In October 2020, India and South Africa submitted an unprecedented proposal to the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS Council) of the World Trade Organization (WTO), calling for a temporary waiver to help combat the global pandemic.Footnote ¹ This waiver aimed to suspend Sections 1, 4, 5, and 7 of Part II of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the related enforcement obligations under Part III to facilitate the “prevention, containment or treatment of COVID-19.” This proposed waiver covered not only patents, but also copyrights, industrial designs, and the protection of undisclosed information (such as test or other data for pharmaceutical products).

Although China was neither a proponent nor a cosponsor of the waiver proposal, it supported the initiative. As the Chinese delegation declared at the TRIPS Council when the proposal was submitted in October 2020:

Such a middle-of-the-road position – or what Jeremy Youde has described as “ambiguous positioning” in global health governanceFootnote ³ – put China between the proponents and opponents of the waiver, the latter of which included most notably the European Union, the United Kingdom, Switzerland, and, to some extent, the United States.

Thus far, China has played several important roles in the global pandemic response, which ranged from vaccine donation and distribution, to transfer of health and medical technology, to support for international intellectual property (IP) reforms. To provide a deeper understanding of these myriad roles, this chapter closely examines China’s position in the debate on the COVID-19 TRIPS waiver at the WTO. While the chapter attributes that position to the country’s changing pharmaceutical landscape and growing ambition to become an IP power, it identifies two additional contributing factors: complex international politics and choices for pandemic diplomacy.

This chapter further explores China’s more assertive position toward the end of the waiver debate – specifically during the deliberations on the proposal that provided the basis of the Ministerial Decision on the TRIPS Agreement (Ministerial Decision) adopted at the Twelfth WTO Ministerial Conference in Geneva in June 2022 (MC12). This later position contrasts significantly with the deferential position China took in the first year and a half of the waiver negotiations at the TRIPS Council. Drawing eight lessons from the international debates on both the waiver and the Ministerial Decision, this chapter offers insights into the roles China can or will play in future international policy debates at the intersection of IP and public health, including those involving the next pandemic.

1 The Changing Pharmaceutical Landscape

Although some policymakers and commentators remain fixated on the somewhat outdated and oversimplified debate on China’s piracy and counterfeiting problems, which have been widely documented in IP literature since the 1980s,Footnote ⁴ the country experienced an “innovative turn” in the mid-2000s, and its IP landscape has since dramatically changed.Footnote ⁵ In June 2008, the State Council adopted a National Intellectual Property Strategy, which “provided a comprehensive plan to improve the creation, utilization, protection, and administration of intellectual property rights.”Footnote ⁶ Paragraph 7 specifically emphasized the need for the active development of independent or self-controlled IP (zizhu zhishi chanquan). Although this term has been frequently translated as indigenous IP – or, in a larger policy context, indigenous innovation – independent IP can be developed through the acquisition of foreign IP assets.Footnote ⁷ There is no requirement that the IP or innovation involved has to be home-grown.

A few months after the adoption of the National Intellectual Property Strategy, China undertook a complete overhaul of its Patent Law – the first revamp of a major IP law following the country’s WTO accession in December 2001. Known officially as the Third Amendment to the Patent Law, this overhaul allowed China to make substantial adjustments to the patent system based on internal needs, as opposed to external considerations.Footnote ⁸ As Guo He recounted, “The impetus for the early amendments [in 1992 and 2000] came from outside, whilst the need for the third amendment originated from within China, that is to say, the majority of the third amendment was to meet the needs of the development of the domestic economy and technology originating in China.”Footnote ⁹

Since the Third Amendment, China has introduced important legislative amendments in different areas of IP law, including trademark, unfair competition, copyright, and patent yet again. In the pharmaceutical area, for instance, China adopted the Fourth Amendment to the Patent Law amid the pandemic in October 2020. Entering into effect on June 1, 2021, article 42 of the amended statute grants a limited extension of the patent term for up to five years to compensate for the time lost when a pharmaceutical product undergoes regulatory review.Footnote ¹⁰ This new provision parallels the Hatch–Waxman Act of 1984 in the United States and similar provisions on patent term extension in TRIPS-plus bilateral, regional, and plurilateral agreements. Article 76 of the amended Patent Law, along with the Provisional Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes, further introduced a new patent linkage system that would prevent the marketing approval of the generic version of a patented drug until after the expiration of its patent. Similar provisions can also be found in TRIPS-plus bilateral, regional, and plurilateral agreements.Footnote ¹¹

In addition, in April 2018, the National Medical Products Administration of China released the draft Provisional Measures for the Implementation of Test Data Protection for Pharmaceutical Products. Article 5 provides six years of market exclusivity to undisclosed test or other data for innovative drugs (chuangxin yao) and twelve years of similar protection for innovative therapeutic biological products (chuangxin zhiliao yong shengwu zhipin). While the WTO accession protocol already required China to offer the former, the latter would put China in parity with the United States, which offers similar protection.Footnote ¹² The proposed standard would also increase the protections for biological products in China to a level higher than those found in regional and plurilateral trade agreements, such as the Trans-Pacific Partnership Agreement (which has been incorporated into the Comprehensive and Progressive Agreement for Trans-Pacific Partnership following the United States’ withdrawal), the United States–Mexico–Canada Agreement, and the Regional Comprehensive Economic Partnership (RCEP) Agreement.Footnote ¹³

As if these recent and proposed legislative and regulatory changes were not revealing enough, the past decade has seen the State Council issue important policy documents that called for the strengthening of the biotechnology sector and the active development of medical products and technologies. Released in May 2015, the Made in China 2025 strategic plan identified biomedicine and high-performance medical devices as among the ten priority sectors.Footnote ¹⁴ The medical products and technologies that China intended to develop included “biologic-based therapeutics, such as antibody drugs, antibody-drug conjugates, new structural proteins, polypeptide drugs, and new vaccines; technologies to support individualized drug treatments (i.e., precision medicine); and breakthrough technologies, such as induced pluripotent stem cells.”Footnote ¹⁵

More recently, the State Council released the Outline for Building a Powerful Intellectual Property Nation (2021–2035), setting the 2025 targets for contributions of the local patent industries to the country’s gross domestic product at 13 percent. This new fifteen-year plan brings to mind the earlier National Patent Development Strategy that the State Intellectual Property Office (now the China National Intellectual Property Administration) adopted in November 2010.Footnote ¹⁶ That earlier plan set a highly ambitious target of 2 million patents per year by 2015, which China surpassed three years before.Footnote ¹⁷

The country’s ambition in the IP and pharmaceutical arenas is clear. No longer content to serve only as the world’s leading supplier of active pharmaceutical ingredients (API),Footnote ¹⁸ China now wants to become a major player in the development of research-based pharmaceutical and biological products.Footnote ¹⁹ As I observed in a recent book chapter:

In terms of health patent publications, the Global Innovation Index 2019 report placed China among the top three in the world in the areas of biotechnology, pharmaceuticals, and medical technology, based on publications from 2010 to 2017.Footnote ²¹

In the past decade, China has made important strides in pushing for the greater use and development of artificial intelligence and machine learning in the health area. As Tencent CEO Ma Huateng observed in the same Global Innovation Index report:

From 1985 to 2017, “China ranked fourth in the total number of healthcare AI patent applications filed, contributing to 12% of the total.”Footnote ²³ In 2016, China already “surpassed Japan and the European Union to become the world’s second largest healthcare AI applicant … which reflects the strong momentum of medical technology innovation in China.”Footnote ²⁴

Taken together, all of these developments illustrate the dramatic transformation of China’s pharmaceutical landscape following its innovative turn in the mid-2000s and the country’s growing ambition to become an IP power. The push for a TRIPS waiver that would suspend close to half of the provisions in the TRIPS Agreement during the COVID-19 pandemic therefore did not sit well with the country’s current policy position, even if such a waiver would have benefitted certain sectors in China as well as those in need of greater access to COVID-19 vaccines, diagnostics, and therapeutics. Being at the forefront of the waiver debate could also have created complications, if not confusion, over the country’s overall strategic direction in the IP area. After all, the rhetoric used in many recent IP policy documents in China goes in the opposite direction of the arguments used to support the waiver.Footnote ²⁵

2 Complex International Politics

Although China’s changing pharmaceutical landscape and growing ambition to become an IP power have explained its reluctance to move to the forefront of the debate on the COVID-19 TRIPS waiver, there were two other contributing factors. The first concerned the complex international politics at the intersection of IP and public health. These politics caused China to maintain a lower profile than many policymakers and commentators would expect from a country with strong developmental needs and serious pandemic-related public health challenges.Footnote ²⁶ The second contributing factor, which the next section will discuss, related to the availability of a wide array of choices for the country’s pandemic diplomacy.

Historically, China has kept a rather low profile in international organizations – be it the WTO, the World Health Organization (WHO), or the World Intellectual Property Organization (WIPO).Footnote ²⁷ Such a low profile can be traced back to former Chinese leader Deng Xiaoping’s plea for practicing self-restraint in the early 1990s, or even earlier.Footnote ²⁸ Among his guiding words were “hide our strength and bide our time” (taoguang yanghui) and “be good at keeping a low profile” (shanyu shouzhuo).Footnote ²⁹ Despite the plea of the late elder statesman, the past decade has seen China becoming more assertive in the international arena. Examples include the country’s dominant role in the RCEP negotiations,Footnote ³⁰ its high-profile development of the Belt and Road Initiative,Footnote ³¹ and its active mask and vaccine diplomacy during the COVID-19 pandemic. Beyond the IP arena, one could also add other instances where China has shown what commentators have referred to as the “wolf warrior” mentality, a term derived from the name of a popular nationalistic Chinese film franchise.Footnote ³² This mentality was on full display in the highly contentious exchange between Chinese Communist Party politburo member and former foreign minister Yang Jiechi and US Secretary of State Antony Blinken in the first major US–China meeting under the Biden Administration in Alaska in March 2021. This heated exchange was widely covered by mainstream media and China observers.

