Improving access to novel COVID-19 treatments: Launch of Member States briefing on how to navigate interfaces between public health and intellectual property
Geneva, 11 April 2023 – The World Health Organization and Unitaid, with the support of Medicines Law & Policy, have today published a briefing document to support country access to affordable COVID-19 treatments.
This briefing document is a factual explanation of some of the legal instruments that WHO Member States can use to promote public health and access to COVID 19 therapeutics in the framework of their multilateral trade obligations and rights, and according to their national legislation and level of development. It is intended to support countries dealing with challenges at the intersection of public health and intellectual property, to increase access to novel COVID-19 therapeutics and to facilitate alternative and more affordable sourcing of such treatments, where possible.
Member States should use all tools available to them and this briefing documents clearly spells out what those are including voluntary licenses to overcome intellectual property barriers. Countries that are not covered by voluntary licenses are encouraged to use to the full flexibilities under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the Doha Declaration on the TRIPS Agreement and Public Health.
WHO Assistant Director-General, Prof. Hanan Balkhy said, “I urge Member States to implement all the available tools they have to make local production possible and to improve access. This includes licenses for access, the use of TRIPS flexibilities and the implementation of the WTO TRIPS decision. WHO will continue providing technical assistance on how to make use of these instruments.”
Dr Philippe Duneton, Executive Director of Unitaid added “It is crucial to prioritize the availability and accessibility of essential health technologies worldwide. By harnessing all tools at our disposal, we can increase access to essential health products and, ultimately, save more lives. At Unitaid, we remain committed to working with our partners to explore all solutions that will enable us to overcome the challenges posed by the pandemic and build a more resilient health system for the future.”
The briefing document contains background information and resources on the therapeutics landscape and WHO recommendations (Section 2); an overview of the Medicines Patent Pool licenses for oral antivirals and the implications for country access (Section 3); the WHO COVID-19 Technology Access Pool (Section 4); other licenses relevant to COVID-19 therapeutics (Section 5); and guidance on the use of TRIPS flexibilities (Section 6).
Existing voluntary licenses for novel COVID-19 treatments do not include many middle-income countries hence they cannot benefit from affordable generic versions of therapeutics recommended by WHO. WHO calls on technology holders to expand the geographic scope of these licenses to allow competition and price reductions so that these important treatments can be used where they are needed the most.
Read the report:
- Improving access to novel COVID-19 treatments: A briefing to Member States on how to navigate interfaces between public health and intellectual property [English version]
- Améliorer l’accès aux nouveaux traitements contre la COVID-19 : Rapport d’information à l’intention des États membres sur la manière de gérer les interfaces entre la santé publique et la propriété intellectuelle [French version]
- Mejorar el acceso a nuevos tratamientos contra la COVID-19: sesión informativa para los Estados Miembros sobre la forma de manejar las interconexiones entre los ámbitos de la salud pública y la propiedad intelectual [Spanish version, upcoming]
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities including advanced HIV disease, cervical cancer, and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator, co-leading with Wellcome the Therapeutics Pillar and participating in the Diagnostics Pillar. Unitaid is hosted by the World Health Organization.
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Overview of mpox antivirals and diagnostics landscape
World Pneumonia Day: Unitaid’s work to enhance global access to medical oxygen will contribute to reducing childhood mortality
Geneva – On World Pneumonia Day 2022, Unitaid reaffirms its commitment to address global inequities in access to medical oxygen as a key driver to reduce the number of deaths in children under five years old.
Despite being preventable and curable, pneumonia, an acute form of respiratory infection, remains the world’s biggest infectious killer of children under-5 years, accounting for more than 740,000 deaths in 2019, mostly in South Asia and sub-Saharan Africa.
Coupled with antibiotics, medical oxygen could save the lives of many children who develop severe pneumonia. But many low- and middle-income countries (LMICs) face serious challenges in accessing safe and affordable oxygen.
Even before the pandemic, it was estimated that 9 in 10 hospitals in LMICs lacked access to life-saving oxygen therapy. COVID-19 has only worsened this situation, leading to many preventable deaths and straining fragile health systems.
