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

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Procurement: an agile way of operating

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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

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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

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• 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!