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Politics, Policy & Law

As Biden backs WTO IP waiver for COVID vaccines, debate focuses on precedent, not access

May 6, 2021 | 12:54 AM GMT

The biopharma industry condemned, and a wide range of politicians and global health advocates praised, the Biden administration’s decision to support a WTO waiver of IP protections for COVID-19 vaccines, but no one predicted that the move will quickly increase vaccine supplies to developing countries. Arguments for and against the policy are focused more on the precedent it sets rather than on its potential for reducing global inequities in access to COVID-19 vaccines.

“The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” U.S. Trade Representative Katherine Tai said in statement. “We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen. Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.”

The decision led to an abrupt dive around 3:00 p.m. Eastern time for shares of vaccine developers such as Moderna Inc. (NASDAQ:MRNA) and BioNTech SE (NASDAQ:BNTX) as well as biotech indexes.

Tai’s statement represents a shift in policy from the Trump administration’s rejection of a COVID-19 IP waiver. It is, however, more measured than the steps advocated by some proponents of compulsory licensing and mandatory technology transfer.

The statement is notable for what is not included. She did not endorse the WTO waiver resolution proposed by South Africa and India. Instead, she committed the U.S. participate in what is likely to be a lengthy negotiating process.

Unlike the joint South Africa and India proposal, which includes therapeutics and diagnostics, Tai limited the Biden administration’s support for an IP waiver to vaccines.

Tai did not say anything about efforts to persuade other countries to support the U.S. position. The EU and several of its members, the U.K., Japan and other industrialized nations have expressed strong opposition to a WTO COVID-19 IP waiver.

WTO could adopt a resolution creating the waiver as soon as its next meeting in June, but it usually takes much longer for it to act. The organization’s rules allow for it to enact resolutions that are endorsed by three-quarters of its members, but in practice it seeks to find consensus.  

WTO Director General Ngozi Okonjo-Iweala has suggested that the organization could find a “third way” that meets the needs of developing countries for access to COVID-19 vaccines and therapies, rewards innovation and does not abrogate IP rights.

Opponents of the IP waiver who assert that it will not lead to increased production point to a commitment from Moderna that it will not enforce IP protections for its mRNA-based COVID-19 vaccine during the public health emergency. Moderna’s policy has not led any company or nation to manufacture its vaccine.

Some COVID-19 vaccine developers have licensed their products and provided technology transfer to manufacturers in developing countries. Serum Institute of India is manufacturing the AstraZeneca plc (LSE:AZN; NASDAQ:AZN) vaccine.

Johnson & Johnson (NYSE:JNJ), which has stated that it will not profit from its COVID-19 vaccine during the emergency, has provided a license to South Africa’s Aspen Pharmacare Holdings Ltd. (JSE:APN) to manufacture its vaccine in South Africa.

Blasted by biopharma

BIO President and CEO Michelle McMurry-Heath and PhRMA President and CEO Stephen Ubl blasted the USTR’s announcement, arguing in separate statements that it will not achieve its stated goals and will set a precedent that will deter industry from developing countermeasures for future public health crises.

“Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine,” McMurry-Heath said. “Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new COVID variants.”

She added that an IP “waiver has the potential to drastically hinder existing efforts to scale up global manufacturing, disrupt efforts to equitably distribute the vaccines to every corner of the globe through COVAX, and further strain the global supply chain.”

McMurry-Heath expressed BIO’s support for initiatives to ramp up COVID-19 vaccine manufacturing and increase access in development countries and noted that the trade association outlined proposals for increasing global supplies in a May 3 letter to Biden. 

The world cannot wait for the construction of new vaccine factories and should not be compelled to rely in vaccines made in hastily constructed plants, BIO Chairman Jeremy Levin told BioCentury. “There was and is no need to rebuild factories around the world where not only will it take a long time to do so but also the standards and capabilities exist in America cannot be easily replicated or guaranteed.”

Levin, who is CEO of Ovid Therapeutics Inc., added that “this decision will act as a disincentive to companies to respond to the next pandemic.”

Ron Cohen, CEO of Acorda Therapeutics Inc. (NASDAQ:ACOR) and a past BIO chairman, expressed concerns that the precedent could be applied beyond pandemic response. He tweeted: “#Alzheimer’s Is also a ‘global crisis.’ So is cancer. Which will be next to have patents broken when this precedent is set? Good luck getting anyone to invest the tens to hundreds of billions of dollars needed for those cures, and, P.S., goodbye to Biden’s #Cancer #Moonshot.”

The statement “sends the wrong signal at a time when the U.S. should be steadfastly protecting IP,” Luciano Borio told BioCentury. Borio is SVP at In-Q-Tel, a national security-oriented investment firm, and a senior fellow for global health at the Council on Foreign Relations

“It is a lot more efficient to manufacture COVID vaccines in the U.S.,” she added. “Rather than taking a symbolic gesture, it would be better to make tangible moves to supply the world with vaccines.”

Borio, who served on Biden’s transition team, said the administration should invest in expanding domestic vaccine production and the creation of fill and finish capacity overseas, and support efforts by U.S. companies that are working in developing countries on COVID-19 vaccine development.  

Support for the waiver

Democratic members of Congress who have been urging Biden to support a WTO COVID-19 IP waiver dismiss biopharma industry criticism, accused drug companies of attempting to perpetuate financially lucrative monopolies at the expense of public health.

Rep. Rohit Khanna (D-Calif.) tweeted his appreciation to Biden “for putting life & dignity over very powerful interests.”

Khanna addressed industry objections, tweeting: “Let’s be clear — this debate was never about quality control over manufacturing vaccines. It was about money & greed.”

WHO Director General Tedros Adhanom Ghebreyesus has endorsed the resolution by South Africa and India. “The flexibilities in the TRIPS agreement are there to be used in emergencies,” he said March 4 in a speech on financing COVID-19 vaccines for Africa. “If not now, then when?”

Organizations supporting a broad IP waiver and technology transfer to increase COVID-19 vaccine manufacturing include Médecins Sans Frontières (MSF), Oxfam and Amnesty International.

In a statement, James Love, director of Knowledge Ecology International, a non-governmental organization that advocates for limiting IP protections on medical products, said, “Now that the U.S. supports a TRIPS waiver, for vaccines, people can stop emphasizing all of the things that won’t be done and start focusing on what needs to be done.”

He added, “It is a good time to brush up on [the] potential for the Biden Administration to use the Defense Production Act to loosen up access to manufacturing know-how and access to working cell lines,” as well as ask WHO what its procedures are for assessing the quality of generic and biosimilar vaccines.

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