Nations Press Waivers for Vaccine Patents --- Deal reached by U.S., EU, South Africa and India needs approval from WTO members

"After 18 months of fierce debate, a group of countries, including the U.S., reached an agreement to waive patent protections on Covid-19 vaccines. Now they are racing to get other countries to support the deal at the World Trade Organization, officials involved in the discussions said.

The U.S. and the European Union reached a compromise with South Africa and India that would allow developing countries to manufacture Covid-19 vaccines without the permission of the holder of the intellectual-property rights. It also would set a precedent for future pandemics.

After the first vaccines began to be approved in late 2020, developed nations quickly struck deals with Western pharmaceutical companies that tied up most of the global-production capacity. That left developing nations demanding that they be allowed to make their own copies of the shots.

The uneven distribution of vaccines has left some countries with less protection and made them potential breeding grounds for new variants, scientists say.

The deal now has to be put to the entire 164-nation membership of the WTO, which requires all member countries to agree for it to be approved. The draft text, which was obtained by The Wall Street Journal, doesn't cover medical treatments and tests, as originally called for by South Africa and India. It says a decision on diagnostics and therapeutics would be taken within six months of the approval of the vaccine deal.

Officials say they hope that consensus among all member nations can be reached by June, when trade ministers are due to meet at the WTO.

The U.K. and Switzerland, which have major pharmaceutical industries and opposed the waiver, weren't part of the talks on the agreement. They complained of a lack of transparency around negotiations in a WTO meeting of all members on March 9, trade officials said.

The text hasn't been officially shared with other WTO members. They are expected to react to it at the next meeting of the WTO forum debating it, which has yet to be scheduled, trade officials said.

The draft text contains a clause that would exclude China as a beneficiary of the waiver. That means that China would still need the permission of the patent holder to manufacture the vaccines of Pfizer Inc., Moderna Inc. or other Western companies.

An official at the Chinese mission at the WTO said they were still studying the draft and didn't have a comment.

The agreement has dismayed the pharmaceutical industry for weakening patent protections. Proponents of waiving patent protections say the deal comes far too late and isn't broad enough to help developing countries sufficiently.

When the Biden administration surprised the pharmaceutical industry by throwing its support behind the waiver, it said it was backing the removal of patent protections for vaccines, but not treatments and tests. The EU initially was opposed to a vaccine waiver, calling for using the existing flexibilities in trade law.

Discussions reached a stalemate last year when the waiver was debated among all member countries. But in recent months, the EU, U.S., South Africa and India broke away into a smaller group to try to end the deadlock.

"While no agreement on text has been reached and we are in the process of consulting on the outcome, the U.S. will continue to engage with WTO Members as part of the Biden-Harris Administration's comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible," said the U.S. Trade Representative.

The Covid-vaccine market, excluding Chinese shots, was worth sales of $66 billion in 2021, which is set to jump to $85 billion this year, according to Airfinity, which collates health data. The market is dominated by the vaccine developed by Pfizer and BioNTech SE, with market share of 57% in 2021, measured by revenue, followed by Moderna, with market share of 26%, Affinity data show." [1]

1. World News: Nations Press Waivers for Vaccine Patents --- Deal reached by U.S., EU, South Africa and India needs approval from WTO members
Shah, Saeed.
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 18 Mar 2022: A.11.