Top trade officials from countries all over the world, including the U.S., recently gathered in Geneva, Switzerland, and waived certain intellectual property protections on COVID-19 vaccines. Their decision undermines the very IP rights that enabled hundreds of collaborations to produce vaccines on a global scale.
And unfortunately, global commitments to protect IP could take an even bigger hit, as the World Trade Organization considers expanding the waiver beyond COVID-19 vaccines to therapeutics and tests. It's up to the Biden administration to prevent the further erosion of IP rights.
Many nations, including the U.S., initially opposed the vaccine waiver when India and South Africa requested it in October 2020, before any vaccines were even authorized by the U.S. Food and Drug Administration or other global regulators. The U.S. government correctly noted that voiding IP protections on vaccines would not increase global supply of the lifesaving shots—but such action could slow life-science research and turn over American IP to rival countries looking to strengthen their own domestic biomedical sectors.
However, in May 2021, the Biden administration bowed to pressure from activists, who demanded the White House "do something" to increase vaccination rates in developing countries. The administration began supporting the waiver, even though health and trade experts on both sides of the political spectrum explained that IP protections weren't restricting production or inoculation.
Just the opposite, in fact. IP protections are the reason we have new medicines, including the COVID-19 vaccines, in the first place. As the Obama administration noted in a 2016 State Department news release, "Intellectual property rights and trade are essential to medical innovation. … Robust intellectual property policies found in the United States and other economies support the development of innovative new treatments that save and improve lives around the world."
The past two years have underscored the truth of those statements. In early 2020, just weeks after scientists first sequenced the novel coronavirus, American biopharmaceutical companies developed and began testing COVID-19 vaccines. The shots would later save 2 million lives and $900 billion in healthcare costs in the U.S.—and even more across the globe.
Those companies then voluntarily partnered with manufacturers throughout the world to increase production as quickly as possible. Pfizer and BioNTech's COVID-19 vaccine, for example, is manufactured at more than 20 facilities on four continents. The two companies evaluated potential partners carefully to ensure patients get safe and effective vaccines.
These voluntary partnerships were so successful that the global market has experienced a large surplus of vaccines for months.
The White House acknowledges this global surplus. So does the World Health Organization. The Serum Institute of India, the world's largest vaccine manufacturer, shut down production in December because it had 200 million excess doses in storage. The Africa Centres for Disease Control and Prevention asked the world to stop donating vaccines because it couldn't administer the doses it already has.
To be clear, vaccination rates remain far too low in some countries. But the problem isn't a lack of doses. Rather, low vaccine uptake exists because of challenges related to distribution and administration—everything from vaccine hesitancy to inadequate refrigeration capacity to trade barriers. As Secretary of State Antony Blinken correctly noted, "Increasing supply by itself is not enough to turn vaccines into vaccinations." And as Jeff Zients, then White House COVID-19 Response Coordinator, acknowledged in April, "vaccine supply is no longer the constraint to getting shots in arms around the world."
Simply put, endorsing this waiver was a publicity stunt that distracts global leaders from those real challenges. It will not add a single safe and effective vaccine to the already more-than-adequate vaccine stockpiles nor end this pandemic sooner.
But it's already emboldening America's economic competitors to disregard our IP and will discourage future investments in U.S. research and development, to the detriment of patients everywhere.
Right now, the world's best and brightest choose to start and grow their companies in America, largely because of our strong legal protections on IP. Global investors also choose to pour their capital into U.S. firms. Approximately 2 in 3 new medicines originate in a U.S. lab.
Surrendering American technologies like mRNA vaccine platforms to foreign manufacturers will cause those investors and founders to rethink those ventures. After all, if the government won't stand up for the rights of vaccine developers today, who's to say whether they'll stand up to international pressure and safeguard the IP protections on the next ground-breaking cure or treatment?
The Biden administration has a chance to limit the damage by ensuring the WTO doesn't expand the waiver to COVID-19 treatments and tests, in addition to vaccines. Such an expansion could threaten the more than 700 COVID-19-related therapies currently in development, which, if the waiver proceeds, may never make it to market.
Rather than expanding the intellectual property waiver, policymakers should focus on solving the distribution and administration barriers preventing patients around the world from accessing the global surplus of lifesaving innovations that America's world-leading industry already has produced.
