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UNITAID’s Strategic Approach to HIV

Diagnostics

Washington DC22 July, 2012

XIX International AIDS Conference

Brenda Waning

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Agenda

UNITAID Market Approach to Public Health

UNITAID Landscape Reports

UNITAID HIV Diagnostics: Recent Investments & New Opportunities

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UNITAID Market Approach toPublic Health

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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

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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.

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UNITAID Market Impact Framework

Market Shortcomings:Price; Availability; Quality; Acceptability; Delivery

www.unitaid.eu

Pathway from market to public health impactCase for intervention

Public health problem & commodity

access issues

Market shortcomings

and their reasons

Innovative market

intervention

Sustainable market impact

Public health impact

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.

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UNITAID is one of several market playersCoordination is critical: Global Fund, PEPFAR, USAID, PDPs, BMGF, WHO, UNAIDS, national governments, etc.

Demand(Buyers

and consumers)

Demand(Buyers

and consumers)

Non-UNITAID Interventions

UNITAIDInterventions

Market Shortcomings

Market Dynamics

Market Shortcomings

Supply(Sellers) Supply

(Sellers)

Policy, regulation, economics, guidelines, innovation, politics

www.unitaid.eu

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UNITAID Landscape Analyses2

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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

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UNITAID HIV Diagnostic Landscapes Jun 2011 Annual Oct 2011 Update Jun 2012 Annual

UNITAIDT E C H N I C A L

R E P OR T

HIV/AIDSDiagnostic Landscape

Maurine M. Murtagh2nd Edition – July 2011

www.unitaid.eu/

2011 HIV/AIDS DIAGNOSTIC TECHNOLOGYLANDSCAPE

SEMI-ANNUAL UPDATE

OCTOBER 2011

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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)

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UNITAID HIV Diagnostics: Recent Investments & New Opportunities

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UNITAID HIV Diagnostic Activities & Investments

Discovery Development Evaluation Registration Market

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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 InvestmentArea

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• 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

Discovery Development Evaluation Registration Market

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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

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

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Thank You

Brenda Waningwaningb@unitaid.who.int

www.unitaid.eu/

www.unitaid.eu

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