The Biden Administration has issued support for a proposal to temporarily waive intellectual property (IP) rights for COVID-19 vaccines as a means to increase vaccine access in developing countries, a position supported by the World Health Organization (WHO) but opposed by the bio/pharmaceutical industry.

The move to waive IP rights for COVID-19 vaccines first arose in 2020 in a proposal made by India and South Africa under the World Trade Organization, and it is an issue still being debated as the US government has now offered its support as WTO negotiations continue.

“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.” Said Katherine Tai, the United States Trade Representative in a May 5, 2021 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.”

A move to waive IP rights to COVID-19 vaccines as a means to increase access to them is also supported by WHO. “This is a monumental moment in the fight against COVID-19,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus in a May 5, 2021 statement. “The commitment by the President of the United States Joe Biden and Ambassador Katherine Tai, the US Trade Representative, to support the waiver of IP protections on vaccines is a powerful example of American leadership to address global health challenges. I commend the United States on its historic decision for vaccine equity and prioritizing the well-being of all people.”

The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the large innovator, research-based companies, and the Biotechnology Innovation Organization (BIO), which represents both large and small bio/pharmaceutical companies, have criticized a move to allow for such a waiver saying that the measure would not increase vaccine access in low-to-middle income countries, which face manufacturing and supply-chain challenges, and that other programs with industry participation are a better way to improve vaccine access. 

“[T]he Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety,” said PhRMA President and CEO Stephen J. Ubl in a May 5, 2021 statement. “This decision will sow confusion between public and private partners, further weaken already strained supply chains, and foster the proliferation of counterfeit vaccines…This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. These are the real challenges we face that this empty promise ignores.”

BIO raised similar concerns. “We are extremely disappointed that the Administration has chosen to support waiving critical protections for American ingenuity and to delay the equitable delivery of needed COVID vaccines to people around the globe,” said Dr. Michelle McMurry-Heath, President and CEO of BIO, in a May 5, 2021 statement. “Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine. 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. The better alternative would have been to follow through on the President’s pledge just last week to make the United States the world’s ‘arsenal of vaccines.’  This policy leads in the opposite direction.”

Dr. McMurry-Heath pointed to alternative measures, such as the COVID Global Strategy for Harnessing Access Reaching Everyone (SHARE) Program. “The Global SHARE Program would ensure sufficient global supply of vaccines, ensure safe and expeditious global access to vaccines and therapeutics, and bolster ongoing efforts to strengthen and support healthcare systems in low-and middle-income countries in addressing COVID,”  Dr. McMurry-Heath said her statement. “It would accomplish these goals without compromising protections for intellectual property or further stretching limited global vaccine expertise to the breaking point.”

 Source: US Trade Representative, World Health Organization, Pharmaceutical Research and Manufacturers of America, and the Biotechnology Innovation Organization