GHTC responds to RFI on Next-Generation Cures Bill

GHTC responded to a request for information (RFI) from Representatives Larry Bucshon (IN-08) and Diana DeGette (CO-01) on what Congress can do to bring about a next generation of treatments through the Next-Generation Cures Bill with the below response, urging decision-makers to be bold in the legislation and expand the aperture of innovation to include global health technologies for low-resource settings.

To the attention of:

Representatives Larry Bucshon and Diana DeGette

We write to you today representing the Global Health Technologies Coalition (GHTC), a group of 50 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. Thank you for the opportunity to contribute GHTC’s thoughts and perspectives to the Next-Generation Cures Bill. 

The 21st Century Cures Act’s legacy and the ideas-turned-legislation from the Cures 2.0 bill have accelerated the global health research and development (R&D) community’s success and provided the United States and the world with critical biomedical innovations. According to a recent report published by GHTC and our partners at Policy Cures Research, US investments in global health R&D have a remarkable return on investment and, over the past 16 years, have generated $104 billion in the economy and added more than 600,000 jobs to the US workforce. We strongly urge you and your fellow members of Congress to ensure that any legislation that tackles biomedical research should include reference to and encourage funding for global health R&D to mitigate health threats of the past, present, and future.

Today, we recommend the following key priority areas for consideration for the Next-Generation Cures Act and offer ourselves as a resource as you develop this future landmark legislation:

1. Strengthening ARPA-H’s mandate for global health.
The Advanced Research Projects Agency for Health (ARPA-H) is a crowning achievement of the push for Cures 2.0 and one that GHTC is a vocal supporter of. GHTC would like to see the Office of International Affairs at ARPA-H empowered to address global health challenges like neglected diseases, emerging infectious diseases, antimicrobial resistance (AMR), and other health threats using the same novel approach ARPA-H is known for. High-risk, high-reward or fail-fast innovation in global health R&D is necessary to create new technologies for low-resourced communities worldwide. Innovation for low-resourced communities in global health could provide benefits for low-resourced settings in the United States. 

2. Including PASTEUR (Sec. 105 of Cures 2.0) into the Next-Generation Cures Act.
The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act would create a program in the Department of Health and Human Services to incentivize the development of new drugs to address AMR through a subscription-based payment model.

Since this was a past priority of Cures 2.0, it should be included in the Next-Generation Cures Act. 

3. Including other bills with no clear paths to passage into the legislation.
The bipartisan Supporting Innovative Global Health Technologies (SIGHT) Act is a piece of legislation that could use a powerful vehicle like the Next-Generation Cures Act to get it across the finish line. The SIGHT Act would create a distinct program and budget line for health R&D at the US Agency for International Development, establish a new leadership role and advisory council to guide investments, grant the agency authority to provide research awards, and mandate annual reporting on health R&D investments and results. This bill would transform our global health toolbox of the future and is worth considering for Next-Generation Cures.

4. Prioritize transparency and authorize loan authorities at BARDA.
The Biomedical Advanced Research and Development Authority (BARDA) is a critical federal agency for biomedical innovation, and greater transparency will assist innovators in understanding what has already been developed and what is still needed. Previously, BARDA has responded to requests to publicly report on its investments, providing valuable information to innovators and stakeholders that engage with the agency and invest in medical countermeasure development. This reporting should be used for all BARDA investments, including chemical, biological, radiological, and nuclear; emerging infectious disease; and AMR countermeasures. This transparency is important for oversight, reduces duplication, and promotes collaboration and coordination with other federal agencies and external partners engaged in global health security research. 

Additionally, BARDA needs a mechanism to support the finance of large-scale projects that could better prepare the United States and the world for future biological threats. With loan authorities, BARDA would be capable of supporting projects like innovative biomanufacturing facilities, such as microneedle patch vaccines.

5. Prioritize deliverability and applicability of all global health technologies for use in low-resource settings.
The deliverability and administration of new medical countermeasures are often blocked by the constraints of low-resource settings in the United States and abroad, where there is limited or inconsistent access to refrigeration, sanitation, electricity, highly trained health care workers, laboratories, and/or other resources. These constraints impeded the global deliverability of first-generation COVID-19 vaccines and therapeutics. Operation Warp Speed was successful at quickly developing safe and effective vaccines, but its leadership told GHTC that deliverability for low-resource settings was not being considered in vaccine portfolio decisions. We should learn from our past mistakes and, across the innovation ecosystem, ensure technologies that can be used for global health challenges are designed for low-resource settings.

6. Encourage growth and strengthening of global health innovation at CDC.
The Centers for Disease Control and Prevention (CDC), through their work in the National Center for Emerging and Zoonotic Infectious Diseases and the Global Health Center, are on the front lines of the next pandemic. By strengthening their mandates for innovation and R&D, the Next-Generation Cures Bill would be an investment in our global health security because of the important work these institutes conduct in surveillance, diagnostics, and delivery. Investments in strengthening the coordination that the Global Health Center conducts are integral to our pandemic preparedness.

Investing and bolstering our global health R&D ecosystem across the US government leads to lives saved, jobs created, and economies strengthened. The global health security of the United States depends on other countries' capacity to fight against endemic diseases and quickly respond to outbreaks. The technologies we pioneer and fund with US dollars fortify our global defenses in preparation for those threats of yesterday, today, and tomorrow. 

By being bold in the Next-Generation Cures Bill and expanding the aperture of innovation to include global health technologies for low-resource settings, we can fight the world’s most pressing health challenges, maintain US leadership in global health diplomacy, and keep our country safe.

Sincerely,

Alex Long

Policy and Advocacy Officer

Global Health Technologies Coalition (GHTC)