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

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

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

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.

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.

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

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

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 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)

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