Challenges for accessing safe and affordable oxygen are multiple and can range from availability, quality, affordability, management, supply, human resources capacity and safety.
Unitaid has invested US$ 130 million to date to secure sustainable access to oxygen and expand access to pulse oximeters, essential life-saving portable devices that can detect when medical oxygen is needed. This work could potentially save the lives of as many as 320,000 pneumonia deaths a year, according to the World Health Organization estimates.
Unitaid has been addressing access to medical oxygen since 2019 through a diverse portfolio of investments including piloting pulse oximetry and fever management at primary health care level to identify and refer critically ill children to hospitals without delay, advancing improved non-invasive ventilation strategies for newborns and oxygen concentrator technologies.
Spearheading progress through market shaping interventions (improved affordability, increased production capacity and accelerated equipment delivery times), technical support and capacity building, Unitaid and partners are also leading efforts to scale-up access and availability to medical oxygen, implementing adequate and sustainable oxygen solutions in LMICs.
Among key achievements, Unitaid has supported oxygen needs assessments in 51 countries, has contributed to securing price reductions for liquid oxygen following unprecedent agreement with two major gas companies that enabled other scale-up partners to secure increased access with the same funding levels, and has ensured sufficient oxygen supply by installing or repairing oxygen production plants and piping systems and other respiratory care equipment.
Increasing the availability of medical oxygen commodities and ensuring a sustainable oxygen ecosystem will enable greater impact of Unitaid’s work to both improve child survival with triage and treatment tools and help respond to future global health emergencies, two programmatic priorities of Unitaid’s strategy 2023-2027.
- Unitaid and medical oxygen (FACTSHEET)
- Boosting medical oxygen supplies in the Democratic Republic of Congo (A photo story):
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Sarah Mascheroni
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Maggie Zander
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G20 health ministers appeal for more TB funding and deliver six key actions to strengthen the global health architecture
28 October, Geneva – World health leaders launched a call to action on financing tuberculosis (TB) today in Bali, Indonesia, where they met ahead of the G20 Summit to discuss strengthening global health architecture.
G20 members recognize that lack of adequate financing remains the top obstacle to ending the TB epidemic, and stress that global investments must increase fourfold by 2030 to meet the targets set for ending this preventable and treatable disease.
The call to action coincides with the recent launch of the World Health Organization’s 2022 Global TB Report, which laid bare the devastating consequences of the COVID-19 pandemic on global efforts to control TB.
The report showed an increase for the first time in many years in the number of people falling ill with TB and drug-resistant TB, along with a decline in 2021 in global spending on essential TB services.
At the same time, G20 members underscored the critical role Unitaid plays in the TB response as the world’s largest multilateral donor to TB research and development, striving for equitable access to life-saving diagnostics and treatment.
Unitaid has contributed to the global efforts by supporting research related to multidrug-resistant TB (MDR-TB) treatment, paediatric TB diagnosis, child-friendly formulations of TB and MDR-TB drugs, TB preventive therapy (the 3HP regimen), and digital adherence technologies. The agency is investing an additional US$ 30 million, aiming to increase TB detection and help to find the missing millions of cases.
Following discussions on strengthening the global health architecture and pandemic prevention, preparedness and response , G20 health ministers delivered six key actions for consideration during the G20 Leaders’ Summit in mid-November.
Unitaid, as a key player for equitable access to health innovation, remains committed to help build global health resilience and response capacity against future pandemic threats.
As co-leader of the ACT-Accelerator’s therapeutics pillar, Unitaid has contributed to substantial progress in the COVID-19 response, demonstrating its unique capability to transform markets and help countries and communities achieve an enabling environment for product adoption.
“Responding to the COVID-19 health crisis, Unitaid and partners have improved access to critical oxygen supplies and facilitated adoption of life-saving therapeutics alongside vital diagnostic tests. But this is not the end of it, much work remains to be done,” Unitaid Executive Director Dr Philippe Duneton said. “We must focus on building resilience at the market and country level in light of unpredictable and fast evolving scenarios. COVID-19 has shown us that reaching equitable global access to medical countermeasures requires a continuum between pandemic preparedness and response efforts.”
