Global Drug Facility Update

South East Asia Regional Green Light Committee Advisory Meeting: 18-19 January 2018

GDF participated in the regional Multidrug-Resistant Tuberculosis (MDR-TB) Advisory Committee Meeting on Fighting MDR-TB in the South East Asia (SEA) Region. The meeting was conducted in Jakarta, Indonesia, from 18–19 January 2018. Key priority countries were represented, including India, Indonesia, Myanmar and Bangladesh, among others. GDF presented updates on Procurement and Supply Management (PSM) from a regional perspective and showcased the increasing trend in SEA countries’ orders of new drugs and regimens: Bedaquiline (BDQ), Delamanid (DLM), optimized pediatric fixed-dose combination (FDC) formulation and the shorter treatment regimen. GDF also presented the global and country challenges to implementing new tools and how GDF and the programmes can overcome these challenges in close collaboration with partners. GDF has also discussed particular country PSM issues, such as reviewing procurement and supply plans and orders in the pipeline during side meetings. GDF will continue to work with each country, particularly with the priority countries, to accelerate the implementation of new drugs, medicine quantification and order management.

Stop TB/GDF Technical Assistance Mission to Indonesia: 22-26 January 2018

GDF conducted a Technical Assistance (TA) mission to Indonesia from 22-26 January 2018 jointly with the Global Fund. The main objective of the mission was to generate quantification in different scenarios of case enrollment and stock levels, and provide a realistic picture of the medicine supply situation regarding the implementation of new tools, particularly the shorter MDR-TB treatment regimen (STR), BDQ and DLM. The National TB Programme (NTP) started the implementation of STR in September 2018, but at a slower pace than previously anticipated due to challenges in administration of medicines, package distribution, unclear national guidelines concerning extension of lung disease as an exclusion criterion, unavailability of line probe assay (LPA) testing and clinicians’ hesitations to put MDR-TB patients on STR, mainly due to fear of treatment failure in the shorter regimen. The NTP and partners have already started to address these barriers with planned activities of releasing a new guideline, advocacy and policy dissemination through a high-level memorandum, more intense monitoring and supervision, etc. A slow uptake of STR could increase the risk of shortages in a few medicines used for the conventional longer regimen. GDF presented two scenarios of STR implementation to capture a more realistic uptake. The programme will make an informed decision about which scenario is the most realistic based on the country activity plans and will place medicine orders with GDF based on this judgement.

Stop TB/GDF Technical Assistance Mission to Tajikistan: 22-29 January 2018

Beginning in April 2018, the NTP will become a sole Principal Recipient of the Global Fund (GF) TB grant and the GF Country Team requested that GDF provide technical assistance in developing a comprehensive plan aimed at strengthening the NTP’s procurement supply capacity. For decades, Tajikistan has had an uninterrupted supply of quality-assured TB medicines, through external funding and GDF procurement. Currently, the country is transitioning to the state-funded procurement of first-line TB medicines (FLD) in 2018 and co-financing for the second-line drugs (SLD) and diagnostics. Tajikistan is the very first country in the European region which introduced optimized child-friendly pediatric formulations through a grant of Global Affairs Canada and first among Central Asian republics in the introduction of Bedaquiline and the shorter treatment regimens for drug-resistant TB (DR-TB) cases. Tajikistan is also one of the first countries which implemented the early warning and quantification system using the QuanTB tool.

Despite significant achievements, the NTP still faces challenges on TB medicine procurement and supply management. Even though the government allocated sufficient funds for FLD procurement, there is no clear plan for quality-assured medicine procurement. Almost half of the DR-TB cases do not have access to new TB medicines and regimens; the TB information system is paper-based and inadequate, hampering quality data collection for quantification and early warning of TB pharmaceuticals and diagnostics. In 2017, the country placed SLD procurement orders for more than 30 months due to the ending of GF grants and new GF finance procedures which state that unspent funds have to be deducted from the following grant. The NTP lacks capacity on TB PSM and the current systems are not institutionalized, which are mostly based on projects implemented by partner organizations and not by the NTP.

During the mission, the above-mentioned challenges were reviewed and discussed with all stakeholders and recommendations were elaborated on, including: options analysis for state procurement of quality-assured TB medicines; expansion of the pilot regions for the scale-up of new TB tools; institutionalization of the PSM systems, including quantification and early warning; carrying out regular and precise quantification exercises and monitoring rational consumption of medicines to prevent overstocks leading to wastage; and a more frequent procurement schedule – the NTP and the GF Country Team have agreed on twice-a-year procurement. GDF, in collaboration with in-country partner organizations and the Global Fund, will continue to provide direct TA to the NTP to ensure successful implementation of the GF grant and transitioning to state funding.