NIH Starts Taking Responsibility for Access

The National Institutes of Health (NIH) are the world’s leading funder of biomedical research, at nearly $50 billion a year. Most new medicines benefit from NIH funding, science or both. But historically, NIH has not taken responsibility for access to its breakthroughs, instead allowing corporations that use lifesaving federal inventions, like the NIH-Moderna vaccine, to price unaffordably and block competition. That changed this summer, when NIH reissued a policy Public Citizen helped inspire and shape over several years, on equitable access planning.

NIH will require drugmakers relying on federal inventions to submit plans ensuring broad public access, addressing availability, affordability, acceptability and sustainability. NIH can turn them down, and will work with drugmakers to improve plans and convene stakeholders that can make access more effective. If that policy had been in place during the pandemic, the U.S. could have prevented Moderna from quadrupling the price of its shot to Americans. NIH would have been equipped to support global access and prevent the vaccine apartheid that cost so many lives.

Public Citizen helped NIH embrace access measures and develop this approach over several years. We pointed out, to surprise and interest, that patenting federal inventions gives NIH power to influence access. We organized experts to discuss, learn and contribute as powerfully as possible to NIH’s request for comment. NIH drew from examples at the University of California established through our allies’ advocacy. NIH’s guidance draws from Public Citizen’s recommendations and makes the policy stronger.

This access planning framework can be strengthened further and represents a promising trend. Imagine if instead of fighting over high prices after a medicine reaches market, research funders established clear access conditions from early development. Vaccine funders have strengthened access planning too, bolstered by the fresh memory of COVID shortages. The Biden administration incorporated access planning in the WHO Pandemic Agreement, which countries adopted this summer. 

For the first time in a generation, NIH is starting to take responsibility for access and for making the medicines it helps develop more affordable. This is a breakthrough, however limited, which finally creates an expectation that drugmakers support affordability and broad access to medicine when they rely on government inventions. Public Citizen’s Access to Medicines Director Peter Maybarduk