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Summary
Pages 1-22

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From page 1...
... They consist of multiple stages, which are often carried out by different organizations in different parts of the world. However, because medical products are particularly important to human health, medical product supply chains have some unique characteristics, including higher levels of oversight and regulation.
From page 2...
... The investment, both financial and human capital, that government and private industry has made in the supply reliability of medical product supply chains has not been sufficient to meet the public health need. In keeping with the committee's charge, this report focuses specifically on the resilience of medical product supply chains, which is defined as the ability to prevent public health and safety from being compromised by disruptions to supplies of medical products.
From page 3...
... Medical product supply chains -- which for the purpose of this report is an all-encompassing term that includes the supply chains for drugs, biologics, medical devices, and medical equipment -- deliver a diverse array of drugs and devices, including the four main categories described in this FIGURE S-1 Simple schematic of medical product supply chains under normal conditions.
From page 4...
... However, as some biologics and vaccines are high-margin, patent-protected pharmaceuticals while others are not, the discussion of profit margins and incentives between originator and generic drugs is still applicable to these medical products. Furthermore, four new reports from the National Academy of Medicine focus on how to prepare for seasonal and pandemic influenza through lessons learned from COVID-19 -- with one report in particular focusing on globally resilient supply chains for pandemic and seasonal influenza vaccines.
From page 5...
... There are two important insights from this overview of medical product supply chains. First, there is no one-size-fits-all strategy for increasing supply chain resilience for all medical products, which implies that a key challenge is to match resilience measures to products in a cost-effective manner.
From page 6...
... To do this, the committee examined how trigger events, including natural disasters, infectious disease outbreaks, or manufacturing process problems, can disrupt medical product supply chains in three primary ways: 1. Demand surge: An event drives demand for a medical product well above the normal level for an extended period of time.
From page 7...
... It is important to note that disruptions can overlap and interact -- demand surges and capacity reductions may occur simultaneously, or capacity reductions may precipitate subsequent demand increases and vice versa. Additionally, disruptions do not cause medical product supply chains to shift instantly from the normal conditions to shortages.
From page 8...
... That is, in general, using awareness measures to give supply chain actors information to make better decisions is more efficient than using mitigation measures to avoid a shortage, which is more efficient than using preparedness measures to prevent shortages from reaching people, which is more efficient than using response measures to deal with shortage situations after the fact. This implies that a resilience strategy for medical product supply chains should carefully consider the awareness foundation and the early protection shields before thinking about the later shields.
From page 9...
... FIGURE S-3 Medical product supply chains resilience framework: potential trigger events and resilience measures.
From page 10...
... The more transparency stakeholders bring into medical product supply chains, the better positioned they will be to identify vulnerabilities and proactively mitigate, prepare for, and respond to potential disruptions in medical product supply chains. As health system purchasing agents have long known, and the COVID-19 pandemic has made glaringly obvious, it is not always known where key components of the medical products are made or where in the supply chain medical products are.
From page 11...
... also calls for volume and capacity transparency to further assess risks directly related to medical product supply chains and to evaluate strategies for ameliorating these. Transparency is required both from manufacturers and from regulators so the public can be both informed about available medical products and empowered to act upon these data through data analysis and potentially put pressure on regulators and lawmakers.
From page 12...
... should take steps to make sourcing, quality, volume, and capacity information publicly available for all medical products approved or cleared for sale in the United States. These steps include the following: a.
From page 13...
... Understand better the vulnerabilities of medical product supply chains as a whole.
From page 14...
... For instance, researchers may detect previously unknown risk predictors that could be used to design new and effective resilience measures for medical product supply chains. MITIGATION Mitigation includes actions taken prior to a disruptive event that helps prevent the event altogether or reduce its magnitude.
From page 15...
... builds on these by tasking health systems with actions that, when taken together with manufacturers and suppliers, will help build robust mitigation strategies into critical medical product supply chains. Recommendation 3 (Resilience Contracting by Health Systems)
From page 16...
... b. Analyze risk levels of supply chain critical medical products and the viability of other response strategies (e.g., capacity buffering)
From page 17...
... Both of these would make capacity buffering a more viable preparedness option, and hence would facilitate a partial shift away from expensive inventory and toward cheaper capacity. As noted earlier, on-shoring is often espoused as a means for increasing the resilience of medical product supply chains via the argument that the more medical products a country produces domestically, the more control it has of supplies during an emergency.
From page 18...
... should take steps to cultivate capacity buffering for supply chain critical medical products where such capacity is a cost-effective complement to stockpiling and as protection against long-lasting supply disruptions or demand surges. These steps include a.
From page 19...
... . Major exporters of medical products, including the United States, should negotiate a plurilateral treaty under the World Trade Organization that prohibits export bans and restrictions on key components of global medical product supply chains.
From page 20...
... advocates forming a working group of key stakeholders who represent the very end of medical product supply chains, to evaluate and improve the allocation and delivery of medical products during shortages. To protect public health it is vital to be ready to manage this final stage well in an emergency.
From page 21...
... BOX S-1 Summary of Recommendations The following points collectively summarize the necessary actions recom mended by the committee that are needed to increase the resilience of medical product supply chains: Awareness 1. Public Transparency -- Make sourcing, quality, volume, and capacity infor mation publicly available for all medical products approved or cleared for sale in the United States.


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