Pandemics and epidemics pose a substantial and growing threat to global health care systems.Footnote ¹ When a large-scale outbreak occurs, time is of the essence to repurpose existing health technologies and develop new medicines to prevent or treat illness, to avoid straining hospitals, and to reduce deaths. Delays in implementing licensing agreements for relevant intellectual property (IP) rights and manufacturing know-how can hinder ramping up production of needed medicines.

Intellectual property rights play a mixed role in pandemics and epidemics. Patents provide inventors with the right to exclude others from making, using, selling, and importing their inventions, among other actions.Footnote ² Coupled with regulatory exclusivities, patents are often credited with incentivizing pharmaceutical companies to develop new medicines and to find new uses for existing ones.Footnote ³ Trade secrets furthermore encourage the development of medicines by allowing companies to protect valuable know-how, such as complex pharmaceutical manufacturing processes.Footnote ⁴

Intellectual property rights, however, can also contribute to medicine shortages. When demand for life-saving medicines surges due to a large-scale outbreak, there is a lag time before companies can scale up production.Footnote ⁵ Although licensing proprietary technology to third-party manufacturers would help speed up production, companies may nevertheless refuse to collaborate. They might also choose to sell these medicines at exorbitant prices, or delay making them available to low- and middle-income countries in order to prioritize orders for higher-paying customers.

Governments in high-income countries provide pharmaceutical companies with substantial funding, for pandemic- and epidemic-specific research and development (R&D), as well as for more general R&D.Footnote ⁶ Yet they typically fail to secure enforceable promises from the funding recipient to ensuring that life-saving medicines are produced in sufficient quantity. Nor do such contracts generally address whether the final medicine will be provided to low-income countries in adequate quantities or at an affordable cost. This can lead to global shortages of taxpayer-funded drugs at a time when they are most needed. Existing measures under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have proven to be inadequate for addressing these problems.

This chapter argues that when governments and nongovernmental entities fund research for pandemic- and epidemic-specific drug development, they should use contractual provisions to provide safeguards to the public. Funding contracts should require the IP rights holder(s) to commit to taking all reasonable measures to produce sufficient quantities of any resulting life-saving drug in the event of a public health emergency. Were a shortage to arise, the relevant pharmaceutical company would be required to cooperate with willing third-party drug manufacturers to increase supply, in exchange for compensation. Complementarily, we argue that medical research funders should contractually secure promises to ensure fair pricing and access to life-saving medicines in low- and middle-income countries during public health emergencies.

We additionally propose that funders of medical research utilize a contractual mechanism called a “dormant license,” which could impose some, or all, of the obligations outlined above. These licenses would be negotiated ahead of crisis situations and activate automatically when a pandemic or epidemic is declared to ensure an adequate supply of needed medicines.

1 Scarcity of Medicines and Inequitable Allocation in Context

The global allocation of critically needed medicines has long been marked by profound asymmetries. Although low-income countries are often disproportionately impacted by infectious disease outbreaks, high-income countries typically obtain greater supplies of medicines to treat them. This trend is exacerbated when severe public health crises cause a spike in demand for medicines, as is typically the case with pandemics and epidemics. COVID-19 is the most recent of a series of outbreaks in which the Global North purchased most of the treatment and vaccine supply.Footnote ⁷

Market-based dynamics drive this inequality. High-income countries have both the resources and the bargaining power to capture much of the initial supply of pandemic and epidemic medicines through bilateral channels. During the COVID-19 and 2009 swine flu pandemics, these countries used advanced purchase agreements to buy vaccine doses from pharmaceutical companies before any were actually produced.Footnote ⁸ Some countries ordered far more doses than necessary to vaccinate their domestic populations.Footnote ⁹ Others engaged in “vaccine diplomacy,” through which they allocated vaccines to allies, as opposed to those with the greatest need, in order to secure some form of regional or international advantage or influence.Footnote ¹⁰ This left lower-income countries with scant access to critically needed medicines during worsening public health crises, and it forced them to wait for global manufacturing capacity to increase or for donated doses. During the 2009 swine flu pandemic, donations only occurred after the pandemic had mostly subsided.Footnote ¹¹

The practice of allocating scarce medicines to the countries that can most readily negotiate with and pay vaccine manufacturers is known as “vaccine nationalism”; it is part of a growing trend of market power overriding need, to the detriment of public health.Footnote ¹² The allocation of COVID-19 vaccines illustrates this phenomenon. The US government initially refused to support international procurement through the COVID-19 Vaccines Global Access (COVAX), a facility co-led by the Coalition for Epidemic Preparedness Innovations, Gavi and the World Health Organization (WHO).Footnote ¹³ Instead, the Trump Administration launched Operation Warp Speed, providing billions of dollars to pharmaceutical companies that were working to develop COVID-19 vaccines and placing advanced purchase agreements with six companies. It attempted to secure priority access to foreign companies’ vaccines by offering them large sums of money, sparking immense backlash.Footnote ¹⁴ The United States was not alone in aggressively stockpiling vaccines – the United Kingdom, Canada, Japan, and some European Union member states procured more vaccines than they actually needed.Footnote ¹⁵

Various countries chose to support COVAX with the goal of facilitating the manufacturing and distribution of COVID-19 vaccines to all countries. However, COVAX fell short of its promises.Footnote ¹⁶ Some countries placed orders, but received their vaccines late or without any advanced notice, or received doses that were about to expire.Footnote ¹⁷ Middle-income countries that did not receive promised vaccines were forced to later negotiate separate deals with vaccine manufacturers, pushing them to the back of the line. The Serum Institute of India was supposed to be a major supplier, but India’s vaccine export ban in 2021 blocked it from delivering orders for several months.Footnote ¹⁸ A major complaint against COVAX was its failure to push for technology transfers to allow countries to manufacture their own doses.Footnote ¹⁹

Lower-income countries are supposed to have legal tools to counter vaccine nationalism and, more broadly, problems of medicine scarcity arising during public health crises. Article 31 of TRIPS allows member countries to utilize “compulsory licensing” and issue licenses for patented technology to third parties.Footnote ²⁰ During emergencies, including pandemics and epidemics, a government need not engage in time-consuming negotiations with the patent holder prior to issuing a compulsory license.Footnote ²¹ Article 31bis further permits countries in need of particular drugs to import them under compulsory license from a country capable of producing them.Footnote ²² Theoretically, these provisions should allow lower-income countries to produce or import the medicines that they need during a pandemic or epidemic.

TRIPS, however, lacks a mechanism for compelling pharmaceutical companies to share the know-how that is needed for third-party manufacturers to quickly replicate medicines. Article 39 requires member countries to protect trade secrets and contains no provision expressly allowing for compulsory licensing.Footnote ²³ Without manufacturing-related know-how, a country may need years to both recreate a vaccine or other complex medicine and to gain regulatory approval.Footnote ²⁴ Lower-income countries furthermore risk higher-income countries retaliating against them for using compulsory licensing.Footnote ²⁵

2 Preparing for Pandemics and Epidemics: The Underexplored Role of Contracts

An underappreciated point in the literature is the fact that many components needed to produce medicines for pandemic and epidemic response are developed well in advance.Footnote ²⁶ When an outbreak occurs, the process of developing drugs and vaccines does not start from scratch. Rather, researchers adapt and use preexisting technology to address the specific challenges posed by a new infectious disease.

The development of vaccines against Ebola and COVID-19 provides an illustration of this point. Vaccines for these diseases were the product of years of pre-outbreak R&D and technology transfer.Footnote ²⁷ During the 2014–2016 Ebola vaccine race, the leading vaccine candidate had actually been developed by 2005. It did not come to market until 2019 due to a lack of private sector interest in initiating clinical trials and seeking regulatory approval.Footnote ²⁸ Similarly, Moderna and Pfizer’s COVID-19 mRNA vaccines utilized technology that had been in development for well over a decade.Footnote ²⁹

The timing of drug development has implications for the practices surrounding technology transfer. During large transnational public health crises, bargaining processes will be rushed, tinged by geopolitics and limited by resource scarcity,Footnote ³⁰ making it difficult to address allocative inequalities among countries. Yet funding contracts governing R&D, transfer, and commercialization of these medicines generally predate the outbreak causing a spike in demand. Consequently, at least some of the contractual requirements governing the sharing and transferring of technology during a pandemic or epidemic can be established when demand is lower – well before bidding wars to pre-purchase most of the vaccines or treatments occur.

We therefore suggest that bargaining regarding the transfer of technology take place as far in advance as possible. Furthermore, attempts to promote the fair allocation of pandemic and epidemic health goods should occur ideally in the pre-pandemic or epidemic period. We discuss two different approaches that R&D funders could use to address affordability and/or equitable allocation obligations in funding contracts governing R&D on these goods. Many existing proposals to expand access to medicines during pandemics and epidemics occur ex post by constraint – as product scarcity and nationalist behaviors combine to exclude populations in lower-income countries. By contrast, our proposed framework would operate largely ex ante, creating binding contractual obligations that arise if and when pandemic or epidemic-driven scarcity occurs.

