March 16, 2022
Albert Bourla
Chairman and Chief Executive Officer Pfizer
235 E 42nd St
New York, NY 10017
Re: Equitable access nirmatrelvir + ritonavir
Dear Mr. Bourla,
We are writing to call on you to accelerate access to nirmatrelvir + ritonavir in low- and middle-income countries, following your inadequate response[1] to three requests from civil society on January 24, 2022, in a letter to you from Public Citizen.[2] We raise additional points on the need for access to your product for clinical trials and access to appropriate combination therapies.
First, you have refused to publicly announce an allocation of any quantity of nirmatrelvir + ritonavir for sale and distribution to the public and private sector in low- and middle-income countries (including upper-middle income countries (LMICs), although a Global Fund official reports that you have decided to allocate only 10 million doses and then only if adequate procurement funds can be raised.[3] 10 million doses is grossly inadequate given that 50% of the world’s population with a higher risk of severe disease and hospitalization based on age and underlying health condition – and thus eligible for priority access to nirmatrelvir + ritonavir – live in LMICs. If the highest risk patient group is expanded to cover those who are unvaccinated, as with the WHO living guidance on molnupiravir, the proportionate need in LMICs is much higher, as it might be if nirmatrelvir + ritonavir is proven to have important clinical benefits even for other populations. You have promised this meager quantity despite the fact that generic versions may not be available in many countries until 2023 or even later. In light of the above, we call on you to immediately increase your allocation for sales to LMICs to meet the two-thirds minimum already demanded by civil society.
Second, you have not indicated any concrete steps you would take to accelerate generic entry of nirmatrelvir + ritonavir. In addition to the previous requests focusing on technical and regulatory data access for Medicines Patent Pool (MPP) licensees, we demand that Pfizer go further. One pressing issue that has come to our attention is the failure of Pfizer to provide or sell reference nirmatrelvir + ritonavir to potential generic producers so that they can undertake bioequivalence studies mandated by national regulatory authorities globally and by the WHO Prequalification Program. We believe that you should provide reference supplies on a cost-plus, not-for-profit basis to all potential generic producers whether or not they are MPP licensees. You should do so either by selling Paxlovid directly to such producers or by cooperating with a commercial or non-commercial entity that is so authorized. The failure of Pfizer to immediately agree to supply reference Paxlovid will inevitably delay generic entry costing lives and livelihoods as a result.
Third, you have not responded to the demand to expand the geographic scope of your MPP license. At this point, the imperatives of accelerating and expanding generic supply, lowering costs, and ensuring equitable distribution are so great that Pfizer should formally agree not to enforce its patent, data protection, patent-registration linkage, and confidential information/know-how rights in all LMICs. Alternatively, it should directly modify its licensing agreement with the MPP to include all LMICs in the licensed territory.
Fourth, Pfizer should agree to provide nirmatrelvir + ritonavir to investigators conducting clinical trials and implementation studies including its use in combination with other anti-covid therapies. This is critical as new therapies are being studied, released, and approved, and understanding the impact of combination therapy is imperative appropriate clinical guidance. It is also important for researchers to investigate combination antiviral regimens in particular, given risks of drug resistance. Pfizer should donate nirmatrelvir + ritonavir for the purpose of such studies or supply it on a not-for-profit basis.
Relatedly, Pfizer should remove the restriction in its MPP license agreement (para. 2.3) that requires prior approval by Pfizer before MPP licensees can co-formulate or co-package nirmatrelvir + ritonavir or its components with any other “substance, products, intermediate and/or active pharmaceutical ingredient.” Although it would be reasonable to condition marketing of any such co-formulated or co-packaged product upon that product being included in clinical guidance and having received regulatory approval equivalent to that required elsewhere in the MPP license, Pfizer should not stand in the way of such products that might have complementary or additional methods of action and thus favorably impact clinical outcomes and/or reduce the risk of drug resistance.
Pfizer is poised to make $22 billion in sales of Paxlovid in 2022,[4] mostly to rich countries that have purchased nearly all of the first half-year supply of Paxlovid in 2022. Such pandemic profiteering is unwarranted at any time, but particularly in the midst of a global pandemic where the inequitable supply of vaccines already has produced more death and suffering and exposed the entire world to threatening cycles of new variants. Pfizer can and must do better.