There are at least four reasons why China kept a low profile during most of the debate on the COVID-19 TRIPS waiver at the WTO. First, China struggled considerably at the domestic level in the early days of the pandemic. It was also conscious of the need to prepare for later waves of the pandemic and the emergence of new variants, such as Delta, Lambda, and Omicron. When a country was busy addressing domestic challenges and priorities, it understandably devoted less attention to international matters. This experience brings to mind China’s approach in the first few years of the WTO accession. As Henry Gao observed in the mid-2000s:

Second, because the outbreak of the SARS-CoV-2 virus was first reported in Wuhan, the origin of the virus continued to attract attention from the United States and other members of the international community.Footnote ³⁴ In early 2021, the WHO undertook an investigation in China as part of a larger global study of the origins of the SARS-CoV-2 virus.Footnote ³⁵ Although the WHO released its report in March, many countries and mainstream media remained dissatisfied with that report, with some calling for a new investigation. Policymakers, commentators, and the media also expressed concern about the lower efficacy of the COVID-19 vaccines produced in China, which were developed using an inactivated SARS-CoV-2 virus rather than the more innovative mRNA or adenovirus technologies.Footnote ³⁶

Third, China remained entangled in disputes over the TRIPS Agreement with both the United States and the European Union. In 2018, the United States Trade Representative (USTR) released a lengthy report on its Section 301 investigation into Chinese laws, policies, and practices in the areas of IP, innovation, and technology development.Footnote ³⁷ This report was quickly followed by a substantial update.Footnote ³⁸ Among the problems identified were forced technology transfer, discriminatory licensing restrictions, computer hacking, trade secret theft, and industrial espionage. Based on the first report, the United States filed its second TRIPS complaint against China, alleging that “China deprive[d] foreign intellectual property rights holders of the ability to protect their intellectual property rights in China as well as freely negotiate market-based terms in licensing and other technology-related contracts.”Footnote ³⁹

More than two months later, the European Union filed a similar but more extended complaint in China – Certain Measures on the Transfer of Technology.Footnote ⁴⁰ Like its US counterpart, this complaint concerned what commentators have referred to as “forced technology transfer.”Footnote ⁴¹ That issue directly relates to the COVID-19 TRIPS waiver, a key goal of which is to bypass the protections offered by the TRIPS Agreement to facilitate the transfer of technology to developing countries in need. Although the issues involved in the waiver debate differed from those implicated by the TRIPS complaints filed by the United States and the European Union against China – with the former focusing on a public health emergency that has claimed millions of human lives and caused worldwide devastation and disruption – both the waiver and the WTO complaints concerned efforts to transfer technology without the authorization of IP rights holders.Footnote ⁴²

Finally, China might have engaged in the practice of strategic deference, considering that article 4 of the TRIPS Agreement will extend “any advantage, favour, privilege or immunity … immediately and unconditionally” to China regardless of its position. Such strategic deference also resembles China’s past engagements in the international arena. For example, during the RCEP negotiations, the country did not advance any proposal for the negotiating text. The four texts that provided the basis of the early rounds of the negotiations originated from the Association of Southeast Asian Nations (ASEAN), India, Japan, and South Korea.Footnote ⁴³ To be sure, China was interested in including an obligation to disclose in patent applications the origin of the biological resources and traditional knowledge used in inventions, similar to article 26 of the Chinese Patent Law.Footnote ⁴⁴ Nevertheless, it strategically deferred to other RCEP negotiating parties that were pushing for a similar position. Notably, India, which was active in the negotiations before its eventual withdrawal in November 2019, advanced a ten-paragraph proposal to cover the area of genetic resources, traditional knowledge, and folklore.Footnote ⁴⁵

Even before the RCEP negotiations, China repeatedly engaged in the practice of strategic deference. When the United States proposed to “issue a joint statement in support of the Doha agenda,” China declined.Footnote ⁴⁶ Likewise, when Argentina and Brazil made their now famous proposal for the establishment of the WIPO Development Agenda, China did not join them, even though it was one of the major leaders in the developing world.Footnote ⁴⁷ The deferential position China took in the waiver debate was actually not that different from its previous policy positions, especially those taken in the first few years of its WTO membership. The waiver-related position only stood out because it differed significantly from the more assertive positions that China has taken in the international arena in recent years. That many observers remain fixated on the old narrative on China’s piracy and counterfeiting problems has also led them to mistakenly assume that the country’s IP positions would align more closely with those of the Global South.

3 Choices for Pandemic Diplomacy

A third contributing factor that accounted for China’s position in the debate on the COVID-19 TRIPS waiver was the availability of a wide array of choices for the country’s pandemic diplomacy. Following the outbreak of COVID-19, countries across the world actively engaged in such diplomacy – whether the country was developed (such as the United States or members of the European Union) or emerging (such as China or India). A key goal of pandemic diplomacy is to gain soft power and goodwill through the donation or delivery of health products and technologies to other countries or through the support of policy positions taken by these countries,Footnote ⁴⁸ such as those relating to the proposed COVID-19 TRIPS waiver.

In the early days of the pandemic, China was very eager to send face masks, other personal protective equipment, and ventilators abroad, especially to developing and least-developed countries. A recent study conducted by the Center for Strategic and International Studies on China’s pandemic diplomacy also reported that the country had “dispatched teams of medical professionals and advisors to assist at least 63 countries in handling the pandemic.”Footnote ⁴⁹ At the opening of the 73rd World Health Assembly in May 2020, President Xi Jinping pledged “$2 billion over two years to help other countries respond to the impact of the coronavirus pandemic.”Footnote ⁵⁰ As locally developed vaccines became available through Sinopharm and Sinovac, the country also sent hundreds of millions of doses abroad. Meanwhile, more than twenty countries hosted trials of Chinese vaccines.Footnote ⁵¹ By October 2021, China had already delivered more than a billion doses of COVID-19 vaccines to over 100 countries, out of which at least tens of millions were donations.Footnote ⁵²

Although China did not immediately join the COVID-19 Vaccines Global Access (COVAX) Initiative – much to the disappointment of its developing country allies and the supportive nongovernmental organizations – it became more active on the vaccine front after joining the initiative in October 2020.Footnote ⁵³ (By comparison, the United States did not join COVAX until a few months later.) In August 2021, at an international forum on vaccine cooperation in China, President Xi pledged the supply of 2 billion doses of COVID-19 vaccines to other countries by the end of the year.Footnote ⁵⁴ He also promised to contribute $100 million to the Gavi COVAX Advance Market Commitment, enabling the provision of donor-funded doses of COVID-19 vaccines to low- and middle-income countries.Footnote ⁵⁵

Considering that China had already made a conscious and deliberate choice to provide vaccines to other parts of the world, the country might not have felt compelled to push aggressively for the adoption of the COVID-19 TRIPS waiver as part of its pandemic diplomacy. Indeed, the export of Chinese vaccines to countries in need, especially those in the developing world, would have allowed China to score more diplomatic points and attain greater soft power than the mere endorsement of a proposal that was advanced by India and South Africa and that had already earned the support of over sixty WTO members.

There are other reasons. First, there were many different policy and diplomatic options that would help China achieve the end goal of promoting global solidarity and enhancing access to vaccines, treatments, and other health products and technologies.Footnote ⁵⁶ These options included vaccine donation and distribution, transfer of health and medical technology, support for the creation of regional or local production capacity, and active participation in international IP reforms (including the negotiation of the COVID-19 TRIPS waiver at the WTO). Because these options were not mutually exclusive, China could easily have supported multiple options simultaneously. The more options there were, the less urgent it would be for China to push aggressively for the adoption of the waiver at the WTO.

Second, the waiver remained controversial in the international arena, especially in the developed world. Even the United States, which made a high-profile announcement of its support for text-based negotiations at the WTO, declined to extend support beyond the narrow area of patents in vaccines. In such a polarized environment, it is understandable why China found it worthwhile to take a step back and hedge the risks of supporting the waiver. Had the proposed instrument been adopted, China would have shown its support. The WTO’s most-favored-nation treatment would also have enabled the country to benefit from this new arrangement. Given that the waiver was rejected – or at least adopted in a substantially different form – China successfully preserved its hard-earned political capital by maintaining a healthy distance from the proposal.

Finally, Sinopharm and Sinovac derived substantial financial benefits from the international sale of COVID-19 vaccines. In July 2021, the COVAX Initiative entered into an agreement to purchase 550 million doses from China, earning the ire of US politicians, commentators, and the mass media.Footnote ⁵⁷ Likewise, studies have shown that a significantly large portion of the COVID-19 vaccines produced in China were sold rather than donated.Footnote ⁵⁸ Thus, the proposed waiver would have undermined these commercial activities.

In short, it is not difficult to understand why China took a middle-of-the-road position in the debate on the COVID-19 TRIPS waiver at the WTO. There was simply no urgent need for the country to move to the forefront of that debate to maximize its global pandemic diplomacy. All it needed to do was refrain from taking actions that would undermine the waiver’s support.

4 The WTO Ministerial Decision

As the previous sections have shown, China was rather deferential in the first year and a half of the waiver negotiations at the TRIPS Council. Nevertheless, it became significantly more assertive toward the end of the debate – specifically during the deliberations on the proposal that provided the basis of the Ministerial Decision adopted at MC12.Footnote ⁵⁹ This section explores why China changed its position in the run-up to this decision.

A month after the United States changed its negotiating position on the waiver in May 2021, the WTO membership agreed to begin text-based negotiations. Nevertheless, these negotiations were stalled by such contentious issues as the scope of the waiver (in relation to both the products and IP rights covered), the waiver’s duration, implementation issues, and the protection of undisclosed information (including regulatory data).Footnote ⁶⁰ In December 2021, the European Union, India, South Africa, and the United States, with the support of the WTO Secretariat, began their own consultations to find a compromise. While China initially welcomed the use of small-group negotiations to break the impasse,Footnote ⁶¹ it found those negotiations highly problematic when they produced an outcome document that sought to single out China for exclusion.

