By JAMEY KEATEN Associated Press
GENEVA (AP) — Several world leaders Thursday praised the U.S. call to remove patent protections on COVID-19 vaccines to help poor countries obtain shots. But the proposal faces a multitude of hurdles, including resistance from the pharmaceutical industry.
Nor is it clear what effect such a step might have on the campaign to vanquish the outbreak.
Activists and humanitarian institutions cheered after the U.S. reversed course Wednesday and called for a waiver of intellectual property protections on the vaccine. The decision ultimately is up to the 164-member World Trade Organization, and if just one country votes against a waiver, the proposal will fail.
The Biden administration announcement 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. On Thursday, French President Emmanuel Macron embraced it as well.
“I completely favor this opening up of the intellectual property,” Macron said at a vaccine center.
However, like many pharmaceutical companies, Macron insisted that a waiver would not solve the problem of access to vaccines. He said manufacturers in places like Africa are not now equipped to make COVID-19 vaccines, so donations of shots from wealthier countries should be given priority instead.
Pfizer, Moderna, Johnson & Johnson and AstraZeneca — all companies with licensed COVID-19 vaccines — had no immediate comment, though Moderna has long said it will not pursue rivals for patent infringement during the pandemic.
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.
India, as expected, welcomed the move. Australian Prime Minister Scott Morrison called the U.S. position “great news.”
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 vaccine patents. But Italian Premier Mario Draghi was more circumspect.
Russian President Vladimir Putin said his country would support it. U.N. Secretary-General Antonio Guterres welcomed the U.S. decision too.
But German Chancellor Angela Merkel’s office spoke out against it, saying: “The protection of intellectual property is a source of innovation and must remain so in the future.”
A Merkel spokeswoman, speaking on customary condition of anonymity, said Germany is focused instead on how to increase vaccine manufacturers’ production capacity.
In Brazil, one of the deadliest COVID-19 hot spots in the world, Health Minister Marcelo Queiroga said he fears that the country does not have the means to produce vaccines and that the lifting of patent protections could interfere with Brazil’s efforts to buy doses from pharmaceutical companies.
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 who was not authorized the discuss the matter and spoke on condition of anonymity.
Some 80 countries, mostly developing ones, have supported the proposal, the official said. China and Russia — two other major COVID-19 vaccine makers — didn’t express a position but were open to further discussion, the official said.
EU Commission President Ursula von der Leyen said the 27-nation bloc is ready to talk about the idea, but she remained noncommittal and emphasized that the EU has been exporting vaccines widely — while the U.S. has not.
EU leaders said the bloc may discuss the matter at a summit that starts Friday.
The pharmaceutical industry has argued that a waiver will do more harm than good in the long run.
Easing patent protections would eat into their profits, potentially reducing the incentives that push companies to innovate and make the kind of tremendous leaps they did with the COVID-19 vaccines, which have been churned out at a blistering, unprecedented pace.
The industry has contended, too, that production of the vaccines is complicated and can’t be ramped up simply by easing patent rights. Instead, it has said that reducing snarls in supply chains and shortages of ingredients is a more pressing issue.
The industry has insisted that a faster solution would be for rich countries to share their vaccine stockpiles with poorer ones.
“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.”
Intellectual property law expert Shyam Balganesh, a professor at Columbia University, said a waiver would only go so far because of bottlenecks in the manufacturing and distribution of vaccines.
Backers of the waiver say that expanded production by the big pharmaceutical companies and donations from richer countries to poor ones won’t be enough, and that there are manufacturers standing by that could make the vaccines if given the blueprints.
“A waiver of patents for #COVID19 vaccines & medicines could change the game for Africa, unlocking millions more vaccine doses & saving countless lives,” World Health Organization Africa chief Matshidiso Moeti tweeted.
Just over 20 million vaccine doses have been administered across the African continent, which has 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 the AIDS virus, malaria and tuberculosis.
“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,” Africa CDC Director John Nkengasong said.
