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With 27 different institutes and centers is under the umbrella of the National Institutes of Health (NIH) – including the National Institute for Allergy and Infectious Diseases (NIAID) – NIH the most the world’s biomedical research agency.
Operating under the U.S. Department of Health and Human Services (HHS), the NIH is now doing a heavy job. annual budget at nearly $ 42 billion.
Within the NIH, the Office of Technology Transfer (OTT) is playing a “strategic role”In support patents and licensing for inventions that emerged from NIH laboratories and also the Centers for Disease Control and Prevention (CDC).
In a win-win business model, NIH has always provided technology licenses (both exclusively and non -exclusively) to the private sector for the use or commercialization of its inventions, with licenses to then drive billions of dollars of royalties back to the NIH coffers.
In fiscal year (FY) 2020 only – October 2019 to September 2020 – the combined data for the NIH and CDC showed that the agencies collected a smooth $ 63.4 million of royalty income.
Under federal law, a portion of the licensing royalties returned at the NIH to support unspecified mission -related activities. The other part is directly to the inventors of the agency, which is allowed up to $ 150,000 of payments each calendar year. the Similarly true of the CDC.
Scientists want to frame these payments as “positive incentive, ”But Protecting the Health of Children Acknowledged by Chairman Robert F. Kennedy, Jr. the rules of royalty as “recipes for controlling corruption. ”
The gift that keeps on giving
Universities too receive royalties if they sell patented technologies. Nearly 25 years ago, a biologist at the University of Michigan complained that two California universities (both public and private) were using royalties as a mechanism to distrust taxpayers.
Cited a technology that is patented and licensed by two universities, the professor said explained that “ordinary people” are already paying through their tax dollars for principal research that has granted patents. He said taxpayers shouldn’t have to continue to pay universities “multiple times the original investment through patent royalties.”
The money that flows to NIH scientists every now and then has attracted the same public outrage.
on 2005, an explosive Associated Press (AP) scoop showed several agency scientists – at NIH’s clear instruction – consistently failed to disclose royalty payments, either to taxpayers or to participants in taxpayer -funded clinical trials attempted to test NIMs performing experimental treatments.
As the AP points out, “Such research can help bring treatment to more potential commercial use, which could bring researchers and NIH higher royalties. ”
Even without royalties (which are classified as “federal fees” rather than “outside income”), the longtime director of NIAID – who describes himself as a humble “government worker” with “ government salary ” – is the country highest fee federal employees.
During the 2005 brouhaha, stated to be “more sensitive about the possibility of an appearance conflict of interest, “Fauci told the public that he donated his payments to charity.
Judging by a late 2020 report from the Government Accountability Office (GAO), there is still much room for improving NIH’s terms of transparency regarding NIH licensing activities.
The GAO said the NIH “does not report which of the patents have licensing or release criteria that would allow the public to assess how licensing affects patient access to the resulting drugs.”
As one of the top two recommendations, the GAO urged the NIH to provide “more public information“- in” an accessible and searchable format as much as possible “- to help citizens and policy makers understand the licensing consequences and effects.
2020: Setting the standard for many historic heights?
“A lot of public information” is clearly lacking in OTT’s FY2020 annual report, which provides just one paragraph of details (and two paragraphs on the boilerplate) in a short section on “Inventions and Agreements.”
In addition to noting $ 63.4 million in FY2020 royal revenue, the paragraph highlights a significant increase in invention disclosures (up to 20% more than in FY2019) and patent applications – 47% more. applications were filed compared to last year. (Invention disclosures are the first step in the patent process.)
Elsewhere, technology transfer statistics show the NIH implemented multiple licenses in FY2020 (n = 359) than in any previous fiscal year since 1985 (when 25 licenses were implemented).
Some more COVID -specific details will be available in the three -page portion of the GAO -targeted report. NIAID (pp. 22-25). We learned there that NIAID and the Technology Transfer and Intellectual Property Office (TTIPO) are working “diligently” and “as quickly as possible” by 2020 to facilitate the worldwide “sharing” of NIAID-grown SARS. -CoV-2 proteins and plasmids (molecules encoding spike proteins) to encourage the development of COVID-19 diagnostics, treatment and vaccination.
These efforts have resulted in:
- Ninety more agreements with 75 academic organizations, non-profit entities, government agencies, international organizations and other entities to provide NIAID spike proteins or plasmids for research project (called a “material transfer agreement”)
- Twenty -one licenses deal with biotechnology or strengthening companies, mostly for the development of the SARS-CoV-2 vaccine-these licenses relate to “most of the vaccines in advanced clinical trials and widely used today around the world” (especially Modern mRNA-1273 vaccine received Emergency Use Permit in December 2020)
- An additional 16 agreements to collaborate on research, including four clinical trial agreements for the SARS-CoV-2 vaccine
Given the area of licensing associated with COVID set in FY2020, it is not surprising to see that NIH royalties also increased in FY2021.
Pfizer’s COVID vaccine partner, BioNTech, is already there payment of royalties for the use of spike protein technology developed by the NIH. Moderna, nga with the owner the COVID vaccine patents with NIAID, not paying royalties.
CDC’s webpage the list of technologies available for licensing (and, therefore, with the potential to generate royalties) has not been updated since May, 2020. At that time, the agency had about 60 technologies on offer, many of which were related. in diagnostics or vaccine development.
Whenever the CDC updates its list, it is likely that the number of available technologies will be even higher.
The pandemic growth model
Where public health agencies are concerned, COVID -19 appears to be very good for business, with many untapped funds – quickly mobilized by the pandemic – leading to deep and likely permanent disruption. -or a public health infrastructure that was once saddened as weak and divided.
The CDC today boasted about the excavation of the largest response effort in its 74 -year history. The agency’s chief financial officer agreed, “More resources are being allocated to the CDC for execution and management. [in FY2020] than ever before ”- including more than double last year’s funding.
Two thirds (66%) of the funds provided made or spent by the CDC in FY2020 were related to COVID-19.
Beyond the NIH, the prospects are much rosier for the agency – and frightening to the public. For FY2022, the Biden administration is asking for a 21% increase in NIH budget (at $ 51 billion), “accelerating the six-year trend of multi-billion-dollar annual budget increases.”
Most of it goes to making a new one NIH Agency to integrate national security with health security, modeled after the military’s Defense Advanced Research Projects Agency (DARPA).
DARPA’s is known disturbing track record, investigator journalist Illustrated by Whitney Webb the new agency’s security mandate as “a recipe for a technological” pre-crime “organization with the potential to criminalize mental and physical illnesses as well as’ wrong thinking.”
Surprisingly, many of the COVID therapies have proven effective in frontline physicians but are active. withheld of federal agencies are inexpensive – far from budget -busting experimental vaccines nga na illegally framed as a solution to the pandemic.
For the public, a major advantage of these therapies – including long -standing fixtures of the World Health Organization list of essential medicines – is the fact that their safety profile, side effects, dosage and drug interactions are well documented.
However, scientists hungry for royalty are not interested in “tried and true, classical… repurposing [of] drugs and strategies that have already been shown to work. “They prefer, to the words by Dr. Ian Lipkin of Columbia University, novel treatments that are “sexy and new and can be patented.”
Nor mesh them with control of the world agenda of a new agency like DARPA NIH that promises to simplify. It is up to the public to reaffirm, loudly, that people and freedom come first.