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Global Drug Facility: Procurement Arm of the Stop TB Partnership. John Loeber Procurement Team Manager. Conference on Quality of Pharmaceutical In gredients Beijing, China, 29 - 31 March 2010

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slide1

Global Drug Facility:

Procurement Arm of the

Stop TB Partnership

John Loeber

Procurement Team Manager

Conference on Quality of Pharmaceutical Ingredients Beijing, China, 29 - 31 March 2010

Tutorial 3: Quality of essential anti-tuberculosis medicines

slide2
An initiative of the Global Partnership to Stop TB (2002)

Housed in WHO and managed by Stop TB Partnership secretariat

Aims to supplyuninterrupted,quality assured, affordable anti-TB medicines, where they are needed, when they are needed

More than a traditional procurement mechanism, GDF is a bundled facility (ie, supplies medicines, diagnostics, provides TA in drug management, and conducts quality assurance)

What is the GDF?

slide3

Global TB estimates

Estimated number of cases (incidence)

Estimated number of deaths p.a.

All forms of TB Greatest number of cases in Asia; greatest rates per capita in Africa

9.15 million

(139 per 100,000)

1.65 million

(25 per 100,000)

Multidrug-resistant

TB (MDR-TB)

~489,000

~130,000

Extensively drug-resistant TB (XDR-TB)

~20,000

~35,000

HIV-associated TB

~709,000

~231,000

slide4

New Diagnostics

GDF SERVICES

slide5
Supply treatments for 25 million patients by 2015 (16 million provided until 2009)

Improve the quality and reduce prices of anti-TB medicines worldwide

Diagnose and treat drug susceptible and MDR TB* patients

Reduce the emergence of drug resistant M/XDR TB**

Contribute to the achievement of Health MDGs

Eliminate TB by 2050

What GDF aims to achieve

* MDR TB = TB bacteria are resistant to at least isoniazid and rifampicin (two most powerful anti-TB medicines today)

** XDR TB = MDR-TB is present, plus resistance to at least three of the six classes of available second-line medicines

slide6

The GDF / GLC model: One Stop Access

Country/Project

NTP /

Delivery

QC, FF

Application

WHO

PA

GDF / GLC

Secr / GLI / FIND

Tech. Review Comm.

GLC Expert Comm.

FIND Expert Review

Procurement

GDF

Grant/Tech.

Agreement/

LoA

Technical

Support / M&E

Pharmaceuticals

gdf tb product portfolio

GDF TB Product Portfolio

GDF TB product portfolio
  • Susceptible TB
    • Adult medicines
      • single medicines & FDC
      • Patient kits – contain all drugs needed to treat one patient
    • Paediatric medicines
      • Mostly FDCs
    • Diagnostic kits
      • 4 separate kits – serve a lab for 1,000 sputum tests
  • Resistant TB
    • Adult medicines
      • single medicines
    • Diagnostics
      • In collaboration with Global Laboratory Initiative (GLI), Foundation for Innovative New Diagnostics (FIND)
      • Rapid diagnostic tests
      • Laboratory commodities – reagents, pipettes, centrifuges, work stations, incubators
slide8

Products

RHZE (4FDC)

RHE (3FDC)

Units

Bulk 1000 tabs Blisters 672 tabs

Bulk 1000 tabs Blisters 672 tabs Bulk 1000 tabs Blisters 672 tabs

Bulk 1000 tabs Blisters 672 tabs

Bulk 1000 tabs Blisters 672 tabs

50 Vials

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

Full treatment for 1 patient

Cat. I & III Patient Kit

Full treatment for 1 patient

Cat. II Patient Kit

product selection paediatric tb drugs

Products

RHZ (3FDC)

Units

Bulk 1000 tabs Strips

Bulk 1000 tabs Strips

Bulk 1000 tabs Strips

Bulk 1000 tabs Strips

50 Vials

Product Selection:Paediatric TB drugs

RH60/30

RH60/60

E100, H100, Z150

S1g

slide12

Product Selection: Diagnostic Kits

Equipment starter kit

Microsope kit

Consumables kit

Sputum container kit

slide13

GDF Global Market Share (USD)First Line Medicines

Public Sector (USD 130 m)

Total Market (USD 325 m)

2010 Data and Estimates

slide14

GDF Global Market Share (USD)Second Line Medicines

Public Sector (USD 120 m)

Total Market (USD 300 m ?)

