Transcript Access to Essential Medicines and Supplies Supporting national capacities Bonface Fundafunda Supply Division UNICEF UNICEF Priorities 2002-5 and The Supply Function Immunisation Plus •School-in-a-Box Kit HIV/AIDS •WES Girls’ Education •Vaccine campaigns •Vaccine security •GAVI •Vaccine safety •Polio eradication Child Protection •Technical.

Access to Essential
Medicines and
Supplies
Supporting national
capacities
Bonface Fundafunda
Supply Division
UNICEF
UNICEF Priorities 2002-5
and The Supply Function
Immunisation
Plus
•School-in-a-Box Kit
HIV/AIDS
•WES
Girls’ Education
•Vaccine campaigns
•Vaccine security
•GAVI
•Vaccine safety
•Polio eradication
Child Protection
•Technical support
•Roll Back Malaria
•ARVs
•Essential medicines
•PMTCT
•Micronutrients
•Test kits
•Water & Sanitation
•Emergency
response
Early Childhood
Products
•BASIC
• Medicines: Antiretrovirals (ARVs), Opportunistic Infections
(OIs), Sexually Transmitted Infections (STIs), Antimalarials
• Test Kits: HIV, STIs, Malaria
• Micronutrients
•SPECIAL
• High Protein energy foods - helping to reduce nutritional
vulnerabilities
• Blended foods for children (UNIMIX)
• Home/Community packs - for improved access/adherence Under development
The UNICEF’s ARV supply strategy is based
on guiding principles:
• Support global policies to ensure equitable, sustainable
availability and access to basic essential drugs
• Follow WHO guidelines incl. Model List of Essential
Medicines
• Focus on primary health care centre – hard to reach
populations
• Assure technically sound procurement
• Assure cost – effectiveness through international competitive
bidding
The main complexities in the procurement of ARVs lie in
international/national law, registration, availability, secure
supply chain systems and patent compliance
Demand
Forecast
Availability
Patents &
Registration
Funding
Procurement
Systems
Compliance
UNICEF supports countries’ supply chain
management by combining its field operations
with global procurement
Demand
Creation
Product
Selection
Monitoring
Effective
Use
Receipt,
Storage,
Distribution
Forecasting
Field Offices
Financing
Supply Division Quality
Product
Procurement
Assurance
Supplier
Agreements
The procurement of ARVs is complex and requires
appropriate procurement, supply and logistics capacity
at global and local levels
•ARV demand has no history and depends on
patient testing and acceptance
Continuous
monitoring
•Secure delivery to treatment sites is essential
– value of ARVs/ poorly-paid health workers
and local logistics personnel
Logistics
arrangements
•Zero tolerance on ARV stock-outs is required
to avoid any interruption in treatment
Copenhagen
stockpile, $1.6m
•Patent and registration situation needs to be
clear in each country
Patents review
•The ARV supply must be accompanied by
timely availability of test kits and supporting lab
equipment and supplies
Comprehensive
supply plans
INCREASED SUPPLIER BASE IN 2006
•WHO pre-qualification ↑
•FDA approval ↑
INCREASED COMPETITION
•FDC d4T + 3TC + NVP 30mg $130.2 per patient/year
•FDC d4T + 3TC + NVP 40mg $138.12 per patient/year
INCREASED COMPLEXITY
•Different specifications
Material specifications (eg, child-proof caps under
FDA)
•Volume discounts
•Lead times
•Careful monitoring of contract awards (paying attention
to lead- times, discounts and actual performance)
UNICEF has 35 one-to- two year purchase
arrangements for ARVs and diagnostics
17
18
Originators, generics, distributors
Diagnostics
ARVs
PAEDIATRIC ARV FORMULATIONS
ARE NOT PERFECT
• More expensive than adult formulations
• No fixed-dose combinations
• Estimating needs is problematic – no weight-guided
dosing
•
•
•
•
Some need cold storage
Distributing glass bottles is more difficult
Taste of formulations is bad
Bottles contain too much volume
Transparency in prices is
provided through Sources
and Prices Report
www.unicef.org/supply
Common supply-related problems
•Relatively new health problem; medicines new,
patented and expensive
•Old medicines useful for opportunistic infections out
of production (pyrimethamine, sulfadiazine)
•Regulatory/Legal impediments – registration,
Intellectual Property protection
•Quantities may be too small to motivate
manufacturers – important to consolidate
•Availability of Pediatric dosage forms severely
restricted
•Programme context not always understood by
procurers – inadequate feedback with procurer
•Quality requirement and Assurance time consuming
Common supply-related
problems - contd.
•Lead time in appropriate in some situations – e.g.
gender based violence
•Existing weak health infrastructure impedes
efficiency
•HIV/AIDS still emotive and politically charged subject
•Ordering of non-essential/non-standard treatment
guideline items
•Funding still a problem
Conclusion
LEGISLATIVE, REGULATORY AND COMMERCIAL
CONTEXT: ensure full compliance in advance
SUPPLIER INTEGRITY: pre qualify suppliers, manage
tender process transparently, monitor performance
PRODUCT AND PROCESS QUALITY: monitor and
evaluate
In Country Logistics: reliable and functioning system is
imperative to assure full access
INFORMATION SYSTEM: maintain information integrity
and flow for action
Supply