Geneva, 27 October 2021 – WHO and Unitaid welcome the signing of a voluntary licensing agreement by the Medicines Patent Pool (MPP) and MSD to facilitate affordable access to molnupiravir, a new medicine being tested in clinical trials for treating COVID-19 in adults.
Molnupiravir, an investigational oral antiviral medicine, was reported to reduce the risk of hospitalization in patients with mild to moderate COVID-19 by 50% in interim phase III clinical trials. It is currently being evaluated for inclusion into the WHO living guideline on COVID-19 therapeutics and is pending authorization for its use from regulatory bodies. If approved, it will be the first oral medicine for non-hospitalized mild-to-moderate COVID-19 patients.
The MPP/MSD licensing agreement is a positive step towards creating broader access to the treatment as quickly as possible by allowing generic licensees from around the world to prepare supplies and create more affordable versions of the medicine, pending WHO recommendations and other regulatory authorizations. This will shorten the time from approval of the medicine to its availability in the 105 low- and middle-income countries covered by the licence and where there is no patent infringement and licensed know-how has not been used. We hope the company will include other key countries in the scope of the agreement in the near future.
We commend MPP for negotiating the licence from a public health perspective – in line with WHO’s COVID-19 Technology Access Pool (C-TAP) principles, it is non-exclusive and transparent.
We urge the manufacturer to provide data of clinical trials to WHO as soon as possible, so that the agency can evaluate the medicine for global use.
Other companies developing vaccines, therapeutics and diagnostics should consider open and transparent licences as soon as possible, especially for other promising COVID-19 health technologies, for which we also need to ensure broad supply and affordability in all countries in order to end the pandemic. Both the Access to COVID-19 Tools Accelerator (ACT-A) and C-TAP, in partnership with MPP, are working to facilitate such licences, and look forward to an open dialogue with relevant developers.
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/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as 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. Unitaid is hosted by the World Health Organization.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States across six regions, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and well-being.
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About the ACT-Accelerator
The Access to COVID-19 Tools (ACT) Accelerator is a global coalition of organizations developing and deploying the new diagnostics, treatments and vaccines needed to end the acute phase of the pandemic. Pooling the expertise of its many partners, the ACT-Accelerator has quickly ushered in rapid, affordable tests and effective medicines, and established the COVAX facility for the equitable procurement and distribution of vaccines in low- and lower-middle-income countries.
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