Official response from ACT-Accelerator therapeutics partners to the IFPMA
This response was sent on 19 May 2022
Dear Mr Cueni,
We note your letter dated 9 May 2022 and are in agreement that our continued collaboration will be vital in supporting countries to introduce lifesaving COVID-19 therapeutics.
As partners in the Therapeutics Pillar, we are all committed to ensuring that vulnerable people everywhere can benefit from rapid access to effective COVID-19 therapeutics. We recognize the continued engagement of pharmaceutical partners with the ACT-A Therapeutics Pillar and their work on enabling development and commercialization of needed products, as well as, via voluntary license processes, supporting development of generic products. These are some of the critical steps on the pathway to ensuring we maximize the impact of emerging therapeutics. We remain hopeful that the pipeline will continue to advance the search for the most suitable pharmaceutical solutions to this fast-evolving pandemic as we work to resolve current roadblocks and support countries’ pandemic responses.
ACT-A partners (WHO, Unitaid, Global Fund, UNICEF, Wellcome) are committed to our ongoing collaboration with industry – but more is needed to achieve equitable access for all. We have engaged with originator companies that are developing and bringing to market various therapeutics, consistently calling for broad access principles that can enable a scaled-up response in countries in need.
We have discussed with the pharmaceutical partners the need to support affordable and transparent pricing policies. Early visibility on pricing terms and availability of originator products can support countries to adequately plan and forecast, simplify procurement processes and increase the speed of the response.
We also seek sustained product access via support to expanded generic production and access in all low- and middle-income countries. We have seen progress in both these areas, but we need more to achieve our shared objectives.
In each of the areas of equitable geographic access, affordable pricing, pricing transparency, and expanded generic production, we have experienced impediments which have slowed down deployment of these new products. We therefore continue to urge IFPMA and pharmaceutical companies to continue to collaborate with ACT-A partners on a pathway for equitable access for all low- and middle-income countries.
An overall approach to product allocation was developed in late 2021, communicated to countries in February 2022, and to date has been launched for three different products, including a preliminary allocation for nirmatrelvir-ritonavir. Product allocation processes are only used when needed, including when supply is insufficient to meet demand. They are based upon the product’s specific use case and, therefore, can only be issued following a WHO recommendation. A major operational challenge for countries to express clear demand for new products is transparency in geographic access and pricing information. A short description of the allocation approach is included in annex to this letter.
To ensure prompt and adequate uptake as products become ready for use, we are working to support country-level deployment. Building on the ongoing work to support early adoption with cross-pillar efforts (Unitaid/FIND country projects), ACT-A partners are mobilizing an additional US$120 million, as announced at the second Global COVID-19 Summit on May 12, for procurement and country-uptake of oral antivirals and diagnostics to prevent hospitalizations and deaths from COVID-19 for those at highest risk. Together with USAID, ACT-A partners will support more than 20 countries to support uptake of test-and-treat programs; efforts that can be reinforced if additional funding is made available.
Finally, we should recognize that countries and ACT-A partners are facing significant budget constraints and uncertainty which impedes deployment of these new products, in addition to the waning political attention to the pandemic and low diagnostic usage. Your support for ACT-A partners and work with manufacturers to expand equitable geographic access, affordable pricing, pricing transparency, and expanded generic production is appreciated and will support effective deployment of new therapeutics.
The ACT-A Therapeutics pillar’s priority remains to secure access, procure affordable products recommended by WHO guidelines, and support prompt and adequate deployment of these life-saving tools. We look forward to continuing to work together to achieve these objectives.
Yours sincerely,
Mr Philippe Duneton
Executive Director, Unitaid
Dr Mariângela Batista Galvão Simão
Assistant Director-General, World Health Organization
Mr Peter Sands
Executive Director, The Global Fund
Annex A: Overview of product allocation methodology and status
Based on principles of equity, transparency, and ethics, as in the vaccine allocation strategy, and recognizing the different context of therapeutic medicines, an approach for equitable allocation was developed in late 2021 for COVID-19 therapeutic products. The development of the approach was accelerated and communicated to countries in February 2022 in anticipation of the release of tocilizumab. The allocation rounds were launched in mid-February and the supply agreement was signed on 15 March 2022.
