Procurement and Supply Management Policies

WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, November 2009 Sophie Logez Pharmaceutical Management Unit

TBS Meeting Geneva, 18 November 2009

Presentation Outline

1. Global Fund grants: portfolio update and results 2. Global Fund approach to pharmaceutical and health products management

TBS Meeting Geneva, November 2009

Status of Global Fund Grants

Financing 678 grants in 140 countries (Nov. 09)

Financial Status

Global Fund financing (US$), November 2009

Proposals Approved (R1-8)

18.7 billion

Grants signed US$

13.6 billion

Money disbursed US$

9.2 billion 45% Objective of the Global Fund “making a “sustainable and significant” contribution to the achievement of the Millennium Development Goals”

TBS Meeting Geneva, November 2009

Rapid scaling up of results

Global Fund Top 3 result indicators (2009)

Intervention HIV:

People on ARV treatment

mid 2007

1.1 million

TB:

People treated under DOTS

Malaria:

Insecticide-treated nets distributed 2.8 million 30 million

mid 2008

1.75 m 3,9 m 59 m

July 2009

2.3 m 5.4 m 88 m

TBS Meeting Geneva, November 2009

Regional Distribution

Rounds 1-8, (July 2009) Global Fund Grant Resources by Region

Middle East & North Affrica 6% East Asia & Pacific 14% Eastern Europe & Central Asia 7% Latin America & the Caribbean 7% South Asia 8% Sub-Saharan Africa 58%

100% = US$ 15.9 billion Percentages of total funds approved by the Board, including Phase 2 & RCC TBS Meeting Geneva, November 2009

OP/140709/2

Disease Components Distribution

Rounds 1-8, (July 2009) Global Fund Resources by Disease Component

Malaria 29% HIV/AIDS 57% TB 14%

100% = US$ 15.9 billion Percentages of total funds approved by the Board, including Phase 2 & RCC TBS Meeting Geneva, November 2009

OP/140709/3

How are Grant Funds Used?

Resources by Expenditure Component (July 2009)

Monitoring and Evaluation 4% Infrastructure and Equipment 9% Administration 7% Human Resources 21% Other 14% Commodities, Products, Drugs 45%

Estimates from Rounds 2-8 proposals 100% = $8.2 billion USD TBS Meeting Geneva, November 2009

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

TBS Meeting Geneva, November 2009

What it can include

Products

• Pharmaceuticals • Health products • Health equipment • Equipment

Activities

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

TBS Meeting Geneva, November 2009 Services

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

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

TBS Meeting Geneva, November 2009

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

TBS Meeting Geneva, November 2009

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 TBS Meeting Geneva, November 2009

Selection Process of ARVs, Anti-TB or Antimalarial products

Yes

2 or more A or B products Available?

No ERP recommended

Product available?

Yes No

• • •

Notify the GF Receive no objection Testing by GF Lab

GF request an ad hoc ERP committee to review eligible product Procure

A or B Product

Procure

ERP recommended

Product

Product unavailability:

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

TBS Meeting Geneva, November 2009

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

TBS Meeting Geneva, November 2009

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

TBS Meeting Geneva, November 2009

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.

2.

3.

• MDR-TB treatment Green Light Committee support services • Voluntary Pooled Procurement and Capacity Building Services Launched in June 2009 • Affordable Medicine Facility for malaria (AMFm) Approved in November 2008

TBS Meeting Geneva, November 2009

• 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

TBS Meeting Geneva, November 2009

How PQR Works?

Price Quality Delivery Conditions The Global Fund Monitor Price Comparison Quality Monitoring Market Information Verify Data Local Fund Agent

TBS Meeting Geneva, November 2009

Principal Recipients General Public Partners

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

TBS Meeting Geneva, November 2009

TBS Meeting Geneva, November 2009

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

TBS Meeting Geneva, November 2009

TBS Meeting Geneva, November 2009

Planning

Technical support

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

Technical support PSM plan preparation

Team work

TA as planned Capacity building as planned TA as planned

Proposal + Attachment B

Preparation Proposal approved Grant signature

Phase 1

Phase 2 review TBS Meeting Geneva, November 2009

Phase 2