S.3187 Food and Drug Administration Safety and Innovation Act (Engrossed in Senate [Passed Senate] – ES)
SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION INDUCEMENT MODEL.
(a) In General- The Secretary of Health and Human Services shall enter into an agreement with the National Academies to provide expert consultation and conduct a study that evaluates the feasibility and possible consequences of the use of innovation inducement prizes to reward successful medical innovations. Under the agreement, the National Academies shall submit to the Secretary a report on such study not later than 15 months after the date of enactment of this Act.
(b) Requirements-
- (1) IN GENERAL- The study conducted under subsection (a) shall model at least 3 separate segments on the medical technologies market as candidate targets for the new incentive system and consider different medical innovation inducement prize design issues, including the challenges presented in the implementation of prizes for end products, open source dividend prizes, and prizes for upstream research.
- (2) MARKET SEGMENTS- The segments on the medical technologies market that shall be considered under paragraph (1) include–
- (A) all pharmaceutical and biologic drugs and vaccines;
- (B) drugs and vaccines used solely for the treatment of HIV/AIDS; and
- (C) antibiotics.
(c) Elements- The study conducted under subsection (a) shall include consideration of each of the following:
- (1) Whether a system of large innovation inducement prizes could work as a replacement for the existing product monopoly/patent-based system, as in effect on the date of enactment of this Act.
- (2) How large the innovation prize funds would have to be in order to induce at least as much research and development investment in innovation as is induced under the current system of time-limited market exclusivity, as in effect on the date of enactment of this Act.
- (3) Whether a system of large innovation inducement prizes would be more or less expensive than the current system of time-limited market exclusivity, as in effect on the date of enactment of this Act, calculated over different time periods.
- (4) Whether a system of large innovation inducement prizes would expand access to new products and improve health outcomes.
- (5) The type of information and decisionmaking skills that would be necessary to manage end product prizes.
- (6) Whether there would there be major advantages in rewarding the incremental impact of innovations, as benchmarked against existing products.
- (7) How open-source dividend prizes could be managed, and whether such prizes would increase access to knowledge, materials, data and technologies.
- (8) Whether a system of competitive intermediaries for interim research prizes would provide an acceptable solution to the valuation challenges for interim prizes.