GENEVA/NEW YORK, NOVEMBER 16, 2021—Pfizer and the Medicines Patent Pool announced a deal today that would allow other companies to produce Pfizer’s COVID-19 treatment worldwide. The deal, however, only covers 53 percent of the world's population and excludes people in several upper-middle-income countries, leaving this promising medicine out of reach for millions, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).
Pfizer’s COVID-19 oral antiviral investigational candidate PF-07321332, used in combination with ritonavir, Paxlovid, is considered a promising treatment, pending regulatory review, World Health Organization guidance, and full data analysis.
Pfizer has yet to disclose a price for this treatment but has mentioned pricing similar to Merck’s pricing for the COVID-19 treatment molnupiravir, at around $700 per treatment course in high-income countries. For low- and middle-income countries, Pfizer is expected to apply a “tiered pricing” strategy based on the income level of each country.
As the pandemic continues and global vaccine access remains woefully inadequate, oral drugs that can be produced easily and more affordably as generics by more producers around the world could lower the number of severe cases of the disease and reduce the burden on health systems. However, licensing deals by pharmaceutical corporations don’t allow enough generic production.
There is no patent yet on the experimental candidate PF-07321332, and ritonavir has been off patent since last year. In the absence of patents on both compounds, able manufacturers—particularly those based in countries excluded from this license—have an opportunity to explore generic production directly. The possible evolving patent landscape shows the urgency for countries to adopt the TRIPS waiver for COVID-19 and use all legal options to remove barriers and uncertainties hindering uninterrupted generic production.
Yuanqiong Hu, senior legal policy advisor for MSF’s Access Campaign, said of the announcement:
“We are disheartened to see yet another restrictive voluntary license during this pandemic while cases continue to rise in many countries around the world. 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.
“Pfizer’s license with the Medicines Patent Pool for its potential oral antiviral treatment offers supply to 95 countries by generic companies that take up the license, covering about 53 percent of the world’s population. This 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.
“As the pandemic has already rattled the public health infrastructure of most low- and middle-income countries, and resources of health ministries are stretched to the maximum, equitable access to new treatments and other COVID-19 medical tools will only be possible if these are priced close to the cost of production and supplied in sufficient quantities. Pfizer is currently talking about a tiered-pricing strategy, which we know from experience is unnecessarily complex, keeps the decision-making power entirely in the hands of 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. 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 licenses, and lift any kind of intellectual property monopoly during this pandemic. Pfizer should also refrain from seeking any new monopolies on ritonavir, either solely or in combination with the other compound, as the drug 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—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.”