1. WHO Department of Essential Medicines and Health Products
Introduction to a WHO Model List of Essential In Vitro Diagnostics (the EDL)
WHO Department of Essential Medicines and Health Products
13 December 2018
Adriana Velazquez Berumen | Senior advisor on medical devices, EMP, Geneva

2. Context of the EDL
WHO recognises that in vitro diagnostics (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 ( ).
In Vitro Diagnostics (IVD’s) are essential for the success of the three strategic priorities of the WHO 13th General Program of Work.
Without diagnostic testing, treatment decisions are challenging to say the least
Health emergencies such as the Ebola outbreaks we are experiencing, cannot be effectively managed without proper diagnostic support,
And screening for disease to identify patients for treatment, helps promote healthier populations.
The Essential Medicines List has been very successful and helpful at assisting countries to prioritize their supply of medicines, and the Essential Diagnostics list is intended to provide similar support for the prioritisation of diagnostics services.
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3. Objectives of the EDL
The EDL sets out a group of IVDs that are recommended by WHO for use at various levels of a tiered laboratory network
The EDL is expected to:
Provide evidence-based guidance to countries for the development of local essential IVD lists
Inform countries, United Nations (UN) agencies and other stakeholders who support regulation, selection, procurement, supply, donations or provision of IVDs
Provide guidance to the medical technology private sector on IVD priorities needed to address global health issues
The EDL is not intended to be prescriptive and member states will need to take various local factors into consideration as they develop their national EDL’s.
More about that in the next workshop.
While the EDL provides a list of important tests required at various levels of the health care system, it is important to note that the EDL itself cannot have an impact without an integrated, connected, tiered laboratory system, with adequate, well qualified human resources, laboratory infrastructure, and regulatory/quality assurance systems. Impact also requires Member States to adopt and adapt the EDL and develop national and regional EDLs, as well as to implement the selection and supply mechanisms necessary to ensure access to the IVDs. This will be discussed further in the workshops.
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4. Benefits of an EDL
Support countries to prioritize their testing and infrastructure needs
Support outbreak preparedness
Facilitate the development of high priority new IVDs by industry and funders
Availability of IVDs will ensure safe and rational use of medicines in the EMLs
Increase affordability by facilitating coordinated procurement
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5. Content of the 1st edition of the EDL
Published in May 2018
Sub-section a
Sub-section b
General IVDs
Disease Specific IVDs
12 Test Categories
11 Test Categories
23 Test Categories
16 Test Categories
62 Test Categories
Organised by Disease:
HBV
HCV
HIV
Malaria
Tuberculosis
HPV
Syphilis
Organised by Discipline:
Clinical Chemistry and Immunology
Blood Transfusion
Serology
Microbiology, Mycology and Parasitology
Haematology
Section I
Primary Care
(No lab available)
The EDL is arranged to divide test categories between those for use in the Primary Care setting where laboratory trained personnel are not available, and those that require laboratory facilities.
In each of those settings, the test categories are arranged in General Laboratory Tests and Disease Specific tests
You can see that there are a total of 62 test categories listed in the first edition of the EDL
We talk about “TEST CATEGORIES” because each category may include several individual tests on the market for that application, and we do not refer to test brand names in the EDL.
ADVANCE SLIDE:
The General Laboratory Tests are organized by discipline as shown and further disciplines such as Anatomical Pathology will be added in future editions
The Disease specific tests are arranged by disease
You can see that the first edition covers WHO high priority disease areas, and this will be expanded in future editions to cover non-communicable diseases as well as neglected tropical diseases.
Section II
Facilities with Laboratories

6. What to expect after the 1st Edition of the EDL
WHO is currently reviewing submissions for the 2nd Edition of the EDL
Submission highlights include:
A set of cancer IVDs including a new anatomical pathology section in the general IVDs
Expanding sexually transmitted infection testing
Outbreak associated IVDs such as Dengue Fever and Zika Virus,
The next SAGE IVD meeting will be in March 2019
The second edition of the EDL will be published in May 2019
An IVD and laboratory web portal has been launched which provides access to all IVD-related documents from WHO
WHO is planning a guidance document to support country implementation

7. 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 WHO welcomes your collaboration
Emphasise the importance of adoption and implementation.
Implementation is the focus of the workshop discussions at this Forum and WHO will be seeking input and opinions from member states on ways to support you in that task.
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8. Gracias Thank you Merci Shokran Xie xie Spasiva
WHO
20, Avenue Appia Geneva
EDL Secretariat
EDL website: s/diagnostics/Selection_in- vitro_diagnostics/en/
Switzerland