When will ViiV, Clinton Health and partners officially repair the mistake on missing out 39 countries from the DTG pricing agreement?

It has been six months since we alerted the Clinton Health Access Initiative (CHAI) to a glaring omission in the “breakthrough pricing agreement” for the optimal dolutegravir-based HIV treatment regimen. We are still waiting for an official announcement that will remove any ambiguity so that all eligible countries can procure the drug with confidence.

In September of 2017, an announcement from CHAI, the Gates Foundation and partners, revealed that a dolutegravir (DTG)-based HIV treatment regimen, would become available to low and middle-income countries (LMICS) at a more affordable price. DTG is an optimal HIV drug with a high resistance barrier and few side effects. The price-lowering licensing agreement for DTG-based treatment supposedly included  ALL low- and middle-income countries, but many countries were omitted. The announcement described it as “breakthrough pricing agreement”, one which “will accelerate the availability of the first affordable, generic, single-pill HIV treatment regimen containing dolutegravir (DTG) to public sector purchasers in LMICs at around US$75 per person, per year”.

Unfortunately the agreement with the Medicines Patent Pool (MPP) missed out 39 countries as we commented on here.

Make Medicines Affordable has since received confirmation from the MMP, CHAI and ViiV (the originator), that Mylan, who will be marketing the generic version of the drug under the agreement, will honor the terms of the pricing agreement for public procurements in these additional 39 countries.

We also have clarification from ViiV that the unique clause in the agreement can be taken at face value. This is the provision that allows generic supply of DTG to any country where no patents have been granted – even when these countries are excluded from the territory of the licence. 

We welcome these clarifications. However a formal, public statement to confirm that generic DTG-based treatment will be available in the additional 39 countries has not been issued. We urge CHAI and partners to officially publish this as a matter of urgency, since the delay creates questions and concerns, such as whether behind-the-scenes, parties are working to find a way to negate the agreement. CHAI and partners must act promptly and without ambiguity to put these concerns to rest.

CHAI states that they look forward to working with us in the future “to accelerate access to optimal treatment options for all people living with HIV”. In order for this to happen, we are now asking that CHAI and its partners, and the Medicines Patent Pool (MPP), publish the complete list of countries, and that these countries each receive an individual letter from the MPP clearly stating that they are now permitted to the procure generic DTG-based combinations from Mylan.