Behind Pfizer's new not-for-profit deal on patented vaccines and drugs

Pharmaceutical giant Pfizer has committed to provide its patented medicines and vaccines, already available in the United States and Europe, at a not-for-profit price to 45 lower-income countries — a move that may help allay criticism that it hasn’t done enough to expand access to lifesaving medicines, though some say it's '’too little too late.”

The deal — announced during the World Economic Forum annual meeting in Davos, Switzerland — includes 23 medicines and vaccines for infectious disease, some cancers, and rare and inflammatory diseases, as well as future products. It could benefit 1.2 billion people, Pfizer said.

Rwanda, Ghana, Malawi, Senegal, and Uganda are the first of 27 low-income and 18 lower-middle-income nations in Africa, the Middle East, and Asia that are included in the deal, Pfizer said.

“This is the most comprehensive offering that we know of that has been made for medicines across multiple therapeutic areas,” Caroline Roan, senior vice president of global health and social impact at Pfizer, told Devex.

The deal also includes the provision of Paxlovid, the company’s oral antiviral treatment for COVID-19.

Country bottlenecks

The initiative goes beyond the supply of medicines, said Pfizer CEO Albert Bourla, emphasizing that it will be coupled with improvements in diagnostics capacity and distribution infrastructure, such as storage, to improve access. The accord includes technical assistance in training health workers, and Pfizer plans to work with countries to expedite regulatory processes for entry of the new medicines.

The company also intends to work with the Bill & Melinda Gates Foundation to develop vaccine candidates for group B streptococcus, a leading killer of newborns in low-income countries, as well as a potential vaccine for respiratory syncytial virus, which would be given to pregnant mothers.

Bill Gates, a co-chair of the foundation, said that through this move, Pfizer is “setting an example for other companies to follow.”

Pfizer has already reached agreement with Rwanda, and the remaining countries in the initial group of five are close to signing, Roan said. Other nations can also join, but given the complicated nature of delivering medicines, Pfizer aims to address bottlenecks in those five countries first as a model.

“As we work with those countries to address those barriers, those learnings then will be adopted and used as we go into implementation,” Roan said. “We don't want to just give the product and then not have it prescribed, not have it used by the patient.”

About two to three years will likely be spent on removing barriers to medicine delivery in those five countries before lessons can be shared, she said.

Many of the deal’s 23 drugs and vaccines are not yet registered in lower-income countries, Roan said.

“Part of this agreement with the governments is that they will do their part to take our dossiers and to make an expedited pathway for approval,” she said.

Conversations with governments suggest that Paxlovid and Zavicefta, an antibiotic, are in demand, in addition to other drugs and vaccines that target infectious diseases, Roan said, adding that there is also interest in the company’s oncology portfolio.

Access to Paxlovid

The World Health Organization has described Paxlovid as the “best therapeutic choice for high-risk patients to date.” Upon issuing a recommendation for the drug in April, WHO said that availability and a lack of transparency around pricing are barriers to access.

Pfizer has a licensing deal with the Medicines Patent Pool that allows a generic version of the drug to be produced and sold in 95 low- and middle-income countries, but widespread production will require more time. The Clinton Health Access Initiative also launched an initiative earlier this month to make generics available at $25 per course.

Last week, the Global Fund to Fight AIDS, Tuberculosis and Malaria said it signed a letter of intent with Pfizer for 6 million treatment courses of Paxlovid. Pfizer also has an agreement with UNICEF for 4 million courses. The company expects to produce up to 120 million courses of treatment this year.

“We actually are ready to ship Paxlovid and have been ready to ship Paxlovid once the regulatory process of WHO approved it,” Roan said. The issue right now is that WHO doesn’t have an allocation framework in place, she said, adding that Pfizer has worked to improve transparency and that countries can access pricing figures through the Global Fund.

Is it enough?

Limited information around Pfizer’s announcement is available, so assessing its impact is difficult, according to Mihir Mankad, a senior adviser for global health advocacy and policy at Médecins Sans Frontières.

Pfizer has been criticized for not doing enough to expand countries’ access to COVID-19 vaccines and drugs throughout the pandemic.

“Certainly it's not anything transformative of the sort that we're otherwise looking for — like, for example, the TRIPS waiver,” Mankad told Devex, referring to a proposal at the World Trade Organization to temporarily waive patent protections on COVID-19 vaccines. “We shouldn't be relying on what's effectively a charitable gesture on the part of the private sector to ensure that people have access to essential, lifesaving medical tools.”

Pfizer opposes the waiver to the Agreement on Trade-Related Aspects of Intellectual Property Rights — which, according to advocates, is already a watered-down version of the original proposal.

“Weakening intellectual property rules will not solve any of these challenges. What it will do is undermine the will and means for the kind of innovations needed to continue to effectively respond to the current and future pandemics,” a Pfizer spokesperson said.

Those on the United Nations’ list of so-called least developed countries don’t need to enforce patents under an exclusion that currently exists in the TRIPS Agreement, according to Melissa Barber, a doctoral candidate in population health sciences at the Harvard T.H. Chan School of Public Health.

The majority of countries on Pfizer’s list for its accord are also on the U.N. list, except for Kenya, Ghana, Kyrgyzstan, North Korea, Syria, Tajikistan, and Zimbabwe. A company in Bangladesh is already producing a generic version of Paxlovid for this very reason.

If Pfizer provides these countries with drugs, that could disincentivize generics manufacturers from moving into these countries over the long term, Barber told Devex. She added that it could also lead to “monosource procurement,” in which a country depends on a single source as a supplier — which can create problems for health security.

“There is a big push in global health — now more than ever, with the supply chain issues experienced in COVID-19 — to push for best practices in procurement, which is multisource procurement to ensure stability and competition,” she said.

Mankad said that generics companies sometimes won’t step in when markets for the drugs are too small. In these cases, there is an opportunity for least developed countries to gain access to the drugs via Pfizer’s portfolio.

The People’s Vaccine Alliance, a coalition that campaigns for equitable access to COVID-19 vaccines, described the announcement as “too little too late.”

“After prioritising selling higher priced doses to rich countries throughout the pandemic while millions died without access to COVID-19 vaccines and treatments, Albert Bourla seems keen to improve Pfizer’s reputation. But taking half-measures on equity won’t cut it,” wrote Julia Kosgei, a policy adviser to the People’s Vaccine Alliance, in a press statement.

Pfizer’s announcement makes it a gatekeeper for who can and can’t manufacture its products, and it leaves out many lower-middle- and middle-income countries that will “pay through the nose” for lifesaving drugs, she said.