2009 delivery data; Public Sector estimate based on 2008 treatment numbers

slide17

Orders Placed Second LineAnti-TB Medicines (USD)

Approx. 70 % y-on-y growth rate

16 m USD UNITAID funding approved

for India 2010 - 2011

slide20

First Line Paedeatric TB MedicinesTop 12 Products in 2009

Suppliers: Cadila, Fatol, Lupin, Macleods

slide22

Strategic Rotating Stockpile

5,800 patient treatments

Stockpile composition subject to change

slide23

Individual MDR Medicines Costs as share of Total MDR Medicines Costs based on average required quantities of medicines per patient

Individual Medicines Costs as share of Total Medicines Costs

based on average required quantities of medicines per patient

slide27

Forecasting Procedures(First Line TB Medicines)

  • Stock levels, patient enrolment and mortality numbers, order plans are collected from the NTP
  • Planning data is validated against historical analysis of supply data vs. planning data
  • Specific factors such as funding delays, regulatory matters (e.g. registration)
  • Client completes and Order Form/Technical agreement
  • Client works with GDF to finalize patient numbers & required quantities using Standardized GDF quantification tool: drugs & diagnostics
  • GDF supports client with technical and drug management support via annual monitoring mission

Distinction between H/L/unknown probability

slide28

Forecasting Procedures(Second Line TB Medicines)

  • GLC patient approvals and enrolments
  • Medicines coefficients per treatment
  • Country planning
  • Donor funding
  • Epidemiology
  • New diagnostics for TB
  • Market dynamics, advocacy, political agenda (national and global), diplomacy
slide29

GLC approved projects at beginning 2009

  • Azerbaijan
  • Armenia
  • Belarus
  • Bulgaria
  • Estonia
  • Georgia
  • Kazakhstan
  • Kyrgyzstan
  • Latvia
  • Lithuania
  • Moldova
  • Romania
  • Russia
  • Serbia
  • Ukraine
  • Uzbekistan

Uncertain demand

  • Bangladesh
  • India
  • Indonesia
  • Myanmar
  • Nepal
  • Timor-Leste
  • Belize
  • Bolivia
  • Costa Rica
  • Dominican Republic
  • Ecuador
  • El Salvador
  • Guatemala
  • Haiti
  • Honduras
  • Mexico
  • Nicaragua
  • Paraguay
  • Peru
  • Uruguay
  • Egypt
  • Jordan
  • Lebanon
  • Pakistan
  • Syria
  • Tunisia
  • Burkina Faso
  • Cameroon
  • DR Congo
  • Ethiopia
  • Guinea
  • Kenya
  • Lesotho
  • Mozambique
  • Rwanda
  • Uganda
  • Tanzania

Higher price

  • Cambodia
  • China
  • Micronesia
  • Mongolia
  • Philippines
  • Samoa
  • Vietnam

GLC-approved projects in 60 countries

~ 50'000 patients approved for enrolment

slide30

MDR-TB Patient enrollment

Total of 130,842 patients have been approved for funding by Global Fund from 2003 until 2013

As of 2009 a total of 61,205 patients have been approved by the GLC to be treated from 2003 until 2011

slide31

Medicines Coefficients

The coefficients assigned to each medicine have been estimated according to the data collected and analysed from different sources, i.e.:

  • Treatments and regimens described by the programs in their GLC applications
  • Coefficients calculated based on percentage of total medicines delivered within their particular subgroup and using the recommendations on treatment guidelines
slide32

GF Round 9

- 2.38 billion USD is the total requested for TB

- 44 / 48 proposals have an MDR component

slide33

Proportion of GLC-enrolled MDR-TB casesin 2007

Estimated MDR total

Estimated MDR SS+

Reported MDR cases

slide34

GDF Funding Horizon

  • New multi-year Agreement to be signed with USAID for US$ 15M p.a. making USAID main GDF donor
  • CIDA, Netherlands and Norway continue to be bilateral donors
  • US$ 54 m for MDR-TB drugs from UNITAID over 5 years
  • US$ 12 m from UNITAID for Paediatric Grants over 5 years.

Pending proposal for additional US$ 33 m.

