In April 2014, the Medicines Patent Pool (MPP) and ViiV Healthcare announced two licensing agreements to accelerate access to dolutegravir (DTG), a promising new antiretroviral, for both adult and paediatric care. The agreements allow generic manufacturers to produce low-cost versions of DTG for at least 95 countries for the adult agreement and 123 countries for the paediatric agreement.
The two parties extended the adult licence to cover all remaining lower middle-income countries in April 2016. The amendment specifically benefits four countries with patents – Armenia, Moldova, Morocco and Ukraine – that were not included in the initial 2014 agreement. As a result, countries that together are home to 94% of adults and 99%[1] of children living with HIV in low- and middle-income countries, are covered by the licence. In November 2020 the two parties signed a new licence agreement to enable greater access to DTG-based regimens in upper-middle-income countries Azerbaijan, Belarus, Kazakhstan and Malaysia. That agreement prompted the inclusion of Belarus and Kazakhstan in the MPP-ViiV existing paediatric DTG voluntary licence.
[1]Coverage rates at time of announcement.
See related licence
Letter of indemnity – Form
Memorenda of Understanding:
In 2018, we signed a MoU with Aurobindo agreeing to exchange information and business leads to fast-track the development and uptake of the antiretroviral dolutegravir (DTG). MPP signed licences with ViiV Healthcare for DTG for adult and paediatric care and has signed sublicences with 17 generic manufacturers to produce DTG and DTG containing formulations for low- and middle-income countries (LMICs). Under the terms of this agreement, Aurobindo shares information on development timelines, regulatory status, technical challenges and sales of DTG in developing countries. MPP may provide Aurobindo with technical assistance and inform procurers about the company’s state of readiness to supply DTG products. Aurobindo holds licences for other MPP-licensed treatments – abacavir (paediatric), atazanavir, bictegravir, daclatasvir, elvitegravir, emtricitabine, lopinavir/ritonavir and tenofovir alafenamide.
Aurobindo has a similar but bilateral licence for DTG with ViiV Healthcare, and since the signature of the above MoU, Aurobindo has regularly shared data on the development and uptake of DTG with MPP.
Under the terms of the collaborative agreement signed by the three parties in 2019, a sub-set of Aurobindo’s data is shared by MPP with ViiV Healthcare. Such a sub-set is valuable for ViiV Healthcare to assess the overall impact on access to DTG made by all generic manufacturers (MPP sublicensees and Aurobindo).
Quality assured formulations from MPP generic partners:
Click the logos to access the sublicensing agreements:
Sublicence Agreement
Amendment of 5 May 2021
Amendment of 31 Mai 2022
Legal
Access to Medicines Tracker
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.