3 Safeguarding Access to Medicines through Pandemic-Specific Funding Agreements

When funding the development of medicines that are likely to be needed for a pandemic or epidemic response, funding entities could use their contracts to proactively anticipate scarcity and pricing problems. One possibility would be to insert provisions into funding contracts requiring pharmaceutical companies benefitting from the funding to produce any subsequently developed medicine in sufficient quantity to meet public health needs.Footnote ³¹ In order to determine whether a particular medicine is tied to funding received under our proposed model, a contract could specify an identification formula or mechanism. For instance, funding could be tied to applied for or granted patents. Under this approach, if funding under the contract results in a patent that covers part of the resulting medicine, then the product as a whole would be covered by the licensing terms.Footnote ³²

The funding contract could provide an initial grace period to allow the company time to secure raw materials and scale up production of the medicine in question. Alternatively, the contract may bind the parties to decide what the appropriate grace period is once a pandemic or epidemic is declared; this approach would cater to the specificities of a given public health crisis. If the shortage persists, the funder could require the company to license out the relevant patents and know-how to willing third-party manufacturers to scale up production more quickly.

The contract would specify a compensatory royalty rate to be paid to the company under such circumstances. The goal would be to set the rate as close to fair market value as possible, while ensuring that third-party manufacturers have sufficient incentive to help produce the needed medicine. By doing this, the company should end up with a higher rate of profits than if the shortage had continued. The funding contract would further specify significant financial penalties for companies that fail to cooperate and could bar future funding to an uncooperative recipient.

The funder could furthermore require the pharmaceutical company to promise that any resulting medicine be priced fairly for low-income countries and be made available to them in sufficient quantity. As discussed earlier, bidding wars have put needed medicines out of reach for much of the Global South during pandemics and epidemics. What assistance high-income governments provide typically comes in the form of donating excess medicines.Footnote ³³ It would be far more efficient for funders to secure low-cost access from pharmaceutical companies when the underlying R&D is funded and to require companies to work with generic drug manufacturers in low-income countries to help ensure an adequate supply.

We acknowledge that funding for R&D in this area is often provided by entities in higher-income countries – the same countries that have repeatedly tried to secure early vaccine access for recent pandemics, notwithstanding the pressing need of those living in lower-income countries.Footnote ³⁴ Although it is unlikely that vaccine nationalism will be fully eliminated ahead of future global public health crises, the COVID-19 pandemic has highlighted the frailty of these approaches.Footnote ³⁵ Countries lacking the vaccines likely prolonged the pandemic by giving rise to mutations that could evade the vaccines’ protection.Footnote ³⁶ In light of the need for global cooperative efforts to prevent and respond to pandemics and large-scale epidemics, the time is ripe for funders in higher-income countries to consider the imposition of requirements that align with this goal.Footnote ³⁷

Moreover, we note that some pharmaceutical companies already utilize licensing agreements to benefit low-income countries. For example, the United Nations-backed Medicines Patent Pool (MPP) negotiated a voluntary license with Pfizer for its oral COVID-19 drug Paxlovid. This allowed MPP to sublicense it royalty-free to thirty-five manufacturers for the duration of the pandemic, benefitting ninety-five lower-income countries; a 5–10 percent royalty will apply for middle-income countries thereafter.Footnote ³⁸ However, not all companies are willing to participate in such programs, and some withhold their most lucrative medicines from such agreements. For example, both Moderna and Pfizer have refused to license out their mRNA vaccine technology, highlighting the need for more formalized licensing obligations.Footnote ³⁹

Anticipating the possibility of pandemic- and epidemic-driven shortages of medicines in funding contracts would offer several benefits. It would allow for production to be rapidly scaled up by decreasing transaction costs for third-party manufacturers that are willing to produce the medicine. When compulsory licensing is used, the third-party producer must waste time replicating the medicine and gaining regulatory approval. Indeed, for biologics such vaccines, the timeline for bringing a biosimilar vaccine to market could exceed the duration of the public health emergency. Under our proposal, third-party manufacturers would be able to obtain access to proprietary information about the optimal way to produce the medicine, eliminating such unnecessary delays.

Another benefit to our proposal is that the third-party-produced medicine may not have to go through full regulatory approval, because it would be made under license from the original manufacturer. Depending on the applicable national regulatory frameworks, such medicines would potentially qualify as follow-on drugs (generics or biosimilars) or may be eligible for other shortened review pathways, as was the case with emergency use authorizations for COVID-19 vaccines.Footnote ⁴⁰ The third-party manufacturer could also potentially benefit from the rights holder’s connections with raw material providers. Furthermore, the funding contract would pre-set the compensation rate, so that time-consuming negotiations do not have to take place once a shortage has arisen.

There are, admittedly, some limitations to our proposal. During the COVID-19 pandemic, there were shortages of supplies that licensing would not have been able to mitigate, such as glass vials to hold vaccine doses.Footnote ⁴¹ Nor will licensing help if medicine manufacturing capacity is insufficient or if logistical limitations arise. For cutting-edge technology such as mRNA vaccines, a shortage of skilled personnel might also exist, and it could take time to train employees at third-party manufacturing facilities to produce highly novel medicines. Finally, securing these promises in the shadow of a pandemic could lead to funding entities paying more to the recipients and would likely lead to larger pharmaceutical companies declining funding.

4 Dormant Licensing Provisions

A “dormant license” is a set of contractual provisions agreed to by the parties before the occurrence of a specified event.Footnote ⁴² Although the provisions are not active at the time that they are agreed to – even if other portions of the agreement have taken effect – they come into force if the event occurs.Footnote ⁴³ We propose that funding entities attach a dormant license when funding R&D for medicines that are typically needed to prevent and respond to pandemics and epidemics. They should condition funding on the acceptance of contractual terms designed to promote the affordability and equitable allocation of the medicines covered by the license.

We recommend a flexible framework to identify relevant medicines, or components thereof, that would be subject to the dormant license. This would be modeled after the list of emerging pathogens maintained by the WHO or a similar group. Funding entities would designate certain emerging pathogens or diseases as “priority” targets and would reserve some funding for recipients who agree to the dormant license terms.Footnote ⁴⁴ Ideally, the funding recipient would also guarantee the affordability and equitable distribution of any subsequently developed products. However, the funding entity may make strategic choices about which areas of R&D are best suited for the dormant licensing model based on political economy constraints.

Dormant licenses are particularly well suited to providing funding for R&D on emerging infectious diseases. Such work has been grossly underfunded and has failed to attract significant funding even after an outbreak occurs.Footnote ⁴⁵ For this reason, the realm of emerging pathogens of concern, as identified by the WHO – or by another public health-oriented institutionFootnote ⁴⁶ – constitutes a good field for our proposal. These pathogens are expected to trigger significant outbreaks in years to come, yet are underrepresented in large pharmaceutical companies’ development pipelines.

The funding entity may tailor the dormant licensing requirements based on its priorities. For example, a funding entity that supports vaccine development might require recipients to promise that a percentage of any vaccine doses produced be allocated to an international procurement facility – such as COVAX – in the event of a relevant outbreak. It could choose to impose pricing requirements by adopting a formula to calculate pricing at the time of commercialization or impose requirements specific to commercialization in lower-income countries. It could furthermore obligate recipients to sublicense the technology on a nonexclusive basis to alleviate shortages, or require them to sublicense to preferred or predetermined partners. Overall, the terms can be adapted depending on the specifics of the technology, the field of R&D, and the profile of the target funding recipients to maximize both goals of health equity and practical implementation.

To increase certainty for the funding recipient, we suggest that the trigger for the dormant license be a formal declaration of an epidemic or pandemic by an agreed-upon public health institution. Although we believe that the WHO is well positioned to serve in this function, the parties could alternatively choose a domestic institution or some other body to fulfill this role. The licensing terms would indicate whether the qualifying event is a formal declaration or merely a declaration of concern,Footnote ⁴⁷ and would identify the institution or institutions producing the qualifying trigger. The contract should also specify how to calculate the period for which the dormant license would remain active, such as the number of months counted from a formal declaration that a pandemic or epidemic is over. It should furthermore address whether the term could be extended if the parties were to desire, and if so, how. Finally, as was the case with our previous proposal, the funding contract could also establish financial penalties for funding recipients that fail to abide by the terms of the license, as well as potentially bar the awarding of future funding to the recipient in breach of the agreement.Footnote ⁴⁸

The approach outlined here offers several advantages over current licensing approaches.Footnote ⁴⁹ First, the licensing terms are negotiated before a large-scale public health crisis unfolds, when there are fewer bargaining pressures. Second, a dormant license furthers the goal of increasing legal certainty by setting clear obligations and corresponding rewards before the need for expedited R&D arises. And third, although the dormant license is designed to impose some sort of limitation on licensees, it would contribute toward monetization of the licensed product or products, as it integrates compensation for the rights holder.

The presence of dormant licensing provisions in funding contracts will admittedly not be attractive to all firms. Large and established pharmaceutical companies, such as Pfizer, are likely to refuse any funding with such conditions.Footnote ⁵⁰ However, several types of firms engaging in pharmaceutical R&D may be willing to agree to a dormant license, particularly for underfunded areas of research. For instance, prior to the COVID-19 pandemic, Moderna was a relatively small company which had never brought a product to market, yet received substantial government funding.Footnote ⁵¹ Smaller companies, companies that are generally dependent on external R&D funding, and especially companies seeking to establish a relationship with government funders are all more likely to agree to the provisions that we propose.

5 Conclusion

Past and current public health crises have shown that high-income countries have failed to proactively address pandemic- and epidemic-driven shortages of critically needed medicines. Worse still, high-income countries frequently hoard scarce medicines with little thought for whether those located in the Global South have access. Governments and institutions providing funding for pharmaceutical development have generally taken few steps to proactively ensure the adequate production, as well as the fair pricing and allocation of medicines. During the COVID-19 pandemic, existing flexibilities under TRIPS provided little relief, because pharmaceutical companies could not be compelled to share vital medicine-manufacturing know-how with third-party manufacturers.

