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‌Affirming pharmaceutical sovereignty: Technology transfer agreements and vaccine geopolitics during a global health emergency

‌Koichi Kameda, Denise Pimenta, and Gustavo Matta

In January 2021, Brazil was one of the countries worst affected by COVID-19. Suffering 200,000 deaths, it was second only in casualties to the United States (Instituto Butantan 2021). On 17 January, the Brazilian health regulatory agency, ANVISA, approved the emergency use of AstraZeneca/University of Oxford and Sinovac’s vaccines (ANVISA 2021). Both were made available as part of the partnerships with two Brazilian public laboratories: Bio-Manguinhos/Fiocruz (hereafter Bio-M) and Butantan Institute. These partnerships, which involved the circulation of knowledge and vaccine shots, national regulatory work, and public and philanthropic funding, were implemented to enable a vaccine campaign in global and national geopolitical scenarios normally unfavourable to public health responses in the developing world. By the following January 81% of the targeted population had been vaccinated.1

One might recall the erratic management of the Brazilian response to COVID-19 when the virus first arrived in the country, particularly the denialism that characterised President Jair Bolsonaro’s engagement with the pandemic. But this mismanagement was present in local as well as federal government, with its effects felt mainly by the regions and populations in more vulnerable situations (Ortega and Orsini 2020). Despite being one of the favourite targets of the president and his followers’ attacks, vaccines were in great demand throughout the whole population, being seen as tools that could reduce deaths and normalise the situation in the country (Peixoto et al. 2023). And indeed, vaccines became key actors in fighting the COVID-19 pandemic.

The development of COVID-19 vaccine innovations has been remarkable, benefiting from scientific advances in response to earlier global health emergencies (Lurie et al. 2020), as well as a combination of funding boosts, regulatory flexibility, and the introduction of ‘next-generation’ platforms such as RNA and viral vector-based vaccines, in co-existence with classic technologies (van Riel and de Wit 2020).2 However, this technological development has gone hand in hand with stark inequalities in access to COVID-19 vaccines between countries. The cooperation between nations expected in such a situation gave way to technological nationalism, with the wealthiest and most industrialised countries racing to secure most vaccine doses, many times greater than those needed to immunise their populations (Jensen et al. 2022). Meanwhile, the monumental failure of the COVID-19 Vaccine Global Access (COVAX) Facility, the global health initiative supposed to make shots equally available in the world, also played a role in this inequality. The pandemic called into question the mainstream pharmaceutical belief in ‘globalisation from the North,’ which was implicit in the idea that in such emergencies ‘magic bullets’ like vaccines would be developed in the North to use in the South (Medina et al. 2014; Pollock 2019). The hoarding of vaccines by the Global North also highlights that during the pandemic, Northern countries halted the globalisation process through ‘technological nationalism’, effectively undermining international cooperation through the World Health Organisation’s COVAX scheme. In contrast, Southern countries continued to push for more globalisation to gain access to knowledge and technologies.

The uneven geographies of pharmaceutical production and access can be seen as a result of the globalisation of the norms related to intellectual property rules and regulatory harmonisation intended to protect technologies and actors from the North, kicking away the ladder from actors in the South (Chang 2002) and consolidating the central role of Big Pharma companies (Sunder Rajan 2017). In this context of pressing inequalities, actors from below might look for creative ways to circumvent the effects of globalisation from above and establish new relationships with actors in the South. Indeed, industrial actors in the Global South already contribute most of the vaccines made available in much of the world today: China and India host 31% of global vaccine manufacturers (WHO 2023). China, India, and Russia have played a crucial role in supplying COVID-19 vaccine doses to low- and middle-income countries (LMICs).3 China alone has supplied nearly 1.3 billion doses to LMICs – more than the global COVAX Facility (Wang 2022). China is also a significant supplier of drug substances (active pharmaceutical ingredients, APIs) to other countries’ pharmaceutical companies for vaccines and antibiotics (Zhang and Bjerke 2023). APIs are a crucial part of vaccines, representing the components made from viruses or bacteria (sometimes also called ‘antigens’). They are responsible for the vaccine’s role in challenging the immune system in such a way as to induce it to fight the disease.

What is the space for Southern countries to develop their technological enterprises within an unequal global scenario marked by old and new dependency relations among countries? How do these national enterprises become feasible, interact with forms of globalisation from the North and the emerging South, and contribute to alternative forms of globalisation? To address these questions, this chapter analyses the manufacturing of COVID-19 vaccines in Brazil. One key concept is pharmaceutical sovereignty, which involves the state’s ability to implement national health policies with regards to promoting access to essential health technologies, from medicines to vaccines and diagnostics. Pharmaceutical sovereignty also comprises the existence of domestic technological and industrial capacity to address local health needs.4 The affirmation of sovereignty forms has been mainly analysed in the context of developing countries’ resistance to the compulsory sharing of biological materials in the context of the fight against previous public health emergencies (Fearnley 2020). However, this has happened without any guarantee of access to the benefits of technological development. In some cases – as with the zika epidemics – this reluctance to share knowledge and technology has had a marked negative impact on timely development and innovation (Kameda et al. 2021; Kelly et al. 2020). We draw on how this bio-sovereignty (van Wichelen 2023) has become increasingly understood in terms of bio-production sovereignty, due to its connection with the right of countries to produce their own health biotechnologies (Kameda 2021). We argue that the increasing production and development role of Southern countries transcends the standard attribution of the South merely as a site of extraction and demonstrates that Global South countries are able to develop technologies that best fit their own needs and independently address national health policies (Pollock 2019). Despite the restrictive norms imposed by global pharmaceutical capitalism, developing countries are still able to exercise sovereignty, be it through alliances that enable the use of patent flexibilities to produce antiretroviral generic drugs (Biehl 2007; Hayden 2007) or material transfer agreements (van Wichelen 2023).

