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COVID-19 Vaccines as Global Common Goods: An Integrated Approach of Ethical, Economic Policy and Intellectual Property Management

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Abstract

The article deals with the current debate about COVID-19 Vaccines as global public/common goods. After a brief introduction on the global epidemiological and economic implication of the pandemic, the problem of the correct characterization of either vaccine or immunization/herd immunity as global public/common good, according to the necessary characteristics outlined by the pertinent economic theories, is addressed. The conclusion is that the term “global public good”/global common goods” has been extensively used in the last two years by policy makers, political leaders, academics, economists, international organizations, NGOs and others health groups, in a sort of “loose way”. Substantially, in order to underscore that equitable access to health products, including vaccines, health and biomedical technologies, medical services, medical devises, whose availability, accessibility, acceptability, affordability to the world is fundamental to tackling the pandemic. The current legal proprietary regime applied to vaccines, extensively covered by IPRs, has transformed an intrinsically non-excludable common/public good (the vaccines, due to their nature and characteristics) in something excludable and rival in consumption. Consequently, the article argues that what is needed is a swift in their legal governance. The current legal discipline of vaccines and health technologies must be changed to bring it into line with the non-excludable nature of these goods. The richest countries in the world, in pursuit of their “vaccine nationalisms”, have already collectively preordered 8.8 billion doses of vaccine, far in excess of need, thus obliging billions of people in the Global South to wait years to be vaccinated. In this respect, the article investigates the EU vaccines strategy and analyzes the Advanced Purchase Agreements signed by the European Commission with the major vaccine producers, enlightening the untenable secrecy and opacity with which the European Union’s executive has handled COVID-19 vaccine supply contracts, and how it has simply paid no more than lip-service to the concept of global common/public good by attributing a broad “private governance” to the pharmaceutical companies. Then, the various arguments, for and against, the Waiver Proposal to several sections of the WTO TRIPS agreement, introduced by India and South Africa on the TRIPS Council on October 2020, have been briefly summarized, accounting the current luck of needed consensus among the various members of the WTO. The article however describes an important number of new global and collaborative efforts already put in place by a myriad public and private actors to allow efficient development and production of vaccines in order to enhance a global access to vaccines. The article concludes by stressing the major developments in the U.S. patent’s landscape and in the Biden Administration’s attitude towards the current global health crisis, that leave hope for “extraordinary measures” to be agreed by the international community in near future. The auspice is that the time has finally arrived for the international community to develop reliable and long term solutions to tackle future global pandemic, preferably by the negotiation of a new WHO global health treaty, to secure universal fair access to essential technologies and vaccines and protecting them as global public/common goods.
Nerina Boschiero*
COVID-19 Vaccines as Global Common
Goods: An Integrated Approach of Ethical,
Economic Policy and Intellectual Property
Management
https://doi.org/10.1515/gj-2021-0042
Published online October 1, 2021
Abstract: The article deals with the current debate about COVID-19 Vaccines as
global public/common goods. After a brief introduction on the global epidemio-
logical and economic implication of the pandemic, the problem of the correct
characterization of either vaccine or immunization/herd immunity as global public/
common good, according to the necessary characteristics outlined by the pertinent
economic theories, is addressed. The conclusion is that the term global public
good/global common goodshas been extensively used in the last two years by
policy makers, political leaders, academics, economists, international organiza-
tions, NGOs and others health groups, in a sort of loose way. Substantially, in
order to underscore that equitable access to health products, including vaccines,
health and biomedical technologies, medical services, medical devises, whose
availability, accessibility, acceptability, affordability to the world is fundamental to
tackling the pandemic. The current legal proprietary regime applied to vaccines,
extensively covered by IPRs, has transformed an intrinsically non-excludable
common/public good (the vaccines, due to their nature and characteristics) in
something excludable and rival in consumption. Consequently, the article argues
that what is needed is a swift in their legal governance. The current legal discipline
of vaccines and health technologies must be changed to bring it into line with the
non-excludable nature of these goods. The richest countries in the world, in pursuit
of their vaccine nationalisms, have already collectively preordered 8.8 billion
doses of vaccine, far in excess of need, thus obliging billions of people in the Global
South to wait years to be vaccinated. In this respect, the article investigates the EU
vaccines strategy and analyzes the Advanced Purchase Agreements signed by the
European Commission with the major vaccine producers, enlightening the unten-
able secrecy and opacity with which the European Unionsexecutivehashandled
*Corresponding author: Nerina Boschiero, Diritto Pubblico Italiano e Sovranazionale, Università
degli Studi di Milano, Via Festa del Perdono 7, 20122, Milan, Italy,
E-mail: nerina.boschiero@unimi.it
Global Jurist 2021; ▪▪▪(▪▪▪): 154
Open Access. © 2021 Nerina Boschiero, published by De Gruyter. This work is licensed
under the Creative Commons Attribution 4.0 International License.
COVID-19 vaccine supply contracts, and how it has simply paid no more than
lip-service to the concept of global common/public good by attributing a broad
private governanceto the pharmaceutical companies. Then, the various argu-
ments, for and against, the Waiver Proposal to several sections of the WTO TRIPS
agreement, introduced by India and South Africa on the TRIPS Council on October
2020, have been briefly summarized, accounting the current luck of needed
consensus among the various members of the WTO. The article however describes
an important number of new global and collaborative efforts already put in place by
a myriad public and privateactors to allow efficient development and production of
vaccines in order to enhance a global access to vaccines. The article concludes by
stressing the major developments in the U.S. patents landscape and in the Biden
Administrations attitude towards the current global health crisis, that leave hope
for extraordinary measuresto be agreed by the international community in near
future. The auspice is that the time has finally arrived for the international com-
munity to develop reliable and long term solutions to tackle future global
pandemic, preferably by the negotiation of a new WHO global health treaty, to
secure universal fair access to essential technologies and vaccines and protecting
them as global public/common goods.
Keywords: COVID-19, vaccines, health care products, global common goods,
economic crisis and costs of the pandemic, inequalities, intellectual property
rights, management of the commons, cooperation and solidarity
1 Introductory Remarks: Coronavirus is Here to
Stay; Global Epidemiological and Economic
Implications
Virus and diseases are given different names (like the HIV, the virus that causes
AIDS). COVID-19 is the ofcial name announced on 11 February 2020 by WHO, in
the International Classication of Diseases (ICD), for a new coronavirus disease
caused by a responsible virus, named by virologists within the International
Committee on Taxonomy of Viruses (ICTV) as the severe acute respiratory syn-
drome coronavirus 2or SARS-CoV-2.
1
For simplicity, we will refer to it in this
article as COVID-19. This is the highly infectious, and highly contagious in
humans, respiratory disease caused by the newly discovered successor to
1WHO. Naming The Coronavirus Disease (COVID-19) And The Virus That Causes It. https://
www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-
coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it.
2N. Boschiero
SARS-CoV-1, the virus that caused 20022004 SARS outbreak, which heavily
affected Asia specically. The reason for this delineation is two-fold. First,
COVID-19 is the name already colloquially known for the virus, and second, the
term COVID-19 effectively distinguishes the new virus from the coronavirus
responsible for the previous SARS epidemic which happily did not spread widely
from the temperate climate places where it generated, and was thought to be
highly pathogenic.
The first known infections from COVID-19 were discovered in Wuhan,
China, in November 2019, although the original source of the viral trans-
mission to humans remains unclear. Because many of those early infected were
workers at the Huanan Seafood Market it has been suggested that the virus
might have originated from the market, coming either from bats directly or
indirectly through any number of intermediate hosts. It is also possible that
visitors may have introduced the virus to the market, which then facilitated
rapid expansion of the infection.
2
The virus, in fact, primarily spreads between
people through close contact and via respiratory droplets produced from
coughs or sneezes.
Those infected with the virus have a wide variety of symptoms as some people
experience mild to moderate respiratory illness and recover without requiring
special treatment, while others, especially those older, vulnerable and fragile (with
underlying medical problems like cardiovascular disease, diabetes, chronic res-
piratory disease, and cancer) might develop much more serious illness or even die
as a result.
3
On 30 January 2020, following the recommendations of the Emergency Com-
mittee, the WHO Director General, Tedros Adhanom Ghebreyesus, declared that
the outbreak constitutes a Public Health Emergency of International Concern
(PHEIC).
4
This was due to the rapid increase in the number of cases outside China
in the rst weeks of 2021, that has since affected a growing number of countries.
The virus spread from the Peoples Republic of China, rst to 20 others countries,
and then to the entire globe. Subsequently, the WHO declared the outbreak a
2A WHO report on a joint WHO-China study stated that human spillover via an intermediate
animal host was the most likely explanation, suggesting it emerged from a bat-borne virus. See
Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19),1624 February
2020, https://www.who-china-joint-mission-on-COVID-19-nal-report.pdf.
3WHO. Clinical Management Of COVID- 19, Interim Guidance, 27 May 2020, https://apps.who.
int/iris/rest/bitstreams/1278777/retrieve.
4WHO. COVID 19 Public Health Emergency of International Concern (PHEIC) Global Research
and Innovation Forum: Towards a Research Roadmap,1112 February 2020, https://www.who.
int/publications/m/item/COVID-19-public-health-emergency-of-international-concern-(pheic)-
global-research-and-innovation-forum.
COVID-19 Vaccines as Global Common Goods 3
pandemicon 11 March 2020.
5
The WHO then issued temporary recommendations
relating to trade, travel, cargo and goods. The United Nations (UN) General As-
sembly (collectively UNGA) adopted a number of resolutions to combat the
pandemic. First, on 2 April 2020, the UNGA adopted a resolution entitled Global
solidarity to ght the coronavirus disease 2019 COVID-19
6
; following this, a sec-
ond resolution was adopted on 20 April 2020, entitled International cooperation
to ensure global access to medicines, vaccines and medical equipment to face
COVID-19.
7
Finally, a third resolution was adopted on September 2020, known as
United response against global health threats: combating COVID-19.
8
These
resolutions were responsible for recognizing the unprecedented negative health,
economic and social impacts on the international community, including the severe
disruption to societies, economies, global trade and travel and the devastating
impact on the livelihoods of people caused by COVID-19 pandemic which con-
tinues to spread globally. The UNGA acknowledged that the poorest and most
vulnerable are the hardest hit by the pandemic and that the impact of the crisis will
reverse hard-won development gains and hamper progress towards achieving the
Sustainable Development Goals. The General Assembly also emphasized that this
pandemic is a powerful reminder of our interconnectedness and vulnerabilities,
as the virus respects no borders, and that combating this pandemic call for an
open, transparent, robust, coordinated, large-scale, science-based and inclusive
global response in the spirit of solidarity. The same concerns and suggestions for
cooperation and collaboration in the spirit of unity and solidarity were advanced in
the World Health Assembly resolution WHA73.1 COVID-19 response.
9
At the time of this writing (early August 2021), the numbers of people that have
fallen victim to this pandemic are impressive: between 31 December 2019 up to
date, 198,778,175 cases of infection, and 4,235,559 deaths have been reported
globally.
10
Even more staggering, these numbers continues to grow every hour and
every day. We already passed fourth million deaths worldwide. Governments
5WHO. Director-Generals Opening Remarks At The Media Brieng On COVID-19, 11 March
2020, https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-
remarks-at-the-media-brieng-on-COVID-1911-march-2020.
6A/RES/74/270.
7A/RES/74/274.
8A/RES/74/307.
9See https://undocs.org/pdf?symbol=en/A/HRC/47/L.21; https://apps.who.int/gb/ebwha/pdf_
les/WHA73/A73_R1-en.pdf.
10 WHO. Corona Virus Disease (COVID-19) Pandemic, https://www.who.int/emergencies/
diseases/novel-coronavirus-2019?gclid=CjwKCAjw9aiIBhA1EiwAJ_
GTStvAhAcf5nP74yqu51UUuKUC-GT-2MbeHTiKJPKFq2V-ibz5i7XeZhoC4RsQAvD_BwE (visited on
3 August, 2021).
4N. Boschiero
around the globe immediately implemented serious restrictions to economic and
social activities in order to slow the spread of the virus, including through policies
of connement, physical distancing and restrictions on travel. These restrictions
aimed at reducing pressure on health systems, allowing sufcient time to improve
health infrastructures and develop diagnostics, vaccines and treatments to effec-
tively respond to the virus. There are already several vaccines that are in use and
that were recently introduced in many countries. Some of these vaccines are based
on the traditional method of using an inactivated vaccine to expose the bodys
immune system to the virus without risking the serious disease responses. Other
are based on an innovative formula (mRNA vaccines) that inject the coronavirus
genetic code into the body, with the goal of triggering the body to make viral
proteins in order to train the immune system to attack the virus.
The first mass vaccination program started in early December 2020 and, ac-
cording to WHO data as of 15 February 2021, at least seven different vaccines and
175.3 million vaccine doses had already administered by the WHO, and many other
potential vaccines are still being developed.
11
In principle, the process for devel-
oping a vaccine is normally very long: each vaccine must be proven safe and
effective in large (phase I, II, and III) clinical trials. Once vaccines are demon-
strated to be safe and efcacious, they must be authorized by national regulators,
manufactured to exacting standards. As a nal step, all approved vaccines require
distribution through a complex logistical process, which includes rigorous stock
management and temperature control.
12
In the case of COVID-19, this process has,
not surprisingly, been very fast. In order to tackle concerns with the pandemic as
soon as possible, not all the COVID-19 vaccine candidates have completed their
phase III trials, and in fact some have been distributed after only providing interim
testing results. To this end, the European Union (EU) has proposed an EU vaccine
strategy for COVID-19 including several temporary (strictly COVID-19-related)
11 WHO issued an Em ergency Use Listing (EULs) f or the Pzer/BioNTech COVID-19 vaccine on 31
December 2020. On 15 February 2021, the WHO issued EULs for two versions of the AstraZeneca/
Oxford COVID-19 vaccine, manufactured by the Serum Institute of India and SKBio. On 12 March
2021, the WHO issued an EUL for the COVID-19 vaccine developed by Janssen (Johnson &
Johnson). The WHO is on track to EUL other vaccine products through June. See also Status Of
COVID- 19 Vaccin es Within WHO EUL/PQ Evaluation Process(unfortunately updated only as to
16 February 2021).
12 On paper, some vaccines prove to have some substantial advantages: that they can be stored in
a standard refrigerator at 28°C. This is the case of the two Chinese vaccines (Sinovac and
Sinopharm) and of the Oxford- AstraZeneca vaccine, which is made from a genetically engineered
virus that causes the common cold in chimpanzees. Others, like Modernas vaccine needs to be
stored at 20 °C and Pzers vaccine at 70 °C. It means that both the Chinese and the Oxford-
AstraZeneca vaccines are denitively more useful to developing countries which might not be able
to store large amounts of the vaccine at such low temperatures.
COVID-19 Vaccines as Global Common Goods 5
derogations from certain rules for clinical trials, in order to facilitate the devel-
opment, authorization and availability of COVID-19 vaccines and treatments.
13
On the one hand, the unprecedented development of several COVID-19
vaccinesinsuchashorttimeisanhistoricachievementinthefieldofglobal
scientific research. On the other, increased concerns surrounding severe blood-
clotting incidents have emerged with AstraZeneca COVID-19 vaccine, recently
renamed Vaxzevria,aswellaswiththeJohnson & Johnsonssingle-dose vaccine.
The potential link of these unusual blood clots with these vaccines already led
some countries (including the United States and the European States) to came to
a sudden halt of immunization after their respective health agencies and regu-
lators either called for a pause in inoculations, or limited it to certain population
groups. Even if the adverse effects appear to be extremely rare, the nations
vaccination efforts are now certainly addressing the vast issue of vaccine hesi-
tancy. The great risk is that if the public suspected their governments of con-
cealing serious potential side effects, far more people might decide against
vaccination, which would ultimately result in exposing the world population to
increased risk of contracting COVID-19. There is, therefore, difcult work to do in
order to facilitate equitable access to safe and effective COVID-19 vaccines for the
billions of people who will need them. One of the major and unprecedented
challenges posed by this pandemic is the need to manufacture the vaccines in
large quantities, while continuing to produce all the other important life-saving
vaccines already in use.
Besides that, obvious challenge, more than 90% of the 100 scientists
(including immunologists and infectious-disease researchers), interviewed on
January 2021 (by the leading journal Nature) and asked whether the virus that
causes COVID-19 could be eradicated, responded that they think coronavirus could
become endemic, meaning that it will continue to circulate within the global
population for years to come.
14
There are many reasons for this conclusion. Ac-
cording to the Natures survey, even if it is possible to eliminate COVID-19 from
some regions, it will continue to circulate in others. In zero-COVID regions there
will be a continual risk of disease outbreaks, with an ever-present risk of reintro-
duction from places where vaccine coverage and public-health measures have not
been good enough. Particularly, it is unclear thus far exactly how effective vaccines
can be at reducing transmission of the disease, stopping a person from passing on
13 Communication from the Commission to the European Parliament, the European Council, the
Council and the European Investment Bank. EU Strategy for COVID-19 Vaccines, COM/2020/245
nal, 17.6.2020.
14 The Coronavirus Is Here To Stay Heres What That Means, Nature, 16 February 2021, https://
www.nature.com/articles/d41586-021-00396-2.
6N. Boschiero
the virus, and thus contributing to the so-called herd immunity. Herd immunity is
only relevant if the world succeeds in having a transmission-blocking vaccine.
Firstly, scientists have outlined that a vaccine which is 90% effective in blocking
transmission will need to reach at least 55% of the population, in order to achieve
temporary herd immunity. This number increases to 67% if fundamental preventive
measures (like social distancing, face masks, remote working etc.) are lifted.
Clearly, vaccinating 55% of the population would be a monumental task for many
countries and, in any case, it would take longer to see how effectively vaccines can
reduce transmission. Secondly, as of late 2020, several variants of COVID-19 have
emerged and are spreading globally. It unclear, however, whether the current
vaccines will continue to remain effective against newer variants of the virus.
15
Therefore, it is likely that COVID-19 vaccines will need to be updated, possibly
every year.