Moving forward, governmental and nongovernmental entities should take a proactive approach to anticipating such scarcity by using funding as leverage for obtaining promises regarding medicine supply and pricing. We propose two levels on which this can operate. More narrowly, when entities fund pandemic- or epidemic-specific R&D, they could extract contractual promises to make any resulting medicine in sufficient quantity to meet demand and to require that the recipient provide the medicine to lower-income countries at reasonable prices. In the event of scarcity, the funding recipient would be obligated to license out its technology to willing third-party manufacturers in exchange for predetermined compensation. More broadly, they could incorporate such promises into other R&D funding agreements – such as for emerging pathogen research – by using a dormant license that triggers in the event of a pandemic or epidemic. These strategies provide funding entities with a flexible mechanism for mitigating pandemic- and epidemic-driven shortages and preventing distributional inequalities, which could ultimately save lives.

As COVID-19 has become less of an emergency and more endemic, the attention of policymakers at the national, regional, and global levels has inevitably shifted to other pressing matters. In the last quarter of 2022, stakeholders in global public health governance – be it international organizations (IOs) such as the World Health Organization (WHO), governments, industry, civil society organizations (CSOs), or academia – are taking the time to evaluate the lessons that policymakers can learn from the global experience of COVID-19 to ensure more equitable access to pandemic response products (PRPs),Footnote ¹ especially vaccines, diagnostics, and treatments. There is a surprising amount of convergence around what the international community broadly needs to do in order to better respond to the next infectious disease pandemic:Footnote ² invest massively to upgrade national health systems, especially in poorer countries; make legally binding commitments to build adequate contingency funding for equitably distributing PRPs to populations in low- and middle-income countries (LMICs) at about the same time as in richer countries; ensure geographic distribution of production facilities so that PRPs are available in all regions, thus protecting against supply shortages; strengthen the international global health architecture, including organizations such as the WHO, so that improved rules and better compliance can be ensured during a future pandemic. However, the one aspect that has had less convergence is which entity should be responsible for coordinating the global response to an infectious disease pandemic, including ensuring procurement and equitable distribution of PRPs, and how such an entity should function.

Focused on global response governance, this chapter highlights the crying need for an effective, adequately funded, empowered, lean, and flexible entity to lead the immediate global response to contain any future pandemic everywhere – an entity responsible for coordinating the procurement and equitable distribution of PRPs in LMICs wherever they are urgently needed.Footnote ³ The primary goal of such an entity would be to contain the pandemic everywhere as soon as possible to minimize both human and economic losses. While there are many worthy long-term causes such as strengthening national health systems, enhancing local technological capacities, sharing intellectual property (IP) rights and manufacturing know-how on PRPs, gender equity, increasing job opportunities, and so on, this entity must stay focused on one goal alone: to effectively respond to containing the pandemic everywhere to minimize its devastating health and economic toll worldwide. This goal would automatically lead to the best outcomes globally, including in LMICs, as equity is best served by a quick end to the pandemic.

While prevention, preparedness, and response (PPR) to a future pandemic have invariably been linked, these require separate sets of actions at different points of time. While during COVID-19, prevention and preparedness – in terms of surveillance of the animal kingdom to detect deadly viruses that can jump to the human species, and to prevent their spread or to detect new variants of circulating deadly viruses; or in terms of building adequate health infrastructure, including training sufficient health personnel; or regionally distributed technological capabilities to produce PRPs – was low to abysmal in LMICs, the major failure in dealing with the pandemic was the lack of an effective, globally coordinated response to the spread of the SARS-CoV-2 virus, in order to end or contain the pandemic as quickly as possible. This chapter is concerned only with coordinating the immediate global response to future pandemics – on which there has been very little focus – as opposed to long-term arrangements on prevention and preparedness where recent efforts by the WHO, the Coalition for Epidemic Preparedness Innovations (CEPI), and the Pandemic Fund seem to be moving in the right direction, even if much more needs to be done. This chapter does not purport to provide all the answers on global governance for pandemic response but at least attempts to raise the questions that the international community needs to ask itself.

This chapter consists of four sections. Section 1 provides a background that situates the global governance challenges in responding adequately to the spread of COVID-19. Section 2 gives a brief description of the challenges faced by global health institutions during the COVID-19 pandemic, and Section 3 lists some of the key initiatives taken and ideas put forward on global pandemic governance following the pandemic. Section 4 then sets out arguments favoring the need for an entity responsible for responding to future pandemics, raising key questions that must be resolved.

1 Background

COVID-19 has been the deadliest pandemic that the world has faced in over 100 years. In the almost four years from its discovery, the SARS-CoV-2 virus and its variants have officially infected over 770 million people and taken about 7 million lives.Footnote ⁴ The official deaths reported are widely recognized to be vastly underestimated, with total deaths projected to be almost three times more at over 18.6 million deaths by April 2023.Footnote ⁵ Additionally, countless of the infected survivors are suffering from debilitating long-term symptoms. To put these figures in perspective, in the decades since the beginning of the HIV/AIDS epidemic, 84.2 million people have been infected with the HIV virus, of which about 40.1 million people have died.Footnote ⁶ Today, about a quarter of the world’s population is infected with tuberculosis, which kills around 1.5–1.6 million persons every year.Footnote ⁷ By these standards, COVID-19 has killed many more people globally faster than any other known pandemic, with the exception of the Spanish Flu of 1918–1919.Footnote ⁸

It is widely recognized that the global response to this deadly pandemic was chaotic and uncoordinated.Footnote ⁹ COVID-19 was not controlled in a timely way despite many key actors in the international health governance community having anticipated the rapid spread and high mortality very early on in the pandemic. And even though several effective COVID-19 vaccines became available at the near-miraculous speed of about a year, thanks in part to the sharing of the genome sequence of SARS-CoV-2 virus by China as early as January 2020. Given the anticipated scale of the pandemic, COVID-19 vaccine manufacturers correctly expected high demand that guaranteed them high revenues and profits. But even so, an important catalyst for the rapid development and deployment of vaccines was the derisking of private research and development (R&D) through public funding, and advance-purchase commitments made by many developed-country governments for some vaccines, even before full knowledge of their efficacy was available, notably by the United States and the European Union.

It is also widely acknowledged that during the COVID-19 pandemic there were sharp inequities in the access to PRPs, especially to life-saving vaccines. As of November 2023, about 80 percent of people living in high-income countries (HICs) had received at least one dose of these vaccines, as against only 33 percent of those living in low-income countries (LICs).Footnote ¹⁰ The world is yet to reach an average of 70 percent of its population vaccinated, a target meant to usher in herd immunity. Yet only 10.9 million vaccine doses were needed to administer two doses to 70 percent of the global population, while 14.8 billion doses had been delivered, and 12.5 billion doses administered, as of November 2022.Footnote ¹¹ This is because richer countries were administering third, fourth, and even fifth doses when most in LICs, including priority populations, had not even received one dose. By the second half of 2022, there was not much uptake of vaccines in poorer countries not only due to the decline in COVID-19 infection cases, but also increasing vaccine hesitancy, lack of correct information on vaccines, and the inability to scale up logistics and infrastructure.

At the very initial stages of vaccine supply, the most effective vaccines, the mRNA vaccines, were inevitably prebooked and overbooked by the richer countries, cutting LICs out. In addition, prioritization of supply to local manufacturers of critical components needed to manufacture vaccines by some countries, including the United States, hit vaccine manufacturers in LMICs; and supply to some regions, particularly Africa, suffered inordinate delays due to export restrictions on finished vaccines imposed by India in early 2021 after a deadly second wave of COVID-19 hit that country.Footnote ¹²

In the initial months of the COVID-19 pandemic when there were no vaccines or treatments, a widely deployed preventive measure to contain the spread of the virus, initiated first in Wuhan, China with some success, was a virtual lockdown of the affected areas/cities/countries. Many governments all over the world restricted movement and closed borders for many months in 2020 and sporadically in 2021–2022. Even though these measures did not fully succeed in controlling the spread of the pandemic, it resulted in a sharp, simultaneous downturn in economic activity in many parts of the world, especially in 2020–2021.

COVID-19 was thus not just a devastating global health crisis; it was also an unprecedented global economic crisis. The International Monetary Fund (IMF) has estimated the loss to global GDP to be $13.8 trillion through to 2024, largely due to a fall in demand that affected many economic sectors, such as travel and tourism.Footnote ¹³ Many countries stepped up fiscal support programs in 2020 and 2021 – the IMF estimates the global fiscal deficit as a percentage of gross domestic product (GDP) due to stimulus packages and loss of tax revenue on account of COVID-19 to be 10.2 percent in 2020, 7.9 percent in 2021, and 5.2 percent for 2022, the biggest jump from 2019 levels being in advanced economies and emerging-market economies as compared to LICs.Footnote ¹⁴ In terms of stimulus packages, Japan leads with almost 55 percent of its GDP, followed by Germany, Italy, and the United States. In the United States, this amounted to a cash injection of almost $5.5 trillion to households, institutions, and businesses, which led to a quick economic recovery but adverse medium-term consequences, including unprecedented levels of inflation, leading to the current economic woes in major economies, including stagflation.Footnote ¹⁵ Poorer and emerging-market economies had less to spend and thus suffered disproportionately higher economic losses, and they will take much longer to recover from COVID-19-related losses. Yet Argentina and Brazil spent 12 percent of their GDP on stimulus packages, while India spent 3.5 percent.Footnote ¹⁶ The World Bank estimates that the lifelong earnings of students may be $17 trillion less globally due to closures of educational institutions.Footnote ¹⁷

All in all, the direct and indirect global economic losses due to COVID-19 five years on from the start of the pandemic may be conservatively “guesstimated” to be $20–25 trillion. Therefore, future pandemic governance should embrace the twin goals of containing both the devastating loss of human lives and keeping global economic losses to the lowest possible level. And, in principle, the international community should logically be willing to spend even up to a trillion US dollars to achieve this goal.Footnote ¹⁸

2 Challenges Facing Current Global Health Institutions

Logically, it is the WHO that has the mandate within the United Nations (UN) system to be the specialized agency to deal with global health challenges such as deadly pandemics. However, despite its Director General (DG) and his senior management team’s early initiatives and strenuous efforts toward global solidarity, the WHO proved ineffective in containing the pandemic even after nearly three years of its declaration of a public health emergency of international concern (PHEIC). The WHO has also been criticized for failing to notify the world in time, for failing to trace the origins of the virus SARS-CoV-2 that caused the pandemic, and for not being able to achieve equity in the distribution of needed PRPs.

