ViiV agree deal to put dolutegravir in the Pool
STOPAIDS urges other drug companies like J&J (Tibotec) and Merck/MSD to immediately open talks with the Pool to facilitate generic production of their antiretroviral medicines.
Although the license covers many developing countries, we are disappointed that it excludes some countries with serious HIV epidemics, extreme inequality and poverty, and people living with HIV who still do not have access to treatment. However, the agreement places no restrictions on generic manufacturers who take up the licence from supplying excluded countries if they issue compulsory licences to access affordable generic versions of the medicine.
Key points of the agreement:
There are two licences: one adult, one paediatric. Both significantly expand on the previous standard ViiV licence geographic scope.
The adult licence now includes the public and non-profit markets in India, Vietnam, the Philippines, Egypt, Indonesia and Turkmenistan after the MPP negotiated a system of tiered royalties for these countries. It covers 93% of people living with HIV in the developing world. The paediatric licence is broader, covering 99% of children living with HIV in the developing world.
The licences allow for export of generic dolutegravir to 50 additional countries where there is no patent, including Thailand.
There are no restrictions on sourcing of the active pharmaceutical ingredient (API), manufacture can happen anywhere, and there are no restrictions on generic manufacturers’ rights to supply generic dolutegravir to countries that issue a compulsory licence.
STOPAIDS Advocacy Manager Diarmaid McDonald said,
“We’ve not yet seen the detail of this agreement, but it looks like a significant positive development in the effort to secure affordable access to the best possible HIV medicines for the millions who need it across the developing world. Dolutegravir is an eagerly anticipated new drug, and was only registered in the US last year. It’s great that through the Pool, ViiV have already agreed a licence that will allow competitive generic production – the key to affordable access.
“The Medicines Patent Pool is making progress. Voluntary licenses between companies were once secret but with the Pool, they are now fully transparent, and that transparency is edging up the quality of the licences. However, the patent pool is only one piece of the puzzle.
“We need to ensure all developing countries can use the flexibilities enshrined in the international TRIPS agreement on intellectual property to ensure affordable access to medical products. Developing countries with serious poverty and access issues were excluded from this deal. They should prepare compulsory licences to secure generic versions of dolutegravir.
“We also need to see countries like South Africa supported in their efforts to fix their broken patent laws; and we need to see reform of the R&D system so we get better drugs for neglected diseases, like TB, that kill people living with HIV.”
Read the full MPP announcement on the ViiV deal here.
Get involved in the Student STOPAIDS Campaign ‘Access to Meds for All’.