This chapter shows how pharmaceutical sovereignty was at stake in Brazil during the COVID-19 pandemic through the analysis of the production of COVID-19 vaccines. The vaccine sector, though historically concentrating on states’ political efforts to achieve production self-reliance, has changed in recent decades. These changes, prompted by a global trend towards state disengagement from vaccine production, has increasingly resulted in their commodification (Blume 2017; Blume and Baylac-Paouly 2021). In the opposite direction, Brazil has established a public vaccine industry due to a longstanding drive to reduce its dependence on imports of health goods, a commitment reaffirmed throughout the country’s history following episodes that exposed its technological vulnerability (Benchimol 2017). It relies on a successful model of technology transfer partnerships to obtain advanced technologies that interest the public health system.

During the COVID-19 pandemic, the two major Brazilian public vaccine manufacturers engaged in the production of COVID-19 vaccines through partnerships: Bio-M – linked to the Oswaldo Cruz Foundation (Bio-M/Fiocruz) – partnered with the British multinational AstraZeneca, which had obtained an exclusive license from the University of Oxford to explore its technology. Meanwhile, the Butantan Institute partnered with the Chinese company Sinovac. Despite the national context of virus denialism and politicisation of vaccines, the Brazilian producers were able to implement this model (Medeiros et al. 2022) thanks to their pre-existing production capacity, their ability to source funding from the national public and private sectors, and regulatory support from the National Health Regulatory Agency, or ANVISA (Fonseca et al. 2023). By analysing the partnership between Bio-M and AstraZeneca, this chapter contributes to the understanding of the links between the exercise of bioproduction sovereignty and the literature on globalisation from below, showing nuances in the power relations in technological partnerships between North and South, but also how national technological projects need to adapt to a new scenario of influential Southern players.

The chapter is organised in four sections. After a first section that outlines the particularity of the Brazilian vaccine manufacturing model, the chapter will analyse the partnership of Fiocruz and AstraZeneca to locally manufacture the University of Oxford’s COVID-19 vaccine to discuss how the Brazilian actors exercised pharmaceutical sovereignty during a global health emergency. The second and third sections discuss the negotiations to conclude the agreements and purchase vaccine ingredients and knowledge ‘transfer’. They indicate the agency of Brazilian actors in pushing for the technological partnership. By purchasing AZ vaccine components and manufacturing knowledge, Brazilian actors indeed supported the technological development of the Northern vaccine. However, the negotiation of contractual terms such as the freedom to use transferred platforms remains a challenge. In the fourth section, the chapter analyses the exercise of sovereignty vis-à-vis the growing dependency of the global pharmaceutical value chain on Chinese and Indian companies. Behind the AZ vaccine are companies from the South that supported the vaccine development initiative in Brazil in a context of scarcity, revealing new asymmetric relations of power. In this scenario, Brazil exerted its sovereignty through diplomatic negotiations over the vital pharmaceutical inputs, but also through work related to the logistics of vaccine importation (establishing plans and partnerships with private and public stakeholders, organising international transport, negotiating customs permissions, the technical work of quality and temperature control, etc.) required to assure vaccine components arrived promptly in Brazil during a global health crisis. The chapter concludes by reflecting on how the multidirectionality of technoscientific globalisation interrelates and affects pharmaceutical sovereignty and new forms of South–South circulation of vaccine technologies.

We mobilised the following methods for data collection: interviews with Fiocruz staff conducted between August and November 2022;5 consulting open-access presentations, contracts, and documents; and consulting documents made public during the Parliamentary Commission of Inquiry into the COVID-19 Pandemic,6 as well as an analysis of how the Brazilian press covered the vaccine rollout.

Pharmaceutical sovereignty? Technology partnerships and public vaccine manufacturing

Vaccine technology institutions in Brazil

One of the specificities of the Brazilian pharmaceutical industry is that it includes a set of ‘official’ pharmaceutical laboratories. These are laboratories under the remit of federal or state governments, universities, and the army. In 2014, 18 official laboratories were active in four Brazilian regions (Hasenclever et al. 2018; Oliveira et al. 2014). In the vaccine sector, two official laboratories, Fiocruz and Butantan, are the leading local vaccine producers and suppliers of the National Immunisation Programme (in Portuguese, Programa Nacional de Imunizações, PNI) of the National Healthcare System (in Portuguese, Sistema Único de Saúde – SUS) – PNI accounts for 90% of the demand for human vaccines in the country (Gadelha et al. 2020).7 Even though primarily focusing on the SUS’ vaccine demands, Bio-M/Fiocruz and Butantan are also relevant actors in global health, being amongst the biggest vaccine players worldwide (WHO 2023), with WHO prequalified yellow fever (Bio-M/Fiocruz) and trivalent influenza (Butantan) vaccines.8

Fiocruz is part of the Ministry of Health and comprises 16 technical and scientific units ‘focused on teaching, research, innovation, assistance, technological development and extension in the health field’.9 It has a presence in 10 Brazilian states and an office in Maputo, Mozambique. The core purpose of Fiocruz’s vaccine-manufacturing activities is to supply the PNI, which was launched in 1973 to control major infectious disease epidemics in the country. The PNI established several compulsory national vaccination schemes against infectious diseases. The PNI model was inspired by the success of the Smallpox Eradication Campaign, which was sustained by mass vaccination initiatives and involved robust monitoring and control. In this programme a range of vaccines were being purchased by the state and freely distributed to the population. The Brazilian PNI was created during one of the military dictatorship governments and in a context marked by the Brazilian population’s vulnerability to preventable diseases, particularly when a meningococcal meningitis epidemic, as well as polio and measles outbreaks, hit the country (Buss et al. 2005).

