness, but this obligation primarily covers essential medicines Since some COVID-19 vaccines are listed under WHO Emergency Use but not on the latest WHO Model List of Essential Medicines, their status as essential medicines remains unclear, thereby affecting States’ legal duty to guarantee access Despite uncertainties about their classification, the global pandemic underscores the necessity for States to ensure vaccine access as part of their obligation to prevent and control outbreaks, which is vital for the full realization of the right to health and human rights Nonetheless, the current global distribution demonstrates significant inequities, highlighting that both individual States and the international community are failing to uphold this fundamental human right.
WAIVER OF INTELLECTUAL PROPERTY RIGHTS ON COVID-19 VACCINES – RECOMMENDATIONS FOR VIETNAM
The interface between Intellectual Property rights and Human rights
In the 1990s, a significant shift occurred as the long-standing separation between HRs and IP rights was challenged, driven by two key developments First, there was increasing recognition of the rights of indigenous peoples and the protection of traditional knowledge, emphasizing the interconnectedness of cultural heritage and IP Second, the linkage between IP and international trade through the TRIPS Agreement underscored the inseparability of IP rights and human rights These events demonstrated that IP rights and human rights are closely intertwined and cannot be fully addressed in isolation.
2.1.1 Approaches to the interface between Intellectual Property rights and Human rights
Policymakers, international bureaucrats, academic commentators, and civil society organizations traditionally assess the relationship between intellectual property rights (IPRs) and human rights (HRs) through two primary frameworks: the coexistence approach and the conflict approach These perspectives explore whether IP rights can harmoniously coexist with human rights or if they inherently conflict, shaping policy debates and legal interpretations globally Understanding these differing viewpoints is crucial for developing balanced policies that safeguard innovation while respecting human rights obligations.
The coexistence approach to the intersection of Human Rights (HRs) and Intellectual Property (IP) law addresses the fundamental question of balancing private monopoly rights with public access Both fields aim to define the appropriate scope of exclusive rights that incentivize authors and inventors to innovate while ensuring the public has adequate access to their creations Proponents believe IP law and HR law are inherently compatible, emphasizing the importance of finding a balanced approach However, there is ongoing debate about where to strike this balance to effectively reconcile the interests of creators and the public.
115 Tran Kien et al., The conflict between human rights and intellectual property rights - Approach from legal philosophy and legal practice, Vietnam National University Hanoi Publishing House, Vietnam National
University Hanoi – Law Department, 2020, Hanoi, page 27, 28
116 Peter K Yu, “Intellectual Property and Human Rights in the Nonmultilateral Era”, Florida Law Review, Vol
International and regional human rights instruments safeguard certain attributes of intellectual property rights, which enhances the overall protection of human rights Strengthening these IP protections can contribute to the promotion and enforcement of human rights globally.
The conflict approach views HRs and IP as being in fundamental conflict
Strong IP protection is viewed by some as incompatible with a broad range of human rights obligations, particularly in economic, social, and cultural rights When treaty obligations conflict, proponents recommend recognizing the normative precedence of human rights law over intellectual property law to resolve inconsistencies While IP rights can sometimes support and enhance human rights, in many cases, IP laws may create barriers or conflicts that hinder the protection of human rights.
Hence, the area of access to medicines normally is debated under the conflict approach where IP rights have posed significant challenges to the protection of HRs 121
2.1.2 Intellectual Property rights, right to health and right to enjoy the benefits of scientific progress and its applications
A human rights-based (HRs) approach to intellectual property (IP) makes the traditionally implicit balance between the rights of inventors and creators and societal interests more explicit and precise within IP paradigms This approach emphasizes the importance of safeguarding individual rights while ensuring that IP policies serve the broader needs of society By clarifying these competing considerations, a HRs perspective promotes more equitable and socially responsible IP frameworks that align innovation with human rights principles.
117 Laurence R Helfer, “Human Rights and Intellectual Property: Conflict or Coexistence”, Minnesota Intellectual Property Review, Vol 5 No 1, 2003, page 48, 49
118 Peter K Yu (2012), Supra note 116, page 1070
119 Laurence R Helfer (2003), Supra note 117, page 48
120 Tran Kien et al (2020), Supra note 115, page 39
121 Peter K Yu (2012), Supra note 116, page 1075
Audrey R Chapman emphasizes the importance of viewing intellectual property rights through a human rights perspective, highlighting how these rights impact access to scientific progress and its benefits She argues that balancing intellectual property laws with human rights principles is essential to ensure equitable access to scientific advancements By integrating human rights considerations into intellectual property frameworks, societies can promote innovation while safeguarding the rights to health, education, and development This approach fosters a more inclusive and just dissemination of scientific knowledge, aligning legal protections with the fundamental rights outlined in the Universal Declaration of Human Rights.