16
Thirdly, the future nature of this virus will also depend on whether it
establishes itself in the wild animal population. There is already evidences that the
virus has infected many animals (not only minks but also cats), with the conse-
quences that it might continue to be passed to people through those intermediate
hosts. Periodic re-vaccinations may continue to be necessary (perhaps indenitely
and essentially everywhere) to contain the steady stream of new variants. Long-
term prospects for the pandemic probably include COVID-19 becoming a perma-
nent endemic global health disease,much like inuenza.
17
In sum, this new virus is here to stay for years to come. It will continue to be a
significant burden on both families and societies and will especially affect those
people who have lost their lives to the disease, those who are battling for their
15 Currently, the most currently prevalent variants, all of which share a mutation in the viruss
spike protein which vaccines target, are: B.1.1.7,rst detected in the UK, which has spread to over
70 countries; P.1,rst detected in Brazil, which has spread to more than 4 countries; B.1.351,rst
detected in South Africa, which has spread to over 30 countries; B.1.427,rst detected in California,
which has spread to 14 countries; B.1.429,rst detected in California, which has spread to 25
countries. See Five Reasons Why COVID Herd Immunity Is Probably Impossible,Nature, 520
522, 18 March 2021, https://doi.org/10.1038/d41586-021-00728-2. For an overview of SARS-CoV-2
Variants of Concern(VOCs) named Alpha, Beta, Gamma and Delta, see https://www.who.int/
publications/m/item/weekly-epidemiological-update-on-COVID-1927-july-2021.
16 DE BOLLE M. Novel Viral Variants: Why the World Should Prepare for Chronical Pandemics,
in Economic Policy for a Pandemic Age. How the World Must Prepare, PIIE Brieng 2122, April
2021.
17 A survey of the WTO on the global production capacity for seasonal and pandemic inuenza
vaccines in 2019, stated that the production capacity had changed marginally since 2015, rising
from 1.47 billion doses to 1.48 billion, see Sparrow E. et al. Global Production Capacity Of
Seasonal And Pandemic Inuenza Vaccines in 2019, Vaccine,15 January 2021, 512520.
COVID-19 Vaccines as Global Common Goods 7
survival and those whose lives and livelihoods have been affected by the crisis.
This crisis overall has caused a horrendous loss of lives, loss of jobs, and an
unprecedented shock to the global economy.
18
In this regard, it is noteworthy that
the levels of extreme poverty were steadily declining for more than two decades
prior to the pandemic. Now, for the rst time in a generation, in the light of the
conrmed cases and deaths worldwide and the distribution of economic losses
largely allocated to countries where the infection was least controlled (with the
poorest in each country suffering the most), UN Sustainable Development Goal 1
(end poverty in all its forms everywhere) of the UN Agenda 2030 has suffered its
worst setback. The World Bank estimated that global extreme poverty (dened as
living on less than $1.90 a day) is expected to rise in 2020/2021 for the rst time in
over 20 years. According to this estimate, the COVID-19 pandemic will push an
additional 88 to 115 million people into extreme poverty, with the total rising to as
many as 150 million by 2021, depending on the severity of the economic contrac-
tion. Extreme poverty already affects between 9.1 and 9.4% of the worlds popu-
lation as of 2020.
19
Before this pandemic, the poverty rate was expected to drop to
7.9% in 2020. Of the 124 million people living in extreme poverty in 2020, the World
Bank calculates that 8 of 10 of these people were living in middle income coun-
tries.
20
Of the million people expected to be pushed into (extreme) poverty by the
pandemic, two-third will be in South Asia.
21
According the World Trade Organi-
zation (WTO) Secretariat, Least Developed Countries(LDC) economies have been
hit hard by the COVID-19 crisis, with a 10.3% decline in exports of merchandise in
2020 compared to 2019 and a 10.5% decline in imports. Due to their dependence on
travel exports, LDC exports of services are estimated to have dropped around 40%
18 Supra, note 14.
19 World Bank. Poverty and Shared Prosperity Report 2020. Reversal of Fortune, https://www.
worldbank.org/en/publication/poverty-and-shared-prosperity.
20 World Bank,COVID-19 to Add as Many as 150 Million Extreme Poor by 2021, 7 October 2020,
https://www.worldbank.org/en/news/press-release/2020/10/07/COVID-19-to-add-as-many-as-
150-million-extreme-poor-by-2021.
21 Oxfam International. Download Dignity Not Destitution: An Economic Rescue Package for
All, 9 April 2020. The report presents analysis which suggests that between 6 and 8% of the global
population could be forced into poverty as governments shut down entire economies to manage
the spread of the virus. This could set back the ght against poverty by a decade, and as much as 30
years in some regions such as sub-Saharan Africa and the Middle East and North Africa. Over half
the global population could be living in poverty in the aftermath of the pandemic. See the analysis,
published by the United Nations University World Institute for Development Economics Research,
conducted by researchers at Kings College London and the Australian National University at
https://www.oxfam.org/en/research/dignity-not-destitution.
8N. Boschiero
in the rst three quarters of 2020, double the decline experienced by the rest of the
world (19%).
22
In addition to the public health imperative, it is crystal clear that the quicker
the vaccines are distributed globally, the sooner the world economy can start to
recover. In October 2019, the International Monetary Fund (IMF) forecasted that
the world economy would grow by 3.4% in 2020; however, in January 2021 the IMF
estimated that world GDP, in fact, fell by 3.5%. The gap between the pre-pandemic
growth path and the 2020 outcome has resulted in a loss of potential output of $6
trillion.
23
Only huge investments in development and manufacturing capacity,
along with a robust global recovery and a resetof multilateral trade governance
could reverse this trend.
2 Understanding the Concept of Global
Common/Public Good. Should Global
Immunizations or COVID-19 Vaccines Be
Considered a Global Common/Public Good?
During this pandemic the concept of global public good/global common goods,
has been extensively used by policy makers, political leaders, academics, econ-
omists, international organizations, Non-Governmental Organizations (NGOs) and
others health groups. In the light of the current discussions about the COVID-19
pandemic, the term global is easy to understand. The coronavirus disease
22 https://www.wto.org/, 19 April 2021; see also International Monetary Fund (IMF). The IMFs
Response to COVID-19, April 8, 2021, https://www.imf.org/en/About/FAQ/imf-response-to-
COVID-19. The Catastrophe Containment and Relief Trust (CCRT) allows IMF to provide debt service
relief for the poorest and most vulnerable countries hit by catastrophic natural disasters or public
health disasters. In April 2020, the IMF expanded its provision of debt service relief underthe CCRT
to cover exceptional balance of payment needs arising from COVID-19, to help low-income
countries create space for urgent spending needs to address the pandemic. See Collins G.C and
Truman E.M. IMFs Special Drawing Rights to the Rescuein PIIE. How the G20 Can Hasten
Recovery from COVID-19, PIIE Brieng 20-1, April 2020, 5660; Mazarei A. Developing Countries
Need Greater Financing And Debt Relief For COVID-19 And Future Pandemics, in PIIE. Economic
Policy for a Pandemic Age. How the World Must Prepare, PIIE Brieng 21-2, April 2021, 5256.
23 Ahuja A. et al. Preparing for a Pandemic: Accelerating Vaccine Availability, Stanford Institute
for Economic Policy Research Working Paper 21-003, 2021, https://siepr.stanford.edu/sites/
default/les/publications/21-003_0.pdf; on global trade growths loosing moment and hard time
for an already fragile framework of international trade, with COVID-19 as a stumbling block
preventing global recovery for trade in services, see https://www.org/ 2 April 2019.
COVID-19 Vaccines as Global Common Goods 9
constitutes an extraordinary globalperil and has already created a global public
health crisis. COVID-19 pandemic could be easily characterized as the global
evil. By contrast, the term global common good or global public good is subject to
diverse uses, depending upon ones educational and academic background.
In the legal discourses of public international law, the term global commons
normally refers to resource domains or areas that lie outside the political reach of
any nation State. According to the United Nations Environment Programme
(UNEP), international law identifies four global commons, namely: the High Seas,
the Atmosphere, Antarctica and Outer Space.
24
In this context the term has a close
relationship with many others corresponding concepts such as public goods,
common interest,common concerns, and common heritage of the mankind,
each of which are all living concepts that could accommodate over time to other
concepts of commons at the international level, such as biodiversity, ecosystems,
oceans, international sea-bed, climate change and others.
25
In respect of these
concepts, two main legal regulatory discourses have been prominent over the
years: the well-known theory of the tragedy of the commonsand what princi-
ples, rules and standards (governance) are needed to regulate the commons. The
concept of the tragedy of the commonswas rst articulated by biologist Garrett
Hardin to the Pacic Division of the American Association for the Advancement of
Science in June 1968, with a six-page article conceived as a critique of laissez faire
theory, through the use of a metaphor describing the destruction of common
pastures as herdsmen increased the cattle graze on them.
26
The public interna-
tional laws discourses on global commons have generally focused on the idea that
some resources belong to all of us, including future generations, and that they
need strong, fair and efcient public regulation to allocate properly exploitations
rights, costs and benets properly.
Applying these concepts to the COVID-19 pandemic, it appears immediately
clear that the term global common goodhas been invoked in a sort of loose way.
24 UNEP. IEG of the Global Commons, http://staging.unep.org/delc/GlobalCommons/tabid/
54404/Default.aspx.
25 Nakicenovic N. et al. 2016. Global Commons in the Anthropocene: World Development on a
Stable and Resilient Planet, IIASA Working Paper; Zou K. 2018. Global commons and the law of
the sea, Leiden and Boston, Brill Nijhoff, XXIV+349. Chapter 1; Ranganathan S. 2016. Global
Commons, European Journal of International Law, 693717; Mattei U. 2015, Il benicomunismo e i
suoi nemici, Torino, Giulio Einaudi Editore.
26 Hardin G. 1968. The Tragedy of the Commons, Vol. 162, Issue 3859, 1243: As a rational being,
each herdsman seeks to maximize his gain Therein is the tragedy. Each man is locked into a system
that compels him to increase his herd without limit in a world that is limited. Ruin is the
destination toward which all men rush, each pursuing his own best interest in a society that
believes in the freedom of the commons. Freedom in a common brings ruin to all.
10 N. Boschiero
The term has been used substantially in order to underscore that equitable access
to health products, including vaccines, health and biomedical technologies,
medical services, and medical devices, are a global priority, and that availability,
accessibility, acceptability, and affordability for all are fundamental to tackling the
pandemic. The scientific consensus believes that the only way this pandemic will
be possibly eradicated is through the vaccination of all the people worldwide. This
goal requires equitable access to vaccines for all people, irrespective of age,
gender, ethnicity, country, social and economic conditions, thus rendering vac-
cines a global common good.
27
The South Centre statement to the World Health
Assembly (WHA) 73 session, on the launch of the WHOs Access to COVID-19 Tools
(ACT) Accelerator, called on the WHO and its Member States to enable timely and
adequate supply, to all and on an equal basis, of diagnostics, treatments and
vaccines for COVID-19 as essential public goods
28
(emphasis added), to prove that
beyond solemn declarations, the international community can work together to
ensure that nobody is left behind. On the same line, M´
edecins Sans Fronti`
eres
International (MSF) in its Access Campaign, appeal to all WTO members to work
together for a global solution that empowers all countries to protect all pop-
ulations, and truly treat vaccines as a global public good. It is about saving lives at
the end, not protecting systems(emphasis added).
29
The United Nations Educational, Scientific and Cultural organizations
(UNESCO) International Bioethics Committee (IBC) and the World Commission on
the Ethics for Scientic Knowledge and Technology (COMEST) have called for a
change of course in current COVID-19 vaccination strategies, specically urging
that vaccines be treated as a global public good to ensure they are made equitably
available in all countries, and not only to those who bid the highest for these
vaccines. According to UNESCO, availability to vaccines to all, in all countries, is
an essential ethical issueand that for real equity in the global access to vac-
cines, a shared ethical recognition of health as a global common good, with no
territorial limit, is needed.
30
On 11th March 2021, the Secretary-General of the
United Nation, António Guterres, issued a statement for the launch of the Only
Togethercampaign, saying that COVID-19 vaccines must be considered a global
27 Yunus M. et al. 2020. COVID-19 Vaccines A Global Common Good, The Lancet, https://www.
thelancet.com.
28 South Centre Statement, Item 13, https://www.southcentre.int/wp-content/uploads/2020/11/
South-Centre-statement-Item-13-WHA-73-resumed.pdf.
29 MSFS intervention at a virtual event titled COVID-19 and Vaccine Equity: What Can the WTO
Contribute?held on 14 April 2021.
30 UNESCO. 2021. Calls For COVID-19 Vaccines To Be Considered A Global Public Good, https://
en.unesco.org/news.
COVID-19 Vaccines as Global Common Goods 11
public good. No country can overcome this crisis in isolation.
31
In a statement
given during the Africa Dialogue Series, the UN Secretary-General afrmed that
quick, equal, affordable access to COVID-19 Vaccine must be considered global
public good (emphasis added).
32
The United Nations Programme on HIV/AIDS
(UNAIDS) called for a peoples vaccineagainst COVID-19, stating that:
governments and international partners must unite around a global guarantee
which ensures that, when a safe and effective vaccine is developed, it is produced
rapidly at scale and made available for all people, in all countries, free of charge.
The same applies for all treatments, diagnostics, and other technologies for
COVID-19Now is not the time to allow the interests of the wealthiest corpora-
tions and governments to be placed before the universal need to save lives, or to
leave this massive and moral task to market forces. Access to vaccines and treat-
ments as global public goods are in the interests of all humanity. We cannot afford
for monopolies, crude competition and near-sighted nationalism to stand in the
way(emphasis added).
33
By contrast, during the negotiations of the WHA resolution on COVID-19,
finally adopted on May 19, 2020, the EU submitted a proposal for a consolidated
zero draft on a WHA73 COVID-19 response, according to which the Seventy-third
World Health Assembly, would have had to recognize population-wide immuni-
zation against COVID-19 as a global public good for health and the crucial role of
quality, safe, and efcacious vaccines therein(emphasis added). The United
States objected to this and instead proposed to change the term global public
goodsubstituting it with the term global benet, after a long discussion in the
drafting process about the distinction to be drawn between vaccinationand
vaccines.
34
In the end, Point 6 in the nal adopted text recognizes the role of
extensive immunization against COVID-19 as a global public good for health in
preventing, containing and stopping transmission in order to bring the pandemic
to an end, once safe, quality, efcacious, effective, accessible and affordable
vaccines are available(emphasis added).
35
The distinction between vaccination and vaccine as global common/public good
for legal discourses is important. Conceptually, global common/public goods are
31 United Nations. COVID-19 Vaccines Must be Global Public Good, 11 March 2021, https://www.
un.org.press/en/2021/sgsm20620.doc.htm.
32 SG/SM/20089, 20 May 2020.
33 UNAIDS. 2020. Uniting Behind A Peoples Vaccine Against COVID-19https://www.unaids.
org/en/resources/presscentre/featurestories/2020/may/20200514_covid19-vaccine-open-letter.
34 Love J. 2020. A Flawed Understanding of the Concept of Public GoodHampers the Fight for
Equitable Access to the Upcoming COVID-19 Vaccine,Developing Economics, A Critical Perspective
on Development Economics, https://developingeconomics.org/author/jamespackardlove/.
35 WHA73.1, 19 May 2020.
12 N. Boschiero
characterized by economists as any material or immaterial entity according to
whether it is excludable (no one can be stopped from consuming it) or rivalrous (its
consumption does not reduce its availability to others).
36
Firstly, a clarication is
needed. Excludability and non-rivalry are characteristics inherent to the goods
which serve to justify different legal regimes. Global warming is a good example
because it is generally characterized as a global public good, but nobody denies
that it has disastrous negative effects for the entire world. Consequently, it would be
more correctto describe it as a global public eviland as such global warming deserves
strong commitments to defeat it, namely through international collaboration.
37
In
conclusion, global public good could be used in nefarious ways depending on who
make use of these things. The decisions of policy makers and politicians determine
the uses these goods. It is always about choices related to governance and political
decisions.
38
Even fresh air, a good that everybody consider non-excludable and non-
rivalrous, could in a near future be put in bottles to be sold like mineral water, and
thus transformed in a private good.
39
Therefore, what really matters is not the
intrinsic nature of the good but the social and political decisions made by the
governments to best balance the potential conicting interests.
40
36 Depending on these two features, economists divide entities in four categories: private goods,
club goods, common goods, and public goods; applied to the COVID-19 Pandemic we can say that
pills and syringes are private goods; knowledge protected by patent a club good; universal
healthcare and health are common goods; public information data-sharing and result-sharing
public goods. Pure public goodsare considered entities that are non-excludable and non-
rivalrous. See. Smith RD. 2003. Global Public Goods and Health, Bulletin of the World Health
Organization, 475; Smith RD. et al. (Eds.). 2003. Global Public Goods for Health: Health Economic
and Public Health Perspectives, Oxford, Oxford University Press; Moon et al. 2017. Global Public
Goods for Health: Weaknesses and Opportunities in the Global Health System, Health Economics,
Policy and Law, Cambridge, Cambridge University Press, 195205; Thomas Y.F. et al., 2020,
Reafrming the Signicance of Global Public Goods for Health. Global Solidarity in Response to
COVID-19 and Future Shocks, G20 Insights, https://www.g20-insights.org/policy_briefs/reaf-
rming-the-signicance-of-global-public-goods-for-health-global-solidarity-in-response-to-
COVID-19-and-future-shocks/.
37 GAVI. 2020. Are Vaccine A Global Public Good?, https://www.gavi.org/vaccineswork/are-
vaccines-global-public-good?gclid=Cj0KCQjw6.
38 Ottone S., Sacconi L. 2015. Beni comuni, economia comportamentale e istituzioni, Sacconi L.,
Ottone S. eds. 2015. Beni comuni e cooperazione: una prospettica etica, economica e giuridica,
Bologna, Il Mulino, 145 ff.; Sacconi L. Beni comuni, contratto sociale e governance cooperativa
dei servizi pubblici locali,ibidem, 175; Denozza F. 2016. Parliamo di beni comuni. Dalla tragedia
dei (falsi) commons al dramma del bail in, https://www.casadellacultura.it/.