Very truly yours,
Access to Medicines Ireland
ACT Alliance
ACT UP Philadelphia
Action Against NCDs in Eswatini
African Alliance
Alliance for Public Health
American Friends Service Committee
Amnesty International
Arms to Lean On (ATLO)
Association of Women of Southern Europe (AFEM)
AVAC
Blossom Trust
Catholic Relief Services
Coalition for Health Promotion and Social Development (HEPS Uganda)
Commission on the Public’s Health System
Community Economic Empowerment and Legal Support
Consolation East Africa
Dandora Community AIDS Support Association
DARE Organization, Tanzania
Decisive Minds
Dynamic Initiative for Healthcare and Human Rights
End AIDS Now
Foundation for Integrative AIDS Research (FIAR)
Frontline AIDS
Fundación Misión Salud
Gift of Hope Foundation
Global Humanitarian Progress, GHP Corp. Colombia
Global Justice Now
Global Women’s Health, Rights, and Empowerment Initiative (GWHREI)
Good Health Community Programmes
Health Global Access Project (Health GAP)
HelpAge International
Hope Alive Health Awareness Initiative
Hope for Change Initiative
Housing Works, Inc.
IFARMA Foundation, Colombia
Indonesia AIDS Coalition
Initiative for Medicines, Access, & Knowledge (I-MAK)
Initiative for Gender Equality Health and Rights (GEHAR)
IPLeft
John Snow, Inc.
Just Treatment
Justice is Global
Kamukunji Paralegal Trust (KAPLET)
Kenya Treatment Access Movement (KETAM)
Kisumu Sex Workers Alliance
Kotagiri Womens Welfare Trust
Kuboresha-Africa
Libai
Life and Hope Rehabilitation Organisation (LHRO)
Life Building Awareness Initiative (LIBAI)
Loving Sister’s CBO
Men for Positive Living Support Community Based Organizations
Metro New York Health Care for All
MSF Access Campaign
NACOPHA
Nairobi Recyclers
National Network for Long COVID Justice
Network Lobby for Catholic Social Justice
New York Trade Justice Coalition
Organisation for Health in Sustainable Development (OHISD)
Oxfam
Partners In Health
People’s Vaccine Alliance (PVA)
Prevention Access Campaign
Public Citizen
Public Eye, Switzerland
Quality Access to Health and Rights
Resource Link Foundation
Rethink Trade
Right to Health Action
Rural Youth Peace and Care Foundation
Salud por Derecho
Section27, South Africa
Sisters Against HIV and Cancer Initiative
Smart Ladies Migori
Solidarity & Healthcare Initiative for Gender Diversity
STOPAIDS
Strategies for High Impact
Strong Women Organization
Tabora House of Empowerment
Tansana Health And Community Integrated Development Initiative (THACIDI)
Tanzania Community Health Information and Support (TaCHIS)
Tanzania Informal Economy Network on AIDS Initiatives (TIENAI)
Tanzania Youths Behavioral Change Organization (TAYOBECO)
The Alliance for Health and Rights Initiative
Third World Network
Treatment Action Group
Universities Allied for Essential Medicines (UAEM)
WACHA Health Mombasa
WACI Health
War on Want
WEKESWA
Women’s Health in Women’s Hands CHC
Wote Youth Development Projects
Youth Wings
[1] https://www.citizen.org/wp-content/uploads/Pfizer-Response-Public-Citizen_01-31-22.pdf.
[2] https://www.citizen.org/wp-content/uploads/Public-Citizen-Paxlovid-letter-to-Pfizer.pdf (“Pfizer can step up in three ways. First, it can set aside at least two-thirds of its 2022 supply for developing countries at a reasonable price, and make transparent its allocation criteria, pricing, and delivery schedules. Second, it can accelerate the entry of generic manufacturers licensed under the Medicines Patent Pool by providing deeper technical assistance and sharing regulatory information. Third, it can expand the scope of the Medicines Patent Pool license to allow the generic producers to supply more countries.”)
[3] https://www.reuters.com/world/pfizer-provide-10-mln-courses-covid-pill-developing-countries-the-global-fund-2022-03-02/.
[4] Rachel Arthur, Pfizer predicts $54bn in 2022 revenue from Comirnaty and Paxlovid (Feb. 8, 2022) ($32bn for Cominaty and $22bn for Paxlovid), https://www.biopharma-reporter.com/Article/2022/02/08/Pfizer-predicts-54bn-in-2022-sales-from-Comirnaty-and-Paxlovid