GENEVA/NEW YORK, DECEMBER 22, 2021—The US Food and Drug Administration (FDA) today issued an emergency use authorization (EUA) for the first oral antiviral COVID treatment. The candidate, nirmatrelvir (PF-07321332), in combination with ritonavir, is produced by 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, millions of people are unprotected against COVID-19, and access to recommended, easy-to-administer medicines is critical. As with COVID-19 vaccines, however, high-income countries are tying up the available supply of nirmatrelvir/ritonavir through advance purchase agreements with Pfizer, leaving limited-to-no supply available for low- and middle-income countries. As generic production of nirmatrelvir/ritonavir is only anticipated by the middle of next year, immediate 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 not disclosed a price for the antiviral. The only indication of potential pricing of the medicine comes from a recently announced agreement with 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 announced voluntary 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 on nirmatrelvir, and ritonavir has been off patent since last year*, there is 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 Bangladesh and India are 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. Oral treatments could ease the burden on overwhelmed hospitals and other essential healthcare services and save lives. They have the potential to be a key tool for health workers trying to manage this pandemic, especially in light of the much more transmissible variant, omicron, now circulating widely.
We are deeply concerned by Pfizer’s business-as-usual approach and rich countries’ repeated hoarding of limited supplies. This 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. They 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. This includes 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. Generic companies should prepare 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.”