USAID Update 2014 Bureau for Global Health Christine

USAID Update 2014 Bureau for Global Health Christine Malati, Pharm. D Anthony Boni Lisa Ludeman, MSPH December 16, 2014 1

Outline • Structure of the Global Health Supply Chain Program • Updates on PQM and SIAPS 2

Global Health Supply Chain Program ($10. 5 Billion) Single-Award Procurement & Technical Assistance IDIQ ($9. 5 b) With the Following Task Orders: 1. Family Planning 2. HIV/AIDS 3. Malaria 4. MCH HIV RTK Procurement IDIQ ($300 m) Small Business Set Aside Multiple-Award Technical Assistance IDIQ ($500 m) Up To Four Awards, Including one Small Business Set Aside Quality Assurance Contract ($123 m) Business Intelligence and Analytics ($20 m) GSA Contract Supply Chain Innovation & Research Annual Program Statement ($40 m) # of Agreements TBD

Single-Award Procurement & Technical Assistance IDIQ • 5 -year single-award IDIQ – 4 task orders (HIV, malaria, family planning and reproductive health, maternal and child health) • Global Commodity Procurement and Logistics • Systems strengthening • Global collaboration 4

HIV RTK Procurement IDIQ • • Five year single award IDIQ Procurement of RTKs Logistics Collaboration within the GHSCP and with other international stakeholders 5

Quality Assurance Award • Goal: Establish and implement a comprehensive QAP for USAID that provides global technical leadership regarding quality issues 1 Quality Assurance Program 2 Quality Control Strategy 3 Technical Leadership 4 Global Collaboration 6

Multiple Award Technical Assistance IDIQ • Goal: Improve the long-term availability of health commodities in public and private services • Objective 1: Systems Strengthening Technical Assistance – Strengthen incountry supply systems • Objective 2: Global Collaboration – strategic engagement to improve the longterm availability of health commodities 7

Multiple Supply Chain Assistance Cooperative Agreements and/or Grants Overall objective: Support research on a focused set of health supply chain systems and related commodity security issues in low and middle income countries. • Objective 1. Improve health supply chain systems through transformative changes that use industry best practice; • Objective 2. Improve the quantity, reliability, and efficiency of financing for health commodities and supply chain systems; • Objective 3. Improve governance and accountability for commodity security. 8

Business Intelligence & Analytics ($20 m) Contract • $20 m Contract • Purpose: to build and maintain as a Software as a Service (Saa. S) USAID GH Business Intelligence and Analytics (BI&A) platform and provide technical services for and on behalf of USAID GH Bureau and the supply chain business initiatives. • Program Management • Data warehouse • Data mapping • Data migration • Knowledge Management Database 9

SIAPS: Recent Accomplishments • Advancing a framework and metrics to measure pharmaceutical systems strengthening • “Enhancing Health Outcomes for Chronic Diseases in Resource Limited Settings by Improving the Use of Medicines: The Role of Pharmaceutical Care” • Improving understanding of the vital role medicines play in Universal Health Coverage • Development of an accreditation framework for the establishment of national pharmaceutical continuous education programs in LMICs. • SIAPS West Africa Regional Project launches an Early Warning System (EWS) for HIV/AIDS commodities • Improving governance capacity for more transparent and accountable pharmaceutical systems • Applying knowledge management approaches to improve pharmaceutical management through collaboration with WHO

PQM: Recent Accomplishments • Promoting the Quality of Medicines Program extended to September 2019 • Two PQM-supported manufacturers in China are the first to be prequalified for Capreomycin Active Pharmaceutical Ingredient (API). • PQM supported the first generic producer of Capreomycin to achieve WHO prequalification, thereby helping to reduce the cost of this medicine. • PQM supported the only major producer of Kanamycin to obtain GMP compliance status from the WHO Prequalification Program for the nonsterilized API of Kanamycin. • Ghana Food and Drug Authority QC lab receives ISO 17025 accreditation for compendial tests used to assess the quality of essential medicines. • With PQM support, the Ethiopian drug regulatory authority (FMHACA) laboratory became the first medical device laboratory in Africa to achieve ISO 17025 accreditation ((testing of male condoms). • Monograph developed (specifications, QC tests to perform, and methods) for Dihydroartemisinin-piperaquine phosphate tablets (DHAP), thereby enabling testing of this important FDC antimalarial.

USAID Update 2014 Bureau for Global Health Christine Malati, Pharm. D Anthony Boni Lisa Ludeman, MSPH December 16, 2014 12