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

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 official name announced on 11 February 2020 by WHO, in the International Classification 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 syndrome coronavirus 2” or 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 SARS-CoV-1, the virus that caused 2002–2004 SARS outbreak, which heavily affected Asia specifically. 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 transmission 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 respiratory 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 Committee, 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 first weeks of 2021, that has since affected a growing number of countries. The virus spread from the People’s Republic of China, first to 20 others countries, and then to the entire globe. Subsequently, the WHO declared the outbreak a “pandemic” on 11 March 2020.^[5] The WHO then issued temporary recommendations relating to trade, travel, cargo and goods. The United Nations (UN) General Assembly (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 fight the coronavirus disease 2019 COVID-19”^[6]; following this, a second 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 continues 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 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 confinement, physical distancing and restrictions on travel. These restrictions aimed at reducing pressure on health systems, allowing sufficient time to improve health infrastructures and develop diagnostics, vaccines and treatments to effectively 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 body’s 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, according 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 developing 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 demonstrated to be safe and efficacious, they must be authorized by national regulators, manufactured to exacting standards. As a final 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) derogations from certain rules for clinical trials, in order to facilitate the development, authorization and availability of COVID-19 vaccines and treatments.^[13]

On the one hand, the unprecedented development of several COVID-19 vaccines in such a short time is an historic achievement in the field of global scientific research. On the other, increased concerns surrounding severe blood-clotting incidents have emerged with AstraZeneca COVID-19 vaccine, recently renamed Vaxzevria, as well as with the Johnson & Johnson’s single-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 regulators 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 hesitancy. The great risk is that if the public suspected their governments of concealing 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, difficult 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. According to the Nature’s 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 reintroduction 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 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 consequences that it might continue to be passed to people through those intermediate hosts. Periodic re-vaccinations may continue to be necessary (perhaps indefinitely and essentially everywhere) to contain the steady stream of new variants. Long-term prospects for the pandemic probably include COVID-19 becoming a permanent endemic global health disease, much like influenza.^[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 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 first time in a generation, in the light of the confirmed 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 (defined as living on less than $1.90 a day) is expected to rise in 2020/2021 for the first 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 contraction. Extreme poverty already affects between 9.1 and 9.4% of the world’s population 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 countries.^[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 Organization (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% in the first 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 “reset” of 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, economists, 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 constitutes an extraordinary “global” peril 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 one’s 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 commons” and what principles, rules and standards (governance) are needed to regulate the commons. The concept of “the tragedy of the commons” was first articulated by biologist Garrett Hardin to the Pacific 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 international law’s 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 efficient public regulation to allocate properly exploitations rights, costs and benefits properly.

Applying these concepts to the COVID-19 pandemic, it appears immediately clear that the term “global common good” has been invoked in a sort of loose way. 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 vaccines a global common good”.^[27] The South Centre statement to the World Health Assembly (WHA) 73 session, on the launch of the WHO’s 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, Médecins Sans Frontières 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 populations, 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 organization’s (UNESCO) International Bioethics Committee (IBC) and the World Commission on the Ethics for Scientific Knowledge and Technology (COMEST) have called for a change of course in current COVID-19 vaccination strategies, specifically 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 issue” and that “for real equity in the global access to vaccines, 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 Together” campaign, saying that “COVID-19 vaccines must be considered a global public good. No country can overcome this crisis in isolation”.^[31] In a statement given during the Africa Dialogue Series, the UN Secretary-General affirmed 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 “people’s vaccine” against 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-19… Now is not the time to allow the interests of the wealthiest corporations 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 treatments 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 immunization against COVID-19 as a global public good for health and the crucial role of quality, safe, and efficacious vaccines therein” (emphasis added). The United States objected to this and instead proposed to change the term “global public good” substituting it with the term “global benefit”, after a long discussion in the drafting process about the distinction to be drawn between “vaccination” and “vaccines”.^[34] In the end, Point 6 in the final 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, efficacious, 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 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 clarification 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 correct to describe it as a global public evil and 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 conflicting interests.^[40]

In this article, the term “global common good” or “global public good” is 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, economic, 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 “good” but 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 benefit that 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 insufficient access to vaccines. In fact, global vaccination coverage has remained the same over the past years.^[41] In order to function properly, and efficiently as requested by economists, vaccination must be non-excludable, due to its huge positive externalities. Any limits in the manufacturing, or shortage, of vaccines must be remedied by the correct legal discipline. In this respect, according to economists, it is first necessary to determine the nature and the various 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 property, 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 “commons” should 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 estimates, 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 benefits 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 benefit for the global community. The eradication of the disease benefits 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 classification has become garbled since eradication (immunization) inevitably comes with vaccines. Vaccines 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 challenges, eliminates all these products (together with hospital beds and services of health care workers) from the category of goods that are “non-rival in consumption”. 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 approvals, 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 information 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 efficacy of products shows that they have undoubtedly non-excludable qualities, especially in presence of COVID-19’s 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 “nature” and “characteristic” of 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 definitively 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 openness of science, technical knowhow and knowledge relative to the development of vaccines and therapeutics, sharing of data, cross-border scientific collaboration within and between the public and the private sector, global production and distribution (through committing to non-exclusive and royalty-free licensing), non-enforcement declarations of patent rights for vital equipment, and finally 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 “nature” of these goods.^[47] By affirming, 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 usual” paradigm by privatizing goods that are not “private”, is a highly hypocritical, completely untenable, attitude.

