Accessing Medicines in Africa Prospects and challenges

1. Accessing Medicines in AfricaProspects and challenges Dr Javier Guzman Director of Research, Health Policy Division The George Institute for International Health jguzman@george.org.au 23 February 2010

2. WHO framework for access to essential medicines Access to Medicines Rational selection Reliable health and supply systems Sustainable financing Affordable prices R&D Delivery • Sources: • Wiedenmayer K (2004) Access and Availability of Pharmaceuticals in International Health. In Managing Pharmaceuticals in International Health. • http://www.wto.org/english/tratop_e/TRIPs_e/hosbjor_presentations_e/07quick_e.pdf

3. New landscape of neglected disease R&D • Long way since “Only 13 new drugs registered for tropical diseases between 1975 and 1997 (Pecoul et al1999)” Since 2000: • 18 Product Development Partnerships (PDPs) established • 5 new industry institutes for neglected disease R&D created • 4 major procurement funds set up • Unprecedented generosity of philanthropists

4. PDPs: a new business model • Public-health-oriented, not-for-profit organisations • Drive neglected disease R&D in conjunction with external partners • Integrators(academic, CRO, industry) • Deliver philanthropic and public funds to the “right” projects • Resource allocators • Select and terminate projects on the basis of their relative merits • Portfolio managers • Conduct global advocacy work to increase the profile of their target neglected disease(s) • Advocates

5. Product Development Partnerships (PDPs)

6. 8 Combined PDP pipeline includes 143 candidates 104 biopharmaceutical candidates in development... ... and 39 diagnostic & vector control candidates Diagnostics Pre Clinical 59 57% Feasibility 7 26% Test Development Phase I 15 14% 7 26% Evaluation 6 22% Phase II 12 12% CD4 Demonstration 1 4% FIND Phase III 10 10% Country Adoption IDRI 6 22% Drugs Registration 2 2% Vaccines Vector control Microbicides Launched 6 6% Early Stage IVCC In Development # candidates # candidates Notes: Includes products not funded by Gates Foundation. Biopharmaceutical candidates in development Include: IAVI, IPM, IVI, GATB, Aeras, MMV, MVI, MVP, PVS, DNDi, iOWH, PDVI, HHVI. Source: PDPs Slide source:

7. R&D fundingneeds • No agreement on global funding need for R&D but: • Dalberg estimated that US$6-10 billion would be needed to mature the 2008 neglected disease drug portfolio over the next 10 years • The Global Plan to Stop TB estimated that USD 9 billion were needed between 2006 and 2015 for R&D of new products for TB • The Global Malaria action Plan estimated that US$ 750 - 900 million were needed per year through 2018 for the development of new tools against malaria • R&D costs: • TB diagnostic US$1m to US$10m (TDR-FIND 2006) • Novel TB drug US$115m to US$240m (Pekar, 2001) • Full vaccine development US$200m to US$500m (Serdobova I, Kieny MP, 2006)

8. In 2008: $2.96bn ($3.09bn) Almost 80% of funding to HIV/AIDS, malaria and TB For other diseases, less than 5% of global funding for each

9. Top 12 global funders • 12 organisations provided > 80% of funding • 2 organisations provided ~ 60% of funding • Public donors accounted for ~ 65% of funding • 10 organisations provided ~75% • 2 organisations provided almost 60%

10. Policy implications • Today’s portfolios are unlike any that policy-makers have seen in the past • Many product candidates now entering clinical trials • How to guarantee sustainablefunding? • Are new financingmechanismsneeded? • Howtomakethe R&D process more efficient? • Many products have already been registered and many more will be registered in the next 5 years • Ability of developing country health systems to absorb new treatments and treatment protocols. • How to avoid the “innovation pile-up” • What should learn from the successful scale-up experiences? • How to fill the ‘upstream’ pipeline that feeds into these projects

11. Thank you