Post on 16-Jul-2020
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
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
Who are we?
Office of Population & Reproductive Health (PRH) - Strategic Framework
• 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
Global Health Initiative Goal for FP/RH
Advance and support voluntary family planning/reproductive health programs worldwide
Global leadership demonstrated in FP/RH policy, advocacy, and services
Intermediate Result 1
PRH Strategic Objective
Support provided to the field to implement effective and sustainable FP/RH programs
Intermediate Result 3 Knowledge generated, organized, and disseminated in response to program needs
Intermediate Result 2
To enable countries to meet the family planning needs of their people
PRH Goal Statement
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)
Goal: Reduce unmet need
Enable 120 million more women and girls to use contraceptives
(by 2020)
Family Planning 2020
• WGGE • Integration • Partnership • Country ownership • HSS • M&E • Rsch & Innovation
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
Goals and Principles: • MCH • Nutrition • FP • HIV • Malaria • TB • NTDs
FP componentry: Commodity procurement Supply chain strengthening Knowledge management Implementation research Biomedical research
Behavior change Data collection M&E Governance Financing
PRH
Prio
ritie
s Technical leadership areas: Gender Poverty/equity Youth HIPs Repositioning
Service delivery Human resources Mgmt & leadership Policy/advocacy
Contraceptive security FP/HIV FP/MCH, incl.PAC LARCs & PMs HTSP Community-based FP
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.
What do we do?
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
A significant budget to offer choice in contraceptive methods
9
Commodity Quantity (unit) est FY 2013
1 Male condoms 727,785,000
2 Oral contraceptives
53,000,000
3 Injectable contraceptives
40,000,000
4 Lubricants 9,000,000
5 IUDs 1,000,000
6 Contraceptive implants
1,000,000
7 Female d
900,000
A global reach and presence in countries
How do we do it?
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
• Male condoms – SRA approved
• USFDA 510 (k) for the formulation being offered • ISO 13485 • 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 13485 • GMP certificate from NDRA in country of manufacture • Evidence of conformance with relevant standard (e.g. ISO 25481:2011)
USAID QA Procedure- Medical Devices
• IUDs – SRA approved
• CE Mark • ISO 13485 • 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 13485 • 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
USAID QA Procedure- Medical Devices
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.
Quality Assurance – FHI 360 Continuous
Improvement Cycle
Maintain a Low Risk to
Product Quality Product
Registration
Risk Management Supplier
Management
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
16
Procurement: an agile way of operating
17
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
• Easy monitoring and tracking
• Transparency and info sharing
The procurement process: the bid and contract award
18
Technical Review Panel
RFP preparation
Centralized quantification
RFP publication
OAA approval
Recommendation and USAID
concurrence
Vendor visit
Contract award
Contract management
1 month 1 month 1 month 1 month
1 month 1 month
• up to quantity • set price • 3-month production leadtime • incoterm: EXW
• release orders will be placed
against the framework contract • release orders will be shipped to
the warehouses or to the countries
Annual IQC (framework contract)
The procurement processes: a constructive vendor management
19
• On-time orders measurement and tracking • Customer service • Performance scorecards • Risk management reports • Registration trackers
• On-boarding materials • Looking for new opportunities • Discuss short/medium/long-term
objectives and seek alignment
• Buyer-vendor interaction • Quarterly supply calls • Annual on-site visit and
strategic meetings
Performance Management
Cost savings
Reduced risk
Increased visibility
Strengthened partnership
Continuous improvement
Commodities: -of high quality -available -at the best price
Contact
• Erin Seaver, Program Advisor, USAID eseaver@usaid.gov
• Xuan-Mai Hua Hurpy, TO5 Procurement Director, USAID Ι
DELIVER PROJECT xhurpy@jsi.com
• Steve Hamel, Director of Product Quality and Compliance,
FHI360 shamel@fhi360.org
Thank you!