Strategic Goal 3

NHSS, 2023-2026 Implementation Plan

Strategic Goal 3:
Ensure a resilient and sustainable public health industrial base and supply chain that can rapidly develop and deploy safe medical countermeasures

Availability of MCMs and other critical supplies is one of the nation's best defenses against health security threats. A sustainable public health supply chain^[3] with diverse manufacturing locations and distribution methods and supported by a skilled supply chain workforce^[4] can ensure the best medicines, supplies, and personal protective equipment are available to responders and the public. Substantial partnerships with the private sector are crucial to expanding this capacity and mitigating potential supply chain shortages in the future. Furthermore, the nation needs to continue advancing the research and development of innovative MCMs that can safely and effectively treat all populations.

The NHSS identifies three objectives to strengthen the public health supply chain and industrial base. The following outlines implementation actions and desired outcomes for the next four years.

3.1 Expand domestic manufacturing capacity, supply chain diversity, and international partnerships with neighbors and allies to fortify a resilient and flexible public health supply chain

The public health supply chain should be resilient and capable of rapidly responding to widespread public health emergencies and disasters. Sourcing critical material from just one location or supplier increases supply chain vulnerability should that supplier be impacted by an unforeseen emergency. To meet future needs, a sustained approach to strengthening the public health supply chain should include expansion of domestic manufacturing with diversified and flexible distribution outlets, while also considering the human capital and training requirements needed to support this effort. MCM manufacturing processes that promote interchangeability of supplies with accurate standards allows for greater agility in an emergency. Diversifying supply chain sources also builds redundancy into the system and reduces the risk of shortages.

Desired Outcomes:

Use of single-source suppliers for critical public health and medical supplies is minimized to limit foreign dependencies.
Plans are developed to create redundant public health supply chain manufacturing and distribution capacities, including involvement of small businesses in supply chain enhancement or surge efforts.
Sustainable investments are made in building and maintaining a competent public health industrial base with rapidly developed and accurate product standards and supply chain workforce.
Policy incentives are implemented to improve production, storage, quality assurance, and deployment processes for critical public health and medical supplies.

Federal Implementation Actions:

3.1.1 Support building, training, and maintaining the supply chain workforce to ensure domestic manufacturing, stockpiling, and distribution capabilities of public health supplies.

3.1.2 Identify sustainable funding mechanisms and incentives to support the development of innovative manufacturing processes to ensure on- or near-shore production of public health supplies.

3.1.3 Establish policy incentives to increase supplier and distribution diversity and redundant manufacturing and deployment practices.

3.1.4 Explore investments in researching and developing additional sources of raw materials, including domestically sourced raw materials, to mitigate vulnerabilities of single-sourced materials.

3.2 Strengthen partnerships with MCM suppliers, manufacturers, and distributors to monitor supply chain vulnerabilities and address shortages during an emergency

Strong public-private partnerships are necessary to identify and mitigate supply chain vulnerabilities and to address supply chain shortages during an emergency. Strong partnerships enable greater information sharing and a more rapid, coordinated response when supply chain challenges occur.

Desired Outcomes:

Partnerships are established with additional stakeholders to increase visibility into the public health supply chain.
Plans to mitigate supply chain shortages are tested and evaluated through tabletop or real-world exercises with public and private sector partners.

Federal Implementation Actions:

3.2.1 Expand partnerships with MCM suppliers, manufacturers, and distributors to identify upstream supply chain risks of critical MCMs.

3.2.2 Consult private sector partners and industry when developing plans to mitigate public health supply shortages, including strengthening cybersecurity and enhancing coordination during an emergency response.

3.2.3 Establish flexible contracting mechanisms and contingency agreements to sustain private sector partnerships and to ensure a rapid response when an incident occurs.

3.2.4 Streamline information sharing mechanisms with industry and SLTT partners to better coordinate resource needs and prioritize geographic distribution of MCMs during shortages.

3.3 Promote innovation across the MCM development pipeline to accelerate the production and equitable deployment of agile, safe, and accessible MCMs

Stronger partnerships between research institutions, government, academia, private industry, and community-based philanthropies, along with innovative, adaptable, standardized, and scalable MCM development technologies can facilitate rapid development of new MCMs to combat emerging threats. Meeting demand during an emergency requires fast production of products with quality control standards to ensure access to safe MCMs. Furthermore, producing and distributing MCMs that meet the needs of at-risk individuals and underserved communities is essential to health security.

Desired Outcomes:

Flexible partnerships and adaptable research, development, and approval processes are in place to conduct research to develop new and repurposed MCMs in an emergency, to assess them for safety and efficacy through clinical trials, to ensure standardization and scale-up of manufacturing, and to determine when and whether they should be authorized for use in the general population.
MCM development and distribution of authorized MCMs is maximized to meet the diverse needs of all segments of the population.

Federal Implementation Actions:

3.3.1 Engage with industry and subject matter experts to identify cutting-edge technologies and opportunities to innovate MCM development, assessment, and regulatory practices.

3.3.2 Examine proven technologies and established partnerships to develop processes that can rapidly standardize and scale up MCM production and equitable distribution during a response.

3.3.3 Expand partnerships and innovation programs for research and development of diagnostics, antimicrobial drugs, therapeutics, and preventative products to combat rising antimicrobial resistance and other neglected threats.

3.3.4 Pursue MCM design and clinical trial approaches that consider diversity, equity, and inclusion to represent the needs of all population segments.

Recommended Partners Activities for Strategic Goal 3

The private sector can enhance supply chain visibility and analytics needed to anticipate, prevent, and mitigate supply chain shortages and disruptions.
SLTT authorities and the private sector can establish stockpiles of critical MCMs and develop resource and supply sharing agreements with regional partners in the event of a shortage.
Drug manufacturers can commit to achieving Quality Management Maturity (QMM), the state attained by having consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.
The private sector can use community-based research approaches in MCM and non-MCM design and efficacy to inform the development of accessible MCMs for all populations.

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³ The public health supply chain consists of drugs, biological products, personal protective equipment, clinical and research laboratory supplies, and medical devices – including diagnostic and testing devices – as well as ancillary supplies.

⁴ The public health supply chain workforce includes manufacturing, stockpiling, and distribution workforces, as well others vital to the end-to-end public health supply chain.

NHSS, 2023-2026 Implementation Plan

Strategic Goal 3

NHSS, 2023-2026 Implementation Plan

Strategic Goal 3:Ensure a resilient and sustainable public health industrial base and supply chain that can rapidly develop and deploy safe medical countermeasures

3.1 Expand domestic manufacturing capacity, supply chain diversity, and international partnerships with neighbors and allies to fortify a resilient and flexible public health supply chain​

3.2 Strengthen partnerships with MCM suppliers, manufacturers, and distributors to monitor supply chain vulnerabilities and address shortages during an emergency

3.3 Promote innovation across the MCM development pipeline to accelerate the production and equitable deployment of agile, safe, and accessible MCMs

Recommended Partners Activities for Strategic Goal 3

Strategic Goal 3:
Ensure a resilient and sustainable public health industrial base and supply chain that can rapidly develop and deploy safe medical countermeasures

3.1 Expand domestic manufacturing capacity, supply chain diversity, and international partnerships with neighbors and allies to fortify a resilient and flexible public health supply chain