Introduction to the first WHO Model List of Essential In Vitro Diagnostics (the EDL)

Adriana Velazquez Berumen | Senior advisor on medical devices, EMP, Geneva www.who.int

Dr Sarah Garner, Co-ordinator ‒ Innovation, Access and Use. Department of Essential Medicines and Health Products

EDL Context

WHO recognises that IVDs are an essential

component to:

• advance universal health coverage

• address health emergencies

• promote healthier populations.

The three strategic priorities of the WHO

Thirteenth General Programme of Work

(2019‒2023).

Source: Image from iStock.com

Why an EDL and why now?

• Accurate diagnosis is needed before

treatment decisions can be made

• Countries will need guidance for selection,

procurement and usage decisions for IVDs.

• There is strong support from the Global

Health community for an EDL.

Source: Image from iStock.com

The EDL sets out a group of IVD tests that is

recommended by WHO for use at various levels of a

tiered laboratory system.

The EDL is expected to:

1. Provide guidance to Member States for the development of

local essential diagnostics lists

2. Inform United Nations (UN) agencies and non-governmental

organizations (NGOs) who support selection, procurement,

supply, donations or provision of in vitro diagnostics

3. Provide guidance to the medical technology private sector

on diagnostics priorities needed to address global health

issues

24/09/2018 | Title of the presentation 4

Objectives of the EDL

EDL scope and oversight

5

First Edition: High-priority infectious diseases

(2018) (TB, malaria/G6PD, HIV, hepatitis B & C, HPV

and syphillis)

Plus general laboratory tests

No brand names or specific products

Annual Review: Add tests for both infectious

diseases and NCDs

Process generally similar to that

for EMLs but adapted for IVDs

SAGE IVD oversight: Scope, prioritisation, inclusion criteria, process

First meeting 16-20 April 2018

(Plan to meet annually)

Source: Image from iStock.com

General principles for inclusion of IVDs in the list

• Public health relevance

• Evidence-based

• Free of conflict of interests

Process generally similar to the EMLs but adapted for IVDs (e.g.: often low

level of evidence, especially in LMICs, IVDs characteristics vary based on

the level of the health care facility)

6

Priority disease areas for consideration in the 2nd edition of the

EDL are Emergency tests, AMR, NCDs & NTDs

What does the EDL look like?

• The first edition of the list published on 15 May 2018 includes more than

100 tests

• The preface to the EDL describes all requirements to implement the list

and encourages member states to adapt the list to their own needs

• Tests are separated to show which tests can be used in primary care

settings where no labs are available, and which tests require lab support

• For each test, a link is provided to any WHO-prequalified products if

available, as well as any relevant WHO supporting documents

• Dedicated page on the WHO web site will be created to centralize all

available information supporting the implementation of the list

7

Sample section of the EDL

8

Member States will need to consider a variety of factors in order to adapt the EDL to local

circumstances: examples are:

• Local demographics and pattern of diseases

• Treatment facilities

• Training and experience of available personnel

• Local testing gaps

• Supply chain

• Quality assurance capacity

• Local availability of treatments

• Financial resources

• Environmental factors

WHO plans to compile information that supports the selection and use of IVDs on the EDL,

on a single web site

24/09/2018 | Title of the presentation 9

Implementation of the EDL

24/09/2018 | Title of the presentation 10

Source: Consultation on Technical and Operational Recommendations for Clinical Laboratory Testing Harmonization and Standardization. Geneva Switzerland: World Health Organization. 2008: Available at: http://www.who.int/healthsystems/round9_9.pdf

