The By-invitation section publishes commentaries from a range of perspectives. For a view in favour of suspending intellectual property rights related to covid and health, read a commentary by Mariana Mazzucato, Jayati Ghosh and Els Torreele.
AMID THE CRISIS, scientists and businesses have made astounding achievements, developing and delivering vaccines against covid-19. Their mission has been to get the world vaccinated, save lives and resurrect the global economy. But oddly, the policies that enabled firms to produce lifesaving technologies at historic speeds are now under attack—with some organisations and countries pushing to nullify the very intellectual property protections that made the innovations possible.
India and South Africa have petitioned the World Trade Organisation for a waiver that will allow countries to force the transfer of all relevant technology, intellectual property and know-how on covid-19 vaccines. Supporters argue this will increase supply and expand access to vaccines, especially in developing countries, by enabling local producers to make them. Europe, Britain and Japan, among others, oppose the move—for now. America is under heavy pressure to support it.
Everyone agrees that getting the world vaccinated is the best way to end the pandemic and to make sure people are safe. We all agree that this requires more global collaboration and significantly more investment by developed countries like America. No one is safe until we are all safe; global and universal access to covid-19 vaccines is a public health and humanitarian imperative.
Nullifying patents, however, offers the illusion of a speedy conclusion to the real difficulties facing the developing world. In reality the opposite is true: the reason we can even contemplate overcoming the crisis is due to advanced technology and the intellectual property protections that underlie it.
Consider how it works in practice. In January 2020, the World Health Organisation announced the discovery of a novel coronavirus. This started a global scramble among research labs, drug companies, universities and foundations to develop vaccines and treatments. Even a slew of artificial-intelligence startups pivoted and focused their work on covid-19 medicines.
Just two months later, Moderna began phase one trials for a vaccine. Pfizer, with BioNTech in Germany, started its trials in May. Johnson & Johnson began trials in July. The reason these firms had products so quickly is because of technologies that they had been labouring on for years—which emerged from an ecosystem that rewards risk-taking, ingenuity and patient investment.
For example, BioNTech started in 2008. In 2018, the company began working with Pfizer on applying mRNA vaccine technology for the seasonal flu. This gave them experience working together, sharing insights and seeing how their corporate and scientific cultures fit. When the pandemic struck, they could quickly agree to fuse BioNTech’s vaccine technology with Pfizer’s manufacturing and clinical trial capabilities. The result was a vaccine approved and delivered in millions of doses within a year.
Researchers had tried and failed for decades to make viable treatments and vaccines using mRNA. Patent protections offered these companies the security that if (a big if) they finally figured out a way to make the technology work, they would have the rights to commercialise it for a limited period of time before it became part of the public domain for all to use. The critical investors wouldn’t have risked their capital otherwise.
After all, though breakthroughs capture headlines, most technologies fail. There have been around 900 unique initiatives to develop drugs, antivirals, and vaccines for covid-19. (I work with many of the leaders and scientists at these companies: more than 70% of these covid-19 programmes came from small biotech firms). What motivates them—working around the clock, risking covid-19 exposure to keep their labs open, and dealing with their own personal covid devastation—is the potential to save human life.
Before the pandemic ends, billions of dollars will have been spent on vaccine candidates and potential therapies that will never come to market or earn a penny in revenue. It’s tempting to focus solely on the success stories. But most experiments never make it out of the lab—and about nine in 10 of those fail in clinical trials. Of the roughly 200 covid-vaccine development programmes, just 10 are available today. Our research and development ecosystem must cover the costs of the failures as well as the successes.
That’s what makes the proposal to waive intellectual property so shockingly misguided: it tells the successful firms and their investors that the results of their effort can be appropriated by anyone in the world and used far beyond the immediate pandemic (as the proposed WTO waiver allows). The proposal undermines the very system that produced the life-saving science in the first place. And it destroys the incentive for companies to take risks to find solutions for the next health emergency.
Supporters of the proposal disagree with me, of course. Governments helped fund covid-19 vaccines, they argue, so it’s unfair for private companies to enforce intellectual-property protections on those medicines.
Government programmes, such as America’s Operation Warp Speed, certainly played an important role in speeding the development of the covid vaccines. And previous government grants for basic scientific research helped advance scientists’ understanding of mRNA at firms like Moderna. But there are also other companies, like Pfizer, that eschewed government R&D funding.