Therapeutics allocation is initiated through an interactive portal that is accessible by country stakeholders. The portal is secured for multiple reasons including data privacy for countries; however, final allocation plans are shared transparently with countries, procurement partners and the relevant manufacturers. Respective manufacturers work closely with the ACT-A teams to optimize deliveries to countries, facilitate regulatory processes and other technical and operational activities.
The process captures complex variables, including adjusted needs estimates that identify appropriate target groups per the WHO treatment guidelines. It automates estimates to avoid long exercises at country level and also uses prioritization criteria to enhance supplies or timing to countries that are the most vulnerable. A typical allocation process takes 2-4 weeks to allow sufficient response times for countries.
In situations where constraints exist, they are also taken into account to ensure the best possible stewardship of therapeutics products such as avoiding over-supply. Constraints vary and can include supply, finance or country capacity to deliver necessary services e.g., ICU capacity for medicines used for hospitalized patients. Allocation exercises require a minimum amount of information and are best launched when there is sufficient visibility to the country on the terms, timing and quantities available. Three different products have been launched via the Therapeutics Allocation Mechanism, including a preliminary allocation for nirmatrelvir-ritonavir where information remains pending.
Unitaid welcomes new agreements from CHAI to accelerate access to affordable COVID-19 antiviral nirmatrelvir/ritonavir in low- and middle-income countries
Geneva – Unitaid welcomes the Clinton Health Access Initiative (CHAI) announcement on agreements with leading generic manufacturers to make nirmatrelvir/ritonavir available to low- and middle-income countries (LMICs) at under US$25 per treatment course. The agreements also settle on production guarantee and allocation capacity for 4.5 million treatment courses per month for LMICs.
Pfizer’s oral COVID-19 treatment — a combination of nirmatrelvir and ritonavir tablets sold under the name Paxlovid — was strongly recommended by the World Health Organization (WHO) last month, based on evidence on prevention of hospitalization and death for mild-to-moderate COVID-19 patients at high risk of developing severe forms of the disease, when administered in early stages of the infection.
These agreements represent an important step in the global COVID-19 response, building on the groundwork Unitaid and partners of the Access to COVID-19 Tools (ACT) Accelerator’s therapeutics pillar have laid to ensure equitable, rapid and affordable access to new treatment options. Focused efforts are aimed at introducing those treatments in LMICs alongside adequate testing to realize the promise of test-and-treat strategies in decentralized settings.
The ACT-Accelerator therapeutics pillar has worked closely with the Medicines Patent Pool, originator and generic companies, to make nirmatrelvir/ritonavir accessible from both originator and generic companies, as access to originator product is essential to avoid delay in the uptake of this important treatment while generic manufacturers work towards WHO prequalification. The pillar is making sure all measures are taken to accelerate the generic pathway in order for a robust and functional generic market to provide a sustainable supply of quality-assured products at a lower price to LMICs as soon as possible.
But continuous support is needed to expand production of generic versions of medicines and ensure that systems are in place for these products to be promptly adopted by countries.
While uncertainties remain a challenge regarding the evolving epidemiology, predictability on potential generic prices and volumes, as announced by CHAI today, are key for planning and simplifying country adoption.
“These agreements are pivotal to ensure timely access to optimal treatment for those at high risk of developing severe or critical COVID-19 in low resource settings.”, Unitaid Executive Director Dr Philippe Duneton said. “Supporting countries in securing access for efficient emerging treatment options, as well as their deployment in the most effective way, is Unitaid and ACT-A therapeutics pillar partners’ priority.”
Media contact:
For more information and media requests:
Sarah Mascheroni
Communications officer
Email: mascheronisa@unitaid.who.int
Mobile: +41 79 728 73 11
Global Fund, United States and Unitaid Launch “Test-and-Treat” Programs at Second Global COVID-19 Summit
GENEVA, WASHINGTON – The Global Fund, the United States and Unitaid, together with FIND and other ACT-Accelerator partners, are launching over US$120 million in support to countries for test-and-treat programs to prevent hospitalizations and deaths from COVID-19 for those most at risk in low- and middle-income countries. The announcement was made at the Second Global COVID-19 Summit, which placed an emphasis on supporting locally led solutions to both immediate and long-term challenges, including the deployment of tests and treatments, especially for the highest-risk populations.
