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TRIPS Waiver on COVID-19 IP Rights Wouldn’t Help Vaccine Access; It Would Just Harm Innovation

TRIPS Waiver on COVID-19 IP Rights Wouldn’t Help Vaccine Access; It Would Just Harm Innovation

March 9, 2021

In the face of a COVID-19 pandemic that has caused 2.6 million fatalities worldwide, life-sciences companies have raced to bring forward a wide range of life-saving innovations, including novel diagnostic tests like Lumira DX’s that can detect the virus within minutes; therapeutics such as Gilead’s remdesivir; and highly effective vaccines such as those from Moderna, Pfizer, and Johnson & Johnson. In fact, over 600 novel COVID-19 treatments are under development, including 130 vaccines in global clinical trials and 176 in pre-clinical trials.

Yet, amidst this unprecedented pace of innovation, some 90 developing nations, led by India and South Africa, have petitioned the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council calling for a waiver to suspend all intellectual property rights (IPR) associated with COVID-19 innovations, again asserting the false narrative that IP rights inhibit access to medicines.

The waiver petition itself suggests the various fallacies underlying the request. First, the waiver (initially submitted on October 2, 2020) acknowledges that, “To date, there is no vaccine or medicine to effectively prevent or treat COVID-19.” This admission immediately confirms that intellectual property rights are not and have never been the challenge in the COVID-19 pandemic. Rather, the challenge initially was the very lack of intellectual property; we had to, and did, discover and invent the scientific and technical knowledge necessary to understand the operation of the virus and how to defeat it with novel vaccines and therapeutics. Much of this involved new-to-the world technologies, such as novel mRNA-based vaccines. Far from being an inhibitor of this process, the robust intellectual property regimes in place in many nations contributed to a body of biomedical knowledge and technologies that provided a crucial platform for the innovation of COVID-19 solutions.

Second, the waiver petition vaguely references “several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients.” The first of two cited instances pertained to Labrador Diagnostic LLC, a patent-licensing firm which—although it did file a suit against a French firm, bioMerieux SA, developing coronavirus tests, in order to ensure that its IP was not infringed—has actually committed to offering its patents royalty-free to any company developing coronavirus tests. The second instance referenced Kentucky Governor Andy Beshear’s call for 3M to release a patent on N95 respirators. But that was it; on those two incredibly thin reeds, with nary any serious evidence whatsoever that IP rights were inhibiting access to COVID-19 treatments—let alone the fact that no COVID-19 vaccines existed at the time—the petitioners took the radical step to call for a suspension of all IPR rights pertinent to COVID-19 technologies throughout the duration of the pandemic.

And while petitioners made this call on the alleged grounds of ensuring sufficient access to needed vaccines and therapeutics, their call for the suspension of every facet of IP rights on every conceivable COVID-19 related technology—even such as for copyrights and industrial designs—betrays the reality that the petitioners’ core goal isn’t really about access, but about undermining the global intellectual property rights system.

To be sure, the developed world needs to be fully committed to ensuring that the world’s citizens receive the COVID-19 vaccines and therapeutics they need. But this can be accomplished through structures such as licensing and product development partnerships, without requiring an abrogation of intellectual property rights. For instance, in February 2021, the Biden administration announced it would contribute up to $4 billion to COVAX, a vaccine alliance seeking to distribute COVID-19 vaccines to 92 low- and middle-income countries. COVAX aims to deliver at least 2 billion vaccine doses by the end of 2021, covering at least 20 percent of the most vulnerable citizens in poor- and middle-income countries.

Innovative life-sciences companies have entered into a number of licensing agreements to facilitate dramatically expanded manufacturing of COVID-19 vaccines and therapeutics. For instance, Gilead Sciences has licensed its therapeutic remdesivir royalty-free to nine generic drug manufacturers, in Egypt, India, and Pakistan. AstraZeneca reached a licensing and technology transfer agreement enabling India’s Serum Institute to manufacture one billion vaccine doses for low- and middle-income countries. The Serum Institute has further entered into manufacturing licenses with a number of developers of yet to be approved COVID-19 vaccines, as have several other Indian vaccine manufacturers. Johnson and Johnson has announced plans to allocate up to 500 million vaccine doses to lower-income countries, with delivery starting by mid-2021. Companies like Johnson & Johnson are making the vast majority of these vaccine doses available on a not-for-profit basis.

Thus, the fundamental problem isn’t high prices due to IP rights; it’s dramatically scaling up manufacturing capacity. It takes 60 to 110 days to produce one batch of COVID-19 vaccine. When Serum Institute CEO Adam Poonawalla was asked if vaccine rollout was slowed because vaccine patentholders were licensing too few manufacturers to make them, he responded, “No. There are enough manufacturers, it just takes time to scale up. And by the way, I have been blown away by the cooperation between the public and private sectors in the last year, in developing these vaccines.” Poonawalla actually cited the lack of global regulatory harmonization as a far greater cause of delays in the vaccine rollout. Even Médecins Sans Frontières’ Rose Scourze acknowledged (in a January 20, 2021 BBC interview) that suspending patent rights “wouldn’t produce millions of more vaccines.”

Instead of forcing the disclosure of IP, policymakers should encourage the use of voluntary licensing agreements to expand production of the needed COVID-19 vaccines and therapeutics. One reason this critically matters is to ensure consistency and safety in the production of these treatments. The mRNA-based vaccines developed by Moderna and Pfizer are incredibly complex biologic products that require specialized experience, expertise, and equipment to manufacture. For example, mRNA vaccines require a complicated technique known as “bioprocess” that requires specialty bioreactors to first manufacture DNA that codes for the desired mRNA sequence, and then uses a second bioprocess to create billions of identical mRNA segments. These are then wrapped in a nanolipid wrapper using yet another very specialized fluidics and mixing process, and for which there are only three facilities in the world that can execute the step of creating the liquid capsule around the RNA.

Instead of simply being forced to divulge their IP or see it be compulsorily licensed to other manufacturers, in light of the extreme complexity of manufacturing COVID-19 vaccines and therapeutics, companies should have the right to evaluate potential license partners and ensure that they can meet the production standards required to safely and reliably produce COVID-19 vaccines or treatments before entering into license arrangements with them. Indeed, this is critical for it would be disastrous if defective vaccines or therapeutics were produced at facilities not properly equipped to produce such complex treatments. As Phil Stevens and Mark Schultz have written, there’s simply no evidence that invalidating IP rights would achieve more than the licensing agreements currently being forged between innovators and reputable vaccine manufacturers in countries such as India and Brazil.

Instead of rolling back intellectual property rights, policymakers in developed and developing nations alike should focus on mechanisms to scale up production of vaccines and make them affordably available to citizens in developing countries. But to achieve that, there is simply no compelling reason for a blanket suspension of the intellectual property rights associated with COVID-19 products and technologies. For this reason, the Biden administration should continue the previous administration’s stance of opposing the waiver at the WTO TRIPS council, where deliberations resume on March 10, and reject calls from some in Congress to endorse the proposed TRIPS waiver.

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