Meeting the Global Challenges for FP: USAID Procurement Policies & Requirements

Transcription

1 Meeting the Global Challenges for FP: USAID Procurement Policies & Requirements Erin Seaver, Program Advisor, USAID Xuan-Mai Hua Hurpy, TO5 Procurement Director, USAID Ι DELIVER PROJECT Steve Hamel, Director of Product Quality and Compliance, FHI360 WHO/UNICEF/UNFPA Manufacturers Meeting Copenhagen September 2013

2 Presentation Outline I. Who are we? Brief Overview of USAID Office of Population & Reproductive Health (PRH) Strategic Priorities USAID Automated Directives System (ADS) 312 Introduction of USAID Ι DELIVER PROJECT II. What do we do? Overview of USAID Ι DELIVER PROJECT Operations III. How do we do it? USAID Quality Assurance Procedure for Contraceptives & Condoms FHI360 Quality Assurance Program for Contraceptives & Condoms USAID Ι DELIVER PROJECT Procurement & Contracting Processes

3 Who are we?

4 Office of Population & Reproductive Health (PRH) - Strategic Framework Global Health Initiative Goal for FP/RH Prevent 54 million unintended pregnancies Increase modern contraceptive prevalence by up to 2 pct points each year Reduce first births to women under 18 by 15 percent PRH Goal Statement To enable countries to meet the family planning needs of their people PRH Strategic Objective Advance and support voluntary family planning/reproductive health programs worldwide Intermediate Result 1 Global leadership demonstrated in FP/RH policy, advocacy, and services Intermediate Result 2 Knowledge generated, organized, and disseminated in response to program needs Intermediate Result 3 Support provided to the field to implement effective and sustainable FP/RH programs

5 PRH Strategic Priorities Global Heath Initiative (GHI) Goal: Sustained improvements in health status, esp for women and girls 54M unintended pregnancies prevented (by 2015) A Promise Renewed Goal: End preventable child and maternal deaths U5M 20/1000 (by 2035) Family Planning 2020 Goal: Reduce unmet need Enable 120 million more women and girls to use contraceptives (by 2020) Goals and WGGE Principles: MCH Integration Nutrition Partnership FP Country ownership HIV HSS Malaria M&E TB Rsch & Innovation NTDs Strategic shifts: Geography High burden populations High impact solutions Education, empowerment, economy, environment Mutual accountability Architecture: Country engagement Performance monitoring & accountability Market dynamics Rights and empowerment PRH Priorities Commodity procurement Supply chain strengthening Knowledge management Implementation research Biomedical research FP componentry: Behavior change Data collection M&E Governance Financing Service delivery Human resources Mgmt & leadership Policy/advocacy Technical leadership areas: Gender Poverty/equity Youth HIPs Repositioning Contraceptive security FP/HIV FP/MCH, incl.pac LARCs & PMs HTSP Community-based FP

6 ADS Chapter 312 Objectives: Provide for the quality of products procured with USAID funds. Provide for the economical procurement of family planning commodities in accordance with relevant USG policies and regulations. Assure that resources made available by USAID in form of commodities make a positive contribution to development. Scope & Applicability: Details policies on the eligibility of family planning commodities financed with USAID funds.

7 What do we do?

8 Back to Basics Our motto No Product, No Program Our target Improve health outcomes by increasing the availability of contraceptives and condoms Help building sustainable capacity in-country Our means A robust and integrated supply chain solution Technical assistance and capacity building 8

9 A significant budget to offer choice in contraceptive methods Commodity Quantity (unit) est FY Male condoms 727,785, Oral contraceptives 3 Injectable contraceptives 53,000,000 40,000,000 4 Lubricants 9,000,000 5 IUDs 1,000,000 6 Contraceptive implants 1,000,000 7 Female 900,000 A global reach and presence in countries 9

10 How do we do it?

11 USAID QA Procedure- Quality Technical Requirements A technical review of all medical devices and pharmaceutical contraceptives includes: Product dossiers & site master files Stability & clinical studies Product testing Lot results in control chart format from the past year (determine process capability) Site visit Samples/packaging and labeling Standard Operating Procedures (SOPs) Proof of registration in USAID priority countries Past references Other

12 USAID QA Procedure- Medical Devices Male condoms SRA approved USFDA 510 (k) for the formulation being offered ISO GMP certificate from NDRA in country of manufacture Evidence of conformance with relevant standard (e.g. ISO 4074:2002) Female condoms SRA approved USFDA 510 (k) ISO GMP certificate from NDRA in country of manufacture Evidence of conformance with relevant standard (e.g. ISO 25481:2011)

13 USAID QA Procedure- Medical Devices IUDs SRA approved CE Mark ISO GMP certificate from NDRA in country of manufacture Evidence of conformance with relevant standard (e.g. ISO 7439:) Personal Lubricant SRA approved USFDA 510 (k) for the formulation being offered ISO GMP certificate from NDRA in country of manufacture Evidence of conformance with WHO/UNFPA/FHI360 Advisory note on use and procurement of additional lubricants for male/female condoms Condom compatibility per ASTM 7661

14 USAID QA Procedure- Hormonal Contraceptives Oral and Injectable Contraceptives and Contraceptive Implants: 1.SRA approved; 2.WHO Prequalified; 3.WHO Expert Review Panel (ERP) reviewed and positive recommendation from USAID risk assessment and management process.

15 Quality Assurance FHI 360 Supplier Management Continuous Improvement Cycle Risk Management Product Registration Maintain a Low Risk to Product Quality

16 16 The USAID DELIVER PROJECT Procurement principles Open and fair competition Importance of a diversified and expanded supplier base Quality-assured commodities Strong on-time delivery performance Competitive pricing Proactive registration approach

17 Procurement: an agile way of operating Pooled and centralized funding Pooled and centralized procurement Centralized inventory in two warehouses Data visibility Two pre-qualified freightforwarders Flexible and available funding Emergency funds A global procurement strategy Possibility to issue IQCs 12-month rolling forecasts Standardized process and one point of contact Smoothed level of and regular orders Reactivity to emergency orders Visibility on a centralized inventory Transparency and info sharing Easy monitoring and tracking 17

18 The procurement process: the bid and contract award Centralized quantification RFP preparation RFP publication Annual IQC (framework contract) up to quantity set price 3-month production leadtime incoterm: EXW Technical Review Panel 1 month 1 month 1 month 1 month Recommendation and USAID concurrence OAA approval release orders will be placed against the framework contract release orders will be shipped to the warehouses or to the countries Vendor visit Contract award Contract management 1 month 1 month 18

19 The procurement processes: a constructive vendor management On-time orders measurement and tracking Customer service Performance scorecards Performance Risk management reports Registration trackers Management Cost savings Commodities: -of high quality -available -at the best price Increased visibility Reduced risk Buyer-vendor interaction Quarterly supply calls Annual on-site visit and strategic meetings Continuous improvement Strengthened partnership On-boarding materials Looking for new opportunities Discuss short/medium/long-term objectives and seek alignment 19

20 Contact Erin Seaver, Program Advisor, USAID Xuan-Mai Hua Hurpy, TO5 Procurement Director, USAID Ι DELIVER PROJECT Steve Hamel, Director of Product Quality and Compliance, FHI360

21 Thank you!