While Fiocruz’s history in the production of biologicals can be traced back to the early twentieth century,10 since its establishment in its current form in the 1970s, the Foundation’s pharmaceutical and biological manufacturing activities have been concentrated in its two pharmaceutical laboratories, Far-Manguinhos and Bio-M, respectively. Bio-M, set up in 1976, is the unit in charge of manufacturing vaccines, diagnostic components, and biopharmaceuticals. When Bio-M was created, its industrial facilities were at first precarious.11 The laboratory focused its initial efforts on providing infrastructure for the required industrial activities and the acquisition of vaccine technology. It decided to invest in the strategy of negotiating technology transfer agreements – a strategy which Bio-M had already employed for its yellow fever vaccine (Löwy 2006). This was seen as a way to ‘rapidly introduce vaccines on the market while learning and strengthening [the laboratory]’ (interview with Bio-M’s representative, 2022). This strategy enabled the Brazilian organisation to begin vaccine production and diversify its portfolio.

Vaccine production models and technology transfer agreements

To get started, in 1976 and 1980 Bio-M negotiated agreements with not-for-profit institutions in France and Japan to obtain the technologies to produce vaccines for meningitis, poliomyelitis, and measles.12 These technology transfer agreements were signed as part of cooperation frameworks. Admittedly, commercial and trade interests were at stake in these agreements, albeit indirectly. Nevertheless, the terms were highly favourable to Bio-M, considerably advancing its goal of mastering the manufacturing of the measles and polio vaccines. This took place in a context where the production of vaccines was not of interest to multinational pharmaceutical companies.

Given the dramatic consequences of PNI product shortages, the Brazilian state decided to invest in the national public production of vaccines. One such shortage in particular prompted the government to invest in expanding vaccine production in the public sector. In the 1980s, a branch of the multinational Syntex, which was the government’s leading supplier of the DTP (diphtheria, tetanus, and pertussis) vaccine, as well as the largest snake antivenom manufacturer in Brazil, saw the commercialisation of its products suspended over quality issues. Rather than invest in enhancing the quality control of its vaccines, the company decided to shut down its production lines in Brazil, which led to a shortage of the products used by the health services (Ponte 2007). Moreover, there were problems with the supply of other vaccines (tetanus toxoid, rabies vaccine, and BCG). To remedy the situation, in 1985, during Brazil’s democratic opening, the government created the National Immunobiological Self-Sufficiency Programme (Programa de Auto-Suficiência Nacional em Imunobiológicos, PASNI). The programme focused most of its investments on the modernisation and building of facilities for the laboratories that were part of the programme, including Bio-M and Butantan.

Subsequently, starting in the late 1990s, Bio-M faced a major existential crisis due to the national political and economic situation. To solve this crisis, which almost caused the institution to shut down, Bio-M implemented a set of administrative and organisational reforms. In particular, given the urgent need to update its scientific and technological platforms and infrastructures, the laboratory adopted a policy of investing in ‘high value-added’ products that it would seek to manufacture by negotiating technology transfer agreements. Bio-M targeted the production of more expensive technologies that the Brazilian state intended to purchase. This resulted in the establishment of technology transfer partnerships, mostly with multinationals.

Productive development partnerships (PDPs)

The first partnership of this kind consisted of an agreement with the Belgian company SmithKline (now GlaxoSmithKline) in 1998 to transfer the Hib (Haemophilus influenzae type B) vaccine. Through this agreement, SmithKline was to receive access to the Brazilian public market for five years and receive 65% of the profits from selling the product to PNI during this time, with the remaining 35% going to Bio-M. Following the end of these five years formally recognised as the duration of the technology transfer, Bio-M was to acquire the production capacity for the vaccine, receive the total revenue from its sale, and gain the right to commercialise the nationalised product in the Mercosur trade bloc, the economic community of South American countries. The state would also benefit by purchasing the vaccine at the price set by the Revolving Fund mechanism of the Pan American Health Organisation (PAHO).13 According to Ponte (2007), partnering with Fiocruz was also valuable for SmithKline, as the public laboratory had invested in expanding its capacity for fill-finish steps. Fill-finish is one of the phases of the productive process of making a vaccine available.14 In the fill-finish phase, the bulk vaccine is transferred into glass bottles, sealed, lyophilised if applicable, labelled, and packed. Bio-M inaugurated its fill-finish centre in 1998, which played a crucial role in securing the agreement with SmithKline since lyophilisation constituted an expensive component in the manufacturing of vaccines, and the Belgian company had a bottleneck in that production step. In order to supply the vaccine in the quantities required by the government, the multinational would need to invest directly in various production steps in the country. Thus, the partnership offered the multinational easier access to the Brazilian market. At the same time, for Fiocruz, the localisation of Hib represented an unprecedented revenue increase that enabled it to invest in the unit’s physical and administrative infrastructure needs and research to improve and develop products (Ponte 2007).15

In the following years, Fiocruz established new agreements leveraging public purchasing power to attract partners to engage in technology transfer agreements. These pertained to vaccines, rapid diagnostic tests, and biopharmaceuticals. Additionally, in 2001, Fiocruz obtained the WHO prequalification of its yellow fever vaccine, becoming one of just four suppliers of this vaccine worldwide.16 With the incorporation of new products into its portfolio and the growth of yellow fever vaccine exports following the WHO certification, the Fiocruz vaccine unit, Bio-M, saw its revenue increase by 6,300% in 2004 – from BR$4 million (Brazilian reals) to BR$280 million (Ponte 2007).