  • GDF to supply US$ 55 m of new Diagnostic Tools funded by UNITAID in partnership with FIND and GLI to 27 countries over

5 years

  • Direct Procurement, including TGF, UNDP, UNICEF, World Bank funding

External evaluation of STB Partnership/GDF gives GDF strong vote of

confidence & confirmation of mandate for 2008 – 2012

GDF retains ISO 9001:2000 certification

slide35

Procurement

  • GDF competitively & transparentlycontracts its procurement agents
  • The Procurement Agent contracts manufacturersthroughLimited International Competitive Bidding
  • GDF Quality Assurance Processcomplies with Global Fund requirements
  • Bulk procurement, standardization and prompt payment policy secure low prices
  • Products supplied by GDF are registered by the National Regulatory Authority where required
  • GDFadheres to Interagency Operational Principles for Good Pharmaceutical Procurement, WHO Manual on Procurement of Goods and Services
slide36
Integrity

Competition

Equal treatment

WHO / GDF objectives

Customer Service

Transparent and fair

Competitive tendering

Same conditions

Meets programme objectives

Customer satisfaction while best value for money

Guiding Principles for Procurement

In line with UN guiding principles on procurement

slide37

GDF Procurement Mechanism

WHO (legal entity)

Stop TB Partnership/GDF

LICB

Sour-cing

Procurement Agents

LICB

Suppliers/Manufacturers

GDF

Order Management System

Control Agent/PSI (Sampling)

Laboratory/Quality Assurance

Freight Forwarders & Insurance

Client (National TB Programme)

slide38

Supplier / Product Sourcing

  • Trade fairs
  • UN Global Marketplace (www.ungm.org)
  • Publications, journals, Chambers of Commerce, business seminars
  • Databases
  • Previous tenders, recommendations (e.g. FIND)
  • Procurement Agent
  • Other market research (internet)
  • Approaches by suppliers
  • Expressions of Interest (every 2 – 3 years; last: September 2008; now rolling submissions with window for entry every 12 months; in future likely: dynamic entry), advertisements
slide39
Under GDF's Drug Quality Assurance Policy, manufacturers and products need to meet the following quality criteria:

A. Manufacturing Site GMP certified by:

1) WHO

2) Stringent (strict) national medicines regulatory authority (SNMRA), i.e. International Conference on the Harmonisation of (ICH) or Associated Member

3) Pharmaceutical Inspection Cooperation Scheme (PIC/S)

Selection of products and suppliersGDF Quality Assurance Policy

slide40
B. Product Approval:

Products shall be in compliance with national regulatory standards and

1) Products shall be pre-qualified by WHO under the WHO PQ Project;

2) Products shall be approved by an SNMRA as defined under point A 2) above

3) Products shall be found acceptable to the GDF through an interim risk assessment process involving a Technical Review Panel, which assesses products based on the information provided in a Pharmaceutical Product Questionnaire (PPQ) under the condition that the product approval process described under either options 1) or 2) is pending. Products shall be eligible for this interim process under specific conditions.

Approvals under 3) shall of limited duration.

For orders funded by The Global Fund (TGF), GDF complies with the TGF's supplier qualification policy.

Selection of products and suppliersGDF Quality Assurance Policy (cont'd)

slide41

ITB / RFP Elements

  • Cover Letter - pages 1 and 2
  • Section 1: Instructions to Bidders – page 3
  • Section 2: Bid Data Sheet – page 6
  • Section 3: Bid Submission Form – page 8
  • Section 4: Special Contract Conditions – page 9
  • Annex 1: Price Schedule Form/Delivery Schedule
  • Annex 2: Packing and Delivery Schedule Sheet
  • Annex 3: General Purchase Conditions
  • Annex 4: Standard Operational Procedures (to be sent electronically)
  • Annex 5. Long Term Agreement (LTA)
  • Annex 6. Data Sheet for Suppliers
  • Annex 7: Code of Conduct
  • Annex 8: Product Specifications (CD ROM)
  • Annex 9: Any other specific P.A. requirements

Public Bid opening, consensus-based Evaluation Committee, Evaluation Report, recourse facility

slide42

First Line TB Medicines LTAAward Criteria

Technical / quality compliance: PQ / SNMRA / Interim

7 suppliers have competed for 18 products (52 short listings)

slide44

First Line TB MedicinesIndividual Request for Quotations (RFQ) Competitions

RFQ awards based on best value, including:

  • Price (IQC or lower)
  • Lead time
  • Registration
  • Vendor Performance (e.g. lead times, responsiveness, registration, stockpiles)
slide48
Thank You

For Your Attention