Large ARV Buyers and Sellers Forum 2016 Consolidated Demand Outlook 29 November, 2016 Geneva, Switzerland Republic of South Africa The Global Fund, PEPFAR and Government of South Africa will work together to improve the consolidated demand outlook What we will do Coordinated approach and messages What we will not do together Long-term agreements with manufacturers Synergistic strategies Direct engagement with suppliers & supplier visits (sometimes) Align on key supplier performance metrics Sharing of synthesized market intelligence and general supplier performance Sharing information (without providing confidential / sensitive information) Providing improved demand visibility Selection of suppliers and demand allocation Execution of purchase orders We will not manage actual supplier performance jointly Managing overall supplier performance (Price, lead-time, delivery etc.) 1 Buyers and Sellers Forum 2016 follows clear ground rules! We would like to reiterate our strong commitment to transparent, fair and competitive procurement processes. For example, according to the Global Fund’s Code of Conduct for Suppliers, corrupt, fraudulent, collusive, anti-competitive or coercive practices are not tolerated, and are subject to sanctions, which could include debarment from eligibility as a Global Fund supplier. Participants to the meeting must not: discuss with other participants your own or your competitors prices, price changes, price differentials, discounts, margins, or any terms of sale that might affect prices discuss individual company figures on costs, capacity, compensation, business opportunities, products or services, or sales, except for industry data such as interest rates that are made widely available to the industry by data services. discuss what individual companies plan to do in particular geographic or product markets or with particular customers or suppliers, including (a) customer or supplier policies, (b) the terms on which specific types of products may be distributed by a firm, (c) the elimination, restriction, or limitation of the quantity or quality of any product or service to be sold, or (d) the division or limitation of sales to particular territories, customers, or classes of customers. discuss specific future plans of your company or other companies concerning the design, production, distribution, pricing terms or marketing of particular products. discuss matters relating to actual or potential individual suppliers or customers that might have the effect of excluding them from any market or of influencing the business conduct of other companies toward such suppliers or customers. disclose to others any other competitively sensitive or confidential information. If you become aware of possible misconduct, this should be reported to the Office of the Inspector General. The Office of the Inspector General treats all reports carefully and protects the identity of all whistle-blowers. 2 Who is here today? Suppliers (manufacturers) - 22 Generic (16); originator (4); API (2); Including potential new entrants Hosts (large buyers) - 3 • PEPFAR/ USAID and its procurement agent GHSC-PSM • Global Fund • South Africa Department of Health • • • • • • • • • • • • • • • • • • • • • • Abbvie Acebright/Desano Aurobindo Pharma Celltrion Cipla Cipla – Quality Chemicals Uganda Emcure Pharmaceuticals Hetero Drugs Huahai pharm Johnson & Johnson/Janssen Laurus Labs Private Limited Lupin Macleods Pharmaceuticals Limited Merck & Co MSN Labs Mylan Laboratories Ltd SpecPharm Strides Sun Pharmaceutical Teva Universal Corporation ViiV HealthCare Partners - 7 • • • • • • • CHAI International AIDS Society Medicines Patent Pool MSF UNAIDS UNITAID WHO Building on the June 2014 ARV Supplier Conference • Increase the transparency of ARV orders for a more stable, visible and predictable demand • Establish inclusive buyer/seller forum with current and potential suppliers • annual in person buyer seller forums and periodic webcast • share forward visibility for 12-18 months: 1st/ 2nd line; transitions • discuss supply and demand opportunities and challenges • Enable annual or longer orders for larger countries and high volume products • Coordinate procurement and timing of low volume products through the multiagency coordinated procurement platform (APWG) • Intensify efforts to enhance retention including encourage programmes to move to multi-month dispensing and work with companies to develop compliance messages on labels • Work to harmonize and improve packaging and labelling specifications (e.g., fewer variants, lower volume packs) • Evolve procurement and sourcing strategies based on the situation needs and implementation experience 4 GLOBAL FUND EXAMPLE There are issues in how we manage demand, and we are currently working to review our processes Order volume fluctuates significantly… …and order placement lead times often cannot be fulfilled Order placement lead time and order fulfillment lead times, %, 2016 Order Volume, TLE, million packs 8 Order placement lead time Order fulfillment lead time 7 6 < 3 months 46% 5 4 3 - 6 months 3 2 6 - 9 months 37% 13% 39% 21% 12% 30% 1 0 Q1 Q2 Q3 2014 Q4 Q1 Q2 Q3 2015 Q4 Q1 Q2 Q3 > 9 months Better demand management needed 13% 37% Planned procurement, enabling best value (product and freight costs) 2016 NOTE: Lead time is defined as a time between purchase order being sent to vendor, and a shipment delivery date. Includes planned delivery. 5 GLOBAL FUND EXAMPLE Tanzania Time dimension is often missing in the forecast Original demand outlook can appear steady… Malawi …while actual orders can fluctuate quarter to quarter Forecasted orders, million packs, 2015 Actual orders, million packs, 2015 6.6 2.9 3.4 1.4 1.5 4.3 2.9 2.9 1.5 1.0 Ø3 Q2 Q3 Q4 1.3 1.3 2.0 1.4 1.9 1.3 Q1 Q2 Q3 Q4 Q1 • Originally project quarterly demand volumes are often relatively smooth across quarters • Shelf life of 85% at pick-up leaves only 3.6 months to distribute the goods (out of e.g. 24 months) – limiting the flexibility to reallocate between the quarters 1.9 0.3 2.3 1.9 0.2 1.7 Ø3 1.7 Actual orders fluctuate substantially due to • Anticipated stock-outs – leading countries to requests for financing and products from several sources at the same time • Uncertainty in government financing – driving unexpected shifts in partners’ demand NOTE: Lead time is defined as a time between purchase order being sent to vendor, and a shipment delivery date. Includes planned delivery. 6 SOURCE: Switching Procurement 5 products from 10+1 countries make up ~55% of demand from Global Fund, PEPFAR and South Africa ARV grant allocations 2015, Number of packs, million (percent of total) PEPFAR ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia Government of South Africa The Global Fund 193 39 52 28 6 103 Total Volume Bold font – non-PPM countries ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire 159 (82%) 33 52 ▪ TLE/TEE ▪ LZN (adult) ▪ LZN (pediatric) ▪ Atazanavir /Ritonavir ▪ Lopinavir /Ritonavir (adult) 23 18 12 75 Non-top-10 countries Top 10 countires Regular font – PPM countries Non-top-5 products in Top 10 countries 106 (55%) 21 34 52 Top 5 products in top 10 countries NOTE: Dates used are vendor INCO fulfillment dates. For the ease of analysis we excluded South Africa from The Global Fund funding. The PEPFAR data is USG Fiscal Year data. 7 SOURCE: Transactions Summary PQR; PEPFAR and Government of South Africa and data To improve demand forecasting we will focus on biggest countries and products to obtain a rough-cut overview In scope Currently, out of scope ▪ 18 months forecasting horizon ▪ Forecasting on a quarterly basis ▪ High-level forecast across top 10 ▪ Forecasts for longer than 18 months out ▪ Monthly forecasts ▪ Detailed bottom-up forecast, and in- countries and top 5 products, covering ~55% of demand country forecast / inventory review procedures ▪ Data from the Global Fund, PEPFAR and ▪ Integrating new sources of data and the government of South Africa ▪ ARVs only additional data sources ▪ Other health products (ANTM, ACT, LLIN) NOTE: ARV = Anti-Retroviral Treatment; ANTM= Anti-malarial medicine; MRDT = Malarial Rapid Diagnostic Test; ACT =Artemisinin-based Combination Therapy 8 Consolidated demand forecast is derived in 5 simple steps 1 Gather grant and order information from across top ~10 countries for top ~ 5 products 2 3 4 5 Translate order dates to the dates when order is placed towards the supplier, adjusting for shipment lead times if necessary Consolidate the information from The Global Fund, PEPFAR and The Government of South Africa Triangulate the data with the general population information and historical order patterns Prepare a product-specific quarterly forecast breakdown and share it with supplier and countries for their feedback 9 Caveats and limitations to the current version of the visibility data Conservative estimates based on currently confirmed orders Prepared based on data currently available to The Global Fund, Government of South Africa and PEPFAR Preliminary estimates for the discussion – and not final purchase commitments May not yet fully capture lead times between order placement at manufacturer and in-country delivery First time the joint consolidated procurement forecast has been prepared and shared 10 WORK IN PROGRESS Consolidated Demand Forecast Outlook Overall ARV Demand Outlook 2017-2018, Number of packs, million Bold font – non-PPM countries ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia PEPFAR Government of South Africa The Global Fund 33 12 9 13 Q1 31 5 9 19 5 9 5 17 Q2 Q3 ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire Regular font – PPM countries ▪ TLE/TEE ▪ LZN (adult) ▪ LZN (pediatric) ▪ Atazanavir /Ritonavir ▪ Lopinavir /Ritonavir (adult) 20 7 9 4 Q4 15 4 10 2 Q1 2017 2018 NOTE: Dates used are vendor INCO fulfillment dates. For the ease of analysis we excluded South Africa from The Global Fund funding. For South Africa, TEE is a predominant first-line instead of TLE. DISCLAIMER: This is an initial version of the forecast, and may