3 The Race for Vaccines: “Us First” Approach or “Vaccine Nationalism” of 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 Club”.^[48] This conclusion inevitably amplifies a strong tension between “national” answers and reactions to the pandemic and a virus that does not respect jurisdictional borders.

The risks of witnessing governments engaging in “vaccine nationalisms” has 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 commerce), 1863 new trade barriers were raised globally in 2020, representing the highest value since the policies were first monitored in 2009.^[50] This trend should not be underestimated since the “race for vaccines” could seriously undermine free trade, bringing new forms of “disguised” protectionism and reducing the diversification 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 public–private partnership was officially 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 confirm one of the vaccines is safe 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 Administration’s America first policies. The U.S. could also invoke the Defense Production Act (DPA) against vaccine manufactures with “priority contracts” with 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 companies, 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 affirmed that it has committed € 2.7 billion in financial 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 sufficient production of vaccines in the EU and thereby sufficient supplies for its Member States through Advance Purchase Agreements (APAs) with vaccine producers via the Emergency Support Instrument ^[55]; and, 2) to adapt the EU’s regulatory framework to the current level of urgency and make use of existing regulatory flexibility to accelerate the development, authorization and availability of vaccines while maintaining the standards for vaccine quality, safety and efficacy.

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 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 conducted 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 financing 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 specific circumstances the obligation – to Participating Member States to buy a specific 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-Pfizer,^[57] Moderna,^[58] AstraZeneca,^[59] Johnson & Johnson.^[60] Two other contracts have been concluded with vaccines still in development: Sanofi-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]

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 negotiations not yet finalized. With Canada, specfically, counting up all vaccines deals per capita, this excess becomes nearly nine doses per person.^[62] Just the confirmed 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 organizations 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 vaccine’s 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 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 authorization 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 population is achieved.^[69] The point here is that the prospect of this scenario ever materializing will inevitably depend on the individual State’s ability to secure effective and speedy government procurement policies. The attempt to secure preferential access to vaccines, inevitably jeopardizes supplies of vaccines elsewhere 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 priority” should 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 nationalisms” to “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 fundamental 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. China’s 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 subsidiary 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, five are made by Chinese firms and the Chinese government 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 Initiative’s infrastructure project), China may ascribe to itself the merit of having corrected the strong imbalance between wealthy and poor nations, with the additional benefit of increase its influence 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 governments in the European Union.^[73]

With regard to Russia, the Gamaleya Institute in Moscow, that has developed the Russian’s 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 five 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 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 EU’s IPRs Traditional Management

In early June 2020, the EU Commissioner for Health and Food Safety Stella Kyriakides 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, purpose, process and governance of the EU’s procurement scheme consisting in Advance Purchase Agreements with vaccine manufacturers, via the EU Emergency Support Instrument, lists this precise objective for negotiations with pharmaceutical companies. Specifically, 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 pharmaceutical 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 EU’s characterization of COVID-19 vaccines as global public goods should logically imply that the Commission has offered to run the single “central procurement procedure” on 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 conditions of the APAs negotiated by the Commission reflect 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 filed 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 Union’s 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 pricing, delivery terms and other key clauses are still confidential. 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 commercial confidentiality 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 EU’s vaccine prices were made public by a tweet screenshot published, by accident, by Belgium’s Budget State Secretary Eva De Bleeker.^[80]

There are no indication in the EU APAs’ texts whether the method used to set the essential terms in a “purchase contract” is 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 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 “pull” incentive mechanisms in which huge European financial 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 production chain which is required for a rapid deployment of sufficient 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 commitments 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, supported 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, CureVac 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 CureVac’s APA,^[83] on the other hand, contains many detailed articles on the Exploitation of the Results of the APA and on Indemnification. With regard to the issue of exploitation, which deals with IPRs, the text (specifically article 1.20) expressly provides that

