It would be an understatement to say the novel coronavirus, SARS-CoV-2, has disrupted everyone’s life and livelihood. More than 1.2 million have had COVID-19 and more than 72,200 have tragically died.
The American private healthcare sector has responded quickly and robustly to fight this pandemic. The biopharmaceutical industry is testing more than 135 treatments, 300 clinical trials are underway for therapies, and seven are being done for vaccines.
The medical technology industry has been working around the clock, sometimes in partnership with other companies, to meet the demand for products like ventilators, laboratory testing kits, N95 masks, medical gowns, and gloves.
The cooperation among manufacturers, researchers, university scientists, and the federal government to get vital supplies out to the medical community in less than three months has been stunning.
But these alliances have not stopped the usual anti-private sector, pro-nationalized healthcare gang on Capitol Hill from trying take advantage of this crisis to implement a socialistic agenda and inject their regressive policies on the research and development of a COVID-19 vaccine.
Johnson and Johnson and its subsidiary Janssen Pharmaceuticals announced on March 30, 2020 that its COVID-19 vaccine was a lead candidate and human clinical studies could start by September under emergency use authorization.
The company aims to have a vaccine available for distribution to the public on a “not-for-profit” basis by early 2021, a risky but astonishing feat since successful vaccines usually take several years to produce and distribute.
Since 2017, the companies have been working closely with the Biomedical Advanced Research and Development Authority (BARDA) at the Department of Health and Human Services’ Office of Preparedness and Response, to discover and develop a portfolio of vaccines and therapeutics for influenza pandemics and other infectious diseases.
BARDA was created to establish “successful public-private partnerships with industry to share risk, improve efficiency and accelerate development all while sustaining a marketplace that guarantees continued access to countermeasures vital to our national security.”
Like any public-private partnership, the government commits a certain amount of funding along with the private entity. For the COVID-19 vaccine, BARDA and Johnson and Johnson have together committed $1 billion to fund research, development, and clinical testing.
Johnson and Johnson will create new vaccine manufacturing capabilities at its own risk to ensure an amble global supply.
Another partnership includes Kaiser Permanente Washington Health Research Institute, which in mid-March injected the first volunteer with a COVID-19 investigational vaccine.
The institute is working with the Massachusetts-based biotech company Moderna, which manufactured the vaccine, and the National Institute of Allergy and Infectious Diseases (NIAID), which provided scientific collaboration and funding for this phase one clinical trial.
The Bayh-Dole Act, passed in 1980, was designed to solve a serious problem with federally-funded research. At that time, only about 5 percent of the inventions or discoveries at universities or other non-profit entities funded by the government had been commercialized due to complex rules on ownership.
Clearly this was a waste of taxpayer money. To solve this problem, the Bayh-Dole Act established a uniform policy to allow the patents to be owned by the research entities and transferred to the private sector, which would take the risk and expense to commercialize them.
Despite the United States creating by far the most new drugs of any country, the nattering nabobs of negativism who have spent most of their lives as an elected official or community organizer, never creating anything beyond a new law or tax, want to stop any private sector “profiteering,” demanding price controls, no patent protections, and a publicly available accounting of the companies’ expenditures.
They want these policies implemented in a future COVID-19 funding bill, whether or not a company developed a coronavirus therapy with federal funding.
In short, they are proposing the outright theft of intellectual property and in turn undermining incentives to develop a COVID-19 vaccine and other therapies.
If they succeed, discoveries funded by federal research are more likely to stay on a laboratory shelf as 95 percent of them did prior to Bayh-Dole, and if these policies are expanded to privately-funded biopharmaceuticals, America and the world would be bereft of many new treatments for not just COVID-19, but also every other illness.
NIAID Director Dr. Anthony Fauci told Roll Call in October 2017, “We always need a pharmaceutical partner. I can’t think of a vaccine, even one in which we’ve put substantial intellectual and resource input, that was brought to the goal line without a partnership with industry.”
If members of Congress continue to attack and threaten companies that collaborate with the federal government, it will not be long before they walk away.
That would be an unhealthy outcome for patients and taxpayers.
