MSF responds to FDA approval of COVID-19 treatment nirmatrelvir/ritonavir

22 December 2021– The US Food and Drug Administration (FDA) today gave emergency use authorisation (EUA) for the oral antiviral candidate nirmatrelvir (PF-07321332) in combination with ritonavir, produced by the US pharmaceutical corporation Pfizer, for the early treatment of people with mild to moderate COVID-19 who are at increased risk of developing severe disease. With vaccination rates lagging behind in many parts of the world, people are left unprotected against COVID-19 and access to recommended, easy-to-administer medicines is critical. However, as with COVID-19 vaccines, high-income countries are tying up the available supply of nirmatrelvir/ritonavir through advance purchase agreements with Pfizer and leaving limited-to-no supply available in the near-term for low- and middle-income countries. As generic production of nirmatrelvir/ritonavir is only anticipated by the middle of next year, access for low- and middle-income countries is precarious.

Pricing is also expected to be a barrier to access. Pfizer, the only manufacturer currently producing this treatment, has still not disclosed a price for the antiviral though many countries continue to grapple with rising COVID-19 cases. The only indication of potential pricing of the medicine comes from a recently announced agreementwith the US government for the purchase of 10 million treatment courses for US$5.29 billion – which amounts to around $529 per treatment course, an exorbitant price.

While Pfizer is expected to apply a ‘tiered pricing’strategy for supplying low- and middle-income countries, this market segmentation could result in limited access for many middle-income countries. These same countries may also be excluded from an existing voluntary license, thus facing eventual patent barriers that block the entrance of more affordable generics. MSF highlighted this limitation in response to the recently announcedvoluntary license between Pfizer and the UN-backed Medicines Patent Pool on  nirmatrelvir/ritonavir, which offers supply to only 95 countries by generic companies that take up the license, covering just 53% of the world’s population and excluding many upper middle-income countries with manufacturing capacity, such as Argentina, Brazil, China, Malaysia and Thailand.

As there is no patent yet on nirmatrelvir and as ritonavir has been off patent since last year*, there is currently a window of opportunity for manufacturers, particularly in the countries excluded from the voluntary license, to establish generic production and supply domestically. Governments should reject patent applications on this life-saving medicine and use all possible measures to remove obstacles, including the use of compulsory licensing, to ensure no barriers for generic production globally. Generic companies in countries like Bangladeshand Indiaare already developing generic versions of this drug, and other countries should follow suit. 

Mihir Mankad, Senior Global Health Advocacy and Policy Advisor at MSF-USA:

“To tackle the global COVID-19 pandemic, there needs to be global access to COVID-19 medicines such as the now-FDA-approved antiviral treatment,  nirmatrelvir/ritonavir, produced by Pfizer. 

“Many low- and middle-income countries, including those in which MSF works, are grappling with overburdened healthcare systems and low rates of COVID-19 vaccination due to extreme inequity in global vaccine access and challenges to implement vaccination and potentially vaccine-evasive and/or more transmissible variants such as currently feared for Omicron. Easy-to-administer oral treatments could ease the burden on overwhelmed hospitals and other essential healthcare services, save lives, and serve as a key tool for health workers trying to manage this pandemic. 

“We are deeply concerned by Pfizer’s business-as-usual approach and rich countries’ repeated hoarding of limited supplies, which may leave low- and middle-income countries with virtually no access to this treatment for at least the first half of 2022. Governments in low- and middle-income countries need to be in the driver’s seat instead of companies, and should take immediate steps to ensure sufficient, timely and equitable access to  nirmatrelvir/ritonavir. The global health priority must be to increase the supply of affordable treatments for all people in all countries—including by allowing the production and supply of lifesaving, affordable generic medicines for everyone who needs them.  

“With patent applications still pending, countries should stand firm and refuse to grant any patents on  nirmatrelvir/ritonavir, while generic companies should start preparing to produce the medicine without waiting for Pfizer's permission. If Pfizer is really interested in ensuring global access to this treatment, it should make clear that it will not stand in the way of generic production and competition anywhere, and refrain from imposing intellectual property barriers everywhere for the duration of pandemic.

“One additional way to ensure that everyone in need everywhere has access to COVID-19 therapeutics is for all governments to support the “TRIPS Waiver” proposed by India and South Africa at the World Trade Organization, which seeks to allow countries to remove all major intellectual property barriers in an effort to enable and expand broad global production of lifesaving COVID-19 medical tools.”

 

* By filing one international patent application (PCT/IB2021/057281, titledNitrile-Containing Antiviral Compounds) under the Patent Cooperation Treaty(PCT), Pfizer can seek the equivalent patent on the drug nirmatrelvir (PF-07321332)in a large number of countries in the future. The PCT application filing date is August 2021 and the PCT timeline of 18 months for international publication will apply. Unless Pfizer requests early publication, this PCT application will be published in the first quarter of 2023 and will enter the national phase consisting of processing the application in the Patent Office of designated countries.  

In March 2020, the Ministry of Health of Israel issued a compulsory license on the HIV treatment drugs lopinavir and ritonavir to enable the generic supply as a potential repurposed treatment for COVID-19. In response to Israel’s issuance of a compulsory license, AbbVie announcedthat it will not enforce its patents ritonavir for any purpose anywhere in the world (a “non-assert declaration”) and has subsequently withdrawn some remaining secondary patents.

 

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Shailly Gupta

+41-79 203 13 02