Pfizer agrees to allow generic versions of 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. Generic companies can start preparations for the product once they get a licence, but have to wait for the regulatory approval before they can supply it.

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 proven to be most effective if taken at an early stage of infection and in combination with an older antiviral called ritonavir.

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

Ellen ‘t Hoen, director of Medicines Law & Policy noted that the deal allows countries that are excluded from the list to ask generic companies to supply the product under a compulsory licence. “This is an important feature of the MPP’s license,” she said. Compulsory licensing is when governments allow to waive patents’ rights without the licence owner’s consent.

“With a small molecule like this – easy to make and probably already being developed by generics – a simple compulsory or voluntary licence is sufficient,” she said, noting that for vaccine production the process is more complex as companies need technology transfer on top of a licence.

“This is an important precedent, as Pfizer has not licensed any COVID-related technology so far. The hope now is that Pfizer will do its second step with the MPP by transferring technology to enable the production of its vaccine,” she added.

Regina Osih, a medical doctor and infectious diseases specialist at the Aurum Institute in Johannesburg, South Africa, agreed on the positive impact of the agreement.

“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.

Still, medical charity Doctors Without Borders (Medecins Sans Frontieres, or MSF) said it was “disheartened” by Pfizer’s announcement, noting that a number of countries including Argentina, Brazil, 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.

Pfizer’s move came after 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 cost 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, Pfizer has 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.

Only 4.6 percent of people in low-income countries have received at least one shot, according to Our World in Data. Globally, 7.54 billion doses have been administered.

“Imagine what would have happened if they (vaccines makers) would have licensed their technology in May 2020,” Hoen, 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.