global drug facility
Download
Skip this Video
Download Presentation
Global Drug Facility

Loading in 2 Seconds...

play fullscreen
1 / 28

Global Drug Facility - PowerPoint PPT Presentation


  • 253 Views
  • Uploaded on

Global Drug Facility. “Securing timely access to quality, affordable Tuberculosis drugs & related supplies”. GFATM Round 6 Proposals STB Consultants Briefing 16 March 2006, Geneva. Introduction. What is the GDF? GDF the Direct Procurement Service?

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Global Drug Facility' - roddy


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
global drug facility
Global Drug Facility

“Securing timely access

to quality, affordable

Tuberculosis drugs &

related supplies”

GFATM Round 6 Proposals

STB Consultants Briefing

16 March 2006, Geneva

introduction
Introduction
  • What is the GDF?
  • GDF the Direct Procurement Service?
  • How GDF can Support GFATM beneficiaries
  • Practical Steps for R6 Proposals
what is the gdf
What is the GDF?
  • 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 timelymanner, for 10 million people with TB by 2010
  • GDF is more than a procurement mechanism:
    • A bundled facility not a procurement agent
partnership framework
Partnership Framework

Global Partners\' Forum

Global Drug Facility

Coordinating Board

Partnership Secretariat

WHO Technical

Advisory Group

W O R K I N G

G R O U P S

DOTS

EXPANSION

TB/HIV

MDR-TB

DOTS PLUS

New

Vaccines

New

Diagnostics

New

Drugs

Advocacy

Communication

Social Mobilization

TASK FORCES : RESOURCE MOBILIZATION / FINANCING

why the gdf
Why the GDF?

GDF was created to secure timelyaccess to affordable, high qualitydrugs to accelerate DOTS expansion

GDF addresses 5 needs:

  • The need for more resources for TB drugs
  • The needfor high quality TB drugs
  • The needfor efficient procurement systems
  • The needfor standardized products
  • The needfor monitoring drug use & tech. assistance for drug management
what does gdf offer
What does GDF offer?
  • Now: 3 Services

Grants of first line drugs, to support DOTS expansion 1

2A direct procurement mechanism for countries and NGOs, to buy

1st & 2nd line drugs for use in DOTS programmes

3A white list of ‘pre-qualified’ manufacturers of quality TB drugs

  • Future: +3 Services
    • Grants of Diagnostic Kits
    • Technical Assistance Service Line
    • Paediatric Formulations
  • Bundled with support for
  • Drug Management/Technical
  • Assistance
key achievements
Key achievements
  • >7 million patient treatments committed in 5 years
  • Deliveries to >60 countries
  • Value for money: US$ 17 - 22 treatment cost per patient
  • Annual procurement volume valued at US$ 35 - 40 million
  • Introduction of innovative packaging: > 1,000,000 Patient Kits delivered to India, Indonesia, Kenya & Philippines
  • Wide range of Direct Procurement Clients: GFATM, DFID, WHO, World Bank, German Bank for Reconstruction, Caritas
  • >150 monitoring and technical assistance missions conducted
who can use the service
Who can use the Service?
  • 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.
why use the service
Why 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 save work - when a robust procurement mechanism is not yet established
  • to access quality assured fixed dose combination tablets
  • to standardise TB drug formulations
  • to access GDF technical support for drug management
  • GDF is ISO 9001: 2000 Certifiedtherefore offering a stringent and client oriented quality service
gdf a solution for donors
GDF: A solution for donors

Direct Procurement turnover 2003 – 2005: $37 million

  • > 25 countries

GFATM – $7.6 million

  • 14 countries:
    • Afghanistan
    • India
    • Indonesia
    • Bangladesh
    • Cote d\'Ivoire
    • Liberia
    • Moldova
    • Mongolia
    • Namibia
    • Serbia & Montenegro
    • Sudan
    • Tajikistan
    • Uzbekistan
    • Ghana

DFID - $ 62 million over 5 years

  • India
gfatm requirements
GFATM requirements
  • to procure quality assured products at the lowest possible price and 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

outsourcing procurement
Outsourcing Procurement
  • 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
procurement supply management psm r6 proposal
Procurement & Supply Management (PSM) R6 Proposal

Selection

Management

Use

Procurement

Support

Distribution

slide17

Products

RHZE (4FDC)

RHE (3FDC)

Units

Loose 1000 tabs Blisters 672 tabs

Loose 1000 tabs Blisters 672 tabs Loose 1000 tabs Blisters 672 tabs

Loose 1000 tabs Blisters 672 tabs

Loose 1000 tabs Blisters 672 tabs

50 Vials

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

RH150/75

RH150/150

EH400/150

E400, Z400, H300

S1g

Cat. I & III Patient Kit

Cat. II Patient Kit

1 2 product selection diagnostic kits
1.2 Product Selection:Diagnostic Kits

Equipment starter kit

Consumables kit

2 forecasting procedures
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
slide20

3.1 Procurement

  • GDF competitively & transparentlycontracts its procurement agent
  • The Procurement Agent contracts manufacturersthroughLimited International Competitive Biddingaccording to World Bank rules
  • GDF Quality Assurance Process fully compliant with GFATM requirements
  • Bulk procurement, standardization and prompt payment policy secure low prices
3 2 procurement
3.2 Procurement
  • All batches underpreshipment inspection and quality control via independent agent
  • GDF adheres to Interagency Operational Principles for Good Pharmaceutical Procurement
  • e-catalogue & e-tracking system for PrincipleRecipients orders
  • All anti TB products supplied by GDF are registered by National Regulatory Authority of the recipient country where required
slide22

R6 Proposal: practical steps - 1

Procurement and Supply Management Section of Proposal

  • In this section, applicants describe their arrangements for procurement & supply management of health products and must specify where purchasing occurs via the Global Drug Facility
  • Which of the following types of organizations will be involved in the procurement of health products? (Tick all that apply.)
      • Sub-contracted procurement organization (s) (international) (specify which one [s]) GLOBAL DRUG FACILITY
  • For each organization to be involved in procurement, please provide

the latest available data on the annual value in Euro or US$ of

procurement of drugs and related medical supplies by that agency.

      • Data on annual GDF turnover in US$ available on GDF website at:

www.stoptb.org/GDF

Tool kit for GFATM Proposals – Round 6

slide24

R6 Proposal: practical steps - 2

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 GFATM Proposals – Round 6

slide25
After Proposal & PSM Plan approval:

Practical 10 STEP approach on how to secure delivery of TB drugs via

GDF

Direct Procurement Service

slide26

Submit signed

form to GDF at

[email protected]

GDF PRC agent

Sends contract for signature

Obtain Order

Form on GDF

website

PR sends signed contract to agent

PR transfers funds or Bank Guarantee to agent account

Steps 1 - 5

Lead time: 2.5 months

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
slide27

Order recorded

in WEB-based

tracking system

and PR issued

username &

password

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

Steps 6 - 10

Lead time: 1.5 to 6 months

6

7

8

9

10

  • PR can track progress of shipment
  • E-mail updates sent at least monthly
  • Preclearance docs
  • sent in advance
  • (1 to 4 weeks)
  • Report on appropriate drug use, progress, needs
  • Agent liaises with
  • PR to ensure
  • REGISTRATION
  • procedures followed
ad