That a new virus named SARS-CoV-2 was spreading rapidly in Wuhan, China and resulting in a very high proportion of infected persons dying was known to the world only at the end of December 2019, when China notified the WHO. The WHO’s initial reaction was to play down this news and to advise that no travel restrictions were necessary.Footnote ¹⁹ Only on January 30, 2020 – after the DG himself visited Beijing – did the WHO declare this to be a PHEIC. By then there were 7,818 total confirmed cases reported worldwide, with 82 cases reported in 18 countries outside China.Footnote ²⁰ The rate of spread of COVID-19 globally was rapid. For example, by March 7, 2020 the number of confirmed cases outside China surpassed 100,000; twelve days later it reached 200,000; just three days after that 300,000; and within two more days the total number of global cases was 400,000.Footnote ²¹ On March 11, 2020 the WHO took the additional step of declaring COVID-19 to be a pandemic and began issuing regular advisories – sometimes contested by scientists and experts – on steps to be taken to prevent the rapid spread of the virus. By this date, the health system in a rich country, Italy, was already struggling to cope with the number of hospitalizations and deaths, and the country was in lockdown,Footnote ²² a pattern repeated in many countries around the world.

One primary reason why the UN system, as it is currently structured, cannot be solely depended upon to fulfill the primary role of responding to deadly pandemics is that its decision-making through a one country, one vote system or through consensus is not only time-consuming but leads to delayed and ineffective solutions, an outcome that is unaffordable in response to a pandemic like COVID-19. As leading scholars have stated, “even as the UN system seeks to bring the world together, governments have too often responded alone, as the universal system of international organizations has faced continuing obstacles in realizing global solidarity.”Footnote ²³

It should not be surprising that the WHO, dependent as it is on its key members, is not able to pressure any of those member states into acquiescence. This is as true of the United States as it is of China. Leading scholars have pointed out ten specific areas where the response was inadequate and rightly put WHO’s slow responses to the COVID-19 pandemic in context by stating that “the WHO has lacked high-level political backing, financing, and convening power.”Footnote ²⁴

The High-Level Independent Panel set up by the G20 said this: “The current global health architecture is not fit-for-purpose to prevent a major pandemic, nor to respond with speed and force when a pandemic threat emerges. As the Global Preparedness Monitoring Board highlights, the system is fragmented and complex, and lacks accountability and oversight of financing of pandemic preparedness.”Footnote ²⁵

Similarly, other public health experts have recognized the need for new governance structures in order to respond to future pandemics. As leading health law scholars aptly put it: “Global health governance is at a crossroads, necessitating a new governance model … The global governance institutions that develop in the aftermath of the COVID-19 crisis will determine the response to future threats.”Footnote ²⁶

Some of the key systemic reasons why either the WHO needs to be radically restructured or a new global coordination entity set up for pandemic response are listed below.

3 Initiatives Taken on Global Pandemic Governance during COVID-19

Correctly anticipating that inequitable distribution of vaccines and other PRPs may be a problem (as it was for vaccines during the H1N1 or Swine Flu epidemics), the Access to COVID-19 Tools (ACT) Accelerator was jointly launched by a number of organizations, notably the WHO and Gavi, the Vaccine Alliance, toward the end of April 2020.Footnote ²⁹ Within the ACT Accelerator, COVAX was the vaccines pillar,Footnote ³⁰ responsible for the procurement and equitable distribution of COVID-19 vaccines. It was jointly convened by CEPI, Gavi, and the WHO, and worked in collaboration with UNICEF.Footnote ³¹ In practice, COVAX, including its advance market commitment (AMC) that aimed to supply vaccines free of cost to ninety-two LICs and LMICs,Footnote ³² was administered by Gavi, in close coordination with UNICEF, which managed the procurement and delivery of the vaccines. Following guidance from the WHO, COVAX aimed to cover initially at least 20 percent of the population of each country equally, and targeted delivery of 2 billion doses by the end of 2021, so that at least priority populations such as health workers and vulnerable persons would be protected, without any attention paid to actual need based on the spread of the disease.Footnote ³³ There was another arrangement for self-financing participants, including HICs, which was not much used. The idea was that COVAX would procure vaccines for all participating countries (eventually numbering 195). COVAX started functioning in June 2020, well before any vaccines had even been approved, but it soon became clear that the rich countries would be served first by vaccine manufacturers as they were the first in line based on advance-purchase arrangements made outside of COVAX, and as COVAX struggled in 2021 to raise the money needed to place orders on behalf of LMICs.

Following the IMF estimates of $50 billion needed to fully vaccinate 40 percent of the global population by the end of 2021 and 60 percent by mid-2022 to end the pandemic,Footnote ³⁴ the WHO got this revised to at least 70 percent of the global population being fully vaccinated by mid-2022.Footnote ³⁵ Yet, according to the IMF and the WHO, by mid-2022 only 61 percent of the global population had received two doses of vaccination and as many as 130 countries had yet to meet the 70 percent target.Footnote ³⁶

COVAX, although well-intentioned and with the eventual backing of 195 participating economies, was hampered right from the beginning by a lack of funding, shortages of inputs and vaccines, the noncooperation of supplier countries, which opted to prioritize their entire populations with primary and multiple booster doses or reap the benefits of “vaccine diplomacy” through bilateral deals. COVAX could supply only half of this target – that is, 1 billion doses by January 2022.Footnote ³⁷ Up to October 2022, it had shipped a total of 1.84 billion doses to 146 countries, of which 1.65 were to AMC countries. Seven countries had not received vaccine doses to cover even 15 percent of their population as of October 2022.Footnote ³⁸

Yet global supply of COVID-19 vaccines had reached 11 billion doses by the end of 2021 and almost 18 billion doses as of October 2022. These changes show that global supply was no longer a problem from the end of 2021, unlike in the first three quarters of 2021. The problem was the delayed funding of COVAX resulting in delayed placement of orders and the highly inequitable distribution of the doses initially, added to the fact that even these deliveries of vaccines were not always rapidly translated into vaccinations, namely jabs into arms, due to innumerable logistical problems and the lack of uptake due to slowing demand.

Although at least fifty vaccines were approved by at least one national authority, and twelve vaccines approved for emergency use by the WHO by December 2022,Footnote ³⁹ only two were in high demand. These were the mRNA vaccines marketed by Pfizer–BioNTech and Moderna, as they showed high levels of effective protection against severe disease, but they were mostly available only in richer countries. These vaccines also needed storage at very low temperatures, equipment for which is not readily available in most LMICs.

The Oxford–AstraZeneca vaccine did not need such low storage temperatures and was the most widely used in LMICs, with 3 billion doses delivered up to mid-2022, and an estimated 600 million lives saved due to it in the very first year of rollout.Footnote ⁴⁰ Unfortunately, by the time problems of inadequate vaccine production and supply were resolved, other problems such as the lack of adequate infrastructure, equipment, personnel, and logistics for quick vaccination delivery, as well as vaccine hesitancy and low uptake due to declining rates of infection, became the predominant barriers to improving vaccination rates in poorer countries.

Sadly, the estimated global wastage of vaccines was as high as 1.1 billion doses due to lack of predictability in donated dose deliveries in LMICs, multi-dose packaging, and relatively short expiry dates.Footnote ⁴¹ Some promising versions of mRNA vaccines are available from ChinaFootnote ⁴² and India,Footnote ⁴³ but the demand for COVID vaccines is on the decline for the reasons discussed above, and the goal of vaccinating the world against COVID-19 is losing momentum. It is likely that any annual vaccinations required against COVID-19 will bypass much of the population in poorer countries, just as is in the case with annual influenza vaccinations.

As for treatments, several known medicines were tested against COVID-19 even before vaccines were available. Of these, and after several fatal mistakes, an old generic medicine, dexamethasone, was considered to be one of the most effective treatments for seriously ill patients. The UK government estimated, at the end of 2021, that the drug had saved a million lives worldwide and 22,000 in that country alone.Footnote ⁴⁴ Gilead’s remdesivir showed some efficacy in reducing time in hospital, but not enough to justify its widespread use.

