COVID-19 patent waiver challenges proliferate — and rightly so

COVID-19 patent waiver challenges proliferate — and rightly so
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As the Delta variant of COVID-19 races around the globe, policymakers have struggled to devise an effective response, especially as developed countries consume much of the available stock of vaccines. 

Nearly a year ago, India and South Africa submitted a bold proposal to the World Trade Organization (WTO): Why not temporarily suspend the patent rights associated with COVID-19 vaccines to allow generic pharmaceutical companies to swiftly produce doses?

Initially, the Trump administration opposed this proposed waiver of the WTO’s so-called Trade-Related Aspects of Intellectual Property Rights (TRIPS). But the Biden White House reversed course and announced its support for the Indian and South African proposal in May, proclaiming that “this is a global health crisis and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.”

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Advocacy groups cheered the announcement, and waiver supporters predicted swift enactment at the WTO. “Our vaccination efforts here at home will only be successful if vaccination efforts in the developing world happen simultaneously,” Sen. Bernie SandersBernie SandersWhite House: Window for finalizing sweeping budget package 'closing' Jayapal says tuition-free community college 'probably won't' be in spending plan Progressives see budget deal getting close after Biden meeting MORE (I-VT) asserted. “Supporting this waiver, and putting people over profits, will help us to do that by speeding up the production and availability of vaccines.” Furthermore, nine Democrats in Congress declared that “a pandemic is not the time to fuss over intellectual property rights” and that the “TRIPS waiver will allow sharing of the intellectual property required for vaccine manufacturing to get underway immediately.” 

So, what’s not to like? A lot, it turns out, as was clear during a spirited debate I moderated at the American Enterprise Institute in June.

First, the suspension of intellectual property (IP) rights will not quickly deliver shots in arms in the developing world, as the past four months have amply shown. The challenge of inoculating the Global South derives not from patents but from deficiencies in supply chains, especially for vaccines requiring refrigeration or deep freezing. Moreover, generic manufacturers cannot simply flip a switch and begin producing doses; instead, they must master the formulation of complex compounds (some of which involve mRNA), and their medicines must undergo local regulatory scrutiny for safety and effectiveness.

Second, the WTO is uniquely unsuited to move quickly on the proposal given its bureaucratic and consensus-driven nature. Opposition to the waiver proposal in late July, primarily from the European Union (EU), has delayed further discussion until at least October, because “disagreement persisted on the fundamental question of what is the appropriate and most effective way to address the shortage and inequitable access to vaccines and other COVID-related products.” By the time the TRIPS waiver receives proper consideration, the Delta wave may have passed.

Finally, the suspension of vaccine-related IP rights fundamentally undermines the global innovation regime that brought us these miraculous drugs in the first place — wildly effective vaccines developed in absolute record time. Patents entail a basic bargain: In exchange for limited exclusivity, inventors concoct lifesaving and life-enhancing breakthroughs and share them with the rest of the world. Violating this bargain by removing the incentive to create will only harm humanity when the next outbreak inevitably occurs. In this case, companies such as Pfizer and Moderna invested tens of billions of dollars in research and development, risking utter ruin in the process. Depriving them of their IP rights will chill future innovation.

What’s the alternative? How can we make sure the developing world recovers, too?

The EU — whose spokesman declared in June that “we don’t think in the short term that [a waiver is] the magic bullet” — has proposed working within the TRIPS framework to impose a compulsory license that would partially compensate drug developers for making vaccines available. And two University of Pennsylvania scholars, writing last month for Brookings, proposed a public-private partnership along the lines of the 2003 PEPFAR program that throttled the HIV/AIDS outbreak throughout the developing world.

But an even faster and more effective solution requires nothing more than for the United States and other Western countries to buy up more vaccine doses and simply hand them out in the developing world. The U.S. also should leverage its unparalleled logistical capabilities to purchase refrigeration equipment and bolster supply chains in the Global South. For all the benefits that such “vaccine diplomacy” would confer — including the demonstration of badly needed American leadership and the accrual of goodwill — a 10- or even 11-figure price tag is a mere pittance, especially in a climate where Congress already has spent trillions of dollars (and is considering spending trillions more).

In the end, tempting as a shortcut such as the TRIPS waiver may seem, there’s no substitute for carefully considered engagement with this thorny problem — and the crafting of thoughtful, effective solutions.

Michael M. Rosen is an intellectual property attorney and writer in Israel, and an adjunct fellow at the American Enterprise Institute. Follow him on Twitter @michaelmrosen.