What’s next for the COVID-19 vaccine intellectual property waiver proposal?

BY MICHAEL ROSEN

Earlier this month, the White House dropped an intellectual property bombshell, announcing that it was relaxing the Donald Trump administration’s opposition to suspending patent rights related to COVID-19 vaccines.

As we previously noted, United States Trade Representative (USTR) Katherine Tai proclaimed that “the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” declared the administration’s support for a waiver of Trade-Related Aspects of Intellectual Property Rights (TRIPS) at the World Trade Organization (WTO), and reiterated the Joe Biden administration’s intention “to get as many safe and effective vaccines to as many people as fast as possible.”

Setting aside the demerits of this approach — which, as we explored, far outweigh its benefits — the global reaction to the White House’s move has cast doubt on when and whether the TRIPS waiver will actually come to fruition.

First, Germany announced its staunch opposition to the WTO suspension motion, which India and South Africa introduced late last year. “The protection of intellectual property is a source of innovation and must remain so in the future,” Germany’s spokesperson said, suggesting instead that the WTO member nations focus on ramping up vaccine production and bolstering the COVID-19 Vaccines Global Access program designed to inoculate the developing world.

While the European Union as a whole has indicated an openness to exploring the waiver, other influential countries with robust pharmaceutical research and development sectors — including Japan, South Korea, and Switzerland — are expected to oppose the proposal.

Second, a survey conducted by The Hill and the Harris Poll in the wake of the announcement of the White House proposal found that 57 percent of Americans oppose it. A Morning Consult poll commissioned by the Pharmaceutical Research and Manufacturers of America drew similar conclusions.

Third, news emerged of a possible split in the administration over the waiver, with President Biden personally pushing for its implementation. “The main thing is we have to speed this up,” Secretary of State Antony Blinken said shortly after the announcement. “None of us are going to be fully safe until . . . we get as many people vaccinated as possible,” and a patent waiver is “one possible means of increasing manufacture, and access to vaccines.” (Emphasis added.)

Fourth, the timetable for potential action on a waiver appears to be stretching. USTR Tai acknowledged in her initial statement that the “negotiations will take time given the consensus-based nature” of the WTO. How much time? Clete Willems, who was part of Trump’s trade mission to the WTO, told Reuters any agreement is unlikely to be completed before the organization’s December meeting. By that time, the crisis gripping India will have long passed.

So given this opposition and the slow pace of enacting the suspension, what’s really going on? Is it possible the proposal is simply a fire under the seats of vaccine manufacturers to increase production?

Some experts believe so. Arthur Appleton, an international law professor and trade expert, told The Lancet that “the threat of a waiver may help drive down the cost of vaccines, therapeutics, and diagnostic tools, and result in increased access in the developing world” and “may also lead to voluntary licensing agreements on terms favourable to developing countries.” Similarly, Reuters surmised that a delayed timetable would “give vaccine producers more time to boost global supplies which could help contain the virus and ease pressure for the waiver.”

But was any of this necessary? Thomas Cueni, the director-general of the International Federation of Pharmaceutical Manufacturers and Associations, told The Lancet that even before Biden’s announcement, the industry was on pace to produce around 11.6 billion vaccine doses by the end of the calendar year. Governments around the world should be collaborating with vaccine manufacturers to increase production, not thwarting innovation with threats of removing the protections that made it possible in the first place.