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 www.who.int

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 25/04/2019

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

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 25/04/2019

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 25/04/2019

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 25/04/2019 | Title of the presentation

Sequence of process to warrant access to appropriate and safe medical devices.

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 25/04/2019

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 25/04/2019

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 25/04/2019 | Title of the presentation

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 25/04/2019

Gracias Thank you Merci Shokran Xie xie Spasiva WHO 20, Avenue Appia 1211 Geneva EDL Secretariat EDL website: http://www.who.int/medical_device s/diagnostics/Selection_in- vitro_diagnostics/en/ Email: edlsecretariat@who.int Switzerland