Toward the end of 2021 or early 2022, two patented drugs, Merck’s molnupiravir and Pfizer’s Paxlovid™ (nirmatrelvir in combination with ritonavir), were approved in many jurisdictions specifically to treat COVID-19 patients to prevent hospitalization and death. By mid-2022, molnupiravir was seen as not being as effective as once believed and Paxlovid™ is effective only in vulnerable populations.Footnote ⁴⁵ Also, just as for vaccines, the demand for these therapeutics has declined. It is now expected that only 15 million doses of molnupiravir and 50 million doses of Paxlovid™ will have been sold by the end of 2022.Footnote ⁴⁶ Both these medicines were licensed to the Medicines Patent Pool (MPP) for onward sublicensing for sale in most LMICs.Footnote ⁴⁷ These licensed companies were expected to begin production by the end of 2022 or early 2023. An Indian manufacturer was the first and only one to get its version of the licensed Paxlovid™ prequalified by the WHO by December 2022.Footnote ⁴⁸ by which time the demand for the product had waned.

Several evaluation reports are now available on the functioning of COVAX, with recommendations for future pandemic preparedness and response, including one by COVAX itself, as well as an external evaluation of ACT-A with COVAX, commissioned by the Facilitation Council of ACT-A led by Norway and South Africa.Footnote ⁴⁹ These and other reports agree that there need to be several improvements in governance arrangements to contain future pandemics.

The WHO also launched the Covid-Technology Access Pool (C-TAP), with the hope that producers of vaccines, therapeutics, and diagnostics would deposit their proprietary technology, data, and know-how to enable these to be widely disseminated to enhance global production of the needed PRPs.Footnote ⁵⁰ While some research organizations and universities, including the NIH, have submitted several technologies to this pool, these are yet to be sublicensed through the MPP, and none of the major vaccine producers have participated.Footnote ⁵¹

Regional organizations, including multilateral development banks, also took initiatives to help members acquire vaccines and other medical countermeasures. In December 2020, the Asian Development Bank (ADB) launched the $9 billion Asia-Pacific Vaccine Facility (APVAX) to help its members procure vaccines.Footnote ⁵² As of September 2021, the ADB had committed $2.3 billion under APVAX.Footnote ⁵³ Others, such as the African Union’s African Vaccine Acquisition Task Team (AVATT) and the Pan-American Health Organization (PAHO), started taking initiatives in early-to-mid 2021 to procure vaccines with the buy-in of their member states as complements to individual countries’ bilateral vaccine contractsFootnote ⁵⁴ (and to increase the local production of vaccines). Many believe that regional partnerships/platforms are required not just as a first step, but as the only way to successfully deliver PRPs at the country level. And that, ultimately, adequate financing of regional initiatives would lead to global coordination and the advantages of scale.

Several prominent voices in civil society, including academics, in the United States and elsewhere, came together and advocated for greater political engagement, suggesting the convening of a summit of world leaders that would support a global framework for a COVID-19 response.Footnote ⁵⁵ The background document of September 2021 sets out such a framework, which clearly recognized that a planning and implementation arrangement was needed to end the acute phase of the pandemic. While the tasks to be handled by such an arrangement were set out in some detail, the proposal was less clear about who should be responsible for these. A suggestion was made to appoint a UN envoy who would function with the support of the Multilateral Leaders Task Force, as well as empower a global task force on supply and manufacturing.Footnote ⁵⁶ Again, in April 2022, one group issued a call for global action to end the pandemic and prevent the next.Footnote ⁵⁷ Civil society and academia have a useful role to play, and their voices must be channeled, as was usefully done through the Pandemic Action Network.Footnote ⁵⁸

Several concrete suggestions have been made to engage the global political leadership at the highest level. The Independent Panel for Pandemic Preparedness and Response (IPPPR) was the first to make a recommendation on this, suggesting that a Global Threats Council at the level of heads of state be established under the General Assembly of the United Nations (UNGA) to lead on pandemic preparedness and response.Footnote ⁵⁹ The DG WHO suggested establishing a Global Health Emergency Council and a Committee on Health Emergencies under the auspices of the World Health Assembly, rather than creating a parallel architecture.Footnote ⁶⁰ The draft of the Pandemic AgreementFootnote ⁶¹ under negotiation has proposed a Conference of Parties (COP) at the head of the governance structure, with subsidiary bodies under it. It is clear that member governments of the WHO are loath to hand over control of decision-making to either the WHO Secretariat or any other independent body. However, UN intergovernmental meetings are unable to resolve urgent issues speedily, as attested by the failure of successive COPs to take any concrete steps to halt climate change under the United Nations Framework Convention on Climate Change (UNFCCC) that entered into force in March 1994.

During COVID-19, it was the G20, under the presidency of Italy and then Indonesia, that took the concrete step of establishing a Joint Finance-Health Task Force (JFHTF) in October 2021 reporting to Health and Finance Ministers of G20 countries, to enhance the collaboration and global cooperation on issues relating to this and future pandemic prevention, preparedness, and response. This body endorsed the WHO targets that 40 percent of LMIC populations be vaccinated by the end of 2021 and 70 percent by mid-2022. The JFHTF meetings were attended by representatives of international organizations such as the WHO, World Bank, IMF, and UNICEF.Footnote ⁶² A High Level Independent Panel (HLIP) on Financing the Global Commons for Pandemic Preparedness and Response was commissioned on January 26, 2021.Footnote ⁶³ At the fourth meeting of G20 Finance and Health Ministers, it was agreed that a Finance & Health Coordination Platform for Pandemic PPR Financing (Coordination Platform) could work to raise funds and assist in the optimal allocation of financing resources for pandemic PPR and could gradually and selectively be broadened beyond the G20 membership. This idea, however, failed to take off. Instead, at the same time, the World Bank Pandemic Fund was endorsed, which effectively put an end to the Coordination Platform idea.Footnote ⁶⁴

The G20 – despite being an incoherent grouping of countries with divergent national interests – has been a source of excellent reports and ideas in the JFHTF. The G20 works with a temporary secretariat brought in by each rotating president on an annual basis, although the JFHTF is assisted by a temporary secretariat located at the WHO and financed by the World Bank.Footnote ⁶⁵

From as early as April 2021, in a panel discussion convened by the Center for Strategic & International Studies (CSIS), I began advocating for the establishment of an International Pandemic Fund with sufficient funds to procure PRPs for LMICs, and which would have a lean, flexible governance structure headed by an Executive Board consisting of donors/contributors that would take decisions on the basis of votes weighted according to the amount of contributions made.Footnote ⁶⁶ Based on an interview in May 2021, the following was recorded:

The details of the proposal were shared widely in the publicity garnered through the CSIS panel, as well as a presentation made at Georgetown University Law Center, based on which I held discussions with several experts in this area.Footnote ⁶⁸

In July 2021, the G20-commissioned HLIP submitted its report and called for both a finance and governance mechanism and proposed a Global Health Threats Board as well as a Global Threats Fund, structured as a FIF at the World Bank. The HLIP authors believed that such a board, bringing Health and Finance Ministers together within an inclusive G20-plus group, would offer the best alternative in effective pandemic governance.Footnote ⁶⁹

In May 2022, Ruchir Agarwal and Tristan Reed fleshed out a credible proposal on finance and governance. They advocated the establishment of an “Advance Commitment Facility” (ACF) for the pooled procurement of vaccines and other countermeasures for LMICs that would have funds ready from day zero of the declaration of a future infectious disease pandemic.Footnote ⁷⁰ To ensure finance from day zero, they proposed that a financier (a commercial bank/consortium of development banks/private foundation/newly established global health financing agency) establishes a credit line of $20 billion for the ACF on day zero, backed by advance commitments made by participating countries. This is about the amount raised by ACT-A.Footnote ⁷¹ They put forward four options to mitigate the credit risk: one, legally binding pledges by donors, as done for Gavi; two, participating LMICs themselves give joint guarantees to cover risk, as done in PAHO’s Revolving Fund, or to obtain credit in advance, as done by the AVAT, which secured credit from the African Export–Import Bank to purchase COVID-19 vaccines; three, the financier issues a pandemic-linked bond and holds the proceeds in safe securities, ready to be distributed in a pandemic or for the principal to be repaid if no pandemic is declared before its maturity;Footnote ⁷² and four, the financier and its shareholders retain all the risk, where payments are made only during the pandemic and no commitments are made in advance.Footnote ⁷³ The last option appears to me to be the most feasible that can be rapidly agreed to, say in the Executive Board of the World Bank, in the face of a deadly pandemic, even if there is currently no enthusiasm for it.

In terms of governance, Agarwal and Reed suggest that the ACF be governed by an independent board, comprising the representatives of LMICs, donor countries, and the financier, which would delegate the day-to-day management to an independent management team with no conflicts of interest, and would follow rules agreed in advance by all participating countries. The model of both users and donors being part of the governing board exists in the Global Fund.Footnote ⁷⁴

Significantly, these ideas were largely endorsed in October 2022 by the aforementioned independent external evaluation report of ACT-A. The modifications rightly introduced in this evaluation report from the Aggarwal–Reed paper are the representation of regional bodies to ensure better regional and global coordination, mobilization of additional funding, and the idea that contributions should be based on a fair-share allocation model. Details on governance are not included except to say that it should be strong and inclusive. A close reading of the external evaluation report shows that key lessons for future pandemic response would inter alia include:

• A pandemic ACF with access to a credit line that relies on strong and inclusive governance with a stronger representation of regional bodies.

• A coordinated mobilization of additional funding during the pandemic rather than by individual agency efforts.

• A central funding pool, which allows for a stronger needs-based allocation (this was not agreed to by all stakeholders).Footnote ⁷⁵

• Additional resource mobilization by a fair-share model that defines a minimum amount to be pledged by donors with the proviso that this needs to be acceptable to all.Footnote ⁷⁶

Based partly on the June 2021 report of the HLIP,Footnote ⁷⁷ which called for a fund with an annual investment of $15 billion in pandemic preparedness and response, a FIF for pandemic prevention, preparedness and response was approved by the World Bank’s board in June 2022. It was finally established in September 2022 and launched as the Pandemic Fund in November 2022 by the G20.