Access more information on the Call to Action on Financing for TB Response here.
Access the G20 Health Ministers Communiqué here.
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Sarah Mascheroni
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The Republic of Korea reaffirms its strong support to Unitaid to ensure equitable access to health tools
Dr Philippe Duneton, Executive Director of Unitaid and Marisol Touraine, Chair of Unitaid’s Executive Board with Mr. Park Yong Min, Deputy Minister for Multilateral and Global Affairs (left) and Mr. Won Do-Yeon, Director-General of the Cooperation Bureau and Unitaid Board Member (right).
Geneva – Unitaid welcomes the contribution of US$5 million from the Republic of Korea to support the implementation of its new strategy.
The Republic of Korea has supported Unitaid’s essential role in the fight against HIV, tuberculosis, malaria and, more recently, COVID-19 as a key donor and member of the Executive Board since 2007.
This latest commitment of funding builds on an US$80 million total contribution from the Republic of Korea since Unitaid’s inception, including support to Unitaid’s COVID-19 response work as part of the Access to COVID-19 Tools Accelerator (ACT-A).
“The Republic of Korea strongly appreciates Unitaid’s work in ensuring access to health innovations and will continue to strengthen its cooperation with Unitaid,” said Mr. Park Yong Min, Deputy Minister for Multilateral and Global Affairs.
Unitaid is grateful for the Republic of Korea’s longstanding support and renewed financial contribution. We value the Republic of Korea’s leadership in global health driven by the Korean biotechnology companies’ excellent R&D and manufacturing capacity,” said Marisol Touraine, Chair of Unitaid’s Executive Board.
The funding commitment was announced on the sidelines of the World Bio Summit, co-hosted by the Republic of Korea and the World Health Organization.
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Maggie Zander
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Canada contributes Can$ 25 million to Unitaid to expand sustainable access to medical oxygen
Geneva and New York City – Unitaid welcomes Canada’s contribution of Can$ 25 million to support the organization’s work to boost access to medical oxygen in low- and middle-income countries, to support the COVID-19 response and future health emergencies.
Prime Minister Justin Trudeau announced this new funding on the sidelines of the Global Fund Seventh Replenishment Pledging Session, during the UN General Assembly in New York.
Canada’s significant contribution aims to support the efforts of the Oxygen Emergency Taskforce to further increase access to liquid oxygen, lower costs of gas and equipment, strengthen infrastructure, expand technical capacity, and ensure safe use of medical oxygen in low- and middle-income countries. It will help expand sustainable access to adequate and affordable oxygen solutions, and support countries to develop strategic national oxygen roadmaps and prepare for future health threats.
With this additional funding, Canada has provided Can$ 60 million to Unitaid for equitable access to COVID-19 treatments, including oxygen, through the ACT-Accelerator.
Dr. Philippe Duneton, Executive Director of Unitaid, said: “No one should die because of a lack of medical oxygen. I am very grateful to Canada for this important contribution to the work Unitaid is leading with partners to address global inequities in access to this essential medicine. The new funding will help save lives now and prepare the world for future health emergencies.”
Prime Minister of Canada, Justin Trudeau and Dr. Philippe Duneton, Executive Director of Unitaid
Oxygen is an essential medicine used to treat many conditions affecting newborns, children, and adults. It is a vital treatment for severe COVID-19 with an estimated 75% of people hospitalized who can survive with oxygen therapy alone. Investing in oxygen now will save lives beyond the pandemic by strengthening health systems and significantly reducing deaths among newborns, children and women in childbirth. It will continue to be a core tool for future health emergencies.
Unitaid has been addressing access to medical oxygen since 2019 through a diverse portfolio of investments including piloting pulse oximetry and fever management at primary health care level to identify and refer critically ill children to hospitals, advancing improved non-invasive ventilation strategies for newborns and oxygen concentrator technologies.