As seen in this section, Bio-M has built a pharmaceutical production model characterised by public production based on partnerships with private proprietary companies to transfer technology and production know-how. In contrast to the experience of Fiocruz’s other production laboratory, Far-Manguinhos, which challenged patents for HIV medicines in order to enable it to produce generics,17 Bio-M is engaged in a partnership model (Cassier and Correa 2018). This model ‘evolved’ from international cooperation with for-profit institutions to the public-private partnership model with for-profit institutions, including ‘Big Pharma’, but also with some partners in the South (for example, Cuba), to rapidly introduce new technologies and platforms to its portfolio. From this model, Bio-M continues to primarily serve the Brazilian public sector (and, in a subsidiary way, other LMIC countries and international organisations). However, it has been increasingly establishing partnerships for ‘high value-added’ products, that is, those that cost more for the Brazilian government. Even if this public model has no profit orientation, the product is not sold at a cost price, and the ‘excess’ is reinvested in research and infrastructure expansion. Moreover, this model of TT partnerships has been generalised as a significant device of industrial policies for the pharmaceutical sector since the 2000s by the successive Workers’ Party governments (Chaves et al. 2016).18 These partnerships, named productive development partnerships (PDPs), target the local production of health technologies that are regularly named as a priority by the Ministry of Health in the sense of making them freely available to the population through the public health system. At the same time, they are intended to reduce the deficit in the trade balance by reducing imports, which is behind the current approach of bolstering the country’s ‘healthcare economic-industrial complex’.

Even though the Bio-M model (and the current health industrial complex framework) relies on technology and knowledge transfer from other companies, this is not a linear relationship that reproduces the mainstream idea of globalisation from the North. The state and public laboratories are behind the choice of technologies, and they trigger the negotiation of partnerships with vaccine owners. Access to the vast Brazilian public market of health technologies is conditioned by access to the knowledge that would enable faster creation of capacity to manufacture and make the technologies available at SUS, a process usually referred to by actors on the ground as ‘nationalisation’. In turn, the companies sell their product exclusively to the government during the technology transfer, which can last five to ten years (Cassier and Correa 2018).

This strategy of partnerships has enabled the Brazilian public sector to ‘capture’ new vaccine technologies to add to its portfolio, reducing its dependence on imports.19 Ironically, the country’s trade balance has gradually deteriorated with the importation of new vaccines as part of the PNI. Notably, it reached an average annual trade deficit of US$664 million between 2015 and 2018 (Gadelha et al. 2020). This trade deficit reveals the limits of this technology transfer–based approach in reducing the country’s technology dependence. The choice of a model of pursuing technology independence through partnerships, instead of more subversive approaches of reverse engineering for copying a medicine, as happened with HIV pharmaceuticals, is usually justified by the fact that patents are not considered the main barrier to the production of biologicals like vaccines; instead, know-how is thought of as the most essential requirement. Moreover, challenging patents in the post–TRIPS Agreement scenario comes with a political cost that is too high for governments in the South. Partnerships with proprietary companies seem like a more viable strategy. However, this approach of pursuing autonomy through partnerships that involve the importation of a whole sociotechnical system reinforces a vicious circle, where more ‘capture’ leads to more technological dependency, feeding the globalisation process from the North.

Technological landscape and the ‘selection’ of the Oxford-AstraZeneca vaccine

Before Bio-M became involved in vaccine manufacturing to fight COVID-19, the laboratory and the Ministry of Health had been monitoring the global landscape of technological development surrounding SARS-CoV-2 vaccines since March 2020. Bio-M had been discussing the vaccine technologies with the proprietary companies as a step towards establishing a partnership. At that point of the pandemic, no vaccines developed by Brazilian institutions were at an advanced stage, justifying pursuing the previous strategy of negotiating a partnership with foreign companies.

Critically, the company had to agree to transfer technology to set up a partnership following the Brazilian institution’s strategy. Pfizer-BioNTech, whose RNA vaccine platform was introduced during the pandemic and had the potential of being applied to numerous immunisation and treatment purposes, conducted clinical trials in Brazil and was interested in selling the shots to the country but refused to engage in a partnership involving knowledge transfer. In Bio-M’s discussions with other companies,20 only two agreed to transfer technology: Sinovac and AstraZeneca. Both companies implemented manufacturing models that involved contracting with manufacturers in the South to expand production capacity. Just as most developers based in high-income countries (HICs) have partnered with manufacturers based in other HICs, companies based in middle-income countries (MICs – China, Cuba, India, Kazakhstan, Russia, and Vietnam) also primarily selected partners in MICs to expand their manufacturing capacity (Global Health Centre 2021).

Sinovac developed one of the four Chinese vaccines with the most significant international footprint – the other companies were Sinopharm-Beijing, Sinopharm-Wuhan, and CanSino. Sinovac’s vaccine, CoronaVac, was based on the classic inactivated virus platform. Ultimately, the Chinese company chose to partner with the Butantan Institute, an initiative considered co-development by Butantan given its involvement in conducting phase 3 of the vaccine clinical trials in the country.21 However, the absence of infrastructure necessary to produce inactivated virus platforms – Level 3 biosafety laboratories, non-existent in the country at that time (interview with Bio-M director, 2022) – prevented the total production of the vaccine in Brazil, a situation that necessitated continuous importation of pharmaceutical ingredients from Sinovac. Indeed, as discussed later, Chinese companies played a role in assuring the Fiocruz and Butantan technological initiatives for COVID-19, indicating an emerging technological globalisation that can sustain national policies in the South, together with market expansion and the creation of new forms of dependency.

In its turn, the vaccine manufactured by the UK-based pharmaceutical AstraZeneca (AZ) was a new vaccine platform based on chimpanzee adenovirus (ChAdOx1 nCoV-19) that was developed by University of Oxford researchers and a company they created, Vaccitech. The Oxford vaccine development took place in an international network that initially had no plans to exclusively license the technology to any one company, an approach that changed under pressure from Bill Gates (Garrison 2020). However, the company pursued the commitment of not making a profit during the pandemic, charging only production and distribution costs. Because the large pharmaceutical company had never operated in the vaccine industry, it created a delocalised model of manufacturing, with agreements to produce API or fill and finish activities in 14 locations, but, in contrast to other HIC-based vaccine developers, AZ established manufacturing partnerships with 5 MICs (Brazil, China, India, Russia and Thailand) (Global Health Centre 2021).