Although the WTO did not immediately release this document despite announcing a major negotiation breakthrough in March 2022, Stat News published a leaked version of the document online.Footnote ⁶² Footnote 1 of that document limited the eligibility of the proposed arrangement to “any developing country Member that [had] exported less than 10 percent of world exports of COVID-19 vaccine doses in 2021.” Because China had slightly over a third of these exports in December 2021, according to the WTO–IMF COVID-19 Vaccine Trade Tracker, the country was de facto the only developing economy that would have been disqualified for the proposed arrangement. By the time the WTO officially released the outcome document on May 3, footnote 1 added new bracketed language stating that “[d]eveloping country Members with capacity to export vaccines are encouraged to opt out from this Decision.”

At the outset, it is not difficult to understand why some WTO members believed that the proposed arrangement should not be available to a country that had the world’s largest or second largest economyFootnote ⁶³ and that accounted for a third of the world’s COVID-19 vaccine exports. After all, the arrangement was negotiated primarily to help countries in need – in particular, those with no or insufficient capacity to manufacture vaccines.Footnote ⁶⁴ It is also no secret that the United States – and likely also the European Union – firmly believed that any negotiated concession in the COVID-19 context should not benefit a major trade power like China, whether due to domestic politics, global rivalry, or the developed countries’ growing effort to limit the special and differential treatment of developing countries.Footnote ⁶⁵

On China’s side, there were also good reasons why the country had limited interest in using the proposed arrangement. As noted earlier, China-based Sinopharm and Sinovac derived substantial financial benefits from the international sale of COVID-19 vaccines during the pandemic. Waiving IP rights, even temporarily, would undermine these commercial endeavors. It was quite telling that a month before the adoption of the Ministerial Decision, China announced in the General Council’s meeting its intention not to use the proposed arrangement provided that the WTO membership agreed to drop the exclusionary language in footnote 1.

Such language was particularly problematic for China. It is one thing to opt out of the proposed arrangement but quite another to be disqualified by other trade powers without ever being consulted. To a large extent, the proposed language had created a major diplomatic blunder by overlooking the border closure to Chinese visitors in the early days of the pandemic, the importance of “face” (mianzi) in Chinese culture,Footnote ⁶⁶ and the country’s historical struggle with what historians have referred to as the “century of humiliation” – an extended period in the nineteenth and early twentieth centuries during which China was reduced to a semi-colony.Footnote ⁶⁷ The exclusion looked even worse when the consultations that generated the new proposal involved only 4 out of more than 160 WTO members – or less than a fifth of the WTO membership if all EU member states were counted (notwithstanding the fact that only some EU members opposed the waiver).

As a result of this proposed exclusion, China quickly moved from a deferential position to a more assertive one, similar to those policy positions it took when it perceived a threat to its state sovereignty. The resistance from China, along with the usual complications regarding eligibility, eventually caused footnote 1 to become the last issue to be resolved by WTO delegates.Footnote ⁶⁸ When the Ministerial Decision was finally adopted in the wee hours of the last day of MC12, that footnote was changed to the following:

Even though the outcome is the same – that China would not use the new arrangement facilitated by the Ministerial Decision – China likely found the adopted language more palatable because it was not an imposition by other trade powers but a recognition of the country’s sovereign decision to opt out of the proposed arrangement.

As many commentators rightly recognize, the adopted language still posed a serious problem from a public health standpoint. Excluding a country like China would greatly reduce both the global demand and global supply of the COVID-19-related health products and technologies.Footnote ⁶⁹ A very high volume of these products and technologies were produced or consumed in China. Nevertheless, the danger of introducing eligibility restrictions is outside the scope of this chapter.Footnote ⁷⁰ Such restrictions would affect not only China, but all developed countries as well as those developing countries that opted out of the arrangement. To a large extent, the public health problem posed by these restrictions was the same as the one confronting the opt-out mechanism in article 31bis of the TRIPS Agreement. It is therefore no surprise that, in the early days of the COVID-19 pandemic, a consortium of nongovernmental organizations and individual experts sought to address the latter problem by calling on WTO members that had previously opted out of the article 31bis system to reconsider their earlier position.Footnote ⁷¹

5 Lessons and Observations

This chapter identifies three distinct reasons why China took a middle-of-the-road position in the debate on the COVID-19 TRIPS waiver at the WTO. The previous section also recounted the country’s more assertive position in the run-up to the adoption of the Ministerial Decision. Drawing eight lessons from the international debate on the waiver and the subsequent Ministerial Decision, this section offers insights into the roles China can or will play in future international policy debates at the intersection of IP and public health, including during the next pandemic.

First, the position China took in the waiver debate is indicative of the country’s changing pharmaceutical landscape and its growing ambition to become an IP power. Because of these developments, China now takes policy positions that align more closely with those of developed countries than those of developing countries.Footnote ⁷² While some policymakers and commentators have been surprised that China did not take the developing countries’ position in what they considered a traditional North–South debate, China has moved gradually away from the developing countries’ policy position since its innovative turn in the mid-2000s. The waiver debate is just one of the latest iterations of this changing policy position. This policy shift also explains why China supported the consultations between the European Union, India, South Africa, and the United States until the outcome document included a footnote that would have excluded the country. As China declared in the TRIPS Council’s meeting in December 2021, shortly after the launch of these consultations:

Second, although China’s ambition to become an IP power has caused the country to move away from the developing countries’ traditional policy positions, it remains reluctant to give up leadership in the developing world and continues to value support for other developing countries, due in large part to the soft power generated from such support.Footnote ⁷⁴ Given this policy dilemma, China will likely push for policies that strengthen IP protection while at the same time promoting the transfer of technology to countries that are less economically and technologically developed. The existence of these seemingly conflicting policy positions is not new. Even though China pushed for stronger IP protection to build national champions in the pharmaceutical sector, it has made strong commitments to promoting universal healthcare.Footnote ⁷⁵ Likewise, although the Fourth Amendment to the Chinese Patent Law adopted during the pandemic strengthens the protection for pharmaceuticals by providing the Hatch–Waxman extension of the patent term and introducing a new patent linkage system, the revised statute provides a six-month grace period for filing patents that has been disclosed during a national emergency to promote the public interest. Articles 50–52 usher in further support for open patent licensing.

Third, China is in a good position to facilitate large-scale transfer of health and medical technology. Commentators have widely noted the importance and urgency of the development of regional supply centers and domestic production capacity.Footnote ⁷⁶ China’s Belt and Road Initiative – in particular, its “Health Silk Road” – will provide an ideal platform for facilitating such development.Footnote ⁷⁷ As noted in a joint statement released in June 2020, China will work with other countries to

Thus far, the Health Silk Road has remained largely a concept, and the Belt and Road Initiative has focused primarily on connectivity and infrastructure development – which is likely to translate to hospitals, treatment centers, and other facilities in the health context. Nevertheless, researchers have found that “countries that have signaled their endorsement of [this] concept scored much higher” in terms of the scope and impact of China’s activities during the COVID-19 pandemic.Footnote ⁷⁹ They also note that “China’s Covid-19 diplomacy was most significant in countries where China already had strong diplomatic relations and sizable influence before the start of the pandemic.”Footnote ⁸⁰

Fourth, unlike those countries that have actively donated vaccines to multilateral initiatives such as COVAX, China has taken a predominantly bilateral – and often decentralized – approach to vaccine diplomacy.Footnote ⁸¹ It reportedly has donated only a small portion of the COVID-19 vaccines produced in China,Footnote ⁸² although it is unclear whether and how much the sales price of those vaccines has exceeded their production costs. At the time of writing, comparative research on pandemic diplomacy remains scant. When more research in this area becomes available, it will be useful to compare the diplomatic efforts across the major players in the global health regime, including China, India, the European Union, and the United States. A deeper understanding of their differing approaches will help anticipate how these players will behave during the next pandemic. It will also provide insight into the competitive dynamics involving these players.Footnote ⁸³

Fifth, China’s predominantly bilateral approach during the COVID-19 pandemic recalls the country’s historical “reluctance to collaborate with surveillance systems or engage in other information-sharing activities that are at the heart of contemporary global health governance.”Footnote ⁸⁴ Although there is a tendency to treat developments during the COVID-19 pandemic as unprecedented, extraordinary, or sui generis, China’s pandemic diplomacy resembles its earlier engagements in public health diplomacy during the SARS, H1N1, and H5N1 outbreaks.Footnote ⁸⁵ As Jeremy Youde explained:

Outside the public health arena, one could further link China’s current engagements in this arena with those in other areas, such as bilateral and regional trade agreements or the Belt and Road Initiative.Footnote ⁸⁷ Given these similarities, it is no surprise that many China critics remain concerned that China would conduct pandemic diplomacy in the same way it has undertaken diplomatic engagements in trade, development assistance, and other contexts. As the Center for Strategic and International Studies’ research on China’s pandemic diplomacy reminded us, “China predominantly engages countries bilaterally to augment its bilateral influence.”Footnote ⁸⁸

Sixth, China will assume influential positions in future debates at the intersection of IP and public health. These debates range from the ongoing discussions on the international treaty on pandemics under the WHOFootnote ⁸⁹ to those concerning the greater deployment of artificial intelligence in public health. Yet it remains difficult to predict where China will stand in those debates in the near future. Thus far, we have rarely seen China take policy positions that differ significantly from those of either developed or developing countries. Instead, its positions often fall somewhere between these two traditionally polarized positions.Footnote ⁹⁰

Seventh, China can bring important benefits to the international community even if it does not move to the forefront of the IP debates at the TRIPS Council. Consider, for instance, the debate on the COVID-19 TRIPS waiver. Regardless of its support for this proposed instrument, China’s donation of face masks, ventilators, vaccines, and other supplies had already helped alleviate the public health challenges in many developing countries. In addition, there was no clear-cut divide, especially at the WTO, between issues at the intersection of IP and public health and those in other trade or trade-related areas, such as agriculture, fisheries, steel, and textiles. Even if China did not take an active position in the former debate, its important role in the latter debates could ultimately influence discussions in the former. In the run-up to MC12, some commentators expressed concern that the proposed waiver might be linked to other trade items in a “take it or leave it” manner.Footnote ⁹¹ These concerns were understandable in view of the past practice of “linkage bargaining” in negotiations at the WTO and the General Agreement on Tariffs and Trade.Footnote ⁹² Indeed, the TRIPS negotiations provide a textbook example of such bargaining, which resulted in an agreement to introduce high IP standards in developing countries in exchange for developed countries’ concessions in textiles and agriculture.Footnote ⁹³ While China did not play an active role in pushing for the adoption of the COVID-19 TRIPS waiver, its positions in other trade or trade-related areas, and its ability to strike side deals at the WTO and in other international fora, could have had a significant impact on the waiver negotiations had they continued.