contain inaccuracies – please refer to caveats and data limitations on page 10. These slides contain a conservative estimate for demand management between the three programs. As such, there may be future volumes not yet financially committed or confirmed. SOURCE: PEPFAR, Government of South Africa, The Global Fund 11 WORK IN PROGRESS TLE – Consolidated Demand Forecast Outlook ARV Demand Outlook 2017-2018, Number of packs, million Bold font – non-PPM countries ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia PEPFAR Government of South Africa The Global Fund 26 4 25 7 9 9 Q1 16 3 9 4 Q2 Regular font – PPM countries ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire 9 17 5 13 9 3 15 3 10 2 Q3 Q4 Q1 2017 2018 NOTE: Dates used are vendor INCO fulfillment dates. For the ease of analysis we excluded South Africa from The Global Fund funding. For South Africa, TEE is a predominant first-line instead of TLE. DISCLAIMER: This is an initial version of the forecast, and may contain inaccuracies – please refer to caveats and data limitations on page 10. These slides contain a conservative estimate for demand management between the three programs. As such, there may be future volumes not yet financially committed or confirmed. SOURCE: PEPFAR, Government of South Africa, The Global Fund 12 WORK IN PROGRESS LZN (Adult) – Consolidated Demand Forecast Outlook ARV Demand Outlook 2017-2018, Number of packs, thousands Bold font – non-PPM countries ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia PEPFAR The Global Fund Regular font – PPM countries ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire 6,290 3,290 2,725 170 2,555 1,249 3,000 800 449 Q1 121 Q2 Q3 2017 1,380 1,259 Q4 0 0 0 Q1 2018 NOTE: Dates used are vendor INCO fulfillment dates. For the ease of analysis we excluded South Africa from The Global Fund funding. DISCLAIMER: This is an initial version of the forecast, and may contain inaccuracies – please refer to caveats and data limitations on page 10. These slides contain a conservative estimate for demand management between the three programs. As such, there may be future volumes not yet financially committed or confirmed. SOURCE: PEPFAR, Government of South Africa, The Global Fund 13 WORK IN PROGRESS LZN (Pediatric) – Consolidated Demand Forecast Outlook ARV Demand Outlook 2017-2018, Number of packs, thousands Bold font – non-PPM countries ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia PEPFAR The Global Fund Regular font – PPM countries ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire 2,136 858 1,278 Q1 1,236 280 Q2 Q3 2017 824 239 585 0 Q4 Q1 2018 NOTE: Dates used are vendor INCO fulfillment dates. For the ease of analysis we excluded South Africa from The Global Fund funding. DISCLAIMER: This is an initial version of the forecast, and may contain inaccuracies – please refer to caveats and data limitations on page 10. These slides contain a conservative estimate for demand management between the three programs. As such, there may be future volumes not yet financially committed or confirmed. SOURCE: PEPFAR, Government of South Africa, The Global Fund 14 WORK IN PROGRESS ATV/r – Consolidated Demand Forecast Outlook ARV Demand Outlook 2017-2018, Number of packs, thousands Bold font – non-PPM countries ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia PEPFAR The Global Fund Regular font – PPM countries ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire 763 568 705 58 398 23 162 126 Q1 375 36 568 18 0 Q2 Q3 2017 Q4 18 0 Q1 2018 NOTE: Dates used are vendor INCO fulfillment dates. For the ease of analysis we excluded South Africa from The Global Fund funding. DISCLAIMER: This is an initial version of the forecast, and may contain inaccuracies – please refer to caveats and data limitations on page 10. These slides contain a conservative estimate for demand management between the three programs. As such, there may be future volumes not yet financially committed or confirmed. SOURCE: PEPFAR, Government of South Africa, The Global Fund 15 WORK IN PROGRESS LPV/r – Consolidated Demand Forecast Outlook ARV Demand Outlook 2017-2018, Number of packs, thousands Bold font – non-PPM countries ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia PEPFAR The Global Fund 577 469 Regular font – PPM countries ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire 642 508 260 297 413 180 382 108 95 Q1 Q2 130 50 Q3 2017 Q4 297 0 Q1 2018 NOTE: Dates used are vendor INCO fulfillment dates. For the ease of analysis we excluded South Africa from The Global Fund funding. DISCLAIMER: This is an initial version of the forecast, and may contain inaccuracies – please refer to caveats and data limitations on page 10. These slides contain a conservative estimate for demand management between the three programs. As such, there may be future volumes not yet financially committed or confirmed. SOURCE: PEPFAR, Government of South Africa, The Global Fund 16 There are several factors that need to be accounted for when preparing a consolidated forecast Different planning and procurement cycles across donors/buyers PEPFAR: one-year Global Fund: (up to) three-years South Africa: three-years Different budget cycles Support for country transitioning to Test/START Potential shifting in orders to accommodate Test/START Introduction and/or implementation of multi-month prescribing (MMP) Many national programs implementing MMP through 2018 Likely transition to Dolutegravir (DTG) A transition from TLE to TLD likely within the next 24 months 17 Consolidated demand outlook is useful beyond the pure forecast numbers Besides improved visibility for suppliers, consolidated demand outlook helps to Maintain dialogue between stakeholders – and to better understand key demand drivers at the global and country level Identify and correct outliers early on and smoothen demand towards manufacturers Work towards improving supply chain to and in the country Going forward, a consolidated data file with demand per buyer per product per quarter will be made available on a quarterly basis for detailed review and feedback 18 PEPFAR Supply Chain Update: New Thinking to Meet Demand, Improving Coordination, and Managing Change John Crowley USAID/GH/OHA/SCH 19 Overview • PEPFAR Approach to Planning and Ordering – New thinking is needed to meet demand • Next Evolution in Coordination – Efforts in collaboration and coordination are maturing • Methodology for Projecting Demand – National quantification forums determine demand • Managing Procurements – PSM manages the procurement process • Managing Change – Critical Procurement Considerations PEPFAR APPROACH Planning Framework to Meet Demand Maintain “Healthy Market” • • • Allocate orders across multiple suppliers “Best Value” contract award strategy Reward performance Support New Products • • • ARV prioritization Innovation criteria in tender evaluations Project OPTIMIZE • Country /product registration management Supplier Relationship Management Longer lead time forecasting Order volume allocation Mitigate Supply Risk • • • Increase Predictability Assure Product Availability • • • • • Annual volume commitments for majority of TLE Coordinated procurement for small volume products Annual quantification Annual supply & ordering plans Monitor on time & in full delivery by vendors Optimize RDC and VMI stock levels NEXT EVOLUTION PEPFAR and Global Fund Coordination • Improving the management of demand and improving partnerships with vendors is the next evolution to this effort • Given the magnitude of ARV demand and the new treatment guidelines, a more strategically aligned and coordinated ordering process for ARVs is essential to PEPFAR’s success – Provide for a more stable and predictable global generic ARV market – Create greater visibility into the timing and quantity of ARV orders – Ensure rational delivery schedule for country programs • Ten target counties: account for 60% and 90% of the GF and PEPFAR’s (respectively) total ARV demand for lower-middle income countries • Five products: combination of first/second line, and pediatric ARVs NEXT EVOLUTION Where is the Majority of ARV Spend? High-Volume Countries Global Fund Spend (FY14-15) PEPFAR Spend (FY14-15) Malawi $ 156,341,107 $0 Tanzania $ 130,956,109 $ 30,440,703 Zimbabwe $ 117,670,265 $ 50,015,649 Ethiopia $ 100,517,865 $ 20,000 Zambia $ 84,898,180 $ 62,111,531 Kenya $ 79,886,219 $ 97,436,412 Mozambique $ 46,963,029 $ 88,685,260 Nigeria $ 45,112,399 $ 99,295,685 Uganda $ 43,243,980 $ 79,509,842 Cote d’Ivoire $ 9,126,215 $ 27,633,044 $ 814,715,368 $ $535,148,126 Total Spend: NEXT EVOLUTION Coordinated Schedule for ARV Procurement • Expanding existing efforts and establishing a joint-forecasting and supply planning process using a coordinated schedule – Five products: combination of first/second line, and pediatric ARVs – Ten target countries: accounting for 60% and 90% of the GF and PEPFAR’s (respectively) total ARV demand for lower-middle income countries • Expanded coordination effort is not a significant shift – Sharing actual procurement scheduling and ordering data between Global Fund and PEPFAR for the next 12-18 months – Ensures a rational delivery schedule for country programs and greater predictability for manufacturers • Global Fund and USAID/SCH will collect, analyze and share ARV orders for the five products in the ten target countries PROJECTING PEPFAR DEMAND What is the Methodology Used? • Procurement data collected from annual country-level national quantification exercises and supply plans (adjusted quarterly) – PEPFAR supply chain technical staff and implementing partners are active participates in national quantification forums – PEPFAR procurement data reflects the agreed upon USG contributions to the national response supply plan based on annual country operational plans • USAID’s GHSC-PSM collected the data from across the ten target countries and synthesized for use • Represents the first time procurement data has been collected globally, merged with Global Fund and South Africa data, and shared with