The COVID-19 Innovation System | Health Affairs
The coronavirus disease 2019 (COVID-19) crisis called for innovations in research, including the development, evaluation, and use of new therapies and vaccines. The need for speed was evident in the branding of the largest public policy response—the U.S. government’s “Operation Warp Speed.” According to one of many trackers, as of this writing there are 362 therapeutics and 221 vaccines for COVID-19 currently in development, many of these in late-stage clinical trials or with preliminary authorizations.1 This response has featured new policies and private actors confronting challenges in novel ways. In this paper, we take stock of the key features of the COVID-19 innovation system.
Before COVID-19, in the U.S. and globally, biomedical innovation policy relied on two major approaches: “push” mechanisms, which promote innovation through direct up-front funding for research and development (R&D) inputs, and “pull” mechanisms, which reward successful development of products.2 The biggest single push actor globally has been the U.S. National Institutes of Health (NIH), with a budget of nearly $40 billion in 2019. NIH funding is heavily oriented toward basic research, primarily through grants to universities and medical schools.3 These push efforts have largely supported fundamental discoveries, with less attention to how these findings are developed into products and diffused through the health care system. The bulk of late-stage, downstream product development, including financing of clinical trials, has been undertaken by private industry.
The dominant pull for the private sector has been through the patent system. Patents allow innovators to avoid competition for limited periods of time. The absence of competition allows innovators to charge higher prices than they would otherwise. Patents promote innovation through the lure of high profits.
Patents are particularly important as innovation incentives in the drug industry.4 Once patents expire, competition ensues and prices typically decrease.5 Concerns that patents create high prices and restrict access have led policymakers to explore tools to limit their effects.6 Patents are also less effective at stimulating R&D for diseases that predominate in poor countries lacking rich markets. In the 1990s responding to these limitations, economists and others proposed using prizes and “advance market commitments” (AMCs) as alternative pull mechanisms for biomedical innovation.2
The COVID-19 innovation policy response has involved different players and policies. While some questions about patents and public funding from the pre-pandemic era persist, new ones have arisen as well.
COVID-19 Innovation Policy: Push Funding
In response to COVID-19, governments, Non-governmental organizations (NGOs), and philanthropies across the world have invested in research and development of therapeutics and vaccines. However, both the funders and the types of activities receiving support seem different than they were before the pandemic. Understanding who has been doing what is challenging, since there are no complete databases on global R&D, some sources are proprietary, and in many cases the funding is non-transparent. However, using data we can piece together, a consistent picture emerges of public sector support for downstream research, development, and production.
The U.S. Push Response
The largest funding response has been from the U.S. government. Roughly $14–$15 billion of the $4 trillion allocated to the COVID-19 response was spent on vaccine and treatment R&D.7,8 Though this increased U.S. federally-funded biomedical R&D by about one-third (compared to previous NIH funding; see online appendix),9 it is small compared to the potential value of these interventions for ameliorating or preventing the disease and securing a return to normalcy.10
With COVID-19, both the focus of the NIH’s activities and its role in the overall innovation system have changed. By late April 2020, when Congress allocated an additional $3.5 billion to NIH for COVID-19 research, a worldwide rush of research on treatments and vaccines had already begun. The NIH took steps to coordinate the efforts of public and private researchers globally, to focus on promising candidates and avoid duplicative research. The centerpiece, announced in April, was the “Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)” partnership, which would “inventory drug and vaccine candidates and decide which should get priority for U.S. funding and testing in humans.”11 The NIH has also funded trials of specific treatments, and helped to support the development of several of the leading vaccine candidates.12
NIH’s efforts were superseded by the White House’s announcement in May 2020 of Operation Warp Speed, an “America First” program for vaccine, therapeutics, and diagnostics development vaguely inspired by the Manhattan Project to develop the atomic bomb during World War II.13 Warp Speed had the goal of developing a vaccine and securing 300 million doses for Americans by January 2021. A partnership between the Department of Health and Human Services (including NIH) and the Department of Defense, Warp Speed appears to have directed over $15 billion to combat COVID-19, through push funding, pull funding, and a combination of the two.8
