By: Dr. Carrie Teicher, MSF USA Director of Programmes, and Christopher J. Morten, JD, PhD, Teaching Fellow/Supervising Attorney, New York University, School of Law
U.S. gives bulk of COVID-19 funding for new medicines, vaccines, and diagnostics to office that won’t tell us how money is being used or if products created will be affordable.
The Biomedical Advanced Research and Development Authority (BARDA) was created to address chemical, biological, radiological, and nuclear threats and has received, to date, more US taxpayer money than any other US government entity to develop new medicines, vaccines, and diagnostics to fight COVID-19: at least $5.5 billion since early 2020.
Unfortunately, we have very little idea how this funding is being used. BARDA does nothing to guarantee that its pharmaceutical and defense industry partners will share research and development (R&D) costs, clinical trial results, or other data that physicians and researchers need. Worse, BARDA does not require its industry partners to make products developed with this funding widely available and affordable once they hit the market here and abroad.
That is good news for pharmaceutical corporations that want BARDA to finance the creation of their COVID-19 products without any strings attached. This includes the US $456 million in COVID-19 money that BARDA has already given to Johnson & Johnson, $30 million to Sanofi, $483 million to Moderna, $1.2 billion to AstraZeneca, and $628 million to Emergent BioSolutions.
But it’s bad news for everyone else who may not be able to access new medicines developed with BARDA funding. No matter how much public funding goes into developing these tools, pharmaceutical companies will be free to charge whatever they want and obtain patents that create 20-year monopolies and block more affordable generic versions from being produced.
Without strings attached to the funding to ensure equitable allocation and global access, countless people all over the world could be completely shut out from these publicly financed medical advances, including many people MSF is treating for COVID-19 around the world.
So there’s concern in MSF that the current acting director of BARDA announced his office would be “prioritizing domestic concerns.” This means BARDA — which was built on the idea that health should be handled like a security threat rather than a basic human right — could finance a medical tool using taxpayer money, and then allow its partners to make it available only in the United States. But we know we can only end the pandemic domestically if we work to end it globally.
BARDA works. It has helped to shepherd more than 50 FDA*-approved products to market since 2007. This includes Merck’s recently approved vaccine for the Ebola virus — a vaccine that MSF used on the ground in Democratic Republic of Congo — that received approximately $175 million in BARDA funding.
But the office has been criticized before for failing to hold companies accountable — something that has real-life public health consequences. For example, BARDA was involved in an expensive deal with Philips to purchase ventilators for the U.S.’s Strategic National Stockpile that left the stockpile without a single Philips ventilator when COVID-19 hit, because the company was slow to ramp up production.
And a recent investigation revealed that BARDA signed misguided contracts in the early days of the COVID-19 pandemic that weakened rather than strengthened its ability to demand fair prices on the vaccines, drugs, and other products its industry partners create with public funds.
We can’t let BARDA repeat such mistakes.
First, BARDA should attach strings to the public money they give industry partners to require medical tools that are created are affordable and widely distributed to people in need around the world.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act that passed earlier this year committed at least $3.5 billion to BARDA — a massive public investment. New bills are proposing billions more.
Second, BARDA should require its industry partners to commit to worldwide, non-exclusive licensing so patents don’t stand in the way of generic manufacturers that want to create more affordable versions of medicines, vaccines, and diagnostics.
This is the best way to meet what will be the vast global demand, and avoid shortages and rationing. For example, as soon as an effective vaccine is developed, billions of doses must be distributed as quickly as possible to meet the medical need — something no single manufacturer, even a giant like Johnson & Johnson, will be able to achieve on its own.
Third, BARDA should ensure that it and its industry partners share R&D costs, clinical trial results, and other research data transparently and widely with the public, physicians, scientists, and policymakers.
For example, it is critical that drug manufacturers have access to data that already exists so they don’t have to replicate clinical trials to collect their own data, which would slow down the production of their own more affordable versions of medicines and stand in the way of adequate global supplies.
Additionally, the public that funded these tools should know how their money is being used and why certain partners were chosen to receive funding. This information helps define what a reasonable price should be once a product hits the market in the US and abroad.
The COVID-19 pandemic is a crisis, and an important moment to do the right thing.
BARDA is making a massive — and much-needed — public investment in lifesaving medical products to tackle this disease. That investment will bear fruit only if BARDA demands that its industry partners make the products created with that investment affordable and accessible to all.
* The Food and Drug Administration is responsible for protecting the public health in the US by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, among other products.