Finally, although policymakers and commentators considered it self-serving when the pharmaceutical industry and its supportive politicians used China and Russia to explain their opposition to the waiver,Footnote ⁹⁴ the competition between IP rights holders in China and those in Europe, the United States, and other developed and emerging countries cannot be overlooked. China has now reached the stage of development where it can compete effectively against other countries both at the technological level and in the pharmaceutical arena. To be sure, the country still does not have internationally recognized pharmaceutical brands that are comparable to those found in Europe or the United States, such as Johnson & Johnson, Merck, Novartis, Pfizer, Roche, and Sanofi.Footnote ⁹⁵ Nevertheless, it is only a matter of time before the generous investment and substantial policy support in China provide the much-needed boost to create globally competitive national champions in the pharmaceutical sector.Footnote ⁹⁶ The concerns in the European and US pharmaceutical industries are therefore not far-fetched. To some extent, such concerns remind us of their earlier unpopular comments about generic competition in HIV/AIDS medicines in Sub-Saharan Africa.Footnote ⁹⁷ Around the time of the highly controversial lawsuit that the global pharmaceutical industry filed against President Nelson Madela’s government in South Africa, an industry representative “suggested that South Africa was a pawn used by India and Argentina to undermine TRIPS.”Footnote ⁹⁸ The industry’s present concerns about the growing rivalry with Chinese companies in the COVID-19 context largely resemble its earlier concerns about generic competition.

6 Conclusion

The COVID-19 pandemic has forced countries in both the developed and developing worlds to make difficult policy choices at the intersection of IP and public health.Footnote ⁹⁹ It has also made salient the fast-changing developments that are already underway in China and other emerging countries. Although many policymakers and commentators still have tendencies to link China’s IP developments to either the age-old debate on piracy and counterfeiting or the traditional North–South divide, a comprehensive reassessment of the country’s role in the international policy debates at the intersection of IP and public health is in order. Such reassessment will better recognize the country’s innovative turn in the mid-2000s, its ambition to become an IP power, and its changing pharmaceutical landscape. In the near future, China will likely subscribe to policy positions that lie somewhere between those adopted by developed countries and their less developed counterparts. Its middle-of-the-road position in the debate on the COVID-19 TRIPS waiver has provided a timely and instructive illustration.

1 Travel Bans, Vaccine Exclusion, and Political Theater

As has been the case outside of Africa, African countries have experienced multiple consequences from the COVID-19 pandemic that extend beyond its immediate impact on human health. In Africa, much like elsewhere in the world, the pandemic has had a significant economic impact, leading to profound global economic distress. African countries have also experienced consequences that are unlike those of much of the rest of the world. For example, the pandemic has contributed to a sovereign debt crisis that led to sovereign defaults by Zambia in late 2020, Mali in early 2022, and Ghana in late 2022, and that might lead to additional defaults.Footnote ¹ Travel bans and COVID-19 vaccine exclusion are key COVID-19 policies that have also had a particular impact in Africa. These and other COVID-19 policies in African contexts reflect patterns of exclusion that are at least in part a consequence of continuing colonial hangover.

In late November 2021, scientists in South Africa and Botswana discovered a new variant of the COVID-19 virus.Footnote ² This new variant was subsequently designated Omicron.Footnote ³ Just a year earlier, in late December 2020, amid concern about an earlier COVID-19 surge, the United Kingdom had announced an immediate travel ban on flights to South Africa; this ban was lifted in October 2021.Footnote ⁴ Shortly after the lifting of the 2020 travel ban, a new travel ban was imposed within two days of the identification of the Omicron variant. In a December 2021 comment in the medical journal The Lancet, a group of South African scientists labeled the UK travel ban a form of “political theater.”Footnote ⁵ UN Secretary General António Guterres referred to the travel bans as a form of “travel apartheid.”Footnote ⁶

Patterns of COVID-19-era exclusion also extended beyond travel bans to access to COVID-19 vaccines. In the earliest days of the distribution of COVID-19 vaccines, many African countries did not receive adequate access to them. As Gavi, the Vaccine Alliance, noted,Footnote ⁷ “early access was inadequate; by the end of 2021, a number of low-income countries, particularly in Africa, had barely been able to vaccinate 10% of their populations … In contrast, many high-income countries had already achieved vaccination rates of 75–80% by this time.”

Vaccine exclusion was due in part to hoarding by wealthier countries,Footnote ⁸ as well as the policies of some vaccine manufacturers that sought to wring maximum profit from their vaccines: “Moderna, whose coronavirus vaccine appears to be the world’s best defense against Covid-19, has been supplying its shots almost exclusively to wealthy nations, keeping poorer countries waiting and earning billions in profit.”Footnote ⁹ Vaccine exclusion was also likely exacerbated because poorer countries were in some instances charged more for vaccines than wealthier ones.Footnote ¹⁰

The experiences of African countries during the COVID-19 pandemic highlight key consequences of colonial hangover and fundamental structural impediments and inequalities evident in global and local contexts. As Oumar Seydi, the Gates Foundation Africa Director, noted in December 2021:

2 Policy Contagion and the Costs of COVID-19 Exclusion

African countries were not the only countries to have experienced COVID-19 travel bans. However, the manner in which bans were imposed on countries in Africa reflects such countries’ disparate and likely discriminatory treatment.Footnote ¹² The travel bans imposed against African countries after the South African announcement of the detection of the Omicron variant reflect a pattern of policy contagion.Footnote ¹³ The spread of COVID-19 policies highlights uncertainties about the nature of policy diffusion during times of crisis,Footnote ¹⁴ as well as ways that public health and other policies and institutions reflect continuing patterns of colonial overhang.

COVID-19 policy contagion, which has been particularly evident in travel bans, may not be grounded in science or even public health best practices:

Travel bans may be counterproductive in a number of ways. The South Africa Omicron travel ban potentially limited access to important sequencing reagents for South Africa’s critically important COVID-19 genomic surveillance activities.Footnote ¹⁶

After its initial South Africa travel ban, the United Kingdom soon extended the ban to other countries in Africa, including Angola, Malawi, Mozambique, Nigeria, and Zambia. Notably, Nigeria, which is more than 2,000 miles away from South Africa, is not even in the Southern African region where Omicron was first identified. This travel ban would be akin to imposing a ban on travelers from the United Kingdom as a result of cases in Cyprus. Further, at the time the United Kingdom travel ban was imposed on Nigeria, the percentage of travelers from Nigeria testing positive for COVID-19 after arriving in England between October 14 and November 3 was “similar to the proportion among those arriving from several European countries” and was less than percentages of travelers testing positive from both Spain and Italy, neither of which became subject to a travel ban.Footnote ¹⁷ This reflects a broader pattern of imposition of Omicron travel bans against countries in Africa when bans were not imposed against countries outside of Africa with much higher levels of COVID-19 cases:

The Omicron travel bans targeted at African countries soon spread across the globe: “Though scientists have little information about the new variant and aren’t certain where it originated, several countries, including the United States, Canada, the United Kingdom and the European Union announced immediate travel bans from South Africa and other southern African nations.”Footnote ¹⁹ In late November 2021, Canada banned nationals of several African countries, including those such as Egypt and Nigeria that are far away from the Southern Africa region where Omicron was first detected.Footnote ²⁰ Notably, Cairo, the capital of Egypt, is farther away from Pretoria, the executive capital of South Africa, than Canada’s capital Ottawa is from London, United Kingdom.Footnote ²¹ Canada also created an innovative policy of imposing a third-party testing requirement on Canadian citizens traveling from the African countries on the banned list, requiring such travelers to stop in a third country and take a COVID-19 test in the third country “before continuing their journey to Canada.”Footnote ²²

Inequity in access to COVID-19 vaccines and travel bans, particularly the Omicron travel bans, mirror and likely intensify existing patterns of global inequality. Lack of access to vaccines led to a widening poverty gap for countries excluded.Footnote ²³

Lack of vaccine equity can also contribute to the emergence of new variants and increase stress for countries that may already be fragile, which could exacerbate political unrest.Footnote ²⁵ Vaccine exclusion might also contribute to precarity, evident in increased poverty, food insecurity, and unemployment.Footnote ²⁶

Exclusion from access to vaccines may boost the likelihood of migration, which is an increasingly contested issue in relationships between countries in Africa and Europe.Footnote ²⁷ The economic impact of travel bans for countries in Africa has been significant. An estimate in early 2022 suggested that South Africa had lost more than 2 billion Rand (more than US$123 million) in tourism spending because of the Omicron travel ban.Footnote ²⁸

3 COVID-19, Exclusion, and International Institutions

Travel bans and vaccine exclusion are a continuation of patterns of exclusion of African countries from international institutions. This exclusion reflects a pervasive colonial hangover that has had a continuing impact locally within Africa, as well as globally. As UN Secretary General António Guterres noted in July 2020:

Colonial hangover is evident in African representation in varied global policymaking contexts. Dominant legal, regulatory, and policy frameworks, within many countries in Africa and globally, can be traced directly back to colonial-era lawmaking and postcolonial legal and policy approaches that have replicated colonial-era patterns.Footnote ³⁰ This means that many today operate under assumptions and use of policies and laws that were created and deployed during and even prior to the colonial era.