Most Warp Speed funding has been routed not through NIH but another HHS agency, the Biomedical Advanced Research and Development Authority (BARDA), established in 2006. BARDA has received more than 4100 funding requests, has entered into discussions with more than 500 prospective recipients, and has funded more than 70 projects.14,15 Many have questioned the Warp Speed/BARDA decision-making processes.16 Though Warp Speed was explicit about the goal of diversifying the U.S. vaccine portfolio,17 coordination with global actors engaged in similar innovation-funding activities, in particular China and the Coalition for Epidemic Preparedness Innovations (CEPI), has been minimal. Commentators have also noted the heavy reliance on military rather than health leadership,18 lack of collaboration with the NIH,19 and a lack of transparency in contracts including with respect to taxpayers’ rights in the resulting products.20
While the NIH has spent about $2 billion on COVID-19 research so far (see appendix for details)9 BARDA contracts amount to nearly $15 billion.21 Both agencies are spending substantial portions on vaccine-related research. At the NIH, about 30 percent of COVID-19 grants (accounting for 47 percent of funding) have vaccine keywords; the comparable figures for FY2019 were 5 percent of grants and 8 percent of funding (see appendix).9 At BARDA, 77 percent of funding is for vaccines or vaccine administration, 13 percent for therapeutics, and 9 percent for vaccine and therapeutic manufacturing, and the remainder for diagnostics and other technologies.21
BARDA is focused on downstream activities. While full contracts are not publicly available, the agency’s announcements15,21 indicated that it is funding not only applied R&D, but also late-stage clinical trials, expanded manufacturing capacity, and scaled up production (including agreements directly with contract manufacturers to reserve production capacity for BARDA-funded projects). The manufacturing investments are considered “at-risk,” since they were made before assurance of R&D success or regulatory approval. Supplemental exhibit 1 summarizes the vaccine contracts.9 Note that several push contracts also include a pull provision (procurement), highlighting that in practice, categories that are distinct in theory blur into each other in the COVID-19 context.
BARDA’s support for therapeutics shows similar patterns. For example, agreements with both Regeneron and AstraZeneca for development of “antibody cocktails” funded both clinical trials and at-risk manufacturing. Another element of the U.S. approach to therapeutics, reflecting the overall focus on addressing downstream challenges, is that the Department of Justice granted leading antibody manufacturers permission to share technical information about production, to facilitate rapid scale-up.22,23
Global Push Efforts
Other global actors have also contributed funding for therapies and vaccines. The European Union (EU) has provided financing from the European Investment Bank (though less than $1 billion), as part of a broader package of loans of over $25 billion for Covid-19 response24 (additional information on how this was calculated is available in the appendix).9 EU member states such as France and Germany have provided research funding, as has the United Kingdom. Several of the leading vaccine firms received funding from a German government program to accelerate research and late-stage product development,25 and the UK government has invested in increasing vaccine manufacturing capacity.26 From what we can infer from funding announcements and proprietary data provided by Airfinity, a science data analytics company,27 public funding in Europe is considerably lower than in the U.S. However, the European funding approach shares similar characteristics with the U.S. approach, including an emphasis on vaccines, and a focus on downstream development and manufacturing. Similar to the U.S., and reinforcing the focus on production, the EU also permitted collaboration to avoid supply shortages.28
Consistent with what we saw in the U.S., global push efforts include the organization and support of clinical trials, particularly “repurposing” trials to learn about the potential use of known medications for treating COVID-19.29 The UK government, for example, sponsored the RECOVERY trial, which evaluated a range of antivirals, antibiotics, antibodies, and steroids, as well as convalescent plasma. At the multilateral level, the World Health Organization (WHO) ran the SOLIDARITY trial to examine 4 medications, including remdesivir and hydroxychloroquine.
Funding data are unavailable from China and Russia, both of whom appear to have made substantial investments in R&D and are responsible for 7 of the 14 vaccines in Phase 3 trials (as of late-2020). More broadly, looking at the 81 vaccines that have begun human trials, 15 originate in China (second to the US), and 4 are from Russia, according to data from Airfinity.27
Philanthropies have also played important roles in encouraging vaccine innovation. In addition to directly funding several vaccine producers, the Bill and Melinda Gates Foundation is also one of the founders of CEPI, created in 2017 to develop vaccines against emerging infectious diseases.30 CEPI has a diversified portfolio of COVID-19 vaccine candidates to which it provided or committed nearly $1.2 billion.31 Here too, push and pull interact: CEPI aims to fund vaccines with the expectation recipients will provide doses to a global purchaser, COVAX (which we discuss below). However, CEPI’s financial contributions are small compared to the resources that the U.S. has provided to some of the same recipients, in these cases limiting CEPI’s ability to steer vaccine allocation.
