Procurement and Supply Management Policies

transcript

TBS Meeting Geneva, November 2010

WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, November 2010

Sophie LogezPharmaceutical Management Unit

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

Money disbursed

Global Fund financing (US$), November 2009

19.7 billion 16.4 billion 12.1 billion 61%

Financing 785 grants in 145 countries (Nov. 10)Financing 785 grants in 145 countries (Nov. 10)

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 June 2010

HIV: People on ARV treatment 1.1 million 1.75 m 2.3 m 2.8 m

TB: People treated under DOTS 2.8 million 3,9 m 5.4 m 7m

Malaria: Insecticide-treated nets

distributed30 million 59 m

88 m 122 m

Malaria treatment 142.4m

Global Fund Top 3 result indicators (2010)

Global Fund Approved ProposalsBy Region (Rounds 1-9)

OP/140709/2

Source: Global Fund Grant Data

Disease Components DistributionRounds 1-9 (July 2010)

Global Fund Resources by Disease Component

100% = US$ 16.4 billion Percentages of total funds approved by the Board, including Phase 2 & RCC

OP/140709/3

Malaria28%

HIV/AIDS56%

Administration7%

Human Resources

Commodities, Products, Drugs

Monitoring and Evaluation

Infrastructure and Equipment

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

QA Policy for Pharmaceutical Products (as of 2009)

Clinical Criteria

• Medicines listed in WHO or national or institutional Standard Treatment Guidelines

• Require applicants/ recipients to provide justification for selection of unlisted products in one of the STGs

Quality Criteria

For all productsAuthorization for use in the recipient countries

For ARVs, anti-TB and anti-malarial products

WHO Prequalified or authorized by a Stringent Regulatory Authority;or Recommended for use by an Expert Review Panel,Only If <2 WHO PQed or SRA authorized products available

Monitoring Quality

• Monitoring quality of products all along the supply chain

• Systematic random quality control testing

• Recipients report testing results to Global Fund

Distribution of Products by Quality Criteria

Number of Purchases Reported to the PRM/PQR by Quality Level

1521 15901696

2005 2006 2007 2008 2009

WHO Prequalified and SRA approved products are purchased in priority, if available.Currently, 95% (in units) of ARVs purchased by PRs are WHO PQed

Publication of QC Results

Partnerships in Quality Assurance

• Close collaboration with WHO PQ

– Expert advice– QA Policy implementation: ERP management

• WHO Disease Programs: HIV, Malaria, TB• Collaboration/information sharing with other donors and

suppliers, such as UNICEF, UNDP• Working toward policy harmonization with partners eg. GDF• Regular communication with manufacturers: annual meeting • Monitoring QA activities and publication of results

Policies Perspectives

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

• Proposed QA Policy for Diagnostic Products– To be endorsed by the Board in December 2010

– Make publicly available price and quality information

• Transparency • Informed procurement decisions

by countries• Basis to develop demand

forecasts – Monitor price and quality information

• Price analysis report • Price trend, regional comparison • Purchase price report • PQR usage & data audit status • QA Compliance

– Analyze procurement information for policy purposes

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

• Budgeting & Grant negotiation– Proposal development, TRP Review, PSM Plan Review

• Grant Implementation– Monitoring of compliance with QA Policy– Review by PRs of prices achieved versus peers

• Grant Performance Reviews– Benchmarking of prices achieved versus peers– Review of QA issues

• Identification of value for money opportunities• Transparency

Use of PQR in Grant Lifecycle

Procurement and Supply Management Policies

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