A waiver of the intellectual property of the Covid-19 vaccine will not kill pharmaceutical innovation
On September 22, President Biden virtually hosted a world summit on Covid-19 during the United Nations General Assembly. He announced a goal of vaccinating 70% of the world’s population over the next year to end the pandemic. At the same time, wealthy countries, including the United States, have already started or are planning to offer booster vaccines to their citizens.
Biden and others have argued that the pursuit of both strategies is possible. But providing third doses to only a few when most of the world has yet to receive an initial dose due to limited vaccine supplies will make its global vaccination target impossible. Instead, that goal must be matched with a commitment to dramatically increase vaccine manufacturing globally.
Only a few manufacturers control the current vaccine supply and have given priority to richer countries that have accumulated a massive surplus. Although necessary, donations of vaccine doses promised by these same countries are not sufficient.
To increase vaccine manufacturing, advocates and governments in southern countries have repeatedly called for sharing production know-how, investing in local manufacturing capacity, and temporarily lifting protections. intellectual property (IP) for Covid-19 health technologies. However, almost no technology has been shared with the established technology sharing pools despite interest from local manufacturers and countries. Instead, Covid-19 vaccine makers have negotiated bilateral deals with richer countries, avoiding multilateral mechanisms like Covax distribute the doses evenly.
In May, Biden announced unprecedented support for the temporary waiver Intellectual property rights for Covid-19 vaccines, which would allow other manufacturers to bypass these barriers and produce the vaccine. But no progress has been made, with World Trade Organization talks suspended over the summer.
This progress has been partly thwarted by the argument that waiving intellectual property rights will reduce profits, thereby discouraging future innovations needed to deal with the next public health crisis or other diseases whose needs do not need to be met. are not satisfied.
The issue of the temporary surrender of these rights is of particular importance to intellectual property law, in part because this limited disclaimer of Covid-19’s intellectual property exposes a system that is in desperate need of fixing before it even begins. the current pandemic. Pharmaceutical companies profit enormously from periods of monopoly protected by intellectual property and thus protect and prolong them through legal and artificial strategies.
A false choice between access and IP waivers and innovation
But the trade-off between ensuring global access to Covid-19 vaccines through intellectual property waivers and innovation is a wrong choice for several reasons, especially in the midst of a devastating pandemic.
First, in the case of Covid-19 vaccines, such monopoly rights are redundant and unnecessary. Through Operation Warp Speed, the U.S. government has funded the development of the Covid-19 vaccine, spending an unprecedented $ 18 billion. This included advance purchase agreements for vaccines before they proved effective, essentially eliminating the risk of business failure.
Additionally, the key technology that led to the currently available mRNA vaccines was developed by the US government. For Moderna, the continued development of booster vaccines has been done in collaboration with and with the support of the National Institutes of Health.
Second, companies have already benefited greatly from Covid-19 vaccines. Pfizer will earn $ 33 billion and Moderna $ 18 billion in sales in 2021 alone. Because this pandemic is unlikely to end anytime soon, companies will continue to profit from Covid-19 vaccines, including vaccines from more expensive recall. The White House recently bought an additional 200 million doses of the Pfizer / BioNTech vaccine at a higher price than last year, and the prices have also been set higher in recent EU orders. Such trends are likely to continue.
Third, the priority given by manufacturers to higher income markets in richer countries has meant that vaccines, especially for infections with pandemic potential, have historically been overlooked. An Ebola vaccine, for example, had been launching since the early 2000s. Promising vaccine candidates against SARS-CoV-1, the coronavirus that led to the SARS epidemic in 2003, quickly lost their funding once they were released. epidemic over. Had this research continued, we may have had vaccine and treatment options sooner for the related Covid-19.
While long-term reform is needed to fill this innovation void, democratizing Covid-19 vaccine manufacturing through a waiver of intellectual property would have little or no negative effect.
Fourth, a waiver of the intellectual property of Covid-19 is unlikely to harm the development of drugs for non-pandemic diseases. As currently constructed, the waiver is limited in time and scope to Covid-19 alone. But to the extent that a waiver of intellectual property would reduce the benefits of the Covid-19 vaccine, the non-partisan Congressional Budget Office recently found that limiting pharmaceutical benefits would result in a relatively small reduction in new drug launches.
In addition, these few drugs may not reflect a truly transformative innovation that meets the needs of our patients up front. Companies frequently invest in new drugs that treat diseases with existing treatments (“me too” drugs) and focus more on share buybacks than research and development. There is therefore little reason to believe that further reducing the profit margins of Covid-19 vaccines through a waiver of intellectual property would harm innovation for non-pandemic diseases.
Fifth, Covid-19 has rapidly validated new vaccine platforms, particularly mRNA, which holds the tantalizing potential to treat other serious infections and cancers. This ability to reallocate largely state-funded vaccine platforms for other diseases means businesses will continue to benefit beyond the current pandemic. Concerns that a waiver of intellectual property could affect future uses of mRNA are tempered by the fact that property rights such as patents will still exist.
Undoubtedly, the remarkable organizational capacity of pharmaceutical laboratories has made it possible to achieve vaccines against Covid-19 and they have been rewarded. But adopting an intellectual property waiver to allow other manufacturers to overcome the ongoing lack of supply is key to curbing the threat of new variants, ending this pandemic, and saving millions of lives in the world. world. While there are real challenges even after an intellectual property waiver, they are difficulties that can be resolved and many manufacturers are willing to collaborate.
The continued and long-term inequity that further fuels what is now a preventable disease should be an unacceptable outcome to this scourge. At the United Nations General Assembly, our world leaders would do well to fight for equitable access to vaccines in order to end this pandemic and to side with the people on the profits.
This column does not necessarily reflect the opinion of the Bureau of National Affairs, Inc. or its owners.
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Dr Ravi Gupta is a physician, associate researcher at the Leonard Davis Institute of Health Economics, and member of the National Clinician Scholars Program at the University of Pennsylvania.
Dr Reshma Ramachandran is a family physician and member of the National Clinician Scholars Program at Yale University.
Gupta and Ramachandran are both members of the Doctors for America Medicines Accessibility Action Team.