For the first time in more than four decades, the U.S. government has laid out a clear roadmap for acting on a long-dormant legal power: seizing patents on medicines developed with public money when drugmakers charge prices that most Americans cannot afford. The Biden administration’s December 2023 C.E. announcement represents a meaningful shift in how Washington is willing to approach the relationship between publicly funded research and private pharmaceutical profit.
At a glance
- March-in rights: A provision of the 1980 C.E. Bayh-Dole Act that lets the federal government grant additional licenses to third parties for products developed with federal funding — if the original patent holder fails to make them available on reasonable terms.
- Drug pricing policy: Under the new draft roadmap, the government will weigh whether only a narrow set of patients can afford a drug and whether companies are exploiting a health emergency by raising prices.
- Public comment period: The administration opened a 60-day window for public input before attempting to finalize the policy, giving researchers, advocates, and industry stakeholders a formal channel to respond.
Why this moment matters
March-in rights have existed on paper since the Bayh-Dole Act was signed into law more than 40 years ago. Their purpose was always to protect the public’s investment. But no administration had ever used them — or even defined a clear standard for when they would apply.
The new policy changes that. It says the government will consider price as a direct factor. If a drug was developed with taxpayer dollars through the National Institutes of Health or another federal agency, and the company behind it is selling that drug at prices that shut out most patients, the government now says it is prepared to license production to competitors.
White House adviser Lael Brainard put it plainly: “When drug companies won’t sell taxpayer-funded drugs at reasonable prices, we will be prepared to allow other companies to provide those drugs for less.”
The law and its history
The Bayh-Dole Act was designed to solve a real problem. Before 1980 C.E., inventions developed with federal funding often sat unused because the government held the patents and lacked the infrastructure to commercialize them. The law gave inventors and universities the right to keep those patents — and it worked. It helped spark decades of biomedical innovation and technology transfer from universities to the marketplace.
But it also included a safeguard: march-in rights. These were meant to prevent exactly the scenario progressives have been pointing to — companies using public research to develop drugs, then pricing them beyond the reach of the public that funded the work.
The COVID-19 pandemic made this tension impossible to ignore. Moderna’s Spikevax vaccine was developed with substantial NIH support, yet the company announced plans to raise its price to as much as $130 per dose after the government contracts expired. That move drew sharp criticism, including a Senate hearing led by Senator Bernie Sanders.
What advocates and critics are saying
Vanderbilt University professor Stacie Dusetzina offered a measured read of the policy. She acknowledged that actually exercising march-in rights could chill investment in pharmaceutical research — but added it might be “useful to have a credible threat if the industry is being completely unreasonable.”
That tension is real. The pharmaceutical industry lobby group PhRMA argued the policy would “stunt innovation and harm patients,” warning it would send the country back to an era when government research sat unused. Critics of that framing point out that much foundational drug research already depends heavily on public funding — and that innovation built on public investment carries a different set of obligations than purely private research.
Newly confirmed NIH Director Monica Bertagnolli struck a careful but committed tone in her first briefing with reporters. “What I will affirm over and over is that I will use every tool I possibly can with the goal of obtaining the access that our patients need,” she said.
A credible threat — and an open question
The policy’s real power may lie less in its direct use and more in what it signals to drugmakers during pricing negotiations. A government willing to define and act on march-in rights changes the leverage in those conversations.
Still, important questions remain. Legal scholars and industry groups have suggested that using Bayh-Dole’s march-in rights specifically to address price — rather than access in a narrower technical sense — could face court challenges. Joseph Allen of the Bayh-Dole Coalition noted that Congress could push back if the policy is found incompatible with the original law’s intent. The 60-day comment period will test how durable the administration’s framework really is.
What is clear is that public support for action on drug pricing is strong and broad. The new roadmap, whatever its legal fate, reflects a growing consensus that publicly funded research should produce medicines that the public can actually afford.
Read more
For more on this story, see: Reuters
For more from Good News for Humankind, see:
- U.K. cancer death rates fall to their lowest level on record
- Alzheimer’s risk cut in half by drug in landmark prevention trial
- The Good News for Humankind archive on global health
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