Friday, April 9, 2021

How can Congress create infrastructure for the next pandemic?

By Nicholson Price, Rachel Sachs, Jacob S. Sherkow, and Lisa Larrimore Ouellette

After approximately 200 Infrastructure Weeks, policymakers now appear to be actually talking about passing legislation about infrastructure! Congress also seems like it might take action to lay the groundwork for combatting the next pandemic; bipartisan efforts are underway. Putting the two together: how should Congress think about creating innovation infrastructure, broadly defined, to help combat the next pandemic? 

Even before COVID-19, experts were sounding alarms about insufficient infrastructure to address the foreseeable risk of a global pandemic. In 2019, an expert group convened by the World Bank and WHO concluded that “[t]he world is not prepared” for the “very real threat of a rapidly moving, highly lethal pandemic of a respiratory pathogen,” among other things because “[t]oo many places lack even the most rudimentary health-care infrastructure.” COVID-19 has magnified these global health inequalities. But inadequate infrastructure investment is not just a problem in low-income countries: COVID-19 has also drawn increased attention to long-apparent weaknesses in many U.S. infrastructure sectors. We suggest priorities for three types of infrastructure: physical infrastructure, knowledge infrastructure, and human infrastructure (recognizing that these categories may overlap).

How can Congress build physical infrastructure for future pandemics?

The early stages of the current pandemic showed the challenges, from a public health perspective, of globalized supply chains and just-in-time inventory. Some of our first posts in this series one year ago investigated PPE shortages and responses including 3D printing. Global supply lines are still struggling to recover. Corporate leaders have some incentives to build more redundant and resilient supply chains going forward, such as by diversifying their supply base, holding more intermediate inventory, and adopting more flexible process innovations. But the government also has a role in encouraging supply chain resilience, including through supply chain mapping for critical goods, investments in transportation infrastructure, diversifying supply routes through investments in developing countries, and clarifying lines of regulatory responsibility in the next emergency.

Reviewing all the physical infrastructure sectors that could benefit from improved pandemic preparedness would take more than a blog post, but one particularly critical investment is in vaccine manufacturing infrastructure. As we have previously explained, scaling vaccine manufacturing and distribution networks are enormous challenges, and poor planning in these areas has led to a slow rollout even in the United States (including substantial manufacturing problems) and tragically few doses administered in low-income countries. The mRNA platform used by the Moderna and Pfizer-BioNTech vaccines is exciting in part because the vaccines can be produced more quickly than with older technologies, but a key bottleneck has been the small number of facilities that can make lipid nanoparticles for encapsulating the mRNA. Building more of these machines takes time, but the government could invest in more capacity now—both to help continue expanding COVID-19 vaccine production and to have facilities ready for the next emerging infectious disease. 

More broadly, policymakers should recognize the benefits of having idle and underused capacity during non-emergency times. The federal government already spends enormous sums on undeployed military capacity in the event of a defense-related emergency, but Americans are also threatened by other kinds of emergencies, ranging from winter storms that overwhelm power grids to pandemics that overwhelm public health systems. Private industry isn’t going to maintain adequate physical infrastructure on its own, so policymakers should consider subsidies, mandates, and getting the public sector more directly involved in commercialization.

How can Congress build knowledge infrastructure for future pandemics?

In addition to physical infrastructure for future pandemics, policymakers can focus on building “knowledge infrastructure,” i.e., shared informational resources used for downstream development. Generating private incentives for knowledge infrastructure can be tough, however, because (as we’ve said before) some knowledge goods are nonexcludable even under strong IP laws. Creating adequate levels of such goods typically requires some direct government investment to supplement private efforts. But even for knowledge goods that may be excludable—think privately generated clinical data—we may want such information to be freely shared in a pandemic. This suggests at least three important areas in which, given our experience in this pandemic, government could do a better job at building a public health-focused knowledge infrastructure for the next one.

First, disease surveillance. The United States did a remarkably poor job at tracking the initial (and later and later) spread of the virus, and continues to be flat-footed in tracking variants of concern. These deficiencies stem from a weak, poorly funded public health infrastructure and one not readily interconnected (at least, en masse) with sequencing laboratories. Now is the time for Congress to invest in building up this country’s disease surveillance capacity; we should know about the next outbreak before it turns into an outbreak. Fortunately, the pandemic has produced several models worth replicating and expanding. For example, the University of Illinois, through SHIELD Illinois, has a scalable saliva-borne virus surveillance system that it makes available for out-licensing and adoption. That said, sequencing capacity has proven to be a significant bottleneck in COVID-19 surveillance and it’s not clear whether the next pandemic will be saliva borne. Policymakers should therefore also think about the development of other types of technologically simple tests, including CRISPR-based systems that are non-perishable, require almost no equipment, cost cents per test, and could, in principle, be used at home.

