Working with the Global Drug Facility Andrea de Lucia 30 October 2012 TBS

Global Drug Facility (11 professional staff, 3 assistants in HQ) Thomas Moore, ad interim Team Leader 14 October 2019 GDF Team Leader Office T. Cordier-Lasalle, Principal Officer P. Marroquin Lerga, Quality Assurance H. Castel, Technical Officer/FIN T. Dansie Assistant A. de Lucia Country Support Team Leader & Francophone AFRO TO J. Lashley, Assistant J. Loeber 1st line Procurement Team Leader E. Mochinova, TO A. Kasi-Nsubuga, TO K. Lunte 2nd line Procurement Team Leader A. Garcia Montes, PO V. Bruniquel, Assistant Regional GDF Staff A. Jafarov (HQ/EUR) VACANT (EMRO) N. Mouzafarova (EURO) VACANT (SEARO) VACANT (AFRO – 3 RSOs) E.Thanaraj (GDF India) 14/10/2019

GDF Model Client Stop TB Partnership/ Global Drug Facility Procurement Agents Manufactures GDF sits in the Stop TB partnership GDF does not conduct procurement itself, but contracts with procurement agents. Procurement agents contract with manufactures, quality control agencies and freight forwarders. GDF acts in a coordinating role between clients and the procurement agents. Quality Control Freight Forwarders

GDF Expansion since 2001 MDR scale-up Paediatric grants FLD grants FDL DP 2nd line DP Diagnostic kits Expand TB GeneXpert 2001 2004 2005 2006 2007 2008 2010 2011 Strategic Revolving Stockpile GDF has expanded its product line since 2001.

Trends in GDF Procurement GDF Business volume has increased 4 fold since 2007. USD 155 million in procurement was conducted in 2011, of which USD 103 million in direct procurement services, and USD 51 million in grant services.

Business Volume 2011 (grant & direct procurement)

GDF QUALITY ASSURANCE POLICY World Health Organization 14 October 2019 GDF QUALITY ASSURANCE POLICY Prequalification criteria for manufacturers and medicines: FPP is authorized by the relevant National Medicines Regulatory Authority (NMRA) in the country of use; AND Product is pre-qualified by WHO under the WHO PQP; OR Product is approved by an SRA; OR Product is found acceptable through a quality risk/benefit assessment process involving an Expert Review Panel (ERP). Time limited approval for 12 months pending WHO PQP or SRA approval This is reflected in the GDF QA policy implemented June 2010 and in full harmonisation with Global Fund QA policy http://www.stoptb.org/gdf/drugsupply/quality_sourcing_process.asp Established 2001 GDF/Stop TB Partnership/WHO 7

GDF DP Ordering Timelines TOTAL WITHIN GDF CONTROL: 3 - 6 MONTHS FROM DATE FUNDS RECEIVED Shipment (1-2 weeks air; 4-6 weeks sea) Pre shipment inspection & batch analysis (CRF) (4 weeks) Manufacturing (8-12 weeks if API is available, if not, add 4-12 weeks) GDF/PA place orders with manufacturers (1-2 weeks) Annual TB drug requirements quantified - unknown time frame NTP signs GDF procurement form/technical agreement for a request for quotation services- (average 2-3 weeks) Funding needs secured – unknown time frame GDF PROCUREMENT CYCLE ~8 MONTHS Lead times are most commonly misunderstood. In blue (right side) is what is out of GDF's control, and in green (left side) is what is in GDF's control. Moving clockwise: quantification, securing funding, requesting quotations is on the initiative of the NTP. Where most bottlenecks occur is in the signing of contracts and payments to procurement agent, which can take up to 2 months. NTP signs PA contract and payment is made (average 2 months) TOTAL WITHIN NTP/PR & DONOR CONTROL: ESTIMATE MINIMUM 5 MONTHS

Request for Quotation: Challenges Buffer stock & Shelf life: GDF recommends calculating a buffer stock in consideration of shelf life of products (most 1st line products have 24 months exp.); if 100% buffer is requested: stagger deliveries (every 6 months). Cost efficiency: limit air freight to no more than 20% of total order. Quotations are only valid for 90 days FLD and 60 days SDL: Client should clarify any outstanding questions on their PSM plan with the FPM prior to a request for quotation. This is will save weeks in quotation revisions.

Manufacturing: Challenges No stockpile available for 1st line drugs (fresh production takes 8-12 weeks); Strategic Rotating Stockpile available for certain 2nd line drugs for emergencies API not always available, especially for Rifampicin Batch requirements for paediatric drugs (manufacturers will wait until they receive enough orders for minimum batch quantities before production in started) API: Active Pharmaceutical Ingredient

GDF 1st Line anti-TB Drug Grants In 2011, GDF saw a sharp increase in requests for 1st line emergency grants: 24 approved 2010 vs 42 approved in 2011. In 2012, already 27 grants approved. Increase in demand commonly due to: late signing of new GF grants, PSM plan approvals, delay of Phase II signing, GF grant discontinued, or national funding not enough to cover needs or just not available.

2nd line anti-TB Patient treatments supplied by GDF, by WHO regions (data June 14, 2012)

GDF Diagnostics Old New New Diagnostics Expand TB Project "Narrowing the Gap: Expanding and accelerating access to diagnostics for patients at risk of MDR-TB" Project Partners GLI, GDF, FIND Operating in 27 countries (23 MOUs signed) 120,000 MDR-TB cases to be detected 87.5 million US$ budget -> Procurement of Liquid Culture and Line Probe Assay equipment via GDF Direct Procurement mechanism Gene Xpert (Cepheid Inc.) TB REACH Initiative 190 machines, 349,000 cartridges delivered 29 projects in 24 countries ~10 million US$ Standard Diagnostics · ~5 million US$ GDF Diagnostics New Diagnostics Old New Microscope Kit LED Microscope Equipment Starter Kit Equipment and Starter Kit Consumables Kit Diagnostics and Consumables Kit Sputum Container Kit

Technical Assistance in Drug Management GDF Monitoring Missions: quantification of annual needs & identification of further TA needs (44 missions in 2011 & ~65 missions in 2012); currently this is free of charge to direct procurement clients; reports shared with the FPMs Further in-country TA support will need to be paid for from GF/donor budget Regional Support Officers being recruited for AFRO and EMRO (Q4 2012) RSOs to provide individualized assistance to countries in order calculation and placement and in-country drug management training

Conclusion: GDF Added Value Pooled procurement: GDF is able to aggregate demand for anti-TB products for more timely & simplified procurement. Pricing: GDF conducts international bidding regularly in order to achieve competitive, transparent pricing. Quantification & Forecasting: GDF assists countries in identifying their drug needs and when they need them. Quality assurance policy aligned with the Global Fund Technical Assistance & monitoring: periodic monitoring of GDF clients and identification of their PSM challenges.