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

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

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

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

  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 (2019-2023). Source: Image from iStock.com

  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 Source: Image from iStock.com

  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 Source: Image from iStock.com

  5. Content of the 1st edition of the EDL • Published in May 2018 Sub-section a Sub-section b General IVDs Disease Specific IVDs • 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) 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 Source: Image from iStock.com

  8. GraciasThank you MerciShokranXiexieSpasiva WHO 20, Avenue Appia1211 Geneva Switzerland EDL Secretariat Email: edlsecretariat@who.int EDL website: http://www.who.int/medical_devices/diagnostics/Selection_in-vitro_diagnostics/en/

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