International institutions exemplify continuing consequences of colonial hangover and African exclusion. Institutions created in 1944 as part of the Bretton Woods system continue to play a key role in global economic and financial matters today. The International Monetary Fund (IMF) and International Bank for Reconstruction and Development (World Bank) were created at Bretton Woods, New Hampshire at a meeting of forty-four nations.Footnote ³¹

The IMF and World Bank have had notable successes, including facilitation of the rapid post-World War II reconstruction of Western Europe and Japan, “which led to the period of the fastest economic growth and, particularly, the fastest growth of international trade in world history.”Footnote ³² The collapse of the original Bretton Woods arrangements in the 1970s led to what economist José Antonio Ocampo describes as “the de facto rise of the current ‘non-system’.”Footnote ³³

Organizations created at Bretton Woods remain a strong institutional force, particularly in African contexts. In the 1990s, during a debt crisis, the IMF and World Bank were described as “institutions, founded half a century ago at the Bretton Woods Conference to serve the needs of the industrialized world, [that] have become the overlords of Africa in the 1990’s.”Footnote ³⁴ The governance structure of the system established at Bretton Woods continues to embody colonial-era power dynamics:Footnote ³⁵

The ad hoc framework that followed the collapse of the original Bretton Woods system has contributed to significant asymmetries between developed and developing countries. Ocampo has noted that such asymmetries have led emerging and developing countries to have a limited share in the creation of international liquidity and greater economic vulnerability.Footnote ³⁶ Ocampo also points out that such countries have an “inadequate voice and representation in international economic decision-making and in the International Monetary Fund (IMF) in particular.”Footnote ³⁷

International public health institutions were created during the same era as international financial institutions, and the United Nations’ “key global health agencies, such as the UNICEF [United Nations Children’s Fund] and the World Health Organization were born in the post-World War II era of 1946–48, in the waning years of colonialism.”Footnote ³⁸

Colonial hangover in COVID-19 contexts mirrors key elements of colonial hangover in the financial and economic sphere and exemplifies specific aspects of such hangover in the intellectual property (IP) and public health arenas: “exclusionary colonialist patterns that centre Euro-Western knowledge systems have also shaped the language and response to the pandemic – which, in turn, can have adverse health outcomes.”Footnote ³⁹

As COVID-19 exclusion thus highlights, colonial hangover has long been evident in the public health arena and is apparent in patterns of knowledge production, as well as policy and funding approaches. External public health donor funding in Africa may be driven by external needs and often external funding institutions. On April 15, 2021, an open letter to the editor in Nature Medicine noted continuing patterns of external donor funding for malaria largely being used to fund institutions outside of Africa:

Public health reflects an “epidemic of illusions … propagated by the coloniality of knowledge production,” which involves questions about the “mechanisms in public health science,” particularly epidemiology, “that enable groups to sanction one account of disease causation over another.”Footnote ⁴¹ COVID-19 vaccine exclusion has been facilitated by structures of global knowledge production that continue to exclude African countries. Few African countries have local capacity to produce COVID-19 vaccines, which both reflects and exacerbates colonial hangover. Less than 1 percent of all vaccines used in Africa are locally produced, which “reveals the region’s intense vulnerability and overdependence on foreign supplies.”Footnote ⁴²

Colonial hangover is evident in a broad range of knowledge production infrastructures, including in relation to research and development (R&D). The lack of local vaccine production capacity mirrors gaps in research capacity more generally and African countries’ tremendous deficit in scientific and technological infrastructure: “[Sub-Saharan Africa] accounts for less than 1 percent of the world’s research output while being home to 13.5 percent of the global population … In 2008, [countries in Africa] produced the same number [of research papers] as the Netherlands,”Footnote ⁴³ which in 2021 had a population of 17.53 million as compared to a population of some 1.391 billion in Africa and some 1.181 billion in Sub-Saharan Africa.Footnote ⁴⁴

Research activities within Africa reflect externalized networks, evident in international collaborations.Footnote ⁴⁵ Current internal research capacity within Africa reflects low levels of local R&D investment, which has led to research being “highly dependent on external funding support, often through intermediary institutions, and thus not optimal for effectively addressing research problems in the region.”Footnote ⁴⁶ Not surprisingly given past patterns, Sub-Saharan Africa significantly lags most of the world in key knowledge production metrics, including R&D expenditures as a percentage of gross domestic product (GDP) and the number of R&D scientists per million people.Footnote ⁴⁷

The exclusion of African countries evident in varied settings reflects both external and internal constraints. External constraints largely emanate from hangovers from colonial-era power arrangements, while internal decisions have too often not sufficiently disrupted such hangovers and may have even exacerbated the negative impact of external constraints:

Colonial hangover is particularly visible in the IP realm: “The international rules governing intellectual property have been framed to protect companies’ investment in research and development. However, intellectual property rights as they are currently designed place developing countries at a constant disadvantage, especially in areas such as public health.”Footnote ⁴⁹ African countries have long criticized current IP arrangements in relation to a number of things, including the World Trade Organization (WTO) Dispute Settlement Mechanism.Footnote ⁵⁰ In the digital era more generally, notwithstanding the potential promise of new technologies, African countries have increasingly been left behind or disadvantaged by various infrastructures, including in relation to digital economy governance, digital economy infrastructure, and the international tax regime.Footnote ⁵¹

Patent protection and access to medicines have long been contested in global IP discussions and became a critical and continuing point of dispute during the HIV/AIDS pandemic. The importance of access to medicines became apparent with the HIV/AIDS pandemic, which has had its greatest impact in Africa.Footnote ⁵² Patents for antiretroviral therapies (ART)Footnote ⁵³ have long been a contested issue.Footnote ⁵⁴ ART helps people with HIV live longer and healthier lives and profoundly reduces risk of HIV transmission.Footnote ⁵⁵ Debates surrounding access to medicines, particularly ART, underscore the interaction of law, policy, and issues related to human well-being that continue to reflect the impact of colonial hangover.Footnote ⁵⁶ The COVID-19 pandemic, which also raises critical patent-related issues for African and other developing countries,Footnote ⁵⁷ may intersect with and worsen HIV/AIDS outcomes.Footnote ⁵⁸

4 Colonial Hangover and Double Marginalization

Vaccine exclusion and travel bans reflect patterns of exclusion of African countries that are not new. Although formal colonialism ended more than half a century ago in much of the world, a pervasive colonial hangover continues to shape relationships within and among countries. Colonial hangovers evident during the COVID-19 pandemic represent one of many colonial hangovers evident in economic relations, global business and finance, international relations, and public health.

External economic relations of African countries have too often been based on a model of plunder and extraction of raw materials that today increasingly extends to data and information. These extractive models have contributed to the economic and political exclusion of African countries in varied global contexts. Extractive models have also reflected significant external determination through which decisions about internal needs are too often based on the needs and interests of external actors. These externally oriented and often extractive models reflect top-down approaches that have contributed to double marginalization in African and other contexts. At the first level of marginalization, African countries are marginalized and to a significant degree excluded from global power relations.

In many African contexts, a second level of marginalization has long been apparent in the exclusion of a significant portion of the population from access to opportunities and resources, including healthcare. Many in Africa are poor, and global poverty is increasingly a Sub-Saharan African phenomenon: “Extreme poverty will become a predominantly Sub-Saharan African phenomenon in the coming decade and the continent will be home to the lion’s share of the global poor by 2030.”Footnote ⁵⁹

High levels of poverty within Africa are a testament to high levels of internal exclusion. In 2018, the World Bank estimated a 40 percent regional poverty rate for Sub-Saharan Africa, which contained 13 percent of the world’s population in 2017,Footnote ⁶⁰ with countries in Sub-Saharan Africa accounting for close to two-thirds of the global population of extremely poor people. While the poverty rate in Sub-Saharan Africa decreased from 56 percent in 1990 to 40 percent in 2018, the number of poor people continues to rise. This means that the poverty rate in Sub-Saharan Africa has not fallen fast enough to keep up with population growth in the region. In 2018, 433 million Africans were estimated to live in extreme poverty, an increase from 284 million in 1990.Footnote ⁶¹ This second level of internal marginalization, which is a key element of the significant double marginalization confronting many countries in Africa, requires targeted locally facing policy interventions.

The impact of internal marginalization soon became apparent during the COVID-19 pandemic. In COVID-19 contexts, vaccines eventually became more widely available in Africa despite continuing external supply limitations. In early 2022, as the supply of COVID-19 vaccines increased in many African countries, the need for policies to promote vaccine uptake became apparent: “Although COVID-19 vaccine supplies to Africa have risen significantly, the continent is struggling to expand rollout, with only 11% of the population fully vaccinated. The vaccination rate needs to increase six times if the continent is to meet the 70% target set for the middle of [2022].”Footnote ⁶²

The 70 percent target was not met in 2022. As of December 31, 2022, the Africa Centres for Disease Control and Prevention (Africa CDC) estimated a 25.6 percent rate of fully vaccinated people in Africa, with utilization of 77.4 percent or 801 million of the 1.0345 billion vaccine doses received.Footnote ⁶³ Despite greater availability of vaccines, existing policies in many countries may not have sufficiently facilitated widespread vaccination efforts or effectively countered vaccine hesitancy. Existing policies have also in some instances contributed to expiration of unused doses of vaccines: “In African countries, public confusion over whether to get inoculated, and if so when and where to do so, has contributed to the expiration of doses. Like Malawi[, which threw away 16,000 expired vaccine doses in early 2021], South Sudan saw 59,000 unused doses expire this month.”Footnote ⁶⁴

Poverty in Africa underscores patterns of exclusion and marginalization that may exist internally within many countries in Africa. Internal exclusion and marginalization draw attention to the continuing internal impact of colonialism and colonial governance, particularly in relation to elite intermediaries. During colonialism, elite intermediaries in former British colonies, for example, were selected, validated, and kept in power by British colonial policies that primarily attended to the needs of external actors and interests.Footnote ⁶⁵

Elite intermediaries were an important aspect of governance structures in varied colonial contexts. The incentives that shaped the behaviors of internal intermediaries during colonialism continue to play an important role in the policy arena that has not fundamentally disrupted the most deleterious aspects of colonial governance. Rather, colonial and postcolonial governance may offer such internal elites opportunities to profit from differences between internal and external legal and governance arrangements through practices such as jurisdictional arbitrage and other forms of elite extraction that may have exacerbated internal contestation.Footnote ⁶⁶

Anthropologist Elizabeth Colson noted how internal contestation played out in the development of customary land law. Contestation was particularly evident in contexts of scarcity when people became aware of “the conflict between the old political obligation to maintain general access to adequate resources for all citizens, and the possibility of extracting an individual profit from areas preempted under the rule that a man might enjoy the fruits of his labor.”Footnote ⁶⁷

The contestation noted by Colson remains fundamentally unresolved, largely because institutional structures were for the most part not put in place during or after colonialism to check internal patterns of extraction. This has led to questionable incentives that may be baked in institutionally and that may continue to the present day in too many African contexts. The combination of internal and external factors and constraints have led to widespread poverty and pervasive scarcity of opportunity, particularly for many young people. This combination has also contributed to a policy environment that would benefit from a focus on the development of sustained strategies and policies for the benefit of the majority of the population in contexts shaped by colonial hangover.