39 Denozza F., ult. op. cit.
40 See the reasonings of Denozza F. applied to the eld of antitrust. 2017. The Future of Antitrust:
Concern of the Real Interests at Stake, or Etiquette for Olipopolists, Orizzonti del diritto com-
merciale, nine ff.; Denozza F. 2015. La Società cooperativa e il problema degli strumenti istitu-
zionali per la gestione dei beni comuni, in Ottone S., Sacconi L. eds. 2015, 145 ff.
COVID-19 Vaccines as Global Common Goods 13
In this article, the term global common goodor global public goodis not
going to be used in the strict sense used by the economists. Rather it will be used in
the sense used by the broad global health community to address the social, eco-
nomic, and political determinants of global public health and well-being of people
everywhere. There is no doubt that the COVID-19 pandemic, and the virus that
caused it, are both non-excludable (to be infected does not depend, or at least does
not totally depends, on personal behavior, due to the heavy negative externalities
of the contagious), and non-rivalrous (if I get sick, you too can contract the disease).
Therefore, COVID-19 is a global public/common evil. The solution to the pandemic
(the global public evil) is both global vaccination and immunization. In principle,
herd immunity is also a global common good, even if (strictly speaking) it is not a
goodbut only a very hypothetical condition. Herd immunity is a status acquired
by a large number of people having developed (via vaccines or on their own) the
antibodies to survive. In order to reach this status worldwide, everybody need the
ability, the capacity, and the legal right to access vaccines, which means positive
actions and regulations need to be put in place by the State. Most important is the
need to have enough vaccines (the relevant resources) to guarantee global access.
Vaccines need to be produced at scale, priced affordably, and allocated globally so
that they are globally available where needed. As shown above, herd immunity
could only be eventually reached through a massive vaccination drive of people
around the world.
Immunization is the benetthat people obtain through vaccination. This is
something more than vaccines in themselves, since vaccination/immunization
implies also how to administer and spreading them. Immunization via vaccination
is not only a global health issue. Over several centuries, immunization was seen as
a very successful story, since inoculations have saved millions of lives and
continue to do every year. Immunization is a key component of primary health care
and also a fundamental human right. It is critical to the prevention and the control
of infectious-disease outbreaks that can underpin global security. Yet, despite
enormous progress in the realm of disease management and immunizations, far
too many people around the world, including more than 20 million infants each
year, have insufcient access to vaccines. In fact, global vaccination coverage has
remained the same over the past years.
41
In order to function properly, and ef-
ciently as requested by economists, vaccination must be non-excludable, due to its
huge positive externalities. Any limits in the manufacturing, or shortage, of vac-
cines must be remedied by the correct legal discipline. In this respect, according to
economists, it is rst necessary to determine the nature and the various
41 See WHO. 2020. Immunization Coverage, https://www.who.int/news-room/fact-sheet/
details/immunization-coverage.
14 N. Boschiero
characteristics (physic, technic, biological, cultural, or moral) of goods, which
determine whether or not their consumption should/must be excludable or non-
excludable, and rivalrous or non-rivalrous. Only after this analysis is completed,
should a proper legal regime be established. It could be a regime of private prop-
erty, collective ownership, state/public property or any other type of legal regime.
In other words, it is important to distinguish the characteristics of consumption of
the good from its form of governance, which may or may not be appropriate to the
nature of the goods. For neoliberal theorists, the commonsshould be treated as
private property, in order to avoid the so called tragedy of the commons. Other
theorists consider that the best legal regime for such goods should consist of new
forms of governance, appropriate for the commons, and should not, be excluded on
the basis of price or of a private right.
In our opinion, even if it is true that privatization of common goods (for
example via strong patent rights on vaccines) maybe avoids the tragedy of the
commons, nevertheless it inevitably determines another tragedy: the famine of the
common goods. People, deprived of access to vaccines due to the private property
legal regime applied to such vaccines, will die not of hunger but of complications
from the pandemic. Public health experts estimate that between 3.2 billion and 4.2
billion persons will need to be vaccinated worldwide.
42
According to other esti-
mates, the number is much higher, amounting to 7.8 billion people.
43
These totals
could obviously rise further if new vaccines are needed to limit the threat to
livelihoods from new variants of COVID-19. Every scientist and policy maker agrees
on the benets of a COVID-19 vaccination, since it protects not only the person
vaccinated, but also the community. A widespread vaccination eliminates hosts
for the virus, therefore contributing to the control of the pandemic, an immense
external benetfor the global community. The eradication of the disease benets
everyone, whether or not they contributed to the eradication effort. Therefore,
immunization against the pandemic must be legally treated as a global public/
common good. However, the reasoning behind this classication has become
garbled since eradication (immunization) inevitably comes with vaccines. Vac-
cines are health products, and goods, similar to drugs, diagnostics, ventilators and
other medical devices, including personal protective equipment used in hospitals.
The dramatic shortage of these goods and other supplies, as well as access chal-
lenges, eliminates all these products (together with hospital beds and services of
42 Wang W. et al. 2020. Global, Regional, and National Estimates of Target Population Sizes for
COVID-19 Vaccination: Descriptive Study, The British Medical Journal 371.
43 WTO. Council For Trade-Related Aspects of Intellectual Property Right, IP/C/W/672, 15 January
2021, 5.
COVID-19 Vaccines as Global Common Goods 15
health care workers) from the category of goods that are non-rival in consump-
tion. As already explained, a good is non-rival if the use by one individual does not
reduce availability for other. The point is that the current legal proprietary regime
applied to vaccines has transformed an intrinsically non-excludable common/
public goods (the vaccines) in something that is clearly excludable and rival in
consumption.
Vaccines are regulated as private goods, protected by intellectual property
rights (IPRs), an ever-growing set of exclusive rights that are granted to inventions,
expressions, designs, data, know-how, clinical evidences used for regulatory ap-
provals, trade secrets and so on.
44
The fundamental mission of IPRs consists,
precisely, in making these goods excludable, even if the global IP system in
principle requires disclosure and dissemination of patent and other IPRs infor-
mation in order to ensure access to technical information which could support
research and development (R&D) needs.
45
Even for knowledge, a common/public
good par excellence, the non-excludability can be a very hard condition to meet
under the current IP system, which protects clinical trial data, as well as patented
documents for inventions related to the prevention, detection, and treatment of
COVID-19. While it is commonly recognized that the evaluation of safety and
efcacy of products shows that they have undoubtedly non-excludable qualities,
especially in presence of COVID-19s health products developed by essential
publicly founded or donor-funded researches, regulatory national policies have
made them totally ownable and excludable in too many jurisdictions.
To conclude on the widespread public call for vaccines, we can surely agree
with their characterization as global common/public goods, which is in line with the
natureand characteristicof the good. Nonetheless, at the time of writing, we
must recognize, on the one hand, that these common goods are legally regulated as
private market goods. On the other hand, vaccination/immunization is for sure non-
excludable, but denitively considered rivalrous. Neither vaccines nor vaccination
could, therefore, be characterized or declared as pure public common goods. One
might wonder about the usefulness of such a characterization. It lays undoubtedly
on the most important aspect of the concept of so-called global commons and the
principles and the rules needed for their regulation. In sum, what matters is not so
much the conceptual (academic) characterizations, but rather the problem of the
proper governance and policies of the commons that should facilitate at maximum
44 Infra para 4.
45 On the tension between IPRs and public health needs, see Boschiero N. 2017. Intellectual
Property Rights and Public Health: An Impediment to Access to Medicines and Health Technology
Innovation? in Pineschi L. ed. 2017. La tutela della salute nel diritto internazionale ed europeo tra
interessi globali e interessi particolari, Napoli, Editoriale Scientica, 259294.
16 N. Boschiero
openness of science, technical knowhow and knowledge relative to the develop-
ment of vaccines and therapeutics, sharing of data, cross-border scientic
collaboration within and between the public and the private sector, global pro-
duction and distribution (through committing to non-exclusive and royalty-free
licensing), non-enforcement declarations of patent rights for vital equipment, and
nally drugs and vaccines that are effective, universally and cheaply available.
46
In addition to representing an impressive challenge to global bioethics, the
COVID-19 pandemic presents too many health, economic and social concerns that
simply result in treating all the health technologies developed to combat as
something that could be excludable and rivalrous. What is needed, consequently,
is a swift in governance of these goods. The current legal discipline of vaccines and
health technologies must be changed in order to bring it into line with the non-
excludable natureof these goods.
47
By afrming, at the same time, that global
immunization or that COVID-19 vaccines are global public goods, when at the
same time too many pharmaceutical companies, backed by western governments,
continue to act according to the business-as usualparadigm by privatizing
goods that are not private, is a highly hypocritical, completely untenable,
attitude.
3 The Race for Vaccines: Us FirstApproach or
Vaccine Nationalismof High-Income
Countries and the Policy Implications in the
Area of Vaccine Distribution. The Case of Europe
Like many other vaccines, those developed to tackle COVID-19 are produced in a
relatively small number of countries. The same is true for the ingredients of these
vaccines and, to a large extent, the medical kits needed to distribute them. These
countries have been called, for the sake of simplicity, the COVID-19 Vaccine
46 Infra, para 5.
47 On the Governance of the Commons, see the fundamental studies of Ostrom Elinor, Co-
Winner of 2009 Nobel Memorial Prize in Economic Sciences, The Royal Swedish Academy of
Sciences: OSTROM E. 1990. Governing the Commons, Cambridge, Cambridge University Press;
Ostrom E. et al. 1994. Rule, Games and Common Pool Resources, Ann Arbor, The University of
Michigan Press; Ostrom E. 2005. Understanding Institutional Diversity, Princeton, Princeton
University Press; Ostrom E. 2015. Elinor Ostrom and the Bloomington School of political economy
vol. 2 (Collected Papers on Resource Governance), Lexington Books, Rowman & Littleeld; Id.
2017. Elinor Ostrom and the Bloomington School of Political Economy Vol. 3 (Collected Papers on
Framework for Policy Analysis), Lexington Books, Rowman & Littleeld.
COVID-19 Vaccines as Global Common Goods 17
Club.
48
This conclusion inevitably amplies a strong tension between national
answers and reactions to the pandemic and a virus that does not respect juris-
dictional borders.
The risks of witnessing governments engaging in vaccine nationalismshas
already materialized, taking the world to a zero-sum result that comes at the
expenses of public health (a truly global common good) of the world population.
49
This kind of nationalism, where each country prioritizes its own needs over the
legitimate needs of others, takes very different forms ranging from export bans or
limits, to increasing the domestic availability of vaccines at the expense of foreign
supply, delays in shipments or conditions delivery imposed on imports of vaccines
from foreign locations. The outbreak of the pandemic in 2019, induced several
countries to adopt trade restrictions measures aimed at protecting the supply of key
items, particularly personal protective equipment. According to the Global Trade
Alert (an independent organism which monitors policies that affect world com-
merce), 1863 new trade barriers were raised globally in 2020, representing the
highest value since the policies were rst monitored in 2009.
50
This trend should
not be underestimated since the race for vaccinescould seriously undermine free
trade, bringing new forms of disguisedprotectionism and reducing the diver-
sication of supply sources.
51
The exceptional rapid development of COVID-19 vaccines has been achieved
by massive public funding in the United States, United Kingdom and the European
Union. The Operation Warp Speed (OWS) is the largest of the global efforts for
development of COVID-19 vaccines. This publicprivate partnership was ofcially
announced on May 15, 2020 and was initiated by the Trump Administration to
facilitate and accelerate the development, manufacturing, and distribution of
COVID-19 vaccines, therapeutics, and diagnostics, intended for US populations. It
provided $18 billion in funding from the CARES Act (Coronavirus Aid, Relief, and
Economic Security). The program promoted mass production of multiple vaccines,
and different types of vaccine technologies, based on preliminary evidence,
allowing for faster distribution if clinical trials conrm one of the vaccines is safe
48 Evenett S.J. et al. 2021. The COVID-19 Vaccine Production Club: Will Value Chains Temper
Nationalism?World Bank Group, Policy Research Working Paper 9565.
49 Bollyky T. J and Bown C. P. 2020. The Tragedy of Vaccine Nationalism: Only Cooperation Can
End the Pandemic, Foreign Affairs; Freund C. and McDaniel C., Three Steps to Facilitate Global
Distribution of a COVID-19 Vaccine, in Evenett S.J. Baldwin R.E., (eds.). 2020. Revitalizing
Multilateralism: Pragmatic Ideas For The New WTO Director- General, CEPR Press.
50 https://www.globaltradealert.org. See also WTO. 2020, Trade in Medical Goods in the Context
of Tackling COVID- 19: Development in the First Half of 2020.
51 WTO. 2020. Standards, Regulations and COVID-19-What Actions Taken by the WTO Members?.
18 N. Boschiero
and effective.
52
This is typically a U.S. centric program because developing enough
vaccines for the American population, as opposed to the global public health
needs, was the logical consequence of the Trump AdministrationsAmerica rst
policies. The U.S. could also invoke the Defense Production Act (DPA) against
vaccine manufactures with priority contractswith the U.S. Government, at the
expense of foreign buyers. Reportedly, the U.S. government has used the DPA to
compel manufacturers to accept and prioritize government contracts ahead of
private sector orders.
53
Other major western powers also partnered with big pharmaceutical com-
panies, pouring billions of dollars and euro to procure raw materials, finance
clinical trials and retrofit factories, plus billions more to buy the finished products.
In a Question & Answer sheet, the European Commission afrmed that it has
committed 2.7 billion in nancial support to the development and production of
COVID-19 vaccines.
54
The European Union has implemented a EU vaccines strategy
which rests on two fundamental pillars: 1) to secure sufcient production of vac-
cines in the EU and thereby sufcient supplies for its Member States through
Advance Purchase Agreements (APAs) with vaccine producers via the Emergency
Support Instrument
55
; and, 2) to adapt the EUs regulatory framework to the current
level of urgency and make use of existing regulatory exibility to accelerate the
development, authorization and availability of vaccines while maintaining the
standards for vaccine quality, safety and efcacy.
On 12 June 2020 the EU Council of Ministers for Health agreed on the need for
joint action to support the development and deployment of a safe and effective
vaccine against COVID-19 by securing rapid, sufficient and equitable supplies for
52 Operation Warp Speed (OWS) is an interagency program that includes components of the
Department of Health and Human Services, including the Centers for Disease Control and Pre-
vention, Food and Drug Administration, the National Institutes of Health, and the Biomedical
Advanced Research and Development Authority (BARDA); the Department of Defense; private
rms; and other federal agencies, including the Department of Agriculture, the Department of
Energy, and the Department of Veterans Affairs. For more details on OWS, see Bown C.P., Bollyky
T.J. 2021. Heres How Get Billions of COVID-19 Vaccines, PIIE series on Economic Policy for a
Pandemic Age: How the World Must Prepare; Lancet Commission on COVID-19 Vaccines and
Therapeutics Task Force Members. 2021. Operation Warp Speed: Implications For Global Vaccine
Security, https://www.thelancet.com/action/showPdf?pii=S2214-109X%2821%2900140-6.
53 Bown C.P and Bollyky T.J., supra note 52, 62.
54 https://ec.europa.eu/commission/presscorner/detail/en/QANDA_21_308.
55 Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support
within the Union as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the
emergency support under Regulation (EU) 2016/369, and amending its provisions taking into
account the COVID-19 outbreak., OJ L 117, 15.4.2020, 3; https://ec.europa.eu/echo/what/civil-
protection/emergency-support-instrument_en.
COVID-19 Vaccines as Global Common Goods 19
Member States. Consequently, the Commission adopted a Decision approving the
Agreement with Member States on procuring COVID-19 vaccines on behalf of the
Member States and related procedures.
56
On the basis of this Agreement, which
sets out the practical modalities of the procurement procedure that will be con-
ducted by the Commission, as well as the reciprocal commitments of the parties,
the Commission has been asked to run a single central procurement procedure,on
behalf of all Member States, with the idea of signing EU level Advance Purchase
Agreements (APAs) with vaccine manufacturers. Those APAs include up-front
EU nancing to de-risk essential investments in order to increase the speed and
scale of manufacturing successful vaccines. In return, the APAs would provide the
right or under specic circumstances the obligation to Participating Member
States to buy a specic number of vaccine doses within a given timeframe and at a
given price. To date, 4 safe and effective vaccines against COVID-19 have been
authorized for use in the EU: BioNTech-Pzer,
57
Moderna,
58
AstraZeneca,
59
Johnson
& Johnson.
60
Two other contracts have been concluded with vaccines still in
development: Sano-GSK and CureVac. CureVac is a European company based in
Germany, that signed a 75 million loan agreement with the European Investment
Bank on 6 July 2020 for the development and large-scale production of vaccines.
Exploratory talks have also concluded with pharmaceutical companies including
Novavax and Valneva.
61
56 C(2020) 4192 nal.
57 The APA with Pzer/BioNTech provides for the initial purchase of 200 million doses on behalf of
all EU Member States, plus an option to purchase up to a further 100 million doses. On 15 December
2020, the Commission decided to purchase these 100 million additional doses. On 8 January 2021
the Commission proposed to Member States to purchase an additional 200 million Pzer/BioNTech
vaccine doses, with the option to acquire another 100 million doses. On 10 March 2021, the Eu-
ropean Commission reached an agreement with Pzer/BioNTech for the supply of 4 million more
doses of COVID-19 vaccines for Member States that come on top of the schedule of deliveries
currently agreed between Member States and Pzer/BioNTech.
58 The APA with Moderna provides for the initial purchase of 80 million doses on behalf of all EU
Member States, plus an option to request up to another 80 million doses. On 15 December 2020, the
Commission decided to purchase 80 million additional doses. On 17 February 2021, the European
Commission approved a second contract with Moderna, which provides for an additional purchase
of 300 million doses (150 million in 2021 and an option to purchase an additional 150 million in
2022) on behalf of all EU Member States.
59 The APA with AstraZeneca provides for initial 300 million doses, plus an option to order an
addition 100 million doses.
60 The APA with Johnson & Johnson provides for 200 million of their single doses COVID-19
vaccine to the EU starting in the second quarter of 2021. The contract, that was closed on 7 October
2020, allows Member States to purchase an additional 200 million doses.
61 Further information on EU Vaccines Strategy |European Commission (europa.eu).
20 N. Boschiero
In sum, the richest countries in the world (Australia, Canada, European Union,
Japan, South Korea, United Kingdom and the United States) have collectively
preordered 8.8 billion doses of the vaccine already, far in excess of need (over three
times their total population) including options to order extra doses and negotia-
tions not yet finalized. With Canada, specfically, counting up all vaccines deals per
capita, this excess becomes nearly nine doses per person.
