Response to Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning

Abstract

The National Institutes of Health (NIH) Office of Science Policy (OSP) has requested input on a draft policy to promote access to products stemming from its intramural research program. Here, we build on our prior academic research to comment on three issues on which the NIH has requested input: 

1. We suggest that the NIH revise its list of “meaningful access approaches” to account for several practical features of the global innovation ecosystem. Specifically, the NIH should acknowledge that public-sector entities may be in the best position to commercialize some licensed technologies, explicitly address the value of global access to NIH inventions, and encourage licensees to undertake investments like in manufacturing innovation that reduce price-quantity-quality tradeoffs and decrease entry costs for other firms.

2. We encourage the NIH to prioritize data collection on the licensing, development, and commercialization of funded inventions. Little is known, in particular, about the costs of biomedical research. The NIH is well-situated to fill part of this knowledge gap. 

3. The NIH should implement this new policy in a way that allows for rigorous assessment of its effects, at various short-, medium-, and long-term intervals. We suggest randomizing some aspect of the program, which will produce the best evidence on the causal effect of changes in licensing policy. For any version of this policy, the NIH should ensure that short- and long-term outcomes are monitored and documented.

Keywords: NIH, pharmaceutical, patent, intellectual property, innovation, commercialization, policy experiments