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