Monday, September 27, 2021

How would the proposed American Pandemic Preparedness Plan help address underinvestment in pandemic-related innovation?

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

Historically, the United States’ preparedness for a pandemic is like Charles Dudley Warner’s aphorism on the weather: everybody talks about it but no one ever does anything. Before COVID-19 struck, it was clear that the threat of a pandemic was real and that the world was not ready. As one of many examples, a September 2019 report from the Global Preparedness Monitoring Board (GPMB)—an expert group convened by the World Bank and WHO—concluded that “there is a very real threat of a rapidly moving, highly lethal pandemic of a respiratory pathogen killing 50 to 80 million people and wiping out nearly 5% of the world’s economy.” Perhaps the tragedy of the current crisis will provide sufficient motivation to better prepare for next time.

As a step in this direction, earlier this month the Biden administration released a twenty-seven page American Pandemic Preparedness Planwith a $65 billion price tag—to provide the United States with “broad and deep protection against biological threats, ranging from the ongoing and increasing risk of pandemic disease, to the possibility of laboratory accidents and the deliberate use of bioweapons.” These include, of course, several innovation policy commitments to encourage the development of pandemic-related tools for COVID-19 and beyond. What are those commitments? How do they work—or would have worked—for COVID-19? And what does this say about innovation policy more generally?

What innovation policies does the Plan contemplate?

The American Pandemic Preparedness Plan is built around five pillars supporting the U.S. response to a future pandemic: (I) Transforming our Medical Defenses, (II) Ensuring Situational Awareness, (III) Strengthening Public Health Systems, (IV) Building Core Capabilities, and (V) Managing the Mission. Within each of these areas, the Plan lays out more specific goals to be achieved. As a whole, these goals involve many sectors of the federal government and envision a holistic response to—or anticipation of—future pandemics. Although it is not possible to include here a complete list of the many goals included in the Plan, we highlight several that are related to the innovation policy issues we have considered in our blog posts over the last year and a half.

Pillar I, Transforming our Medical Defenses ($41 billion), focuses on the types of health technologies we have considered in several prior posts: vaccines, therapeutics, and diagnostics. Within each of these categories, the Plan includes aims targeted at developing, distributing, and administering these technologies, recognizing the need for governmental support all along this process. The Plan does include specific benchmarks for several of these aims—for instance, noting the need to “[e]nable design, testing, and review of a safe and effective vaccine … within 100 days after the recognition” of an emerging threat. But others are framed more generally at this time, and are not tied to specific time or quality benchmarks. 

Pillar II, Ensuring Situational Awareness ($5.4 billion), is intended to improve our ability to detect potential pandemic threats as early as possible and monitor their spread and evolution. Some of the Plan’s specific proposals in this area take inspiration from relatively new strategies used in forecasting the spread of COVID-19, such as the use of “environmental sequencing” including wastewater sampling to detect the level of virus circulating in a community. The Plan also aims to track viral variants and the potential impact those variants might have on the types of technologies prioritized elsewhere in the Plan.

Pillar III, Strengthening Public Health ($9.3 billion), aims to both modernize our public health infrastructure to manage biological threats and establish the international infrastructure to do so. Several of these proposals relate to the types of knowledge infrastructure or human infrastructure considered in previous Biden Administration proposals. For instance, the Plan intends not only to strengthen the public health workforce and its ability to engage in evidence-based communication, but also to invest in public health laboratories and their digital infrastructure to enable data sharing across stakeholders. 

Pillar IV, Building Core Capabilities ($8.8 billion), includes a broader range of goals, intending to (1) support the availability of personal protective equipment, (2) restore and expand the United States’ pandemic stockpiles, (3) prevent laboratory accidents and deter bioweapons development, and (4) improve regulatory capacity for a wide range of health technologies. Some of these proposals may take inspiration from other countries which have successfully implemented some of these strategies. 

Pillar 5, Managing the Mission ($0.8 billion), envisions the creation of a “U.S. Mission Control” for our pandemic preparedness. Mission Control would have the ability to “manage, integrate, and ensure accountability” for our pandemic preparedness and response, in a way that should have the ability to avoid at least some of these issues going forward.

It is difficult to say which of these pillars the Plan prioritizes, though one indication is certainly the amount of proposed funding dedicated to each area. Out of a proposed budget of $65 billion, the Plan allocates $24.2 billion to its various vaccine goals, and another $11.8 billion to therapeutics and $5 billion to diagnostics, such that more than 60% of the proposed budget goes toward Transforming Medical Defenses (Pillar I). To be sure, these are also extremely capital-intensive endeavors, and it is surely more expensive to fund the development and manufacturing of novel, highly adaptable vaccines than it is to create a federal Mission Control (at $0.8 billion). Nonetheless, it seems that the American Pandemic Preparedness Plan is one largely centered on healthcare technologies. 

How do these policies address failures highlighted by the COVID-19 pandemic?

Despite the success in developing effective vaccines and therapeutics against COVID-19, some of the American Pandemic Preparedness Plan’s vision arises from perceived weaknesses of the U.S. innovation ecosystem that have been highlighted by the ongoing pandemic.