62
Just the conrmed
advance purchases of these governments alone jointly accounted for about 60% of
all APAs as of the end February 2021.
63
The deals already disclosed speak of 7.4
billion doses already secured by the wealthiest part of the world. Inevitably, the
fact that some countries have already pre-ordered billions of doses of COVID-19
vaccines, including most of the 2021 manufacturing capacity for the leading new
vaccine candidates, through advance purchase agreements implies, de facto,a
decrease in the ability to address the gap in access to COVID-19 vaccines by or-
ganizations like the Coalition for Epidemic Preparedness Innovations (CEPI), GAVI
(the Vaccine Alliance) and WHO. These Organizations lead an international plan
for global access (and affordable cost) to COVID-19 vaccines, known as the
COVID-19 Vaccine Global Access (COVAX) Facility, an activity of the Access to
COVID-19 Tools Accelerator, to negotiate costs for large bulk purchases of those
promising vaccines from companies able to guarantee a fair allocation.
64
Clearly,
the prospect of billions of people waiting years to be vaccinated is not only
intrinsically unfair, but it is also a threat to global health. No region is safe until the
virus is under control everywhere. As rightly recognized by the EU Commissioner
for Health and Food Safety, no one is safe, until everyone is safe.
65
In addition, severe production delays and lack of deliveries of the vaccines
doses secured by APAs has induced the European Union to introduce an export
authorization regime for COVID-19 vaccines, explicitly conditioning export
authorization on the capacity of manufactures to meet domestic needs, thus de
facto requiring exclusive and priority supply to the procurer. This export control
62 How COVID Vaccines are Being Divided Up Around the World, Nature Medicine,30
November 2020, https://www.nature.com/articles/d41586-020-03370-6; see also the statistic re-
ported by Airnity, a science information and analytics company founded in 2015, https://www.
airnity.com.
63 Supra note 62; Duke Global Health Innovation Center. 2020. Mapping COVID-19 Vaccines Pre-
purchases Across the Globe, https://launchandscalefaster.org/COVID-19.
64 Infra,para6;WHO.2020.Fair Allocation Mechanism For COVID-19 Vaccines Through The
COVAX Facilityhttps://www.who.int/publications/m/item/fair-allocation-mechanism-for-COVID-
19-vaccines-through-the-covax-facility. CEPI and the Duke Global Health Innovation Center esti-
mates that it could be 20232024 before enough vaccines for the world population can be
manufactured.
65 European Commission, Press Release, 17 June 2020, Brussels.
COVID-19 Vaccines as Global Common Goods 21
regime, that only applies to exports from companies with which the EU has
concluded Advance Purchase Agreements (APAs), allows for an export shipment
to be prohibited if it poses a threat to the execution of Union [Advanced Purchase
Agreement] APAs concluded with vaccines manufacturers. With Regulation 2021/
442 of 11 March 2021, the European Commission introduced a new export autho-
rization regime for COVID-19 vaccines applicable until 30 June 2021 replacing the
one initially established (Regulation 2021/111 of 29 January 2021).
66
On 24 March
2021, the European Commission further intervened on the export authorization
mechanism through the adoption of EU Implementing Regulation 2021/521, which
introduced the principles of reciprocity and proportionality as new criteria for the
granting of the authorization.
67
According to said principles, the EU authorized the
Italian Government to block shipment of 250,000 Oxford/AstraZeneca COVID-19
vaccine doses destined for Australia in early March of 2021, clarifying that, in order
to grant the authorization, the national competent authorities must assess whether
the country of destination of the export restricts its own exports of vaccines and
active substances to the EU, as well as the relevant conditions prevailing in the
country of destination of the export, including the epidemiological situation, and
the existing availability of such products.
68
It is no surprise that some western governments have indicated that excess
COVID-19 vaccine doses will be made available for the rest of the world, only once
secured access to a safe and effective vaccines at the scale needed by their pop-
ulation is achieved.
69
The point here is that the prospect of this scenario ever
66 Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation
of certain products subject to the production of an export authorization, OJ L 85, 12.3.2021, 190
197.
67 Commission Implementing Regulation (EU) 2021/521 of 24 March 2021 making specic ar-
rangements to the mechanism making the exportation of certain products subject to the pro-
duction of an export authorization, C/2021/2081, OJ L 104, 25.3.2021, 5254; Eliantonio M. 2021.
Vaccine Wars and Composite Procedure, Gibt Es Noch Richter in Berlin?, Quaderni di Sidiblog. It
is worth noting that up to date the main beneciary of EU exports (since the measure was intro-
duced, shipments were authorized to more than 30 countries) was the United Kingdom with over
10 million vaccine doses, by the way without receiving a single dose in return.
68 The Italian government justied this restriction on the basis that Australia was not a
vulnerable country.
69 President Biden, under intense pressure to do more to address the surging pandemic abroad,
including a dramatic humanitarian crisis in India, recently declared to make up to 60 million doses
of the AstraZeneca vaccine available to other countries, so long as federal regulators deem the
doses safe, The New York Times, 26 April 2021, https://www.nytimes.com/2021/04/26/us/politics/
biden-vaccine-india.html.
22 N. Boschiero
materializing will inevitably depend on the individual States ability to secure
effective and speedy government procurement policies. The attempt to secure
preferential access to vaccines, inevitably jeopardizes supplies of vaccines else-
where and more generally the equitable distribution of these vaccine.
70
This risk
has obviously grown, with strong ethical concerns, since the richest nations are
considering (summer 2021) the possibility of a third shot of vaccine to be inoculated
to their elderly and fragile population, while the world top priorityshould be to
vaccinate people who have received no doses of the COVID-19 vaccine as soon as
possible.
This scenario has unsurprisingly determined a shift from vaccine national-
ismsto vaccine diplomacy. Vaccine diplomacy can be defined as a strategic
use of vaccines, vaccines ingredients, and the necessary knowhow to produce
them, in order to achieve geopolitical objectives. Obviously, from a public health
perspective, as global common good, this is not an optimal solution, since it is
intrinsically driven by foreign policy considerations rather than by the funda-
mental goal of improving global efficiency in vaccine production. However, this
strategy has already produced some interesting results in the fight against this new
coronavirus. Two countries, particularly, China and Russia are already at the
forefront of this race. Chinas President Xi Jinping publicly pledged to subsidize $2
billion for the African continent, and offered Latin American and Caribbean
countries a $1 billion loan to buy vaccines.
71
Sinopharm Group Co, Ltd, a sub-
sidiary of the state-owned China National Pharmaceutical Group (Sinopharm), and
Sinovac, plus the CanSino Ad5 vaccine that has already received approval in China,
have already produced 250 million doses of COVID-19 vaccines, which have been
administered both in China and overseas. Among the 19 current vaccines that are
going through the process, ve are made by Chinese rms and the Chinese gov-
ernment has promised nearly half a billion vaccines through bilateral deals, signed
even before the vaccines had secured an emergency use listing. China has already
entered into deals with United Arab Emirate, Brazil and Indonesia. In the end, by
building some sort of health silk road(in parallel to Belt and Road Initiatives
infrastructure project), China may ascribe to itself the merit of having corrected the
strong imbalance between wealthy and poor nations, with the additional benetof
70 McMahon A. 2020. Global Equitable Access To Vaccines, Medicines and Diagnostics For
COVID-19: The Role of Patents As Private Governance, Journal of Medical Ethics; Gupta R. and
Morain S. 2020. Ethical Allocation of Future COVID-19 Vaccines, Journal of Medical Ethics.
71 Covid: What Do We Know About Chinas Coronavirus Vaccines?BBC News, 14 January 2021.
COVID-19 Vaccines as Global Common Goods 23
increase its inuence and soft power in the world.
72
Unfortunately, the contents of
these Chinese deals are secret. It not clear if Chinese vaccines will be donated or
provided in return for payment to local manufactures; it is also unclear how much
these vaccines will cost. A deal-by-deal approach could mean that some (poorer)
countries will end up paying more for the vaccine than richer countries. Already,
countries including South Africa, Mexico, Brazil, Turkey and Uganda pay different
amount per dose for the AstraZeneca vaccine and, ultimately, more than govern-
ments in the European Union.
73
With regard to Russia, the Gamaleya Institute in Moscow, that has developed
the Russians vaccine Sputnik V (with V standing for vaccine), a vector vaccine,
already employed and authorized in Russia, but that has yet to be licensed by an
international regulatory body, has production agreements with at least ve
different pharmaceutical companies in India, to supply around 500 million doses
per year. Russia also secured agreements with South Korea and a number of other
places and has accepted to share its licensing and knowhow and related
technology.
74
In the end, even if these vaccines will have a lower efficacy rate than the
Western-made ones, the extensive supply of Chinese and Russian vaccines will
make a real difference to the low and middle-income countries of the Global South,
which would rather have these vaccines than nothing. The poorer countries and
developing nations will subsequently look to China and Russia for assistance. At
the moment, seemingly, the only alternative for the Global South to gain more
72 Zhaoyi P. 2020. Chinese Vaccines Will Be Made Global Public Good, Says Xi, https://news.
cgtn.com/news/2020-05-19/Chinese-vaccines-will-be-made-global-public-good-says-Xi-
QCpFSGlL2g/index.html. According to a report published by Reuters on March 9, 2021, India has
urged the other Quad members (United States, Japan and Australia) to invest in its vaccine pro-
duction capacity in an attempt to counter Chinas widening vaccine diplomacy. The nancing
agreement to support an increase in manufacturing capacity for coronavirus vaccines in India,will
focus particularly on companies and institutions in India manufacturing vaccines for American
drugmakers Novavax Inc and Johnson & Johnson. See Quad Nations Meeting To Announce
Financing To Boost India Vaccine Output U.S. Ofcial, https://www.reuters.com/article/us-
health-coronavirus-vaccines-quad-excl-idUSKBN2B12QM.
73 Is Vaccine a Private Patent or a Global Public Good?, CSmonitor.com., March 1, 2021. The
prices of vaccines vary and differ from deal to deal. AstraZeneca has said that it will provide its
vaccine around $34 US dollar per dose, that is to say between ve and 10 times cheaper that the
estimated prices of other leading vaccines, such as Pzer/BioNTech and Moderna. The current
explanation for different prizes imposed to low and middle-income countries, compared to U.S.
and EU, is that these governments have already heavily subsidized R&D of the main manufacturer
companies.
74 https://www.democracynow.org/2021/3/11/rich_countries_block_vaccine_patent_waiver, 11
March 2021.
24 N. Boschiero
access to COVID-19 vaccines consists entirely in buying them from China and
Russia.
75
4 Global Public Goods Versus Intellectual
Property Rights: The Fallibility of EUs IPRs
Traditional Management
In early June 2020, the EU Commissioner for Health and Food Safety Stella Kyr-
iakides said that: [w]orking together will increase our chances of securing access
to a safe and effective vaccine at the scale we need and as quickly as possible. It will
ensure fair and equitable access for all across the EU and globally, thus offering the
best opportunity of finding a permanent exit strategy from the COVID-19 crisis.
76
The Annex to the Commission Decision approving the agreement with Member
States on procuring COVID-19 vaccines on behalf of the Member States and related
procedures,
77
which contains Initial Considerations regarding the structure, pur-
pose, process and governance of the EUs procurement scheme consisting in
Advance Purchase Agreements with vaccine manufacturers, via the EU Emergency
Support Instrument, lists this precise objective for negotiations with pharmaceu-
tical companies. Specically, the objective states that
In the negotiations with the pharmaceutical industry under the present Agreement, the
Commission will promote a COVID-19 vaccine as a global public good. This promotion will
include access for low and middle income countries to these vaccines in sufficient quantity
and at low prices. The Commission will seek to promote related questions with the phar-
maceutical industry regarding intellectual property sharing, especially when such IP has
been developed with public support, in order to these objectives. Any vaccines available for
purchase under the APAs concluded but not needed and purchased by Participating Member
States can be made available to the global solidarity effort (emphasis added).
In principle, the EUs characterization of COVID-19 vaccines as global public goods
should logically imply that the Commission has offered to run the single central
procurement procedureon behalf of all Member States in line with the related
need to guarantee the access to the vaccines also to low and middle-income
countries as well. This is a societal, moral and ethical imperative, given the
impressive loss of life and the millions pushed into poverty around the world as a
result of the pandemic. Therefore, one would have expected that the terms and the
75 Its Time to Trust Chinas and Russias Vaccines, The New York Times, February 5, 2021.
76 European Commission, Press release, 17 June 2020, Brussels.
77 C(2020)4192 nal, Brussels, 16.6.2020.
COVID-19 Vaccines as Global Common Goods 25
conditions of the APAs negotiated by the Commission reect this fundamental
objective. After months of growing pressure, from Members of the European
Parliament (MEPs) and civil society, and the action taken by the Corporate Europe
Observatory that has led two Freedom of Information requests to the European
Commission to throw light on the excessively secretive negotiations about APAs
for COVID-19 vaccines,
78
the European Ombudsman started investigating, early
this year, the secrecy with which the European Unions executive is handling
COVID-19 vaccine supply contracts.
79
Finally, after this extensive back and forth,
the EU Commission has only recently posted on its website the texts of the supply
contracts agreed upon.
The released documents merit close scrutiny since they clearly reveal the
highly hypocritical attitude of Europe in respect to its commitment to provide
universal, fair access to COVID-19 diagnostics, treatments and vaccines and how
such documents have simply paid no more than lip-service to the concept of global
common/public good. All of the EU APAs show the same characteristics: the pric-
ing, delivery terms and other key clauses are still condential.As to the price per
dose agreed for each of the vaccines covered by APAs, the Commission has
continuously said it cannot disclose those prices as a result of the APAs com-
mercial condentiality agreements, notwithstanding the calling for months by
civil society groups, MEPs and health advocates to reveal them under the argument
that deals involving taxpayer funds should have greater transparency. Finally, for
a short time, the EUs vaccine prices were made public by a tweet screenshot
published, by accident, by Belgiums Budget State Secretary Eva De Bleeker.
80
There are no indication in the EU APAstexts whether the method used to set
the essential terms in a purchase contractis fair or if the texts reflects the huge
public investment in the development of the final product. This, is despite the
announcement in the Annex of the EU Commission decision that the conditions of
each contract will reflect the balance between the prospect of the producer
78 Tansey R. et al. 2020. Power and Prot During a Pandemic. Why the Pharmaceutical Industry
Needs More Scrutiny Not Less, https://corporateeurope.org/en/2020/09/power-and-prot-
during-pandemic.
79 See the Ombudsmans letter announcing the inquiry, https://corporateeurope.org/sites/
default/les/2021-01/INFO_202100085_20210122_090103.pdf; and the text of the Ombudsmans
letter to the Commission, https://www.ombudsman.europa.eu/en/correspondence/en/137152.
80 According to the screenshot, the EU has spent between 1.78 and $18 US dollar per corona-
virus vaccine. The price per dose listed for each of the six vaccines are as follows: Oxford/
AstraZeneca: 1.78; Johnson & Johnson, $8.50; Sano/GSK: 7.56; Pzer/BioNTech 12; CureVac:
10; Moderna: $18. See Deutsch J. and Gijs C. 2020. Belgian Secretary of State Accidentally
Reveals EU Vaccine Prices, POLITICO, https://www.politico.eu/article/belgian-secretary-of-
state-accidentally-reveals-eu-vaccine-prices/.
26 N. Boschiero
providing a safe and effective vaccine quickly and the investment needed to deploy
the vaccine on the European market. On the other hand, many clauses are redacted
in extensive ways, showing how these APAs are simply pullincentive mecha-
nisms in which huge European nancial support is made available for the clinical
development and production of what is hoped to become a marketable product at a
later stage. The aim of EU APAs essentially consists in order to de-risk the
necessary investments related to both vaccine development and clinical trials, and
the preparation of the at-scale production capacity along the entire vaccine pro-
duction chain which is required for a rapid deployment of sufcient doses of an
eventual vaccine in the EU and globally(emphasis added). The funding provided
up front will be considered as an advance payment for any eventual purchase by
Member States, thus reducing the amount that Member States will have to pay
when eventually purchasing that vaccine.
The trouble with such an approach is that the EU has undertaken huge com-
mitments with upfront payments without the necessary guarantees that effective
and safe vaccines will be developed. In addition, all these financial contributions
(whether given or promised) will be not refunded if the final product, a COVID-19
vaccine, is either not approved by EMA, or if development of vaccine ends up in
causing serious and rare side-effects. This is, definitively, a curious way to link
public founding with public interest. For example, the German pharmaceutical
company CureVac has already received 300 million Euro from the German Federal
Government, 75 million Euro in a loan from the European Investment Bank, sup-
ported by Horizon 2020 programme, and 13.5 million US dollars from the Coalition
for Epidemic Preparedness Innovations, for Phase I research, into developing
another potential mRNA-based coronavirus vaccine.
81
According to its CEO, Cur-
eVac plans to release late-stage trial results in the coming weeks. The company is
now predicting an output of one billion doses in 2022, that, in prospect, could
compensate the losses caused by the contracts signed by the Commission with
AstraZeneca and J&J.
82
The text of CureVacs APA,
83
on the other hand, contains many detailed arti-
cles on the Exploitation of the Results of the APA and on Indemnication. With
81 t Hoen E. and Boulet P. 2021. The European Commission Says COVID-19 Vaccines Should Be
Global Public Goods, But Do Their Agreements With Pharma Reect This?Medicines Law &
Policy.
82 The EU has opted against renewing these two vaccine contracts once they expire at the end of
the year, https://www.ercepharma.com/pharma/europe-s-vaccine-rollout-slagging-after-j-j-
and-az-holdups-curevac-readies-doses-for.
83 https://ec.europa.eu/info/sites/info/les/curevac_-_redacted_advance_purchase_
agreement_0.pdf.
