Brook Baker, Health GAP
The voluntary licensing agreement reached between ViiV and the Medicines Patent Pool for long-acting cabotegravir has received significant media attention, criticism, and protests because of the millions of people excluded from direct or indirect access to in upper-middle-income countries excluded from the license. According to protestors, ViiV will remain the sole supplier of CAB-LA for several years before qualified generic licensees are identified and they develop the technical capacity to manufacture nanoparticle formulations. As the sole manufacturer, ViiV’s discount pricing scheme results in prices that are still disproportionately too high compared to the estimated costs of production.
One aspect of the licenses that has not yet received much attention is the precise listing of: (1) the 90 countries included in the licensed territory (including those having public sector access only and a 5% royalty obligation); (2) the 31 countries/territories that can be supplied by ViiV/MPP licensees in the future because of a provision in the license agreement that allows supply to a country if there is no pending or granted patent on CAB-LA in that countries; and (3) the 19 upper-middle-income countries totally excluded supply by a ViiV/MPP license unless a compulsory license is issued in the country of importation or use.
Activists are justly concerned about the exclusion of coverage for 19 countries, including several with large populations of key populations at heightened risk of HIV infection and most likely to benefit from access to affordable CAB-LA. Excluded countries include several with generic manufacturing capacity and that provided clinical trial evidence for CAB-LA’s use. ViiV should certainly take steps to include all U-MICs and drop its public-sector only restrictions. In the meantime, however, countries excluded from the license or whose private sectors are excluded should considered issuing coordinated compulsory licenses once ViiV/MPP licensees are identified. Those licensees will face no restrictions concerning the quantity of CAB-LA that can be exported and will be assured of supply from qualified manufacturers at what is hoped to be a more affordable price.
ViiV/MPP licensed territory list (highlight and *, public sector only 5% royalty):
Afghanistan, Algeria*, Angola, Bangladesh, Benin, Bhutan, Bolivia (Plurinational State of), Botswana, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Comoros, Congo, democratic Republic of the, Congo, Côte d’Ivoire, Djibouti, Egypt*, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Gabon, Gambia (the), Ghana, Guinea, Guinea-Bissau, Haiti, Honduras, India*, Indonesia*, Iran (Islamic Republic of), Kenya, Kiribati, Korea (Democratic People’s Republic of), Kyrgyzstan*, Lao People’s Democratic Republic (the), Lebanon, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Micronesia (Federated States of), Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Philippines*, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Syrian Arab Republic, Tajikistan*, Tanzania, United Republic of, Timor-Leste, Togo, Tunisia, Tuvalu, Uganda, Ukraine*, Uzbekistan, Vanuatu, Viet Nam*, West Bank and Gaza, Yemen, Zambia, Zimbabwe
31 non-territorial countries with no patent/no patent status on CAB-LA that can be supplied under MPP license
19 U-MICs excluded from licensed territory and from supply from an MPP licensee because of granted or pending patents, can be supplied by a licensee if a compulsory license is issued:
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