Procurement and Supply Management Policies

TBS Meeting Geneva, 18 November 2009

Procurement and Supply Management Policies

WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, November 2009

Sophie LogezPharmaceutical Management Unit

TBS Meeting Geneva, November 2009

Presentation Outline

1. Global Fund grants: portfolio update and results

2. Global Fund approach to pharmaceutical and health products management


Status of Global Fund Grants

Financial Status Proposals

Approved

(R1-8)

Grants signed

US$

Money disbursed

US$

Global Fund financing (US$), November 2009

18.7 billion 13.6 billion 9.2 billion 45%

Financing 678 grants in 140 countries (Nov. 09)Financing 678 grants in 140 countries (Nov. 09)

Objective of the Global Fund“making a “sustainable and significant” contributionto the achievement of the Millennium Development Goals”


Rapid scaling up of results

Intervention mid 2007 mid 2008 July 2009

HIV: People on ARV treatment 1.1 million 1.75 m 2.3 m

TB: People treated under DOTS 2.8 million 3,9 m 5.4 m

Malaria: Insecticide-treated nets

distributed30 million 59 m

88 m

Global Fund Top 3 result indicators (2009)


Regional DistributionRounds 1-8, (July 2009)

100% = US$ 15.9 billionPercentages of total funds approved by the Board, including Phase 2 & RCC

Global Fund Grant Resources by Region

OP/140709/2

Eastern Europe & Central Asia

7%

Middle East & North Affrica

6%

Latin America & the Caribbean

7%

East Asia & Pacific14%

Sub-Saharan Africa58%

South Asia8%


Disease Components DistributionRounds 1-8, (July 2009)

Global Fund Resources by Disease Component

100% = US$ 15.9 billion Percentages of total funds approved by the Board, including Phase 2 & RCC

OP/140709/3

Malaria29%

HIV/AIDS57%

TB14%


Administration7%

Human Resources

21%

Commodities, Products, Drugs

45%

Monitoring and Evaluation

4%

Infrastructure and Equipment

9%

Other14%

How are Grant Funds Used?

Resources by Expenditure Component (July 2009)

Estimates from Rounds 2-8 proposals

100% = $8.2 billion USD

OP/140108/6


The Global Fund Approach

Pharmaceutical and Health Product Management

• Principles and minimum standards, not detailed procedures

“Operational principles for Good Pharmaceutical Procurement”

• Build upon existing systems• Principal Recipients responsible for all PSM activities


What it can include

Products• Pharmaceuticals• Health products• Health equipment• Equipment

Services

• Registration• Selection• Forecasting• Procurement• Transport• Quality assurance/QC• Storage• Distribution• Monitoring• Pharmacovigilance

Activities• Procurement costs• Quality Assurance costs• Distribution costs• Training• Technical Assistance• Capacity Building


Outline

• Global Fund principles on PSM• QA Policy for pharmaceutical products (1 July 2009)• Price & Quality Reporting


Policies and Principles

• Quality-assured products • Lowest possible price• National laws and international

agreements

• Transparent, fair and competitive

procurement

Guide outlines what PRs need to do


Revised QA Policy for Pharmaceutical Products (July 2009)

Quality Criteria

1. Quality criteria for all products

Authorization for use in the recipient countries

2. Quality criteria for ARVs, anti-TB and antimalarials: in addition to criteria 1.,

Selection of FPPs:

- WHO prequalified (option A) or SRA authorized (option B)

Or - permitted for use based on the advice of the Expert Review Panel


ERP recommended Product available?

2 or more A or B products Available?

Procure A or B Product

Yes

GF request an ad hoc ERP committee to review eligible

product

• Notify the GF• Receive no objection• Testing by GF Lab

Procure ERP recommended Product

Yes No

No

Selection Process of ARVs, Anti-TB or Antimalarial products

Product unavailability: Inability to supply sufficient quantity of product within not less 90 days of the requested delivery date


Revised QA Policy for Pharmaceutical Products

Monitoring quality product

•Monitoring quality of products all along the supply chain

• Systematic random quality control testing

• Recipients report testing results to Global Fund


Policies Perspectives

• Study on the QA status of medicines other than ARVs, anti-TB and antimalarial products– Develop QA requirements for such medicines

• Study on the QA status of Diagnostics– Development of a QA Policy for IVDs by 2010


Policies and Initiatives

Objectives

• Significantly increase speed of grant implementation and grant performance

• Reduce the burden on recipient by easing procurement bottlenecks in country

• Coordination with partners.

1. MDR-TB treatment• Green Light Committee support services

2. Voluntary Pooled Procurement and Capacity Building Services• Launched in June 2009

3. Affordable Medicine Facility for malaria (AMFm)• Approved in November 2008


• It is mandatory, as a part of the Grant Agreement that PRs enter procurement and quality data for key health products in the PQR

• Health Products to be reported:– ARVs – Antimalarial medicines– Tuberculosis medicines– Bednets– Condoms– Rapid Diagnostics Kits


How PQR Works?P

rinci

pal R

ecip

ient

Prin

cipa

l Rec

ipie

nt

The Global FundThe Global Fund

PartnersPartners

General Public

General Public

Local Fund AgentLocal Fund Agent

Verify Data

Principal RecipientsPrincipal

Recipients

Quality

Delivery Conditions

Price

Monitor

Rep

orts

Rep

orts

Price Comparison

Quality Monitoring

Market Information


Objectives

• Monitor procurement price and quality information on key health products procured with Global Fund funds:– Inform implementers on market conditions– Monitoring Pricing and supplier performance– Monitoring QA Policy compliance

• Make publicly available price and quality information – Inform procurement decisions by countries– Basis for stakeholders to develop long-term demand forecasts

• Analyze procurement information for various policy and decision-making purposes



Work Plan

• More features and reports are available (October 09) – Price analysis report

– Price trend

– Purchase price report

– PQR usage & data audit status

– QA Compliance regional comparison

• Data quality monitoring and follow-ups with PR• Further Improve functionality and speed



Planning

Proposal +Attachment B

Proposal approved

Phase 1 Phase 2

Grant signature

Phase 2 review

Technical support to prepare the proposal:•PSM experts•Laboratory experts•Regulatory authorities•IPR experts

Technical supportPSM plan preparationTeam work

TA as planned

TA as planned

Capacity building

as planned

Preparation

Documents

Procurement and Supply Management Policies