Waiving intellectual property rights is a flawed solution to achieving Covid-19 vaccine equity

When the history of the Covid-19 pandemic is written, readers will be as stunned by the flagrant collective flaw in not getting vaccines to all those who needed them as they will by the remarkable successes in vaccine and drug development.

A huge failure has been the global health care community’s inability to meet its moral obligation to older adults, people living with chronic conditions, and others in low- and middle-income countries who are most susceptible to developing severe cases of Covid-19 or dying from it. The inequitable distribution of Covid-19 vaccines is not the fault of any single entity. The global health care community as a whole — governments, international organizations, nongovernmental organizations, the biopharmaceutical industry, and others — has failed on its promise to leave no one behind.

What’s more, we are not out of the woods for this pandemic, as the disease continues to surge in regions around the world.

Today, 2 billion vaccines are stuck in refrigerators around the world, while in some countries older adults and others vulnerable to serious Covid-19 have still not received their full course of vaccines. By December 2021, the global production of Covid-19 had reached nearly 11 billion doses, but vaccine manufacturing capacities are now being scaled back. The Serum Institute of India is halting the production of the AstraZeneca vaccine, and Aspen Pharmacare in South Africa fears it will have to permanently shut its two Covid-19 vaccine production lines unless a new order comes in shortly. Aspen executive Stavros Nicolaou told the media: “If Aspen can’t produce Covid vaccines, what hope is there for others.”

Getting Covid-19 vaccines to everyone who needs them remains a huge challenge. Vaccines sit in storage while vaccination efforts fail because many health care systems are insufficiently funded and lack trained staff in both urban and rural settings; there is a lack of coordination and political commitment; the complexity of handling vaccines; and vaccine hesitancy.

Because lack of demand, not lack of supplies, is at the root of the current challenges, it is surprising that talks are still moving forward on a proposal initially submitted by India and South Africa to the World Trade Organization in October 2020 that would waive intellectual property (IP) rights on Covid-19 vaccines to help increase vaccine production. Talks on waiving the Trade-Related Aspects of Intellectual Property Rights (TRIPS) are all the more puzzling because according to health intelligence analyst Airfinity, there are more than 380 partnerships for Covid-19 vaccines and 150 for Covid-19 therapeutics. India and South Africa are two countries that have benefited from technology transfer to the extent that, in 2021 India was the third-largest producer of Covid-19 vaccines, ahead of the United States.

The premise of an intellectual property waiver for Covid-19 vaccines was flawed from the outset. Such a waiver is not sufficient to enable a manufacturer to consistently produce high-quality vaccines. Vaccine manufacturers in low-income countries are the first to acknowledge that voluntary technology partnerships need to be just that — voluntary — and done by sitting down together to find solutions to production, workforce, supplies, quality, and regulatory approvals.

It is difficult to understand the rationale behind the United States lending its support to the proposed waiver in May 2021, the early days of the Biden administration. At the time, the U.S. had on its books enough vaccines to vaccinate its population six times over, the manufacturing scale up was well underway globally and, if shared equitably, there would have been enough vaccines to vaccinate the world. The TRIPS waiver proposal makes even less sense when no one can point to intellectual property being a barrier to scaling up global manufacturing. It is also not clear how the U.S.’s interests would be served by undermining IP, since more than 40% of U.S.’s gross domestic product comes from IP-intensive industries. It sends a chilling message to one-third of the total workforce that work in these industries.

The single biggest factor affecting vaccine scarcity last year was not IP but trade. The U.S. Defense Protection Act slowed down the manufacturing scale-up by hampering the vaccine supply chain, and India’s export ban of COVAX vaccine supplies severely affected equitable distribution of vaccines to most countries in Africa for much of 2021. People in Africa were let down badly by not receiving the COVAX orders secured from the Serum Institute. The shortfall was made up in a matter of months by other vaccine manufacturers.

And looking ahead, the biopharmaceutical industry (Johnson & Johnson, Moderna, Pfizer , and BioNTech) is supporting initiatives to help build up vaccine manufacturing capacity on the African continent. Moreover, the infrastructure necessary for local production by any country will itself be fostered by strong IP protection that rewards successful innovation.

Ahead of the World Trade Organization’s Ministerial Conference, which starts on Sunday, negotiators are poring over the wording of the latest TRIPS waiver document, which purports to simplify procedures and address challenges of scaling up production. But they should be mindful that rather than fixing a notional problem, the waiver proposal is more likely to undermine innovation by creating uncertainty and hampering future research and partnerships by changing the very framework that facilitated the unprecedented number of partnerships, voluntary licensing, and knowledge sharing that have emerged in the wake of Covid-19. The biggest loser will be global health security, the exact opposite of what needs to be done for future pandemics.

The TRIPS waiver proposals are a political distraction for industrial policy purposes by some countries, and political grandstanding by others. The potential casualty in this fraught and disingenuous debate on the waiver is finding solutions to equitable access, without which global health security cannot be achieved. Whatever the next unknown disease will be, this pandemic has demonstrated that science and scientific endeavor combined with collaboration and solidarity will be at the heart of how well, fast, and fairly the world can respond.

It is only by being brutally honest about what worked and what did not that we stand a chance to respond better to a next pandemic, even as we continue to fight this one.

Thomas B. Cueni is director-general of the International Federation of Pharmaceutical Manufacturers and Associations. The opinions expressed here are his own.