Like the NIH, CEPI has also been playing a coordinating role, including “matchmaking” to find competent global producers for different types of vaccines currently in development, eyeing the need for global scale up.32 Other philanthropies have also participated. For example, in Latin America, the Carlos Slim Foundation has supported at-risk manufacturing of the Oxford/AstraZeneca vaccine in Argentina and Mexico.33
In addition to vaccines, philanthropies have also has been active in the push for treatments. The Gates Foundation, along with the Wellcome Trust and Mastercard, established the “COVID-19 Therapeutics Accelerator” to support development and scale-up. The Therapeutics Accelerator reports having made 11 grants (totaling $98 million) for evaluating approved drugs as treatments and for studying new therapeutics.34
Finally, philanthropic actors have also contributed to the World Health Organization’s (WHO) COVID-19 response. CEPI co-leads the vaccines pillar of the WHO’s “Access to Covid Tools (ACT) Accelerator,” and Wellcome co-leads the workstream dedicated to treatments.35
Collectively, the major push efforts globally represent a funding effort very different from the dominant one before the pandemic. Push efforts around the world are more focused on vaccines than therapeutics. Even before the pandemic, downstream vaccine research featured substantial public support,36 and that is reflected in the COVID-19 approach. But the degree of shift—including billions in funding for late-stage trials, building manufacturing capacity, and manufacturing at risk—is remarkable. Other aspects are also notable: though individual funders are supporting multiple firms and approaches in attempts to diversify, there is limited coordination among the push efforts. Finally, in the U.S. and globally, push efforts also appear to involve facilitating collaboration among private actors.
COVID-19 Innovation Policy: Pull Mechanisms
Patents
It is unclear if the prospect of patent protection offers meaningful pull. Patent applications are published 18 months after filing, and then can take several years to grant. Depending on how long the pandemic lasts, patents filed in 2020 may arrive too late to offer meaningful protection, unless they qualify for one of the United States Patent and Trademark Office’s limited accelerated examination programs.37.38 Another source of uncertainty, one that is always present in pharmaceutical R&D but compounded by the rush of activity during the pandemic, is that competitors may have filed for overlapping claims. Firms may also have diminished expectations about the enforceability of patents and the ability to use them to command high prices during the pandemic.39
The pre-pandemic patent landscape may have a greater effect on pull incentives than future patent prospects do. The mRNA technology platforms are widely patented, as are viral vector delivery systems.40 Possibly these patents provide firms with some exclusionary rights in the short run, and shape incentives for follow-on innovation and development. Similarly, therapeutics that were already under development for other purposes and have patent term remaining (e.g. remdesivir) may be more commercially attractive for repurposing to COVID-19 than those that are off-patent. In principle, push mechanisms could encourage investment in older drugs too, as illustrated by the RECOVERY trial’s demonstration of the efficacy of dexamethasone. It is unclear, however, the extent to which the public sponsors of repurposing initiatives pay attention to the patent environment in prioritizing which drugs to study.29
Other Pull Incentives
Since early in the pandemic, economists and others have called for the use of other pull instruments to incentivize drug development and manufacturing, such as prizes and advance market commitments, whereby governments, donors or philanthropies commit to purchasing large volumes that could then be made available at low prices.10,41,42 As discussed, BARDA has included procurement agreements in its funding contracts. Many other countries beyond the US also made advanced purchases, including the European Union, UK, Australia, Canada, Israel, and Japan, and countries throughout the Global South. Note that these are producer-specific rather than the market-wide commitments suggested in previous AMC or prize proposals.2,41
At the global level, the most important pull arrangement for vaccines is COVAX, a pooled procurement initiative led by Gavi, CEPI, and the WHO.43 COVAX includes an AMC that aims to raise funding from donors and through development assistance44 to procure enough vaccine doses to be able to vaccinate 20 percent of the population against COVID-19 in 92 low- and middle-income countries. COVAX also has facilities for upper-middle- and high-income countries, including those that have purchased doses directly from vaccine developers, to participate in pooled procurement.