Critically, existing governance approaches have left many governments with insufficient tools to address crises such as COVID-19. Internal and external constraints and governance structures make navigation of difficult external and internal challenges potentially perilous for many within African contexts. This became particularly evident during COVID-19, when many countries in Africa lacked the internal capacity to produce vaccines, were too often last in line to gain access to critically needed vaccines but became first in line for travel bans and other products of policy contagion that had a significantly negative impact across the African continent.

5 Learning from COVID-19 Exclusion: Strategies and Policies to Disrupt Colonial Hangover

Policy approaches to COVID-19 should not be limited to dealing with COVID alone but should be the start of robust processes that disrupt knowledge production structural impediments and inequalities. Lack of local vaccine production capacity in Africa highlights continuing patterns of external dependence that are a hallmark of colonial hangover. This lack of capacity underscores the need for knowledge production and innovation infrastructures that disrupt colonial hangover. External actors and sources of authority continue to be given primacy in too many African contexts with insufficient scrutiny of whether such primacy is merited and ways in which modification of external policies might lead to better outcomes.

Colonial hangover is evident in models of governance, policies and laws, and institutions developed during colonialism. These models, laws, policies, and institutions were created to a large extent by external powers with an external orientation. During colonialism, verbatim copying of laws and policies was a norm. Patterns of external determination underscore potential problems that come from indiscriminate borrowing from external sources. Borrowing from other contexts comes with histories, contexts, assumptions, disputes, and accommodations. External determination reflects persistent patterns of policymaking and lawmaking that fail to sufficiently consider the local. A clear need exists today for strategies that better incorporate the local. As a 2021 Policy Brief from the African Policy Research Institute notes, in crafting a digital economy agenda, African countries must “ensure that policies and strategies are not indiscriminately copied from other contexts. National and regional policymakers should exercise creativity and judgement that reflect the specificities of African contexts in formulating their digital policies.”Footnote ⁶⁸ This suggested approach should extend beyond just digital economy policies.

Intellectual property laws are key mechanisms that govern knowledge production and innovation. In African contexts, IP frameworks have been implemented with insufficient consideration of the local. Colonial hangover has led to fractured and highly fragmented IP frameworks in Africa “comprising an array of partially overlapping and sometimes conflicting agreements, laws, policies and sub-regional organisations.”Footnote ⁶⁹ As many commentators have noted, the COVID-19 pandemic underscores the need for local patent reform within African countries and globally to give greater attention to the critical need for local vaccine manufacturing and other types of capacity in Africa and other developing countries.

The COVID-19 pandemic draws attention to a persistent lack of consideration of the local impact of knowledge production frameworks. This inattention has hampered policy, planning, and local vaccine production. As a result, much of the population in Africa remained unvaccinated well after widespread dissemination of vaccines in developed countries. Even if vaccines were to have flowed in greater quantities to countries in Africa at an earlier point in time, other potential limitations might have impeded vaccination efforts. In late October 2021, UNICEF projections suggested that “to reach the new COVID-19 vaccination targets, and assuming an unhindered vaccine supply next year, there could be a shortfall of up to 2.2 billion auto-disable syringes.”Footnote ⁷⁰

The ability to accurately measure infections and death rates remains a persistent problem in many countries in Africa.Footnote ⁷¹ The COVID-19 pandemic illustrates the high costs of insufficient measurement because reported numbers of infections and deaths may not be accurate. This is certainly not an exclusively African problem. The COVID-19 pandemic has highlighted pervasive underestimates of COVID-19 deaths within and outside of Africa. For example, according to official South African data, by mid-2021, 90,000 people had died from COVID-19.Footnote ⁷² An analysis in South Africa found excess deaths during the pandemic of more than 190,000 between May 2020 and July 2021.Footnote ⁷³

Healthcare inequities in African contexts highlight the increasing number of poor people in Africa. The COVID-19 pandemic also exposes patterns of double marginalization that combine pervasive external marginalization of African countries with significant levels of internal marginalization within such countries. Responses by external actors to COVID-19 in African countries reflect the inability of such actors to overcome their tendency to recreate persistent patterns of exclusion.

South Africa has experienced significant external marginalization evident in vaccine exclusion and travel bans. The country has the largest and most integrated local vaccine production capacity in Africa.Footnote ⁷⁴ However, it also faces continuing challenges in internal marginalization. For example, it has excellent private healthcare in a highly unequal health system, particularly for the 70 percent of the population that relies on the public healthcare system.Footnote ⁷⁵

South Africa is not alone in having unequal internal access to healthcare. Many countries both inside and outside of Africa have significant internal exclusion and marginalization. In African contexts, double marginalization must be considered in crafting innovative and hybrid policies that take sufficient account of local contexts and needs. Increasing local R&D funding and local science, technology, engineering, and math (STEM) capacity are of critical importance in establishing the groundwork for greater local ability to manage digital economy strategies and address COVID-19, healthcare more generally, and other local needs in African contexts.

COVID-19 highlights consequences of ineffective strategies for dealing with the internal and external. The pandemic also draws attention to the need for greater targeted internal funding and strategies to promote development of sustainable innovation ecosystems. Public and private funding, including from venture capitalists, have been important sources for financing STEM innovation globally.Footnote ⁷⁶ Internal STEM funding in African contexts is far too often insufficient and may continue to be shaped by colonial hangover. Inadequate internal funding of R&D and other elements of scientific and technological capacity have made external funding even more important.

However, as malaria funding patterns discussed in the Nature Medicine letter to the editor suggest, funding by external donors can be governed by external needs and priorities that may leave little funding for or room for input from local organizations. External private funding in African contexts can be driven by biases imported with investors that may replicate racial patterns and funding biases evident in Silicon Valley and other contexts that some have described as a form of neocolonialism. These funding patterns were highlighted in a July 2020 article in The Guardian, with the title “Silicon Valley has Deep Pockets for African Startups – If You’re Not African.”Footnote ⁷⁷ This article noted that of seventeen companies that raised $1 million or more from venture capital in Kenya in 2019, only one was founded by locals, four by a mix of expatriates and locals, and eleven by expatriates only.

COVID-19 has revealed critical shortcomings in local enabling environments and capacity in African countries, including in relation to public health. Policy approaches to the COVID-19 pandemic should disrupt structural impediments and inequalities that reflect colonial hangover. These approaches can also be a part of broader strategies intended to facilitate local capacity and diminish continuing patterns of exclusion for many countries in Africa.

Disrupting colonial hangover and double marginalization will require attention to the external and internal. Approaches to COVID-19 vaccine exclusion may be crucial in the emerging recognition of the critical importance of attention to both the internal and external. For example, in April 2021, the Africa CDC and the African Union (AU) Commission held the virtual summit “Expanding Africa’s Vaccine Manufacturing for Health Security.”Footnote ⁷⁸ This summit and the New Health Policy announced by the Africa CDC and AU Commission in September 2022 reflect approaches that combine scrutiny of the internal and external.

The New Health Policy calls on governments, multilateral organizations, nongovernmental organizations, the private sector, and civil society organizations to support implementation of Africa’s New Public Health Order, which is seen as a “roadmap to sustainable health outcomes and health security.”Footnote ⁷⁹ Critically, in addition to calling for new partnerships to advance vaccine manufacturing within Africa, the New Public Health Order emphasizes the importance of internal investments in capacity building, including domestic health infrastructure, manufacturing capacity, institutional and governance structures, and public health workforce and leadership development.Footnote ⁸⁰

The New Public Health Order presents a potential model that could be applied in other contexts to address internal and external conditions that have exacerbated colonial hangover and double marginalization. Alternative and hybrid models have the potential to provide a basis for greater inclusion of African countries within global policy frameworks and institutions. Such models may also play an important role in ameliorating internal conditions that reflect colonial hangover and in fostering internal inclusion. Reducing internal and external exclusion will be a key element in truly disrupting the shadows of colonial hangover in Africa.

Latin American and Caribbean (LAC) countries were severely hit by the COVID-19 pandemic.Footnote ¹ As of April 2021, the region was reported to have experienced nearly 30 percent of the world’s COVID-19 deaths, despite accounting for less than 10 percent of the population.Footnote ² The devastation continued through 2021, a period when vaccines had been approved, but access to these essential products remained limited. National vaccination campaigns in many LAC countries were slow to take off, allowing illness and death rates to soar. While LAC countries’ estimated number of cumulative excess deaths per million people was 100 at the end of 2020, this increased to over 300 by October 2021 as Figure 15.1 shows.

Figure 15.1 Cumulative excess mortality in Latin America and the Caribbean (per million people).

Excess deaths are calculated as the number of all-cause deaths minus the number of deaths expected for the same period based on previous data, per million people. The data in the figure are cumulative, relative to the baseline of January 2020. Although Our World in Data includes Mexico as part of “North America,” the data used for the figure are based on a recalculation with Mexico included as part of LAC. Note that I report LAC alone, and not inter-regional comparisons, because high levels of missing data from other regions make such comparisons unreliable.