vendors – Fair to assume there may be inconsistencies – This is a first step in regular sharing of data (adjusted quarterly) MANAGING PEPFAR PROCUREMENT How Will Procurement Occur? • USAID’s GHSC-PSM is the intermediary for all USG procurement in the applicable target countries • USAID’s GHSC-PSM will collect, update and share procurement data through USAID Supply Chain for Health Division • USAID’s GHSC-PSM will implement a sourcing strategy focusing on – Annual minimum volume for TLE • Use standard industry evaluation criteria • enable improved production planning & greater efficiency • Multi-vendor PSM Procurement strategy uses the AQSCIR model Evaluation Criteria Weight (DRAFT) Assurance of Supply / Regulatory tbd% Quality tbd% Service tbd% Cost tbd% Innovation tbd% Price tbd% Total 100% ARV LTC RFQ team will establish requirements and technical questions aligned with AQSCIR model DRAFT not for circulation outside the USG 27 MANAGING PEPFAR PROCUREMENT GHSC-PSM Sourcing Strategy for LTC Volume Long Term Commitments (LTC) Allocate 75% of ‘committed’ country annual volumes of select ARV pharmaceuticals among vendors employing the AQSCI-P evaluation model to evaluate offers and allocate contracts Example for 100K packs: Country Committed Total Volume Vendor LTC Total Allocation Vendor A – Rank 1 - ##% ##K Packs Vendor B – Rank 2 - ##% ##K Packs Vendor C – Rank 3 - ##% ##K Packs Vendor D – Rank 4 - ##% ##K Packs Vendor E – Rank 4 - ##% TLE 100K packs TLE 75K packs Vendor F – Rank 4 - ##% ##K Packs ##K Packs Holdbac k 25% / 25K Packs Reserve Incentive Award Multi-vendor award allocations based on ARV LTC RFQ evaluation rankings MANAGING CHANGES IN PROCESS Procurement Planning Considerations • Different planning and procurement cycles across donors – PEPFAR: one-year – Global Fund: up to three-years – South Africa: three-years • Different planning and budgeting cycles • PEPFAR support for country transitioning to Test/START – Potential shifting in orders to accommodate Test/START • Introduction and/or implementation of multi-month prescribing (MMP) – Many national programs implementing MMP through 2018 • Likely transition to Dolutegravir (DTG) – A transition from TLE to TLD likely within the next 24 months Background on USAID’s OPTIMIZE Project • USAID-funded consortium launched in 2015 • Purpose: improve treatment outcomes – Optimize ARV drugs & formulations – Accelerate their introduction in LMICs • Approach integrates research, implementation science, and market access activities • Consortium members: Wits Reproductive Health & HIV Institute (lead), ICAP at Columbia University, Mylan, University of Liverpool, MPP (funded by UNITAID) • Target drugs: DTG, EFV400,TAF, DRV/r • Point of contact: Emily Harris, [email protected] Joint effort with UNITAID and other key players • USAID & UNITAD launched joint ART Optimisation Programme Advisory Committee (PAC), which is co-chaired by WHO and Global Fund – Aims to coordinate and communicate on ART optimization efforts – Harmonize & align investments of USAID & UNITAID • UNITAID ART programme includes closely aligned activities – CHAI Optimal project– market preparedness & community engagement – Wits RHI, University of Liverpool, University of New South Wales, Institut Bouisson Bertrand/ANRS– clinical trials and studies & community engagement – Related initiates: MPP, WHO Enabler, and WHO PQ activities • PAC developed multiple recommendations, including: – Coordinate key forecasts to align assumptions and portray a single, harmonized analysis – Expand PEPFAR and Global Fund’s coordination on procurement to include transitions to new products South Africa Mr Gavin Steel Chief Director: Sector-wide Procurement South African National Department Of Health Geneva November 2016 Contents 1. Demand Forecast 2. Value For Money 3. Supplier Performance 33 1. Demand Forecast 34 Demand Forecast Method Procurement Data Patients per regimen • Patient numbers = average of: o Patients derived from Procurement data (RSA Pharma database), and o District Health Information System (DHIS) data Programme Patient Data 35 Deriving Patient Numbers Cascade method used to derive patient numbers from procurement data Regimens • South African National Consolidated Guidelines for the Prevention of Mother-to-Child Transmission of HIV and the Management of HIV in Children, Adolescents and Adults, 2015 Adult 1L TDF+FTC+EFV TDF+FTC+NVP TDF+3TC+EFV TDF+3TC+NVP AZT+3TC+EFV AZT+3TC+NVP ABC+3TC+EFV ABC+3TC+NVP Adult 2L TDF+3TC+LPV/r TDF+FTC+LPV/r AZT+3TC+LPV/r AZT+TDF+3TC+LPV/r ABC+3TC+LPV/r TDF+3TC+ATV/r TDF+FTC+ATV/r AZT+3TC+ATV/r AZT+TDF+3TC+ATV/r ABC+3TC+ATV/r Peds 1L ABC+3TC+LPV/r ABC+3TC+EFV ABC+3TC+NVP Peds 2L AZT+3TC+LPV/r AZT+ABC+LPV/r 36 Patient Growth • Monthly growth rate calculated based on DHIS data • Number of adults and children under the age of 15 started on ART per month • Monthly growth rate using a 3 month’s average of new patients on ART, per month Total: o Monthly growth Adults: 52 450 patients 54 373 patients o Monthly growth Paediatrics: 1 923 patients • Scale up for Universal Test and Treat: • Based on a modeling study1 • Estimated increase in patient numbers: 164 000/annum • Included across all regimens 1. Bor J, Ahmed S, Fox M, Rose S, Meyer-Rath G, Katz IT, Tanser F, Pillay D, Bärnighausen. Effect of eliminating CD4-count thresholds on HIV treatment initiation in South Africa: an empirical modeling study. Unpublished manuscript. 2016 37 Attrition Rates • Definition: loss of patient due to death and loss to follow up • Adult attrition rate: o Based on epidemiological studies (adults: Ahonkhai et al1) o After 12 months on ART, attrition rate is 26% o Monthly attrition rate: 2.48% Assumptions & limitations: • Attrition rate same for all patients and all months o 1st line and 2nd line o Newly initiated and existing patients • Attrition rate is same amongst all provinces • Attrition rate of paediatrics is half of the adult rate 1. Ahonkhai AA., Noubary F., Munro A., et al. “Not All Are Lost: Interrupted Laboratory Monitoring, Early Death, and Loss to Follow-Up (LFTU) in a Large South African Treatment Program.” PLoS Med. 2012 March; 7(3): e32993. Migration Rate From 1st to 2nd Line Regimens Migration rate (epidemiological data): • Adult o After 5 years on ART, 10.1% patients switch from 1st to 2nd line therapy1 o Monthly switch rate: 0.18% • Paediatric o After 42 months on ART, 6.3% virological failure rate2 o Monthly switch rate: 0.15% Assumptions & limitations for migration rates: • Migration to 2nd line are the same for all 1st line patients • Stay constant throughout forecast period • Same for all provinces 1. MP., Cutsem GV., Giddy J., et al. “Rates and Predictors of Failure of First-line Antiretroviral Therapy and Switch to Second-line ART in South Africa.” J Acquir Immune Defic Syndr 2012;60:428-437. 2. Davies M., Boulle A., Technau K., et al. “The role of targeted viral load testing in diagnosing virological failure in children on antiretroviral therapy with immunological failure.” Trop Med Int Health. 2012 November; 17(11):doi:10.1111/j.1365-3156.2012.03073.x. Other input assumptions Switches within regimens: Switch rates based on epidemiological data1 and expert advice Assumptions: switches within regimens • Remains constant between 1st line regimens throughout forecast period • Same for all provinces • No switches within 2nd line regimens Paediatric weight distribution Based on data from Rahima Moosa Hospital (Gauteng) Assumptions & limitations: • Weight distribution remains constant over forecast period • Applies to all provinces 1. Njuguna C., Orrell C., Kaplan R., et al. “Rates of Switching Antiretroviral Drugs in a Primary Care Service in South Africa before and after introduction of Tenofovir .” PLOS ONE 2013; vol 8: issue 5: pp1-7 Forecasted Patient Numbers (Current) Avg./month Avg./month Dec. 2016 2017 2018 Total adults 3 531 373 3 478 507 4 330 796 Total paediatrics 204 200 196 090 234 702 Total patients 3 735 572 3 674 597 4 565 497 41 1st line regimen distribution: Adults 1st Line Regimen TDF + FTC + EFV TDF+FTC+NVP TDF+3TC+EFV TDF+3TC+NVP AZT+3TC+EFV AZT+3TC+NVP ABC+3TC+EFV ABC+3TC+NVP Total (Current) Dec. 2016 2 940 284 244 160 47 219 814 11 966 3 261 103 641 4 099 3 355 444 Avg./month 2017 3 145 057 346 304 45 756 539 5 969 2 934 90 495 3 457 3 640 510 Avg./month 2018 3 521 002 492 114 44 857 239 5 093 2 363 73 574 2 503 4 141 745 42 1st line regimen distribution: Paeds 1st Line Regimen ABC + 3TC + LPV/r ABC+3TC+EFV ABC+3TC+NVP Total (Current) Dec. 2016 98 833 101 798 1 650 202 281 Avg./month 2017 104 194 107 892 1 028 213 115 43 Avg./month 2018 114 079 118 135 963 233 177 2nd line regimen distribution: Adults 2nd Line Regimen TDF + 3TC + LPV/r TDF+FTC+LPV/r AZT+3TC+LPV/r AZT+TDF+3TC+LPV/r ABC+3TC+LPV/r TDF+3TC+ATV/r TDF+FTC+ATV/r AZT+3TC+ATV/r AZT+TDF+3TC+ATV/r ABC+3TC+ATV/r Total (Current) Dec. 2016 12 909 33 330 69 090 4 395 43 529 5 132 1 864 2 678 73 2 931 175 929 Avg./month 2017 Avg./month 2018 12 298 29 620 87 582 3 747 37 112 4 375 1 589 2 283 62 2 499 181 167 11 380 24 037 115 410 2 772 27 456 3 237 1 175 1 689 46 1 849 189 051 44 2nd line regimen distribution: Paeds TABLE: Number of Patients 2nd Line Regimen AZT + 3TC + LPV/r AZT+ABC+LPV/r Total (Current) Dec. 2016 1 067 852 1 919 Avg./month 2017 Avg./month 2018 985 786 1 771 848 677 1 525 45 Estimated Financial Value DEC 2016 Total Estimated Annual Value (12 months) Average Value per Month R 537 413 861 2017 2018 R 2293 926 793 R 2 554 121 629 R 573 481 698 R 638 530 407 Total Estimated Value (2017 + 2018) R 4 848 048 421 Avg. Value per Month (2017 – 2018) R 606 006 053 2017: January 2017 – December 2017; 2018: January 2018 – December 2018; Prices from MPC, November 2016 Current contract expires early 2018 Planning has been initiated for new tendering process, including market and business intelligence to ensure security of supply and competitive pricing. 