The AstraZeneca technology transfer was effectively kicked off by a Brazilian researcher in charge of the vaccine’s development at the company, Sue Costa Clemens. She first approached the Brazilian Ministry of Health on 8 May 2020 as part of the preparation of Phase 3 clinical trials in Brazil, to determine the vaccine’s safety, efficacy, and immunogenicity. After technical meetings involving AstraZeneca Brazil and the Embassy of the United Kingdom, the company expressed its interest in partnering with Bio-Manguinhos and agreed to transfer the vaccine technology, a decision that was formally made on 22 June 2020 (Clemens 2021).22

Aside from the fact that the Oxford-AZ vaccine was at the most advanced technological development stage at that time – in Phase 2-3 – and had just started Phase 3 clinical trials in Brazil, another benefit of the agreement was the vaccine platform itself, according to Bio-M. It represented a new addition to the laboratory’s vaccine portfolio, with the possibility of developing future uses. Moreover, the similarity between the manufacturing processes of the Oxford vaccine and those of a biopharmaceutical previously introduced in Bio-M’s manufacturing routine would facilitate the transfer. Bio-M had added two biological medicines – the recombinant human erythropoietin (alfapoetina) and the interferon alpha-2b – to its portfolio through partnerships with two Cuban institutions, the Centro de Imunologia Molecular and Heber Biotech, in 2004 and 2008. The acquired alfapoetina production capacity, in particular, with the use of ‘Chinese hamster ovary cell’ (CHO) cultures using bioreactors, would facilitate the technology transfer.23 Bio-M decided to use the industrial area previously dedicated to its other biopharmaceutical, interferon, for COVID-19 vaccine manufacturing, since the former’s production had been interrupted after its replacement by more effective medicines in hepatitis C treatment (treatments based on ‘direct-acting antiviral agents’).

Even though most of Bio-M’s partnerships are with Big Pharma companies and institutions from the North, this episode shows that Southern institutions also own strategic technologies that can make them equally essential partners of Brazilian technological enterprises. Furthermore, the partnership with Cuban institutions counterbalances the criticism of the technology transfer–based model of pharmaceutical capacity creation by indicating that this strategy can bring benefits beyond the development of one specific product, installing infrastructure and expertise that can later benefit other technological projects. The existing production capacity for erythropoietin informed the decision to go for the vaccine partnership with AstraZeneca and indicates Bio-M’s agency in the partnership. It contributes to questioning the assumption in global health discourses of the South as a place dispossessed of production capacity. It reinforces the argument that the primary barrier to more institutional manufacturing in the South is the assetisation of IP by the North (Birch 2020) rather than the unavailability of previous infrastructure. But how did the negotiations proceed in practice?

The negotiation of legal instruments to enable technology transfer and vaccine localisation

The pandemic forced Bio-M to engage in negotiations to secure a technology that was still under development. Although the AZ vaccine was the most advanced vaccine candidate when the partnership was established – it had begun Phase 3 clinical trials at the time of its selection for the Bio-M partnership – it still carried the risk of revealing data that would upend the venture. For Bio-M and the Brazilian government, this meant investing upfront in technology despite the risk of it failing. This type of instrument, namely the leveraging of public procurement to spur innovation in different areas, has been employed in Europe and the United States for many years (Edquist and Zabala-Iturriagagoitia 2012). However, the Brazilian government had never implemented such a tool for vaccine procurement – the strategy of Bio-M, as part of the federal government, had so far involved negotiating the purchase and transfer of technology already available on the market and registered with the regulatory agency. A specific technological contract was then adopted: the ‘encomenda tecnológica’ (ETEC, or technology purchase order), a type of contract first introduced by the Brazilian Innovation Law of 2004 and modified by the 2016 Scientific and Technological Framework (Marco da C&T). This ETEC instrument allows the state to acquire ‘an R&D venture to find a solution not available on the market for a specific application’.

Encomenda tecnológica is a process that allows you to pay in advance for a project that may not work out […] everyone wanted to sell and not put their own money in, these companies, big multinationals wanted to sell, the US put much money in, the European countries, in the governments that have more flexibility, let us say, put the money from the pharmaceutical companies and they sold vaccines that did not exist yet, that may not even exist. […] And it was still under clinical study, and many people know that many vaccines are rejected during the clinical study phase. (Interview with Bio-M director, 2022)

This legal instrument was employed for the first time for a vaccine enterprise in Brazil. It enabled technological globalisation from a Northern vaccine but in the terms defined by Bio-M and its purpose of nationalising the imported technology. The aforementioned interview also sheds light on how a Southern state can support technological development in the North. Moreover, this new instrument contributed to risk sharing of an innovation that was still in development, despite its advanced stage, and had the risk of not reaching the market.

The stated intention to agree did not make the negotiation of the partnership conditions any less critical. It required the involvement of lawyers from different Fiocruz departments (Bio-M, its technological management coordination department, and the office of the lawyer of Fiocruz) as well as officials of the Foundation to face critical aspects of the negotiation, as described by a lawyer who took part in the process.

A first critical aspect was that these negotiations had to consider the urgent need to secure drug substances in a context marked by competition for vaccine doses and active pharmaceutical ingredients (API), a scenario that made visible the international inequalities among countries and their varying ability to access lifesaving technologies. As part of the technology transfer strategy, Fiocruz would first receive ready-made doses and pharmaceutical ingredients as part of the learning process. This meant that until the vaccine’s nationalisation, it would rely on API imported from a Chinese company designated by AstraZeneca (AZ), Wuxi Biologics. This required Bio-M to split the agreement with AZ into two contracts: the ETEC, which would cover the purchase of the API for the first vaccine doses produced by Bio-M and supplied to the government, and the actual technology transfer agreement.

