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Briefing for Delegates to the 65th World Health Assembly

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  1. 1. UNITAID Briefing for Delegates to the 65th World Health Assembly Market-based approaches for public health in the globalization era Palais des Nations Geneva, Switzerland 21 May 2012Page 0
  2. 2. Agenda 1 UNITAIDs Market Approach to Public Health UNITAIDs Success in Increasing Access to 2 2nd-line HIV Medicines: markets dominated by donor funding Challenges & Opportunities to Increase Access 3 to TB medicines: markets dominated by middle-income country fundingPage 11Slide
  3. 3. 1 2 3 How UNITAID intervenes in markets UNITAID’s role depends upon the particular circumstances in a given market: • Market catalyst: identify and facilitate adoption and uptake of new and/or superior public health products; • Market creator: provide incentives for manufacturers to produce otherwise unattractive products with low demand that yield little profit but substantial public health benefit to those in need; and • Market “fixer”: address severe market inefficiencies (e.g. grossly inaccurate demand forecasts and excessive transaction costs) that contribute to low access to quality- assured public health products.Page 2
  4. 4. 1 2 3 UNITAID Market Impact Framework • Begins and ends with identifying and addressing access problem • Market interventions are merely tools to increase access Case for intervention Pathway from market to public health impact Public health Market Innovative Sustainable problem & shortcomings Public health market market commodity and their impact intervention impact access issues reasons Benefit of a market approach: Market impact (e.g., price reductions, improvements in quality & formulation) from UNITAID interventions are accessible to all purchasers, not just UNITAIDs direct beneficiariesPage 3
  5. 5. 1 2 3 UNITAID Results in 2nd-line HIV Market 450k in need 260k in need 210k on ART 76k on 71k ART UNITAID 2005 2010 2012 Price: $1500/person/year Price: <$500/person/year Supply: <5 quality formulations, Supply: >20 formulations, ARVs required refrigeration, ARVs are heat-stable, no pediatric formulations, pediatric formulations, 2 manufacturers >9 manufacturersPage 4
  6. 6. 1 2 3 Key factors in success of HIV 2nd-line market evolution and increased access • Donors provided majority of funds (Global Fund, PEPFAR, UNITAID) • Similar donor requirements on procurement & quality policies • Coordinated approach to price negotiation & price transparency • Interventions to improve ARV process chemistry to reduce prices • Efficient quantification & pooling of ARV demand • Communication to suppliers about current & future needs • Monitoring & reporting of supplier performance & API availability • WHO guidelines simplified: recommend a few ARVs, regimens – Most treatment provide by public sector that follows WHO guidelines Result: Consolidated & efficient market where donors exert strong market power to shape markets for maximum accessPage 5
  7. 7. 1 2 3 Whats different about TB markets? • Domestic funding ~87% of expected 2012 funding • Procurement & quality policies differ dramatically across countries • Little coordination on price negotiation & price transparency • Few interventions to improve process chemistry to reduce prices • Inefficient quantification of global TB medicine demand • Poor communication to suppliers about what will be needed • Little monitoring & reporting of non-donor supplier performance • Private sector provides substantial treatment: regulation challenges, may not follow WHO guidelines, poor adherence Result: Fragmented & inefficient market where donors have little market power; a few countries dominate in local & global marketsPage 6
  8. 8. 1 2 3 Private sector volumes of 1st-line TB Medicines Size of private market, using first-line drugs as a proxy • Private sector capacity to India supply first-line drugs Indonesia varies widely across Philippines countries Weighted average Pakistan China • Private sector supply Thailand fosters MDR-TB through: Russian Federation • non-standardized Bangladesh dispensing of medicines, Viet Nam irrational use of medicines, South Africa of uncertain quality) • patient loss to follow-up 0% 40% 80% 120% % of all incident MDR-TB cases that can be treated by first-line drugs in the private-sector marketSource: WHO Progress report 2011. Towards universal access to diagnosis and treatment of MDR- and XDR-TB by 2015.Data from Wells W et al. Size and Usage Patterns of Private TB Markets in the High Burden Countries. 2011.Page 7
  9. 9. 1 2 3 Trends in MDR-TB market evolution & access 440k in 440k in need need Estimated treatment coverage (GLC only) Estimated UNITAID coverage 45k 2005 2010 2012 Price: High, unaffordable prices Price: High prices ($>2,000/tx) Supply: Few PQ formulations, Supply: Few PQ formulations, Injectable medicine needed, Injectable medicine needed, Lots of side effects, Lots of side effects, Treatment of 18 months, Treatment of 18 months, Few manufacturers, Few manufacturers, Insecure API supplyPage 8
  10. 10. 1 2 3 Innovation & emerging opportunities in TB Diagnosis Treatment • 2 new MDR-TB Medicines in 2012-2013: TMC-207, OPC- 67683 • Global TB Alliance: • New, shorter regimens with existing medicines GeneXpert: • New medicines & new Revolutionized TB regimens: safer, cheaper diagnosisPage 9
  11. 11. Middle-Income Countries are Leading 1 2 3 TB Efforts & will Play Increasingly Important Roles (1) • “Market anchors” through early adoption of new technology & large scale purchases – End of 2011, >50% of GeneXpert cartridges purchased by S. Africa • Innovation & technology incubators – GeneXpert fast followers likely to emerge from India or China • Local pharmaceutical production – Substantial production capacity for APIs & finished products • Technology transfer – Brazilian ARV tech transfer to Mozambique • Government funding & service provision – Brazils commitment to free ARVsPage 10
  12. 12. 1 2 3 Middle-Income Countries are Leading TB Efforts & will Play Increasingly Important Roles (2) • Regulatory efficiency & harmonization – “Not a single regulator today can work meaningfully in isolation,” “The future of medicines regulations is more in harmonisation, collaboration, and network.” Lembit Rago at Brazilian Meeting on Regulation, May 2012 • Coordinated or pooled procurement – Aggregate demand across multiple buyers & communicate to suppliers for planning for medicines in low demand • Information sharing – Funding, product availability, quality, price, supplier performance, guidelines • Pharmacovigilance – Careful monitoring & “protection” of new medicines & regimensPage 11
  13. 13. 1 2 3 Summary & Conclusions • Many donors & international organizations have recently adopted market approaches to improve public health – Most interventions leverage purchase power, policy conditions on funding, guidelines & standards, and other tools to shape markets • Donors are no longer the only source of leverage; middle-income countries dominate TB markets • BRICS have unique opportunity to define a common TB agenda – Drive MDR-TB Scale-up: proper diagnosis, better medicines – Opportunities for global leadership & improving country program efficiency • Interventions in BRICS will have ripple effects in poorer countries; fragmented TB market requires BRICS leadership to consolidate and reshape for improved global access • New paradigm must emerge where BRICS lead and work in collaboration with donors who can represent the poorer countriesPage 12
  14. 14. 1 2 3 Thank you Acknowledgements • Janet Ginnard Contact Information • Brenda Waning: waningb@unitaid.who.intPage 13