The mission of Stop TB’s Global Drug Facility (GDF) is to promote worldwide, equitable access to TB medicines and diagnostics. Playing the role of global TB market steward, GDF brings together key stakeholders – spanning the entire product life cycle – to ensure quality products are developed, adapted, affordable, and available for immediate introduction upon product launch and/or WHO Recommendation.
GDF is strategically positioned as the world’s largest procurer of TB products. GDF’s commitment to equity aims to ensure every country has access to GDF services and products. Heads of states and government representatives TB encouraged all nations to use the Stop TB Partnership’s Global Drug Facility in the 2018 UN Political Declaration on the Fight Against TB.
GDF applauds the 1/4/6 x 24 Campaign which aims to expedite access to new, shorter, optimized TB treatment regimens and pledges to:
1. Create an enabling environment for manufacturers to develop and supply TB products needed for 1/4/6 regimens
* Implement risk-sharing and incentives that encourage suppliers to develop fixed-dose combination products for 1/4/6 regimens to improve acceptability and adherence, as well as pediatric formulations so these are available once research studies confirm and WHO recommends 1/4/6 regimens for use in children.
* Together with the WHO Global TB Programme and other members of the GDF-led TB Procurement and Market-Shaping Action Team, ensure new products being developed by suppliers move swiftly through regulatory and policy channels that are required prior to national adoption, including: WHO Prequalification, WHO Model Essential Medicines List, Global Fund Expert Review Panel, Global Fund List of Health Products.
* Offer – through the GDF Product Catalog – the opportunity for all countries to procure all TB products needed to provide a complete package of TB care services
* Provide suppliers with regular forecasts to guide investment decisions and production planning.
* Ensure global supply security by attracting and maintaining a sufficient number of suppliers; and equitably prioritizing medicines in times of supply shortages and/or supply chain crises.
1. Support key stakeholders to expedite introduction of 1/4/6 regimens
* Collaborate with WHO and the Global Fund to develop Procurement and Supply guidance documents to support National TB Programs with 1/4/6 regimen introduction and scale-up.
* Monitor national introduction plans and in-country stock and conduct regular estimations of additional funding needed at national level for National TB Programs and global level for donors.
* Support National TB Programs and Global Fund Principal Recipients with budget revisions, reprogramming, and drafting of concept notes.
* Provide technical assistance to National TB Programs on supply planning in order to phase-out old regimens and phase-in new 1/4/6 regimens.
* Provide technical assistance to National TB Programs on procurement and supply planning to ensure consistent supply and avert treatment interruptions.
* Utilize unique GDF services such as the Strategic Rotating Stockpile to expedite new regimen introduction and avert stockouts.
* Identify and address procurement and policy issues that limit or delay 1/4/6 introduction and scale-up.
* Work closely with global and national civil society platforms to establish and lead a task force under the TB Procurement and Market-Shaping Action Team to assess and address the risks associated with increased domestic procurement in reaching 1/4/6×24 goals.
* Monitor & report on progress with procurement and adoption of 1/4/6 regimens and share with stakeholders.
* Provide procurement services to researchers to facilitate access to medicines needed to conduct clinical research for 1/4/6 regimens.
* Use initiatives such as the 2023 UN High-Level Meeting on TB and the December 2022 Rome 6 Meeting to advocate for funding and commitment to reach 1/4/6 goals, including development and implementation of new models of care to find, diagnose and treat children.