'Far From Enough': Pfizer's Covid Drug License Excludes Almost Half of the Global Population

While many observers called Pfizer's new licensing agreement allowing generic drug manufacturers to produce its promising Covid-19 treatment a welcome step, public health experts also condemned the deal for shutting out nearly half of the world's population--and asked why the pharmaceutical giant remains unwilling to share vaccine know-how and technology.

"Billions of people will still be left without as the deal excludes many developing countries."

A recent interim study found that Paxlovid, Pfizer's potential Covid-19 oral antiviral treatment, reduced the risk of hospitalization or death by 89% in non-hospitalized high-risk adults with Covid-19. The pharmaceutical company on Tuesday asked the U.S. Food and Drug Administration to authorize the pill, which it has already started manufacturing, as soon as possible.

While Paxlovid--which combines candidate PF-07321332 and ritonavir, a U.S. taxpayer-funded antiretroviral drug--is awaiting comprehensive data analysis, regulatory review, and World Health Organization guidance, Pfizer also announced Tuesday that it would grant a royalty-free license for the pill to the United Nations-backed Medicines Patent Pool.

Although the move "would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world's population," the Associated Pressreported, it "excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a Brazilian drug company could get a license to make the pill for export to other countries, the medicine could not be made generically for use in Brazil."

In response, Robbie Silverman, People's Vaccine Alliance spokesperson and Oxfam America's senior advocacy adviser, said that Pfizer's licensing decision "is welcome but is far from enough."

"It means billions of people in developing countries will be able to access the treatment through generic production," Silverman noted in a statement, "but billions of people will still be left without as the deal excludes many developing countrieslike Iraq and Lebanon."

Yuanqiong Hu, senior legal policy adviser at Medecins Sans Frontieres' (MSF) Access Campaign, said in a statement that Pfizer's patent pool offer "again shows how voluntary licenses come up short and do not harness the full capacity available globally for sufficient and sustainable production and supply of lifesaving medical tools for all. Many upper-middle-income countries, such as Argentina, Brazil, China, Malaysia, and Thailand, where established generic production capacity exists, are excluded from the license territory."

MSF--also known as Doctors Without Borders-- is "disheartened to see yet another restrictive voluntary license during this pandemic while cases continue to rise in many countries around the world," said Hu. "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."

More than 5.1 million people and counting have died from Covid-19, including over four million since India and South Africa first introduced their widely supported motion to temporarily waive the World Trade Organization's (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Suspending coronavirus-related patent protections for the duration of the pandemic would enable qualified factories to boost the artificially limited global supply of tests, treatments, and vaccines, but Big Pharma and a handful of rich nations have stonewalled the proposal.

Just 4.6% of people living in low-income nations have received at least one dose of the Covid-19 vaccine, compared with nearly 73% in high-income countries, according to the latest figures from Our World in Data. Earlier this week, public health experts issued fresh warnings that the longer this glaring inequality persists, the higher the chances that a vaccine-resistant variant will emerge, endangering millions of lives and livelihoods around the globe.

Given the ongoing gap in vaccination rates between rich and poor countries, which health justice advocates have dubbed "vaccine apartheid," MSF said Tuesday that "oral drugs that can be produced easily and more affordably as generics and supplied by as many as possible producers, together with the rollout of Covid-19 diagnostic testing, could lower the number of severe cases of the disease and reduce the intense burden on health systems."

However, the organization added, "licensing deals by pharmaceutical corporations that create uncertainties and segmentation for generic production and supply continue to be part of the problem rather than part of a real solution."

"Equitable access to new treatments and other Covid-19 medical tools," Hu stressed, "will only be possible if these are priced close to the cost of production and supplied in sufficient quantities."

Pfizer has yet to disclose prices for Paxlovid but is expected to charge similar amounts as its rival, Merck, which has also developed a Covid-19 oral antiviral treatment.

In early October, Merck announced that it would charge high-income countries more than $700 per patient for molnupiravir, a 4,000% markup on the U.S. taxpayer-funded pill that costs just $17.74 to produce. Almost immediately, rich nations rushed to buy up supplies of the drug, provoking fears of an imminent "therapeutics nationalism" akin to the "vaccine nationalism" that has resulted in wealthy countries hoarding--and wasting--lifesaving doses.

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Late last month, Merck negotiated a similar deal with the Medicines Patent Pool to allow generic drug manufacturers to produce its pill for use in 105 countries--a move that was, like Pfizer's new agreement, simultaneously welcomed and critiqued as inadequate in the face of a devastating global public health emergency that demands universal access.

Pfizer, meanwhile, is "expected to apply a 'tiered pricing' strategy based on the income level of each country," according to MSF, which criticized such an approach for letting corporations retain the power to make unilateral calls on matters of life-and-death.

"Relying on the voluntary actions of pharmaceutical companies alone will not secure urgently needed access to tests, medicines, and vaccines for everyone, everywhere."

"We know from experience," said Hu, that "a tiered-pricing strategy... is unnecessarily complex, keeps the decision-making power entirely in the hands of the pharmaceutical corporations, and results in higher prices in many countries."

"We have witnessed Pfizer's continued resistance to share its Covid-19 mRNA vaccine technology broadly, and are now seeing Pfizer taking very limited action on therapeutics," Hu continued. "If Pfizer really wants to live up to its promise to contribute to equitable access to this new treatment, it should clearly state that [it] will not stand in the way of open generic production and competition," and it should "lift any kind of intellectual property monopoly during this pandemic."

In addition, "Pfizer should also refrain from seeking any new monopolies on ritonavir, either solely or in combination with the other compound," said Hu. The drug, which has been off patent since last year, "remains an important part of some antiretroviral regimens for people living with HIV."

"It is extremely important that governments continue to use all means, including refusing to grant any patents on this treatment, and the adoption of the 'TRIPS Waiver' at the upcoming WTO Ministerial Conference at the end of November," Hu added, "to ensure that there are no restrictions on generic production of this and other Covid-19 treatments anywhere, in order to ensure true global access and save as many lives as possible."

Oxfam's Silverman, for his part, emphasized that despite all of its shortcomings, Pfizer's voluntary licensing agreement "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?"

"Perhaps the answer," he said, "is in the profit they continue to reap thanks to their monopoly, hundreds of dollars every single second."

Pfizer has raked in billions of dollars in profits thanks to corporate-friendly intellectual property rules at the WTO, which allow Big Pharma to monopolize publicly funded knowledge and technology. While rejecting demands to share its vaccine recipe with other drug manufacturers to ramp up global production, the company has sold nearly two billion doses almost exclusively to wealthy nations, with less than 1% of its jabs going to impoverished countries.

According to Silverman, Tuesday's licensing agreement "shows that Pfizer is feeling the pressure from global campaigners. But it is clear that relying on the voluntary actions of pharmaceutical companies alone will not secure urgently needed access to tests, medicines, and vaccines for everyone, everywhere. Only concerted action by governments to force them to share technology, know-how, and intellectual property will achieve this."

"All governments must move to immediately support the proposal of South Africa and India at the World Trade Organization for a temporary waiver on all Covid-19 medical technologies," Silverman added, "and they must also insist on the mandatory transfer of vaccine technology to the many competent manufacturers all over the developing world who stand ready to produce the vaccines."