Philippe Duneton 11 February 2009

Deputy Executive Secretary

5th Consultative Stakeholder Meeting

UN Prequalification of Diagnostics,

Medicines & Vaccines

• 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

Today

UNITAID Strategy: Portfolio 2006-2012

Scope of work in the Pharmaceutical value chain

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

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

• 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

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

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

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

• 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

Today

UNITAID Strategy: Portfolio 2006-2012