Patent protection reversal causes stir from G7 and drug companies
Waiver Woes
The Biden administration said that it will support a proposal from developing countries to allow a temporary waiver on COVID-19 vaccine patents in order to enable new suppliers to begin manufacturing the vaccines to reduce the global shortage of the vaccines. The policy position is a major shift for the United States, which had previously refused to support a patent waiver.
South Africa and India first proposed the patent waiver proposal last October. The plan was supported by more than 100 countries, largely in the developing world arguing that it would allow them to rapidly produce their own generic vaccines, rather than wait months or years for sufficient doses. U.S. officials helped to block this World Trade Organization proposal that was introduced last year to stop enforcing patents for coronavirus-related medical products.
“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” said U.S. Trade Representative Katherine Tai. “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. The United States will now move forward with international discussions to waive the protections for the duration of the pandemic.”
The policy reversal by the United States on vaccine patent protection has upset G7 members, who refuse to support the U.S. position. The Pharmaceutical Research and Manufacturers of America predicted that allowing more manufacturers to begin making shots would spark new competition for limited ingredients, slow down existing production and lead to counterfeit vaccines. The move was enthusiastically supported by health activist groups, which have been lobbying for a waiver and holding rallies in favor of it. I was championed by U.S. politicians such as Bernie Sanders and Elizabeth Warren.
The World Trade Organization, which operates on consensus, cannot approve a new policy if key countries oppose it. The G7 meeting ended a few hours before the U.S. announcement. It did not make a statement on the vaccine patent issue. An intellectual property waiver would need consensus at the 164-member World Trade Organization.
The G7 foreign ministers said that they had agreed to push for the accelerated production of affordable vaccines, but they did not ask big pharmaceutical companies to waive their intellectual property rights. They said they would work with the industry to encourage “voluntary licensing and tech transfer agreements on mutually agreed terms.”
Tedros Adhanom Ghebreyesus, the World Health Organization’s director-general, called the U.S. support for the waiver proposal is “a monumental moment” in the fight against the pandemic. He described it a “historic decision for vaccine equity and prioritizing the well-being of all people everywhere at a critical time.”
The United States said that it supported the waiver only narrowly for COVID-19 vaccines, not for other technology such as medical treatments or tests, which had been included in the original waiver proposal last October. By narrowing the waiver proposal, the U.S. may be trying to reduce the pharmaceutical industry’s opposition to it.
The changing U.S. stance might be enough to make progress on the waiver at the WTO meetings. Opposition from wealthy countries has prevented the WTO from moving to the next step in the process: text-based negotiations. They have a greater chance of moving ahead. The supporters of the waiver have already signaled that they are willing to revise the wording of their proposal.
“We will actively participate in text-based negotiations at the WTO needed to make that happen,” Ms. Tai said. “Those negotiations will take time, given the consensus-based nature of the institution and the complexity of the issues involved.”