COVID-19 Vaccines as Global Common Goods 27
regard to the issue of exploitation, which deals with IPRs, the text (specically
article 1.20) expressly provides that
[the] Parties acknowledge and agree that the contractor shall be the sole owner of all intel-
lectual property rights generated during the development, manufacture, and supply of the
Product, including all know-how (collectively, the Product IP Rights). The contractor shall
be entitled to exclusively exploit any such Product IP Rights. Except as expressly set forth in this
APA, the contractor does not grant to the Commission and/or the participating Member States
by implication, estoppel or otherwise, any right, title, license or interest in the Product IP
Rights. All rights not expressly granted by the contractor hereunder are reserved by the
contractor (emphasis added).
It is, therefore, the contractor (in this case CureVac), and not the EU, that retains all
the rights generated as a result of the EU funding, including clinical data. This
means that the EU is not in a very favorable position to negotiate the nal price (not
yet disclosed in the Agreement), either for the European patients or for the least
developed countries in the world that are in most need of the product, which is
contrary to the explicit negotiation objectives stated in the EU/Member State
Agreement. Furthermore, the EU member States are entitled to re-sell, export and/
or distribute the future vaccine to any other EU or European Economic Area (EEA)
Member State and Switzerland, provided that these States expressly agrees in
writing to fully assume the indemnity obligations codied in the APA. The contract
also contains an astonishing provision (Article I.10.2) which states that:
[the] participating Member States shall take the appropriate measures to ensure that the
Products supplied to them pursuant to this APA will not be (i) re-sold or (ii) exported,
distributed or donated for free to another country outside the EU and EEA and Switzerland,
including for donation via NGOs or the World Health Organization, without prior consent of
the contractor.
This means that the EU has shamefully guaranteed a de facto veto right to the
private company to provide universal, fair access of vaccines through the current
channel of global solidarity. None of the EU APAs have clauses that will ensure
global non-exclusive licenses to third parties, which would be able to guarantee
the accessibility/affordability of COVID-19 health technologies. The EU has
voluntary given up all its signicant potential leverage in such context. The second
shocking provision included in all EU APAs, concerns the problem of Indemni-
cation for liability. With the excuse that these APAs are concluded under epidemic
conditionsand, as such, require some special/exceptional treatment reecting
the exceptional circumstances of the COVID-19 pandemic and the need to develop
new vaccines at an unprecedented speed in order to allow for very large scale
immunization, the Commission has undertaken steps to ensure (Article 1.23) that
28 N. Boschiero
each participating Member State shall indemnify and hold harmless the contractor, its Afli-
ates, sub-contractors and sub-licensees, including contract partners involved in the research,
development (including pre-clinical and clinical testing), manufacturing and/or delivery;
and ofcers, directors, employees and other agents, representatives and service providers of
each (together, the Indemnied Persons)for liability incurred and normally borne by them
relating to harm, damages and losses (together, the "Losses") as further specied in Article
I.23.5 arising from the use and deployment of the Products supplied to the participating
Member State (or another entity appointed by that participating Member State) under this
APA, irrespective of the time when the Losses occur (emphasis added).
Therefore, the administration of the final product (the vaccine) will be conducted
under the sole responsibility of the participating Member States. Contrary to what
normally happens in ordinary agreements, where the risks are carried by the
company, the Commission and the Member States will take all the responsibility
for indemnication for liability. This is openly in contrast with the EU framework
depicted rhetorically as an insurance policy, which transfers some of the risk from
industry to the public authorities in return for assuring Member States equitable
and affordable access to a vaccine, should one become available(emphasis
added).
From the point of view of Big-Pharmaceutical companies this is, for sure, the
best profit-maximizing model, as it is responsible for pushing for public money with
no-strings-attached, strong monopoly patent rules, and the possibility to restrict
access to COVID-19 drugs and vaccines, thus prolonging the pandemic in the name
of prot.
84
The only action taken by the EU to secure its interests has been to start
legal action after a longstanding dispute with AstraZeneca over shortfalls and
delays in delivery hundreds of millions of doses of the vaccine (only a third of the
300 million doses are expected to be delivered). The issue is whether AstraZeneca
has done everything in its power to meet its delivery schedule. in the light of the
language of the contract that requires the best effortsto deliver the purchase
doses on time.
85
To conclude, it is abundantly clear that Europe is in no way pursuing the
announced negotiating objective of promoting COVID-19 vaccines as global
public good. Released documents conrm how the European Federation of
84 Farmaceutica: per i big anti COVID protti raddoppiati: 971 miliardi, Il Sole24Ore,14.03.
2021. All the EU EPAs contains the same provision on applicable law and settlement of disputes: the
Parties shall rst refer such disputes to informal dispute resolution discussions between their
respective representatives; if this informal procedure (through good faith negotiations) would fail,
the EU APAs shall be governed by the laws of Belgium and the courts corresponding to that
applicable law will be exclusively competent to hear settle any dispute which may arise under or in
connection with this APA or the legal relationships established by this APA (see Article 1.21. of
CureVac APA).
85 EUSues AstraZeneca over Missing Vaccine Doses, The New York Times, April 26, 2021.
COVID-19 Vaccines as Global Common Goods 29
Pharmaceutical Industries and Associations (EFPIA) lobbied against the original
European tool, designed to facilitate equitable access and pricing for pandemic
treatments in Europe and elsewhere, thus de-prioritizing the public interest. The
pharmaceutical industry, when it comes to protecting its monopoly privileges,
unsurprisingly came out with the pandemic narrative saying Support us or lose
out, and characterizing the US Biomedical Advanced Research and Development
Authority (BARDA) (that had given $30 million to Sanoto go towards its research)
as the best model for how public collaboration with industry should work. This
model provides that public money is used to de-riska pharmaceutical companys
investment, and if it is successful, the company still gets to keep the IP, dictate
prices, and reap in the prots.
86
A question for written answer (E-004464/2020) submitted by the European
Parliament to the Commission askingifitcanconfirmthatitwantsthe
COVID-19vaccinetobeauniversal common goodas declared by the Presi-
dent, if the Commission could clarify the legal denition it uses for universal
common good,andwhatlegal implications does this denition entails as it
pertains to intellectual property rights and licensing, has received an aston-
ishing answer given by Commissioner Ms. Kyriakides. According to the
Commissioner,
[the] notion of universal common good highlights the importance for humanity of finding a
vaccine that can be employed in prevention of COVID-19, an infection that knows no borders.
It is not a legal concept producing legal consequences, also in the context of intellectual property
(IP) rights. An effective IP system is crucial to ensure incentives for the development of
innovative vaccines. As set out in the abovementioned EU Vaccines Strategy, the Commission
supports voluntary pooling and licensing of IP related to COVID-19 therapeutics and vaccines, to
promote equitable global access as well as a fair return on investments (emphasis added).
87
It is clear that when the EU Commissioner says that the global common good is
not a legal concept producing legal consequences she is totally unaware of the
efforts made by some national parliaments to regulate this legal category,
elaborating a discipline specically designed for ensuring a reinforced system of
protection of these kind of goods that are essential for the collectivity and for the
common interest of citizens. Just to mention the case of Italy, in 2007 the Minister
of Justice established a special Commission on public goods, chaired by Professor
Stefano Rodotà, for the elaboration of the principles and guidelines of a draft law
delegated to the Government to amend the rules of the Italian Civil Code on
86 Tansey et al., supra note 78.
87 Parliamentary questions, 28 October 2020, https://www.europarl.europa.eu/doceo/
document/E-9-2020-004464-ASW_EN.html.
30 N. Boschiero
Public Property,
88
in light of the express reference made by the Italian Consti-
tution of Public Property and the social functionalization of the same assets for
the general interest needs (article 42).
89
As explained above, the concept of
global public/common goods has much to do with the governanceof the
commons. Therefore, it also has much to do with intellectual property, which
attributes a broad private governanceon any kind of innovation, including
medical technologies and medicines urgently needed in relation to COVID-19
pandemic.
5 Intellectual Property Rights and the Pandemic:
The Waiver Debate within the TRIPS and
Beyond. The Same Old Arguments
The COVID-19 pandemic has amplified the systemic and structural inequities, and
particularly the health inequities, that disproportionately and negatively impact
poor and under-represented groups across and within communities, countries,
regions, and continents.
90
The challenge and ongoing discourse about the
response to COVID-19 crisis, its prevention and treatment, the development and
fair global allocation and distribution of COVID-19 vaccines, has inevitably reig-
nited the debate, that has lasted for nearly three decades, over the current IPRs
system. The point is whether the WTO Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS), Agreement, the most comprehensive multi-
lateral agreement on IPRs, represents a signicant and positive factor in facili-
tating access to existing technologies and in supporting the creation,
manufacturing and dissemination of new technologies, including the extensive
array of medical products, medicines, diagnostics as well as vaccines, required to
fully respond to the COVID-19 crises. Or if the TRIPS is rather a suboptimal system,
88 See Disegno di legge recante modiche al codice civile in materia di beni comuni e di contenuti del
diritto di proprietà, Senato della Repubblica, XVIII legislatura, n.1436, https://www.giustizia.it/
giustizia/it/mg_1_12_1.wp?facetNode_1=3_1&facetNode_3=0_10_21&facetNode_2=0_
10&previsiousPage=mg_1_12&contentId=SPS47617.
89 For an excellent analysis of global common goods and their governance, see Mattei U. 2011.
Beni comuni. Un manifesto, 7ed, Bari, Laterza; Capra F., Mattei U. 2017. Ecologia del diritto.
Scienza, politica, beni comuni, Arezzo, Aboca Edizioni.
90 Thomas Y.F. et al. 2020. Reafrming The Signicance Of Global Public Goods For Health:
Global Solidarity In Response To COVID-19 And Future Shockshttps://www.g20-insights.org/
policy_briefs/reafrming-the-signicance-of-global-public-goods-for-health-global-solidarity-in-
response-to-COVID-19-and-future-shocks/.
COVID-19 Vaccines as Global Common Goods 31
that simply facilitate the monopoly granted to IPRs owners over the R&D,
manufacturing and distribution of new diagnostics, treatments, and vaccines.
91
Following the declaration (on 11 March 2020) by the World Health Organiza-
tion (WHO) of the COVID-19 as a global pandemic, and the caution expressed by
the World Trade Organization WTO that this [p]andemic represents an unprece-
dented disruption to the global economy and world trade, as production and
consumption are scaled back across the globe,
92
taking into account the break
down in global supply chains (coupled with growing supply-demand gaps), the
delegations of South Africa and India have called (in the TRIPS Council meeting
held on 30 July 2020) for a holistic approach that takes account of TRIPS exibilities
in the area of patents, copyright, design rights and trade secrets.
93
This request
advanced by the two WTO members has been translated later in a formal
Communication on Intellectual Property and the Public Interest: Beyond Access to
Medicines and Medical Technologies Towards a More Holistic Approach to TRIPS
Flexibilities,
94
followed (on 2 October 2020) by a joint Communication on Waiver
from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and
Treatment of COVID-19.
95
By that time, the pandemic was already widespread, and
there were no vaccines or medicines to effectively prevent or treat COVID-19. India
and South Africa expressed their deep concern, as new diagnostics, therapeutics
and vaccines for COVID-19 start to be developed, on how these will be made
available promptly, in sufcient quantities and at affordable prices to meet global
demand, outlining several reports about intellectual property rights (not only
patents but also other IPRs) hindering, or potentially hindering, the timely pro-
visioning of affordable medical products to patients. In addition, these countries
stressed that many developing countries have faced institutional and legal dif-
culties when using the exibilities available in the TRIPS agreement, particularly
countries with insufcient or no manufacturing capacity to take advantage of the
Special Compulsory Licensing for Export, rst introduced in 2003 by means of a
waiver decision to TRIPS and as of 2017 permanently incorporated in Article 31 bis
of the amended TRIPS Agreement. This is a system that in principle has been
conceived expressly to facilitate access to affordable medicines for countries that
91 An excellent r´
esum´
e of the various positions and arguments, for and against, the current
multilateral IPRs system is provided by the Report of the United Nations Secretary-Generals High-
Level Panel on Access to Medicines, September 2016, http://www.unsgaccessmeds.org/nal-
report.
92 https://www.wto.org/english/tratop_e/covid19_e/covid19_e.htm.
93 WTO ofcial document no. IP/C/M/95/Add.1, (all the WTO ofcial documents are published at
https://docs.wto.org/).
94 WTO ofcial document no. IP/C/W/666.
95 WTO ofcial document no. IP/C/W/669.
32 N. Boschiero
rely on import of medicines to deal with a public health problem,
96
but judged by
India and South Africa as an overly cumbersome and lengthy process for the
import and export of pharmaceutical products.
The proposal submitted by South Africa and India calls for a Waiver for all
WTO members of certain provisions of the TRIPS Agreement in relation to the
prevention, containment or treatmentof COVID-19. According to the Pro-
ponents, the objective of the proposal is to avoid barriers to the timely access of
affordable medical products including vaccines and medicines, and the
scaling-up of research, development, manufacturing and supply of essential
medical products. The Waiver would cover obligations in four sections of the
TRIPS Agreement. It is proposed to last for a specic number of years, to be
agreed by the General Council, in any case until widespread vaccination is in
place globally and the majority of the worldspopulationisimmunized,but
reviewed annually by the WTO members until termination. If agreed and
enacted, the waiver would prevent WTO members from challenging any mea-
sures taken in conformity with the provisions of the waiver under sub-
paragraphs 1(b) and 1(c) of Article XXIII of GATT 1994, or through the WTOs
Dispute Settlement Mechanism.
97
The Waiver proposal has been the subject of intense and comprehensive
discussions in all the TRIPS Council (formal and informal) meetings following its
submission.
98
Despite the growing support for the proposal, that has been co-
sponsored by Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela,
96 See WTO doc. W/T/L/540, 2003 and WT/L/540/Corr.1, 2005. The Special Compulsory Licensing
System covers pharmaceutical products, including medicines, vaccines and diagnostics, needed to
address public health problems as set out in the Doha Declaration on the TRIPS Agreement and
Public Health, addressing a specic problem identied in the Doha Declaration, enabling the
vulnerable countries to make effective useof compulsory licensing. See WTO. 2020. The TRIPS
Agreement and COVID-19. Information Note, 10.
97 The interested Sections of TRIPS are: Section 1 on copyright and related rights, Section 4 on
industrial designs, Section 5 on patents and Section 7 on the protection of undisclosed informa-
tion. See Annex, Draft Decision Text: Waiver From Certain Provisions Of The Trips Agreement For
The Prevention, Containment And Treatment Of COVID-19, IP/C/W/669, 34.
98 The proposal has also been the subject of some doctrinal comments: see Bacchus J. 2020. An
Unnecessary Proposal: A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines. The
Last Thing the WTO Needs Is Another Debate Over Perceived Trade Obstacles to Public Health,
https://www.cato.org/free-trade-bulletin/unnecessary-proposal-wto-waiver-intellectual-
property-rights-COVID-19-vaccines; Mercurio B. 2021. WTO Waiver From Intellectual Property
Protection For COVID-19 Vaccines And Treatments: A Critical Review, https://papers.ssrn.com/
sol3/papers.cfm?abstract_id=3789820, forthcoming in Virginia Journal of International Law On-
line 2021; McMahon A., supra note 70; Desierto D. 2021 –“Equitable COVID Vaccine Distribution
and Access: Enforcing International Legal Obligations under Economic, Social, and Cultural
Rights and the Right to DevelopmentEJIL: Talk!.
COVID-19 Vaccines as Global Common Goods 33
Mongolia, Zimbabwe, and Egypt,
99
endorsed through civil society (more than 400
organizations in the United States calling on President Biden to endorse the
waiver),
100
115 members of the European Parliament who issued a declaration
urging the EU to drop its opposition to the TRIPS waiver proposal, as well as
national parliaments
101
multiple intergovernmental and other international or-
ganizations,
102
several high-income countries opposed the waiver. These opposing
countries diverged with the Proponents on what role IPRs play in achieving that
goal, while at the same time reiterating their common goal of providing timely and
99 Sixty-two countries, including the ACP (Africa, Caribbean, and Pacic) group, Afghanistan,
Argentina, Bangladesh, Cambodia, Sri Lanka, Honduras, Cuba, Nepal, Nicaragua, Nigeria,
Indonesia, Tunisia, Mali, and Mauritius strongly supported the waiver proposal; the same is true
for the African Group and the LDCs Group. The total of countries in favor of the Waiver is more than
two/thirds (at least 119 among the 164 WTO members). Also, the Holy See, which has observer
status at the WTO, has expressed itself in support of the Waiver, underscoring the need to put
billions of humans lives before the prots and patents of Big Pharma. See Third World Network.
2021. Two-Thirds Of WTO Members Issue Call For A TRIPS Waiver, TWN Info Service on WTO and
Trade Issues.
100 Rich versus Poor (Again) at WTO, 10 March 2021, https://foreingpolicy.com. See also the
appeal addressed to Italian Government to support the waiver proposal by the Comitato Nazio-
nale per lIniziativa dei Cittadini Europei (ICE)/petizione europea Right2cure No proton
pandemic”“Diritto alla Cura, nessun protto sulla pandemic, which brings together 67 Italian
organizations.
101 According to the Declaration from Members of the European Parliament to urge the Com-
mission and Member States not to block the TRIPS waiver at the WTO and to support global access
to COVID-19 vaccines, Brussels, 24 February 2021, https://haiweb.org/: The WTO decision on a
potential waiver offers a crucial and much-needed act of effective solidarity, as it is an important
step towards increasing local production in partner countries and, ultimately, suppressing this
pandemic on a global scale. Also the Chamber of Deputies of the Italian Parliament has approved
a motion (with 384 votes in favor, 28 against and 22 abstentions) which commits the Italian
government to pushing within the European Union for a temporary waiver to TRIPS rules, Il Fatto
Quotidiano, 24 March 2021. More than 65.000 European citizens have signed a petition calling
upon the EU to make anti-pandemic vaccines and treatments a global public good, freely
accessible to everyone; the campaign has one year to collect one million signatures in EU member
States in order to encourage the European Commission to propose legislation to implement this
demand. See https://europa.eu/citizens-initiative/initiatives/details/2020/000005_en.
