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3rd Stakeholders Meeting on Prequalification Geneva, 4th February 2008. Update on Prequalification of Diagnostics Dr Steffen Groth Director, Essential Health Technologies Health Systems and Services. Essential Health Technologies.

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3rd stakeholders meeting on prequalification geneva 4th february 2008

3rd Stakeholders Meeting on Prequalification Geneva, 4th February 2008

Update on Prequalification of Diagnostics

Dr Steffen Groth

Director, Essential Health Technologies

Health Systems and Services

essential health technologies
Essential Health Technologies
  • Assists countries in integrating health technologies into health systems and services
  • Supports the Millennium Development Goals in reducing child mortality, improving maternal health and combating HIV/AIDS, Malaria and other diseases
eht ensuring improved access quality appropriate use of technologies
EHT - ensuring improved access, quality & appropriate use of technologies

Areas of work

  • Blood Transfusion Safety
  • Diagnostic Imaging
  • Diagnostics and Laboratory technology
  • e-Health for Health Care delivery
  • Injection Safety
  • Emergency and Essential Surgical Care
  • Transplantation
why are diagnostics so important
Why are diagnostics so important ?

Scaling up interventions for:

HIV, TB and Malaria

Both prevention efforts and increased access to treatment and care

Generate increased demand for appropriate diagnostics

hiv anti retroviral therapy situation as of december 2006
HIV Anti-retroviral Therapy Situation as of December 2006

No. Patients (ooo's)

68% of the world's unmet need

21% of the world's unmet need

rapidly increasing range of malaria rapid diagnostic tests
Rapidly increasing range of malariaRapid Diagnostic Tests
  • 40 manufacturers with named products known to WHO
  • 30 tests million procured in 2005
  • Most endemic countries have no / weak regulations
prequalification of diagnostics why is it needed
Prequalification of Diagnostics – Why is it needed?
  • There are many new manufacturers producing HIV and malaria rapid tests of variable quality
  • Many diagnostic technologies are not assessed by stringent regulatory authorities
  • Often the performance and appropriateness of the diagnostics are not assessed for their intended use setting (e.g. resource limited settings)
aim of prequalification
Aim of prequalification
  • To promote and facilitate access to safe and appropriate diagnostic technologies of good quality in an equitable manner
prequalification of diagnostics how do we approach it
Prequalification of Diagnostics - How do we approach it ?
  • Through a rigorous process identify diagnostics that meet the quality standards
  • Harmonize the WHO prequalification process
    • More stringent dossier assessment of diagnostics
    • Inspection of the GMS at production site (ISO 13485/GMP)
    • Laboratory assessment of performance characteristics
    • Building capacity at country level (NRA and NRLs) for post market surveillance of diagnostics
  • Partnering with well known regulatory authorities and with key technical partners
prequalification of diagnostics process

Manufacturer pays fee and submits dossier

Manufacturer submits application

Accepted

Application is screened

Declined

Declined

Dossier is reviewed

Accepted

Product Laboratory Evaluation

Manufacturing Site Inspection

Does not meet WHO requirements

Meets WHO requirements

Meets WHO requirements

Does not meet WHO requirements

Product is prequalified

Prequalification of Diagnostics Process
prequalification of diagnostics what will be the impact at country level 1
Prequalification of Diagnostics – What will be the impact at country level? (1)
  • Prequalification of HIV/AIDS, TB and malaria diagnostics provides the evidence for:
    • transparent selection of diagnostic test of good quality
    • adapted to the intended-use conditions in low and middle income countries.
  • Who will benefit from prequalification ?
    • Regulatory authorities, national reference laboratories, manufacturers, donors and patients
prequalification of diagnostics what will be the impact at country level 2
Prequalification of Diagnostics - What will be the impact at country level? (2)
  • A range of good quality diagnostics appropriate for all levels of the health system in resource limited settings
  • Increased access to quality diagnostics at reduced prices
  • Improved access to impartial technical information on diagnostics
  • Improved capacity at country level to monitor the quality of diagnostics in their market
prequalification of diagnostics what will be the impact at country level 3
Prequalification of Diagnostics - What will be the impact at country level? (3)
  • Streamlined and fair procurement tenders
  • Sustainable and secure markets for manufacturers, with some healthy competition
  • Simplified procurement and supply management
  • Better services for users of diagnostics, including maintenance and repair of equipment
  • More standardized diagnostic practices, facilitates training and implementation of quality assurance.
who brings added value
WHO brings added value …
  • Considerable expertise in assessing diagnostics for priority diseases
  • Extensive networks of WHO Collaborating Centres with a wide range of technical expertise
  • Long term experience in advocating for the development of appropriate diagnostics adapted to resource limited settings in LI and MI countries
  • It has successfully loweredprices for HIV, malaria and other diagnostics through the UN procurement scheme
  • Extensive experience in providing technical support and building capacity at country level, seen as impartial.
  • Extensive reach out networks, MoH, UN agencies; key stakeholders