Like the push funding, most of the known U.S. and global procurement agreements focus on vaccines rather than therapeutics. Exceptions include BARDA’s support of Regeneron and AstraZeneca’s monoclonal antibodies, where the agreements also appear to reserve some of the early doses;15 and the Gates Foundation reportedly reached a pre-approval agreement with Eli Lilly for the supply of its COVID-19 antibody for lower- and middle-income countries.45
Collectively, the contracts with individual countries and global purchasers may have incentivized and accelerated development among participating firms.46 Another way to think about advance procurement agreements is not as innovation incentives, but as mechanisms for countries to secure priority access to vaccines,46,47 as we discuss below.
What incentives are motivating the many other firms, beyond those with procurement contracts, involved in vaccine and treatment research? It may simply be the expectation that there will be demand for their products and ways to exclude competitors. Given uncertainties about the timing and enforceability of patents, other barriers to imitation from competitors could be particularly important.
COVID-19 Innovation Policy: Diffusion, Prices, And Access
Patents And Access To Medicines
Long before the pandemic, observers expressed worries that high prices can lead to restricted access to medicines, and have explored legal tools to circumvent patents to alleviate these concerns.6 The use of such tools has been proposed for COVID-19 technologies. Though these may not be relevant in the context of advanced purchase agreements, where the prices have already been established, they could be important for securing lower prices of approved products going forward.
In the U.S., some suggest using legal provisions allowing government use of patents, and also the never-deployed “march-in” provisions of the Bayh-Dole Act, to promote generic competition on drugs and vaccines developed through public funding.48 Government rights could be particularly relevant now, given the extensive public role even in late-stage development. Though, it appears some government contracts restrict taxpayer rights in publicly-funded inventions.20
Globally, activists and some countries have also called for similar access-enhancing measures (compulsory licensing, patent pools, exemptions to global patent laws) employed (or considered) for promoting generic competition in developing countries even before the pandemic.49 During the global HIV/AIDS crisis, the absence of patents in India allowed Indian drug manufacturers to sell inexpensive drugs, substantially increasing access to treatment.50
Limiting patent protection will be most effective for products where imitation is easy and manufacturing capacity is abundant, e.g. traditional, “small molecule” pharmaceuticals, as was the case with HIV/AIDS drugs. For vaccines and many biologics, which tend to be more complex, limiting intellectual property rights alone may not be sufficient to enable rapid and robust generic competition. Non-patent barriers to competition, e.g. tacit manufacturing knowledge, complementary technologies and capabilities, may provide more important constraints on entry.
Perhaps an even harder policy challenge than generating the innovations will be scaling up production to manufacture the volumes of doses that the world needs. Scaled-up production on a global scale requires significant technology transfer between pharmaceutical companies. The WHO’s “Covid-19 Technology Access Pool” (C-TAP), modeled on the Medicines Patent Pool,51 provides a setting for pharmaceutical firms to license their patents, and share technology, data, and know-how. Yet pharmaceutical firms’ voluntary participation in C-TAP has been minimal.
Most funders have not used their financial resources (push or pull) to compel or encourage firms to share their technology. One risk of requiring sharing may be disincentivizing participation in the R&D efforts; this is a difficult balance to strike. It may also be difficult to achieve the technology transfer required through contracting requirements or by fiat, given problems with monitoring the level and quality of firms’ efforts towards these goals.52
Purchase Agreements, Access, And Prices
The dynamics of purchase commitments will also shape vaccine pricing and access. Within the BARDA procurement agreements, the pre-purchased doses are reserved for the U.S. government to distribute for free (though health care providers can charge for administration). COVAX too intends to distribute its doses at low cost.43 Across the board, the pricing of doses beyond the original agreements is unclear. Some companies have committed to selling their vaccines at cost during the pandemic (though how costs are measured, and when a pandemic is over, are subjective).
A final factor shaping access will be the allocation of scarce supply.53,54 Supplemental exhibit 2 shows the projected production capacity of leading vaccine developers and the doses that they have committed to the European Union and 3 high GDP countries (Japan, the United Kingdom, and the United States).9 For some vaccines, many of the doses that will be manufactured through 2021 are being bought up by rich country governments (including, but not restricted to, governments that provided push funding). Several suppliers have already committed much—if not all—of their projected output through bilateral agreements, so there may be limited supply left for COVAX.
