Building Resilience into the Nation's Medical Product Supply Chains (2022) / Chapter Skim
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1 Introduction
1 Introduction
Pages 25-48
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medical product supply chains and their inability to deliver essential medical products to patients who need them, both in so-called normal times and during disasters or public health emergencies (Accenture, 2021; Phuong et al., 2019)
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Failure in medical product supply chains can result in serious harm to patients or even death. As a result, medical products -- which for the purpose of this report is an all-encompassing term that includes drugs, biologics, medical devices, and medical equipment -- and manufacturing processes are subject to more government oversight and regulation than supply chains for many other consumer goods.
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Medical product supply chains are highly multinational and interdependent, with products commonly including inputs from multiple countries and manufacturing steps taking place in disparate locations. As a result, the United States depends upon other countries, including China, India, the EU, Mexico, and Canada, for medical products (CRS, 2020a, 2020b, 2020c)
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Therefore, rather than looking for arguments for or against any specific remedy, the committee decided to approach the medical product supply chain vulnerability problem by starting with a clear goal and then considering a full range of alternatives in order to identify appropriate elements of an integrated strategy: The primary goal of resilient medical product supply chains is to prevent public health and safety from becoming compromised by disruptions to supplies of medical products. Many trigger events, including production interruptions, natural disasters, disease outbreaks, and geopolitical events can produce supply shortages by either directly impacting medical product supplies or indirectly impacting supplies and components needed to manufacture medical products.
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medical product supply chains.5 A number of other reports that examine medical product shortages and medical product supply chains were released prior to the COVID-19 pandemic and afterward in response to it. This study builds on and complements the recommendations from other contemporary reports (see Appendix B)
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critical drugs for the treatment of COVID-19 patients were under short supply (CIDRAP, 2022) .While the extremely rapid development, production, and distribution of vaccines against COVID-19 has demonstrated the impressive capabilities of some global medical product supply chains, the pandemic has also laid bare the fragility of others, including supply chains that Americans depend on for their health and safety during emergencies and routine times.
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2. Provide recommendations to improve the resilience of the supply chain for critical drugs and devices and to address any supply vulnerabilities or potential disruptions of such products that would significantly affect or pose a threat to public health security or national security, as appropriate, which may include strategies to ° promote supply chain redundancy and contingency planning; ° encourage domestic manufacturing, including consideration of eco nomic impacts, if any; ° improve supply chain information gaps; ° improve planning considerations for medical product supply chain capacity during public health emergencies; and ° promote the accessibility of such drugs and devices.
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This in turn requires a framework to help systematically enumerate measures, to identify synergies between different policies, and to evaluate the relative cost-efficiency of alternatives to improve the resilience of medical product supply chains. An effective supply chain resilience strategy must be diversified and comprehensive to address the array of supply chain risks that threaten the public health and national security of the United States.
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This report discusses broader, systemic supply chain problems that existed prior to the COVID-19 pandemic, problems that led to drug and device shortages in noncrisis times and exacerbated them during the pandemic. To identify options for increasing resilience, the committee examined the full length of medical product supply chains -- from raw materials to finished products, including all intermediate steps, plus transportation and the administration of the medical product to the end user and management of shortages by end users to mitigate their adverse effects.
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• Demand surge: A substantial increase in demand for a medical product or products triggered by an external event, such as a natural disaster or outbreak of disease. • Diversification: A mitigation strategy that involves building reliability into the medical product supply chain by adding parallel capacity at some or all stages.
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. • Hardening: A mitigation strategy that involves building reliability into medical product supply chains through improved execution of existing stages.
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• Resilience: The ability to prepare and plan for, absorb, recover from, or more successfully adapt to actual or potential adverse events. In the context of this study, resilience is specifically the ability of medical product supply chains to match supply with demand under both normal and emergency conditions.
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Government agencies at the federal, state, territory, tribal, and local levels can use the report to identify and address gaps in medical product supply chains and plan for future public health emergencies. Policy makers may find the report useful in informing decisions regarding legislation and regulations aimed at promoting the security and resilience of the medical product supply chain during routine functioning and any potential emergency events that may occur.
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38 FIGURE 1-1 Stakeholders in a medical product supply chain. NOTE: GPO = group purchasing organization.
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These stakeholders can use the report to identify areas within their supply chains that need to be secured, and improve the resilience of the supply chains they depend on to continue conducting business. Health Systems, Public Health Agencies, and Providers Ultimately, a medical product supply chain is designed to deliver products to consumers, which are composed of public health agencies, health systems, pharmacies, and nursing homes -- in which physicians, nurses, pharmacists, and other care providers administer and deliver services to the patients that rely on them.
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Through the Industrial Base Expansion Program Office, ASPR is establishing integrated capabilities for a resilient domestic medical product supply chain and investing in the sustainability of domestic manufacturing of medical products. VA Awareness, The Department of Veterans Affairs (VA)
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promotes the development of medical countermeasures to public health threats. BARDA's role in medical product supply chains has focused on making strategic investments to expand the infrastructure and capacity of domestic pharmaceutical manufacturing (BARDA, 2021)
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Patients require medical products for their health, and therefore drive demand for medical products. The general public can use this report to understand and recognize that medical product supply chains may have shortages, which can affect clinical outcomes for individual patients and broader communities.
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of medical product supply chains. REFERENCES Accenture.
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2020b. COVID-19: China medical supply chains and broader trade issues.
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2021. VA acquisition management: Comprehensive supply chain management strategy key to address existing challenges.
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2021. The security of America's medical product supply chain considerations for critical drugs and devices: Proceedings of a workshop.
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2021. Building resilient supply chains, revitalizing american manufactur ing, and fostering broad-based growth: 100-day reviews under Executive Order 14017.
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