102 African Commission of Human and PeoplesRights, Amnesty International, Drugs for
Neglected Diseases initiative (DNDi), Human Rights Watch, MSF, Peoples Health Movement,
South Centre, Third World Network, Joint United Nations Programme on HIV/AIDS (UNAIDS),
UNITAID, Experts of the UN Ofce of the High Commissioner for Human Rights, and World Health
Organization (WHO). According to a brief document updated 18 November 2020, more than 300
civil society organizations, globally, have called for governments to support the proposal. See,
India and South Africa Proposal for WTO Waiver From Intellectual Property Protections For
COVID-19-Related Medical Technologies, https://msfaccess.org/sites/deault/les/202011/
COVID_Brief_WTO_WaiverProposal_ENG_v2_18Nov2020.pdf.
34 N. Boschiero
secure access to high-quality, safe, efcacious and affordable vaccines and med-
icines for all.
It would be impossible, due to the length constraint of the present analysis, to
summarize all the arguments (including both pros and cons) advanced during
several months of discussions inside the Council for Trade-Related Aspects of
Intellectual Property Rights, recorded in several WTO official documents.
103
In
extreme synthesis, the arguments advanced are the same now as the old ones
raised by developing countries 20 years ago to overcome the pharmaceuticl
companiesmonopolies on the drugs for treating the HIV/AIDS epidemic, in order
to foster generic production and competition to save millions of people who could
not afford the extremely high prices that Big Pharma charged for these medicines.
According to the Proponents many developing countries face limitations in
developing and scaling up manufacturing capacity due to IP barriers and the fact
that existing vaccine manufacturing capacities in those developing countries
remain unutilized exactly because of IP barriers. As a result, insufficient amounts
of vaccines were being produced to end the COVID-19 pandemic. It is, therefore,
necessary that all IP, knowledge, technology and data related to COVID-19 health
technologies can be utilized by everyone to ensure uninterrupted production and
supply by any competent country or manufacturer worldwide, thus eliminating all
IP and technology barriers. The Proponents see their Waiver proposal as a
powerful enabler of meaningful knowledge-sharing and technology transfer, that
will represent an open and expedited global solution allowing uninterrupted
collaboration in the production and supply of health products and technologies
required for an effective COVID-19 response. Additionally, the Proponents argued
that all of the COVID-19 medicines being developed with substantial public
funding. Consequently, the pharmaceutical companiesargument that IPRs are
needed to protect their investment is weak. Since the start of this pandemic,
pharmaceutical corporations have continued with their business-as-usualap-
proaches by maintaining their exclusive rights and refusing to offer non-exclusive
licenses with worldwide coverage to facilitate global access. Rather these com-
panies are simply pursuing secretive and monopolistic deals with wealthy coun-
tries representing only 13% of the global population, that already have
pre-purchased half of the doses of the ve leading vaccines.
According to the countries opposing the Waiver proposal, which not surpris-
ingly account for 60% of the globally administered COVID-19 vaccines, the waiver
is a too sweeping measure. In order to ensure the proportionality of any measures
103 See WTO ofcial documents IP/C/W/670, 23 November 2020; WT/GC/223, 24 November 2020;
IP/C/671, 27 November 2020; IP/C/W/672, 15 January 2021; IP/C/W/673, 15 January 2021; IP/C/W/
674, 15 January 2021.
COVID-19 Vaccines as Global Common Goods 35
taken in response to the COVID-19 global pandemic, it should first be demon-
strated that the option of compulsory licensing and other flexibilities under TRIPS
are inadequate to address public health concerns. Citing the role of IP as an
incentive for innovation to fight the current and future pandemics, and as un-
derpinning the licensing, manufacturing, procurement and distribution of
COVID-19 diagnostics, therapeutics and vaccines, they urged an evidence-based
discussion on examples where IP would pose a barrier to manufacturing and
access to vaccines that could not be addressed by the multiple existing TRIPS
exibilities. Particularly impressive are the declaration and communication sub-
mitted by the EU to TRIPS Council. Those texts simply reiterate the legal certainty
of TRIPS exibilities. In this respect they do not either meaningfully contribute to
the text-based negotiations of the IndiaSouth Africa waiver proposal, nor do they
aim at promoting any new policy measure that would effectively accelerate the
production and equitable global distribution of vaccines and medicines.
104
Pro-
ponents were, conversely, asked to cite specic examples of where IP challenges
have impeded or prevented local production or manufacturing and the timely
procurement of COVID-19 diagnostics, equipment, therapeutics or vaccines,
104 See Communication from The European Union to The Council for Trips: Urgent Trade Policy
Responses to The Covid-19 Crisis: Intellectual Property, Brussels, 4 June 2021, https://trade.ec.
europa.eu/doclib/docs/2021/june/tradoc_159606.pdf; Draft General Council Declaration on The
Trips Agreement on Public Health in the Circumstances of a Pandemic; Communication from The
European Union to The Council For Trips, 18 June 2021, IP/C/W/681. Actually, a range of policy
options (conrmed under the TRIPS Agreement and the Doha Declaration on TRIPS and Public
Health, adopted on November 2001), if implemented in domestic law, remains available to WTO
members as tools to deal with public health issues where needed. For example, Article 30 of the
TRIPS Agreement states that members may provide limited exceptions to the exclusive rights
conferred by a patent (provided that such exceptions do not unreasonably conict with the normal
exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent
owner, taking account of the legitimate interests of third parties); among the possible limited
exceptions to patent rights, two in particular might have great relevance in the context of the
current COVID-19 crisis: the research and experimental use exception and the regulatory review (or
Bolar) exception. Article 31 of TRIPS Agreement also allows compulsory licensing and government
use of a patent without the authorization of its owner under a number of conditions aimed at
protecting the legitimate interests of the patent holder. All WTO members may grant such licenses
and government-use orders for health technologies, such as medicines, vaccines and diagnostics,
as well as any other product or technology needed to address COVID-19. Article 31 bis of the
amended TRIPS Agreement provides a Special Compulsory Licensing System specically designed
to enable export to countries that are especially dependent on imports for medicines. TRIPS also
provides policy options and exibilities (exceptions and limitations) in other areas of IPRS of
particular importance when considering the question of access to medical technology and inno-
vation to aid responses to the COVID-19 such as copyright (Article 13), Trademarks (Article 17),
clinical trial data and undisclosed information (Article 39.3). See WTO. The Trips Agreement and
COVID-19, supra note 96, 811.
36 N. Boschiero
particularly to describe when and how they were not able to issue compulsory
licenses under Article 31 of the TRIPS Agreement in relation to COVID-19.
All the examples of IP issues and barriers in COVID-19 pandemic on access to
therapeutics, vaccines and diagnostics, offered by the Proponents, have been
dismissed by High Income Countries (HICs). They rejected also the observation that
the existing mechanisms for compulsory licenses under Article 31 and Article 31 bis
of the TRIPS Agreement contain territorial and procedural restrictions that make
the practice of issuing product-by-product compulsory licenses a prohibitively
complex process that can offer neither an expedited nor global solution, or the
unduly political and trade pressure put by high-income countries on developing
countries when they make use of compulsory licenses, as well as the geographical
restrictions contained in all the voluntary licensing mechanisms, even the threat of
legal dispute for patent infringement against two Italian engineers that in March
2020 reverse-engineered and 3D-printed replacements valves at a cost of about
USD 1 in the Lombardy region in Northern Italy, thus stopping them from
distributing the digital design le.
105
The opponents insist that equitable access
can be achieved through the existing exibilities provided by the TRIPS Agree-
ment, particularly compulsory licenses, and donor-funded and voluntary collab-
oration mechanisms already in place, such as COVID-19 Technology Access Pool
(CTAP), the ACT- Accelerator and COVAX Facility, arguing that suspending large
parts of the TRIPS Agreement would be counterproductive, as it would undermine
currently ongoing efforts to scale up manufacturing novel and highly complex
COVID-19 vaccines in such a short time, to achieve global access, that has been
only possible due to protection provided to intellectual property rights.
The result is that, as of July 2021, consensus on the Waiver proposal has not
been reached within the deadline of 90 days set out in Article IX:3 of the Agreement
Establishing the WTO, with the consequence that WTO members are still engaged
in a stall dialogue within the TRIPS Council, without any outcome and no progress
towards text-based negotiations.
106
The discussion around alternative routes to
achieving equivalent results continues, with the WTO Director-General Dr. Ngozi
Okonjo-Iweala proposing a third wayto facilitate equitable access to COVID-19
medicinal products, namely a technology transfer within the framework of
multilateral rules. In Addition, a concurrent proposal from the Ottawa Group at
105 IP/C/W/673, paras 3643, 56; see also https://www.techtimes.com/articles/248121/
20200317/maker-ventilator-valves-threatens-sue-volunteers-using-3d-printed-coronavirus.htm.
106 The WTO rules allow for Members to vote on the proposal; for the Waiver to be adopted a
three-fourths majority of the WTO members is needed; nevertheless, the WTO members have never
abandoned the consensus decision-makingin favor of a vote. It is therefore unlikely that they
decide so in respect of this Proposal.
COVID-19 Vaccines as Global Common Goods 37
WTO,
107
which calls for the easing of export restrictions and tariffs that might be
restricting the ow of COVID-19 medicinal products, is in discussion.
108
But things
on this matter go quickly, showing that Governments might reconsider their po-
sition in the view of the worsening of the pandemic, as we will see in our
concluding remarks.
109
We will investigate in the following section whether the many examples of
voluntary collaborative efforts to facilitate cooperation for research and develop-
ment of COVID-19 related health technologies put in place by some governments,
private sector actors, and international bodies, can really deliver what is required
in both developing and least developed countries to address the current pandemic.
As to the model of donation and philanthropic responses suggested by HICs, it
simply relies on the business-as usualmonopolistic model. As such, in the end, it
would undermine the very fundamental right of developing and least developed
countries to produce the needed medical technologies for themselves.
6 The Inadequacy of Collaborative Global Efforts
to Support Ethical, Qualify, Safety and Efficacy
Global Access to COVID-19 Vaccines
It is certainly true that under Article 31 of the TRIPS Agreement, all WTO members
may grant compulsory licenses for health technologies, such as medicines, vac-
cines and diagnostics, as well as any other product or technology needed to
combat COVID-19. However, by insisting on such policy options, the HICs seem to
voluntarily underestimate the multiple obstacles that exist to the effective use of
compulsory licensing agreements for addressing the COVID-19 pandemic. First of
all, compulsory licenses are granted only at the national level of the State, since
patent rights are territorial in nature, and the legal avenues to obtain a compulsory
107 Australia, Brazil, Canada, Chile, the European Union, Japan, Kenya, Republic of Korea,
Mexico, New Zealand, Norway, Singapore and Switzerland.
108 See Annex: Draft Elements of a Trade and HealthInitiative to WTO doc. WT/GC/223.
109 Infra, para 8. After the Biden Administration declared its support for negotiating the TRIPS
waiver, the co-sponsoring countries submitted a revised waiver language to the WTO TRIPS
Council. See, Council For Trade-Related Aspects of Intellectual Property Rights: English Waiver
From Certain Provisions of The Trips Agreement For The Prevention, Containment and Treatment
of Covid-19: Revised Decision Text. Communication from The African Group, The Plurinational
State Of 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, 25 May 2021, IP/C/W/669/Rev.1.
38 N. Boschiero
license under national laws may be really heavy or unclear. Second, compulsory
licensing needs to be considered for each and every single new drug/vaccine/
health technology on a case-by-case basis. A preliminary patent landscape study
has revealed a very high level of primary and secondary patents on anti-viral
therapies led and granted in nearly 50 out of 60 jurisdictions expiring between
2036 and 2038; more than 100 patents on mRNA platform technology used for
COVID-19 vaccine development are exclusively owned by different companies,
110
and several patent disputes have already arisen between different mRNA vaccine
developers.
111
Third, stricter legal protection for patent holders normally applies
under investment treaty law or bilateral and regional trade agreements that limit
the use of this policy option placing additional restrictions on its use. Fourth, many
HICs (including the E.U.) provide severe regulatory obstacles to the effective use of
compulsory licenses, like marketing and data exclusivity periods, thus preventing
generic producers from obtaining approval for generic medicines during this time.
Fifth, a powerful obstacle for effective utilization of compulsory licenses is the
unwillingness of HICs to use this option. Many lower income countries that have
resorted in the past to compulsory licenses for the procurement of medicines have
faced litigation and trade sanctions.
However, the COVID-19 pandemic has brought about an important change,
since some high-income countries have recently eased procedures to grant
compulsory or government use licenses (Canada, Germany and Hungary) and, in
March 2020, one State (Israel) allowed a compulsory license for the import of
lopinavir/ritonavir (a generic version of AbbVies patent drug Kaletra) from India
for the purpose of exploring the possibility of treating COVID-19 patients.
112
This
move had a powerful effect on the manufacturing company which subsequently
announced it would not enforce its patents on Kaletra anywhere in the world, thus
allowing the possibility of producing generic versions of Kaletra globally without
fear of patent infringement challenges.
113
In addition, Moderna, a company that
has developed a messenger RNA (mRNA) vaccine against COVID-19 and that holds
a number of patents relevant to the vaccine, announced that it will not enforce
110 See IP/C/W/670; IP/C/W/673.
111 Hammond E. 2020, Lawsuit Reveals Intellectual Property Is Holding Back Production Of
CEPI-And Gates Foundation-Founded COVID-19 Vaccine Candidates,TWN Series on Intellectual
Property and COVID-19 Vaccines, https://www.twn.my; Moderna loses Key Patent Challenge,
Nature Biotechnology (2020) 1009;; Pzer-BioNTech, Regeneron Sued For Patent Infringement
With COVID-19 Products, October 6 2020, https://www.ercepharma.com/pharma/pzer-
biontech-regeneron-sued-for-infringement-allele-s-patent-their-COVID-19-products; IP/C/W/672,
para 53.
112 WTO. The Trips Agreement and COVID-19,supra note 96, p. 9.
113 McMahon A., supra note 70,145.
COVID-19 Vaccines as Global Common Goods 39
those patents during the pandemic to allow other COVID-19 vaccines in develop-
ment to use the technology. It also stated its willingness to license the companys
intellectual property for COVID-19 vaccines to competitors upon request for the
period after the pandemic.
114
Nevertheless, this decision has come after Moderna
has lost patent disputes, over ownership of some of the intellectual property sur-
rounding the delivery technology it uses, to Arbutus Biopharma and U.S. federal
scientists.
115
These example shows clearly that when the greater number of States showtheir
willingness to use the deterrent of compulsory licenses for COVID-19, the more
public intervention can be a powerful instrument against potential uses of patents
for profiteering off of the Pandemic. Normally, the mere threat to use a compulsory
license is enough to encourage patent holders to voluntary license their products on
more reasonable and favorable terms. That said, the impossibility of obtaining a
compulsory license in more than one State highlights in itself that such a measure,
alone, could never be a blanket solution for access to COVID-19 vaccines and
technologies, regionally or globally. Moreover, the recourse to this flexibility in the
context of COVID-19 pandemic does not represent an expedited solution.
116
Compulsory licenses aresimply part of a broader kit that permits the rebalancing of
patent holderspower in favor of public health needs. Voluntary licensing agree-
ments (VL) have multiple advantages over compulsory licenses.
117
First, they are
premised on the patent holdersconsent, with the consequence that, normally, they
would not be challenged in courts or otherwise disputed. Second, VLs can be set up
at a regional or an international level, and in contrast to compulsory licenses that are
limited to the use of the patent rights, they can be, and normally are, designed to
provide broad transfer of technology and data sharing to effectively help to expedite
the development, manufacturing and marketing oftests, treatments and vaccines.
118
Scaling out global vaccine manufacturing requires the cooperation of multiple
countries due to the complexity of upstream raw material and other components
value chains. Accordingto a WTO study, a typical vaccine manufacturing plant will
use in the realm of 9000 different materials sourced from some 300 suppliers across
114 https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-
intellectual-property-matters-during-COVID-19.
115 https://www.biopharmadive.com/news/moderna-coronavirus-vaccine-patents/586678/, 8
October 2020.
116 IP/C/W/672, para 76.
117 For the proposal to establish global, regional, or national licensing facilities for essential
medicines, see Abbot F.M. and Reichman J. H. 2020. Facilitating Access to Cross-Border Supplies
of Patented Pharmaceuticals: The Case of the COVID-19 Pandemic, Journal of International
Economic Law, 535561.
118 McMahon A, supra note 70, 146 ff.
40 N. Boschiero
approximately 30 different countries.
119
The components, raw materials and tech-
nology required to produce vaccines are normally subject to IPRs. Under conven-
tional IP practice, patents could be applied for on nearly every single stepand aspect
of vaccine development, production and use, ranging from starting materials,
composition process, and the nal products to methods of lling and packaging,
methods of vaccination and vaccine schedules.
120
Simply relying on voluntary licensing agreements that entirely depend on the
patent holderswillingness to ensure that patented inventions are licensed for the
global pandemic is not enough. As UNESCO has clearly stated new global ap-
proaches and mechanisms should be urgently put in place to allow efficient
development and production of vaccines.
121
Happily, while the WTO members
could not agree if an IPRs Waiver is the best way to achieve a full response to the
COVID- 19 pandemic, since the outbreak of the global health crisis a myriad of
public and private actors have launched collaborative global efforts to develop
treatments, vaccines and diagnostics with the aim of guaranteeing equitable ac-
cess to those technologies, including substantial investments in product devel-
opment partnerships (PDPs), and large multi-stakeholder R&D initiatives, to
support non-commercial development of a COVID-19 vaccine.
122
These kinds of
collaborative arrangements represent an entirely different form of governance
123
119 WTO. 2020. Developing and Delivering COVID-19 Vaccines Around The World, https://
www.wto.org/english/tratop_e/covid19_e/vaccine_report_e.pdf, p. 17-8; see also Bown C.P, Bol-
lyky T.J., supra note 52,64-5.
120 IP/C/W/673, para 24, https://msfaccess.org/sites/default/les/2018-06/VAC_report_A%
20Fair%20Shot%20for%20Vaccine%20Affordability_ENG_2017.pdf.
121 UNESCOs Ethics CommissionsCall For Global Vaccines Equity and Solidarity, SHS/BIO/
IBC-COMEST/COVID- 19 Vaccines, 24 February 2021, 5, http://www.sbbioetica.org.br/uploads/
repositorio/2021_02_24/Unesco2021GlobalVaccineEquityESolidarityStatement-fev2021.pdf.