Test-and-treat programs will save lives, reduce global inequities in access to COVID-19 testing and treatment, help strengthen formal and community systems for health in low- and middle-income countries, protect front-line health workers, and mitigate the knock-on impact of COVID-19 on programs to fight HIV, TB and malaria.
The Global Fund will procure up to US$80 million in COVID-19 rapid test kits and oral antiviral drugs, and USAID will provide US$20 million in technical assistance for piloting test-and-treat fast-paced implementation in eight countries. Unitaid will provide an additional US$22 million to expand and accelerate the introduction of new treatments through the ongoing Unitaid–FIND early-adoption test-and-treat programs launched in late 2021. These combined investments of US$122 million will support test-and-treat implementation in over 20 low- and middle-income countries globally.
“Getting more people to test for the virus is fundamental to containing transmission, identifying the emergence of variants and getting people on new treatments,” said Peter Sands, Executive Director of the Global Fund. “We are extremely grateful to the United States and ACT-Accelerator partners for their renewed commitment to support the global response to the pandemic. Successful test-and-treat programs can save many lives, but success will require scaling up testing, deploying new COVID-19 antiviral drugs, and ramping up technical assistance to enable those most at risk to gain rapid access to tests and treatments.”
“This new co-investment is a critical step toward equitable access to optimal treatment alongside adequate tests for those at high risk of developing severe or critical COVID-19 in low-resource settings,” said Unitaid Executive Director Dr. Philippe Duneton. “We now have treatment options that can prevent hospitalizations and deaths and will be key in the response to the pandemic. Supporting countries in securing access for these emerging options, as well as their deployment in the most effective way, is our priority.”
Media contact:
For more information and media requests:
Sarah Mascheroni
Communications officer
Email: mascheronisa@unitaid.who.int
Mobile: +41 79 728 73 11
Unitaid statement on the MPP agreements for local production of generic versions of the oral COVID-19 antiviral nirmatrelvir
Geneva – Unitaid welcomes the agreements signed by the Medicines Patent Pool (MPP) with generic manufacturers to produce Pfizer’s oral COVID-19 treatment nirmatrelvir, co-administered with ritonavir, accelerating access to this promising outpatient medicine in low- and middle-income countries (LMICs).
Nirmatrelvir is an oral antiviral co-administered with ritonavir for non-hospitalized mild-to-moderate COVID-19 patients at highest risk of developing severe forms of the disease. According to a study conducted by Pfizer, the new medicine can notably avert progression to severe illness and reduce the risk of hospitalization and death when administered in early stages of the infection. The oral outpatient antiviral is currently under assessment by the World Health Organization.
With COVID-19 vaccine coverage still limited in low resource settings, oral outpatient treatments can play a critical role in the management of COVID-19, with a potential to save lives and ease the pressure on healthcare systems. But challenges in equitable access remain and global efforts are needed to support production of generic versions of medicines and ensure systems are in place for these products to be promptly prequalified and adopted.
This is a significant step for the work the Access to COVID-19 Tools (ACT) Accelerator’s therapeutics pillar partners are leading, working closely with the MPP, originator and generic companies, to rapidly introduce new treatments in LMICs, alongside adequate testing, and ensure rapid and affordable access to those products.
These sub-licenses follow the voluntary licensing agreement MPP and Pfizer signed in November 2021 and will enable 36 qualified sub-licensees, across thirteen countries in Asia, the Caribbean, the Middle East and Eastern Europe, including Ukraine, to supply 95 LMICs, comprising more than half of the world’s population.
Unitaid pays tribute to the MPP for these agreements, in line with WHO’s COVID-19 Technology Access Pool (C-TAP) principles for licensing, that will help expand access to affordable oral outpatient COVID-19 treatments in LMICs.
Unitaid hopes other manufacturers, notably on the African continent, will be able to sign such agreements in the near future to ensure a manufacturing base as geographically wide as possible is established.
