Pfizer Agrees to Allow Generic Drug Companies to Make COVID-19 Pill, Waives Royalties

Pfizer Agrees to Allow Generic Drug Companies to Make
COVID-19 Pill, Waives Royalties 1

Pfizer Inc. signed a deal with a U.N.-backed group to allow other manufacturers to produce its COVID-19 pill, as well as waive royalties on sales in low-income countries and countries covered by the agreement while COVID-19 continues to be a public health emergency, according to the Associated Press.

The antiviral pill is designed to lessen symptoms of COVID-19, thereby reducing the amount of hospitalizations.

Pfizer said it would grant a license for the pill to the Geneva-based Medicines Patent Pool in a statement Tuesday. This would let generic drug companies manufacture the pill for use in 95 countries. According to the Associated Press, that makes the pill available to around 53 percent of the world’s population.

Some large countries that have endured COVID outbreaks are excluded, such as Brazil. A Brazilian drug company could receive a license to make the pill for export to other countries, but it could not be made generically to use in Brazil.

Health officials said that because the deal was struck before Pfizer‘s pill has even been authorized anywhere, it could help to end the pandemic faster.

“It’s quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than 4 billion people,” said Esteban Burrone, head of policy at the Medicines Patent Pool.

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Burrone estimates other drugmakers will be able to start making the pill within months, but he accepts the agreement wouldn’t satisfy everyone.

“We try to strike a very delicate balance between the interests of the (company), the sustainability required by generic producers and most importantly, the public health needs in lower and middle-income countries,” he said.

Pfizer stated that the COVID-19 pill decreased the risk of hospitalization by nearly 90 percent in people with mild to moderate COVID infections earlier this month. Independent experts recommended stopping the study because of the promising results.

For more reporting from the Associated Press, see below.

In a statement on November 16, 2021, drugmaker Pfizer Inc. said it has signed a deal with a U.N.-backed group to allow other manufacturers to make its experimental coronavirus antiviral pill, and would waive royalties on low-income countries and countries covered by the agreement. Above, the Pfizer logo is displayed at the company’s headquarters in New York on February 5, 2021.
Mark Lennihan/AP Photo, File

Pfizer said it would ask the U.S. Food and Drug Administration and other regulators to authorize the pill as soon as possible.

Since the pandemic erupted last year, researchers worldwide have raced to develop a pill to treat COVID-19 that can be taken at home easily to ease symptoms, speed recovery and keep people out of the hospital. At the moment, most COVID-19 treatments must be delivered intravenously or by injection.

Britain authorized Merck’s COVID-19 pill earlier this month, and it is pending approval elsewhere. In a similar deal with the Medicines Patent Pool announced in October, Merck agreed to let other drugmakers make its COVID-19 pill, molnupiravir, available in 105 poorer countries.

Doctors Without Borders said it was “disheartened” that the Pfizer deal does not make the drug available to the entire world, noting that the agreement announced November 16 also excludes countries including China, Argentina and Thailand.

“The world knows by now that access to COVID-19 medical tools needs to be guaranteed for everyone, everywhere, if we really want to control this pandemic,” said Yuanqiong Hu, a senior legal policy adviser at Doctors Without Borders.

The decisions by Pfizer and Merck to share their COVID-19 drug patents stand in stark contrast to the refusal of Pfizer and other vaccine-makers to release their vaccine recipes for wider production. A hub set up by the World Health Organization in South Africa intended to share messenger RNA vaccine recipes and technologies has not enticed a single pharmaceutical to join.

Fewer than 1% of Pfizer’s COVID-19 shots have gone to poorer countries.

Robbie Silverman of Oxfam America welcomed Pfizer’s agreement to let other makers produce its COVID antiviral pill, but he noted that billions would still be left without access, including to the company’s vaccine.

“This move also begs the important question: If Pfizer can share data and intellectual property on a medicine, why have they so far categorically refused to do so for their COVID vaccine?” Silverman said.

Pfizer, COVID-19 Pill, Agreement
Nathan Chavis, 6, gets a Pfizer COVID-19 vaccination from Noah Raaum at a Park County Health Department Pfizer vaccination clinic for kids at the fairgrounds on November 14, 2021 in Livingston, Montana. Pfizer Inc. signed an agreement with a U.N.-backed group to allow generic drug companies to make its COVID-19 pill, as well as waive royalties for sales in low-income countries and countries covered by the agreement.
William Campbell/Getty Images

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