46 2. Value For Money 47 Visibility & Analytics Network The VAN is the combination of People, Process, Technology and Policy organised coherently to ensure medicine availability and supply chain efficiencies: Element The VAN is… The VAN is more than just… • A team of dedicated professionals with defined roles and responsibilities, the right skills and knowledge, and a patient-centred, proactive approach to evidence-based quality improvement. • A new name for the existing roles. • Minor changes to organisational structures. • A small once-off change management effort. Process • Data driven processes that use analytical methods to continually plan, proactively respond to, and recommend improvements. • New standard operating procedures • Business process re-engineering • One-off system redesign Tech • The integration of multiple data systems, to generate alerts and actionable insight across the value chain with automation wherever possible. • A new logistics and information system to support procurement and stock or financial transactions • Dashboards, reports and analytics platforms • A cross-cutting governance framework with clear responsibilities and accountability and empowered decision makers with defined ‘spans of control’ across the value chain. • An improvement mechanism for one domain (e.g. just procurement, warehousing). • A project to improve milestones/KPIs for one program e.g. CCMDD. People Policy Policy Tech Process People The VAN is an Operating Model, the combination of People, Process, Technology and Policy 48 Demand Forecasting and Planning Bottom Up Top Down Demand planning applies anticipated trends and constraints to historical data treated with statistical rigor (baseline forecast) to develop a consensus Demand Plan across products and facilities: Forecasted Gross Adds • By geography • Demographics • Epidemiology Forecasted EML / MPC • Product • Lifecycle / STG Relevance • Price point / Affordability • Campaigns Historical Data • Consumption • Availability to Consume • Historical Campaigns • Epidemiology Statistical Modeling • Analyze consumption trends • Adjust based on forecasted gross adds and formulary picks by province / facility • Constrain Forecast by Available Budget Product View by: • Product type • Programmes • Campaigns • STGs Demand Plan Geography View by: • Province / District • Channel • Facility/Treatment Tier 49 Supply Planning Supply planning determines inventory targets based on the demand plan, variables that are channel specific, and supplier input to determine a consensus supply plan across products and geographies: Demand Plan By product By Geography Planning Variables Demand Forecast accuracy Replenishment frequency Stock on Hand Sample Rate Demand variability Product availability Order cycle time / total lead time Product Expiry / Longevity Supplier Collaboration Manufacturing constraints (e.g. API) Production schedules Supplier Stock Holding (VMI) Lead times Inventory Netting Depot Cycle Stock + Safety Stock – On-Hand Inventor –y Open Orders + Facility Cycle Stock + Safety Stock – On-Hand Inventor –y Open Orders Product View by: • Product type • Programmes • Campaigns • STGs Supply Plan (orders) & Replenishment Plan (shipments) Geography View by: • Province / District • Channel • Facility/Treatment Tier 50 3. Supplier Performance 51 Antiretroviral Supply Contract • • • • http://www.health.gov.za/tender/docs/contracts/HP132015ARVApril2015toM ar2018.pdf INCOTerm – Delivery Duty Paid (DDP) Performance Management Criteria – Lead Time Performance (LT) – On Time and In Full Deliveries (OTIF) – Contractor Engagement & Reporting Monitoring – System development, RSA Pharma, where suppliers report monthly on LT & OTIF as well as fortnightly on their pipeline – Scorecards that inform future contract award – Dashboards to manage operational activities 52 OTIF for ARV Suppliers 53 Supplier OTIF for TEE Supply 54 LT for ARV Suppliers Average: 65% 55 Supplier LT for TEE Supply 56 Thank You 57 Implementing the Global Fund’s Market Shaping Strategy 29 November 2016 Geneva Global Fund has proactively shaped markets to improve health outcomes since 2004 Market Shaping Strategy is approved by Board, with focus on pooling procurement, value for money, capacity building and ARVs With WHO, recipients transitioned to ACTs from suboptimal therapies 2004 2007 Board approves first Market Shaping Strategy, including Price & Quality Reporting and Voluntary Pooled Procurement 2011 2013 2015 Operational initiatives through Procurement for Impact strengthen market shaping tools Changing market dynamics, context, and new Global Fund strategy prompted revision of Market Shaping Strategy 59 Market Shaping Strategic objectives: New strategic actions & level of effort: 2015 Strategic objective Ensure the continued availability and affordability of health products Continue, Refine, Institutionalize a) Continue to facilitate market transparency d) Extend benefits of market shaping b) c) Leverage strategic procurement via PPM Prevent and respond to potential stock-outs and emergency orders Continue to define and enforce quality standards for Global Fund-financed products c) Strengthen quality standards for diagnostics & other non-pharmaceutical health products a) Promote consistent quality standards Support efforts to stimulate innovation Accelerate the adoption of new and/or more cost-effective products Prepare for country transition and support long-term market viability Strengthen key market shaping enablers Invest going forward b) Support the WHO prequalification programme and collaborative registration a) Recognize value of innovation in sourcing strategies, with differentiated approaches a) Accelerate the introduction of products for which there are few QA’d suppliers a) Invest in strengthening in-country PSM systems and national regulatory authorities a) Continue to strengthen and operationalize partnerships Investment already made; little additional required b) d) b) Proactively optimize product selection within WHO guidance Coordinate with partners to develop and implement “roadmaps” for key product needs Coordinate with partners to reduce risk of market entry Build in-country PSM capacity c) Incorporate market health in transition plans d) Assess additional market implications of transition and develop interventions c) b) Strengthen tools and systems for forecasting, market intelligence and data management Substantive upfront, or some ongoing investment Significant initiative over period of strategy The Global Fund has introduced a more balanced supply system based on 5 elements to improve supplier performance A E Benefit sharing D Risk management A Cost competitiveness Balanced supply system B Performance Providing products at the lowest possible affordable and sustainable price to reach the maximum number of patients Reducing price volatility and eliminating predatory pricing Supplying product timely and in full B Incentivizing suppliers to introduce better formulations C Supporting new suppliers to ensure sufficient supply and mitigate geographic supply risks Investing in suppliers with sustainable manufacturing practices Maintaining well-diversified supplier base D Meeting The Global Fund and national quality requirements Mitigating implementation risks C Sustainability Publishing reference prices E Building capacity and implementing rapid supply mechanisms 61 Selection of suppliers depends both on commercial and other technical / value criteria Supplier / product score 45.5% 45.5% 54.5% 54.5% Commercial Technical and Value Initial price Target pricing: 1st line products; equalization of pricing for alternate 1st and 2nd line products; better pediatric formulations Delivery performance (OTIF) Quality elements: shelf life, national registrations API supply security (alternative sources) Supply of high and low volume products Commitment, ability and approach 62 TOP 5 PRODUCTS ACROSS TOP 10 COUNTRIES Today's process for The Global Fund is primarily a top-down approach Forecast calculated Process steps Data sources/ rationale Owners Gather key countries / products information Extrapolate for other countries Prepare Forecast Share allocations Gather grant / order information across top ~10 countries / top ~ 5 products Create initial demand estimate Add 30% to the demand estimate to account for other countries / products Informal info from individual countries List of Health Products (LOHP)1 Historical: value for non-top 10 countries 5 products was ~30% of total Safety buffer for an unexpected demand and product transitions Procurement Procurement Procurement Add certain safety margin to derive a PPM Forecast Final forecast released Calculate and share commitments Share 80% volume of the PPM forecast as the allocation value Reserve 20% for new entrants (PPM) Communicate 70% of PPM forecast volume as commitment volume Driven by the Global Fund policy Driven by the Global Fund policy Procurement Procurement Ongoing Time Forecast today is generated top-down based on informally gathered information on key countries and products, and could be further strengthened by incorporating triangulation with orders history, clear preparation timeline and regular reviews 1 Derived from national in-country quantification 63 Global Fund demand: 10 countries/5 products TLE LZN LZN paed ATV/r LPV/r Total Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 8,957,753 4,476,900 12,710,418 3,034,602 1,540,000 2,979,790 448,714 2,555,417 121,168 1,278,324 279,691 1,236,025 584,680 57,534 143,221 374,711 107,543 95,343 382,256 50,036 13,380,944 5,443,869 17,258,827 3,790,486 1,540,000 ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire Bold font – non-PPM countries Regular font – PPM countries Global Fund 2017-2019 Funding Cycle • Donors pledged US$ 12.9 billion at the Global Fund’s 5th Replenishment in September for the 2017-2019 funding cycle • Eligible countries will receive their allocation amount in December 2016 • Able to access their funding over the 2017- 2019 period • Grants can start after the current grant ends, last 3 years as standard and end at least a year after the allocation period in order to allow a 12 month buffer to