Source: Our World in Data (https://ourworldindata.org/excess-mortality-covid)

Although restricted access to vaccines in 2021 was due to multiple factors (and, of course, death rates are attributable to more than access to vaccines), many observers came to link the dire effects of COVID-19 to the region’s dependence on imported vaccines that were in scarce supply. Vaccination in LAC countries relied mostly on purchases from the World Health Organization’s (WHO) joint procurement facility, COVAX,Footnote ³ and directly from vaccine manufacturers. A common diagnosis that emerged is that more local or regional production of vaccines could have ameliorated the impact of the pandemic – and local production has subsequently come to be regarded as a way to assure that what transpired in the COVID-19 pandemic is not repeated during future health emergencies. To that end, regional organizations and many national governments embarked on strategies to increase local production.Footnote ⁴ As the authors of a report by the United Nation’s Economic Commission for Latin America and the Caribbean on “self-sufficiency” put it, “while the pandemic has laid bare the health vulnerabilities of the region, it has also been an opportunity to re-evaluate its productive and technological capacities, and to reformulate strategies and policies for strengthening local manufacturing and innovation systems for components of goods and services linked to the health complex.”Footnote ⁵

The reckoning that occurred throughout Latin America and the Caribbean is hardly specific to this region.Footnote ⁶ Dependence on – and lack of access to – imported vaccines was acute in Africa as well, and similar diagnoses and proposals have followed.Footnote ⁷ Indeed, the WHO links differences in health outcomes and access to vaccines globally to uneven production patterns,Footnote ⁸ and throughout the world (including in wealthy countriesFootnote ⁹), vulnerabilities revealed by the pandemic are motivating actions to increase production capabilities.Footnote ¹⁰

This chapter looks forward by looking back, examining the production of COVID-19 vaccines in the LAC region. The focus is on technology transfer for local production. That is, while efforts to produce original, “home-grown” vaccines are discussed, attention is primarily directed at the extent (or absence) of production in LAC countries of the leading vaccines that were most used internationally, such as those made by AstraZeneca, BioNTech/Pfizer, the Chinese firms Sinopharm and Sinovac, as well as Johnson & Johnson (J&J), Moderna, and Russia’s Sputnik-V. The research reveals a limited degree of local vaccine production during the pandemic, what can be regarded as an under-utilization of the region’s pharmaceutical production capabilities.

Through the analysis of the technology transfer initiatives, as well as the accompanying regulatory challenges, the chapter sheds light on the intense challenges involved with pandemic vaccine production in the Global South. The analysis also shows, however, that relaxing intellectual property rights to enable “independent” production would not be feasible either, and thus suggests we orient attention to factors that are likely to make partnerships and technology transfer more common.

The chapter proceeds as follows. Section 1 presents an overview of the universe of local production arrangements for which information is publicly available. Section 2 then drills down to the cases where technology transfer advanced the furthest, examining the production experiences of the AstraZeneca vaccine in Brazil and jointly in Argentina and Mexico. Both partnerships illustrate the challenges of building and sustaining supply chains during the pandemic. The Brazil case highlights key steps that enabled relative success, including rapid and proactive efforts by public sector institutions. The Argentina–Mexico case, which appeared to be both more ambitious and better positioned from the start but did not yield the same outcome, sheds light on the technological and regulatory obstacles that may confound such projects. Section 3 provides a broader view of the experience of technology transfer during the pandemic, considering the role of intellectual property rights and pointing to the collaborative dimensions of production partnerships. Section 4 synthesizes the main findings and points to avenues for future research.

To be sure, with LAC vaccination rates among the highest in the world by 2023, the issues discussed in this chapter may no longer appear to be pressing. But building local and regional production capabilities – and making more use of existing capabilities – has important implications for preparedness for future pandemics.Footnote ¹¹

1 COVID-19 Vaccine Production in Latin America: Overview

COVID-19 vaccines can be distinguished among four types: viral vector, inactivated virus, mRNA, and protein-based. While inactivated virus and protein-based vaccines are traditional technologies that have long been used, viral vector and mRNA are both newer platform technologies that involve insertion of genetic code into delivery vessels.Footnote ¹² Table 15.1 presents the landscape of production partnerships in Latin America and the Caribbean by type of vaccine, and also according to the different stages of the production processes that are being executed locally. Firms may manufacture the “drug substance,” which is the core of the vaccine (sometimes referred to as the “antigen”), or they may manufacture the final product that is administered to humans, a stage referred to as “fill–finish” that consists of formulating the drug substance and putting the formulated versions of the vaccine into sterile vials that can be distributed for use.Footnote ¹³ The table shows partnerships for production of five different vaccines across three technological platforms, involving a mix of public and private firms. Manufacturing activities consist mainly of fill–finish, with limited drug substance production. The remainder of this section provides brief overviews, by technological platform.

2 AstraZeneca in Latin America

Having provided an overview of the landscape of production partnership agreements in the region, I now examine in more detail the two most important cases: the technology transfer and manufacturing arrangements for production of the AstraZeneca vaccine in Brazil, and jointly in Argentina and Mexico. Both partnerships were supported by combinations of public and private financing to minimize the risks involved. To understand this important dimension of the COVID-19 response, we need to remember the urgency of the situation – not just the need for new vaccines, but large volumes of new vaccines that would be produced quickly. With a premium on speed, steps were taken to transfer technology and build production networks while the products were still in trials, so large-scale production could commence, and doses be available immediately upon (or soon after) receipt of marketing authorization. These expenditures were thus “at-risk,” because if clinical trials revealed the vaccine candidates to be unsuccessful, the investments would be lost.Footnote ⁴⁸

3 Technology Transfer and Production of COVID-19 Vaccines: Collaboration v. Competition

None of the arrangements reviewed in this chapter featuring technology transfer for local production constitute independent manufacturing undertaken by LAC firms. That includes the AstraZeneca arrangements discussed in the previous section, the most advanced examples of local vaccine production in Latin America. In the case of mAbxience and Liomont, these firms were contracted by AstraZeneca to produce for a regional supply chain; mAbxience had no rights to or control over the drug substance it produced, and the same is so for the final doses produced by Liomont – all of this belonged to AstraZeneca.Footnote ⁷⁴ Nor would it be accurate to describe BioManguinhos as independent, despite being a licensee rather than contract manufacturer. Even in the second stage of the partnership, when making the full vaccine itself and thus no longer dependent on AstraZeneca for the supply of drug substance, what BioManguinhos could do with its output remained limited by the conditions imposed by AstraZeneca.Footnote ⁷⁵ These arrangements were partnerships for production of originator products via technology transfer; they did not feature local firms involved in the independent manufacturing of their own “generic” versions of these products.

While these characteristics of the vaccine production arrangements may be regarded as limitations, in that the local actors were not making independent and autonomous decisions about production and distribution,Footnote ⁷⁶ they also came with advantages: local labs benefitted from technology transfer, and the vaccines they produced were not required to go through their own clinical trials but rather were included in the originators’ dossiers and authorization processes. In normal times, such advantages might be outweighed by the disadvantages of lacking control and being in a subordinate position to the originator firms, but in the midst of a global pandemic the calculus may differ. That is, when massive amounts of output are needed as quickly as possible, it is not clear that independent production is the most fruitful path. For all of the difficulties that the joint Argentina–Mexico scheme for production of the AstraZeneca vaccine faced, for example, proceeding without the originator would have been even slower and less fruitful.

These characteristics of production during the pandemic have important implications for debates over intellectual property (IP) rights.Footnote ⁷⁷ Where production depends on the active engagement of originators, to help master production processes and satisfy regulatory requirements as quickly as possible, as is essential for vaccines during a pandemic, the absence or removal of IP rights is unlikely to increase supply quickly. What is needed in such circumstances is not subtractive – that is, removing the restrictions that IP rights create – but rather additive – that is, technology transfer from the originator to partners. In contrast, then, to what was witnessed with HIV/AIDS medicines earlier in the century, where the absence of patents and the existence of simple regulatory pathways enabled generic producers (public and private) to make abundant and affordable treatments available,Footnote ⁷⁸ efforts to expand global supply of vaccines during the COVID-19 pandemic needed to rely on originator firms transferring technology, know-how, and data to manufacturing partners. Where such sharing does not happen, independent production of vaccines may still occur, but is likely to proceed at a substantially slower pace, which places severe limits on its usefulness during a pandemic.Footnote ⁷⁹

Importantly, the LAC partners involved in the production of vaccines did not regard the forms of collaboration as being restrictive, but rather as creating opportunities that could generate new capabilities. The fact that BioManguinhos was working under the conditions set by AstraZeneca according to the terms of the licensee was not regarded as a drawback. To the contrary, BioManguinhos officials knew that on their own they could not produce the vaccine fast enough. In fact, BioManguinhos officials expressed excitement regarding capability enhancement that the collaboration would bring. Accessing the adenovirus, viral vector technology, it was expected, would position BioManguinhos on a new research and knowledge pathway. Although its immediate objective was to contribute to the COVID-19 pandemic response in Brazil by manufacturing vaccines, the technology transfer promised by this partnership would grant BioManguinhos access to a new technological platform that could be applied to additional products going forward. Working closely with AstraZeneca not only enabled a faster route to COVID-19 vaccine production in Brazil, but, BioManguinhos officials stress, the acquisition of new competencies in a new technological area generates possibilities for collaboration with more external actors.Footnote ⁸⁰

Similarly in Argentina, the collaboration with AstraZeneca was seized by mAbxience as an opportunity. Although already an accomplished firm with proficiency in biological processes, and always regarding the shift to vaccine production as a temporary deviation from its core activities, mAbxience officials expected to benefit from the transfer of skills regarding business operations (for example, product, audits, purchasing, record-keeping).Footnote ⁸¹ Working with AstraZeneca to obtain approval of the vaccine from the European Medicines Agency, for example, required the introduction of new practices regarding data collection and documentation, changes that would be useful for placing its own products in the EU market. Moreover, mAbxience officials regarded this as the potential start of a new relationship as a local partner for one of the world’s largest pharmaceutical firms with a portfolio (and pipeline) of innovative products. While BioManguinhos officials referred to the acquisition of capabilities that will allow it to take on new projects, mAbxience officials stressed the new commercial opportunities that arise from working with a firm such as AstraZeneca.Footnote ⁸² Officials of Liomont, in Mexico, expressed similar sentiments. And, though neither the União Química nor Richmond collaborations for the production of Sputnik-V advanced far, representatives from both of those firms explicitly regarded their relationships as opportunities.Footnote ⁸³

In fact, none of the actors involved in local vaccine production that I spoke with for this project expressed concern about their activities being constrained by originator firms’ exercise of IP rights. Nor did they cite IP rights as a barrier to entry. Given my own priors, based on research of conflicts between Latin American and transnational pharmaceutical firms over IP rights,Footnote ⁸⁴ this was surprising. Yet local firms repeatedly explained that originators’ IP rights were not getting in the way of their abilities to produce COVID-19 vaccines in the pandemic, emphasizing, to the contrary, that even in the absence of any IP rights they would not have been producing COVID-19 vaccines on their own.Footnote ⁸⁵

These observations have broader implications for how we think about technology transfer and local production. In contrast to the prominent image of renegade pharmaceutical producers in the Global South, an image forged by the experience of the HIV/AIDS crisis that featured Indian firms launching their own products and thereby challenging the power and influence of the international pharmaceutical industry, the firms involved in local production of COVID-19 vaccines in Latin America were working closely with the originators. And they were content to be doing so; partnerships were appreciated as being beneficial more than resented as being constraining. To be sure, there are certainly rebellious firms in the region that may have wished to confront “big pharma,” as they still do with many medicines, but without the engagement of the originators they had little chance of producing COVID-19 vaccines during the pandemic.