You have two moments there: first the ETEC and then the technology transfer contracts. [We] chose to separate that for the sake of agility to have that start and the receipt of the API, the formulation already at Bio-M and the vaccine available as soon as possible. If we had to take care of a contract on our own, it would take much longer to close it, and we were concerned about logistics and the geopolitics surrounding the API, […] we never know where we are in the queue. So AstraZeneca had the knife and cheese in hand. However, we also had the capital to be able to be a partner that would contribute to the success of their vaccine as well. (Interview with a Fiocruz lawyer, 2022)

AZ would initially supply the Brazilian government with enough API to manufacture 30.4 million vaccine doses. However, the pressure from the international competition for vaccines and their components was felt very quickly: in the initial AstraZeneca Brazil (AZB) proposal, made on 22 June 2020, based on the costs of the API supply (US$50 million) and the fill-finish steps to be performed by Fiocruz (US$30 million), the estimated average production cost, and the vaccine licensing fees (US$25 million), the partnership was to cost Brazil a total of US$105 million. Two days later, the company revalued the API required for 30.4 million doses, increasing its price by US$22 million, due to commitments to other countries agreed shortly prior and the restriction on API exports from some API-producing countries, thus raising the final amount to US$127 million (Brazilian Ministry of Health 2020).

The Brazilian government was awaiting the results of the Phase 3 clinical trials before committing to purchasing additional API for manufacturing the vaccines. However, after AZ informed the government that this could lead to uncertainty for the delivery of the vaccine ingredients and potentially affect its vaccination strategy, the latter decided to approve the purchase of the pharmaceutical materials necessary to produce an additional 70 million doses.24 The health crisis was felt not only in the scarcity of health goods but also in the inflation of prices that affected national public health policies in the South. The risky investments from the South helped expand global demand, and the global sociotechnical system needed to supply these ingredients.

A second key aspect of the negotiation was ensuring that the partnership was not limited to the sale of API but also involved the complete transfer of the University of Oxford’s platform. Fiocruz feared that with the technology transfer agreement taking longer to negotiate, once the company had provided the ingredients for the vaccine, it might change its mind about the transfer, something that had already happened to the Foundation in the past.25 Thus, the Brazilian institution had to make full use of its available ‘bargaining power’ – in this case, the vaccine was not ready.

A third concern was the impact of intellectual property rights and the contract clauses on Bio-M’s exploration of the transferred platform. This entailed verifying whether the vaccine, owned by the University of Oxford and later licensed to AZ, was not affected by patents owned by third parties that were not included in the agreement with Bio-M. Moreover, it involved negotiating with AZ the ‘freedom to operate’ for using the platform without incurring legal liability for this use. Patents would not be an obstacle in this case, as there were no patents granted or pending for the Oxford vaccine platform in Brazil (Fonseca et al 2023). However, it was still necessary for Bio-M to negotiate the use of all other non-patented information necessary to set up manufacturing after the transfer period, so that the company could explore the platform and even make improvements or develop new uses for it.26 As explained by a Fiocruz lawyer when describing more broadly the negotiation of technology transfer agreements:

Usually, these technology transfer agreements occur like this: you will learn to make the product exactly the way the guy makes it, following the whole standard; if there is any modification, it has to be approved by the partner, so you cannot change the product, you will make it exactly like he makes it and you have inherent learning by the people who work in this, they assimilate the technology, right? So you have know-how relating to the use, and you also have the IP rights associated with that technology […] with regards to the industrial secret of the know-how, they pass it on with instructions. Finally, with regards to patents, you have to respect them, but the patents become public at some point, right? However, many things are not even written on the patent. So, the company needs to pass on – there are techniques for writing the patent whereby you do not disclose exactly what makes up the raw material or the formulation process … a temperature range, for example … So, we have to assimilate all of this. Then we have to work on the contract, a clause that guarantees us the freedom to use it at the end, right? So, we make several types of contracts, but as a rule, we try to guarantee that after the contract expires, we have the freedom to use the technology that was transferred without paying royalties. In some cases, when a patent survives, you still have to pay a percentage of royalties for a while, but we try to guarantee in the contracts that we will have the freedom to use the technology after the contract expires. (Interview with Fiocruz lawyer, 2022)

In this sense, whereas technology transfer instruments may contribute to the implementation of national vaccination plans, their clauses might establish more or less freedom, and their negotiation has decisive implications for long-term pharmaceutical sovereignty in the South.

The vaccine geopolitics of the South and the logistics of imports

In this subsection, we discuss how the process of establishing national vaccine manufacturing was affected by geopolitics at both national and global levels by looking back at two episodes involving the importing of critical ingredients and doses from India and China to support the Brazilian vaccination strategy, as well as the equally fundamental role of logistics in the process. It contributes to discussing different forms of technological globalisation at play, their role in affirming pharmaceutical sovereignty, and, finally, the nuances of globalisation promoted by Northern and Southern actors.

According to Bio-M’s strategy of acquiring vaccine manufacturing capacity, the steps towards acquiring the production process started with AZ supplying the API to Bio-M, which performed the fill-finish of the vaccine doses to be supplied to the government; then, Bio-M learned and carried out the full manufacturing process, including the production of the drug substance (Fonseca et al. 2023).

