Pfizer COVID-19 Treatment Licensing Deal with Medicines Patent Pool Excludes Almost 50% of the Globe Perpetuating Medical Apartheid
Nearly 100 health, development, and human rights organizations sent a letter today to Pfizer CEO Albert Bourla demanding immediate steps to increase access to COVID-19 antiviral medicines in low- and middle-income countries.
The letter demands Pfizer:
Publicly communicate a plan to allocate two-thirds of its supply of nirmatrelvir + ritonavir (Paxlovid) for sale and distribution in low- and middle-income countries where there is proportionate need.
Take concrete steps toward accelerating generic entry of nirmatrelvir + ritonavir by not only focusing on technical and regulatory data access for MPP licensees, but also by supplying Paxlovid as a reference product to non-licensee generic manufacturers.
Formally agree to not enforce patent, data protection, patent-registration linkage, and confidential information/know-how rights in all lower- and middle-income countries.
Provide nirmatrelvir + ritonavir to investigators conducting clinical trials and implementation studies including its use in combination with other anti-COVID therapies.
Remove the restriction in its Medicines Patent Pool license agreement requiring prior approval by Pfizer before MPP licensees can co-formulate or co-package nirmatrelvir + ritonavir or its components with any other substance or products, which would stand in the way of action that could impact clinical outcomes or reduce the risk of drug resistance.
The letter was signed by Amnesty International, Partners in Health, the American Friends Service Committee, Oxfam, Public Citizen, the African Alliance, Catholic Relief Services, Third World Network, Treatment Action Group, AVAC, Frontline AIDS, People’s Vaccine Alliance, Médecins Sans Frontières Access Campaign, Section27, WACI Health, and Salud por Derecho among dozens of other groups.
“Pfizer shamefully once again has prioritized rich countries for the distribution of treatments. Governments in Latin America must take urgent measures to ensure access for the people. Latin America must be included in generic production plans, including Pfizer’s license with the Medicines Patent Pool. Latin American governments should issue compulsory licenses to increase the availability of treatments,” said Luz Marina Umbasía, Global Humanitarian Progress, GHP Corp, Colombia. “These measures they will save lives and ease the social and economic burden on our countries. It is unjust that Pfizer gets rich while so many of our people die from lack of treatment.”
This week’s disappointing developments on WTO negotiations over intellectual property rights between the EU, India, the U.S. and South Africa, exclude treatments from any deals, focus only on patents (not any other IP barrier), and require drug by drug, patent by patent licenses.
“Albert Bourla should be ashamed,” said Asia Russell, Executive Director of Health GAP. “His deal with the MPP and reservation of highly limited quantities for people in low- and middle-income countries reveals how far his drive to profiteer will go. Geographic restrictions and restricted supplies should have no place in a deadly pandemic, where the race must be to protect as many people as possible, as quickly as possible, no matter where they live. The U.S.’s lack of willingness to spend political capital to support a waiver shows just how ensnared they are with Pfizer and other big pharma companies’ corporate interests.”
In addition, the Medicines Patent Pool (MPP) today announced sublicensing agreements with 35 generic companies that will be authorized to manufacture and distribute generic versions of nirmatrelvir + ritonavir (Paxlovid®) in 95 low-income, lower-middle income, and recently graduated upper-middle income countries. However, this announcement will do nothing to eliminate the monopoly Pfizer maintains over unlicensed countries – all high-income and almost all upper-middle income countries, representing 47% of the world’s population and historically experiencing the highest rates of COVID-19 infection.
Similarly, this announcement will do nothing to address the immediate need for affordable nirmatrelvir + ritonavir as an outpatient treatment in all low- and middle-income countries as newly authorized generic licensees will undertake protracted product development and regulatory approval challenges that will most likely delay market entry well into the future. At present Pfizer has preferentially sold all of its Paxlovid doses from the first half of 2022 to a handful of high-income countries and has tentatively promised to supply only 10 million courses of treatment to LMICs out of the 120 million courses of treatment to be manufactured in 2022.
“Pfizer, like Merck, wants to reap only praise for its outrageously flawed licensing agreement. Although eventual generic supply to 95 countries will help alleviate supply shortages and unaffordable pricing, Pfizer maintains its profit-driven stranglehold on more than 50% of the global population that could most benefit from early outpatient access to nirmatrelvir + ritonavir,” said Brook Baker, Senior Policy Analyst, Health GAP and Professor at Northeastern University School of Law. “And, there’s no mystery about Pfizer’s cold-hearted calculations – its CEO has reported expected sales of Paxlovid to top $22 billion in 2022, almost all of it profit.”
Countries and organizations around the world are responding to Pfizer’s reprehensible behaviors. Applications for compulsory licenses on nirmatrelvir + ritonavir have been filed previously in Chile and the Dominican Republic. Latin American activists have sent a joint letter to their governments demanding that they override Pfizer’s patents and issue compulsory licenses. DNDi has publicly raised its inability to secure Paxlovid samples to undertake studies of combination outpatient therapies in Africa.
“People in the Global South cannot bear the burden of treatment apartheid on top of the vaccine apartheid that Pfizer and other vaccine producers including Moderna have already engineered,” continued Russell. “Intellectual property barriers to nirmatrelvir + ritonavir must be removed immediately and everything possible to accelerate generic entry.”