HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017 Global development and stewardship framework Peter Beyer WHO HQ 27-03-2017
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HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Global development
and stewardship framework
Peter Beyer
WHO HQ
27-03-2017
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Resolution 68.7 / UN Political Declaration
WHO, together with FAO and OIE, to finalize a global development
and stewardship framework to support the (1) development, (2)
control, (3) distribution, and (4) appropriate use of
• new antimicrobial medicines,
• diagnostic tools,
• vaccines, and
• other interventions,
while preserving existing antimicrobial medicines, and promoting
affordable access to
• existing and new antimicrobial medicines, and
• diagnostic tools,
taking into account the needs of all countries, and in line with the
Global Action Plan on Antimicrobial Resistance
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Framework
The term framework refers to a basic structure that
can be skeletal/conceptual providing a system or a
concept
Working definition:
A specific overarching structure to fulfil some key
objectives of the Global Action Plan (GAP) that will
be developed over time
Source: Getty
Building a framework:
Work in progress!
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
R&D
Regulation
Manufacturing
Selection
Procurement & Supply
Distribution
Prescribing Medicines & Diagnostics
Dispensing
Appropriate use by end user
Framework covers the whole value chain
There is a veterinary side to all these steps and an
agricultural side to many, some linked to the human
side (e.g. selection, others not, e.g. R&D)
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Starting point: R&D
Priority pathogens: systematic assessment WHO list published in March 2017
Antibiotic R&D Pipeline WHO publication end of 2017
New Expert Committee on Health R&D will validate priorities
WHO/DNDi Global Antibiotic R&D Partnership (GARDP) can tackle R&D priorities
Global funding mechanism – G20?
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Starting point:
stewardship & access
Classification of essential antibiotics into 3
categories: core, targeted, conserved
EML revision May 2017
How will we use these three categories?
Measures to facilitate access & conservation
Global stewardship principles/measures
to be identified for human/animal use across
whole value chain with OIE/FAO
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Immediate action until WHA 70
Consult with Member States
Informal meetings & Information session
on 16 March
Develop roadmap: how to develop
framework, outline content
Publish on the WHO website ahead of
WHA
70th WHA
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
EML Review of Antibiotic Medicines
21st Expert Committee on the Selection and Use of Essential
Medicines: 27 to 31 March 2017
Review of antibiotics for bacterial infections in paediatrics
Review of antibiotic dosing for children
Review of antibiotics for specific sexually transmitted infections
Evaluation of antibiotic awareness campaigns
Subject to approval by the Committee!
http://www.who.int/selection_medicines/committees/expert/21/en/
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Critically Important Antimicrobials
First developed in 2005, next revision May 2017
Objective: preserve the effectiveness of antimicrobials
Reference to help formulate and prioritize risk
assessment and risk management strategies for
containing resistance coming from the food chain (non-
human use)
Antimicrobial agents are ranked as
Critically important
Highly important
Important
Recommends not to use in animals or plants
classes not currently used in food animals (such as carbapenems)
new classes developed for humans
http://www.who.int/foodborne_disease/resistance/cia/en/
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
WHO Guidelines on Animal Use
WHO guidelines to preserve effectiveness of
critically important antimicrobials for human
medicine
FAO and OIE participate as observers
To be published by mid-2017
– Systematic & literature reviews commissioned
– Recommendations on antimicrobial use in
food providing animals to protect public health
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
New/other instruments?
To ensure stewardship & access along the value chain:
Manufacturing/promotion: commitment of industry, code of conduct, guidelines or regulation?
Regulatory instruments: quality, labelling and appropriate use in human, animal and agricultural and crop sector
Distribution: role of wholesalers?
Use and access: inpatient and outpatient
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Collaboration with FAO & OIE
• Preferable through existing mechanisms
– the tripartite meetings
– Interagency Coordination Group
HIS/EMP | Communications Planning WHO/HIS/EMP | April 5, 2017
Roadmap
• Setting up a team in WHO: staff + budget
• Advisory group for framework needed with
expertise in human, animal & agriculture side
• Consultations with all stakeholders
– Start with Member States in autumn 2017
– Member States, R&D/generic industry;
professional organizations…
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