apply for new funding http://www.theglobalfund.org/en/applying/funding/resources/ Large ARV Buyers and Sellers Forum 2016 – Breakout Session Demand Management – potential for improving process and visibility November 29, 2016 Geneva, Switzerland Republic of South Africa Buyers and Sellers Forum 2016 follows clear ground rules! We would like to reiterate our strong commitment to transparent, fair and competitive procurement processes. For example, according to the Global Fund’s Code of Conduct for Suppliers, corrupt, fraudulent, collusive, anti-competitive or coercive practices are not tolerated, and are subject to sanctions, which could include debarment from eligibility as a Global Fund supplier. Participants to the meeting must not: discuss with other participants your own or your competitors prices, price changes, price differentials, discounts, margins, or any terms of sale that might affect prices discuss individual company figures on costs, capacity, compensation, business opportunities, products or services, or sales, except for industry data such as interest rates that are made widely available to the industry by data services. discuss what individual companies plan to do in particular geographic or product markets or with particular customers or suppliers, including (a) customer or supplier policies, (b) the terms on which specific types of products may be distributed by a firm, (c) the elimination, restriction, or limitation of the quantity or quality of any product or service to be sold, or (d) the division or limitation of sales to particular territories, customers, or classes of customers. discuss specific future plans of your company or other companies concerning the design, production, distribution, pricing terms or marketing of particular products. discuss matters relating to actual or potential individual suppliers or customers that might have the effect of excluding them from any market or of influencing the business conduct of other companies toward such suppliers or customers. disclose to others any other competitively sensitive or confidential information. If you become aware of possible misconduct, this should be reported to the Office of the Inspector General. The Office of the Inspector General treats all reports carefully and protects the identity of all whistle-blowers. 67 Contents Background: current state and main issues Way forward: potential changes and enablers required Breakout discussion: challenges and next steps Value creation levers and case studies Breakout discussion: challenges and next steps Background: Supplier Performance Evaluation Breakout discussion: challenges and next steps 68 GLOBAL FUND EXAMPLE There are issues in how we manage demand, and we are currently working to review our processes Order volume fluctuates significantly… …and order placement lead times often cannot be fulfilled Order placement lead time and order fulfillment lead times, %, 2016 Order Volume, TLE, million packs 8 Order placement lead time Order fulfillment lead time 7 6 < 3 months 46% 37% 13% 5 4 3 - 6 months 3 2 6 - 9 months 39% 21% 12% 30% 1 0 Q1 Q2 Q3 2014 Q4 Q1 Q2 Q3 2015 Q4 Q1 Q2 Q3 > 9 months Better demand management needed 13% 37% Planned procurement, enabling best value (product and freight costs) 2016 NOTE: Lead time is defined as a time between purchase order being sent to vendor, and a shipment delivery date. Includes planned delivery. 69 GLOBAL FUND EXAMPLE Countries have below-benchmark forecast accuracy, annual forecasts much more accurate than quarterly Forecast accuracy (FCA), across top 10 countries, Percent (Monthly) FCA benchmarks Quarterly (2015) Annual (2015) ▪ Most countries annual and quarterly FCA is below monthly FCA benchmarks ▪ Quarterly accuracy is substantially lower than annual, suggesting improvement potential along timing dimension 99% 79% Top: 72% Avg: 65% 66% 74% 69% 64% 50% 44% 46% 40% 47% 36% 23% 27% 18% 12% 8% 19% 19% 14% 1% BF 44% 0% CM CG CI GH GQ 0% MW MZ NG TZ UG ZM NOTE: Forecasting accuracy is defined as 100%- (ABS(FCT - ACT) / ACT); quarterly accuracy is the average accuracy of forecasts for Q1- Q4 2015 Dates are the delivery dates for actuals / in-country need-by dates for forecasts 70 SOURCE: Transactions Summary PQR; McKinsey POBOS GLOBAL FUND EXAMPLE Tanzania Time dimension is often missing in the forecast Original demand outlook can appear steady… Malawi …while actual orders can fluctuate quarter to quarter Forecasted orders, million packs, 2015 Actual orders, million packs, 2015 6.6 2.9 3.4 1.4 1.5 4.3 2.9 2.9 1.5 1.0 Ø3 Q2 Q3 Q4 1.3 1.3 2.0 1.4 1.9 1.3 Q1 Q2 Q3 Q4 Q1 • Originally project quarterly demand volumes are often relatively smooth across quarters • Shelf life of 85% at pick-up leaves only 3.6 months to distribute the goods (out of e.g. 24 months) – limiting the flexibility to reallocate between the quarters 1.9 0.3 2.3 1.9 0.2 1.7 Ø3 1.7 Actual orders fluctuate substantially due to • Anticipated stock-outs – leading countries to requests for financing and products from several sources at the same time • Uncertainty in government financing – driving unexpected shifts in partners’ demand NOTE: Lead time is defined as a time between purchase order being sent to vendor, and a shipment delivery date. Includes planned delivery. 71 SOURCE: Switching Procurement 5 products from 10+1 countries make up ~55% of grant allocations by Global Fund, PEPFAR and South Africa ARV grant allocations 2015, Number of packs, million (percent of total) PEPFAR ▪ Malawi ▪ Tanzania ▪ Zimbabwe ▪ Ethiopia ▪ Zambia Government of South Africa The Global Fund 193 39 52 28 6 103 Total Volume Bold font – non-PPM countries ▪ Kenya ▪ Mozambique ▪ Nigeria ▪ Uganda ▪ Cote d'Ivoire 159 (82%) 33 52 ▪ TLE ▪ LZN (adult) ▪ LZN (pediatric) ▪ Atazanavir /Ritonavir ▪ Lopinavir /Ritonavir (adult) 23 18 12 75 Non-top-10 countries Top 10 countries Regular font – PPM countries Non-top-5 products in Top 10 countries 106 (55%) 21 34 52 Top 5 products in top 10 countries NOTE: Dates used are vendor INCO fulfillment dates. For the ease of analysis we excluded South Africa from The Global Fund funding. The PEPFAR data is USG Fiscal Year data. For South Africa, TEE is reported instead of TLE. 72 SOURCE: Transactions Summary PQR; PEPFAR and Government of South Africa and data To improve demand forecasting in the short-term, we will focus on biggest countries and products to obtain a rough-cut overview In scope Currently, out of scope ▪ 18 months forecasting horizon ▪ Forecasting on a quarterly basis ▪ High-level forecast across top 10 ▪ Forecasts for longer than 18 months out ▪ Monthly forecasts ▪ Detailed bottom-up forecast, and in- countries and top 5 products, covering ~55% of demand country forecast / inventory review procedures ▪ Data from the Global Fund, PEPFAR and ▪ Integrating new sources of data and the government of South Africa ▪ ARV drugs only additional data sources ▪ Other health products (ANTM, LLIN) NOTE: ARV = Anti-Retroviral Treatment; ANTM= Anti-malarial medicine 73 Contents Background: current state and main issues Way forward: potential changes and enablers required Breakout discussion: challenges and next steps Value creation levers and case studies Breakout discussion: challenges and next steps Background: Supplier Performance Evaluation Breakout discussion: challenges and next steps 74 Demand Management is one of value creation levers aimed at creating mutual benefits, rather than purely attacking suppliers’ margin Detailed further Different levers employed aim at facilitating processing factors without Typical cost structure, illustrative Levers used Example impact Margin Price-centric RFP approach Freight Overhead Direct labor CAPEX Materials Sourcing Demand management Processes and product lifecycle Supply chain optimization Competitive bidding situations Firm price negotiations Cheaper raw materials due to volume commitments API supplier optimization Reduced freight costs from better mode selection No rush order overtimes Less overheads to deal with regulatory and compliance Batch size optimization Cheaper transportation from better space utilization Reduced write-off risks Rather than focusing purely on price reduction through margin – value creation levers address other cost components (which make up a much larger share of total product cost), creating value for both parties without “squeezing the suppliers” 75 There are tangible benefits for all stakeholders from the improved demand management process Demand Management Patients & HIV programs Partner organizations Suppliers Increased delivery reliability More affordable and sustainable prices Optimized raw materials sourcing Supply security and less need for “rush orders” Better transparency into country requirements More efficient production scheduling Lower “safety stock” requirements Lead time reduction Reduced write-offs and obsolescence 76 TOP 5 PRODUCTS ACROSS TOP 10 COUNTRIES Today's process for The Global Fund is primarily a top-down approach Forecast calculated Process steps Data sources/ rationale Owners Gather key countries / products information Extrapolate for other countries Prepare Forecast Share allocations Gather grant / order information across top ~10 countries / top ~ 5 products Create initial demand estimate Add 30% to the demand estimate to account for other countries / products Informal info from individual countries List of Health Products (LOHP)1 Historical: value for non-top 10 countries 5 products was ~30% of total Safety buffer for an unexpected demand and product transitions Procurement Procurement Procurement Add certain safety margin to derive a PPM Forecast Final forecast released Calculate and share commitments Share 80% volume of the PPM forecast as the allocation value Reserve 20% for new entrants (PPM) Communicate 70% of PPM forecast volume as commitment volume Driven by the Global Fund policy Driven by the Global Fund policy Procurement Procurement Ongoing Time Forecast today is generated top-down based on informally gathered information on key countries and