Bio-M was relying on this process to start supplying the first 30 million doses manufactured with the drug substance. These components would come from the Chinese company Wuxi Biologics, one of the certified contract manufacturing organisations licensed by AZ to produce its COVID-19 vaccine components. But restrictions imposed by the Chinese government led to delays in receiving the drug substance. They affected the initial Bio-M plan to supply immunisation to the Brazilian government in December 2020, when the United Kingdom started vaccination with the same AZ shots. This led the federal government to look to import ready-to-use AstraZeneca vaccine shots. The Brazilian government looked for doses in the United States and the United Kingdom but failed. The Serum Institute of India (SII), another of AZ’s certified contract manufacturing organisations, agreed to supply 2 million doses to the Brazilian government. At US$5.25 per unit, however, the price was almost twice as high as that previously agreed with AZ ($3.16 per unit) (Brazilian Ministry of Health 2020). This shows how the existence of Southern players enables pharmaceutical plans in other parts of the South, but their dynamic, too, is less about solidarity than market opportunities.

This deal was affected by the Indian government’s restriction on exports of locally produced vaccines. The Brazilian Ministry of Health had been elaborating its vaccine strategy with the support of ANVISA, which had been reviewing regulatory applications to temporarily authorise the AstraZeneca and Sinovac vaccines. It ultimately issued emergency use authorisations for these two vaccines on 17 January 2021. A few days after obtaining the use authorisation, the federal government announced that it would be sending a plane to India to collect the doses from the SII. However, the Indian government discouraged the Brazilian flight, stating that it had the final say in sending the doses and would announce its decision later. Once India issued this statement, Brazil was among the first vaccine destinations, which ultimately reached the country on a flight departing from Delhi on 22 January 2021 (Banerjee 2021).

Although the Brazilian government had negotiated additional doses from the SII, by late February 2021, one month after receiving another 2 million doses, there was growing uncertainty about when the remaining doses (12 million had been negotiated) would arrive. This uncertainty was heightened by the resurgence of COVID-19 cases in India in April 2021, with the country becoming the new epicentre of the disease and interrupting the export of locally manufactured doses. In a press release, the Brazilian government affirmed its solidarity with the Indian government and anticipated that the situation would further affect its vaccination programme (Banerjee 2021). This first episode reveals how players from the South (India) have become both part of globalisation from the North and actors that enable national technological enterprises in other Southern countries. The exercise of pharmaceutical sovereignty in Brazil is affirmed by its decision to manufacture the COVID-19 vaccines locally instead of importing them. However, the process still requires importation even though it is ‘temporary’. The national interests of the North and South are interrelated to globalisation processes. The paradox is that the pandemic was an opportunity to expand vaccine markets for North and South while contradictorily serving as a counter-movement to globalization through the closing of frontiers and restriction of vaccine exportation.

The second episode involved importing drug substances from Chinese companies to enable Bio-M to manufacture the first 30 million doses of the AZ vaccine. Butantan’s vaccine also relied on importing drug substances from China, as it had partnered with Sinovac to locally manufacture the CoronaVac. The original timeline for receiving the API for both vaccines was affected by delays in receiving the ingredients. Bio-M and Butantan had to wade through obstacles imposed by the Chinese government to release the ingredients for export. While this decision ultimately tells of the subordination of Brazil’s strategy to Chinese vaccine nationalism – that is, China reserving Chinese technologies for its vaccine strategy – there was speculation among experts and the media in Brazil about other reasons for these delays.

At around this time, President Bolsonaro was speaking out publicly against China on many occasions, suggesting its responsibility for the virus and questioning the quality of the Chinese vaccines. These statements aligned with Donald Trump’s policy of denialism and confrontation with China and contrasted with the friendlier approach to India (Banerjee 2021). Bolsonaro’s attitude also seemed to be informed by national politics, mainly that the governor of São Paulo, João Doria, from the right-wing party PSDB – Bolsonaro’s primary political opponent at the time – had come out defending vaccines. The Butantan Institute, which belongs to the state of São Paulo, had partnered with the Chinese company Sinovac to produce the latter’s vaccine, CoronaVac.

As a result, though a clear pandemic denialist and vaccine sceptic, the president ultimately supported the Bio-M vaccine strategy, mainly to capitalise on it in his struggle against his political opponent. This behaviour also had health implications by spreading doubt among Brazilian society regarding the quality of CoronaVac, the vaccine that was first made available in the country (Gramacho and Turgeon 2021), because of its Chinese origin. The politicisation of vaccines by the federal and São Paulo governments created unprecedented competition between the two public laboratories, which raised additional challenges for the stakeholders involved in the public health response to the pandemic. Conversely, frustrated by the many delays to the arrival of APIs, health expert Margareth Dalcomo – a researcher from Fiocruz who had become a media figure in the fight against misinformation during the pandemic – criticised the government’s foreign policy for its inability to secure the supply of vaccines. In a television interview, the researcher stressed that all vaccines were made in China, and the ingredients for both the Fiocruz and Butantan vaccines came from that country.27

This second episode indicates another aspect of technological globalisation from below at play, related to the sociotechnical imaginaries built around what comes from the South (Jasanoff and Kim 2015). China had partnered with the Brazilian vaccine enterprises by taking part in development initiatives and selling drug substances, but this didn’t prevent it becoming the target of attacks from President Bolsonaro, whose imaginary of China was aligned with that of US President Trump. This reveals how globalisation from below also involves dealing with powerful imaginaries that question the South based on comparisons with norms and quality standards imposed and assumptions defined by actors in the North.