Biotechnology firms certainly recognise the important role that public investments in basic research and government support for covid vaccines played. But the fastest Western vaccine was developed without government funding and the timelines for all the Western vaccines were dramatically shortened by private efforts—the labs, clinical trial infrastructure, and know-how needed to defeat a pandemic amassed through decades of private capital, fueled by assurances of intellectual-property protections for the discoveries made along the way. Biotechnology firms also have made global access and affordability of the vaccines a top priority.
I’ve seen the importance of intellectual property from multiple perspectives. As an academic researcher, I saw how licensing deals between university labs and private companies helped turn promising early-stage discoveries into tangible products. As an official at America’s Food and Drug Administration, I focused on reforms to clinical trial regulations and saw the efforts companies made to get proprietary technology approved for patient care. During my time at Johnson & Johnson, my colleagues were the scientists who leveraged their knowledge from developing an Ebola virus vaccine to quickly develop an inoculation against covid-19 based on viral-vector technology.
Intellectual property is the invisible filament that turns ideas into products. It also increases productivity, by providing the legal certainty to enable companies to collaborate globally. The result is a win for investors, economies—and patients—everywhere. For covid-19, Novavax and AstraZeneca are getting vaccines to developing countries by having signed deals with the Serum Institute of India, the world’s largest vaccine manufacturer, to produce more than two billion doses for poorer countries. Other agreements with other makers are in the works. It is licensing technology, not abrogating patents, that gets jabs into arms.
This is especially true for the manufacturing of complex biologic drugs like covid-19 vaccines. Production is complicated and few firms around the world can do it at scale, at low cost and in compliance with strict standards and public expectations of safety. The scarcity of vaccines is not because of intellectual property but because of regrettable production and distribution challenges. There is currently a global shortage of some of the over 100 components and ingredients needed. There is also the scarcity of human expertise to assist the complex production.
Starting new manufacturing lines would require billions of dollars and take between six months to a year, regardless of patents. And time is precious. We are in a global race against covid variants that might render current vaccines useless. The WTO waiver wouldn’t overcome these obstacles. As Bill Gates recently said about efforts to “open source” vaccine manufacturing: “there’s not a single additional vaccine that would have come out of that.” Developing countries need vaccine access now, not years from now. Society needs to ask: how can people solve this problem in the fastest way possible, rather than make empty gestures that place the cost and responsibility back on the laps of the neediest countries.
Allowing governments to waive patents would undermine the global collaboration that has been underway and led to more than 900m vaccine doses being administered so far. The world is currently on track to have enough vaccines for 70% of the global population by year end—a remarkable feat of industry, not just science.
Yet we can’t settle for that success: even more must be done to ensure that vaccines are distributed equitably. The Biden Administration was right to rejoin the World Health Organisation and join COVAX, the global initiative designed to equitably distribute vaccines across the world. And now we must ensure that it has the resources it needs. This will help make up for the Trump Administration’s underinvestment in global, collaborative efforts.
Wealthy nations can also help the rollout of vaccines in developing countries, many of which have received doses but struggle to administer them due to a shortage of refrigeration infrastructure, trained healthcare workers and other logistical challenges. Supporting healthcare-delivery systems will improve global vaccination rates and make the world better prepared for future pandemics.
Additionally, countries need to take a strong stand against vaccine nationalism, so that the most at-risk patients can get quick access to vaccines, no matter where they live. This means making decisions about releasing stockpiles of vaccines in developed countries. America is estimated to have an oversupply of hundreds of millions of vaccines by as early as July.
One must also consider the possibility that the nations pushing hardest for the patent suspension are self-interested—exploiting the pandemic to acquire innovative technology invented in America and Europe. This could have national security implications: mRNA platform technology has bioweapon potential. The WTO waiver would allow any country—even those with ill intentions—to forcibly expropriate technology.
Global access to technology is the crux not only of overcoming the pandemic but other global challenges, from climate change and agriculture productivity to poverty reduction. The speed with which covid-19 vaccines were developed will go down as one of science’s greatest achievements. We need to vaunt, not devalue, the intellectual-property system that made it possible.
Michelle McMurry-Heath is the chief executive of the Biotechnology Innovation Organization, a trade association for the biotech sector. She was previously a researcher at Duke University and a practicing physician. She served as an official at America’s Food and Drug Administration in 2010-14 and was a vice president at Johnson & Johnson.