procurement and supply management policies

TBS Meeting Geneva, October 2012

Procurement and Supply Management Policies

WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, October 2012

Sophie LogezPSM Hub


Global Fund Grants

Financial Status Proposals

Approved

Grants signed

US$

Money disbursed

US$

Global Fund financing (US$), November 2012

19.7 billion 16.4 billion 12.1 billion 61%

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


Intervention June 2012

HIV: People receiving antiretroviral treatment 3.6 m

TB: new cases of infectious tuberculosis detected and treated 9.3m

Malaria: Insecticide-treated nets distributed 270 m

Malaria treatment delivered 260 m

Global Fund Top 3 result indicators (2010)


Global Fund Approved ProposalsBy Disease Component (End 2011)

Source: Global Fund Grant Data


Global Fund Approved ProposalsBy Region (2002 to mid-2011)

Source: Global Fund Grant Data


Distribution of funding

37% of funds for health products


Outline

• Global Fund principles on PSM• QA Policy for pharmaceutical products • Price & Quality Reporting


Policies and Principles for PSM

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

agreements

• Transparent, fair and competitive

procurement

Outlines what PRs need to comply with

• Principles and minimum standards “Operational principles for Good Pharmaceutical Procurement”

• Build upon existing systems• PSM activities


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

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Monitoring product quality

“The quality of FPPs procured with Global Fund grant funds must be monitored.” “PRs to conduct systematic random testing, and report testing results to Global Fund”

Principles of quality monitoring:

• Concerns all products (including WHO-prequalified and SRA-authorized products)

• Monitoring done all along the supply chain

• Systematic random quality control testing (following a plan - not all products / lots will be tested)

1. Clinical Criteria 2. Quality Criteria 3. Monitoring Quality


“Guidance for Reinforcing and /or Establishing Pharmaceutical Quality Control Systems and Related Stock Management Activities in

Countries Supported by the Global Fund “

:• support implementation of the Global Fund’s QA Policy.

• provide technical guidance to recipients on quality control testing activities

•http://www.theglobalfund.org/documents/psm/PSM_QCMonitoringGFPRsVP_Guide_en.pdf

• Frequently Asked Questions


at country level


Quality monitoring at country level Q

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Procurement: Product selection according to Global Fund QA Policy

Pre-shipment quality control testing for ERP-reviewed products (organized by Global Fund Secretariat as per QA Policy)

Receipt in country, storage, distribution

Quality control in countries:

Step 1: Selection of quality control laboratory

Step2: Designing a sampling and testing programme

Step 3: Sampling

Step 4: Transport of samples to the laboratory

Step 5: Quality control testing results and reports

Step 6: Records and documentation

Monitoring storage and distribution sites

Safe disposal of pharmaceutical products

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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


– Make publicly available price and quality information

• Transparency

• Informed procurement decisions

• Basis to develop demand forecasts

– Monitor price and quality information

• Price analysis report

• Price trend, regional comparison

• Purchase price report

• QA Compliance

– Analyze procurement information for policy purposes

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


Global Fund Financed Procurement of key products since 2009

• From 2009-2011, more than US$ 2.122 billion1 of antiretrovirals, long-lasting insecticidal nets, antimalarial medicines and anti-TB medicines were delivered to Global Fund Principal Recipients and reported to the PQR.

1 As reported to the PQR on 02 April 2012

Product Category Total Product Cost (USD)

Bednet $863,800,266

Anti-Retroviral $816,509,939

Anti-Malaria Medicine $145,187,211

Diagnostic test $135,067,022

Anti-TB Medicine $124,169,159

Condom $37,407,498

Grand Total $2,122,141,095


• 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

Documents