After years of prodding, the National Institutes of Health has adopted a new policy requiring companies seeking licenses to sell medical products invented with government research to submit plans for ensuring greater access to patients.
Going forward, a company would not only have to submit an access plan when seeking to license the rights to sell a drug, vaccine or device, but would also have to update that plan as product development progresses. And a version of the plan would have to submitted within three months of regulatory approval that the NIH may publish or otherwise make distribute.
In explaining its move, which was signaled last May with a notice in the Federal Register, the agency noted in its new policy that it “relies on partners, including licensees, to turn inventions into new products and services that can directly impact people’s lives… but all too often patients across the globe may be unable to access products they need.”
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