Biden agrees to waive COVID-19 vaccine patents, but it’s still complicated


Biden agrees to waive COVID-19 vaccine patents, but it's still complicated
FILE - Vials for the Moderna and Pfizer COVID-19 vaccines are displayed on a tray at a clinic set up by the New Hampshire National Guard in the parking lot of Exeter, N.H., High School, Feb. 25, 2021.

The Biden administration has agreed to support waiving intellectual property (IP) restrictions on COVID-19 vaccines at the World Trade Organization (WTO), a breakthrough in the global fight against the pandemic that can empower governments to tackle vaccine scarcity and inequity.

U.S. Trade Representative Katherine Tai announced the administration’s position in a statement Wednesday afternoon.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” she said. “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.”

Biden has been under immense pressure to waive vaccine patents, one of his campaign promises. Activists demonstrated in Washington on Wednesday, joining calls from world leaders, Democratic lawmakers, humanitarian organizations, public health experts and Nobel laureates to support a proposal that would loosen patent restrictions so countries can manufacture generic versions of the coronavirus vaccines without the risk of being sued by pharmaceutical companies and entities that own IP.

Just hours before the announcement, White House press secretary Jen Psaki said that while Biden supported the waiver during the campaign, he also believes in the administration’s internal policy deliberation process spearheaded by Tai.

“He’s a details guy,” Psaki said, “and he wants to dig into the pros and cons and all of the considerations for any decision.”

India and South Africa put forward the proposal in November 2020 to waive certain provisions of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS); hence, the proposal is often called the TRIPS waiver.

Officials have stressed that the administration’s objective is to widely distribute supply to the global community as quickly and cost-effectively as possible, whether it’s through the TRIPS waiver, licensing agreements or other forms of technology transfer.

A recap of country data shows that 1.2 billion vaccine doses have been administered worldwide, equal to 16 doses for every 100 people, but that there is a stark gap of vaccination rates among countries. Some countries have more than 50% of their populations vaccinated, and some have yet to report a single dose.

Biden agrees; now what?

Now that Biden has agreed to support the waiver, it doesn’t mean U.S. pharmaceutical companies must start giving away vaccine recipes so developing countries can make their own.

The WTO is a consensus-based organization and cannot move forward unless the European Union, which is against the waiver, and everyone else agrees. Once all WTO members agree, the next steps would be for countries to implement it at the national level by removing legal risks that hinder production and supply by alternative producers. To clarify these implementation options, countries must start text-based negotiations at the WTO, going through each item of the complex and multilayered IP legal requirements — a process that could take months, or even years.

“I’m not going to put odds on how likely it is to find an agreement,” said WTO spokesman Keith Rockwell, summarizing the WTO closed-door General Council meeting on the TRIPS waiver Wednesday.

But he said there was consensus on the need for wider access to COVID-19 vaccines and treatments.

“When people begin to voice very clearly their share objectives, it makes it easier to get to ‘yes,’ ” Rockwell said.

There is not a single “recipe” for a COVID-19 vaccine — the vaccines are complex in terms of ingredients, manufacturing technology, delivery vehicles, etc., and each vaccine has dozens, if not hundreds, of IPs attached, many of them under patent pending litigation, making the granting of waivers an even more complicated and lengthy process.

There are many complex challenges in scaling up COVID-19 vaccine production. The waiver is just one tool and does not offer a blanket solution, said Yuanqiong Hu, a senior legal and policy adviser with Doctors Without Borders, one of the organizations that support the TRIPS waiver.

But as an important enabler, Hu added, “the earlier the waiver can be adopted, the sooner its impact can be realized.”

If countries are given the permission and know-how to produce vaccines, waiver proponents say, they don’t have to wait in line while pharmaceutical companies fulfill orders from rich countries who have the resources to do so.

But even if a full waiver is not approved, proponents are hoping the pressure will become leverage to force vaccine producers to ramp up global manufacturing capacity via additional licensing agreements, or donate or sell doses at a reduced cost.

TRIPS waiver opponents

Drug manufacturers, including Pfizer and Moderna, oppose the waiver, saying that easing patent rules could actually backfire, creating a further backlog for limited vaccine ingredients and impeding response to emerging variants. They also warn that waivers could give China and Russia access to trade secrets and more ammunition for their aggressive global vaccine diplomacy.

Another big opponent is Microsoft co-founder Bill Gates, whose Bill and Melinda Gates Foundation sponsored Gavi, the Vaccine Alliance — the driving force behind COVAX, the U.N. mechanism to improve low- and middle-income countries’ access to vaccines. Despite more than two decades of philanthropic work to immunize the world’s poor, Gates is a fierce defender of IP protection.

On Wednesday, WTO Director-General Ngozi Okonjo-Iweala spoke to representatives from developing and developed countries and again urged them to quickly agree on this issue, over which countries have been at odds for six months.

The ‘third way’

Opponents insist a waiver would not help accelerate vaccine access or address supply chain and logistical constraints. It would still take a long time for governments to set up factories, train staff and procure materials to make vaccines.

They say the faster and better way to do it is through technology transfer partnerships and licensing agreements, such as the one between AstraZeneca and the Serum Institute of India, which produced doses for COVAX. The agreement has been halted by the government of Indian Prime Minister Narendra Modi, which wants to prioritize doses for its own populations as it deals with another wave of COVID-19 cases.

Licensing agreements, including those between Britain’s AstraZeneca and Brazil’s Fiocruz, or the Chinese company Sinovac Biotech and the Indonesian firm Bio Farma, have shown that middle-income countries have the capacity to produce vaccine doses within months after technology transfer.

These licensing agreements and other means of technology transfer have been praised by Okonjo-Iweala as the “third way,” an alternative to vaccine protectionism and waiving IP rights.

However, these agreements can include restrictions — for example, geographical limitations on where, when and to whom the doses can be sold. Most bilateral agreements on COVID-19 vaccine production are contract manufacturing agreements through which the contracted entity manufactures on behalf of a licenser that maintains full control over the use of its technology, the volume of production, and where and at what prices vaccines may be supplied.

The Biden administration said it would continue to ramp up efforts, working with the private sector and all possible partners to expand vaccine manufacturing and distribution, and increase the raw materials needed to produce the vaccines.

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