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Philippe Duneton 11 February 2009 Deputy Executive Secretary

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

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  1. Philippe Duneton 11 February 2009 Deputy Executive Secretary 5th Consultative Stakeholder Meeting UN Prequalification of Diagnostics, Medicines & Vaccines

  2. 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

  3. 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

  4. Scope of work in the Pharmaceutical value chain

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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

  12. 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

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