An HRs approach to intellectual property (IP) emphasizes aligning IP regimes with the norms of the ICESCR, ensuring that protection policies foster scientific progress and benefit all society members It sets a higher threshold for patent approval by requiring inventions to uphold human dignity and HRs norms, reflecting the universal nature of rights and prioritizing support for the most vulnerable Access to scientific and technological advancements must be equitable, demanding government policies that guide scientific investment and development Additionally, this approach recognizes the importance of public participation in scientific decision-making, affirming individuals' rights to discuss, evaluate, and influence technological progress It also underscores the necessity of safeguarding society from potential harmful effects of scientific progress, highlighting the complex balance between innovation, human rights, and societal well-being beyond simple economic considerations.
Many vaccines capable of approval were developed by private enterprises and are protected under intellectual property (IP) rights, allowing these companies to expect fair financial returns for their investments and research However, the CESCR emphasizes that intellectual property is not a human right but a social construct with a social function, especially concerning the right to health and access to scientific advancements.
States Parties have a responsibility to ensure that IP and patent legal regimes do not
Inappropriate cost structures can jeopardize the enjoyment of economic, social, and cultural rights by making essential public goods such as vaccines and medicines inaccessible to developing countries and impoverished communities, thereby hindering equitable access to vital health resources.
International norms mandate that business entities, particularly pharmaceutical companies, have limited obligations to respect the rights outlined in the ICESCR These companies should not exploit intellectual property rights in ways that hinder individuals' access to safe and effective COVID-19 vaccines Governments must ensure that pharmaceutical companies do not use intellectual property protections to obstruct universal access to COVID-19 vaccines domestically or internationally, aligning corporate practices with the right to health.
Waiver of Intellectual Property rights on COVID-19 vaccines
As the pandemic persists, countries must develop innovative strategies to boost vaccine manufacturing and ensure timely, affordable distribution Rigid adherence to the TRIPS Agreement’s strict intellectual property rules may hinder these efforts, highlighting the need for flexible, collaborative solutions to address global health challenges effectively.
A wide range of medical products, including vaccines, are now essential for an effective response to the COVID-19 pandemic Many of these products and their components are protected by various IP rights such as patents, copyrights, trade secrets, and industrial designs Current legal flexibilities mainly focus on improving access to medicines under patent protection but are insufficient to address the impact of other IP rights on the availability of critical medical supplies during the pandemic.
124 United Nations, Economic and Social Council (2020), Supra note 73, page 2, paragraph 6
125 United Nations, Economic and Social Council (2020), Supra note 73, page 3, paragraph 7
The exercise of intellectual property rights has created significant challenges to the mass production and affordability of COVID-19 medical products The India-South Africa waiver proposal addresses three key concerns: first, that IP rights currently hinder or threaten to limit access to affordable medical supplies; second, that IP protections on various technologies may deter innovation efforts for new COVID-19 solutions; and third, despite WTO amendments to the TRIPS Agreement aimed at improving access during health emergencies, procedural complexities have hampered their effective implementation, especially in countries lacking domestic manufacturing capacity.
2.2.1 Legal framework for waiving Intellectual Property rights for COVID-19 vaccines
The waiver from specific TRIPS Agreement provisions for COVID-19 prevention, containment, and treatment is based on the Draft Decision and the officially adopted Decision on TRIPS Agreement, referencing proposals 128 and 129 The legal foundation for this waiver is rooted in Articles IX.3 and IX.4 of the Marrakesh Agreement Establishing the World Trade Organization.
Article IX.3 of the Marrakesh Agreement regulates that “In exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade Agreements” And that “A request for a waiver concerning the Multilateral Trade Agreements in Annexes
127 Biswajit Dhar, K.M Gopakumar, India – South Africa proposal for a waiver from certain obligations under the TRIPS Agreement, Third World Network, Briefing Paper, 2020, page 3
128 WTO (2020), Supra note 105, page 3, the Annex, preamble; See also WTO (2021), Supra note 108, page 3, the Annex, preamble
1A or 1B or 1C and their annexes shall be submitted initially to the Council for Trade in Goods, the Council for Trade in Services or the Council for TRIPS”
Following Article IX.3 of the Marrakesh Agreement, Article IX.4 provides that
A waiver granted by the Ministerial Conference must specify the exceptional circumstances justifying it, along with the terms and conditions for its application and its termination date Waivers exceeding one year are subject to annual review by the Ministerial Conference to assess if the justifying circumstances persist and if the conditions are met Based on these reviews, the Conference can decide to extend, modify, or terminate the waiver.
A waiver from obligations under the TRIPS Agreement is only granted in cases of exceptional circumstances The term “exceptional circumstances,” as outlined in Articles IX.3, signifies conditions that justify such waivers, emphasizing their rarity and the need for specific justification This stringent criterion ensures that waivers are granted only under truly extraordinary situations, maintaining the integrity of TRIPS commitments and promoting balanced global intellectual property standards.
IX.4 of the Marrakesh Agreement, is not defined in the WTO Agreements The term
"Exceptional circumstances" refer to situations where a country’s ability to waive certain obligations is permitted under WTO law, typically to address urgent conditions that would otherwise be illegal The COVID-19 global pandemic clearly qualifies as an "exceptional circumstance" under Articles IX.3 and IX.4 of the WTO Agreement, enabling nations to implement necessary measures in response to the crisis while maintaining compliance with WTO regulations.
