Séminare sur les poliitiques pharmaceutiques, Sept 2015

EML at 40

Nicola Magrini Secretary,

WHO Expert Committee on the Selection and Use of Essential Medicines, Essential Medicines Department, WHO

Essential Medicines List: Concept and Procedures 2 |

Expert Committee on the Selection and Use of Essential Medicines 2017 – Open Session

Contents of the presentation

• EML present rules and future approaches

• EB109/8

• Relationship with WHO GLs

• EML Working Groups and more comprehensive review

• Improving access to • Available evidence for decision-making

• Available drug utilization data on the use of Essential Medicines

and feedbacks from countries (NEMLs)

• Implementation at country level and feedbacks

from countries

Essential Medicines List: Concept and Procedures 3 |

The EML reform in 2001:

more explicit criteria

Essential Medicines List: Concept and Procedures 4 |

A more transparent and

evidence-based process (EB109/8 2001)

Essential Medicines List: Concept and Procedures 5 |

EML criteria (EB 109/8, 2001)

Disease burden and public health need/relevance

Sound and adequate data on the efficacy (on relevant outcomes),

safety and comparative cost-effectiveness

– “Absolute cost of the treatment will not constitute a reason to exclude a

medicine from the Model List that otherwise meets the stated selected criteria”

– “Affordability changed from a precondition into a consequence of the selection”

(Hogerzeil, BMJ, 2004)

WHO responsible management and oversight of CoIs

2008: WHO new Guideline Manual, adopting GRADE

Other considerations: availability, guidelines

Essential Medicines List: Concept and Procedures 6 |

Expert Committee on the Selection and Use of Essential Medicines 2017 – Open Session

Contents of the presentation

• EML present rules and future approaches

• EB109/8

• Relationship with WHO GLs

• EML Working Groups and more comprehensive review

• Improving access to

• Available evidence for decision-making

• Available drug utilization data on the use of Essential Medicines

and feedbacks from countries (NEMLs)

• Implementation at country level and feedbacks from

countries

Essential Medicines List: Concept and Procedures 7 |

EML and WHO guidelines:

towards more explicit linkages

Share a “coordinated” evidence base: commissioned

systematic reviews, metanalysis and NMA

Share best available evidence: trials and SRs in press ,

issues on publication and outcome reporting bias, …

Privilege a comprehensive comparative approach among all

available options

Share/follow WHO policy recommendations

Essential Medicines List: Concept and Procedures 8 |

Expert Committee on the Selection and Use of Essential Medicines 2017 – Open Session

Contents of the presentation

• EML present rules and future approaches

• EB109/8

• Relationship with WHO GLs

• EML Working Groups and more comprehensive review

• Improving access to

• Available evidence for decision-making

• Available drug utilization data on the use of Essential Medicines

and feedbacks from countries (NEMLs)

• Implementation at country level and feedbacks from

countries

Essential Medicines List: Concept and Procedures 9 |

EML WGs

and more comprehensive reviews

Need for standing EML Working Groups to

– Propose more comprehensive approaches

– Prioritise drugs and interventions

– Define explicit criteria for evaluation

– Commission preparatory work

Reason: have a leadership role and reduce dependency on

applications of variable quality

Examples: cancer, antibiotics

Essential Medicines List: Concept and Procedures 10 |

Expert Committee on the Selection and Use of EM – Open Session

Contents of the presentation

• EML present rules and future approaches

• EB109/8

• Relationship with WHO GLs

• EML Working Groups and more comprehensive review

• Improving access to

• Available evidence for decision-making

• Available drug utilization data on the use of Essential Medicines

and feedbacks from countries (NEMLs)

• Implementation at country level and feedbacks from

countries

TRS TEMPLATE 2017

2017 e-EML

ELECTRONIC EML

ELECTRONIC DATABASE

ONLINE SEARCH ENGINE

LINK TO WHO GUIDELINES

TEMPLATE EVIDENCE SYNTHESIS

Essential Medicines List: Concept and Procedures 13 |

Expert Committee on the Selection and Use of EM – Open Session

Contents of the presentation

• EML present rules and future approaches

• EB109/8

• Relationship with WHO GLs

• EML Working Groups and more comprehensive review

• Improving access to

• Available evidence for decision-making

• Available drug utilization data on the use of Essential Medicines

and feedbacks from countries (NEMLs)

• Implementation at country level and feedbacks from

countries

Essential Medicines List: Concept and Procedures 14 |

EML and drug utilization data

• Importance of drug utilisation data (benchmarking and

education) from countries: specifically for antibiotics

• Availability and shortages: surveys in place

• NEMLs and affordability /prices: surveys in place

Essential Medicines List: Concept and Procedures 15 |

Expert Commiitee on the Selection and Use of EM – Open Session

Contents of the presentation

• EML present rules and future approaches

• EB109/8

• Relationship with WHO GLs

• EML Working Groups and more comprehensive review

• Improving access to

• Available evidence for decision-making

• Available drug utilization data on the use of Essential Medicines

and feedbacks from countries (NEMLs)

• Implementation at country level and feedbacks from

countries

Essential Medicines List: Concept and Procedures 16 |

EML implementation at country level

• Link to NEMLs and reimbursement lists

• New website & implementation manual

• Feedback from countries for future updates

• Importance of preparatory work (in between EC meetings)

on specific topics:

• HIV, TB, Malaria, NTDs

• Cancer

• AB

• …