On the eve of the World Bank proposal of April 2022 for the establishment of a FIF for pandemic preparedness and response, the WHO put out a press release supporting the FIF but at the same time laying down multiple conditions for its functioning. The WHO said inter alia that:

Although the G20 Health and Finance Taskforce gave the WHO and the World Bank an equal role in planning the FIF, there were obviously tensions between the two organizations right from the planning stage. As of mid-November 2022, only a little more than 10 percent of the annual budget of $10.5 billion (an amount of $1.4 billion) had been committed to the Pandemic Fund, of which only about $536 million had been received.Footnote ⁷⁹ This fell far short of its own target of $10.5 billion and of the $15 billion annual commitment called for by the HLIP or the $20 billion advocated by Agarwal and Reed based on the actual expenditure of the ACT-A.Footnote ⁸⁰

The Pandemic Fund’s remit is defined narrowly as bringing “additional, dedicated resources for pandemic prevention, preparedness, and response, incentivize countries to increase investments, enhance coordination among partners, and serve as a platform for advocacy.”Footnote ⁸¹ It has also been said to provide “a dedicated stream of additional, long-term financing to strengthen PPR capabilities in low- and middle-income countries and address critical gaps through investments and technical support at the national, regional, and global levels.”Footnote ⁸² The Pandemic Fund’s website further states:

This would reassure existing organizations/entities involved in different aspects of pandemic preparedness and response that there is no intention of taking over or duplicating any of their functions. However, if a critical gap in funding is involved, what of the other critical gap of global pandemic response governance, namely pooled procurement of PRPs for LMICs? How can the Pandemic Fund achieve its avowed goal of enhancing coordination among its partners involved in a global response to a pandemic? How would the international community address the total lack of coordination in the global response to COVID-19? If the charter of the Pandemic Fund were to merely strengthen national health systems or route funds to various implementing agencies, would many LMICs be motivated to use such an entity, let alone finance it?

In terms of governance, the Pandemic Fund’s Governing BoardFootnote ⁸³ led by two co-chairs (Indonesia and Rwanda) includes twenty-one voting members with representation of nine sovereign donors, nine sovereign co-investors (countries that could benefit from Pandemic Fund projects while also contributing to them), one philanthropic and two civil society organizations (one from the Global North and the other from the Global South).Footnote ⁸⁴ In addition, there are several nonvoting members, including the chair and vice-chair of the Technical Advisory Panel and the G20 Presidency. The World Bank, in its various capacities, and the WHO participate as observers on the Governing Board alongside other multilateral development banks (MDBs) and agencies selected as implementing entities.Footnote ⁸⁵

4 Need for a Global Response Coordinator and Chief Procurer for Future Pandemics

As demonstrated in the preceding section, the existing global governance architecture failed to respond coherently and effectively to end or contain the COVID-19 pandemic. Therefore, the world needs to come together and agree a global strategy as well as a credible implementation entity to better respond to future global infectious disease pandemics. Such a planning and implementation entity must have the necessary funding to enable efficient manufacture and procurement of vaccines and other PRPs and ensure their equitable distribution in LMICs based on actual need, even if it means swapping periods of delivery with HICs and UMICs so that those in greatest need get the products first.

While it may look as though the international community has solved the global pandemic governance issues with the establishment of the Pandemic Fund, it is becoming increasingly clear that this entity will only deal with preparedness and not with response.Footnote ⁸⁶ It will provide initial funding to incentivize national governments to invest in three priority areas: comprehensive disease surveillance and early warning systems; laboratory systems; and human resources and public health and community workforce capacity. Clearly the Pandemic Fund will not deal with procurement and distribution of PRPs, a role assigned in COVID-19 to ACT-A and in the future possibly to an ACF, as recommended by the ACT-A evaluation report. It is certainly not the one-stop International Pandemic Fund – that should be the overarching coordinating entity responsible for containing a pandemic as quickly as possible – that I had advocated for. Many questions arise about the management of a global response to a future infectious disease pandemic and about the nature of governance of a new LMIC procurement and global response coordination entity that would be most effective in containing a future pandemic. Some of these questions are raised below and require consideration by the international community but, given the October 2023 draft of the WHO Pandemic Agreement,Footnote ⁸⁷ it is clear that only general language on response may be agreed and that, despite the activism around this issue, equity in the distribution of PRPs will remain a vague objective.

5 Conclusion

What we have learned from our experience so far with containing COVID-19 is that the key constraint for overcoming a future pandemic is inadequate funding and coordinated global response to contain the pandemic, and that the glaring lack of a coherent, well-coordinated global strategy to procure and equitably distribute vaccines and other PRPs to LMICs led to new variants of the SARS-CoV-2 virus, thus unnecessarily prolonging the pandemic. In response, this chapter advocates for a new, independent, global procurement and response coordination entity and has raised key questions that need to be debated in considering how the effectiveness of this entity can be optimized to plug this gap for future pandemics.

LMICs urgently need an effective entity that is responsible for ensuring the timely procurement and equitable distribution of vaccines and other PRPs to contain or end global infectious disease pandemics as quickly as possible. Such an entity should be fully empowered financially, and be independent, lean, and flexible if it is to meet its primary goal to contain the pandemic everywhere as soon as possible in order to minimize both human and economic losses. This goal would lead to the best outcomes globally, including in LMICs, as equity is best served by a quick end to the pandemic.

Although the financial solutions on offer by multilateral development and financial institutions, including the Pandemic Fund, would help pandemic preparedness at the national level, the pandemic would not end unless there was a coherent, empowered, and efficient global response coordination and procurement entity. Unfortunately, effectively containing global pandemics is not the only transboundary public good problem that the international community is grappling with; a few others that come to mind are reducing the deleterious impact of climate change, eliminating extreme poverty, dealing with antimicrobial resistance, and addressing other urgent public health and economic development and security challenges to prevent cross-boundary spillovers. The international community, including the international financial institutions, need to find ways to effectively tackle all these transboundary public goods without further loss of time; and in doing so should not underestimate the reality of future pandemics. Should the international community not take the steps now to empower an entity to effectively lead the world out of future pandemics as quickly as possible then humanity will be fated to muddle through – as we have done during COVID-19 – based upon the underlying, incorrect premise that that each country can solve its own problems without concern for the rest of the world, resulting in an unprecedented loss of lives and livelihoods all over the globe.

The unprecedented scale of the COVID-19 virus has brought to the forefront many questions associated with exclusive rights, information sharing, and innovation. How do we get effective vaccines, therapeutics, diagnostics, medical devices, and personal protective equipment (PPE) quickly, safely, and affordably to people around the world? More specifically, how do we ensure that effective products in sufficient quantities are researched and developed, approved by regulatory agencies, and produced for public distribution; that repairs of existing equipment can be performed as needed; that such health products are affordable; and that the needed products are equitably distributed globally and locally? Among many challenges on the road to these outcomes is the difficult question of how to handle information that is valuable, in part, because others do not know it. In other words, what do we do about trade secrets? Addressing this issue will continue to be critical to COVID-19 responses, as well as to responses to future pandemics and similar worldwide problems.

Because trade secrecy can apply to wide swaths of information, it can hide a shockingly broad range of critical and life-saving information from view. For this reason, assertions of trade secrets constitute much of the primary knowledge necessary for countries to combat and even potentially eradicate COVID-19. Indeed, trade secrets are everywhere in the battle to defeat COVID-19, including clinical trial data, pharmaceutical and medical equipment manufacturing processes, and regulatory compliance information.

Trade secrets raise three primary issues. First, if an entity is forced to share trade secrets to expedite development and to expand the supply of needed products, must or should the government compensate the rights holder? Although we address this question, we think it is largely unnecessary to answer it. This is because compensation is not required under international law (at least to address public health emergencies), because national law may sometimes already provide for compensation when compelling licensing (as well as when mandating sharing that eliminates secrecy), and because we think reasonable compensation should normally be provided for compelled trade secret sharing. Second, does international law prohibit governments from compelling the sharing of trade secrets, including by compulsory licensing? The short answer is no. Third, what authorities currently exist or could be adopted for governments to compel the sharing of trade secrets? We present below a general overview of a range of existing authorities, as well as a framework for addressing the latter two questions and for understanding the complexity of the first question.

Section 1 provides brief background on the nature of trade secrets, trade secret laws, and takings law. Within trade secrets, we distinguish between codified knowledge and recorded data on the one hand and uncodified “know-how,” “show-how,” and expertise on the other. All of these may qualify as trade secrets and may need to be shared to expedite or expand research and development (R&D) and manufacture of needed products such as pandemic vaccines, although it may be much more difficult both legally and practically to compel the sharing of uncodified knowledge.

Section 2 discusses COVID-19 and the experiences with trade secrets regarding vaccines. We use the COVID-19 vaccine example to explain why trade secret sharing is needed, why patent disclosures and compulsory licenses are inadequate to meet current needs, and what kinds of trade secrets may need to be shared from rights holders to other users, with or without rights holders’ voluntary consent. We thus demonstrate the necessity of compelled trade secret sharing to address public health needs generally, as the voluntary sharing of trade secrets has proven inadequate to assure timely, affordable, and equitable global access to the medical products described above. The need for such trade secret sharing will only grow in the event of an even more serious, rapidly escalating future pandemic.