Media contact:
For more information and media requests:
Sarah Mascheroni
Communications officer
Email: mascheronisa@unitaid.who.int
Mobile: +41 79 728 73 11
Unitaid commits US$ 56 million to boost access to medical oxygen globally, calls on other donors to close US$ 1 billion gap
- New investments will boost access to medical oxygen globally and save lives during the COVID-19 pandemic and beyond
- In low- and middle-income countries, these grants will increase liquid oxygen supplies, lower costs, strengthen infrastructure, expand technical capacity, and ensure the safe use of medical oxygen
- Oxygen remains a critical component of the global COVID-19 response – 75% of patients hospitalized for COVID-19 can be treated with oxygen alone — without any other advanced care
- Oxygen is a high-return lifesaving treatment, a hallmark of functional health systems. Investments now will save lives for years to come. But access to oxygen still does not meet needs for COVID-19 and/or other serious illnesses
- Unitaid calls on donors to close the ~US$ 1 billion gap in the oxygen response, building on the ~US$ 700 million investments by the Access to COVID-19 Tools Accelerator Oxygen Emergency Taskforce partners since the beginning of 2021
Geneva – Unitaid announces today US$ 56 million of investments to increase and enhance access to medical oxygen, a life-saving essential treatment for severe COVID-19 and other severe illnesses.
The four Unitaid-funded projects, designed to rapidly address global inequities in access to medical oxygen, will be implemented by ALIMA (The Alliance for International Medical Action), the Clinton Health Access Initiative (CHAI), Partners in Health (PIH) and the WHO Health Emergencies Programme. The projects will not only ensure medical oxygen is available for COVID-19 patients but will also lay the groundwork to improve access to oxygen for the long-term. These investments will support reliable, equitable access to oxygen and will pay dividends now and going forward, as a critical foundation for future pandemics.
Oxygen is a high-return, lifesaving treatment for COVID-19 and a hallmark of functional health systems. Investments now will continue to save lives beyond the pandemic. It is an essential medicine for the treatment of many conditions affecting newborns, children, and adults – including pneumonia, the world’s biggest infectious killer. But, even before the health crisis, access to safe and affordable oxygen in low- and middle-income countries (LMICs) was low. The pandemic has exacerbated this situation, leading to many preventable deaths. Challenges for accessing oxygen in LMICs are multiple and can range from complex logistics with oxygen supply not always reaching the destination on time, to the need for good infrastructure and upkeep for most oxygen systems, or to a lack of market competition in countries resulting in high prices and fragmented access.
These investments directly support the work of the Access to COVID-19 Tools Accelerator (ACT-A) Oxygen Emergency Taskforce (Oxygen Taskforce) by ensuring countries have access to adequate, affordable oxygen solutions such as bulk liquid oxygen, oxygen generation systems and other important oxygen equipment. They also complement the significant oxygen investments of the U.S. Agency for International Development (USAID), the Global Fund and the World Bank’s COVID-19 emergency health response. They will expand on the unprecedented efforts of Oxygen Taskforce partners that have included technical support and emergency procurement for medical oxygen for nearly 100 countries, as well as successfully achieving ~15% price reductions for bulk liquid oxygen versus current pricing and between 10-50% reductions in filled cylinder pricing.
The Oxygen Taskforce, launched one year ago and led by Unitaid, is working to maximize the impact of these investments and to dramatically increase liquid oxygen supply, repair broken equipment and expand the number of functioning oxygen generation systems available in LMICs.
While some countries are seeing a downturn in COVID-19 cases and less disease severity, other countries continue to face oxygen surges and need is still outstripping supply. Current reports from Hong Kong indicate that hospitals are running out of oxygen during the worst COVID-19 outbreak yet, and some Asia Pacific countries have surging COVID-19 oxygen needs.
Unitaid’s investment represents an important commitment towards closing the funding gap of ~US$ 1 billion identified in the ACT-A Strategic Plan and Budget for 2022 , and builds on the US$50 million USAID has committed in new funding for oxygen as pledged at President Biden’s Global COVID-19 Summit in September 2021. Unitaid is calling on donors, including governments, foundations, and private sector partners to join in the effort to help meet this significant need for medical oxygen globally and save lives.
