Introduction to the first WHO Model List of Essential In Vitro Diagnostics (the EDL) - World Health Organization
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Introduction to the first WHO Model List of Essential In Vitro Diagnostics (the EDL) Dr Sarah Garner, Co-ordinator ‒ Innovation, Access and Use. Department of Essential Medicines and Health Products Adriana Velazquez Berumen | Senior advisor on medical devices, EMP, Geneva www.who.int
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
Objectives of the EDL
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
EDL scope and oversight
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
5General 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)
Priority disease areas for consideration in the 2nd edition of the
EDL are Emergency tests, AMR, NCDs & NTDs
6What 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
7Sample section of the EDL
8Implementation of the EDL 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
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
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
24/09/2018 | Title of the presentation 10Process for review of applications
for inclusion in the EDL
Application
assessed by
EDL Successful Submission Submission Expert Assessment SAGE IVD SAGE IVD
Secretariat candidates posted on assessed reviews reports recommend recommend
for invited to WHO by experts published presented at inclusions & ations
completeness make full website for selected by on WHO SAGE IVD exclusions presented
& circulated submissions review WHO website meeting to WHO to WHO DG
to WHO
departments
Screening application receivedTimeline and next steps
2018 2019
April May June July Aug Sept Oct Nov Dec Jan Feb Mar April May
1st SAGE 2nd SAGE
IVD Meeting IVD Meeting
Open call for Deadline for Deadline for SAGE IVD
1st Edition of pre- pre- full review and web 2nd Edition of the EDL to
the EDL submissions submissions submissions publication of be announced
announced for 2nd EDL for 2nd EDL for 2nd EDL submissions for during WHA 2019
2nd EDL
EDL Secretariat review of pre- Consultation
submissions for 2nd EDL with member
Invitation to selected pre- states, industry
submissions for full submission & non-state
actors
Call for Renewed SAGE IVD EDL Secretariat Activities:
applications commences work • Develop lab web portal combining all WHO resources
for renewed • Draft guidance for national lists
SAGE IVD • Develop web based platform for 2nd EDL
membership • Update manual on labs
24/09/2018 | Title of the presentation 12Summary of information to be
included in the EDL application
1. Applicant’s information 2. Disease or conditions addressed
• Name of WHO focal point • Type of disease to be addressed
• Name/info of applicant organisation(s) • Evidence for public health relevance & necessity
• Name/info of Institutions consulted or • Application of IVD (i.e. diagnostic testing
supporting the application algorithm)
• Patient information (condition, morbidity,
mortality life quality, economic impact)
3. IVD description 4. Evidence summary (as available)
• Category of test • Diagnostic accuracy
• Intended use, detection target and setting • Summary of evaluation studies
• Specimen type and sample volume • Proof of clinical evidence
• Performance of test • Summary of non-clinical data (appraisal of
• End-user quality, performance, ease of use, summary of
• Access to IVD results) and relevant references
• Bio-safety requirements
5. Societal impact information (as appropriate) 6. Budget and resources
• Ethical issues • Summary of data on comparative cost and cost-
• Human rights issues effectiveness
• Equity issues • Resources and budget impact on health care
systems (specialised HR, training etc)
13IVD web portal to support the EDL
Under construction…
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
Expected launch date: Sept 30th
24/09/2018 | Title of the presentation 14Expected future needs
Supporting EDL adoption
1. Regulatory:
Empower of countries to build regulatory
support for market approval of IVDs
(including regional collaboration)
2. Procurement:
Development of technical specifications Experts
for procurement of IVDs listed in the EDL
Workshops
3. Laboratory Capacity Building:
Laboratory infrastructure, skills, quality Funding
management systems….
4. WHO Resources:
Updating of WHO documents relevant to
IVDs and laboratory services
24/09/2018 | Title of the presentation 15Conclusion: 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
24/09/2018 | Title of the presentation 16Gracias
Thank you
Merci
Shokran
Xie xie
Spasiva
WHO
20, Avenue Appia EDL Secretariat EDL website:
1211 Geneva http://www.who.int/medical_device
Email: edlsecretariat@who.int s/diagnostics/Selection_in-
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