[the] Parties acknowledge and agree that the contractor shall be the sole owner of all intellectual 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 final 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 codified 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 significant potential leverage in such context. The second shocking provision included in all EU APAs, concerns the problem of Indemnification for liability. With the excuse that these APAs are concluded under “epidemic conditions” and, as such, require some special/exceptional treatment reflecting 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

each participating Member State shall indemnify and hold harmless the contractor, its Affiliates, sub-contractors and sub-licensees, including contract partners involved in the research, development (including pre-clinical and clinical testing), manufacturing and/or delivery; and officers, directors, employees and other agents, representatives and service providers of each (together, the “Indemnified Persons”) for liability incurred and normally borne by them relating to harm, damages and losses (together, the "Losses") as further specified 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 indemnification 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 profit.^[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 efforts” to 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 confirm how the European Federation of 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 Sanofi to 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-risk’ a pharmaceutical company’s investment, and “if it is successful, the company still gets to keep the IP, dictate prices, and reap in the profits”.^[86]

A question for written answer (E-004464/2020) submitted by the European Parliament to the Commission asking if it can confirm that it wants the COVID-19 vaccine to be a “universal common good” as declared by the President, if the Commission could clarify the legal definition it uses for “universal common good”, and what legal implications does this definition entails as it pertains to intellectual property rights and licensing, has received an astonishing 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 specifically 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 Public Property,^[88] in light of the express reference made by the Italian Constitution 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 “governance” of the commons. Therefore, it also has much to do with intellectual property, which attributes a broad “private governance” on 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 reignited 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 multilateral agreement on IPRs, represents a significant and positive factor in facilitating 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, 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 Organization (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 unprecedented 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 flexibilities 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 sufficient 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 provisioning of affordable medical products to patients. In addition, these countries stressed that many developing countries have faced institutional and legal difficulties when using the flexibilities available in the TRIPS agreement, particularly countries with insufficient or no manufacturing capacity to take advantage of the Special Compulsory Licensing for Export, first 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 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 treatment” of COVID-19. According to the Proponents, 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 specific 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 world’s population is immunized, but reviewed annually by the WTO members until termination. If agreed and enacted, the waiver would prevent WTO members from challenging any measures taken in conformity with the provisions of the waiver under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994, or through the WTO’s 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, 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 organizations,^[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 secure access to high-quality, safe, efficacious and affordable vaccines and medicines 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 companies’ monopolies 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 companies’ argument that IPRs are needed to protect their investment is weak. Since the start of this pandemic, pharmaceutical corporations have continued with their ‘business-as-usual’ approaches by maintaining their exclusive rights and refusing to offer non-exclusive licenses with worldwide coverage to facilitate global access. Rather these companies are simply pursuing secretive and monopolistic deals with wealthy countries representing only 13% of the global population, that already have pre-purchased half of the doses of the five leading vaccines.

According to the countries opposing the Waiver proposal, which not surprisingly 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 taken in response to the COVID-19 global pandemic, it should first be demonstrated 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 underpinning 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 flexibilities. Particularly impressive are the declaration and communication submitted by the EU to TRIPS Council. Those texts simply reiterate the “legal certainty” of TRIPS flexibilities. In this respect they do not either meaningfully contribute to the text-based negotiations of the India–South 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] Proponents were, conversely, asked to cite specific 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, 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 file.^[105] The opponents insist that equitable access can be achieved through the existing flexibilities provided by the TRIPS Agreement, particularly compulsory licenses, and donor-funded and voluntary collaboration 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 way” to 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 WTO,^[107] which calls for the easing of export restrictions and tariffs that might be restricting the flow of COVID-19 medicinal products, is in discussion.^[108] But things on this matter go quickly, showing that Governments might reconsider their position 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 development 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 usual” monopolistic 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, vaccines 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 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 filed 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 AbbVie’s 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 those patents during the pandemic to allow other COVID-19 vaccines in development to use the technology. It also stated its willingness to license the company’s 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 surrounding 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 show their 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 are simply part of a broader kit that permits the rebalancing of patent holders’ power in favor of public health needs. Voluntary licensing agreements (VL) have multiple advantages over compulsory licenses.^[117] First, they are premised on the patent holders’ consent, 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 of tests, 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. According to a WTO study, a typical vaccine manufacturing plant will use in the realm of 9000 different materials sourced from some 300 suppliers across approximately 30 different countries.^[119] The components, raw materials and technology required to produce vaccines are normally subject to IPRs. Under conventional IP practice, patents could be applied for on nearly every single step and aspect of vaccine development, production and use, ranging from starting materials, composition process, and the final products to methods of filling and packaging, methods of vaccination and vaccine schedules.^[120]

Simply relying on voluntary licensing agreements that entirely depend on the patent holders’ willingness to ensure that patented inventions are licensed for the global pandemic is not enough. As UNESCO has clearly stated “new global approaches 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 access to those technologies, including substantial investments in product development 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] compared to the patent holders’ private 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 diagnostics, 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 materials 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 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 distribution, 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 Technology 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 fight 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, 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 undertakes 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 constitutes 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 sector partners 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 fight COVID-19 with associated activities seeking to promote equitable access to these new tools.

