Sec. 308. National Academies study on prizes
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Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the National Academies ) to conduct a study to examine— alternative models for directly funding, or stimulating investment in, biomedical research and development that delink research and development costs from the prices of drugs, including the progressive replacement of patents and regulatory exclusivities on new drugs with a combination of expanded support for research and innovation prizes to reward the successful development of drugs or achievement of related milestones; the dollar amount of innovation prizes for different stages of research and development of different classes or types of drugs, and total annual funding, that would be necessary to stimulate investment sufficient to achieve such successful drug development and related milestones; the relative effectiveness and efficiency of such alternative models in stimulating innovation, compared to the status quo that includes patents and regulatory exclusivities; strategies to implement such alternative models described in paragraph (1), including a phased transition over time; and the anticipated economic and societal impacts of such alternative models, including an assessment of impact on— the number and variety of new drugs that would be developed, approved, and marketed in the United States, including such new drugs intended to prevent, diagnose, or treat a rare disease or condition; the rate at which new drugs would be developed, approved, and marketed in the United States; access to medication and health outcomes; average lifespan and disease burden in the United States; the number of manufacturers that would be seeking approval for a drug or bringing a drug to market for the first time;
Federal discretionary and mandatory spending; and public and private insurance markets. To carry out this section, there is authorized to be appropriated $3,000,000 for fiscal year 2024. In conducting the study pursuant to subsection (a), the National Academies shall hold not fewer than 2 public listening sessions to solicit feedback from interested parties, including representatives of academia, professional societies, patient advocates, public health organizations, relevant Federal departments and agencies, drug developers, representatives of other relevant industries, and subject matter experts.
Not later than 2 years after the date of enactment of this Act, the National Academies shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on the study conducted pursuant to subsection (a).