1. Supporting Implementation of the EDL
Mercedes Perez Gonzalez
Department of Essential Medicines and Health Products
December 2018
Adriana Velazquez Berumen | Senior advisor on medical devices, EMP, Geneva

2. 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
Source: Image from iStock.com
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3. Some of the main benefits of an EDL
Help countries to better prioritize their laboratory testing and infrastructure needs
Help countries improve outbreak preparedness by increasing laboratory capacity
Facilitate the development of new IVDs through identification of priority needs to inform IVD developers, industry and funders.
Availability of IVDs will ensure safe and rational use of medicines in the EMLs
Increase affordability by facilitating purchasing
Source: Image from iStock.com

4. Adaptation of the EDL to local needs
Member States will need to consider many factors 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 infrastructure
Quality assurance capacity
Local availability of treatments
Financial resources
Environmental factors
Source: Image from iStock.com
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5. The EDL doesn’t stand alone…
Delivery of in vitro diagnostic services is supported by a broad range of systems, which must all work together to ensure that each test result can be trusted.
These systems are:
An integrated, connected, tiered laboratory system
Well qualified primary care and laboratory personnel
Laboratory infrastructure
Regulatory/quality assurance systems
Supply chain management
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6. 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:
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7. Sequence of process to warrant access to appropriate and safe medical devices.

8. WHO plan for supporting country implementation
Develop Guidance Document for EDL Implementation
Establish data on which countries have IVD lists
Collect the challenges and successes experienced by countries who have developed and implemented a program of access to IVDs
Develop a draft document laying out guidance to support country implementation
SAGE IVD Implementation Working Group review
Develop implementation pilot programme in 3 selected countries to be executed over 18 – 24 months
Prepare procurement specifications
Finalise guidance document based on all learnings
WHO welcomes your collaboration
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9. Relationship between the EDL and list of WHO prequalified IVDs
Essential Diagnostics List
List of WHO Prequalified IVDs
Supports policy development
Larger Scope: Includes WHO recommendation for high priority IVDs including General IVDs
Product Categories – No brand names
Listing in the PQ list is not a requirement for inclusion in the EDL
Prequalified products that correspond to certain categories of tests in the EDL are referenced
Supports procurement – assessed for quality safety and performance
Targeted Scope: HIV, Malaria, HCV, HBV, HPV, Syphilis, Cholera & G6PD
Specific IVDs listed by product name and manufacturers name
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10. IVD Resources for Member States
Purpose of the IVD Web Portal: Online place for all WHO information IVD relevant resources to support member states with lab EDL implementation
Topics covered:
National Policies and Strategic Plans on IVD’s and Lab Services
Laboratory Setup & Management
IVD’s in the Primary Health Care Setting (Where no lab is available)
Human Resources & Skills Development
Quality Management
Regulation and Market Approval of IVD’s
Procurement and Supply of IVD’s
Disease Specific IVD Resources
IVD Innovation
WHO Regional Information on IVD’s and Lab Services
WHO Collaborating Partners on IVD’s and Lab Services
Launched:
November 2018
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11. 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
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12. 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