122 See the standalone section An Integrated Health, Trade and IP Approach to Respond to The
COVID-19 Pandemicin the 2020 study jointly published by the World Health Organization (WHO),
the World Intellectual Property Organization (WIPO) and the WTO. 2020. Promoting Access to
Medical Technologies and Innovation: Intersections Between Public Health, Intellectual Property
And Trade(second edition), https://www.wto.org/english/res_e/publications_e/who-wipo-wto_
2020_e.htm, 713, 11 ff.
123 This is in line with Articles 7 and Article 8 of the TRIPS relating to its objectives and principles.
Article 7 of the TRIPS Agreement describes the objectives of the global IP system in terms of a
balance of rights and obligations. The objectives of TRIPS are the protection and enforcement of
IPRs in a manner which contributes to the promotion of technological innovation,the transfer
and dissemination of technologyto the mutual advantage of both producers and users of
technological knowledge, and also social and economic welfare. Article 8 states that members
may adopt measures necessary to protect public health and nutrition and to promote the public
interest in sectors of vital importance to their socio-economic and technological development that
are consistent with the provisions of the TRIPS Agreement.
COVID-19 Vaccines as Global Common Goods 41
compared to the patent holdersprivate governance over discovery, development
and delivery of new medical technologies that could restrain or adversely affect the
international transfer of the knowledge necessary for research and development of
COVID-19 related health technologies. In particular, this new form of collaborative
governance can effectively help expedite the development, manufacturing and
marketing tests, health treatments and vaccines (global public/common goods).
124
In line with the call made by the UN General Assembly in its resolution A/RES/
74/274, and the World Health Assembly resolution WHA73.1, on international
organizations and other stakeholders [] to work collaboratively at all levels to
develop, test, and scale-up production of safe, effective, quality, affordable di-
agnostics, therapeutics, medicines and vaccines for the COVID-19 response,
including, existing mechanisms for voluntary pooling and licensing of patents in
order to facilitate timely, equitable and affordable access to them.
125
The WHO launched in 2019 its COVID-19 Strategic Preparedness and Response
Plan (SPRP) that includes actions to coordinate international R&D efforts and the
use of a R&D Blueprint Global Coordination Mechanism.
126
This plan highlights the
importance that virus materials, clinical samples and associated data should be
rapidly shared for immediate public health purposes and that fair and equitable
access to any medical products or innovations that are developed using the ma-
terials must be part of such sharing.
127
The SPRP was updated in February 2021
and built upon what WHO has learned about the virus and collective response over
the course of 2020.
128
On 23 March 2020 the President of Costa Rica asked the Director-General of the
World Health Organization to undertake an effort to pool rights to technologies
that are useful for the detection, prevention, control and treatment of the COVID-19
pandemic.
129
On 29 May 2020, the Pool was formally launched by President Carlos
Alvarado Quesada and the Director-General of WHO with the Solidarity Call to
124 WHO. 2020. Making the Response to COVID-19 A Public Common Good, https://www.who.
int/docs/default-source/coronaviruse/solidarity-call-to-action/solidarity-call-to-action-01-june-
2020.pdf?sfvrsn=a6c4b03d_4.
125 On the role of International Organization during the pandemic, see Acconci P. 2020. Re-
sponses of International Organizations to the Health Emergency Due to the COVID-19. A First
Impression, Rivista di Diritto Internazionale, 415452; von Bogdandy A., Villarreal P. 2020.
International Law on Pandemic Response: A First Stocktaking In Light Of The Coronavirus Crisis
MPIL Research Paper Series, 129.
126 https://www.who.int/publications/i/item/strategic-preparedness-and-response-plan-for-
the-new-coronavirus; https://www.who.int/teams/blueprint/COVID-19.
127 https://www.who.int/teams/blueprint/COVID-19.
128 https://www.who.int/publications/i/item/WHO-WHE-2021.02.
129 Letter to Dr. Tedros Adhanom Ghebreyesus, 23 March 2020, https://www.keionline.org/wp-
content/uploads/President-MoH-Costa-Rica-Dr-Tedros-WHO24March2020.pdf.
42 N. Boschiero
Action.
130
The Solidarity Call to Action contains key elements addressed everyone
from governments and other research and development funders, to the holders of
knowledge, IPR, and data related to new therapeutics, diagnostics and vaccines,
and to the researchers and stakeholders. On the premise that the COVID-19
pandemic has revealed the fallibility of traditional ways to deal with equitable
access to essential health technologies, this alternative initiative aims to promote
the global public health goods on the basis of equity, science, open collaboration
and global solidarity. The document calls on the global community: to provide
public disclosure of gene sequences and trial data through accessible data bases;
the governments and R&D founders to include clauses in funding agreements with
pharmaceutical companies and other innovators concerning equitable distribu-
tion, affordability and transparency; to voluntarily license IPRs on a non-exclusive
and global basis to the Medicines Patent Pool and/or through other public health
research and development mechanisms, consortia or initiatives that facilitate
global and transparent access; the voluntary non-enforcement of intellectual
property rights to facilitate the widescale production, distribution, sale and use of
such health technologies throughout the world; the publishing under open
licenses of all the research outcomes; and to share voluntarily the relevant
knowledge, IP and data to enable worldwide production, distribution and use of all
the needed technologies and raw materials through mechanisms such as Tech-
nology Access Partnerships (TAP) hosted by the UN Technology Bank or through
the Open CODIV Pledge Initiative. To date, these initiatives have been endorsed by
only 40 WHO members (not yet by E.U., U.S., China or India) and a number of
intergovernmental and non-governmental organizations.
131
To operationalize this call, the WHO has created voluntary licensing initiatives
for COVID- 19 including pledges and pools. In May 2020, the WHO launched the
COVID-19 Technology Access Pool (C-TAP) with the task of compiling, in one place,
pledges of commitment made under the Solidarity Call to Action to voluntarily
share COVID-19 health technology related knowledge, intellectual property and
data. C-TAP means to accelerate the development of products needed to ght
COVID- 19 as well as to accelerate the scale-up of manufacturing and the removal of
barriers to access in order to make products available globally.
132
C-TAP works
through its implementing partners: the Medicines Patent Pool,Open COVID Pledge,
130 WHO, Making The Response To COVID-19 A Public Common Good, Solidarity Call To Action,
https://www.who.int/initiatives/COVID-19-technology-access-pool/solidarity-call-to-action.
131 https://www.who.int/initiatives/COVID-19-technology-access-pool/endorsements-of-the-
solidarity-call-to-action.
132 WHO. 2020. Operationalizing The COVID-19 Technology Access Pool (C-Tap). A Concept
Paper, https://www.who.int/publications/m/item/c-tap-a-concept-paper.
COVID-19 Vaccines as Global Common Goods 43
and the Technology Access Partnership launched by the UN Technology Bank with
UNDP and UNCTAD.
133
The Open COVID Pledge (OCP) was launched in April 2020
and operates as a repository mainly for soft and hard technologies relevant to
COVID-19 but is also open to offers from vaccine or therapeutic manufacturers. The
OCP has been conceived as a mechanism where companies make available a non-
exclusive, royalty-free, world-wide license for a time-limited period, in this case
until one year after WHO declares the COVID-19 pandemic over. So-far, about 30
companies have made pledges, including large technology companies such as
Microsoft and IBM.
134
The Open COVID-19 Declaration, published on June 2020, for
now is supported by 90 companies. By signing the declaration, the declarer un-
dertakes a pledge to
not assert any patent, utility model, design or copyright (against any individual or other entity
during the period starting with the date of this Declaration and ending on the date on which
the World Health Organization (WHO) declares that the COVID-19 outbreak no longer con-
stitutes a Public Health Emergency of International Concern, with respect to the activities
whose sole purpose is stopping the spread of COVID-19, such as diagnosis, prevention,
containment and treatment of COVID-19.
135
On 24 April 2020, as a complementary initiative to C-TAP, the WHO together with a
group of other global health actors, private sectorpartners and other stakeholders,
136
also launched the Access to COVID-19 Tools Accelerator (ACT-A).
137
The mission of
this global collaboration is the accelerated development, equitable allocation and
scaled-up delivery of vaccines, therapeutics and diagnostics, principally through
funding for the development of the new tools necessary to ght COVID-19 with
associated activities seeking to promote equitable access to these new tools.
COVAX, is one ofthe three pillars of Access to COVID-19Tools (ACT) Accelerator.
Specifically, COVAX is the vaccines pillarof the ACT-A.
138
It is coordinated by
GAVI, and co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), and
the WHO, alongside key delivery partner UNICEF. Its aim is to accelerate the
development and manufacture of COVID-19 vaccines, and to guarantee fair and
133 https://www.who.int/initiatives/COVID-19-technology-access-pool/what-is-c-tap.
134 Open COVID Pledge, https://opencovidpledge.org/.
135 Open COVID-19 Declaration, https://www.gckyoto.com/s/COVID.docx.
136 Including the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness
Innovations (CEPI), GAVI, the Vaccine Alliance, the Global Fund, UNITAID and Welcome Trust.
137 https://www.who.int/publications/m/item/access-to-COVID-19-tools-(act)-accelerator;
WHO.2021. One-year anniversary of the Access to COVID-19 Tools Accelerator, https://www.
who.int/news-room/events/detail/2021/04/23/default-calendar/one-year-anniversary-of-the-
access-to-COVID-19-tools-accelerator.
138 https://www.gavi.org/covax-facility.
44 N. Boschiero
equitable access for every country in the world. It is acting as a platform that will
support the research, development and manufacturing ofa wide range of COVID-19
vaccine candidates, and negotiate their pricing, in order to maximize the chances of
successfully developing COVID-19 vaccines and manufacture them in the quantities
needed to end this crisis. All participating countries, regardless of income levels, will
have equal access to these vaccines once they are developed. The initial aim is to
have 2billiondoses available by the end of 2020. GAVI has also created the COVAX
Facility through which self-nancing economies and funded economies can
participate and an entirely own funding mechanism. Self-nancing countries and
economies participating in the Facility can request vaccine doses sufcient to
vaccinate between 10 and 50% of their populations. In addition, GAVI has estab-
lished the COVAX Advance Market Commitment (AMC), which will support access to
COVID-19 vaccines for lower-income economies.
139
So far, the AMC has raised about
$700 million of the initial seed capital target of $2 billion US dollars needed by the
end of 2020. As of the writing of this article, COVAX has delivered over 49 million
COVID-19 vaccines (supplied by three manufacturers, AstraZeneca, Pzer-BioNTech
and the Serum Institute of India [SII]) to 121 participants across six continents,
following the rst deliver which covered 300,000 people in Ghana on 24 February
2021. Of the over 100 economies reached, 61 are among the 92 lower-income econ-
omies receiving vaccines funded through the Gavi COVAX Advance Market
Commitment (AMC).
140
Alongside the above mentioned examples of technology
polls, other notable examples of voluntary collaborative efforts include permissive
licenses to allow open access to design les and software for ventilators and transfer
of know-how; free global licenses to use IP; sharing of IP to develop vaccines;
initiatives to transfer technology and know-how to make, adapt or use COVID-
19-related technologies; free access to COVID-19 publications protected by copy-
right; open-source software for contact-tracing technology; open access to research
results, and information-sharing initiatives.
141
139 https://www.gavi.org/vaccineswork/covax-explained. Other initiatives aimed to address
local supply constraints in pharmaceutical production include the African Unions Pharmaceu-
tical Manufacturing Plan which, through the Africa Medical Supplies Platform, seeks to ensure
equitable and efcient access to critical supplies for African governments and expand COVID-
19-related medical supplies from local manufacturers. The platforms pooled procurement uses an
approach pioneered by the Pan-American Health Organization (PAHO) Revolving Fund (RF) in
vaccination procurement. The PAHO RF is one of the procurement channels for the COVAX
Facility.
140 https://www.who.int/news/item/08-04-2021-covax-reaches-over-100-economies-42-days-
after-rst-international-delivery.
141 Se for more information on these WTO. The TRIPS Agreement and COVID-19supra note 96,
35, 1213.
COVID-19 Vaccines as Global Common Goods 45
All these initiatives are impressive because they show an unprecedented
proactive level of partnership and coordinating efforts; therefore, they are very
welcome. Unfortunately, they are not enough to ensure that all countries,
regardless of their income levels, will have equal access to the developed vaccines.
These initiatives are certainly helpful, but overall insufficient. Initiatives such as
COVAX, ACT-A,COVAX Advanced Market Commitment aim to provide 2 billion
vaccine doses (for one billion people if we consider the necessity of any two dose of
vaccines) to the world, by the end 2020. This simply means that they have been
designed to address only the initial, acute phase of the pandemic and to deliver to
only 20% of the least or low developed countries in the world. This is largely
inadequate to meet the medium- and long-term needs of the 7.8 billion people of
the world.
142
The funding raised, though commendable, is only a low percent of the
actual need.
143
Besides, the pharmaceutical industry collectively rejected partici-
pation in any initiative devoted to encourage voluntary contribution of IP, tech-
nology and data sharing to scale-up of manufacturing and supply of COVID-19
medical and pharmaceutical products,
144
citing concerns that these initiatives
would undermine IPRs and disincentivize innovation and that manufacturing the
vaccine is a very complex process that needs specic expertise and know-how.
According to the western pharmaceutical companies, the manufactures in lower-
income countries do not have either the equipment nor the capacity to effectively
utilize this knowledge on their own.
145
The WTO estimated that more than one-
third of vaccines manufactured at the moment have fewer than four suppliers,
which is clearly a limited number to cater to the needs of the global population. It is
noteworthy that CEPIs June 2020 survey of COVID-19 vaccine manufacturing ca-
pacity identied capacity in 41 countries,
146
parties of an already existing network,
Developing Countries Vaccine Manufactures Network, a public health driven, in-
ternational alliance of manufacturers, established in the year 2000, that supplied
some 3.5 billion vaccines to the globe annually.
147
142 IP/C/W/672, para 24.
143 The European Union has been among the largest global supporters of the COVAX initiative. Its
Global Coronavirus Response pledging campaign (launched by European Commission President
Ursula von der Leyen) and the Global Goal: Unite for our Future pledging summit co-organized with
Global Citizen, raised out of 15.9 billion, by the Member States, the Commission and the European
Investment Bank. See https://global-response.europa.eu/index_it.
144 Including the three U.S. base drug manufactures with approved vaccines (Pzer, Moderna,
Johnson & Johnson).
145 IP/C/W/672, paras 81, 108, 169.
146 WTO. Developing and Delivering COVID-19 Vaccines Around the World,supra note 119, 16.
147 https://www.devex.com/organizations/developing-countries-vaccine-manufactures-
network-dcvmn-international-68701#::text=About%20DCVMN%20The%20Developing%
20Countries,of%20vaccines%20affordable%20to%20all.
46 N. Boschiero
7 Coup de Th´
eâtre: The U.S. Government has Filed
Multiple Patents Covering New Way to Stabilize
Coronavirus Spike Proteins, Relevant to
COVID-19 Vaccines
On November 18, 2020, Public Citizen, a nonprofit consumer advocacy organiza-
tion that champions the public interest, published an article entitled Leading
COVID-19 Vaccine Candidates Depend on NIH Technology.
148
It was about coro-
navirus spike proteins, under which coronaviruses are given their name (because of
their crown-like appearance). These proteins play a critical role in viral infection,
helping the virus fuse with human cells by attaching to cellular receptors. The
article asserted that developing antibodies to the prefusion spike protein is critical
for vaccines. Natural spike proteins in isolation-are inherently unstable, and thus
are unable to retain the prefusion shape. As a result, they represent a signicant
challenge for development of a coronavirus vaccine. The article went on to explain
that in 2016, long before this pandemic, NIH (the U.S. National Institute of Health)
scientists, working with academic researchers from the University of Texas, came
up with a solution and obtained the prefusion spike protein for an earlier coro-
navirus known as Middle East respiratory syndrome coronavirus (MERS-CoV). The
scientists led one patent application covering this approach.
149
When COVID-19
emerged, the U.S. scientists realized that the same approach could work for the
new virus and led another patent application.
150
Then, they led one patent that
should have been issued on March 30, 2021, according to NHI.
151
The article
concluded that most of the leading rst-generation COVID-19 vaccine candidates
including those by Pzer/BioNTech, J&J, Novavax, CureVac and Modernaare
using the publicly developed 2P approach. Years of public investment have fueled
the rapid advancement of COVID-19 vaccine candidates.
152
148 Public Citizen. 2020. Leading COVID-19 Vaccine Candidates Depend on NIH Technology,
https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/USG-Spike-
Protein.pdf; Zain Zirvi, The NIH Vaccine, 25 June, 2020, https://www.citizen.org/article/the-nih-
vaccine/.
149 U.S. Application No. 16/344,774, https://www.ott.nih.gov/technology/e-234-2016.
150 U.S. Application No. 62/972,886; see also A Coronavirus Vaccine Rooted in a Government
Partnership Is Fueling Financial Rewards For Company Executives, The Washington Post, July 2,
2020, https://tinyurl.com/y5ex9z6s.
151 U.S. Patent No. 10,960,070.
152 See also Public Citizen, Blind Spot: How the COVID-19 Outbreak Shows the Limits of Phar-
mas Monopoly Model, https://www.citizen.org/article/blind-spot/, which highlights the critical
importance of government-funded research. Since the SARS outbreak, the National Institutes of
COVID-19 Vaccines as Global Common Goods 47
On March 25, 2021 the New York Times published an article, entitled Prefusion
Coronavirus Spike Proteins and Their Use, on vaccine access and how the tech-
nology, invented and owned by the U.S. NIH worked, thus reafrming that the
invention would be needed to manufacture several COVID-19 vaccines.
153
The
invention (developed under Dr. Berny Grahams direction) has been licensed to
several companies, including BioNTech for the Pzer-BioNTech vaccine and
Moderna. According to a study on U.S. government-owned inventions related to
COVID-19 vaccines,
154
all licenses must contain a clause stating that the govern-
ment may terminate the license if the licensee fails to achieve practical application
of the licensed invention (35 U.S.C. § 209(d)(3)(A)). U.S. law establishes an obli-
gation to achieve practical application of technologies licensed from the federal
government. Practical application is dened as manufacturing, operating, or
practicing an invention in such a manner as to establish that the invention is
being utilized and that its benets are to the extent permitted by law or Govern-
ment regulations available to the public on reasonable terms(35 U.S.C. § 201(f)).