First, across the five pillars, the Plan reflects a commitment to more pandemic-related R&D funding, particularly for basic research. The federal government already invests heavily in basic research; as noted in the Plan, the success of COVID-19 vaccine developed built on decades of “fundamental scientific research, spurred by the emergence of SARS and MERS, [which] provided detailed knowledge about coronaviruses, including revealing which protein to target and how to stabilize it.” But the Plan also notes that most viruses that infect humans are less well understood than coronaviruses, and the GPMB report faulted the world for “insufficient R&D investment and planning,” including for vaccines, broad-spectrum antivirals, and targeted therapeutics like monoclonal antibodies. The Plan thus reflects the latest in a long tradition of public support for basic research in the United States in response to destabilizing events, from World War II until now.

Second, the Plan indicates an understanding that developing drugs and vaccines requires more than additional funding: it also requires the infrastructure to rapidly determine whether they are effective. We have previously explained the benefits of the UK’s RECOVERY trial, which used size, speed, randomization, and simplicity to quickly determine which COVID-19 interventions were most effective, avoiding the wasteful use of drugs in inconclusive trials (or outside of any trial at all). Pillar IV calls for the promotion of “efficient, large-scale clinical trials networks” that could be used during pandemic situations, which may have been inspired by RECOVERY. National-level coordination of clinical trials may also help standardize trials in ways that make it easier to compare the relative efficacy of different interventions.

Third, the Plan recognizes that pandemic-related R&D doesn’t stop once a product is developed: figuring out how to scale up manufacturing and equitable distribution of any health-related technology entails its own challenges, contributing to the concern that the U.S. healthcare system is “all breakthrough, no follow-through.” For everything from masks to vaccines to therapeutic antibodies, COVID-19 has repeatedly exposed insufficient attention to both manufacturing bottlenecks and distribution hurdles. The Plan includes provisions to address these failures: Pillar I includes funding not just for vaccine, therapeutic, and diagnostic development but also production and distribution. Pillar III will help rebuild our crumbling public health infrastructure, including at the state and local level. Pillar IV includes funding to improve the manufacturing of PPE and to improve supply chains for medical products. We have previously described the need to build infrastructure for the next pandemic; these appear to be steps in the right direction.

Fourth, the Plan at least acknowledges the importance of equitable distribution, with funding “to mitigate the health inequities exacerbated during a public health emergency, including prioritizing allocation of public health emergency response resources … to vulnerable and under-served communities.” As we have explained in prior posts, COVID-19 has highlighted the degree to which legal institutions are complicit in creating a healthcare system with disparities by race, gender, and class, and hopefully efforts to strengthen U.S. pandemic preparedness can help address these challenges.

Finally, the Plan would promote greater coordination of our pandemic response. As we have written about previously, the lack of interagency coordination in many areas was detrimental in our response to the COVID-19 pandemic. Establishment of a Mission Control hopefully would smooth coordination among relevant agencies—including NIH, CDC, BARDA, FDA, CMS, DoD, DoE, and VA—while providing greater sharing of expertise among them.

What is missing from the American Pandemic Preparedness Plan?

While the Plan has much to laud, it seems to focus on a relatively classic view of innovation policy where the government’s role is to spend on technological research, mostly basic but also applied. Largely left out are other spaces where the past two years have shown profound lapses in both knowledge and capacity.

Most notably, the Plan focuses strongly on technological ends: vaccines, therapeutics, diagnostics, and the like. These products embody classic knowledge goods that are easy to hold up and celebrate. But there are a host of other knowledge goods which are also crucial in combating pandemics, including knowledge about tailoring medical practice or hospital coverage or evaluating the effectiveness of non-technological interventions like wearing masks or social distancing. In criticizing global underinvestment in pandemic-related R&D, the GPMB report cited not just traditional vaccines and drugs, but also non-pharmaceutical interventions, including public safety protocols. This information is crucial but largely nonexcludable—that is, difficult for innovators to keep others from using (and therefore difficult for private actors to use to make a profit). Useful but nonexcludable innovation should typically receive more government attention, not less, because the private market is expected to underinvest in such nonexcludable goods. 

In addition, the Plan leaves relatively untouched the arsenal of private incentives that help drive biomedical innovation. Nothing describes modifications to patents (which have received substantial blame during the pandemic, some of it misplaced). No funds seem directed to prizes or tax credits or other solutions that drive private investment. And while there are gestures to public-private partnerships, the vast majority of the Plan seems to center on direct government spending. Effective innovation policy—especially for an unknown pandemic that may not operate like COVID-19 and require a suite of different approaches—likely requires a broader diversity of mechanisms

Overall, the Plan is a laudable effort to prepare the U.S.—and the world—better for the next pandemic. To be sure, it leaves out some areas where the current pandemic has encountered notable failures, especially with regard to nonexcludable knowledge goods. But the perfect can be the enemy of the good—and the Plan is good! While there is room for improvement, it’s a giant step in the right direction. Congress has a lot on its plate, but the Plan is worthy of its attention—sooner rather than later.

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

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