“Securing timely access

to quality, affordable

Tuberculosis drugs &

related supplies”

Global Drug FacilityGlobal Drug Facility

GF grant negotiation and implementation of TB grants Anglophone African countries

13 December 2007, Geneva

• GDF Services

• GDF Direct Procurement Service

• How GDF can Support GF beneficiaries

• Practical Steps for Grant Negotiation & Implementation

• Challenges and opportunities for GDF: 2008 & beyond

Introduction

� GDF is an initiative of the Global Partnership to Stop TB

� GDF is housed in WHO & managed by Stop TB partnership secretariat

� GDF aims to supply quality assured, affordable drugs in a timely manner, for 15 million people with TB by 2010

� GDF is more than a procurement mechanism:

• A bundled facility not a procurement agent

What is the GDF?

GDF was created to secure timely access to affordable, high quality drugs to enhance DOTS expansion & implementation

GDF addresses 5 needs:

� The need for more resources for TB drugs

� The need for high quality TB drugs

� The need for efficient procurement systems

� The need for standardized products

� The need for monitoring drug use & TA for drug management

Why the GDF?

Services (1)

Services (2)

Services (3)

• >10 million patient treatments in 6 years

• Deliveries to >70 countries

• Value for money: US$ 22 cost per treatment

• Annual procurement volume US$ 45 - 50 million

• Introduction of innovative packaging: > 2 million Patient Kits delivered

• Wide range of DP Clients: GF, WHO, World Bank, DFID, German Bank for Reconstruction (KfW), National govts.

• >250 monitoring and technical support missions

• Small countries, small demands, same services: quality assured products, low prices (c.f. large countries and large demands)

GDF Achievements

Direct Procurement (DP) Service

• Over 35 countries have placed DP orders in last 12 months

• Cumulatively 29 countries have used GF grants via DP service

• Value of DP orders Oct. 2006 to Oct. 2007 US$ 16m

• US$ 250,000 secured from OGAC to support Drug Management Technical Assistance for Global Fund DP clients

• Working with World Bank to try and streamline procedures for WB loan recipients to purchase TB drugs via GDF

• New tender prices to be published by mid Dec. 2007

Direct Procurement Service – First line

• Countries implementing the DOTS strategy in 90% or more of the population & NGOs supporting DOTS in these countries.

• Countries or NGOs approved by the GDF for a grant of free TB drugs.

• Countries or NGOs approved for a grant for tuberculosis control by the Global Fund to fight AIDS, Tuberculosis & Malaria

• Organizations, donors and technical agencies supporting the above categories of countries or NGOs.

Who can use the Service?

• to save money - so that more funds can be used for other aspects of DOTS

• to ensure quality - when adequate quality assurance programmes are not in place

• to save time - e.g. in an emergency GDF provides rapid lead times for delivery

• to access quality assured fixed dose combinations

• to standardise TB drug formulations

• to access GDF technical support for drug management

• GDF is ISO 9001: 2000 Certified therefore offering a stringent and client oriented quality service

Why use the Service?

GF Grant Negotiation/implementation

& GDF

• to procure quality assured products at the lowest possible priceand in accordance with national laws and international agreements

• to conduct procurement in a transparent fashion

• Principal Recipients are accountable for security of the supply of all procured goods

• All Second line TB drugs must be procured via

Green Light Committee (GLC) approval: GDF & GLC are now converged = all-in-one-service for 1st & 2nd line drugs

GF requirements

• Where Principle Recipients capacity is unable to meet these principles, procurement can be outsourced

• The GDF Direct Procurement Service provides an excellent outsourcing option adhering to all GF principles

• The Service will assist PRs with key elements of the Procurement and Supply Management Cycle:

– 1. Product Selection

– 2. Forecasting

– 3. Procurement (including low cost and assured quality)

– 4. Drug Management support

Outsourcing Procurement

Procurement & Supply Management (PSM)

Selection

ProcurementManagementSupport

Distribution

Use

1.1 Product Selection: Standardized list of products in blisters, patient kits and bulk following WHO guidelines and regimens

Products

RHZE (4FDC) RHE (3FDC)

Units

Loose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabs Loose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabs50 Vials

RH150/75

RH150/150

EH400/150

E400, Z400, H300

S1g

Cat. I & III Patient Kit

Cat. II Patient Kit

1.2 Product Selection: Second line drugs

$0.1303$13.03100250 mg tabletProthionamide

$1.6060$48.18304 gr granules sachetPASER

$0.0349$3.49100200 mg tabletOfloxacin

$0.0698$6.98100500 mg tabletLevofloxacin 500

$0.0392$3.92100250 mg tabletLevofloxacin 250

$0.3716$18.5850Powder for injection - 1 gram vial

Kanamycin

$0.1021$10.21100250 mg tabletEthionamide

$0.1412$14.12100250 mg capsuleCycloserin (B)

$0.5096$50.96100250 mg capsuleCycloserin (A)

$1.0700$1.071Powder for injection - 1 gram vial

Capreomycin (B)

$3.2100$3.211Powder for injection - 1 gram vial

Capreomycin (A)

$1.3370$13.3710500 mg / 2 ml injectable vialAmikacin

Avg. cost per Pill/Vial/Kit

Unit Price (US$)