products, and could be further strengthened by incorporating triangulation with orders history, clear preparation timeline and regular reviews 1 Derived from national in-country quantification 77 REPUBLIC OF SOUTH AFRICA EXAMPLE Demand Forecasting and Planning process in South Africa Demand planning applies anticipated trends and constraints to historical data treated with statistical rigor (baseline forecast) to develop a consensus Demand Plan across products and facilities 78 PEPFAR EXAMPLE Demand Forecasting process used by PEPFAR Procurement data collects from annual country-level national quantification exercises and supply plans (adjusted quarterly) PEPFAR supply chain technical staff and implementing partners are active participates in national quantification forums PEPFAR procurement data reflects the agreed upon USG contributions to the national response supply plan based on annual country operational plans USAID’s GHSC-PSM collects the data from across all PEPFAR countries1 and synthesizes for use Represents the first time procurement data is collected globally, merged with Global Fund and South Africa data, and shared with vendors Fair to assume there may be inconsistencies This is a first step in regular sharing of data (adjusted quarterly) 1 Not including Kenya, where it is collected by KEMSA 79 TOP 5 PRODUCTS ACROSS TOP 10 COUNTRIES There are opportunities to improve today’s process Create a forecast with the time dimension Initial forecast calculated Update and finalize forecast Analyse demand Prepare and triangulate a master forecast (quarterly for 18 months out) Review forecast with other stakeholders Incorporate obtained feedback Compare the actual vs historical forecast quantities The Global Fund PR, PEPFAR and South Africa orders Revised inputs Partners’ feedback Unanticipated orders from PRs, PEPFAR, and South Historical forecasts Actual orders Procurement Procurement Procurement Partners Procurement Weeks 4 – 5 Weeks 6 – 9 Weeks 10 – 12 Ongoing Prepare forecast Collect, clean and capture the data The Global Fund PR, PEPFAR and South Africa orders HIV program relationship Weeks 1 – 3 Process steps Owners Time Introduce forecast expost analysis Final forecast released Gather stakeholders’ feedback (PRs / funders / buyers) Gather information Data sources Key changes Assign clear owners for forecast updates The review process happens twice a year – with major changes communicated back to suppliers when necessary Introduce strict deadlines for forecast preparation and update Analyze forecast Discipline & Accountability are key factors of success 80 To get from “as-is” to “to-be”, several enablers will need to be activated Immediate steps Actions we need to take Country Program Ownership ▪ ▪ Adjust incentives Collaboration between parties Top 10 countries prepare anticipated orders for next 18 Countries have the best overview of months, and monitore actual demand across top 5 medications their own future demand and other stakeholders rely on this information PEPFAR, RSA and The Global Fund compile the gathered data in country dashboards ▪ Strict timelines Benefits ▪ ▪ Strict timelines and schedule for each of the participants to adhere to Forecasts are reported by countries regularly Forecasting review and update process is performed every half-a-year Timely provision of information ensures preparation of accurate forecasts ▪ ▪ ▪ Countries are incentivized to stick to forecast 6–9 months lead times are firmly communicated Counterparties adhere to commitments made Allows for more stable demand forecast, accounting for time dimension Reduces ad-hoc buys will help to stabilize demand ▪ Top 10 countries / top 5 products approach adopted by non PPM, PEPFAR, GSA PEPFAR, TGF and GSA collect and exchange data on a regular basis Collaboration on data collected by big LMIC donors Allows for one consolidated forecast across Global Fund, RSA and PEPFAR Improves transparency and ability to plan capacity for suppliers ▪ ▪ 81 Contents Background: current state and main issues Way forward: potential changes and enablers required Breakout discussion: challenges and next steps Value creation levers and case studies Breakout discussion: challenges and next steps Background: Supplier Performance Evaluation Breakout discussion: challenges and next steps 82 Large ARV Buyers and Sellers Forum 2016 – Breakout Session Value for Money – options and incentives for improved collaboration 29 November, 2016 Geneva, Switzerland Republic of South Africa Buyers and Sellers Forum 2016 follows clear ground rules! We would like to reiterate our strong commitment to transparent, fair and competitive procurement processes. For example, according to the Global Fund’s Code of Conduct for Suppliers, corrupt, fraudulent, collusive, anti-competitive or coercive practices are not tolerated, and are subject to sanctions, which could include debarment from eligibility as a Global Fund supplier. Participants to the meeting must not: discuss with other participants your own or your competitors prices, price changes, price differentials, discounts, margins, or any terms of sale that might affect prices discuss individual company figures on costs, capacity, compensation, business opportunities, products or services, or sales, except for industry data such as interest rates that are made widely available to the industry by data services. discuss what individual companies plan to do in particular geographic or product markets or with particular customers or suppliers, including (a) customer or supplier policies, (b) the terms on which specific types of products may be distributed by a firm, (c) the elimination, restriction, or limitation of the quantity or quality of any product or service to be sold, or (d) the division or limitation of sales to particular territories, customers, or classes of customers. discuss specific future plans of your company or other companies concerning the design, production, distribution, pricing terms or marketing of particular products. discuss matters relating to actual or potential individual suppliers or customers that might have the effect of excluding them from any market or of influencing the business conduct of other companies toward such suppliers or customers. disclose to others any other competitively sensitive or confidential information. If you become aware of possible misconduct, this should be reported to the Office of the Inspector General. The Office of the Inspector General treats all reports carefully and protects the identity of all whistle-blowers. 84 Contents Background: current state and main issues Way forward: potential changes and enablers required Breakout discussion: challenges and next steps Value creation levers and case studies Breakout discussion: challenges and next steps Background: Supplier Performance Evaluation Breakout discussion: challenges and next steps 85 Value creation levers aim at creating mutual benefits rather than purely focusing on suppliers’ margin Different levers could help jointly improve key cost components Typical cost structure, illustrative Levers used Example impact Margin Standard RFP approach Freight Overhead Labor CAPEX Materials Sourcing Demand management Processes and product lifecycle Supply chain optimization Competitive bidding situations Firm price negotiations Cheaper raw materials due to volume commitments API supplier optimization Reduced freight costs from better mode selection No rush order overtimes Less overheads to deal with regulatory and compliance Batch size optimization Cheaper transportation from better space utilization Reduced write-off risks Rather than focusing purely on price reduction through margin – value creation levers address other cost components (which make up a much larger share of total product cost), creating value for both parties without “squeezing the suppliers” 86 There are several value creation levers across key dimensions, driving value for all parties without squeezing suppliers Description of lever in supplier collaboration Value levers ▪ Sourcing / Supplier performance management Demand management Process and product lifecycle ▪ ▪ Supplier purchasing practices and conditions to other upstream suppliers Demand planning, supply reliability, inventory and capacity management Product lifecycle and processes at supplier and integration to own development Leveraging volume Bundling high- and low-volume products A COGS-based negotiation (e.g. cleansheets) Balanced allocation and commitment model B Demand forecast visibility and limited volatility Demand specification standardization and optimization Better planning (especially, along the time dimension) Continuous production process improvement along the product lifecycle C Good procurement practice up the entire supply chain Innovative packaging Supply chain optimization ▪ Distribution network and supply chain integration Sound sourcing strategies for raw materials Supplier “make” vs. “buy” decisions Product regulatory strategy D Freight and packaging optimization Staggered deliveries Stock visibility In-country supply chain capacity strengthening 87 A Advanced clean sheet yields substantial cost improvement through supplier collaboration Example: Clean sheet gaps Percent of actual price 1 Gap is potentially driven from ▪ Higher than expected supplier raw material (resin) discounts ▪ Higher than estimated supplier margin ▪ Supplier’s lack of understanding of true cost structure 2 Optimal operations include ▪ Higher equipment utilization ▪ Lower scrap rates 3 Additional opportunities include: ▪ Design to Value ▪ Resin innovation ▪ Leading edge supplier equipment technology ▪ ▪ Actual Price Should cost gap Incumbent should cost** Optimal operations gap Best in class cost DTV & innovation savings Target Supplier collaboration effort drives transparency into suppliers’ cost structure enabling joint efforts to reduce cost Total identified opportunities as part of supplier collaboration effort yields substantial cost improvement B Better demand visibility will help