Briefing for Delegates to the 65th World Health Assembly

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 2012
Page 0

2. Agenda
1 UNITAID's Market Approach to Public Health
UNITAID's 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 funding
Page 11
Slide

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.
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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 UNITAID's direct beneficiaries
Page 3 www.unitaid.eu

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 manufacturers
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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 access
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7. 1 2 3
What's 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 markets
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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 market
Source: 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.
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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 supply
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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
diagnosis
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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
– Brazil's commitment to free ARVs
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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 & regimens
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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 countries
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14. 1 2 3
Thank you
Acknowledgements
• Janet Ginnard
Contact Information
• Brenda Waning:
waningb@unitaid.who.int
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