Transparency and access to pretomanid and the Nix-TB regimen
Advocates request responsible investment in pretomanid promoting transparency and equitable access.
On 29 July 2019, advocates sent an open letter to a group of stakeholders meeting in Italy, including donors and government representatives, to raise considerations related to pretomanid access and transparency, and concerns regarding the lack of community representation at the meeting.
“Further investments in pretomanid should be made responsibly, and include terms that promote transparency and equitable access as well as a strong return on public investment. We respectfully request your support to:
1. Make publicly available the full terms of the TB
Alliance’s licensing agreement with Mylan;
2. Secure from the TB Alliance an articulation of how it will
use revenue generated from sale of an FDA PRV [US Food and
Drug Administration Priority Review Voucher] if received as
expected;
3. Ensure a low global price based on costs of production
plus a reasonable margin;
4. Ensure availability and proper stewardship of pre-approval
access to pretomanid;
5. Expedite the additional toxicity studies required for
paediatric investigations of pretomanid to begin; and
6. Meaningfully consult with communities while determining
access plans and before committing any resources to the roll
out of this regimen [the Nix-TB regimen].”
To read the full letter, click here.