Some analysts have proposed ethical frameworks for vaccine allocation.55,56 If the international technology transfer and manufacturing scale-up issues could be solved,22 this could help defuse the conflicts over allocation.
Conclusion
The COVID-19 innovation system represents a departure from business as usual. Considering the remarkable progress to date, especially on vaccine development, this raises the question of whether this model is useful only for crisis times, or whether biomedical innovation policy in “normal” times might productively incorporate some elements of the COVID-19 model as well. While the costs of COVID-19 justified high levels of push and pull support, the value of health improvements in general are also exceptionally high. Perhaps more important than funding levels, the COVID-19 system is structurally different from the biomedical innovation system before it, which by and large followed a model of innovation where the public sector supported fundamental research, and firms (incentivized by the prospect of patent-protected profits) did most of the applied research, trials, and development.
On the push side, applying the COVID-19 model beyond the pandemic would mean more public funding for late-stage research, clinical trials, development, and manufacturing. One potential objection, common through the history of public funding, is that more applied research would come at the expense of basic research. We acknowledge this concern; indeed, it seems unlikely that the rapid COVID-19 response would have been possible without pre-existing investments in basic research on mRNA and monoclonal antibodies.57 Nonetheless, the returns to government support of more applied activities may also be high, and worth exploring beyond the pandemic.
On the pull side, the COVID-19 effort seems to support the idea of using advance purchase agreements as innovation levers.2 After all, we have seen rapid vaccine innovation despite considerable uncertainty about whether or when firms will be able to secure and enforce patents, the traditional pull. However, at this point it is difficult to untangle the effects of the purchase agreements from the effects of other features of the COVID-19 response (e.g. risk reduction through push policies), the prospect of reputational gains for companies involved in combatting the crisis, or the presence of non-patent barriers to imitation.
Beyond spotlighting aspects of the COVID-19 model that may be useful beyond the pandemic, it is also important to recall where the response has come up short, since some of these may still be actionable. On the push side, this includes lack of coordinated funding for the full range of potential therapeutics (prophylactics and treatments; intravenous and oral; newer and older), and for expanding capacity to scale-up vaccine and therapeutic manufacturing more quickly. There has been a lack of effective global coordination, e.g. with China and CEPI on vaccines, and around clinical trials for therapeutics.
On the pull side, there are questions of whether firms avoided certain types of research that would have been useful, due to lack of patent or other incentives.29 Concerns about constrained manufacturing capacity for vaccines suggest that larger purchase commitments could have been useful too.58
Though individual actors tried to coordinate within their own push and pull efforts, e.g. through pursuing diverse portfolios, there has been a lack of serious global coordination. This may have had consequences for the speed of innovation and the types of vaccines and therapeutics we invested in, and it may also affect access to them throughout the world.
Indeed, a more general way in which the COVID-19 efforts have been deficient is attention to diffusion, both nationally and globally. In the U.S. and elsewhere, there have been supply shortages of remdesivir, and also of antibody therapies. And even where there is adequate supply, roll-out and distribution of vaccines and some therapeutics have been challenging. Globally, we have already noted the challenges of scaling-up complex therapies and vaccines, and the implications that may have for access, and why circumventing patents alone may not solve this problem. In addition, the fact that the leading vaccines from the U.S. effort may not scale in developing countries (due to storage and distribution requirements), emphasizes that beyond the rate of innovation, the direction of innovation also influences diffusion and, ultimately, health outcomes. The COVID-19 pandemic has demonstrated that effective biomedical research policy does not end with drug and vaccine development alone.
ACKNOWLEDGMENTS
Preliminary comments about and graphics from this research were presented at Implications of the Pandemic for Science and Innovation Policy: Insights from Economists, a National Academies of Sciences, Engineering, and Medicine panel discussion (virtual), October 16, 2020. Bhaven Sampat has received research funding from the National Science Foundation, the European Research Council, the Sloan Foundation, and the Yusuf Hamied Fellows Program and has been a consultant for RAND Europe. Kenneth Shadlen has received research funding from the British Council. None of these activities were related to or supported the research in this manuscript. [Published online February 4, 2020.]
NOTES
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