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Pfizer reaches deal to allow generic versions its COVID pill

Pharmaceutical giant Pfizer has signed a deal enabling the production and supply of its experimental COVID anti-viral drug in dozens of lower- and middle-income countries.

The agreement between the US company and the UN-backed international public health group Medical Patent Pool (MPP) would allow producers to manufacture and supply generic versions of the drug in 95 countries without the threat of patent infringement.

Most of the countries included in the deal are in Africa and Asia, covering about 53 percent of the world’s population.

“Pfizer remains committed to bringing forth scientific breakthroughs to help end this pandemic for all people,” Albert Bourla, Pfizer’s chief executive, said on Tuesday.

“We believe oral antiviral treatments can play a vital role in reducing the severity of COVID-19 infections, decreasing the strain on our healthcare systems and saving lives,” he added.

Later on Tuesday, Pfizer asked regulators in the United States to grant its pill emergency use authorisation.

The company has said its late-stage trials showed the pill cut the chance of hospitalisation or death for adults at risk of severe disease by 89 percent. The trials evaluated data from 1,219 positive cases across North and South America, Europe, Africa, and Asia.

The drug has shown to be most effective if taken at an early stage of the infections and is given in combination with an older antiviral called ritonavir.

Bourla told the news agency Reuters in early November that for low-income countries, the company was considering several pricing options, with the goal of “no barrier for them as well to have access”.

Medical charity Doctors Without Borders (Medecins Sans Frontieres, or MSF) said it was “disheartened” by the deal, noting that a number of countries including Brazil, Argentina, China and Thailand were excluded from the agreement.

“We are disheartened to see yet another restrictive voluntary licence during this pandemic while cases continue to rise in many countries around the world,” said Yuanqiong Hu, a senior legal policy adviser with MSF Access Campaign.

“If Pfizer really wants to live up to its promise to contribute to equitable access to this new treatment, it should clearly state that they will not stand in the way of open generic production and competition, instead of signing restrictive voluntary licences, and lift any kind of intellectual property monopoly during this pandemic,” she said.

Regina Osih, a medical doctor and infectious diseases specialist at the Aurum Institute in Johannesburg, South Africa, said the deal was “very important”.

“These kind of deals enable everybody to potentially access COVID medicament – they are still going to exclude someone, but they will improve the conversation around equitable access,” she said.

Pfizer’s move came after the US pharmaceutical company Merck signed a similar royalty-free deal with the MPP last month to allow its anti-viral drug, molnupiravir, to be made and sold at low costs in 105 developing countries. Merck’s drug was approved by regulators in the UK earlier this month.

The moves by Pfizer and Merck to share the patents for their COVID-19 drugs came amid international pressure on pharmaceutical companies to share and transfer technologies to allow the production of generic versions of their COVID-19 vaccines. So far vaccine makers, Pfizer included, have refused to do so.

Critics have long argued that the reluctance to share vaccine recipes has contributed to the starkly uneven distribution of shots between rich and poor countries.

Of the 7.54 billion doses of jabs that have been administered globally, only 4.6 percent of people in low-income countries have received at least one shot, according to Our World in Data.

“Imagine what would have happened if they (vaccines makers) would have licensed their technology in May 2020,” said Ellen ‘t Hoen, director of Medicines Law & Policy, referring to the date the World Health Organization launched the Technology Access Pool (C-TAP) platform for companies to share vaccines’ intellectual property and know-how.

“Then, we would have enabled production capacity even in areas where today it does not exist,” she said.




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