1. Accessing Medicines in Africa Prospects and challenges
Dr Javier Guzman
Director of Research, Health Policy Division
The George Institute for International Health
23 February 2010

2. WHO framework for access to essential medicines
Access to Medicines
Rational selection
Affordable prices
Sustainable financing
Reliable health and supply systems
R&D
Delivery
Sources:
Wiedenmayer K (2004) Access and Availability of Pharmaceuticals in International Health. In Managing Pharmaceuticals in International Health.

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 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

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. Combined PDP pipeline includes 143 candidates8
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%
Phase I 15
14%
Development 7
26%
Evaluation 6
Phase II 12
22%
12%
CD4
Demonstration 1 4%
FIND
Phase III
10% 10
Adoption 6
IDRI
22%
Registration 2% 2
Drugs
Vaccines
Vector control
Microbicides
Launched 6% 6
Early Stage
IVCC
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 funding needs No agreement on global funding need for R&D but:
Dalberg estimated that US$6-10 billion would be needed to mature the 2008 neglected disease drug portfolio over the next 10 years
The Global Plan to Stop TB estimated that USD 9 billion were needed between 2006 and 2015 for R&D of new products for TB
The Global Malaria action Plan estimated that US$ 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
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 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

11. Thank you