Marrakesh Agreement, since it is the largest global health crisis in the last 100 years, stealing lives all over the world and causing unprecedented economic and social devastation 130
Additionally, in general, the waiver shall be granted collectively to WTO Members The WTO system has in the past, particularly, in the period from 1995 to
2015 and 2019, provided 3 waivers with respect to provisions under the TRIPS
130 Prabhash Ranjan (2021), Supra note 126, page 5, 7
The TRIPS Agreement includes a provision (Article 31f) that limits the use of compulsory licenses primarily to the domestic market, posing challenges for developing countries and LDCs in accessing affordable, quality pharmaceuticals Recognizing this limitation, developing nations proposed solutions leading to the inclusion of Article 31bis through a collective waiver The 2001 Doha Declaration on TRIPS and Public Health acknowledged these challenges, emphasizing that WTO Members with limited or no manufacturing capacity could face difficulties effectively utilizing compulsory licensing While the Declaration highlighted flexibilities within TRIPS, it did not fully resolve issues related to compulsory licensing for countries lacking pharmaceutical production capabilities.
131 Médecins Sans Frontières (2020), Supra note 5, page 8; See also WTO, “Waivers – 2019 – Note by the
Secretariat”,https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S009-
The attached table provides information for delegations, listing waivers granted by the WTO General Council in 2019, including those previously granted and still in effect, noting some expired during the year In response to manufacturing capacity issues, the WTO adopted Decision No WT/L/540 on August 30, 2003, implementing a mechanism under Trade-Related Aspects of Intellectual Property Rights (TRIPS) to waive certain restrictions when exporting countries supply products under compulsory licenses requested by importing countries This decision waived restrictions under Article 31(f) and provided remuneration waivers under Article 31(h) of the TRIPS Agreement, facilitating access to essential medicines Two years later, on December 6, 2005, WTO Member States agreed to amend the TRIPS Agreement permanently through a protocol including the proposed Article 31bis, solidifying the interim waivers granted earlier and promoting greater flexibility for developing countries.
The amendment to the TRIPS Agreement, including its annex and appendix, defines the conditions under which countries can suspend Article 31(f) Implemented in 2017, this amendment replaced the previous waiver for member countries that accepted it Discussions on the limitations of TRIPS flexibilities, especially amid the current pandemic, will be addressed in the next section of this chapter.
Paragraph 4 of the DOHA Declaration emphasizes that the TRIPS Agreement should not hinder member countries from implementing measures to safeguard public health It affirms that, while reaffirming commitment to the TRIPS Agreement, it can and should be interpreted in a way that prioritizes public health needs.
132 Rojina Thapa, “Waiver Solution in Public Health and Pharmaceutical Domain under TRIPS Agreement”,
Journal of Intellectual Property Rights, Vol 16, 2011, page 470, 471
133 WTO, Decision No WT/L/540 of August 30, 2003 on Implementation of Paragraph 6 of the DOHA Declaration on the TRIPS Agreement and Public Health, page 2, paragraph 2
135 WTO, Decision No WT/L/641 of December 06, 2005 on of the TRIPS Agreement
136 Rojina Thapa (2011), Supra note 132, page 471 implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.”
The original India–South Africa waiver proposal and its revised version both request a waiver of 40 articles related to diagnostics, therapeutics, and vaccines, while excluding certain sections such as Protection of Performers, Producers of Phonograms, and Broadcasting Organizations (Article 14), Industrial Designs (Section 4), Patents (Section 5), and the Protection of Undisclosed Information (Section 7) These proposals also seek to suspend enforcement of intellectual property rights under Parts II and III of the TRIPS Agreement, specifically addressing copyright, related rights, and patent protections The co-sponsors justify each section waiver by emphasizing the urgent need to facilitate access to essential health technologies during global health emergencies.
The Co-sponsors highlighted that the exceptions outlined in Articles 13, 139, and 26 of the TRIPS Agreement are inadequate for safeguarding public health, with their application being uncertain in emergency situations They emphasized that numerous IP holders are involved with products and technologies, making the process of identifying rights, negotiating licenses, and managing claims complex, costly, and time-consuming Moreover, some IP holders may refuse to license their rights, which can hinder swift access to vital health technologies Legal restrictions should not impede urgent public health responses during emergencies.
137 WTO (2021), Supra note 108, page 3, the Annex, paragraph 1
138 WTO (2021), Supra note 109, page 6, paragraph 34, 35, 36 and page 7, paragraph 41
Article 13 of the TRIPS Agreement emphasizes that limitations or exceptions to exclusive rights must be limited to specific, special cases that do not interfere with the normal use of the work Such exceptions should also not unreasonably harm the legitimate interests of the copyright holder, ensuring a balanced approach between public access and rights holders' protection.