4 Discussion and Conclusion

Technology transfer for production of COVID-19 vaccines in Latin America and the Caribbean was less extensive than might be expected from a region with many middle-income countries that have important pharmaceutical sectors.Footnote ⁸⁶ Most activities observed during the pandemic consisted of LAC firms applying the final steps to prepare vaccines, using drug substance imported from outside the region. Outside of Cuba, which developed and produced its own vaccines, only two LAC manufacturers, Brazil’s BioManguinhos and Argentina’s mAbxience, advanced significantly on manufacturing drug substance; and only BioManguinhos produced the full vaccine – that is, drug substance plus fill–finish.

This final section explores some of the factors accounting for this scenario and explores the obvious question of whether there could have been more. Focus is directed at three sets of issues: the interest of vaccine developers to partner with local manufacturers; the extent of vaccine production capabilities in the region; and initiatives by governments to cultivate and develop partnerships.

Local and regional production of the type discussed in this chapter cannot advance in the absence of the originators being willing to transfer the essential technology, know-how, and data that they possess. Realizing the potential benefits derived from working with originators, discussed in the previous section, depends on originators having both the desire and means to collaborate with local partners. The inclusion of “means” is important, for, as was the case with the Cuban vaccines (and also the Texas Children’s Hospital’s vaccine), even originators that express desire to transfer technology may face resource constraints that limit their abilities to do so.Footnote ⁸⁷

Among originator firms with the resources, we know little about why vaccine developers pursued different approaches to scaling up production. What we do know, however, is that AstraZeneca stands out, with a commitment to decentralized and “distributed” production based on transferring technology, know-how, and data to partners across the globe, and, importantly, dedicating resources to help this to proceed quickly. Had more companies adopted similar postures on their own or been encouraged to do so with appropriate incentives and instruments, there likely would have been more cases of technology transfer than those covered in this chapter. Ultimately, understanding originator companies’ differing approaches to technology transfer and the construction of global manufacturing networks for COVID-19 vaccines is a crucially important area that demands additional research.

As importantly, more research is also needed to understand better the appropriate set of instruments to encourage such behavior. Proposals to compel, mandate, or force the sharing of technology, know-how, and data are common, but this is easier said than done. Researchers need to think carefully about what national and international actors can effectively achieve in this regard. This could include more explicit conditions attached to research funding and strategic use of purchasing that rewards producers for meeting output targets that could only be achieved by engaging in wider technology transfer.

The existence of local partners with sufficient capabilities of course matters too. Even without fully understanding originators’ strategies, and accepting that some international firms simply did not prioritize or were not interested in producing in Latin America and the Caribbean (and were not adequately incentivized to do so), it is reasonable to expect that firms that were prepared, in principle, to transfer technology would only do so with partners possessing adequate capabilities. As it happened, partnerships tended to be located in the countries with the largest pharmaceutical sectors, with the most advanced technological and production capabilities. This is not surprising, and points to the importance of legacies of development in national pharmaceutical industries. Consider the case of Argentina, where the August 2020 announcement of the AstraZeneca production arrangement involving mAbxience was celebrated as validation of the country’s scientific community.Footnote ⁸⁸ This outcome was not just made possible by the country’s strong science base, but, specifically, a strong pharmaceutical industry, as it is the existence of the manufacturing firm that allowed this to happen: firms like mAbxience not only are staffed by highly qualified scientists and technicians, but they possess the industrial and management capabilities that enable engagement with originators. Indeed, this is precisely what the then head of AstraZeneca for the Southern Cone said at the time of the announcement in August 2020: “This agreement highlights our country’s great level of professionals, quality of science, and production capabilities.”Footnote ⁸⁹

Could more LAC firms have become engaged? The universe of potential partners for technology transfer and production, though not infinite, almost certainly exceeds the handful of firms that have been discussed in this chapter. Lists of firms with approved biological products, for example, a useful indicator of capacity to manufacture vaccines, includes many companies that have not been mentioned here.Footnote ⁹⁰ In 2021, Argentina’s Ministry of Productive Development undertook a survey of biological production capabilities in the pharmaceutical industry, reporting seven firms producing the active ingredients for injectable biological products that could contribute to vaccine production.Footnote ⁹¹

Capabilities is not a binary category, however, something that companies either have or do not have, but rather sets of attributes that exist in varying degrees. Nor are the same capabilities equally important for producing all vaccines. Even for the same vaccines, firms that participated in COVID-19 production partnerships did so with different levels of capabilities; mAbxience needed less technical assistance from AstraZeneca to make the drug substance than BioManguinhos did, for example. It is difficult to identify and measure what level and type of capabilities are needed, and which firms have those specific capabilities. Yet it is reasonable to conclude that there are plenty of LAC firms with latent capabilities that, with the engagement of originators, could be useful partners. As an illustration, consider that Richmond, which partnered to produce Sputnik-V and is now collaborating with CanSino, was not one of the firms mentioned in the Argentinean government’s survey of biological producers in Argentina – though it almost certainly would be now, were another landscaping exercise of this sort to be undertaken.

Of course, not all potential local partners are interested. That BioManguinhos would participate in the venture with AstraZeneca is unsurprising; this is what it does. BioManguinhos is a public lab that engages in technology transfer to produce vaccines and other biological products for Brazil’s Ministry of Health, and it actively prospected for technology transfer partners.Footnote ⁹² The interest of private firms is more variable. mAbxience and Liomont had new facilities that were available and saw opportunities to seize; likewise União Química and Richmond regarded collaboration to manufacture Sputnik-V as a point of entry into the world of vaccine production. Not all potential partners found themselves in such a position, able and willing to use production capacities for available facilities.Footnote ⁹³

This brings us to the issue of government initiatives to establish partnerships. In Brazil, BioManguinhos and the Ministry of Health worked together to advance the technology transfer arrangement with AstraZeneca, while the production of Sinovac emerged from the initiative of Butantan working with the government of the state of São Paulo. In no other LAC country are such active steps to identify partners and generate partnerships evident, and in Brazil the laboratories most involved in COVID-19 vaccine production are part of the public sector. In Argentina and Mexico, although the arrangement involving mAbxience and Liomont was celebrated by both governments, it was not driven by the governments but rather AstraZeneca and the Slim Foundation. Likewise, Richmond’s venture to produce Sputnik-V, though receiving public funding, came about through its own initiative.

It is possible that public actors, LAC governments or the Pan-American Health Organization, could have done more to increase the participation of local firms in vaccine production. This might have taken multiple forms. With regard to firms that possessed the requisite (or latent) capabilities but were not interested, with the right incentives these could potentially have been motivated to participate. More ambitiously, and analogous to what was witnessed in the United States and United Kingdom, where government officials regarded vaccine development and local manufacture to be a high priority and engaged with private firms in new ways,Footnote ⁹⁴ governments of LAC countries with large pharmaceutical industries could potentially have contacted foreign originators (and the governments and international organizations sponsoring some of the originators) in efforts to broker deals. Consider again the arrangements for the AstraZeneca vaccine to be produced in Argentina and Mexico. An Argentinean partner could have been engaged originally for the fill–finish stage – not somehow mobilized on an emergency basis as an afterthought in 2021, which was proposed but infeasible for the reasons discussed in Section 2, but included in the original design of the agreement in 2020. One reason given for the binational arrangements including a Mexican partner is that this was a condition of the Slim Foundation’s financing, but that only begs the question of why philanthropic resources played such an important role, presupposing the Slim Foundation’s involvement. Could, potentially, the Argentine government have made this happen, working directly with AstraZeneca (and other originators) and national firms? More generally, and beyond Argentina per se, might governments have been able to do more to make production partnerships come to fruition, exploiting existing and latent capabilities in their pharmaceutical industries and providing the incentives to entice partners? Future research should explore how governments in countries with large pharmaceutical industries can leverage local capabilities to attract originators and foster technology transfer agreements.

Going forward, one way to make more partnerships more likely is to have more potential local partners. To that end, LAC governments and regional organizations, regarding the paucity of local manufacture of COVID-19 vaccines as a source of vulnerability that must not be allowed to repeat, appear to be investing in pharmaceutical production capabilities.Footnote ⁹⁵ LAC firms are also involved in the WHO’s mRNA vaccine program.Footnote ⁹⁶ Initiatives to increase local production are not just for vaccines, but the full range of essential medical countermeasures, including treatments, diagnostics, oxygen, personal protective equipment, and so on. While a full review of these efforts is beyond the scope of this chapter, what they have in common is that they are directed toward decreasing the region’s heavy dependence on imports, which has come to be regarded as an Achilles’ heel, a dangerous source of vulnerability to be addressed.