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Philippe Duneton 11 February 2009 Deputy Executive Secretary. 5th Consultative Stakeholder Meeting UN Prequalification of Diagnostics, Medicines & Vaccines. Addressing Global HIV/AIDS Challanges. Today 9.5 million people in need of treatment
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Philippe Duneton 11 February 2009 Deputy Executive Secretary 5th Consultative Stakeholder Meeting UN Prequalification of Diagnostics, Medicines & Vaccines
Addressing Global HIV/AIDS Challanges • Today 9.5 million people in need of treatment • 4 million people on HIV/AIDS treatment and rapid expansion of access required • Only 42% of needs currently being met of which 276,000 children (38% coverage) • New treatment guidelines (CD4 <350) = more people in treatment • Financial crisis: funding is not increasing • Key challenge: keep HIV/AIDS on top of the global agenda
UNITAID Strategy: Portfolio 2006-2012 Time 2006 2009 2010 2011 2012 New treatments/regimens (FDCs) 2nd line treatments HIV/AIDS Paediatric treatments (scaling up/transition) PMTCT(Lessons Learnt) Viral Load Prevention commodities? Malaria LLIN ACT– increase access Rapid tests? New 1st line treatments? (2mths) 1st line treatments Tuberculosis MDR- TB treatments MDR- TB tests Co-morbidities HCV? Today
Lower prices of treatments Enable more patients to be treated (e.g. with the same budget) Facilitate government adoption of improved medicines Formulation-related benefits FDCs: Facilitate adherence, reduced risk of resistance, simplified supply chains Paediatric formulations: Improved quality treatment for infants and children, reduced shipment costs for solids (vs. liquids) Heat-stable: Enabled use in resource-poor settings Seeking efficient use of funds and public health benefits
UNITAID Strategy 2010-2012 Goal Objectives Mission UNITAID’s mission is to contribute to scaling up access to treatment for HIV/AIDS, malaria and tuberculosis, primarily for people in low-income countries, by leveraging price reductions for quality diagnostics and medicines and accelerating the pace at which these are made available. [Constitution] Using innovative, global market based approaches to improve public health by increasing access to quality products to treat, diagnose and prevent HIV/AIDS, tuberculosis, malaria and related co-morbidities in developing countries. • To increase access to efficacious, safe and assured quality products that address Public Health problems • To support adaptation of products targeting specific populations • To ensure affordable and sustainably priced products • To assure availability in sufficient quantities and timely delivery to patients
Scope on Diseases and Products Strategy 2010-2012 • Products to treat and diagnose HIV/AIDS, TB, and malaria • Targeted prevention products that align with UNITAID goals and objectives • Products for co-morbiditieswhere: • burden of disease is high • efficacious and cost-effectiveness products are available • opportunity for positive public health & market impact is attainable
Boosting WHO Quality Assurance Programmes Additional support and multi-year commitment to Accelerate the pace at which priority HIV/AIDS, malaria and TB medicines are prequalified Increase the number of QA laboratories in developing countries Control the quality of strategic medicines close to treatment centers 2006-2012: US$ 47 million approved
Support to WHO QA Diagnostic Programme Prequalify priority HIV/AIDS and malaria diagnostics Address costs concerns Build or strengthen national regulatory capacity 2009-2013 support: US$ 7,5 million approved Boosting WHO Quality Assurance Programmes
Patent Pool: innovation and better products • Diversifying supply sources to reduce prices • Expanding generic market size to reduce prices & expand access • Facilitating the development of improved formulations (e.g. Fixed Dose Combinations (FDCs), paediatric and heat-stable formulations) • Increasing legal certainty for generic companies and patent-holders • Reducing transaction costs for licensing agreements (e.g. FDCs)
Partnership: Looking ahead • Reduced prequalification timeline for priority medicines: • Quality assured atazanavir/rto achieve second line therapy objectives • Quality assurance timing in line with theUNITAID project cycle • Second Line ARV transition: 2010-2011 • Paediatric HIV/AIDS transition: 2011-2012? • Increased number ofinnovative FDCs, heat-stable and paediatric formulationsfacilitated by the Patent Pool • Key role in providing technical support to manufacturers • Address new products not based on innovators • Quality APIs to boost global generic supply • Strengthen capacity of NRAs • Access to prequalified HIV and malaria diagnostics
UNITAID Strategy: Portfolio 2006-2012 Time 2006 2009 2010 2011 2012 New treatments/regimens (FDCs) 2nd line treatments HIV/AIDS Paediatric treatments (scaling up/transition) PMTCT(Lessons Learnt) Viral Load Prevention commodities? Malaria LLIN ACT– increase access Rapid tests? New 1st line treatments? (2mths) 1st line treatments Tuberculosis MDR- TB treatments MDR- TB tests Co-morbidities HCV? Today