1. Page 0 UNITAID’s Strategic Approach to HIV Diagnostics  Washington DC 22 July, 2012 XIX International AIDS Conference Brenda Waning

2. Page 1 Agenda UNITAID Market Approach to Public Health UNITAID Landscape Reports UNITAID HIV Diagnostics: Recent Investments & New Opportunities 2 3 1

3. Page 2 Slide 2www.unitaid.eu UNITAID Market Approach to Public Health 1 312

4. Page 3 Why UNITAID works through markets Healthy markets, healthy people UNITAID aims to promote “healthy”, dynamic market conditions whereby manufacturers have incentives to invest and innovate, while at the same time supply quality public health products at affordable prices and in acceptable formulations that enable the maximum number of people to access them. www.unitaid.eu 312

5. Page 4 How UNITAID intervenes 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, low-demand products that yield little profit but have 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. 312

6. Page 5 Slide 5 UNITAID Market Impact Framework Market Shortcomings: Price; Availability; Quality; Acceptability; Delivery www.unitaid.eu Reasons for Market Shortcomings: Absence of market; Lack of external grant funds when commercial incentives are insufficient; Unbalanced market structure (e.g.,monopsony / oligopsony); Structural & capacity issues along the supply chain; Information asymmetries; Barriers to entry & exit. 312

7. Page 6 Slide 6 UNITAID is one of several market players Coordination is critical: Global Fund, PEPFAR, USAID, PDPs, BMGF, WHO, UNAIDS, national governments, etc. www.unitaid.eu 312

8. Page 7 UNITAID Landscape Analyses 2 2 13

9. Page 8 Slide 8 UNITAID Landscape Analyses 1. Disease: public health problem and access issues, global goals, future directions & guidelines for diagnosis & treatment 2.Technology: comparison (pros and cons) of products currently on the market and products in the pipeline; 3.Market: overview of market dynamic trends (past & future), market shortcomings and their reasons, global positioning of key stakeholders Systematic, forward-looking to proactively and strategically address tomorrow’s challenges and opportunities...today Identify issues & market opportunities in each niche 2 13

10. Page 9 UNITAID HIV Diagnostic Landscapes Jun 2011 Annual Oct 2011 Update Jun 2012 Annual www.unitaid.eu/

11. Page 10 Utilization & Dissemination of Landscapes Results inform UNITAID’s own strategy & investment decisions UNITAID Annual HIV Market Forum: bring together the world's leading experts (prevention, diagnosis, treatment) to identify & prioritize market-based opportunities for all organizations Close linkage to WHO Treatment 2.0 through WHO HIV Diagnostics Working Group & Global Fund through Market Dynamics Advisory Group Commitment to transparency & Public Goods (data, information, methods, tools, results, lessons learned) 2 13

12. Page 11 UNITAID HIV Diagnostics: Recent Investments & New Opportunities 3 2 13

13. Page 12 UNITAID HIV Diagnostic Activities & Investments DiscoveryDevelopmentEvaluationRegistration Market 2 13 CHAI/UNICEF (Mar 2012): Catalyze Market; Scale-up MSF (Mar 2012): Operational Research Landscape Analyses Market Intelligence Systems: monitoring, estimate impact Market Entry (Dec 2012): Address Developers’ Market Barriers Collaboration with and others New Investment Area

14. Page 13 Unprecedented innovation in HIV POC diagnostics, but several market entry barriers exist Market entry definition: "completion of the marketing approval steps required to commercialize a product" Most significant market entry barriers: Unclear, absent, and/or inconsistent regulatory pathways to market, register, and use new diagnostics – each country has own requirements Slow global quality assurance processes Private funding (venture capital) hard to access New Area: Market Entry Barriers HIV POC Diagnostics DiscoveryDevelopmentEvaluationRegistration Market 2 13

15. Page 14 Implications of market entry barriers for new POC HIV Diagnostics Delay in market entry of new products Additional costs and resources needed to enter market may increase final price & limit extent of uptake Limited competition. First-to-market may capture market share and block market entry of better, less expensive products in the pipeline Long term disincentives for continued innovation UNITAID will consider new investments to developers & leverage existing projects (CHAI/UNICEF, MSF) to address market entry barriers

16. www.unitaid.eu Summary & Conclusions After a decade of suboptimal access to diagnostics, new innovative POC products offer real promise to bring diagnostics to underserved populations & increase quality of HIV care UNITAID’s comprehensive, strategic approach to HIV diagnostics: Landscape reports & market intelligence (public goods) Investments in projects to scale-up access POC diagnostics Investments to address POC market entry barriers Collaboration with stakeholders. Global Fund: coordinated approach, supplier meetings, etc. and WHO/UNAIDS Treatment 2.0: umbrella to share information, results, lessons learned for future guidance

17. Page 16 Slide 16 Thank You Brenda Waning waningb@unitaid.who.int www.unitaid.eu/ www.unitaid.eu 2 13