More support easing vaccine patent rules, but hurdles remain

by Joseph K. Clark

The move to support waiving intellectual property protections on vaccines under World Trade Organization rules marked a dramatic shift for the United States — and drew cheers from activists, complaints from Big Pharma, and many questions about what comes next. Washington had previously lined up with many other developed nations opposed to the idea floated by India and South Africa in October.

But he also expressed doubt — as the pharmaceutical companies have — that the measure would be the panacea of some hope. Even if patents are waived, he said, drug makers in places like Africa currently are not equipped to make COVID-19 vaccines — so donations of doses should be prioritized instead.


Another critical hurdle remains: Any country could block a Geneva-based trade body of 164 member states’ decision at the WTO to agree to a waiver.

The EU Commission president, Ursula von der Leyen, said the 27-nation bloc was ready to discuss the U.S. proposal — but remained noncommittal.

“We are ready to discuss how the U.S. proposal for waiver on intellectual property protection for COVID vaccines could help” end the crisis, she said in a video address. “In the short run, however, we call upon all vaccine-producing countries to allow exports and to avoid measures that disrupt supply chains.”

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

“A waiver is the simple but the wrong answer to 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 by reducing the incentives that push innovators to make tremendous leaps, as they did with the vaccines churned out at a blistering, unprecedented speed to help fight COVID-19.

Supporters say a waiver would be vital because it would allow manufacturers worldwide to get access to the recipes for making the life-saving vaccines and the ingredients. They point to unused capacity — factories that could churn out vaccines but can’t because of intellectual property protection.

Some critics say developing countries have been seeking to water down those protections for years — long before the pandemic — and say it’s not clear that any manufacturers are standing by that are ready or able to produce COVID-19 vaccines. They note that the vaccines on the market can be incredibly difficult to make, and the know-how is a more significant obstacle to ramping up manufacturing.

Many experts and advocacy groups say any such waiver would need to be followed up by transferring the required technology to developing countries.

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

In closed-door WTO talks last month, the EU, Britain, and Switzerland said upending or undermining IP rights was a “no-go” because those rights helped contribute to expanding production of COVID-19 vaccines, according to a Geneva trade official, who spoke on condition of anonymity because he was not authorized to discuss the matter publicly.

Last month, Norway’s Foreign Minister, Ine Eriksen Soereide, warned against “this experimental trade policy” during the pandemic when “we should rather be concerned with practical solutions that give us more vaccines.”

After the Biden announcement, Eve Geddie, Director of Amnesty International’s EU Office, called on Europe now to “put everyone’s health and human rights before private profit” and add its support to the waiver idea.

“Today, Europe wakes up to a new political reality that its position on hoarding the rights to make COVID-19 vaccines is now untenable,” she said.

She was but one voice among civil society, progressive groups, and international institutions that were euphoric about the Biden administration’s stance, 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 of 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.

Over 20 million vaccine doses have been administered across Africa, counting some 1.3 billion people. Gavi, the vaccine alliance, 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 boost production of the raw materials that go into vaccines and are in short supply.

Doctors Without Borders, an advocacy group known as Medecins Sans Frontieres that sends health workers to impoverished countries, said many low-income countries where it operates have only received 0.3% of the global supply of coronavirus vaccines.

“MSF applauds the U.S. government’s bold decision to support the waiving of intellectual property on COVID-19 vaccines during this time of unprecedented global need,” said Avril Benoît, executive director of MSF-USA.

She said any waiver should apply to vaccines and other medical tools for COVID-19, including treatments for infected people and testing systems.

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 report contributed to Associated Press writers Raf Casert and Lorne Cook in Brussels, John Leicester in Paris, Jan M. Olsen in Copenhagen, Denmark, and Cara Anna in Nairobi, Kenya. Follow more of AP’s panel’s coverage at and

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