Second, we need to increase funding for fundamental research on microbiology, including, of course, knowledge of viruses and vaccines. This time around, we all “got lucky” on the successful development of COVID-19 vaccines. But a 2019 joint World Bank–WHO report notes that we still face a continuing pandemic preparedness problem when it comes to fundamental research: “Research infrastructure and level/predictability of funding are weak.” We still have basic questions about viruses, such as the level and role of recombination in positive-stranded RNA viruses. Ensuring, expanding, and diversifying funding for basic microbiology research infrastructure should be one of policymakers’ top priorities.

Third, we need better knowledge infrastructure for manufacturing pharmaceuticals, particularly biologics. Manufacturing pharmaceuticals is—and continues to be—ad hoc; improvements are typically made as manufacturers see fit. (See, e.g., biologics, small-molecule drugs, nucleic acid vectors.) This becomes a knowledge infrastructure problem because much of this information is cloistered away in relatively few companies which, generally, do not share such information. There is room, here, for more direct government investment on expanding the knowledge infrastructure of manufacturing, including basic research on manufacturing processes. And beyond direct spending, there is room for regulatory improvement, too: FDA considers much of the manufacturing information submitted to it “confidential business information” or CBI. Having the Agency narrow the scope of CBI—and sharing what is not confidential, publicly and accessibly—could provide a foundation for manufacturing knowledge infrastructure going forward.

How can Congress build human infrastructure for future pandemics?

The need for investments in knowledge infrastructure is closely related to the need for investments in human infrastructure: investing in the training and development of people with skills and expertise that will be needed in advance of the next pandemic, and doing so in an accessible, equitable manner. For instance, not only have we underfunded our public health knowledge infrastructure (as noted above), but we have also underfunded public health professionals—critical human infrastructure elements. There would be many ways to invest in further training of public health professionals, some leveraging federal-state relationships (such as through grant funding to states and local governments), and others focusing at the federal level (such as through investments in the Public Health Corps). 

Policymakers should also invest in developing and training scientists with expertise in these areas. Although NIH and NSF grants are often thought of as supporting particular substantive projects, much of this funding is used to support the people working on these projects. Indeed, there is some empirical evidence that basing grant selection criteria on people, not projects, results in higher-impact research—though also a potential for biased selection. But whether funding agencies invest in people who seem likely to become experts in virology, in the microfluidics essential to mRNA manufacturing and encapsulation, or in projects related to these technologies (along with the people who happen to be working on them), developing human capital for the next pandemic should be a guiding policy concern. 

Policymakers might also think about the ability of existing scientists to reallocate or redirect their research when urgent needs arise, such as in the pandemic context. Extramural researchers are often unable to redirect their lab capacity or expertise without obtaining permission from their funding organizations (if their funding agreements permit it at all). Funding agencies could seek to increase flexibility in reallocating extramural grants in the event of particular declared public health emergencies. Similarly, policymakers might seek an increase in intramural research done by government-employed scientists at NIH, and particularly at NIAID, which might be able to be reallocated more quickly in the event of a pandemic.

Congress should pay special attention to using funding to ameliorate disparities in medical and scientific education, which are driven by factors including structural racism (as we have discussed in previous posts). The American Rescue Plan contains an important template of this approach, specifically directing $3 billion (of the $40 billion in the Higher Education Emergency Relief Fund) to historically Black colleges and universities and minority-serving institutions, some of which, like Xavier University, serve as sources of training for a disproportionate number of Black health professionals.

Yet human infrastructure is not only about training new scientists and public health professionals. It must also be about building connections between them to enable them to cooperate, share knowledge, and develop new insights at the intersection of their fields. These efforts might take many forms, such as encouragement of interagency coordination, or through support for interdisciplinary scientific work. There is also surely an important role to play for particular individuals or entities as hubs of connections, such as a pandemic response team, or even a broader innovation regulator, to better our pandemic preparedness infrastructure.

This post is part of a series on COVID-19 innovation law and policy. Author order is rotated with each post.

No comments:

Post a Comment