1. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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

2. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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

3. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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

4. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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

5. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics HIV diagnostic test kit procurement 1998-2007

6. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics WHO Procurement of HIV and Malaria tests 2007

7. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics WHO Procurement of HIV and Malaria tests by region 2007 MalariaHIV

8. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics HIV Anti-retroviral Therapy Situation as of December 2006 68% of the world's unmet need 21% of the world's unmet need No. Patients (ooo's)

9. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics Rapidly increasing range of malaria Rapid Diagnostic Tests  40 manufacturers with named products known to WHO  30 tests million procured in 2005  Most endemic countries have no / weak regulations

10. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics A wide variety of tests ….…. Quality ?

11. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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)

12. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics Aim of prequalification  To promote and facilitate access to safe and appropriate diagnostic technologies of good quality in an equitable manner

13. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics Prequalification of Diagnostics - How do we approach it ?  Through a rigorous process identify diagnostics that meet the quality standards  Harmonize the WHO prequalification process 1.More stringent dossier assessment of diagnostics 2.Inspection of the GMS at production site (ISO 13485/GMP) 3.Laboratory assessment of performance characteristics 4.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

14. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics Prequalification of Diagnostics Process Manufacturer submits application Accepted Declined Application is screened Manufacturer pays fee and submits dossier Dossier is reviewed Accepted Declined Manufacturing Site Inspection Meets WHO requirements Does not meet WHO requirements Meets WHO requirements Does not meet WHO requirements Product is prequalified Product Laboratory Evaluation

15. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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

16. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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

17. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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.

18. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics 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 lowered prices 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

19. 3rd WHO Prequalification Stakeholders Meeting :Diagnostics WHO webpages www.who.int/diagnostics_laboratory www.who.int/diagnostics_laboratory Thank you