Illustrative example of a tiered diagnostic testing system

The types of testing that are appropriate at each tier will be country-specific and will include, among

others, factors like access to electricity, reagent grade water, phlebotomy and specialized human

resources more

Process for review of applications for inclusion in the EDL

Application assessed by

EDL Secretariat

for completeness & circulated

to WHO departments

Successful candidates invited to make full

submissions

Submission posted on

WHO website for

review

Submission assessed by experts selected by

WHO

Expert reviews

published on WHO website

Assessment reports

presented at SAGE IVD

meeting

SAGE IVD recommend inclusions & exclusions to WHO

SAGE IVD recommend

ations presented

to WHO DG

Screening application received

April May June July Aug Sept Oct Nov Dec Jan Feb Mar April May

24/09/2018 | Title of the presentation 12

Timeline and next steps

2018 2019

1st SAGE

IVD Meeting

1st Edition of

the EDL

announced

Open call for

pre-

submissions

for 2nd EDL

Deadline for

pre-

submissions

for 2nd EDL

Deadline for

full

submissions

for 2nd EDL

SAGE IVD

review and web

publication of

submissions for

2nd EDL

EDL Secretariat review of pre-

submissions for 2nd EDL

Invitation to selected pre-

submissions for full submission

2nd SAGE

IVD Meeting

2nd Edition of the EDL to

be announced

during WHA 2019

Call for

applications

for renewed

SAGE IVD

membership

Renewed SAGE IVD

commences work

EDL Secretariat Activities:

• Develop lab web portal combining all WHO resources

• Draft guidance for national lists

• Develop web based platform for 2nd EDL

• Update manual on labs

Consultation

with member

states, industry

& non-state

actors

13

Summary of information to be included in the EDL application 1. Applicant’s information 2. Disease or conditions addressed

3. IVD description 4. Evidence summary (as available)

• Name of WHO focal point

• Name/info of applicant organisation(s)

• Name/info of Institutions consulted or

supporting the application

• Type of disease to be addressed

• Evidence for public health relevance & necessity

• Application of IVD (i.e. diagnostic testing

algorithm)

• Patient information (condition, morbidity,

mortality life quality, economic impact)

• Category of test

• Intended use, detection target and setting

• Specimen type and sample volume

• Performance of test

• End-user

• Access to IVD

• Bio-safety requirements

• Diagnostic accuracy

• Summary of evaluation studies

• Proof of clinical evidence

• Summary of non-clinical data (appraisal of

quality, performance, ease of use, summary of

results) and relevant references

• Ethical issues

• Human rights issues

• Equity issues

5. Societal impact information (as appropriate)

• Summary of data on comparative cost and cost-

effectiveness

• Resources and budget impact on health care

systems (specialised HR, training etc)

6. Budget and resources

Change

colour to

show

pre-sub

info

Purpose of the IVD Web Portal:

One place online for all WHO information resources relevant to in vitro diagnostics to

support member states with lab capacity development

Topics to be covered:

• National Policies and Strategic Plans on IVD’s and Lab Services

• Laboratory Setup & Management

• IVDs in the Primary Health Care Setting (Where no lab is available)

• Human Resources & Skills Development

• Quality Management Systems

• Regulation of IVD’s

• Procurement and Supply of IVD’s

• IVDs by Disease Areas

• IVD Innovation

• WHO Regional Information on IVDs and Lab Services

• WHO Collaborating Partners on IVDs and Lab Services

Under construction…

24/09/2018 | Title of the presentation 14

IVD web portal to support the EDL

Expected launch date: Sept 30th

1. Regulatory:

Empower of countries to build regulatory

support for market approval of IVDs

(including regional collaboration)

2. Procurement:

Development of technical specifications

for procurement of IVDs listed in the EDL

3. Laboratory Capacity Building:

Laboratory infrastructure, skills, quality

management systems….

4. WHO Resources:

Updating of WHO documents relevant to

IVDs and laboratory services

Supporting EDL adoption

24/09/2018 | Title of the presentation 15

Expected future needs

Experts

Workshops

Funding

24/09/2018 | Title of the presentation 16

Conclusion: The need to implement the EDL

Ultimately, effective medical

practice relies on diagnostic

capabilities

The EDL is only a list until it is

adopted by countries to support

access to in vitro diagnostics

testing

WHO welcomes your

collaboration Source: Image from iStock.com

Gracias Thank you Merci Shokran Xie xie Spasiva

WHO

20, Avenue Appia 1211 Geneva

Switzerland

EDL Secretariat

Email: edlsecretariat@who.int

EDL website: http://www.who.int/medical_devices/diagnostics/Selection_in-vitro_diagnostics/en/