(Statement) The Medicines Patent Pool on the Inclusion of its Licensed Antiretrovirals on the World Health Organization’s New Essential Medicines List
Geneva, 7 June 2017 — The Medicines Patent Pool welcomes yesterday’s publication of the World Health Organization (WHO)’s Model list of essential medicines (EML) for 2017, and particularly the inclusion of MPP-licensed dolutegravir, WHO-recommended as an alternative HIV first-line treatment. Updated every two years, the WHO’s list is an inventory of key medicines that treat the world’s most pressing health concerns, selected for their public health importance, safety, efficacy and comparative cost-effectiveness.
Dolutegravir, licensed from ViiV Healthcare by the MPP in 2014, has a good barrier to resistance as well as high efficacy and tolerability at a relatively low dose, and is considered a significant advancement in HIV therapy. The ViiV-MPP licence allows generic manufacture of the drug for supply in at least 92 low- and middle- countries and three of MPP’s nine generic partners developing the treatment have already filed for WHO prequalification.
Additional formulations of MPP-licensed medicines are also now included in the 2017 EML. These include atazanavir/ritonavir; efavirenz/lamivudine/tenofovir and a new indication for emtricitabine/tenofovir for pre-exposure prophylaxis (PrEP). In total, the MPP holds licences for 13 formulations on the WHO model list of essential medicines, including hepatitis C antiviral daclatasvir, and is currently exploring an expansion of its voluntary licensing model to all patented essential medicines on the WHO list.
The WHO EML, first compiled by a World Health Organization (WHO) expert panel in 1977, now comprises 433 medicines for such priority conditions as malaria, HIV/AIDS, tuberculosis, reproductive health and, increasingly, for noncommunicable diseases such as cancer and diabetes. This year’s list also includes new guidance on antibiotic use.
 Medicines in the WHO EML licensed to the MPP: Abacavir (ABC) (paediatrics); ABC/lamivudine (3TC) (paediatrics); Atazanavir (ATV); ATV/ritonavir (r); Daclatasvir (DCV); Dolutegravir (DTG); Efavirenz (EFV)/3TC/tenofovir disoproxil fumarate (TDF); Raltegravir (RAL) (paediatrics); Lopinavir/ritonavir (LPV/r); Ritonavir (r); TDF, TDF/FTC/EFV, TDF/FTC for treatment and pre-exposure prophylaxis, Valganciclovir (access agreement with the MPP).