Health Product Manufacturers and Innovators COVID-19 Impact Assessment: Lessons Learned and Compelling Needs.

Abstract

United States health care spending consumes nearly a fifth of the GDP [1]. While, in many respects, the U.S. health care system is enviable and highly innovative, it is also characterized by elements of ineffectiveness, inefficiency, and inequity. These aspects, resulting from pre-existing vulnerabilities within the system and interactions between the various stakeholders, were acutely highlighted by the COVID-19 pandemic. As health product manufacturers and innovators (HPMI) took steps to mitigate the immediate crisis and simultaneously begin to develop a longer-term sustainable solution, six common themes arose as areas for transformational change: support for science, data sharing, supply chain resiliency, stockpiling, and surge capacity, regulatory and reimbursement clarity and flexibility, public- and private-sector coordination and communication, and minimizing substandard care offerings. Within these categories, the authors of this paper suggest policy priorities to increase the effectiveness, efficiency, and equity of the HPMI sector and writ large across the U.S. health care system. These priorities call for increased scientific funding to diversify the pipeline for research and development, strengthening the nation’s public health infrastructure, building and maintaining “ever warm” manufacturing capacity and related stockpiles, instituting efficient and effective regulatory and reimbursement frameworks that promote innovation and creativity, devising structures and processes that enable more efficient collaboration and more effective communication to the public, and implementing rewards that incentivize desired behaviors among stakeholders. This assessment draws from the collective experience of the authors to provide a perspective for the diagnostics, hospital supplies and equipment, medical devices, therapeutics, and vaccines segments. While the authors of this paper agree on a common set of key policies, sub-sector-specific nuances are important to consider when putting any action priority into effect. With thoughtful implementation, these policies will enable a quicker, more robust response to future pandemics and enhance the overall performance of the U.S. health care system.