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.