29 developing countries excluded from optimal HIV treatment - a dangerous oversight or deliberate tactic?

29 developing countries excluded from optimal treatment - a dangerous oversight or deliberate tactic?
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This World AIDS Day (1 December 2017) we’re pleased to have reached a point where more people are set to benefit from optimal HIV treatment, but a glaring omission means too many are still being left behind.

An announcement in September, from the Clinton Health Access Initiative (CHAI), Gates Foundation and partners, largely received a welcome response. No surprise, when it was to say that a new agreement meant that the exorbitantly priced dolutegravir would now be made available in more countries at a more affordable price.

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 low- and middle-income countries (LMICs) at around US$75 per person, per year”.

Welcome news indeed when we’ve been waiting years for affordable and optimal HIV treatment for everyone. Dolutegravir is easier to take, has better efficacy, much fewer side effects and is very effective in reaching viral suppression quickly. Not only is DTG necessary for improving the quality of life of people living with HIV, it is also known to be effective in cases of drug resistant HIV. It’s also cheap to produce.

That’s why the announcement refers to the ARV as “best-in-class’, and it’s been included in the World Health Organization’s treatment guidelines as an alternative first-line regimen since 2015, and in the WHO’s list of essential medicines since June this year. However, access has remained limited, with price, as well as confusion around license agreements, being two key barriers.

Limited access

Until now, ViiV Healthcare has been slow to roll out of the drug, so while this is now progress, it still doesn’t go far enough. The announcement was limited to 92 low- and middle-income countries. It appears to be based on a voluntary license that ViiV previously signed with the Medicines Patent Pool (MPP) for 88 countries, with an additional four added in 2016, taking it to 92.

However, the license agreement includes a very important provision that allows supply to any country where no patents have been granted, even when these countries are excluded from the territory of the licence. This should increase the official territory to 121 which means 29 countries have been omitted from the license, whether accidentally or deliberately. The license also allows supply to any country excluded from the licence when compulsory licences are issued.

The September agreement contradicts previous advice to countries, such as Tunisia. Like many of the other countries not explicitly included, Tunisia had received official advice from the MPP, encouraging them to procure generic versions of DTG. This is because they meet the proviso that no patent has been granted in the country and therefore the agreement should apply to them.

However, the ambiguity caused by contradictions and confusion means that the brakes have been put on procurement. In the meantime, people living with HIV in these 29 countries will continue to battle with side-effects and personal consequences of out-dated treatment unless the agreement is officially extended.

Therefore, as a coalition of treatment activists, Make Medicines Affordable is calling on all parties behind the agreement announced in September, to revise this and make it explicitly clear that the territory covered is 121 countries, plus allows for supply to any country excluded from the licence but that issues a compulsory licence. Health is a right, and this agreement needs to be put right in order for everyone to access optimal HIV treatment.

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