NIH Licensing Guidelines Put Life Sciences Innovation at Risk 

The Trump Administration has chosen to uphold NIH’s new “access planning” licensing guidelines, a regulatory shift originally introduced at the end of the Biden era. While designed to promote affordability, these rules threaten to disrupt the delicate balance that fuels life sciences innovation in the U.S. 

Under the just released guidelines, companies seeking exclusive licenses to NIH-funded inventions must submit detailed “access plans” describing how future products will be made available, affordable, acceptable, and sustainable. NIH retains the authority to revisit those plans years later — and revoke or penalize licensees if outcomes don’t meet its evolving standards. 

Why does this matter? First, it’ll lead to greater uncertainty for companies. Firms already take enormous risks in bringing discoveries to market. Adding the possibility of license revocation based on future pricing or distribution judgments makes deals far less attractive. Secondly, venture capital depends on license security, and if core IP is subject to retroactive affordability reviews, investors will hesitate, stifling new company formation. Third, tech-transfer offices may struggle to attract partners, meaning NIH-funded discoveries could sit idle instead of reaching patients. Lastly, it creates a global competitiveness problem - if U.S. firms retreat from federally linked technologies, international competitors may seize opportunities, eroding America’s edge in biomedicine. 

This isn’t new. NIH’s 1990s “reasonable pricing” clause had the same effect: companies walked away. It was scrapped when it became clear that affordability mandates, however well-intended, killed commercialization. The new access guidelines risk repeating that mistake. 

The Bayh-Dole framework has long balanced public and private interests, ensuring federally funded inventions are translated into products that benefit society. These new guidelines tilt the balance dangerously. By emphasizing affordability mandates over commercialization incentives, they may inadvertently choke off the very pipeline of therapies and technologies patients depend on. Without licensees willing to invest, there will be no products to make accessible — affordable or otherwise. 

For the life sciences community, this moment demands strong engagement. Industry leaders, universities, and investors must speak with one voice: innovation cannot flourish under regulatory uncertainty. Policymakers should: 

• Revisit and revise the guidelines before they stall promising collaborations. 

• Restore confidence in NIH licensing by reaffirming Bayh-Dole’s original balance. 

• Explore alternative mechanisms — such as incentives for access — that do not jeopardize commercialization. 

If left unaddressed, these rules could discourage licensing, block startups, and leave groundbreaking NIH-funded discoveries stranded in laboratories. For patients, that means fewer therapies. For the U.S., it means losing ground in the global innovation race.