to secure production capacity for ARV vs. high-margin products and stabilize the load Scenario 1: “Flexible competition” without long-term forecast High-margin product ARV 100% High-margin product ARV Capacity utilization 50% Product 2 Product 1 High-margin product Product 3 High-margin product If the ARV medication is competing vs. the high-margin products in an environment when the manufacturing capacity hasn’t been reserved, the flexible allocation is likely to be margin-based – driving the ability to react in ARV low, compared to that of higher-margin products Time Scenario 2: “Reserved capacity” based on the long-term forecast 100% Capacity utilization 50% ARV Product 2 Reserved capacity coupled with the long-term forecast would allow to allocated certain capacity to the “baseline ARV load” – leaving sufficient flexible buffer to be used for the higher-margin product High-margin product High-margin product Product 1 ARV baseline load Time 89 ILLUSTRATIVE EXAMPLE C Collaborative effort to reduce supplier Lead Time leads to inventory optimization, improved order quality and increased OTIF Approach Impact ▪ Supplier lead time ▪ ▪ ▪ ▪ Conduct joint project with suppliers in order to – Increase flexibility – Reduce cost in supply chain – Improve information flow Map the current end to end process - from forecast to final delivery Identify improvement opportunities along the supply chain, e.g. Order raw materials based on forecast, postpone order differentiation point, etc. Setup joint improvement teams and regular update sessions, assure implementation at supplier and within own system Install monthly S&OP planning with supplier -13% 120 days Old lead time 90 days New lead time ▪ Reduced safety stocks ▪ Improved order quality due to ▪ shorter reaction time Increased OTIF 90 ILLUSTRATIVE EXAMPLE D Significant opportunities captured in optimizing packaging through introducing e.g. shrink packaging Example: Introducing new packaging options … … brings large savings Removing additional carton packaging increases number of bottles per box from 108 to 144 Placing leaflets on top of the bottles (instead of on each bottle) also helps to reduce space needed ▪ Looking at the properties of the shrink packaging, and taking into account some efficiency loss, the expected savings around 20-30% on direct volumeweight-related costs ▪ This translates into an expected average saving of direct freight-costs of 5-7k USD per 100,000 packs 91 We have overlaid the key ARV attributes to the product lifecycle to determine the strategic priorities … Pipeline Attributes Challenges for suppliers Emerging Growing Mature Few FPP suppliers More suppliers Technical driven licensing Continous process improvement and investment No more investment Focus on in-house API supply Diversification of API sources Few API sources Less competition Competitive drive Lack of clarity for investment Recover from investment & growth Reducing FPP suppliers Declining Concentration of API sources Fewer FPP suppliers Few incentives to manufacture Brutal competition Ethical exit plan Address long lead-time and poor delivery performance Strategic Implication Early engagement Competitive cost Deliver sustainability: Mitigate price volatility and secure supply Time 92 ILLUSTRATIVE … which in-turn allows to leverage different value levers across lifecycle stages Key focus and main drivers Emerging Growing Mature Declining Ramp-up volume and investment case uncertainty Proactively manage complexity Economy of scale, trying to globalize launches to a maximum possible extent Fast onset of rival products shortens the window for profitability Gaining market share Develop and launch the extensions Proactively manage complexity Divest and substitute with the next generation Demand forecast visibility and limited volatility Balanced allocation and commitment model Continuous production process improvement Demand specification standardization Potential value levers COGS-based negotiation (e.g. cleansheets) Sound sourcing strategies Innovative packaging Supply Chain optimization Product regulatory strategy Joint scenario planning Joint scenario planning Time 93 NON-EXHAUSTIVE There are several situations in the ARV market, when pulling value creation levers need to be applied New products enter the market Implications for supplier Implications for patients and program Transition to the new treatment regimen (e.g. switch side effects) Potential supply gap between old and new product, and delayed access Wastage of old regimens New API sources potentially necessary Decreasing demand for old product New price re-negotiations Global and national regulatory implications Innovative packaging and customized labelling Investments in developing new packaging necessary Simpler or more complex supply chain, depending on geographical coverage of new packaging Quality and regulatory risks Large and unexpected shifts in demand between suppliers Cancellation of orders Drop in capacity utilization, which could be hard to fill with other products Upstream supply challenge Alternative API sources potentially necessary Better supply availability if packaging allows for wider distribution Potential cross-market “grey market” redistribution Need to switch to products from alternative suppliers Risk to the continuity of supply 94 Contents Background: current state and main issues Way forward: potential changes and enablers required Breakout discussion: challenges and next steps Value creation levers and case studies Breakout discussion: challenges and next steps Background: Supplier Performance Evaluation Breakout discussion: challenges and next steps 95 Large ARV Buyers and Sellers Forum 2016 – Breakout Session Balanced supply system – criteria and performance evaluation 29 November, 2016 Geneva, Switzerland Republic of South Africa Buyers and Sellers Forum 2016 follows clear ground rules! We would like to reiterate our strong commitment to transparent, fair and competitive procurement processes. For example, according to the Global Fund’s Code of Conduct for Suppliers, corrupt, fraudulent, collusive, anti-competitive or coercive practices are not tolerated, and are subject to sanctions, which could include debarment from eligibility as a Global Fund supplier. Participants to the meeting must not: discuss with other participants your own or your competitors prices, price changes, price differentials, discounts, margins, or any terms of sale that might affect prices discuss individual company figures on costs, capacity, compensation, business opportunities, products or services, or sales, except for industry data such as interest rates that are made widely available to the industry by data services. discuss what individual companies plan to do in particular geographic or product markets or with particular customers or suppliers, including (a) customer or supplier policies, (b) the terms on which specific types of products may be distributed by a firm, (c) the elimination, restriction, or limitation of the quantity or quality of any product or service to be sold, or (d) the division or limitation of sales to particular territories, customers, or classes of customers. discuss specific future plans of your company or other companies concerning the design, production, distribution, pricing terms or marketing of particular products. discuss matters relating to actual or potential individual suppliers or customers that might have the effect of excluding them from any market or of influencing the business conduct of other companies toward such suppliers or customers. disclose to others any other competitively sensitive or confidential information. If you become aware of possible misconduct, this should be reported to the Office of the Inspector General. The Office of the Inspector General treats all reports carefully and protects the identity of all whistle-blowers. 97 Contents Background: current state and main issues Way forward: potential changes and enablers required Breakout discussion: challenges and next steps Value creation levers and case studies Breakout discussion: challenges and next steps Background: Supplier Performance Evaluation Breakout discussion: challenges and next steps 98 We all are working to deliver on our mission to achieve 90/90/90 99 GLOBAL FUND EXAMPLE Supplier OTIF for ARV products is low and highly variable – creating potential risks for patients (1/2) On-Time In-Full delivery (OTIF), Q1 – mid-Nov 2016, % 88% Supplier 1 81% Supplier 2 74% Supplier 3 72% Supplier 4 Supplier 5 67% Supplier 6 66% Supplier 7 40% LZN example: one supplier in 2013/2014 had 76% of product deliveries late, with ~10% of product deliveries being late 100 or more days Number of stockouts have reduced over the past 3 years Average: (77%) Note: LZN is an first-line HIV treatment drug, a combination of Lamivudine, Zidovudine and Nevirapine 100 GOVERNMENT OF SOUTH AFRICA EXAMPLE Supplier OTIF for ARV products is low and highly variable – creating potential risks for patients (2/2) Average: 65% 101 GLOBAL FUND EXAMPLE We all have balanced supply systems built around similar key elements A E Benefit sharing D Risk management A Cost competiveness Balanced supply system B Performance Providing products at the lowest possible affordable and sustainable price to reach the maximum number of patients Reducing price volatility and eliminating predatory pricing Supplying product timely and in full B Incentivizing suppliers to introduce better formulations C Supporting new suppliers to ensure sufficient supply and mitigate geographic supply risks Investing in suppliers with sustainable manufacturing practices Maintaining well-diversified supplier base D Meeting quality requirements Mitigating implementation risks C Sustainability Publishing reference prices E Building capacity and implementing rapid supply mechanisms 102 Reliable Lowest price often means poor performance Product price, LZN, 2013-2014, USD per pack Price performance Low-price supplier Median supplier 8.4 8.2 8.0 0 Share of orders, % Volumes