Should vaccines be protected property? U.S., France now say no.

In a dramatic shift, the United States announced it backs temporarily waiving patent protections for vaccines in order to help poorer countries gain access to more doses. But critics say bottlenecks in manufacturing and distribution are bigger problems.

First Look

France joined the United States on Thursday in supporting an easing of patent protections on COVID-19 vaccines that could help poorer countries get more doses and speed the end of the pandemic. While the backing from two countries with major drugmakers is important, many obstacles remain.

American support for waiving the protections marked a dramatic shift in the country's previous position, and many thought it could lead to a breakthrough, drawing cheers from activists and complaints from Big Pharma. Still, even just one country voting against a waiver would be enough to block efforts at the World Trade Organization.

With the administration’s announcement on Wednesday, the U.S. became the first country in the developed world with big vaccine manufacturing capacity to publicly support the waiver idea floated by India and South Africa in October. And the vocal support that followed from French President Emmanuel Macron suggested that countries were reassessing their positions.

“I completely favor this opening up of the intellectual property,” Mr. Macron said Thursday on a visit to a vaccine center.
Like many pharmaceutical companies, Mr. Macron also insisted that a waiver of intellectual property rights will not solve the problem of access to vaccines. Those protections give companies that developed vaccines special rights about how the manufacturing know-how is used – and by whom.

Even if those protections are eased, manufacturers in places like Africa are not now equipped to make COVID-19 vaccines – so donations of shots should be prioritized instead, Mr. Macron said.

Many other leaders chimed in – though not all expressed immediate support. Italian Foreign Minister Luigi Di Maio wrote on Facebook that the U.S. announcement was “a very important signal” and that the world needs “free access” to patents for the vaccines. But Italian Premier Mario Draghi was more circumspect.

Australian Prime Minister Scott Morrison called the U.S. position “great news” but did not directly respond to a question about whether his country would support a waiver. South Korean officials say they ware also paying close attention to the Biden administration’s call but also sidestepped questions on whether Seoul endorses the idea.

Russian President Vladimir Putin said his country would support it.

In closed-door talks at the WTO in recent months, Australia, Britain, Canada, the European Union, Japan, Norway, Singapore, and the U.S. opposed the waiver idea, according to a Geneva-based trade official who spoke on condition of anonymity because he was not authorized to discuss the matter publicly.

Brazil was the only developing country to oppose it, while China and Russia – two other major COVID-19 vaccine makers – didn’t express a position either way but were open to more discussions, the official said.

Some 80 countries, mostly developing nations, have supported the Indian and South African proposal, the official said.

While Mr. Macron was forceful, others in Europe were not. The EU Commission president, Ursula von der Leyen, said the 27-nation bloc was ready to talk about the waiver idea, but remained noncommittal for now and emphasized that the bloc has been exporting vaccines widely – while the U.S. has not.

That echoed the position of the global pharmaceutical industry, which insists a faster solution would be for rich countries that have vaccine stockpiles to start sharing them with poorer ones. Several European leaders also underscored that.

“All countries around the world where vaccines are produced must be prepared to export it to others, too,” said German Health Minister Jens Spahn. “The EU stands ready in word and deed. ... We are happy if the U.S. is, too, now.”

EU leaders said the bloc will start discussing whether they should join the U.S. move, possibly at a summit that starts Friday.

The pharmaceutical industry has resisted the waiver, insisting that production of coronavirus vaccines is complicated and can’t be ramped up by easing intellectual property protections. Instead, it says that reducing bottlenecks in supply chains and a scarcity of ingredients that go into vaccines are the more pressing issues for now.

“A waiver is the simple but the wrong answer to what is a complex problem,” said the International Federation of Pharmaceutical Manufacturers and Associations. “Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis.”

The industry also says an IP waiver will do more harm than good in the long run. Easing patent protections would eat into their profits, reducing the incentives that push innovators to make the kind of tremendous leaps they did with the COVID-19 vaccines, which have been churned out at a blistering, unprecedented pace.

Critics and supporters have disagreed on whether there are any manufacturers standing by that could make the vaccines if they were given the blueprints. Those opposed have noted that the COVID-19 vaccines can be incredibly difficult to make.

Intellectual property expert Shyam Balganesh, a professor at Columbia Law School, said a waiver would remove “a lot of the bureaucracy” around WTO rules, but it would only go so far because of other bottlenecks in the manufacturing and distribution of vaccines.

But activists and public health advocates cheered the U.S. move, which marks a nearly complete reversal in U.S. policy under the Trump administration that was critical of both the WTO and the World Health Organization.

“A waiver of patents for #COVID19 vaccines & medicines could change the game for Africa, unlocking millions more vaccine doses & saving countless lives. We commend the leadership shown by South Africa, India & the United States, & urge others to back them,” WHO Africa chief Matshidiso Moeti tweeted.

Just over 20 million vaccine doses have been administered across the African continent, which counts some 1.3 billion people.

Gavi, the vaccine alliance that is co-leading the U.N.-backed effort to get shots to countries where they are needed, also welcomed the U.S. decision and an American commitment to also boost production of the raw materials that go into vaccines and are in short supply.

There is precedent. In 2003, WTO members agreed to waive patent rights and allow poorer countries to import generic treatments for HIV/AIDS, malaria, and tuberculosis.

Many hope for a historic replay to fight COVID-19.

The Africa CDC director, John Nkengasong, told reporters: “We believe that when the history of this pandemic is written, history will remember the move by the U.S. government as doing the right thing at the right time.”

This story was reported by The Associated Press. AP writers Raf Casert and Lorne Cook in Brussels; John Leicester in Paris; Jan M. Olsen in Copenhagen, Denmark; Cara Anna in Nairobi, Kenya; Nicole Winfield in Rome; and Frank Jordans in Berlin contributed to this report.

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