The COVID-19 TRIPS IPR Waiver Remains a (Bad) Solution Searching for a Problem

Jaci McDole Stephen Ezell March 25, 2022
March 25, 2022

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On March 15, the European Union, India, South Africa, and the United States reportedly reached a tentative agreement concerning a proposed TRIPS waiver for intellectual property (IP) related to COVID-19 healthcare innovations. Although the agreement is significantly limited compared to the original proposal and its subsequent revisions in May and September of 2021, it still misses the point entirely: IP has never been the problem to tackling the COVID-19 pandemic. Waiving IP rights will not solve the challenges faced by global vaccination efforts because underdeveloped distribution infrastructure remains the real problem.

When India and South Africa initially submitted their waiver petition in October 2020, they acknowledged that, “To date, there is no vaccine or medicine to effectively prevent or treat COVID-19.” Amazingly, these countries were already trying to force waivers on IP that didn’t even exist yet, illustrating that from the very beginning, calls for waiving IP rights on COVID-19 vaccines and therapeutics lamentably represented more an assault on IP rights than a serious endeavor to get shots in the arms of citizens everywhere desperately needing them.

If IP were ever a challenge in this crisis, it was only that the world didn’t initially have the IP it needed to develop the vaccines, therapeutics, and diagnostics required to address the pandemic. And indeed, innovative life sciences companies responded rapidly to create the needed vaccines and treatments, with Moderna delivering the first doses of its vaccine for clinical trials a mere six weeks after Chinese scientists put the genetic sequence of the novel coronavirus online with others following that summer. Likewise, the first therapeutic treatment arrived by October 2020. The tremendous bench strength of American biomedical talent, scientific knowledge, and infrastructure—the product of decades of robust public and private investment alike, supported by robust IP rights—enabled these rapid innovations.

Once the needed IP existed, companies responsibly engaged in voluntary licensing to dramatically scale global production. For instance, Johnson & Johnson contracted with Indian generics maker Biological E to produce 600 million doses of the company’s single-dose COVID-19 vaccine a year (part of J&J’s plan to produce three billion vaccine doses in 2022). Pfizer and BioNTech entered into an agreement with the Cape Town, South Africa-based Biovac Institute, known as “Biovac,” to manufacture their COVID-19 vaccine for distribution within the African Union. And by April 2021, Gilead Sciences had already signed non-exclusive voluntary licensing agreements with nine generic pharmaceutical manufacturers based in Egypt, India, and Pakistan to expand supply of its COVID-19 therapeutic, remdesivir, to 127 nations.

By engaging in licensing agreements, vaccine and therapeutic manufacturers ramped up production while ensuring their global partners were adequately equipped to meet stringent safety and quality standards. A host of supply chain and manufacturing issues, including a lack of raw materials, a short supply of knowledgeable workers, and broader supply chain issues initially impeded vaccine production, but many of those challenges have since been overcome. As Phil Stevens and Mark Schultz have convincingly written, there’s simply no evidence that invalidating IP rights can achieve more than the licensing agreements that have been forged between innovators and reputable vaccine manufacturers in countries such as Brazil, Egypt, India, and South Africa.

Indeed, innovator and licensee manufacturing of COVID-19 vaccines has scaled rapidly, with 12 billion produced by year-end 2021, and a total of 24 billion expected to have been produced by mid-2022. As of March 15, 2022, 65.3 percent of the global population had received at least one COVID-19 dose, with 58 percent fully vaccinated and 19 percent receiving an additional booster. Over 90 percent of Brazilians have received at least their first dose of the vaccine. And Tedros Adhanom Ghebreyesus, chief of the World Health Organization (WHO), stated in February that the COVID-19 pandemic’s acute phase could end by the middle of 2022 if about 70 percent of the world is vaccinated.

The globally needed COVID-19 vaccines and therapeutics are indeed being produced, undermining the fundamental rationale for why an agreement is needed that would waive COVID-19 vaccine IP protections for the next three to five years. Moreover, it’s become increasingly apparent that the real challenge lies in underdeveloped public health infrastructure in many nations, making logistical distribution of the vaccines difficult. For instance, in December 2020, developing countries turned away 100 million COVID-19 vaccines because they were reaching their expiration date. The Congo alone destroyed 1.7 million doses, and Nigeria another 1 million. Vaccine hesitancy also remains a challenge in many developing nations, just as it has been in the United States. But, regrettably, for nearly two years, civil society advocates have focused the world’s attention on repealing IP rights when those attentions and energies would have been far more fruitfully placed in championing the safety and efficacy of those vaccines while positioning the world to effectively distribute COVID-19 vaccines and therapeutics once they became widely available.

In other words, the TRIPS COVID-19 IPR waiver remains a solution in search of a problem; moreover, it’s not just a solution but a threat to productive IP-based life sciences innovation ecosystems. Indeed, the proposed agreement includes a mandate to review within six months whether to extend the waiver to include COVID-19 diagnostics and therapeutics. Furthermore, an IP waiver disincentivizes the very thing it claims to value. Professor Mark F. Schultz from the University of Akron School of Law articulates the dilemma well, noting, “In the future, if one has a new technology platform, such as mRNA vaccines, one has to consider the risk of loss from deploying it to fight a pandemic. There are reasons both humanitarian and commercial that one might do so, but creating such risk and friction is unwise.”

In conclusion, waiving IP sets a precedent. In the future, it won’t only be for COVID-19 vaccines and therapeutics but other medicines and then for goods and technologies addressing other global challenges, such as climate change. Moving forward, governments will be more inclined to pilfer innovations deemed “necessary for some public good” rather than investing in more and better innovation. What is deemed a public necessity could expand beyond the TRIPS Agreement’s intended scope. It’s a snowball effect leading to disincentivizing innovators.

Global leaders should look to the facts rather than finalizing the tentative IP waiver agreement. The end is (hopefully) in sight. The world has the tools it needs; it just needs to solve the actual problem. Global efforts and resources would be better spent improving distributional infrastructure than solving an IP-related problem that simply doesn’t exist.