More Support Easing Vaccine Patent Rules, But Hurdles Remain

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FILE - In this March 24, 2021, file photo, a vial of the AstraZeneca COVID-19 vaccine, manufactured by the Serum Institute of India and provided through the global COVAX initiative, is removed from a portable cold storage box in preparation for a vaccination, in Machakos, Kenya. France joined the United States on Thursday, May 6, in supporting an easing of patent and other protections on COVID-19 vaccines that could help poorer countries get more doses and speed the end of the pandemic. (AP Photo/Brian Inganga, File)

GENEVA (AP) — Several world leaders on Thursday praised the U.S. move to expand access to COVID-19 vaccines for poor nations by suspending patent protections on the shots. But it wasn’t clear if that would actually lead to the measures being lifted — and what it would mean if they were.

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Activists and international institutions cheered but Big Pharma fired back after the U.S. reversed course Wednesday and called for a waiver of intellectual property protections. If even just one country votes against a waiver at the World Trade Organization, it would be sunk.

The Biden administration move made the U.S. the first country in the developed world with big vaccine manufacturing 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 on Thursday suggested that countries were reassessing their positions.

“I completely favor this opening up of the intellectual property,” Macron said at a vaccine center.

Like many pharmaceutical companies, 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 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, Macron said.

Pfizer, Moderna, Johnson & Johnson and AstraZeneca — all companies with licensed COVID-19 vaccines — did not comment, though Moderna has long said it will not pursue patent infringements during the pandemic.

But U.S. Secretary of State Antony Blinken underscored the urgency of moving fast now.

“On the current trajectory, if we don’t do more, if the entire world doesn’t do more, the world won’t be vaccinated until 2024,” he said in an interview with NBC while visiting Ukraine on Thursday.

Many leaders praised the move — though not all said they would ultimately support it themselves.

India, as expected, welcomed it. Australian Prime Minister Scott Morrison called the U.S. position “great news” and South Korean officials say they ware paying close attention — but neither country’s leaders would say if they would endorse it.

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.

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 United States opposed the waiver idea, according to a Geneva-based trade official on condition of anonymity because he was not authorized to discuss the matter publicly.

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

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.

While 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 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 the impact listing the patent restrictions would have.

The industry says the manufacturers with the know-how and a track record of producing complicated vaccines should expand their own production, with rich countries donating excess doses they no longer need as their vaccination campaigns near their peak.

Backers of the waiver say that won’t be enough, and that there are manufacturers standing by who could make the vaccines if they were given the blueprints.

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,” 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.

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.

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.”


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