Unitaid is chairing the Oxygen Emergency Taskforce established in February 2021 to drive the multilateral oxygen support effort and is co-leading the ACT-Accelerator’s Therapeutics pillar with the Global Fund and Wellcome.
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Sarah Mascheroni
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Maggie Zander
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Next generation pulse oximeters have great potential to reduce maternal and child mortality, PATH and Unitaid report says
A technology and market landscape report by PATH and Unitaid
To date, maternal and child mortality rates remain unacceptably high. In 2020, still over 5 million children under 5 years of age died, mostly in low- and middle-income countries, and mostly from conditions that are preventable or treatable, such as pneumonia, diarrhea, malaria and preterm birth complications.
To reach maternal and child global health targets by 2030[1], equitable access to innovative devices that have the potential to support health care workers in low-resource settings as they make decisions and provide fit-for-purpose treatment solutions, is urgently needed.
Pulse oximeters (POs) are noninvasive devices that measure blood oxygen saturation and pulse rate. They are used to help health care workers detect hypoxemia – a low level of oxygen in the blood – and to know how much oxygen to administer to patients. Detecting hypoxemia can allow timely treatment with oxygen therapy and save hundreds of thousands of lives each year.
The PATH-Unitaid technology and market landscape report, launched today, reviews the nascent global market for the next generation of pulse oximetry – multimodal POs.
These devices expand the features of standard POs by collecting additional clinical measurements, such as respiratory rate, temperature, and/or haemoglobin integrated into a single device that is appropriate for use in low-resource settings. These promising products can provide objective measurements to caregivers, via the same device and at the same time, to support clinical decision-making and ultimately save lives.
The report analyzes existing and emerging products and aims to assess their potential to improve screening for various illnesses that affect maternal and child health in low- and middle-income countries.
The report also examines market and technological challenges that hamper the adoption, scale-up and wide access in low-resource settings to these potentially lifesaving tools and maps out opportunities to overcome barriers limiting equitable access, including issues related to quality, availability, affordability, demand and supply.
Multimodal POs that are affordable, high-quality, and appropriately designed have the potential to achieve meaningful impact.
In addition to reducing mortality, multimodal POs could further optimize efficient use of resources and reduce the overall strain on health systems by minimizing the need for costly testing, strengthening referral decisions, and reducing unnecessary hospitalizations, intensive therapy, and overuse of antibiotic treatments.
In its work to address fever management and promote the adoption and scale-up of POs in primary health care, Unitaid has a portfolio of two complimentary grants for this purpose. Namely, Améliorer l’Identification des Détresses Respiratoire chez l’Enfant (AIRE) led by the Alliance for International Medical Action (ALIMA) and Tools for Integrated Management of Childhood Illness (TIMCI), led by PATH.
As part of the broader TIMCI project, PATH is currently initiating an evaluation and operational research study to assess performance and feasibility of using these tools by primary health care providers in Kenya, Senegal, Tanzania, and Uttar Pradesh, India.
Over the past four years, Unitaid and PATH have worked together to expand access to high-quality POs and clinical decision support algorithms to enable primary health care workers to better identify severely ill children and refer them for appropriate treatment without delay. The COVID-19 pandemic has brought the need for reliable access to such devices as part of sustainable and equitable oxygen delivery system even more to light.
- Access the Next Generation Pulse Oximeters Technology and Market Landscape here
[1] Sustainable Development Goal 3: Target 3.1, By 2030, reduce the global maternal mortality ratio to less than 70 per 100,000 live births. Target 3.2, By 2030, end preventable deaths of newborns and children under 5 years of age, with all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under‑5 mortality to at least as low as 25 per 1,000 live births.
Related projects and publications:
- Better tools to detect signs of severe illness in children Tools for Integrated Management of Childhood Illness (TIMCI) PATH project
- Better technology to identify critically ill children Alliance for International Medical Action (ALIMA) AIRE project
- Fever diagnostic technology landscape, 1st edition february 2018
For more information:
Sarah Mascheroni
For media requests:
Maggie Zander
Communications officer
M: +41 79 593 17 74