As current incentives to promote the development of new infectious disease treatments have yet to reach their potential, researchers in a new Food and Drug Law Journal paper suggest forming a research and development treaty.
The “most far-reaching” policy tool “may be a research and development treaty, which would provide a focal point for future global coordination, provide a long-term commitment to funding, and build on what has been learned from existing approaches,” authors Jonathan Darrow, Michael Sinha, and Aaron Kesselheim of the Program on Regulation, Therapeutics and Law (PORTAL), Harvard Medical School and Brigham & Women’s Hospital write.
The authors noted that such a treaty would be an international agreement that leverages a global base of potential resources, “but could also reduce duplicative effort, ensure equitable contributions by nations that are sensitive to each nation’s ability to pay, and help to ensure a stable funding stream over time,” they write.
The PORTAL researchers also explain how current incentives are not bearing the fruit that was expected when they were created, noting particularly how the antibiotic market has not responded to patent-based incentives.
“The public health value of infectious disease products is poorly correlated with market-based financial incentives because of the unusual disease, patient, product, and public health characteristics of this market,” they write. “An understanding of the unusual characteristics of the infectious disease marketplace helps explain why the market-based approaches implemented by Congress have so far produced only modest results.”
Such modest results mean Congress may have to go back to the drawing board to come up with new incentives.
“Extensions of patent or statutory exclusivities such as those found in the GAIN Act are linked to market size, not public health value, and in any event offer distant revenues with heavily discounted present values,” the researchers write. “Priority review vouchers create timely rewards for the successful development of certain tropical infectious disease products, but their value is de-linked from the public health value of the newly created infectious disease product—like infectious disease markets themselves.”
The paper comes as FDA Commissioner Scott Gottlieb called for reimbursement reforms for antimicrobial treatments recently, with “a mix of milestone payments and subscription fees for developers of FDA-approved products with high economic and clinical value, targeted at multi-drug resistant organisms and linked to proven clinical outcomes.”
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email firstname.lastname@example.org for more information.
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