secured 100% Low-price supplier consistently undercuts prices in the market… … which allows them to secure high share of orders (~50%)… … however, the delivery performance is low Avg. ~50% 50% 0% Q1 2013 Q2 Q3 Average delay, days Delivery performance GLOBAL FUND EXAMPLE Q4 Q1 2014 Maximum delay, days +79% (+75 days) +39% (+13 days) 33 45 95 Median Low-price Median 170 Low-price Similar issues have been observed with several TLE suppliers in 2015-2016 Note: LZN is an first-line HIV treatment drug, a combination of Lamivudine, Zidovudine and Nevirapine 103 Responsible Both buyers and sellers’ strategies in the market affect the price GLOBAL FUND EXAMPLE Supplier behaviors Quoted tender price, TLE, USD per pack The Global Fund target pricing Actual price, TLE, USD per pack 11 Suppliers who responded to tender price 10 10 Suppliers who did not respond to tender price 9 9 8 8 0 Initial 0 Initial 11 +15% 1H 2015 2H 2015 2016 -14% 1H 2015 2H 2015 2016 • Some suppliers responded to Global Fund target pricing, but others could not or would not – offering 15% higher than the target price • After the allocation, suppliers who could not offer target pricing subsequently reduced prices by up to 14% below the target pricing, which were captured through the “most favored nation” clause NOTE: TLE = combination of tenofovir (TDF) in combination with lamivudine (3TC) and efavirenz (EFV) 104 SOURCE: The Global Fund TLE pack prices Responsive Changes introduced in 2015 improved supply Supplier delivery performance (OTIF) has improved … Percent 62% 51% 43% Best Average1 85% 74% 58% Worst 35-45% … and lead times and urgent orders reduced Average lead time for WHO-optimal products2 and share of late orders, days / percent 26% 141 BEFORE July 2013 -June 2014 AFTER July 2014 - Sep 2016 • Supplier OTIF increased by 35-45% (15-25 percentage points) for all suppliers • Volume-weighted OTIF improved from 41% to 75% GLOBAL FUND EXAMPLE BEFORE 2013-2015 xx Average lead times xx Share of orders 19% -47% 75 AFTER 2016 • Since implementing vendor managed inventory (VMI) in 2015, average lead time to delivery decreased by 47% (from 142 to 75 days) • Number of urgent orders went down from over 25% in 2015 to under 20% in 2016 1 Simple non-weighted average across top 7 suppliers 2 For Rapid Supply Mechanism (RSM) products, time of order to time of demanded delivery by PR 3 Less than 3 months between ordering and time of demanded delivery by PR 105 Main changes to achieve a balances supply system From To Timing Spot market purchases • Purchase of orders on a need basis, potentially leading to unpredictable pricing and performance Longer-term tender agreements • Improved forecasting leading to higher committed purchase volumes • Bundled volumes with lower volume drugs to ensure availability Relationships Transactional relationships • Relationship purely based on one-time buyer–supplier interactions Strategic partnerships • Preferred suppliers of choice based on quality of supplier • Quality standards transparency Visibility Black box • No clear visibility as to how the contract distribution has been allocated Transparent selection criteria • Full transparency into selection criteria • Support as to how to improve to acquire higher share • Focus on demand visibility Cost efficiency Lowest price • Price push to ensure high quantity with little regard to sustainability and quality Joint cost optimization • Keep number of suppliers high • Grow new suppliers • Ensure quality of products Perception Market position • Selection based on history and market positioning Awards based on capability and performance • Evaluation based on supplier’s technical capabilities and commercial terms 106 Contents Background: current state and main issues Way forward: potential changes and enablers required Breakout discussion: challenges and next steps Value creation levers and case studies Breakout discussion: challenges and next steps Background: Supplier Performance Evaluation Breakout discussion: challenges and next steps 107 Large ARV Buyers and Sellers Forum 2016 Breakout sessions – key takeaways and next steps November 29, 2016 Geneva, Switzerland Republic of South Africa Demand Management is one of value creation levers aimed at creating mutual benefits, rather than purely attacking suppliers’ margin Detailed further Different levers employed aim at facilitating processing factors without Typical cost structure, illustrative Levers used Example impact Margin Price-centric RFP approach Freight Overhead Direct labor CAPEX Materials Sourcing Demand management Processes and product lifecycle Supply chain optimization Competitive bidding situations Firm price negotiations Cheaper raw materials due to volume commitments API supplier optimization Reduced freight costs from better mode selection No rush order overtimes Less overheads to deal with regulatory and compliance Batch size optimization Cheaper transportation from better space utilization Reduced write-off risks Rather than focusing purely on price reduction through margin – value creation levers address other cost components (which make up a much larger share of total product cost), creating value for both parties without “squeezing the suppliers” 109 BREAKOUT NOV 29 Demand Management – challenges and opportunities (1/2) Closer engagement with country programs Most value will be derived from the discussions about the forecast and numbers – what does it say/not say; where are the apparent inconsistencies Communication and alignment Open communication and dialogue, periodically publish aggregate actual volumes earlier and joint problem-solving together on large deviations to help build “trust in the forecast” Develop aligned messaging around the importance and benefits of better demand planning for all parties (win-win) Methodology Engaging decision makers and make economic and program implications clearer Include more countries and products to increase scope beyond 55% demand Avoid double-counting of volumes between buyers More real-time sharing of volume data; providing more regular forecast updates More nuanced forecasting accuracy metric can highlight where issues / opportunities are Indicate level of certainty in the forecast (including “firm commitments” vs. “less certain’) Alignment on the definitions and time-points; portray production and in-country timelines separately 110 BREAKOUT NOV 29 Demand Management – challenges and opportunities (2/2) New products and regimens In-country processes Provide forecasts for new/old products as volumes ramp-up/down to enable better formulation and API planning Obtaining more timely data on country forecasts and quantifications Countries systems and methodology are the key drivers of procurement accuracy Consider either stockholding or Vendor Managed Inventory Weak capabilities and systems Increase accountability 111 Value creation levers aim at creating mutual benefits rather than purely focusing on suppliers’ margin Different levers could help jointly improve key cost components Typical cost structure, illustrative Levers used Example impact Margin Standard RFP approach Freight Overhead Labor CAPEX Materials Sourcing Demand management Processes and product lifecycle Supply chain optimization Competitive bidding situations Firm price negotiations Cheaper raw materials due to volume commitments API supplier optimization Reduced freight costs from better mode selection No rush order overtimes Less overheads to deal with regulatory and compliance Batch size optimization Cheaper transportation from better space utilization Reduced write-off risks Rather than focusing purely on price reduction through margin – value creation levers address other cost components (which make up a much larger share of total product cost), creating value for both parties without “squeezing the suppliers” 112 BREAKOUT NOV 29 We have jointly brainstormed on collaborative opportunities Sourcing Demand management Optimal API make vs. buy decisions Use volume commitments to drive cheaper raw material prices Encourage staggering of procurements under long term arrangements Stabilize order management process Smoothen demand, including more aligned order schedules between buyers More certainty on time dimension of demand Explore optimized Supply chain set ups Process and product lifecycle Supply chain optimization Optimize packaging (e.g., e.g. shrink packaging) to reduce material and logistics cost Streamline administrative process to reduce inventory and write-off process Early engagement buyer, seller, and countries, e.g. on new regimens Optimization and consistent application of product standards (e.g. multi-month packs) Optimization of batch sizes and reduce bulk ordering Create stable partnership and demand outlook to allow sustainable investments (e.g., scale up, process development) … BREAKOUT NOV 29 Overcoming some key barriers will help to create value significantly (examples) Non-customized labelling Transparency on supplier shipments across buyers to improvement accuracy of forecast Increase demand/ stock visibility on country level, covering >70% of demand Increase country ownership of volatility in forecasting and ordering, incentivize stable supply chain Stronger coordination between buyers re. the ordering cycle …. What are the next steps for each of the stakeholders going forward? Next steps ▪ Continue to maximize transparency for suppliers on ▪ Definition of performance with clear metrics ▪ Consequences of poor/good performance for suppliers ▪ Supplier performance throughout tenure period Buyers Suppliers Partners ▪ Ensure clear path to enter for new entrants ▪ Consider whether and how to enable poor performers to improve and gain share ▪ Engage countries still focusing on lowest price to have a more balanced approach ▪ Communicate wider on cost of poor performance ▪ ▪ Invest in ability to respond to enhanced requirements ▪ Support country programmes to plan better Voluntarily provide market intelligence more frequently
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