COVAX, is one of the three pillars of Access to COVID-19 Tools (ACT) Accelerator. Specifically, COVAX is the “vaccines pillar” of 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 equitable access for every country in the world. It is acting as a platform that will support the research, development and manufacturing of a 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 2 billion doses available by the end of 2020. GAVI has also created the COVAX Facility through which self-financing economies and funded economies can participate and an entirely own funding mechanism. Self-financing countries and economies participating in the Facility can request vaccine doses sufficient to vaccinate between 10 and 50% of their populations. In addition, GAVI has established 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, Pfizer-BioNTech and the Serum Institute of India [SII]) to 121 participants across six continents, following the first 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 economies 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 files 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 copyright; open-source software for contact-tracing technology; open access to research results, and information-sharing initiatives.^[141]

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 participation in any initiative devoted to encourage voluntary contribution of IP, technology 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 specific 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 CEPI’s June 2020 survey of COVID-19 vaccine manufacturing capacity identified capacity in 41 countries,^[146] parties of an already existing network, Developing Countries Vaccine Manufactures Network, a public health driven, international alliance of manufacturers, established in the year 2000, that supplied some 3.5 billion vaccines to the globe annually.^[147]

7 Coup de Théâtre: 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 organization that champions the public interest, published an article entitled Leading COVID-19 Vaccine Candidates Depend on NIH Technology.^[148] It was about coronavirus 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 significant 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 coronavirus known as Middle East respiratory syndrome coronavirus (MERS-CoV). The scientists filed 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 filed another patent application.^[150] Then, they filed one patent that should have been issued on March 30, 2021, according to NHI.^[151] The article concluded that “most of the leading first-generation COVID-19 vaccine candidates—including those by Pfizer/BioNTech, J&J, Novavax, CureVac and Moderna—are using the publicly developed 2P approach. Years of public investment have fueled the rapid advancement of COVID-19 vaccine candidates”.^[152]

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 technology, invented and owned by the U.S. NIH worked, thus reaffirming that the invention would be needed to manufacture several COVID-19 vaccines.^[153] The invention (developed under Dr. Berny Graham’s direction) has been licensed to several companies, including BioNTech for the Pfizer-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 government 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 obligation to achieve practical application of technologies licensed from the federal government. Practical application is defined as manufacturing, operating, or practicing an invention in such a manner as “to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms” (35 U.S.C. § 201(f)). The “reasonable terms” on 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 specific regulations, to the extent that a vaccine relies upon the U.S. NIH’s 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 technology 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 development from the U.S. government. This amount represented 100% of Moderna’s R&D costs.

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 Africa’s and India’s 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 lawmakers 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 America’s moral and public health leadership in the world by siding with the majority to prioritize saving lives over protecting pharmaceutical corporation monopolies and profits”.^[158] One month later, in May 2021, President Biden has publicly declared American administration’s 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 Administration’s 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 partners – to expand vaccine manufacturing and distribution. It will also work to increase the raw materials needed to produce those vaccines.^[159]

Immediately after this statement was released, the WTO Director-General, twitted that this move is “a monumental moment in the fight 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, finally and for the first time abandoning the EU’s hostility against any attempt to undermine TRIPS rules and the ongoing collaborative efforts, said that the European Union’s 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 predecessor’s 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 Waiver’s proposal, the fact that all the mRNA vaccines currently developed rely upon the NIH’s patent, provides important leverage for the new U.S. government to force companies to adhere to the WHO’s 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 highlights 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 countries that at this point have administered 75% of all COVID-19 vaccines, drug companies will always try to maximize their profits at the expenses of global common/public good (in this case the public health).

Governments should learn from past experiences. For example, Gilead’s monopoly 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 public’s 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 remdesivir’s development through early federal grants ($70.5 million) and ongoing clinical trials around the world today. Gilead’s Veklury^® (remdesivir) has been approved for temporary use as a COVID-19 treatment in approximately 50 countries worldwide. Following significant pressure from civil society,^[164] on top of the important precedent of the legal suit brought by the previous U.S. Administration, Gilead has finally 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 distribution in 127 countries (nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant 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 Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a 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 AstraZeneca’s 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 AstraZeneca’s vaccine manufacturing programme ($750 million to support the manufacturing, procurement 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 profiteer on public subsidized vaccines during the pandemic is in blatant contrast with the attempts of the India and South Africa’s governments to seek the Waiver from certain provisions 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 usual” practices, 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’ profits.^[168]

Apart from the final fate of the TRIPS′ Waiver 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 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 pursued, 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, efficacious 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 nations 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 collaborative voluntary licensing arrangements and initiatives have proved to be insufficient 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]