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Philippe Duneton 11 February 2009
Deputy Executive Secretary
5th Consultative Stakeholder Meeting
UN Prequalification of Diagnostics,
Medicines & Vaccines
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• Today 9.5 million people in need of treatment
• 4 million people on HIV/AIDS treatment and rapid expansion of access required
• Only 42% of needs currently being met of which 276,000 children (38% coverage)
• New treatment guidelines (CD4 <350) = more people in treatment
• Financial crisis: funding is not increasing
• Key challenge: keep HIV/AIDS on top of the global agenda
Addressing Global HIV/AIDS Challanges
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Today
UNITAID Strategy: Portfolio 2006-2012
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Scope of work in the Pharmaceutical value chain
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Lower prices of treatments• Enable more patients to be treated (e.g. with the
same budget)• Facilitate government adoption of improved
medicines
Formulation-related benefits• FDCs:
– Facilitate adherence, reduced risk of resistance, simplified supply chains
• Paediatric formulations: – Improved quality treatment for infants and children, reduced
shipment costs for solids (vs. liquids)• Heat-stable:
– Enabled use in resource-poor settings
Seeking efficient use of funds and public health benefits
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Using innovative, global market based approaches to improve public health by increasing access to quality products to treat, diagnose and prevent HIV/AIDS, tuberculosis, malaria and related co-morbidities in developing countries.
Goal Objectives
• To support adaptation of products targeting specific populations
• To assure availability in sufficient quantities and timely delivery to patients
• To ensure affordable and sustainably priced products
• To increase access to efficacious, safe and assured quality products that address Public Health problems
Mission
UNITAID’s mission is to contribute to scaling up access to treatment for HIV/AIDS, malaria and tuberculosis, primarily for people in low-income countries, by leveraging price reductions for quality diagnostics and medicines and accelerating the pace at which these are made available.
[Constitution]
UNITAID Strategy 2010-2012
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• Products to treat and diagnose HIV/AIDS, TB, and malaria
• Targeted prevention products that align with UNITAID goals and objectives
• Products for co-morbidities where: – burden of disease is high– efficacious and cost-effectiveness products are available– opportunity for positive public health & market impact is
attainable
Scope on Diseases and ProductsStrategy 2010-2012
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Additional support and multi-year
commitment to
– Accelerate the pace at which priority HIV/AIDS, malaria and TB medicines are prequalified
– Increase the number of QA laboratories in developing countries
– Control the quality of strategic medicines close to treatment centers
– 2006-2012: US$ 47 million approved
Boosting WHO Quality Assurance Programmes
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Support to WHO QA Diagnostic Programme
– Prequalify priority HIV/AIDS and malaria diagnostics
– Address costs concerns
– Build or strengthen national regulatory capacity
– 2009-2013 support: US$ 7,5 million approved
Boosting WHO Quality Assurance Programmes
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Diversifying supply sources to reduce prices
Expanding generic market size to reduce prices & expand access
Facilitating the development of improved formulations (e.g. Fixed Dose Combinations (FDCs), paediatric and heat-stable formulations)
Increasing legal certainty for generic companies and patent-holders
Reducing transaction costs for licensing agreements (e.g. FDCs)
Patent Pool: innovation and better products
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• Reduced prequalification timeline for priority medicines:
• Quality assured atazanavir/r to achieve second line therapy objectives
• Quality assurance timing in line with the UNITAID project cycle
• Second Line ARV transition: 2010-2011• Paediatric HIV/AIDS transition: 2011-2012?
• Increased number of innovative FDCs, heat-stable and paediatric formulations facilitated by the Patent Pool
• Key role in providing technical support to manufacturers• Address new products not based on innovators
• Quality APIs to boost global generic supply
• Strengthen capacity of NRAs
• Access to prequalified HIV and malaria diagnostics
Partnership: Looking ahead
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Today
UNITAID Strategy: Portfolio 2006-2012
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