3rd Stakeholders Meeting on Prequalification Geneva, 4th February 2008
-
Upload
thomas-alvarez -
Category
Documents
-
view
23 -
download
0
description
Transcript of 3rd Stakeholders Meeting on Prequalification Geneva, 4th February 2008
3rd WHO Prequalification Stakeholders Meeting :Diagnostics
3rd Stakeholders Meeting on Prequalification Geneva, 4th February 2008
Update on Prequalification of Diagnostics
Dr Steffen GrothDirector, Essential Health Technologies
Health Systems and Services
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
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
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
3rd WHO Prequalification Stakeholders Meeting :Diagnostics
HIV diagnostic test kit procurement 1998-2007
0
2
4
6
8
10
12
14
16
18
To
tal n
um
be
r o
f te
sts
(m
illio
n)
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
UNICEF
WHO
3rd WHO Prequalification Stakeholders Meeting :Diagnostics
WHO Procurement of HIV and Malaria tests 2007
Number of Tests
(Millions)
US$(Millions)
Number of Tests
(Millions)
US$(Millions)
WHO 7.3 5.9 4.9 2.8
UNICEF 10.5 10.8 7.0 3.5
Total 17.8 16.7 11.9 6.3
HIV Malaria
3rd WHO Prequalification Stakeholders Meeting :Diagnostics
WHO Procurement of HIV and Malaria tests by region 2007
88.03%
0.90%
4.05%
3.18%3.84%0.00%
16.48%
30.88%51.50%
0.25% 0.79%0.09%
AFRO
EMRO
AMRO
EURO
SEARO
WPRO
Malaria HIV
3rd WHO Prequalification Stakeholders Meeting :Diagnostics
HIV Anti-retroviral Therapy Situation as of December 2006
0
1000
2000
3000
4000
5000
6000
7000
AFRO LAC EE Europe&Central Asia
Middle East &North Africa
Asia
On ARV Needing ARV
68% of the world's unmet need
21% of the world's unmet need
No.
Pat
ient
s (o
oo's
)
3rd WHO Prequalification Stakeholders Meeting :Diagnostics
Rapidly increasing range of malariaRapid Diagnostic Tests
Manufacturer Product Access Bio Carestart Malaria ACON laboratories Malaria Rapid Test Device Alldiag Palutop Ameritek dBest Malaria Rapid Test Amgenix OnSight Malaria Binax NOW-ICT r-Biopharm MalaQuick (~NOW-ICT) Bio-Quant Inc. One Step malaria Rapid Test Biotech Trading Partners Malaria Pf-only Rapid Test Cellabs Rapimal Brittney Immu-Sure Malaria Bio-Analytics C.A. Malaria Test Core Diagnostics Core Malaria Cortez Malaria P.f. RapiCard InstaTest CTK CTK Onsite Diamed AG OptiMal Fortress Diagnostics Malaria Test Genelabs Assure Malaria GlobaleMed Smart Check Malaria Guangzhou Wondfo One Step Malaria Human Gmbh Hexagon Malaria Inbios International Immunodiagnostics Malaria Test Card J Mitra Advantage Malaria KAT Medical KatQuick Makro Medical MakroMAL Merlin Labs Malaria Pf test Omega Diagnostics Visitect malaria Orchid Biomedical Systems Paracheck Premier Medical Corporation First Response Malaria Antigen Test R&R Marketing ICT Malaria SDHO Span Diagnostics ParaHIT Standard Diagnostics SD Bioline Malaria Syntillent ADI Malaria Tashima Trinity Biotech Uni-Gold Malaria Unimed FirstSign / Paraview Malaria Vision Biotech Malaria Pf Zephyr Biomedical Systems Falcivax
40 manufacturers with named products known to WHO
30 tests million procured in 2005
Most endemic countries have no / weak regulations
3rd WHO Prequalification Stakeholders Meeting :Diagnostics
A wide variety of tests ….…. Quality ? A wide variety of tests ….…. Quality ?
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)
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
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
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
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
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
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.
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
3rd WHO Prequalification Stakeholders Meeting :Diagnostics
WHO webpages
www.who.int/diagnostics_laboratory
Thank you