Extraordinary Measures for Extraordinary Times: Biden Administration Supports Waiver of IPR Protection for New Crown Vaccine

The Biden administration announced U.S. support for waiving protection of intellectual property rights related to the new coronavirus vaccine, calling it an extraordinary and exceptional measure necessary in the midst of a global pandemic crisis. However, supporters and opponents of the White House policy remain divided within the United States.

U.S. Trade Representative Katherine Tai issued a statement Wednesday afternoon (May 5) that the U.S. government supports an exemption from the Trade Related Intellectual Property Rights (TRIPS) protections associated with the new coronavirus vaccine.

This is a global health crisis, and the extraordinary circumstances of the new coronavirus pandemic require us to take extraordinary measures,” said Tai. The U.S. government believes in protecting intellectual property rights, but the United States supports waiving intellectual property protection for the Neovirus vaccine in order to end this global epidemic. We will actively participate in the negotiation of the relevant texts needed to achieve this goal under the World Trade Organization framework.”

U.S. economist Chris Balding believes that the U.S. government’s decision is the right one. He tweeted, “This is a major step, especially important for India. I do not support a permanent exemption or a broader exemption. But in special cases like this, a limited exemption makes sense.”

USTR Dyche meanwhile said these negotiations will take time, given the consensus-based nature of the mechanism and the complexity of the issues involved.

Earlier this week, the U.S. Trade Representative’s office has said it will promote close trilateral cooperation between the World Intellectual Property Organization, the WTO, and the WHO. Katherine Tai held an online meeting with WIPO Director General Daren Tang on Monday. The two sides discussed how to increase vaccine production and the role of intellectual property in the response to the new crown outbreak.

Public Health Experts Support Washington’s Action

As early as October of last year, India and South Africa were the first to propose that intellectual property rights related to the new crown virus should be temporarily opened up in light of the global new crown epidemic.

Following the second wave of the New Coronavirus outbreak in India, the Biden administration began considering a push for an exemption to intellectual property rights on the New Coronavirus vaccine. The White House’s relief was due to pressure from the public health community, as well as from congressional Senate Democrats.

A number of Democratic Senators in the Congressional Senate, had sent a letter to President Biden urging the U.S. government to allow local production of the vaccine in countries around the world in order to accelerate the widespread availability of the New Crown vaccine and treatment and reduce unnecessary deaths.

U.S. experts in the field of public health generally support the exemption of intellectual property rights for the New Crown vaccine, arguing that doing so would ensure that much-needed New Crown vaccine is available to the world’s poorer countries and is in the national interest of the United States.

Richard Ebright, a professor of chemistry and biology at Rutgers University in New Jersey, argues that it is not only in the U.S. interest from both a public health perspective and a U.S. global diplomacy perspective for Washington to do so; it is also, from the perspective of basic ethics and basic humanity, the the right decision.

Public health experts interviewed by Voice of America generally agreed with the U.S. government’s decision and believed it was in line with the attitude of the vast majority of countries around the world.

But Ebright also cautioned that even an intellectual property exemption for the New Crown vaccine does not mean that there will be enough vaccine immediately to save people from the current epidemic crisis, including in countries such as India.

“But it will accelerate the process, and by doing so, it will also accelerate the process of ending the pandemic and returning to normalcy,” Ebright said.

Drugmakers and IP advocacy groups oppose exemptions

Contributing to the White House’s earlier delay in announcing its commitment to support the waiver was the strong opposition the Biden administration faced from drugmakers and interest groups. U.S. drugmakers say an IP exemption for the new crown drug would cede the relevant technology to China and Russia, aiding Beijing and Moscow’s vaccine diplomacy.

On the other hand, U.S. NGOs that advocate for innovation and intellectual product protection also oppose breaking the protection of New Crown drug IP. The Information Technology and Innovation Foundation, a Washington-based NGO, is one of them.

Jaci McDole, a senior analyst with the organization, said the U.S. should not support the exemption because it does not achieve the goals of timely access to affordable medical products, including vaccines and medicines, and expanding research, development, manufacturing and supply of critical medical products needed to fight the new crown epidemic.

“The exemption also does not provide the means for safety and quality control. Intellectual property rights are not a barrier in addressing the needs of the new crown epidemic, so an exemption would be inappropriate,” she said.

She told Voice of America that maintaining quality control within the supply chain is important in light of the recent surge in counterfeit New Coronavirus vaccines, therapeutic drugs, personal protective equipment and other products.

There is no way to protect the supply chain and control quality if counterfeiters or ill-equipped manufacturers invade an already limited supply chain and put counterfeit or substandard products on the market that are second best. This could result in significant financial losses for the drug manufacturers and developers who hold these patents.

The pharmaceutical companies fear that once patent protection is waived, there will be mass production in countries around the world, to the detriment of the patent holders. India is known to be the world’s largest producer of generic brands and off-patent drugs, which analysts believe could be a major concern for drugmakers.