Presentation WHO PQP February 2010

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Presentation WHO PQP February 2010 Powered By Docstoc
					    5th Consultative Stakeholder Meeting
     UN Prequalification of Diagnostics,
              Medicines & Vaccines



Philippe Duneton                11 February 2009
Deputy Executive Secretary
    Addressing Global HIV/AIDS Challanges

•   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
               UNITAID Strategy: Portfolio 2006-2012
   Time     2006                         2009         2010          2011           2012


                2nd line treatments                       New treatments/regimens (FDCs)
HIV/AIDS        Paediatric treatments (scaling up/transition)

                PMTCT (Lessons Learnt)

                                                      Viral Load
                                                      Prevention commodities?

  Malaria                                LLIN
                ACT – increase access                           Rapid tests?

                1st line treatments                                        New 1st line treatments? (2mths)


Tuberculosis MDR- TB treatments
                MDR- TB tests
 Co-
 morbidities                                                 HCV?

                                         Today
Scope of work in the Pharmaceutical value chain
          Seeking efficient use of funds and
                public health benefits

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
                  UNITAID Strategy 2010-2012

      Mission                           Goal                      Objectives


UNITAID’s mission is to         Using innovative, global    • To increase access to
contribute to scaling up       market based approaches      efficacious, safe and
access to treatment for        to improve public health     assured quality products
HIV/AIDS, malaria and          by increasing access to      that address Public Health
tuberculosis, primarily for                                 problems
                               quality products to treat,
people in low-income           diagnose and prevent         • To support adaptation of
countries, by leveraging       HIV/AIDS, tuberculosis,      products targeting specific
price reductions for quality   malaria and related co-      populations
diagnostics and                morbidities in developing
medicines and                  countries.                   • To ensure affordable and
accelerating the pace at                                    sustainably priced
which these are made                                        products
available.
                                                            • To assure availability in
                                                            sufficient quantities and
       [Constitution]                                       timely delivery to
                                                            patients
     Scope on Diseases and Products
                                             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
  Boosting WHO Quality Assurance Programmes
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
      Patent Pool: innovation and better products


 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)
            Partnership: Looking ahead
•    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
               UNITAID Strategy: Portfolio 2006-2012
   Time     2006                         2009         2010          2011           2012


                2nd line treatments                       New treatments/regimens (FDCs)
HIV/AIDS        Paediatric treatments (scaling up/transition)

                PMTCT (Lessons Learnt)

                                                      Viral Load
                                                      Prevention commodities?

  Malaria                                LLIN
                ACT – increase access                           Rapid tests?

                1st line treatments                                        New 1st line treatments? (2mths)


Tuberculosis MDR- TB treatments
                MDR- TB tests
 Co-
 morbidities                                                 HCV?

                                         Today

				
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