By Nancy S. Jecker.
The extraordinary circumstances of a global pandemic warrant waiving intellectual property protections for COVID-19 vaccines. The World Trade Organization (WTO) is currently considering such a move, which over 100 Nobel laureates and 75 former heads of state have backed, calling it a “vital and necessary step” that would “expand global manufacturing capacity unhindered by industry monopolies.” Internationally, intellectual property is protected by a 1995 WTO agreement, mandating compulsory protection of IP rights, and requiring WTO members to enforce them within their territories. Importantly, the agreement required countries to treat pharmaceuticals as an area protected by patents.
President Biden has supported a wavier, along with Russia and China. International organizations are on board, including the World Health Organization (WHO) and the United Nations AIDS charity, UNAIDS. Yet WTO members who urge staying the course, including Japan, the European Union, South Korea, and the United Kingdom, assert there is “no concrete indication” IP rights are “a genuine barrier” to accessing COVID-19 vaccines and IP is only “one aspect of many that affect the manufacture and distribution of the new vaccines.”
Should we stay the course? There is ample evidence that the current approach has fallen short. As of June 2021, 85% of shots that have gone into arms worldwide were administered in high and upper-middle income countries, and only 0.3% in low-income countries. While controversy exists about the most expedient method to increase global vaccine access, it is plausible to think that continuing the present course will continue falling short.
Will a temporary waiver help? Bill Gates has stated it’s too late for that — “At this point, changing the rules wouldn’t make any additional vaccines available,” since few manufacturers can make COVID-19 vaccines and they are at capacity. Others point out that manufacturing COVID-19 vaccines requires technical knowhow, technology, raw materials, and equipment that that LMICs lack and that takes years to develop.
Yet, since the pandemic began, we have learned it takes less time than previously thought to expand capacity for vaccine manufacturing. Repurposing facilities and vetting them for safety and quality can often happen in 6 or 7 months, about half the time previously thought. Some middle-income countries are already producing COVID-19 vaccines, and some manufacturers in LMICs are already able to manufacture viral vector vaccines, such as AstraZeneca’s, and to contribute to the fill-and-finish stage of vaccine production.
Since COVID-19 will not be the last pandemic the world faces, expanding vaccine manufacturing is crucial preparation for future pandemics. According to the WHO, 80% of global sales for COVID-19 vaccines come from 5 large multi-national corporations. When only a handful of pharmaceutical companies control global vaccine manufacturing, the world is vulnerable to supply disruptions, as occurred when India was forced to halt vaccine exports amidst a surge of COVID-19 cases.
Ethically, defenders of IP protections argue that IP protections are essential to spur innovations, which benefits everyone. Suzman, CEO for the Bill and Melinda Gates Foundation puts the point this way: “At our foundation, we believe that IP fundamentally underpins innovation.” The suggestion is that absent such profits, discoveries would languish, and progress would slow.
Yet how much profit do companies require to spur innovation? In 2021, Pfizer/BioNTech will score $15-$30 billion USD for COVID-19 vaccine sales, while Moderna could rake in $18-20 billion USD and Johnson & Johnson $10 billion USD. The usual costs associated with vaccine research and development were substantially offset by governments, which invested heavily, pouring billions into procuring raw materials, financing clinical trials, and retrofitting factories for drug companies.
Even in ordinary times, compared to other large companies on the S&P 500 index, large pharmaceutical companies have significantly higher profits. It seems reasonable to think lower profits would be adequate to sustain innovation.
Proponents of IP protections also argue that vaccines are the brainchild of pharmaceutical companies, who own the product of their labor.
Yet do pharmaceutical companies wholly own COVID-19 vaccines? A 2021 review of published research on the technologies used in candidate COVID-19 vaccines, which spanned a range of diverse methodologies, found that these technologies were funded primarily by the public sector, principally governments. What’s more, the translational part of product development would be impossible without enormous upstream public investment
Loosening the grip of IP protections is not a miracle fix, and there are many other barriers to a safer world. Governments, especially in wealthy nations, should stand up to influence peddling by pharmaceutical companies, and should do their part, beginning with WTO members voting for a temporary waiver to IP protections for COVID-19 vaccines.
Author: Nancy S. Jecker and Caesar A. Atuire
Affiliations: Dr. Jecker is affiliated with the University of Washington School of Medicine, Department of Bioethics and Humanities and the University of Johannesburg, Department of Philosophy. Dr. Atuire is affiliated with the University of Ghana, Department of Philosophy and Classics and the University of Oxford, All Souls College.
Competing interests: None
Social media accounts of post author: Twitter: profjecker