The reasonable termson which an invention must be available to the public
include reasonable price in addition to the timing of delivery and distribution.
According to all the commentators, these specic regulations, to the extent that a
vaccine relies upon the U.S. NIHs patented claims, give the U.S. government some
leverage that could be used to expand access to the invention and the cell-lines,
data and knowledge necessary to make the vaccine. If the company manufacturing
the COVID-19 vaccine does not have a license, or if the license is terminated, the
NIH could pursue remedies in the form of compensation for infringement.
155
The
Biden Administration could also resort to use the Defense Production Act or other
measures to force technology transfer and require corporations to share technol-
ogy and the know-how to scale up supply around the world.
156
This is especially
true for Moderna, which received over $1 billion dollars for research and devel-
opment from the U.S. government. This amount represented 100% of Modernas
R&D costs.
Health (NIH) alone has spent nearly $700 million on coronavirus R&D; Wilbur T. 2019. IP
Explained: Myth versus Fact About Strong Patent Protections in the Biopharmaceutical Industry,
PhRMA, https://tinyurl.com/rv5yntq.
153 Gebrekidan S. and Apuzzo M. 2021. Rich Countries Signed Away a Chance to Vaccinate the
World, The New York Times.
154 Ardizzone K. 2021. License to NIH Spike Protein Technology Needed in COVID-19 Vaccines
Demonstrates Available to the Public on Reasonable TermsRequirement, https://www.
keionline.org/35746.
155 35 U.S.C. § 284.
156 See The Biden-Harris Plan to Beat COVID-19, https://buildbackbetter.com/priorities/
COVID-19/.
48 N. Boschiero
8 Concluding Remarks
Along with the European Union and other western HICs, the Trump administration
blocked for long the proposal advanced by South Africa and India to waive IPRs for
COVID-19 vaccines and treatments. Now, the new Democratic administration has
recently decided to reverse course, considering the proposal positively, thus
demonstrating that the U.S. is ready to prioritize human lives over U.S. corporate
profit. As reported by the press, the White House in March 2021 was weighing
whether to support South Africas and Indias formal request to the WTO to waive
the patent protection until the pandemic is over.
157
This occurred in response to
pressure from developing nations and subsequent support from progressive law-
makers in a letter sent in late March by House Speaker Nancy Pelosi, according to
whom, by supporting the Waiver on a temporary basis, the Biden Administration
could help restore Americas moral and public health leadership in the world by
siding with the majority to prioritize saving lives over protecting pharmaceutical
corporation monopolies and prots.
158
One month later, in May 2021, President
Biden has publicly declared American administrations support for the Waiver
Proposal. The U.S. Trade Representative, Ambassador Katherine Tai, released on
May 5, 2021, a statement on COVID-19 TRIPS Waiver stating that
[this] is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic
call for extraordinary measures. The Administration believes strongly in intellectual property
protections, but in service of ending this pandemic, supports the waiver of those protections
for COVID-19 vaccines. We will actively participate in text-based negotiations at the World
Trade Organization (WTO) needed to make that happen. Those negotiations will take time
given the consensus-based nature of the institution and the complexity of the issues involved.
The Administrations aim is to get as many safe and effective vaccines to as many people as
fast as possible. As our vaccine supply for the American people is secured, the Administration
will continue to ramp up its efforts working with the private sector and all possible part-
ners to expand vaccine manufacturing and distribution. It will also work to increase the raw
materials needed to produce those vaccines.
159
157 The White House Weighs Temporarily Lifting Intellectual Property Shield On COVID-19
Vaccines, March 26 2021, https://www.cnbc.com/2021/03/26/covid-vaccine-updates-white-
house-mulls-lifting-intellectual-propertyshield.html?source=sharebar|twitter&par=sharebar.
158 To Help End the Pandemic as Quickly as Possible and Restore U.S. International Cooperation,
Please End Trumps Blockade of the COVID-19 Emergency Waiver of WTO Rules So More Vaccines
and Treatment Can Be ProducedFebruary 26, 2021, Attachement-A-COVID-vaccine-patent-waver-
letter.pdf (seattle.gov). https://www.amnestyusa.org/our-work/government-relations/advocacy/
amnestyinternationalusa-and-400-ngos-call-on-biden-to-support-covid19-wto-trips-waiver/.
159 Available on https://ustr.gov/about-us/policy-ofces/press-ofce/press-releases/2021/may/
statement-ambassador-katherine-tai-COVID-19-trips-waiver.
COVID-19 Vaccines as Global Common Goods 49
Immediately after this statement was released, the WTO Director-General, twitted
that this move is amonumental moment in the ght against COVID-19(emphasis
added). Clearly, the U.S. support is critical for reaching the needed consensus
within the TRIPS Council, as demonstrated by the fact that the day after support
was given, the President of the European Commission, Ursula von der Leyen, in a
speech to the European University Institute in Florence, nally and for the rst time
abandoning the EUs hostility against any attempt to undermine TRIPS rules and
the ongoing collaborative efforts, said that the European Unions priority is to
ramp up production to achieve global vaccination. At the same time, we are open
to discuss any other effective and pragmatic solution. In this context we are ready
to assess how the U.S. proposal could help achieve that objective.
160
Actually, as
stated above, this proposal did not originate with the U.S., but was put forward by
India and South Africa in early October 2020. Clearly the President of the European
Commission refers herself to a new text that those original Proponents agreed to
submit to the TRIPS Council in a bid to reconcile positions among the WTO
members, that has to be discussed before the formal TRIPS Council meeting,
scheduled for early June.
161
In addition to supporting the temporary Waiver, the U.S. government also
committed promote multilateral efforts to scale up the production of COVID-19
health products. In an important reversal of his predecessors U.S.-centric
approach to tackling the coronavirus pandemic, President Biden has not only
rejoined the WHO, but has also indicated, during the last G7 virtual summit, that
the U.S. would contribute up to $4 billion to COVAX (2 billion to COVAX up front,
and then another $2 billion over the coming two years, provided other nations
fulfill their own commitments to the program).
162
Apart from the Waivers pro-
posal, the fact that all the mRNA vaccines currently developed rely upon the NIHs
patent, provides important leverage for the new U.S. government to force com-
panies to adhere to the WHOs Technology Access Pool (C-TAP), the voluntary
collaboration platform aimed at encouraging companies to share their IPRs on
COVID-19 products and medicines to increase global supply. This clearly high-
lights the power that Governments have in pushing the so-called third way,
suggested by the Director-General of the WTO to encourage voluntary licensing
schemes for COVID-19 that offer useful global/regional mechanisms to access
COVID-19 health technologies. Without a strong public intervention in the
160 https://english.lokmat.com/international/eu-chief-says-ready-to-discuss-covid-vaccine-
patent-waiver/.
161 WTO, General Council May 5, 2021, New Items; supra note 109.
162 Biden Pledges Up To $4 Billion To Help Get Poorer Countries Vaccinated Against COVID-19,
February 19, 2021, CBS News.
50 N. Boschiero
countries that at this point have administered 75% of all COVID-19 vaccines, drug
companies will always try to maximize their prots at the expenses of global
common/public good (in this case the public health).
Governments should learn from past experiences. For example, Gileads mo-
nopoly pricing over a drug for HIV prevention therapy (called Truvada for PrEP),
that made the company billions of dollars by marketing the medicine, induced the
Trump administration, committed to eradicate new cases of HIV and AIDS by 2030,
to file a lawsuit in 2019 to protect the publics investment in HIV prevention. The
high price of the drug, in fact, prevented hundreds of thousands of Americans from
accessing this technology, despite it being a taxpayer funded invention,
163
and a
drug which was patented early in 2015 by the U.S. Centers for Disease Control and
Prevention. Gilead is also the patent owner of the drug remdesivir, that proved to be
effective against coronaviruses. In the United States, public investment supported
and continues to support every stage of remdesivirs development through early
federal grants ($70.5 million) and ongoing clinical trials around the world today.
Gileads Veklury®(remdesivir) has been approved for temporary use as a COVID-19
treatment in approximately 50 countries worldwide. Following signicant pres-
sure from civil society,
164
on top of the important precedent of the legal suit
brought by the previous U.S. Administration, Gilead has nally published on its
web-site that it has signed non-exclusive voluntary licensing agreements with
generic pharmaceutical manufacturers based in Egypt, India and Pakistan to
further expand supply of Veklury®(remdesivir). These agreements, according to
the drug company, will allow nine companies to manufacture remdesivir for dis-
tribution in 127 countries (nearly all low-income and lower-middle income coun-
tries, as well as several upper-middle- and high-income countries that face
signicant obstacles to healthcare access). Under the licensing agreements, the
companies have a right to receive a technology transfer of the Gilead manufacturing
process for remdesivir to enable them to scale up production more quickly. In
addition, the licenses are royalty-free, but only until the World Health Organi-
zation declares the end of the Public Health Emergency of International Concern
regarding COVID-19, or until a pharmaceutical product other than remdesivir or a
163 Pharma giant prots from HIV treatment funded by taxpayers and patented by the govern-
ment, 06/12/2019, https://www.washingtonpost.com/business/economy/trump-administration;
The Washington Post, November 7, 2019, https://www.washingtonpost.com/business/economy/
trump-administration-sues-drugmaker-gilead-sciences-over-patent-on-truvada-for-hiv-
prevention/2019/11/06/68b1cc52-010c-11ea-8501-2a7123a38c58_story.html1.
164 Public Citizen. 2020. Remdesivir Should Be in the Public Domain; Gileads Licensing Deal
Picks Winners and Losers, https://www.citizen.org/news/remdesivir-should-be-in-the-public-
domain-gileads-licensing-deal-picks-winners-and-losers/.
COVID-19 Vaccines as Global Common Goods 51
vaccine is approved to treat or prevent COVID-19, whichever is earlier.
165
Since
many other vaccines have since already approved to treat COVID-19, clearly the
royal-free licensing commitment has long ceased!
Another example is provided by the AstraZenecas vaccine developed with the
University of Oxford. This vaccine is already a part of the COVAX initiative. The
agreement signed by AstraZeneca with COVAX and the Coalition for Epidemic
Preparedness Innovations (CEPI), which helped fund AstraZenecas vaccine
manufacturing programme ($750 million to support the manufacturing, procure-
ment and distribution of 300 million doses of the vaccine), was to sell vaccines at
cost, with a ceiling price of $3 US dollar per dose. The company entered into a
licensing agreement with the Serum Institute of India (SSI) that sought to produce
one billion doses under license from AstraZeneca for India and low-income
countries. In addition, the Serum Institute has received funding from GAVI and the
Bill & Melinda Gates Foundation to produce COVID-19 vaccines both for India and
the global South. Despite the agreements to sell vaccines at cost, recently it has
come to light that Serum has begun selling vaccines to other low-income countries
at much higher prices.
166
The intent of the Indian company to proteer on public
subsidized vaccines during the pandemic is in blatant contrast with the attempts of
the India and South Africas governments to seek the Waiver from certain pro-
visions of the TRIPS agreement for the prevention, containment and treatment of
COVID-19. These examples clearly show how drug companies are always ready to
embrace their business as usualpractices, in addition to the intrinsic limits of
mechanism such as voluntary licensing, as explained above.
167
Governments
should be strong enough to impose to companies a global health and bioethics
perspective. The public interest must prevail over pharmaceutical companies
prots.
168
Apart from the final fate of the TRIPSWaiver proposal, there is always the
possibility of realizing the so-called third way (envisaged by the Director-General of
the WTO) through binding commitments. The solution could consist of multilateral
action in international institutions outside the WTO.
169
This can take either the
form of a COVID-19 Vaccine Investment and Trade Agreement, whose purpose
165 See www.gilead.com/purpose/advancing-global-health/COVID-19/voluntary-licensing-.
166 Reneging on the no-prot pledgeto supply Oxford vaccine, January 30 2021, https://www.
thehindu.com/sci-tech/science/reneging-on-the-no-prot-pledge-to-supply-oxford-vaccine/
article33705151.ece.
167 Supra para 6.
168 Recently, President Biden pressured the pharmaceutical giant Merck to help make vaccines
for its competitor Johnson& Johnson; Merck To Help Make Johnson & Johnson Coronavirus
Vaccine, 3 March 2021, https://www.washingtonpost.com/.
169 Bacchus, supra note 98.
52 N. Boschiero
would be to create the incentives necessary to ensure the timely and sizable scaling
up of output, as well as the input of investments to respond to the pandemic and
future pandemic threats,
170
or a new international treaty negotiated at the highest
political level and rooted in the WHO Constitution, to foster a comprehensive
approach to strengthen national, regional and global capacities and resilience to
future pandemics. This, in itself, would be a very important initiative to be pur-
sued, due to the temporary nature of the Waiver proposal. Reliable and long-term
solutions are needed to tackle any future global pandemic. In a letter published on
30 March 2021, on leading new platform and published by the world media, a
number of Prime Ministers and Presidents of various WHO member States, along
with the European Union, called for a collective commitment to ensuring universal
and equitable access to safe, efcacious and affordable vaccines, medicines and
diagnostics for this and future pandemics, restating that immunization is a global
public good. This proposal should be translated into a WHO global health treaty
(which would be added to the extremely successful precedent of the WHO
Framework Convention on Tobacco Control), whose main goal should be to foster
an all-of-government and all-of-society approach, strengthening national,
regional and global capacities and resilience to future pandemics. According to the
letter calling for such initiative, this new treaty should include greatly enhancing
international cooperation to improve, for example, alert systems, data-sharing,
research, and local, regional and global production and distribution of medical
and public health counter measures, such as vaccines, medicines, diagnostics and
personal protective equipment.
171
The COVID-19 pandemic has already tested the commitment of wealthier na-
tions to Agenda 2030 (leaving no one behind) and has dramatically revealed
institutional rigidity, very weak accountability systems and inadequate police
space to protect heath-governance systems.
172
The current crisis is an excellent
opportunity to shape an entirely different global legal framework, tailored on
different global governance mechanisms needed to secure universal fair access to
essential technologies and vaccines and protect global public/common goods. The
existing voluntary alliances and mechanisms such as COVAX, as well as other
170 For such a proposal see Bown C.P and Bollyky T.J, supra note 52.
171 See WHO. 2021. COVID-19 Shows Why United Action Is Needed for More Robust International
Health Architecture,United Nation. 2021. World Leaders Call for New International Treaty To
Improve Pandemic Response, https://news.un.org/en/story/2021/03/1088652.
172 Ekström A.M. et al. 2021. The Battle for COVID-19 Vaccines Highlights the Need for a New
Global Governance Mechanism, Nature Medicine, https://www.nature.com/articles/s4191-021-
01288-8.
COVID-19 Vaccines as Global Common Goods 53
collaborative voluntary licensing arrangements and initiatives have proved to be
insufcient for funding vaccines, their development and their allocation. What is
needed is a strong international collaboration across all sectors based on political
and legal solutions committed to justice and shared global responsibility.
173
173 Editorial, Its Time to Consider a Patent Reprieve for COVID Vaccines, 30 March 2021, Nature
Medicine, https://www.nature.com/articles/d41586-021-00863-w; Thomas Y.F. et Al, supra note
36; Yunus et al., supra note 27. The proposal to the Italian Government to sponsor a new Treaty on
Global Public Goods for Health has been also advanced a while back by the Forum on Inequalities
and Diversity, coordinated by professor Fabrizio Barca, a renowned Italian statistician and
economist.
54 N. Boschiero
... Moreover, COVID-19 vaccines should be seen as a "global public/common good" which should be available and accessible to everyone, notwithstanding their national or personal economic status [42]. Although vaccine manufacturers deserve income, bottlenecks and challenges that constrain the availability and accessibility of vaccines, especially in developing countries, should be removed. ...
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There is an urgent need for collective action to improve key aspects of our global health that can be realized only by addressing the global systemic and structural health inequities that impose significant social, economic, and inter-generational costs. Health disparities have continued to increase within and across countries, regions, and continents, despite gains in some localities. COVID-19 has amplified health inequities that disproportionately impact poor and vulnerable groups around the world. The global scramble to respond to the COVID-19 pandemic has demonstrated the need for a global reaffirmation of health as being integral to the social, economic, and environmental resilience of our planet. Equitable approaches to COVID-19 and future shocks require global collective action on Global Public Goods for health.
healthcare and health are common goods; public information data-sharing and result-sharing public goods
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healthcare and health are common goods; public information data-sharing and result-sharing public goods. "Pure public goods" are considered entities that are non-excludable and nonrivalrous. See. Smith RD. 2003. "Global Public Goods and Health", Bulletin of the World Health Organization, 475; Smith RD. et al. (Eds.). 2003. Global Public Goods for Health: Health Economic and Public Health Perspectives, Oxford, Oxford University Press; Moon et al. 2017. Global Public Goods for Health: Weaknesses and Opportunities in the Global Health System, Health Economics, Policy and Law, Cambridge, Cambridge University Press, 195-205;
Are Vaccine A Global Public Good?
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The Tragedy of Vaccine Nationalism: Only Cooperation Can End the Pandemic
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Bollyky T. J and Bown C. P. 2020. "The Tragedy of Vaccine Nationalism: Only Cooperation Can End the Pandemic", Foreign Affairs; Freund C. and McDaniel C., "Three Steps to Facilitate Global Distribution of a COVID-19 Vaccine", in Evenett S.J. Baldwin R.E., (eds.). 2020. Revitalizing Multilateralism: Pragmatic Ideas For The New WTO Director-General, CEPR Press.
Standards, Regulations and COVID-19-What Actions Taken by the WTO Members?
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WTO. 2020. "Standards, Regulations and COVID-19-What Actions Taken by the WTO Members?".
Developing and Delivering COVID-19 Vaccines Around The World
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WTO. 2020. "Developing and Delivering COVID-19 Vaccines Around The World", https:// www.wto.org/english/tratop_e/covid19_e/vaccine_report_e.pdf, p. 17-8; see also Bown C.P, Bollyky T.J., supra note 52, 64-5.
Making the Response to COVID-19 A Public Common Good
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WHO. 2020. "Making the Response to COVID-19 A Public Common Good", https://www.who. int/docs/default-source/coronaviruse/solidarity-call-to-action/solidarity-call-to-action-01-june-2020.pdf?sfvrsn=a6c4b03d_4.