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ACCESSING MEDICINES IN AFRICA Prospects and challenges Dr Javier Guzman Director of Research, Health Policy Division The George Institute for International Health [email protected] 23 February 2010 WHO framework for access to essential medicines Access to Medicines Rational selection Affordable prices R&D Sustainable financing Reliable health and supply systems 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 New landscape of neglected disease R&D • Long way since “Only 13 new drugs registered for tropical diseases between 1975 and 1997 (Pecoul et al 1999)” 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 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 Product Development Partnerships (PDPs) Combined PDP pipeline includes 143 candidates 104 biopharmaceutical candidates in development... ... and 39 diagnostic & vector control candidates Diagnostics Pre Clinical 59 Phase I 57% 14% 15 Phase II Feasibility 7 26% Test Development 7 26% Evaluation 12% 12 6 Demonstration Phase III Registration 10% 10 Drugs Vaccines Microbicides 6% 6 0 4% Country Adoption 2% 2 Launched 1 6 0 2 4 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 40 60 # candidates 6 22% 8 5 IVCC In Development 7 0 2 4 6 8 # candidates Slide source: CD4 FIND IDRI Vector control Early Stage 20 22% R&D funding needs • 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) 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 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% 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 sustainable funding? » Are new financing mechanisms needed? » How to make the 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 Thank you