1. Access to Essential Medicines and Supplies
Bonface Fundafunda
Supply Division
UNICEF
Access to Essential Medicines and Supplies
Supporting national capacities

2. UNICEF Priorities 2002-5 and The Supply Function
School-in-a-Box Kit
WES
Immunisation
Plus
HIV/AIDS
Girls’ Education
Vaccine campaigns
Vaccine security
GAVI
Vaccine safety
Polio eradication
Technical support
ARVs
PMTCT
Test kits
Roll Back Malaria
Essential medicines
Micronutrients
Water & Sanitation
As the Medium Term Strategic Plan (MTSP) was developed, Supply Division reviewed its role and priorities in order to strengthen UNICEF’s capacity to achieve its corporate objectives in the five priority areas. These efforts include an increased collaboration with Programme Division as well as Country and Regional Offices, in determining supply solutions that best support the situation of children, whether through advocacy, information and technical support or the direct provision of supplies.
Early Childhood
Child Protection
Emergency response

3. Products BASIC SPECIAL
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

4. 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
Scaling up access to essential medicines is critical to global efforts to prevent millions of death a year, reducing suffering, and help reduce the economic burden of illness on the poorest families.
Essential medicines save lives, reduce suffering, and improve health, but only if they are of good quality and safe, available, affordable, and properly used. The concept of essential medicines encourages health systems to focus on access to those medicines that represent the best balance of quality, safety, efficacy and cost to meet priority health needs within any given health care setting. Hard to reach populations: Remote and nomadic rural populations; Adolescents, both rural and urban; Migrants;
Internally displaced persons; People who are HIV positive or who are living with AIDS.

5. 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
Procurement of ARV drug is more complex than procurement of basic essential drugs. At present demand for these is limited, not because they are not required but because the cost of treatment is still very high and there is limited health infrastructure to manage treatment. There are no firm forecast of need which makes industry production planning difficult and limits our ability to negotiate further with the industry around affordability. Availability is at the moment not at problem, but production lead times are fairly long and further availability when going to scale must be considered. Patents and drug registration can be seen as bottle necks and in all circumstances a clear overview of the country situation in this regard is a must in relation to procurement. Presently funding is not a big concern as both GFATM and the World Bank MAP funds are available to many countries for procurement of ARVs. Future secure funding need to be considered carefully and treatment with ARVs is lifelong. Procurement can be done by UNICEF and other organizations and though complex not problematic. Health systems infrastructure is big concern as well as patients compliance to treatments.

6. UNICEF supports countries’ supply chain management by combining its field operations with global procurement
Demand
Creation
Monitoring
Product
Selection
Effective
Use
Forecasting
Receipt,
Storage,
Distribution
Financing
Field Offices
Supply Division
Product
Procurement
Quality
Assurance
Supplier
Agreements

7. 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
Secure delivery to treatment sites is essential – value of ARVs/ poorly-paid health workers and local logistics personnel
Zero tolerance on ARV stock-outs is required to avoid any interruption in treatment
Patent and registration situation needs to be clear in each country
The ARV supply must be accompanied by timely availability of test kits and supporting lab equipment and supplies
Continuous monitoring
Logistics arrangements
Copenhagen stockpile, $1.6m
Patents review
Comprehensive supply plans

8. 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 $ per patient/year

9. INCREASED COMPLEXITY Different specifications Volume discounts
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)

10. UNICEF has 35 one-to- two year purchase arrangements for ARVs and diagnostics17 18
Originators, generics, distributors
Diagnostics
ARVs

11. 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

12. Transparency in prices is provided through Sources and Prices Report

13. 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

14. 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

15. 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

16. Supply