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Associated Press 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, Frank Jordans in Berlin and Matthew Lee in Kyiv, Ukraine, contributed to this report.
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Follow more of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine.
EXPLAINER: Why patents on COVID vaccines are so contentious
The Biden administration’s call to lift patent protections on COVID-19 vaccines to help poor parts of the world get more doses has drawn praise from some countries and health advocates.
But it has run into resistance from the pharmaceutical industry and others, who say it won’t help curb the outbreak any time soon and will hurt innovation.
Here’s a look at what patents do and why they matter:
HOW DO DRUG PATENTS WORK?
Patents reward innovation by preventing competitors from simply copying a company’s discovery and launching a rival product. In the U.S., patents on medicines typically last 20 years from when they are filed, which usually happens once a drugmaker thinks it has an important or lucrative drug. Because it often takes a decade to get a drug approved, companies typically enjoy about a dozen years of competition-free sales. But drugmakers usually find ways to improve their product or widen its use, and they secure additional patents that can extend their monopoly for many more years.
WHY IS PATENT PROTECTION SO IMPORTANT TO DRUGMAKERS?
Medicines are incredibly expensive to develop. Most experimental drugs fail at some point during the years of laboratory, animal and finally human testing. Averaging in the cost of those flops, it typically costs over $1 billion to bring a drug from discovery to regulatory approval. Without the prospect of years of sales without competition, there’s far less incentive to take that risk.
WHY IS THE U.S. BACKING EFFORTS TO LIFT PROTECTIONS ON COVID-19 VACCINES?
The Biden administration has been under intense pressure, including from many Democrats in Congress, to get more COVID-19 vaccines to the rest of the world. Support for the waiver idea floated by India and South Africa in October has been growing in other countries while the outbreak worsens in some places, especially India.
WHY HAVE THE U.S. AND OTHERS OPPOSED LIFTING PROTECTIONS IN THE PAST?
The U.S. and some other wealthy countries lead the world in many areas of research and innovation, particularly medicines. Aside from the prestige that confers, pharmaceutical companies provide millions of well-paying jobs, generate tax revenue and provide new medicines that can save or improve lives. Drugmakers and their trade groups spend millions every year lobbying governments to maintain the status quo on patents.
WHY IS THE INDUSTRY SO OPPOSED TO THE EFFORT?
In a word, money. In the U.S., pharmaceutical companies can charge whatever they want for their medicines. They typically raise prices twice a year, often doubling or tripling them during a drug’s patent-protected years. That makes the big, long-established drugmakers among the world’s most profitable companies. But a huge amount of innovation also comes from startup companies, which relay heavily on investors to fund early research. Without the prospect of a big payday, it would be much harder to attract investment.
Les Funtleyder, health care portfolio manager at E Squared Asset Management, thinks the industry is less worried about protecting its patents for the COVID-19 vaccines than about the “slippery slope” such a precedent could create.
WHAT IS THE PROCEDURE FOR LIFTING PATENT PROTECTIONS?
The decision is up to the 164-member World Trade Organization, which administers complex trade rules among nations. And all of them would have to agree for it to happen. If waivers are approved, vaccine developers would then have to share their know-how for the very complex manufacturing.
HAS THIS EVER HAPPENED BEFORE?
There’s no precedent for vaccines, but two decades ago WTO members passed a temporary waiver allowing poor countries to import cheap generic drugs for HIV, tuberculosis and malaria amid health crises. That temporary waiver eventually was made permanent.
WHAT WOULD LIFTING PROTECTIONS ON COVID-19 VACCINES ACCOMPLISH?
That’s not entirely clear, but drugmakers and analysts say waiving patent rights won’t do much to get COVID-19 vaccines to developing countries faster. That’s because making them is far more complex than following a recipe, requiring factories with specialized equipment, highly trained workers and stringent quality control. There is also little available factory capacity. In addition, many raw materials to make the vaccines, along with vials, stoppers and other components, are in very short supply, which won’t change soon.
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AP Business Writer Tom Krisher contributed to this report from Detroit.
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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.