Section 3 explains why the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)Footnote ¹ of the World Trade Organization (WTO)Footnote ² does not prohibit governments from compelling trade secret rights holders to share trade secrets with others in the same or different jurisdictions, at least to address public health needs. Because such compelled sharing may take the form of compelled licensing where compensation is awarded, or because governments may themselves award compensation for the sharing, there should be no need for additional compensation. Nevertheless, the TRIPS Agreement does not prohibit compelled sharing to address public health needs even when compensation is not provided.Footnote ³ And we do not believe any investor expropriation or unfair treatment claims for compensation against governments, under bilateral or regional investor–state dispute settlement (ISDS) treaties, would be successful (particularly if some compensation is already provided under national law for compelled trade secret sharing or licensing).

Section 4 surveys some of the existing authorities already possessed by federal and state governments in the United States and by the European Union to compel trade secret sharing, with or without compensation, or to compel trade secret licensing by trade secret rights holders. These authorities include the Defense Production Act (DPA),Footnote ⁴ antitrust authorities, federal health authorities, and state police powers (to the extent not preempted by federal law). The point of reciting these provisions is to demonstrate that compelling trade secret sharing is much less “exceptional” than opponents may claim, and that there is nothing, save for political opposition, standing in the way of assuring that trade secrets can be compulsorily shared or compulsorily licensed to ensure expanded R&D, clinical testing, and production to better protect global public health. We also discuss the possibility of legislative changes that would provide even more explicit authority, as well as the use of conditional funding approaches that would make the acceptance of government funds conditional on voluntary agreement to share trade secrets as needed.

We believe that global public health needs must be given greater importance in the debates on international policies concerning intellectual property (IP) rights and trade. These are ultimately political decisions, and legal authority already exists to make them. We explain the pathways for policymakers who choose to compel trade secret sharing, along with the theoretical foundations that underlie those pathways.

1 Trade Secret and Related Protection

In the COVID-19 context, trade secret law raises a critical policy question: Is information sharing needed to rapidly combat the spread of disease and to enable vaccine production? In the case of COVID-19 vaccines, potential trade secrets included manufacturing processes, test data, medical formulas, and other biological resources.Footnote ⁵ This is because vaccines and other biologic medicines, cell lines, genomic information, and other biological material can also be held as trade secrets. Similarly, data about the effectiveness of medicines and vaccines are trade secrets. Manufacturing processes – the “know-how” of producing vaccines – can be a paradigmatic trade secret,Footnote ⁶ or can fall into the amorphous quasi-trade secret categories of “know-how” or “show-how.”Footnote ⁷ All of this information is essential to the rapid development of, and access to, safe and effective COVID-19 diagnostics, treatments, and vaccines worldwide.

Similarly, data for developing vaccines may be held as trade secrets.Footnote ⁸ Typically, clinical data are not required to be made public as a condition of regulatory marketing approvals, even if the government can use such data when evaluating requests for generic product approvals.Footnote ⁹ In many cases, such data and methods need not be disclosed to assure compliance with good manufacturing practices that permit product marketing.Footnote ¹⁰ Methods of assuring that the public can “make and use” patent disclosures and legal authorizations in the patent context, such as compulsory patent licenses, cannot assure private access when needed to scale up research, development, regulatory approvals, and manufacturing supplies.Footnote ¹¹

Methods for manufacturing may also be treated as trade secrets. Such methods often are colloquially known as “know-how,” a subset of trade secrecy doctrine involving information that is valuable and difficult to transfer but that is not necessarily secret because it is generally known among industry players.Footnote ¹² Such information may not always be protectable under trade secret law.Footnote ¹³ Nonetheless, because of its value in manufacturing processes and difficulty to acquire, know-how that does not achieve trade secret status operates similarly to trade secrecy as property that can be licensed.

In the case of COVID-19 research, product development, commercialization, and data and manufacturing processes are key trade secrets.Footnote ¹⁴ After all, if a company knows what works and what does not then it has a competitive advantage over others who lack that knowledge. When it possesses efficient means of production, the trade secret owner enjoys a significant competitive advantage. As has been evident regarding COVID-19 vaccine production from the beginning, such information sharing is critical to worldwide supply needs, but has occurred only to a limited extent through voluntary licensing among a mostly restricted set of global pharmaceutical companies and manufacturers.Footnote ¹⁵ Global pharmaceutical companies have rejected requests from various generic pharmaceutical producers to license the trade secrets and know-how to scale up production.Footnote ¹⁶

2 Trade Secrecy and COVID-19

Should actual trade secrets be shared? To answer this question, it is important to understand how and when trade secrets ensure that the protected information best serves public uses, and how and when they do not. Here we focus on the vaccine manufacturing process.

In the COVID-19 context, certain possible trade secrets, like production processes, might serve society more thoroughly through wider public access to the information, allowing full technology transfer that would foster more rapid expansion of needed manufacturing capacity and also might reduce prices through greater competition and increased supplies. Other trade secrets, like those in the R&D phase, might be held as trade secrets to encourage market entrants to act quickly, although doing so may hinder follow-on competition.Footnote ⁴⁴ Deciding when trade secrecy promotes or hinders such developments poses questions that historically have been answered by experts in vaccine manufacturing and industry structure, as the economics literature does not provide clear answers.Footnote ⁴⁵ As they involve public choices about competing values, moreover, they invariably require political determinations.

Because trade secrecy spans the range of vaccine development, clinical practice, and regulatory approvals, production, and distribution, changes in how trade secrets are treated can have vast and rippling consequences. We do not address all these issues, much less the difficult issues involved in assuring better global public health systems and adequate supply and distribution chains.Footnote ⁴⁶ Rather, we make the case that compelled knowledge sharing notwithstanding trade secret law is possible and desirable.

3 Compelling Trade Secret Sharing Complies with International Treaty Law

Any government-compelled actions may make a trade secret public (and thus destroy its secrecy) or may only assure competitors’ abilities to use the trade secret (as by compelled licensing that also requires secrecy relative to the public).Footnote ⁷⁸ Either the loss of the trade secret through publicity or the government-authorized third-party use of the secret may be compensated. This should (in most cases) avoid concerns about uncompensated regulatory expropriation of the value of the trade secret. And even if international law does not prohibit – or even if it explicitly authorizes – compelled trade secret sharing, national laws may need to be amended or existing national legal authorities may need to be exercised, such as by issuing orders compelling the sharing.

The WTO’s TRIPS Agreement is the principal international treaty governing IP. The TRIPS Agreement incorporates relevant provisions of the Paris Convention for the Protection of Industrial Property.Footnote ⁷⁹ But the TRIPS Agreement does not expressly or impliedly prohibit governments from compelling trade secret sharing, unlike its provision expressly prohibiting compulsory licensing of trademarks.Footnote ⁸⁰ Further, as a matter of interpretation, the obligations for trade secrets (“undisclosed information”) apply only to protection against “unfair competition,” defined as “disclos[ur]e … or use” “contrary to honest commercial practices”;Footnote ⁸¹ for “undisclosed test or other data,” the provision applies only to protection against “unfair commercial use.”Footnote ⁸² Although the nature of the prohibited acts has not been officially interpreted in any dispute resolution proceeding in the WTO,Footnote ⁸³ it is unlikely that the TRIPS Agreement prohibits governmental decisions to compel sharing of such information for public need or public benefit, as the recited prohibitions are focused on commercial morality.

Even if the TRIPS Agreement did impliedly prohibit compelled licensing or other compelled sharing of trade secrets, the TRIPS Agreement’s national security exceptionFootnote ⁸⁴ may authorize national governments to compel trade secret sharing in a pandemic.Footnote ⁸⁵ Specifically, article 73 provides that “nothing in this Agreement shall be construed: … (b) to prevent a Member from taking any action which it considers necessary for the protection of its essential security interests … (iii) taken in time of war or other emergency in international relations.”Footnote ⁸⁶ In short, the TRIPS agreement cannot and does not prohibit member countries from compelling trade secret sharing to address public health needs.Footnote ⁸⁷ Nor would any ISDS treaties authorize any injunctive relief to prevent trade secret sharing from being compelled.

4 National Routes for Expanding Access to Trade Secrets

Compelling trade secret sharing or requiring compulsory licensing of trade secrets is not in any way unusual or exceptional. Even if it is not a “commonplace” occurrence, the authority exists to be employed whenever it is appropriate to do so. Such authority has been used routinely in the past without any concern for destroying the trade secret status or for the adequacy of compensation to the rights holder. It is only where legislation specifically and expressly prohibits agencies from exercising authority to publicize trade secrets that the authority to share (much less to publicize, and thus render no longer secret) a trade secret may be lacking.Footnote ¹²¹

5 Conclusion

Because the sharing of, or failure to share trade secrets creates life-or-death consequences for hundreds of millions of people around the world, COVID-19 has forced the question of public access to trade secrets to the front of the long list of global health challenges that we face. If we are to defeat pandemics in a safe, effective, and expeditious manner, then we will need to find a new balance between the interests of trade secret owners and the public. As a recent review has noted, when arguing for changing worldwide IP and health rules through the yet-to-be negotiated Pandemic Treaty, the COVID-19 funding agreements did not adequately transfer know-how for vaccine production, leaving many parts of the world without needed protection.Footnote ¹⁷¹

The ability to compel trade secret sharing is critically important, and not just for COVID-19 pandemic protection. Adding these measures to the routine arsenal of government actions can help address future pandemics and other global problems, such as climate change mitigation and adaptation.Footnote ¹⁷² This chapter makes the case that it is also unexceptional to do so, as worldwide sentiment has already produced significant agreement (albeit with some gaps) on sharing requirements for different kinds of information that might be kept as trade secrets or as confidential business information – that is, access to the pathogens themselves and to genetic sequence information that can accelerate global response to pandemic diseases.Footnote ¹⁷³

The potential for litigation and compensation, and the desire to preserve competitive trade and technology advantages, should not deter governments (particularly wealthy governments) from taking needed actions to compel trade secret sharing to protect global health. Even without treating this as a moral obligation (the “Golden Rule”),Footnote ¹⁷⁴ it will likely protect the citizens of the sharing jurisdiction from death, disease, and hardship far more than any short-term competitive advantages and benefits that might otherwise be obtained.

