Transcript Slide 0 - World Health Organization

GLOBAL DRUG FACILITY
Improving country access to anti-TB medicines
Andrea de Lucia, GDF Team Leader 1st line Country Support
WHO/UNICEF Technical Briefing Seminar on
Essential Medicines Policies
1 October 2011
ROLE OF GDF
Established 2001, GDF is an initiative of the Stop TB
Partnership hosted by WHO
• Public Sector procurement of anti-TB drugs, of the right quality,
quantity, and price, and deliver them at the right time to the right
people
• Originally established to provide in-kind 1st line anti-TB drug
grants, since added direct procurement services as countries
have other sources of funding available
• Provide limited technical assistance by monitoring drug
management in countries utilising GDF’s services and highlight
system strengthening requirements.
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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GDF PROCUREMENT FACTS 2010
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Total value of goods procured: USD112,107,433
Value of grant expenditure: USD36,792,474
Value of direct procurement services expenditure: USD75,305,619
Total cost of procurement agents: USD5,322,781 (GIZ 3.9%, IDA 4.2%)
Estimated FLD patient treatments: 2,293,207 (242,490 paediatrics)
Estimated SLD patient enrolled: 10,742
Number of countries using GDF’s services: 93
Stock-outs reported to GDF thru monitoring missions: 12 (10 in Africa
region)
Emergency and urgent orders requested: 87
Global FLD market estimated b/w USD261 – 418 million in 2008*
GDF has approximately USD50 million of this market
Global SLD market is unknown**
GDF has approx USD57 million of this market
Source:
*TB Alliance (2008) **(2011)
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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GDF PROCUREMENT FUNDING TRENDS
Millions
ex works
value
or orderplaced
placed2007-2010
2007-2010 per
Ex Works
value
of orders
per funding
fundingservice
service
$120
$112
$100
$80
$75
$71
DP
$62
$60
Grant
total
$40
$42
$38
$40
$37
$29
$20
$22
$21
$17
$2007
2008
2009
2010
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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GDF PROCUREMENT CHALLENGES – FLD/SLD SUPPLY
• Limited number of API producers.
• Stringent prequalification requirement results in a lack
of incentives to prequalify products
• Insufficient number of quality assured products can
result in the interruption of supply of drugs
(Streptomycin)
• Limited number of TB drug manufacturers also results
in a lack of competition (high prices) and
overstretches suppliers (late deliveries).
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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GDF PROCUREMENT CHALLENGES – FLD/SLD DEMAND
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Market fragmentation: multiple entities procuring
Poor forecasting of requirements by clients
Insufficient budgetary and procurement planning
Volatile funding commitments from donors and
governments cause havoc in planning
• Emergency requests with short delivery lead times
stress all actors (allow 8 months delivery lead time).
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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COMMENTS ON FLD BIDDING 2011
Prices have increased significantly since 2009
GDF observed:
• Increased unit prices attributable to API costs, namely R, and
fuel costs in India
• For products where there was competition, price ranges were
generally similar
• For those products where there was no competition, price
increases appeared unreasonable and unjustifiable – eg
paediatrics
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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PRICING OF HIGH DEMAND FLDS AND PROJECTED DEMAND*
* Based on retrospective analysis of demand in 2010
TB20Drug
Manufacturers
Meeting, New Delhi, 29-30 August 2011
th Coordinating
Board Meeting | Washington DC| 31 March – 1 April 2011
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COMMENTS ON SLD BIDDING 2011
General price containment since 2009
GDF observed:
• Out of 23 products, 12 have only 1 quality assured manufacturer – ie
no competition
• Excepting capreomycin and moxifloxacin, no significant price
differentials since 2009
• Volumes procured to date have not resulted in price reductions
• Price reductions are only likely in future if demand is further
consolidated
• Market sustainability is a concern
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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PRICING OF HIGH DEMAND SLD’S AND PROJECTED DEMAND*
* Based on retrospective analysis of demand in 2010
TB
Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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GDF'S RESPONSE TO PROCUREMENT CHALLENGES
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Manufacturers offering staircase pricing where demand can be
consolidated (move towards quarterly ordering and have a dedicated
forecasting staff at GDF)
New FLD/SLD LTA's have a heavier liquidated damages clause for
suppliers not honouring delivery lead times
Rethinking stockpile options:
– warehouses in strategic logistical locations and financing
scheme options.
Continue providing adult/paediatric FLD grants as we expect budgetary
gaps due to price increases over 2011-2012: countries must plan and
identify gaps early to allow for application review and delivery (8
months)
Strengthened GDF technical assistance at regional level beginning
2012: Regional Technical Officers to provide assistance in procurement
planning, quantification, monitoring and order placement.
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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TECHNICAL ASSISTANCE – GDF MONITORING MISSIONS
Monitoring missions conducted in 55 countries in 2010
Objective
•Validate stock levels
•Monitor GDF terms & conditions (grant & direct procurement)
•Assess overstocking and stock outs
•Assist with planning for future requirements
•Highlight problems in supply chain
Key Observations
•Gaps in PSM staff capacity/training
•Lack of Standard Operating Procedures
•Poor information management (manual vs computerised)
•Inadequate planning of requirements/funding
•Reliance on donor funding and associated volatility
•Political commitment to change is not always evident
TB
Manufacturers
Meeting,
New
Delhi,
29-30
August
20thDrug
Coordinating
Board Meeting
| Washington
DC|
31 March
– 1 April
2011 2011
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TECHNICAL ASSISTANCE – GDF DRUG QUANTIFICATION TOOL
Developed in partnership with MSH for 1st line drugs
Objective
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Quantify countries annual needs for procurement planning and budgeting
purposes (GDF 1st line drug prices), using morbidity data
Determine low long quantities of stock on hand will treat estimated patients
Determine trigger dates for reordering
Adjust buffer stock % based on projected demand & available budget
Key Observations
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User friendly but staff training is required to utilise and interpret the
information for planning purposes
Quantification requires good data – NTP needs a good surveillance system
to know:
– exact number of patients treated last year
– number of patients in each treatment category
– existing stock levels of each item
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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TECHNICAL ASSISTANCE – DRUG MANAGEMENT WORKSHOPS
With our partner MSH, GDF organizes drug management workshops focused on
helping countries identify their PSM bottlenecks and develop an Improvement Plan
Curriculum includes:
• Selection
Rational drug use
• Quantification
Quality assurance
• Procurement
Inventory control
• Hosting country site visit to relevant sites (Central NTP, Central warehouse, NRA, health
centres)
• In 2010, regional workshops held in AFRO and EURO; joint consultants training for
EMRO/AFRO (Nairobi)
•In 2011, global workshop focused on the drug management and 2nd line drugs (Sri
Lanka)
•In 2012, continued regional workshops with new Regional Technical Officers once
recruited.
TB Drug Manufacturers Meeting, New Delhi, 29-30 August 2011
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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Main messages
1. FLD price increases will affect most countries' planned budgets
2. Start early to identify gaps in drug procurement budgets
3. Allow sufficient time for securing additional funding (if necessary), order
placement, manufacturing lead times, and SEA shipment (most costefficient)
Thank you!
Andrea de Lucia
[email protected]
20th Coordinating Board Meeting | Washington DC| 31 March – 1 April 2011
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