Building a Sustainable Biopreparedness Industrial Base

The ability of the U.S. government (USG) to develop, procure, and secure access to critical medical technologies, products, and supplies is integral to national, health, and economic security for three reasons. First, the United States requires sufficient access to these goods to protect the homeland and US partners abroad against biological threats (intentional, accidental, or naturally occurring) that pose grave risks to global safety, stability, and security. Second, the US health care system depends on continual access to critical medical supplies and medicines during crisis and between crises. Finally, the bioeconomy will dominate 21st Century national security and economic interests as a rapidly growing segment of the global economy.

The USG relies heavily upon the private sector for research and development (R&D) in the area of biopharmaceuticals, including development of medical countermeasures. The biopharmaceutical sector demonstrated its value during the Coronavirus 2019 (COVID-19) pandemic, when the industry used mRNA [messenger ribonucleic acid] technology to rapidly develop and then scale and deliver two highly effective vaccines. Based on this success, the industry is poised for tremendous growth globally. However, The MITRE Corporation considered the USG unprepared to meet the threats to the biopharmaceutical industrial base. In particular, the team found that the biopharmaceutical industry, though one of the most advanced in the world, faces both internal and strategic competition from foreign competitors, principally China.

This report first provides background on the global state of the biopharma industry, and then summarizes the objectives that the USG should pursue. Next, it presents MITRE’s findings regarding the shortfalls in the USG’s current ability to sustain a robust mRNA industrial base, centered on three primary areas: USG capabilities, the mRNA industry, and the mRNA supply chain and ecosystem. To counter strategic competition in this industry, the United States needs a focused approach to drive action and accountability on sustaining needed capacity and capabilities. However, a history of inconsistent priorities and funding constitutes a significant barrier to creating a strong partnership between government and industry in this sector.

Sustaining the biopharma industrial base requires an integrated system of actions across the whole of government. MITRE recommends four interrelated courses of action (COAs) as a system of effort that the USG must undertake simultaneously to be effective. The first COA is defining and implementing an industrial base strategy, which should be tied to the appropriate policy, authorities, and accountabilities to execute against it. Second, the USG needs to identify the financing infrastructure to enable sustained investment in industrial base capability and capacity, to include an adequate and trained workforce. Third, the USG needs the situational awareness to act on risks and threats to market access and capacity of the industrial base. Fourth, the USG needs to reframe the government and industry relationship from a transactional one to one of mutual long-term benefit.

To initiate these COAs, the USG should develop a strategy and implementation plan for sustaining and expanding the biopharma industrial base. The strategy should center on protecting the US population from future biological threats (naturally occurring, accidental and intentional), as aligned with core global health security principles. Developing supply chain resilience will help secure needed supplies to respond to these threats. Finally, the strategy should support maintenance of the US leadership of the bioeconomy to meet domestic needs as well as global export requirements during both crises and peacetime. The USG should support the strategy with policy, programs, funding, and clear accountability. This strategy should be supplemented with a strategic implementation plan with clear roles across industry and government and incorporating implementation into the FY23 budget request.