- Following civil society advice, Vietnam’s Ministry of Health recommended TLD for HIV treatment. This was back in November 2019.
- Vietnam can access generic versions of TLD due to a voluntary license (VL) agreement.
- The first few thousand people started receiving the drug from January 2020 and the government has committed to scaling up access.
- However, even with a VL in place, civil society is concerned about overpricing stemming from a lack of competition.
- When PEPFAR and Global Fund support is withdrawn, there could be additional barriers to accessing optimal HIV treatment, unless steps are taken now to ensure competition.
Advocacy for increasing access to optimal HIV in Vietnam has yielded some significant successes. In early 2019, civil society began lobbying the Ministry of Health (MoH) to incorporate optimal HIV treatment to the national guidelines. Simultaneously, a campaign focused on reaching people living with HIV to increase awareness of newer treatment. By June the same year, 1400+ people living with HIV had signed a letter to the MoH within a period of just 2 weeks, asking for the opportunity to access improved drugs,
Less than six months later, by November 2019, TLD was added to the national treatment guidelines. The first procurement arrived on Human Rights Day (10 December 2019), and by January 2020, the first people in Vietnam began to receive the drug.
“The Ministry of Health was receptive to our advocacy asks for optimal HIV treatment to be made available to people in Vietnam. Thousands have benefitted, but many more are still waiting” says Do Dang Dong, Chairman of the Vietnam Network of People living with HIV (VNP+), the civil society organization which led the actions, and Make Medicines Affordable partner.
The drug, which is now incorporated in national HIV treatment guidelines is a fixed dose combination of tenofovir, lamivudine and dolutegravir (TLD). There are multiple patents granted for dolutegravir (DTG) in Vietnam, applied for by, and granted to, ViiV Healthcare.
Some, compound patents, do not expire until 2026, and others, e.g. for combination therapies, stretch as far as 2032. Vietnam is included in a voluntary license, meaning that Vietnam can procure generic versions while a VL remains in place.
However, the government, despite its own recommendations, cannot directly procure the drug itself unless it has three market authorizations, which first requires generic companies to register the drug in the country.
Vietnam currently receives support from PEPFAR and the Global Fund. They are not bound by the ‘rule of three’ and therefore PEPFAR has so far provided treatment for 9,000 people, and the Global Fund for 16,000 more.
The MoH target is for 25,000 people to received TLD by December 2020, increasing to 30,000 by December 2021. Additionally, it has set a target to ensure 90% of people living with HIV receive treatment by 2025 and 95% by 2030.
“The government has set out clear targets, not just with regards to increasing access but also in ensuring that the treatment people access is more optimal and beneficial,” says Dong. “It makes sense all round. TLD is better for patients as it has less side-effects, and works for people as a first, second and third-line regimen and is safe across different ages and populations.”
“This means that the MoH can decrease the number of different regimens needed, leading to easier supply. In theory this means savings, but we need competition even among generic suppliers for these savings to be realised, and for Vietnam to be able to afford to reach its targets. This is even more important as donors begin to phase out their support.”
PEPFAR support is due to end in September 2021, but will only maintain support for 4,800 people between now and then, and Global Fund support is guaranteed only up until 2023. At the moment it is unclear whether support will continue past this date.
“The government will not only need to take over current procurement, but also increase it,” says Dong.
He explains that any drug procurements that made directly by the government are made via its Social Health Insurance (SHI) fund, and that for the Vietnamese government to take over procurement a number of things need to be in place:
1. The drug needs to listed as a preferred regimen in national guidelines – completed, thanks to civil society advocacy work.
2. The drug itself needs to registered and have marketing approval – completed.
3. At least three marketing authorizations (MAs) need to be in place – so far, there is only one.
Healthy competition is needed
“The lack of marketing authorizations is currently the main barrier to the MoH procuring TLD. Only one MA is in in place, with the current supplier, Mylan,” says Dong.
“In September this year, VNP+ directly contacted a number of generic manufacturers in India to encourage them to submit. Two companies replied to state that they had already submitted documents,” says Dong.
“It is not clear what the hold-up is. We have asked the Drug Administration Vietnam (DAV) to respond. It is unclear if the generic companies’ proposals fulfil the MoA, or how long assessment will take. In the meantime it is holding up access to drugs that could improve the lives of many thousands more.”
“136,000 people living with HIV are on treatment in Vietnam. It is a success that thousands of people are now receiving more optimal treatment but the option is still out of reach for the majority. Competition is key to the MoH reaching its targets and for more people to experience an improved quality of life.”
