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Regulatory News | 06 May 2021 | By Joanne S. Eglovitch
Pharmaceutical industry groups in the US and the EU lambasted a recent decision by the Biden Administration to support a proposal pending in the World Trade Organization (WTO) that would waive intellectual property patents for coronavirus vaccines, charging that the waiver is a bad idea that would compromise vaccine efficacy and safety. Their views clash with World Health Organization’s (WHO) arguments and other groups that the waiver is necessary to increase access to the vaccines in the developing world.
The temporary waiver of these Trade-Related Aspects of Intellectual Priority Rights (TRIPS) rules was proposed by India and South Africa last year and has the backing of 60 WTO members.
President Joe Biden on 5 May endorsed the proposal after bowing to pressure from Democratic lawmakers, who drafted a 30 April letter signed by 106 Democratic members urging him to temporarily lift IP restrictions and allow countries to locally manufacture COVID-19 vaccines. Previously, the administration was opposed to the proposal.
“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” announced US Trade Representative Katherine Tai on 5 May. “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. We will actively participate in text-based negotiations at the World Trade Organizations (WTO) needed to make this happen.”
Proposal pits public health groups against pharma industry
WHO announced its support of the move. “I commend the United States on its historical decision for vaccine equity and prioritizing the well-being of all people everywhere at a critical time. Now let’s all move together swiftly, in solidarity, building on the ingenuity and commitment of scientists who produced life-saving COVID-19 vaccines,” said WHO Director-General Tedros Adhanom Ghebreyesus, the head of the World Health Organization. He added that “this is a monumental moment in the fight against COVID-19.”
Doctors Without Borders/Medecins Sans Frontieres (MSF) also said that the decision will “increase sufficient and timely access” to these vaccines; the group asserts that many of the low-income countries in which MSF operates have only received .3% of global vaccine supply while the US has secured enough doses for its entire population.
Knowledge Ecology International, a non-profit non-governmental organization, also “applauded” the decision. The group said that “it is a good time to brush up on 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 and ask the WHO what its procedures are for evaluating quality of generic/biosimilar vaccines.”
Yet major pharmaceutical industry groups in the US and the EU expressed disappointment in the decision.
Stephen Ubl, the CEO of the Pharmaceutical Research and Manufacturers of America, said the decision will “sow confusion between public and private partners, further weaken already strained supply chain 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.”
Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization, concurred that it was a bad move. “Handing needy countries a recipe book without the ingredients, safeguards, and sizeable 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 decision was also blasted by Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations, who called the proposal “short sighted” in a 6 May statement. She said “increasing capacity to deliver doses to citizens around the world requires the skills and technical know-how of the vaccine developer to bring on-board partner manufacturing organizations. You simply cannot achieve this kind of capacity expansion by waiving patents and hoping that hitherto unknown factories around the world will turn their hand to the complex process of vaccine manufacture.”
In response to the US decision to back the waiver proposal, European Commission President Ursula von der Leyen said the EU was open to discussions on the proposal. A week earlier the European Parliament voted down an amendment to back the IP waiver.
WTO TRIPS waiver proposal
USTR announcement on TRIPS waiver
Editor's note: This article has been updated to correct an erroneous date.
Tags: coronavirus, global, patent waivers, TRIPS, US, WTO