Tivicay licence has widest geographic potential for improving access
The non-exclusive voluntary licence for the HIV/AIDS medicine dolutegravir (Tivicay®) covers all low-income, least developed, and sub-Saharan African countries, and 95% of low- and middle-income countries in scope.
To expand the reach of licensing to get drugs to markets that would otherwise struggle with access.
Middle-income countries often fall outside the scope of non-exclusive voluntary licences.
Middle-income countries (MICs) are home to the majority of the world’s poor and shoulder the greatest share of the global disease burden. Compared to low-income countries (LICs), they have greater purchasing power and thus represent more attractive commercial markets. MICs are thus more likely to be excluded from non-exclusive licensing agreements for medicines – preventing their populations from accessing the dual benefits of increased affordability and a more secure supply that such licensing agreements can provide.
When agreeing the terms of non-exclusive voluntary licences, rights-holding companies – in negotiation with generic medicine manufacturers, or parties such as the MPP – agree a geographic scope (or licence territory) within which generic manufacturers are permitted to supply the product.
What makes this a best practice?
GSK continues to represent best practice here. It sets the single largest geographic scope of any voluntarily licensed product. GSK was recognised for the same practice in 2014 and 2016. GSK’s non-exclusive voluntary licence for paediatric formulations of dolutegravir (Tivicay®) – negotiated via the MPP – achieves the widest reach of any non-exclusive voluntary licence agreed by any company within the scope of the Index, covering countries that are together home to 99% of children living with HIV in low- and middle-income countries. The licence for the adult version has the widest reach, facilitating the possible entry of generic versions to countries that are home to more than 94% of adults living with HIV/AIDS in low- and middle- income countries.
Dolutegravir is a key product in HIV/AIDS treatment. It is a best-in class integrase inhibitor, appears on the WHO EML and is recommended by WHO as an alternative first-line HIV/AIDS regimen.
Reaching countries in need
The paediatric licence covers 121 countries in total (compared to the paediatric licence with the lowest number of countries – Merck & Co., Inc.’s raltegravir (Isentress.) – at 92 countries) and includes all LICs, all Least Developed Countries (LDCs) and all sub-Saharan African (SSA) countries, in addition to several upper middle-income countries. The licence covers all MICs in scope of the Index except four: Brazil, China, Mexico and Suriname. Looking at disease burden per MIC, the licence includes seven of the ten countries within scope outside of SSA which bear the highest burden of HIV/AIDS.
Notably, GSK also permits the supply of dolutegravir (Tivicay®) outside of the agreed territory to wherever patents are not in force or where the sale of a generic version does not infringe on an existing patent. This further expands the potential reach of this licence to at least 131 countries.