According to the manager in charge of imports at Bio-M, when it came to ensuring delivery of vaccine doses and ingredients, another factor was equally as important as the political context, diplomatic negotiations, and various business dealings required. This factor was the existing infrastructure and the logistics that needed to be established to receive these technologies during a time of uncertainty and emergency, and to ensure their use without wastage. Importing the API vaccine involved organising a whole sequence of steps for the ingredients – including ingredients that required transportation at very low temperatures (between -65 and -95 degrees Celsius) – to reach Bio-M ‘as fast, cheaply, and safely as possible’, according to the manager of the Imports Division:

A few months before we imported […], we mapped the flow; we asked first the quality control departments of Bio-Manguinhos importers what would be the deadlines, the temperature, the appropriate transport equipment, what would be the best route, the companies, the reliable partners who had the know-how, expertise in transporting perishable products, vaccines. […] We drew up contingency plans – both our experience here of importing vaccines previously and our partners’ were fundamental. For example, the pharmacist of RioGaleão [the international airport Tom Jobim, in Rio de Janeiro] had the idea and convinced RioGaleão … to rent a refrigerated container just for the API of the COVID-19 vaccine, […] the API, because it was something new and needed to be here very fast, we adopted it, we got the Federal Revenue Service’s permission, even the Federal Police’s support to escort our cargo, and RioGaleão allowed our refrigerated trucks to enter the cargo terminal’s yard. So, by the time our cargo left the plane, it had virtually already entered the truck. (Interview with the manager of the Imports Division at Bio-Manguinhos/Fiocruz, 2022)

All these steps were intended to ensure the integrity of the ingredients, with temperature serving as the leading indicator. In other words, as the staff in charge of imports admitted, in addition to contract negotiations, the temperature was also a significant concern within the framework of the Bio-M strategy. Logistics were required and involved a legal, technical, and political complex that could organise the flows of trade goods – in this case, vaccines and drug substances. On a material level, this also involved instruments and infrastructure such as refrigerators, flights, and telephone cameras (Quet 2018: 202). This logistics organisation is a crucial point of globalisation, enabling technological expansion and circulation.

When the plane took off, we ran there to take pictures of the temperature monitor. […] So, the agreements were difficult; there were meetings no matter what time it was because we talked to people from China, from England, we had so many people involved in the meeting that I did not know. […] However, when we stopped at the airport to wait for the cargo, that was that moment: ‘I do not have much to do now; I just hope that everything works out when it gets here’. Then we ran to take pictures of the temperature; I sent them to the WhatsApp group where almost the whole company was. I sent the picture of the temperature, and there was that ‘whew, it arrived!’. With all our effort, money, and hope, many people were waiting to get this vaccine.

Conclusion

This chapter contributes to debates on globalisation and its interlinkage with sovereignty through the analysis of the Brazilian COVID-19 manufacturing model based on a public-private partnership involving technology transfer. The analysis of a technological enterprise set up during a global health emergency sheds light on how globalisation has become a multidirectional phenomenon. Brazilian actors participate in at least three forms of technological globalisation.

Firstly, Brazilian vaccine initiatives participate in globalisation from above. By partnering with AstraZeneca and the United Kingdom, the Brazilian actors show their agency by coordinating the negotiation of access to Northern technology and knowledge transfer and ultimately contributing to technological development by assuming the risks of innovation. While the legal innovation and previous negotiation on TT granted BioM full access to know-how and drug ingredients, and enabled full nationalization of the Oxford vaccine, negotiations around the freedom to operate the platform after the transfer, and to the vaccines’ further uses, constituted a major challenge. In this sense, Brazilian actors may engage and contribute with globalisation from above to address their public health interests, but this engagement may condition the fulfilment of pharmaceutical sovereignty purposes in the future.

However, when negotiating contractual terms defining the freedom of use, Brazilian institutions are in a less favourable position than many Northern players in the current global pharmaceutical system. Brazil was able to engage and reaffirm the global IP rules by not choosing the ‘confrontational approach’ employed in the copy of HIV drugs (the use of patent flexibility for reverse engineering), not considered appropriate for the local production of a biological product, particularly a new vaccine platform, which requires access to knowledge not present in patents.

Secondly, Brazilian actors also participate in technological globalisation alongside Indian and Chinese pharmaceutical actors. These countries have become inescapable global suppliers of vaccine shots and ingredients, and their presence in the global pharmaceutical value chain reframes relationships of power with the North. In the scenario of international inequality, the emergence of Southern alternatives enables technological enterprises in the South through opportunities for new forms of commercial partnerships and technological agreements and the expansion of Southern technological markets. However, these relationships are unstable, particularly with the yet-to-be-understood impact of influential emerging Asian players and the varying sociotechnical imaginaries of the Chinese and Indian presence in Brazil and other Southern countries, with potential effects on sovereignty.

Thirdly, Brazilian actors are involved in the globalisation of their technologies. The primary purpose of the public biotechnology manufacturing model in Brazil is to affirm sovereignty and ensure the implementation of national health policies for all Brazilians in an unequal country. Although they have less global reach than Chinese and Indian industries, Brazilian public laboratories are essential global suppliers of yellow fever and influenza vaccines, with the COVID-19 pandemic offering new impetus for the expansion of this model. Moreover, the advances of indigenous vaccine development in Brazil during COVID-19, though not timely to address the pandemic, indicate both the existence of R&D capacity and bottlenecks in the national innovation system. Although Brazilian institutions have been shifting their discourses to embrace the approach of nationally developed platforms, these require long-term investments. Freedom to operate clauses in technology transfer agreements should be seriously considered in national and regional vaccine manufacturing plans.

Finally, this chapter can only be finished by considering the agency of the SARS-CoV-2 virus that obliges us to reconsider the globalisation phenomenon. The virus behind the COVID-19 pandemic exposed the contradictory scenario of pharmaceutical market expansion and the damaging effects of globalisation forms based on dependency, either on the North or the emerging South. The investigation of the Brazilian vaccine initiative indicates how, in a scenario of uneven pharmaceutical geography, access to vaccines in the South is enabled by the creative assemblage of the national and the global (Ong 2004). Sovereignty related to pharmaceutical manufacturing plays a role in the equitable distribution of health innovations required to face a global health crisis. However, this bioproduction-related sovereignty is not straightforward to affirm, requiring complex legal instruments to negotiate (van Wichelen 2023) or long-term investment in local innovation. A better global scenario would be supporting countries and regions through relationships of solidarity in the promotion of their capacity to equitably address their populations’ needs related to vaccines and other public health goods.

Endnotes‌

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