Biden Administration Weighs Temporarily Suspending IP Protections For Covid-19 Vaccine Developers
Biden Administration Weighs Temporarily Suspending IP Protections For Covid-19 Vaccine Developers
The Biden Administration is considering whether to temporarily lift intellectual property protections (IPP) on Covid-19 treatments and vaccines.
Last October, at a World Trade Organization meeting, representatives from India and South Africa proposed a
temporary suspension of patent rights for Covid-19 treatments and vaccines. This proposal has since received support from 58 nations.
A number of prominent U.S. policymakers and legislators have echoed calls from low- and middle-income countries to temporarily suspend patent rights on Covid-19 products. They view Covid-19 treatments and vaccines as
public goodsintended for worldwide administration. Accordingly, they have urged the Biden Administration to suspend IPP to allow other countries – especially developing and emerging market nations – to replicate existing vaccines in particular, and mass produce to meet the needs of local populations. Given that more than 30 nations haven’t even begun vaccinating residents, and many more have only vaccinated a very small fraction of the population, there’s an acute need for a substantial boost in supply of vaccines.
In this context, concerns have arisen regarding the fact that the U.S. and a few other wealthy nations maintain large inventories and hold the rights to a disproportionate amount of the global supply of vaccines. The world’s richest countries have administered 86% of the total number of vaccine doses thus far. Only
0.1% of doses have been administered in low-income countries. Proponents of IPP suspension point to vaccine equity as a global concern. Within this frame of reference, the slogan, no-one is safe until everyone is safe, applies.
Reinforcing the public good argument is the fact that a massive amount of
public funding has been poured into vaccine research, development, manufacturing, and advanced market commitment purchasing. While Pfizer/BioNTech declined federal funds earmarked for R&D, Johnson & Johnson, Moderna, and Novavax each received hundreds of millions of dollars in research support.
By contrast, biopharmaceutical industry trade groups are vehemently opposed to waiving of patent protections. Intellectual property protections encourage innovation by rewarding the developer of a treatment or vaccine with monopoly rights with respect to the commercial exploitation of their products for a defined period of time. Critics of the policy of lifting IPP or granting compulsory licensing suggest it is myopic. Here, compulsory licensing refers to when a government allows an entity to produce a patented product without the consent of the patent owner, in exchange for a set fee for the license.
In their view, without IPP, private sector funding of R&D for future treatments and vaccines would shrink dramatically. In this regard, they worry about undermining innovation to fight future diseases. This is not our last pandemic, or acute disease crisis, commentators remind us.
There isn’t, however, a monolithic industry voice on this matter.
Last October one of the major vaccine developers and manufacturers, Moderna,
announced it would not enforce its coronavirus vaccine patent rights during the pandemic. Moderna also declared that it is willing to consider out-licensing its intellectual property once the pandemic is over.
Other vaccine manufacturers haven’t been as forthcoming about their post-pandemic patent plans.
In terms of policy prescriptions going forward, there is a large gray area in which a balance must be struck between affordable access and assuring there is long-term innovation.
The Covid-19 pandemic has accentuated the mutually beneficial relationship that has existed between industry and government for many decades. Federal government efforts at formulating and implementing industrial policy, coordinating and (partly) funding R&D, and procuring large quantities of products, are indispensable. But, one stakeholder cannot be successful without the other. The public-private partnership has been key to the success story of Covid-19 vaccines. Certainly the federal government alone could not have embarked upon the project of developing vaccines at lightning speed. It required partnering with private firms with the know-how, technology platforms, and clinical development skill set and experience.
Policymakers invariably attempt to find the middle ground between preserving incentives for private firms to innovate and ensuring worldwide, affordable access to a sufficient supply of vaccines. While formulating a sustainable policy to achieve these ends, in the interim, the U.S. government has pledged
$4 billion in contributions to COVAX, the vaccine alliance co-run by the World Health Organization. This program distributes Covid-19 vaccines to 92 low- and middle-income countries. The U.S. government could also consider providing at nominal or no cost some of the
excess supply of vaccine doses it presently has. The U.S. is currently sitting on a stockpile of tens of millions of vaccine doses from AstraZeneca that it has not even approved for emergency use authorization. Meanwhile, there are many countries that have authorized the vaccine but have insufficient supplies.
A potential longer-term solution would be to enable governments to purchase or license intellectual property rights. If on their own the current set of vaccine manufacturers cannot produce the billions of vaccines needed worldwide in the short term, then they could be paid to share the patented information to facilitate vaccine production by other companies.
Of course, such a scheme becomes compulsory licensing if it’s done without the consent of the originator companies. As Vice President, Biden was opposed to compulsory licensing. And, the biopharmaceutical industry has explicitly asked the Biden Administration to reject compulsory licensing. So, the Biden Administration will need to tread a fine line if it were to decide to try and coax companies into selling their licenses.