“With limited COVID-19 vaccine coverage in low resource settings, many countries continue to face high rates of hospitalization and equitable access to medical oxygen remains critical,” Unitaid Executive Director, Dr Philippe Duneton, said. “This additional investment fills an immediate access gap for safe and affordable oxygen, but the job is not finished. More funding is vital to scale-up supply and prepare countries for future case surges. Just this month, 20 countries have surging COVID-19 oxygen needs. Beyond COVID-19, ~7 million children with hypoxic pneumonia will need oxygen. Oxygen is an essential medicine. Investing now will save lives.”
EDITOR’S NOTES
Background
Medical oxygen shortages around the world have been a tragic feature of the pandemic, impacting the poorest countries disproportionately. These access difficulties were entrenched in many parts of the world before COVID-19, and have been exacerbated by the pandemic, putting strain on fragile health systems and resulting in preventable deaths. Even before COVID-19, pneumonia was the world’s biggest infectious killer of adults and children, claiming the lives of 2.5 million people in 2019. The pandemic has exacerbated this problem, particularly in ‘double-burden’ countries which are contending with high levels of pneumonia and COVID-19. As well as meeting the immediate needs of the pandemic, the Oxygen Taskforce would look to leverage gains in this area to help with long-term pneumonia control.
About the Access to COVID-19 Tools Accelerator (ACT-A) Oxygen Emergency Taskforce (Oxygen Taskforce)
The Oxygen Taskforce was launched in February 2021 to bring together key partners already working to address critical oxygen gaps, as part of a coordinated COVID-19 response. The Oxygen Taskforce is led by Unitaid, under the Therapeutics Pillar of the Access to COVID-19 Tools Accelerator. Partner organizations include Unitaid, WHO (and the Biomedical Consortium it coordinates), UNICEF, The Global Fund, the World Bank, UNOPS, the Every Breath Counts coalition, CHAI, PATH, Save the Children, The Bill and Melinda Gates Foundation, Access to Medicine Foundation, the Pan American Health Organization (PAHO), and the Africa Centre for Disease Control and Prevention.
Media contacts:
For more information and media requests:
Hervé Verhoosel
Head of Communications
M: +41 79 249 35 29
verhooselh@unitaid.who.int
Maggie Zander
Communications officer
M: +41 79 593 17 74
zanderm@unitaid.who.int
Canada commits an additional $20 million CAD contribution to Unitaid to further enhance global access to COVID-19 treatments
Geneva – Unitaid welcomes the contribution of C$20 million from Canada to its work under the Access to COVID-19 Tools (ACT) Accelerator’s Therapeutics pillar to increase and enhance access to effective medicines and lifesaving medical oxygen in low- and middle-income countries.
Canada’s significant funding will contribute to build on the groundwork the ACT-Accelerator therapeutics pillar partners have laid to address research & development gaps, and rapidly introduce new effective treatment options alongside adequate testing in low- and middle-income countries (LMICs).
Harjit S. Sajjan, Minister of International Development and Minister responsible for the Pacific Economic Development Agency of Canada said: “Since the beginning of the pandemic, Canada has worked in close partnership with the ACT-Accelerator because we know that our health depends on the health of everyone. We have more to do to end this health crisis and Canada is committed to ensuring equitable access to lifesaving tools everywhere.”
Securing rapid, equitable access to emerging products is key in the global response to the pandemic, and new oral outpatient treatments are potential gamechangers in the management of COVID-19. But we need to expand global efforts to support production of generic versions of medicines and ensure that systems are in place for these products to be promptly prequalified and adopted.
This new contribution will also finance further oxygen procurement and delivery, and support the repair, maintenance and scale up of local medical oxygen production in LMICs, helping to meet the essential medical oxygen needs of 6 to 8 million severe and critical COVID-19 patients by September 2022.
“With vaccine coverage remaining limited in LMICs and many countries still facing high rates of hospitalization, there is a continued need for effective access to oxygen and medicines. Unitaid hails Canada’s strong support to ensure reliable and equitable access to those lifesaving products,” Unitaid Executive Director Dr Philippe Duneton said.
The funding comes in addition to last year’s contribution, bringing Canada’s direct support to Unitaid for equitable access to COVID-19 treatments up to C$35 million.
Media contact:
Sarah Mascheroni
Communications officer
Email: mascheronisa@who.int
Mobile: +41 79 728 73 11