At the outset of the COVID-19 pandemic, numerous observers recognized the potential for patents and other intellectual property (IP) rights to hinder the development and dissemination of medical equipment and products responsive to the virus. Concerns over the impact of IP rights on pandemic response led to a range of national and international governmental interventions. Yet these concerns also spurred voluntary, private action by IP rights holders. This chapter discusses and assesses these private initiatives, with a focus on the Open COVID Pledge (OCP), an initiative that I helped to organize. The OCP eventually led to the voluntary commitment of an estimated 500,000 patents to the COVID-19 response, was endorsed by Universities Allied for Essential Medicines (UAEM) and adopted by the World Health Organization’s (WHO) Covid Technology Access Pool (C-TAP) as a recommended mechanism for making technology available in the COVID-19 response.Footnote ¹

1 COVID-19 and IP Rights Concerns

Concerns about patents and other IP rights emerged in early 2020 as the COVID-19 pandemic began to spread globally. Many potential vaccines, diagnostics, and treatments for COVID-19 were originally targeted at related diseases including malaria, hepatitis C, influenza, Marburg virus, Ebola, Middle East Respiratory Syndrome (MERS), severe acute respiratory syndrome (SARS), and human immunodeficiency virus (HIV).Footnote ² A number of these compounds were covered by existing patents and patent applications held by companies and institutions across North America, Asia, and Europe. One study identified over 120 different entities holding patents covering diagnostic tests relevant to COVID-19.Footnote ³ In addition, researchers identified a large number of patents covering the manufacture, operation, and components of devices and equipment used to treat the symptoms of COVID-19 and to monitor and contain its spread, including respirators, ventilators, diagnostic kits, facial masks, algorithms, mobile apps, and the like.Footnote ⁴

Early in the pandemic, a number of high-profile incidents involving patents galvanized concern over these issues. For example:

• In February 2020, the Wuhan Institute of Virology in China announced that it had filed a patent application claiming the use of Gilead Sciences’ experimental antiviral drug remdesivir to treat COVID-19.Footnote ⁵ The announcement caused significant concern, given that the Wuhan Institute did not develop the drug and its effectiveness against COVID-19 was still unproven.Footnote ⁶ Gilead’s own patents on the drug also caused controversy, prompting thirty state attorneys general to request that the US National Institutes of Health (NIH) exercise its march-in rights under the Bayh–Dole Act of 1980 to authorize additional manufacturers to operate under Gilead’s patents in order to meet predicted demand for the drug.Footnote ⁷

• In March 2020, two engineers in Brescia, Italy, a region particularly hard hit by the pandemic, used a desktop 3D printer to fabricate replacement valves for more than 100 ventilator machines used at a local hospital.Footnote ⁸ Early news reports claimed that a ventilator manufacturer threatened to sue the engineers for infringing patents covering the valves.Footnote ⁹ While the existence of the threat and the patents themselves remains murky, the incident sparked a flurry of commentary regarding the risks that volunteers and hospitals could face from patents.Footnote ¹⁰

• Later in March, patent assertion entity (PAE) Labrador Diagnostics sued French firm bioMérieux and its Utah-based subsidiary BioFire Diagnostics for patent infringement. Labrador alleged that diagnostic kits being developed for COVID-19 infringed patents it had acquired from defunct blood-testing company Theranos.Footnote ¹¹ News of the lawsuit sparked a wave of negative publicity that quickly persuaded Labrador’s parent company, Fortress Investments, to end the lawsuit and offer royalty-free licenses to anyone conducting COVID-19 testing.Footnote ¹²

• On April 1, Kentucky governor Andy Beshear publicly called on 3M Corporation to grant broad access to more than 400 patents covering “N95” respirators used by healthcare workers and other individuals at high risk of infection.Footnote ¹³ Beshear was responding to severe shortages of protective equipment in his state, which he and others attributed to patents that prevented firms other than 3M from manufacturing them.Footnote ¹⁴ He is reported to have urged 3M to license its patents to “the nation” as its “patriotic duty” in a time of national crisis.

• Beginning in April, another PAE, Swirlate IP, brought patent infringement suits against more than a dozen manufacturers of products including ventilators and blood glucose monitors.Footnote ¹⁵ The asserted patent covered wireless communications technology and was originally owned by Panasonic.

• In July, Vancouver-based AbCellera Biologics sued rival Berkeley Lights for the infringement of eight patents originally issued to the University of British Columbia.Footnote ¹⁶ In the suit, AbCellera sought an injunction to prevent Berkeley from selling its Beacon Optofluidic System, which was used for the discovery and development of antibodies against COVID-19.

• From the earliest weeks of the pandemic, patents were also perceived as hindering research efforts relating to COVID-19. As one senior molecular biology researcher recalls:

  [F]rom the first moment we started having these [COVID-19] meetings there were discussions of patents. There were discussions of things that we couldn’t do because they were patented; there were discussions of things where we didn’t know if we could do them, if they were valid things that we could use to pursue strategies to deal with the pandemic because of patents. And even more astonishingly to me, there were already discussions about patenting the things that were going to happen in these Covid labs.Footnote ¹⁷

• Finally, in the crucial area of vaccine research, it soon became apparent that a patent “gold rush” was on. One news report in May 2020 announced, “Virus Researchers Race to File Patents,”Footnote ¹⁸ long before any vaccine candidate was close to approval. Echoing concerns over the inaccessibility of patented vaccine technologies during the SARS and Ebola outbreaks, the WHO urged governments and the private sector to make patents broadly available in the fight against COVID-19.Footnote ¹⁹

These examples demonstrate that the specter of patent liability and litigation manifested itself from the early days of the pandemic in areas ranging from basic research and vaccine development to the manufacture, supply, and distribution of medical supplies and equipment.

2 Private Ordering Responses to COVID-19 IP Threats

The public reaction to concerns over IP rights was swift and included the issuance by half a dozen countries of compulsory licensing orders for COVID-related biomedical technologies.Footnote ²⁰ Later in 2020, calls were made to the World Trade Organization (WTO) to waive trade-related penalties on countries that imposed compulsory licensing requirements on COVID-19 vaccines and other technologies.Footnote ²¹ But voluntary efforts also emerged to address perceived areas in which patents and other IP could hinder the response to COVID-19.

3 The Open COVID Pledge

This section describes the genesis and evolution of the OCP and details some of the considerations that went into its design, drafting, and implementation, as well as its adoption in the market.

4 Conclusion

Intellectual property concerns characterized the COVID-19 pandemic from its outset. In addition to various governmental and international efforts to address these concerns, private sector organizations made a number of voluntary pledges in an effort to facilitate the pandemic response. One such effort was the Open COVID Pledge, which was modeled on successful public licensing structures previously developed by the open-source software community and Creative Commons. An estimated 500,000 patents were pledged under the OCP within a short period of time. However, the willingness of IP holders to make pledges varied considerably by market segment. At one end of the spectrum, few pledges were made with respect to biopharmaceutical products such as vaccines and treatments, most likely due to the substantial economic gains that awaited the successful producers of those products. In this area, more direct governmental intervention may be required to encourage IP holders to make their IP more broadly available to expand access to lifesaving vaccines and therapies.

At the other end of the spectrum, however, a significant amount of IP was pledged in the areas of PPE and digital innovation, and to a lesser degree in diagnostics and medical devices. Pledges made through the OCP and other pledging mechanisms enabled the development and manufacture of hospital ventilators and replacement parts, respirators, and a variety of other medical tools and devices. In addition, large quantities of IP covering digital innovation were pledged for public use, including biopharmaceutical discovery tools, contact tracing methodologies, disease modeling algorithms, emergency response systems, supply chain enhancements, and social media mechanisms for ensuring the accuracy of information disseminated to the public. The participation of leading multinationals in this effort signals an openness to market entry that should be attractive to innovators in a broad range of technology markets. Moreover, even if innovators are unaware of specific pledged IP, or the existence of such pledges, the resulting lack of IP enforcement in these market segments should, itself, encourage further development and innovation that might otherwise be chilled in an atmosphere of active IP enforcement.

Thus, while measuring the impact of IP pledges on markets is difficult, particularly given the large pledges made under the OCP and similar programs, there is cause to be optimistic that such pledges may be having an effect on the willingness of innovators to invest in the development and supply of products that may contribute to the pandemic response. This “opening” of fields to innovation and new market entry is among the principal benefits of the OCP.

Regrettably, COVID-19 is not likely to be the last public health emergency to afflict the world. Future pandemics, as well as global climate change and its associated health impacts, will create even greater demand for access to innovative, lifesaving technologies. It is hoped that the OCP, which was designed to balance the competing interests of broad user adoption with acceptability to IP holders in a lightweight and legally enforceable manner, may be a useful model for future IP sharing endeavors.