Licensing for Oral Therapeutics

Both Merck and Pfizer have taken steps to increase supply and access to their drugs through licensing. They have licensed their oral therapeutics to a total of 35 manufacturers each. All licenses from Pfizer are through the Medicines Patent Pool (MPP), while Merck has issued eight direct voluntary licenses to generic manufacturers in India in addition to 27 sublicenses via the MPP.

Source: COVID GAP analysis, updated March 25, 2022

The licenses were issued in a number of countries, including many middle-income countries. Majority of the manufacturers for both drugs are based in India.

Source: COVID GAP analysis, updated March 25, 2022

The licenses through the MPP cover only a subset of countries for distribution. Merck’s deal covers 105 low- and middle-income countries and Pfizer’s deal covers 95 low- and middle-income countries. Both licensing deals left out some notable upper-middle income countries, shown in yellow in the map below.

Source: Medicines Patent Pool

In the absence of significant purchases, generic manufacturers are unlikely to ramp up production. This uncertain demand may in part be linked to the lack of test-and-treat capacity globally. Without an effective way to distribute the treatment, countries are unlikely to spend limited resources on oral therapeutics. Existing test-and-treat strategies built by the Global Fund, PEPFAR, and the US President’s Malaria Initiative (PMI) to address malaria, HIV/AIDS and other infectious diseases provide instructive examples and could be leveraged to increase access to COVID treatments.

For more analysis and recommendations on how to improve access to oral therapeutics for COVID, see our recent report Pills to People.