Pills/Vials/Kits

DescriptionProduct

1.3 Product Selection:

Diagnostic Kits

Equipment starter kit

Consumables kit

• >10 countries have placed order requests for diagnostic kits with GDF since addition to catalogue in Q2 2007

• Diagnostic kits are:

– Equipment starter kit (US$ 169.87)

– Consumables kit (US$ 183.25)

– Microscope kit (US$ 1266.29)

– Sputum containers x 1000 (US$ 58.17)

Diagnostic Kit Orders – 1.3.1

2. Forecasting Procedures:

• Principle Recipient completes and Order Form/Technical agreement

• Principle Recipient works with GDF to finalize patient numbers & required quantities using Standardized GDF quantification tool: drugs & diagnostics

• GDF supports Principle Recipient with technical and drug management support via annual monitoring mission

DIRECT PROCUREMENT ORDER FORM &TECHNICAL AGREEMENT

SECTION A. CONTACT DETAILS

Country:

Contactperson:Position:

Address:

Telephone:

Fax:

Email:

SECTION B. ESTIMATES OF PATIENTS TO BE TREATED WITH DOTS

Year: Date drugs required:

Category Regimen Total estimatedcases to be treated

with DOTS

Estimated cases to betreated with drugs

supplied through theGDF

1

2

3

• GDF competitively & transparently contracts its procurement agent

• The Procurement Agent contracts manufacturers

through Limited International Competitive Bidding

• GDF Quality Assurance Process fully compliant with GFATM requirements

• Bulk procurement, standardization and prompt payment policy secure low prices

3.1 Procurement

3.2 Procurement

• All batches under preshipment inspection and quality control via independent agent

• GDF adheres to Interagency Operational Principles for Good Pharmaceutical Procurement

• e-catalogue & e-tracking system for Principle Recipients orders

• All anti TB products supplied by GDF are registered by National Regulatory Authority of the recipient country where required

Key Budget Assumptions for requests from GFATM

► Drugs, commodities and products

Provide a full list of all drugs, commodities and products to be used in the proposed program, together with unit costs and volumes. These unit costs and volumes must be fully consistent with the detailed budget. If prices from sources other than those specified below are used, a rationale must be included.

For GLOBAL DRUG FACILITY all available information is on GDF website at:

www.stoptb.org/GDF

Tool kit for GF Beneficiaries – NEXT PAGE

Drug & Diagnostic budgets

Drug & Diagnostic budgets

After Grant Negotiation:

Practical 10 STEP approach on how

to secure delivery of TB drugs via

GDF

Direct Procurement Service

Submit signed

form to GDF atgdfprs@who.int

GDF PRC agent

Sends contract for signature

Obtain Order

Form on GDF

website

1 2 3 4 5

• Patient numbers

• Regimens

• Consignee details

• Specifies terms of support

• Specifies Payment Method

• Includes pro-forma invoice

• PR ensures clauses acceptable

• PR Signs contract

PR sends signed contract to agent

PR transfers funds or Bank Guarantee to agent account

Steps 1 - 5

Lead time: 2.5 months

Order recorded

in WEB-based

tracking system

and PR issued

username &

password

6 7 8 9 10

• Agent liaises with

PR to ensure

REGISTRATION

procedures followed

• PR can track

progress of

shipment

• E-mail updates

sent at least

monthly

Products analysed

independently

before shipment

then SHIPPED

4 to 6 months later GDF sends

Technical Support Mission

Agent places

order with GDF

prequalified

& contracted

suppliers

Confirmation of

receipt & clearance

of goods sent to

Agent

Lead time: 1.5 to 6 months

• Report on

appropriate

drug use,

progress,

bottlenecks,

support

• Preclearance docs

sent in advance

(1 to 4 weeks)

Steps 6 - 10

Technical Support

• GDF Regional Support Officers in South East Asia and the Middle East continue to provide TA to GDF supported countries

• A GDF Regional Support Officer will be placed in the Africa Region in 2008 (based in Harare).

• In collaboration with MSH, Drug Management TA will be provided to GLC approved projects/programs in 2008 for the first time

• GDF to organize at least two Drug Management training workshops in 2008

Technical Assistance (TA) - 1

� Additional 3.5 million 1st line patient treatments delivered

� Rapid scale-up of 2nd line anti-TB drug supply

� Reduced prices and improved capacity for 2nd line TB drug manufacture

� Rapid scale-up of paediatric drug supply and introduction of standardized child-friendly formulations

� Establishment of effective TB Market Dynamics task force for 1st

and 2nd line drugs and diagnostics

� Improved and Scaled up Drug Management support to countries

� Realistic, practical and useful MoU with Global Fund (as part ofSTB Partnership MoU).

� Enhanced partnership with UNITAID, including Diagnostics supply.

2008 – Expected Results

� Ensuring sufficient donor funds to complete 2008-2009 Grant commitments and optimally fund activities

� Ensuring effective positioning of GDF with respect to Global Fund's Voluntary Pooled Procurement Service

� Working with WHO/EDM to increase the number of prequalified TB products particularly: 2nd line and paediatric drugs

� Securing additional funds from UNITAID for MDR-TB and Paediatrics

� Overcoming barriers to effective access: importation restrictions, registration, market protection

� Marketing and strengthening of GDF's Direct Procurement Service; making it more self-sustaining.

2008 – Expected Challenges

Thank you for your support

from the GDF Team!

gdf@who.int