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Access to Medicine
Foundation
Adrián Alonso Ruiz, Researcher
25 June 2018, Heidelberg University
Table of Contents
• Access to Medicine Foundation
• Resistance and Appropriate Access to antibiotics
• The Antimicrobial Resistance Benchmark
5 billion people
have access to medicine
2 billion to go
Access to
Medicines
Availability
Accessibility
Acceptability
Quality
What is access to medicines?
What is access to medicines?
Source: Bigdeli et al.
Access to
Medicines
Availabi
lity
Accessi
bility
Accepta
bility
Quality
• Research on, and incentives for, pharmaceutical
companies and access to medicine
• Independent, non-profit organisation
• Multi-stakeholder approach
The Access to Medicine
Foundation
Build consensus
on what to expect from the industry and
where incentives and disincentives exist.
Stimulate a race to do well
in key access-to-medicine areas, by creating
competition on targets and topics.
Diffuse best practices
to share information and new insights
into the best approaches for driving change.
Our model for change
What we do
Our tools in action
Our tools in action
66 signatory investors: $8.7 trillion AUM
Antibiotic
Resistance and
Appropriate Access
to antibiotics
Antibiotic resistance
There are two alternative pathways to acquire
resistance:
• Random changes in the bacterial DNA produces
resistance by chance
• Incorporation of resistance genes from other bacteria or
bacteriophages.
Antibiotic
resistance
Source: ReACT. https://www.reactgroup.org/toolbox/understand/antibiotic-resistance/mutation-and-selection/
Antibiotic resistance
Source: Nature Chemical Biology; 2007; 3: 541-548.
Antibiotic deployment
Antibiotic resistance observed
Appropriate
Access to
antibiotics
Although antibiotic use has increased in the last 15 years in countries like India...
Access to
Medicines
Availabil
ity
Accessi
bility
Accepta
bility
Quality
...the burden of disease for
infectious diseases keeps being
high.
Appropriate
Access to
antibiotics
Source: Institute of Health Metrics and
Evaluation
Multicausal issue:
• Lack of WASH and infection
prevention and control policies.
• Lack of access to appropriate
treatment.
What’s the
Industry’s role in
combating
Antimicrobial
Resistance?
Industry’s role in AMR
Market failure
• Externalities:
• Societal benefit: using antibiotics prevents infection from spreading.
• Societal loss: using antibiotics can foster resistance.
• Imperfect information: Resistant infection? When will resistance
emerge? Viral or bacterial infection? Are new antibiotics going to be used?
• RISK.
Industry’s role in AMR
Industry’s role in AMR
Industry’s role in AMR
• Davos Declaration. January
2016.
• Industry Roadmap for
Progress on Combating
Antimicrobial Resistance.
September 2016
Industry’s role in AMR
Antimicrobial
Resistance
Benchmark 2018
• A new tool to map how pharmaceutical companies are
responding to the rise of antimicrobial resistance
• Pharmaceutical companies, generic medicine manufacturers,
biopharmaceutical companies
• Independently funded by the UK and Dutch government
The Antimicrobial
Resistance
Benchmark
What the Benchmark does
on the role and responsibilities of
pharmaceutical companies, to guide
company action on AMR
within companies, governments and
investors.
covering priority areas in R&D,
Manufacturing & Production
and Stewardship & Access
Research areas and scopes
• Impact on Media
The Antimicrobial
Resistance
Benchmark
The Antimicrobial
Resistance
Benchmark: Company scope
Research & Development
• How pharmaceutical companies
fill the pipeline with new
antimicrobials
• Considering priority pathogens as
defined by CDC and WHO lists.
• Not only the quantity, but also
how they promote access &
stewardship and how they
collaborate with other
stakeholders
A.2 R&D pipeline
New medicines and vaccines are needed to curb AMR.
Ideally, companies spend a substantial amount of their R&D
investments on antimicrobial R&D, having large pipelines with
novel/innovative drug candidates and new vaccines.
Scope: R&D project selected based on priority pathogens lists (WHO
& CDC)
Assessment:
• Pipeline size (distinction between preclinical vs. clinical)
• Novelty (WHO definition)
• Vaccines
How is this relevant to
AMR?
What does good look like?
Indicator development
Few novel clinical-
stage projects
targeting priority
bacteria
• The 20 R&D-based
companies together
develop 9 novel candidates
and 14 vaccines
• 6 out of 9 are developed by
biopharmaceutical
companies
Manufacturing & Production
• How pharmaceutical companies
ensure the production of
antibiotics does not contribute to
resistance
• Two aspects
• Companies release waste into the
environment with
antibiotics/antibiotic-resistant
bacteria
• Manufacturing of substandard
products.
B.1 Environmental Risk
Management
Active antibiotic ingredients in the wastewater can
accelerate the development of antibiotic resistance in
bacteria.
Pharmaceutical companies should limit antibiotic discharge to
a degree that is under the Predicted No-Effect Concentration
(PNEC) for its own manufacturing sites, third party
manufacturing sites and external waste treatment plants.
The company:
1. Has an environmental risk management strategy in
place
2. Performs audits on the implementation of its strategy
3. Sets antibiotic discharge limits
How is this relevant to
AMR?
What does good look like?
Indicator development
Depth and breadth of
environmental risk-
management strategies
vary widely
• Six large research-based
pharmaceutical companies are
leading this areas by including
the most elements in their
strategy.
• Generic medicine manufactures
mainly focus their strategies on
their own manufacturing sites.
Access and Stewardship
Stewardship: Ensuring medicines are
used appropriately
Access: Ensuring medicines are
Available and Accessible
Supporting HCP
Education
How is this relevant to
AMR?
What does good look like?
Indicator development
Results
Increasing HCP’s knowledge is key to reduce misuse
•Ensure that HCPs receive the most updated epidemiological data and
guidelines
It was a controversial topic during the stakeholder consultation
•Controlling conflict of interest, content development.
•Companies have expertise and knowledge that can be shared.
Takes into account two general variables:
•Conflict of Interest mitigation.
•Type of content delivered
•Additional variables
GSK SOAR: General Conflict of Interest mitigation strategy (don’t pay
HCPs, outsource selection procedures, etc.).
•Johnson & Johnson: stakeholder engagement and unrestricted
educational grants.
Antimicrobial
Resistance Benchmark
Questions?
Thank you
Access to Medicine
Foundation
www.accesstomedicinefoundati
on.org
www.amrbenchmark.org
@AtMIndex // @AdrianATM90
aruiz@accesstomedicinefounda

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Amrb heidelberg seminar22062018-1

  • 1. Access to Medicine Foundation Adrián Alonso Ruiz, Researcher 25 June 2018, Heidelberg University
  • 2. Table of Contents • Access to Medicine Foundation • Resistance and Appropriate Access to antibiotics • The Antimicrobial Resistance Benchmark
  • 3. 5 billion people have access to medicine 2 billion to go
  • 5. What is access to medicines? Source: Bigdeli et al. Access to Medicines Availabi lity Accessi bility Accepta bility Quality
  • 6. • Research on, and incentives for, pharmaceutical companies and access to medicine • Independent, non-profit organisation • Multi-stakeholder approach The Access to Medicine Foundation
  • 7. Build consensus on what to expect from the industry and where incentives and disincentives exist. Stimulate a race to do well in key access-to-medicine areas, by creating competition on targets and topics. Diffuse best practices to share information and new insights into the best approaches for driving change. Our model for change
  • 9. Our tools in action
  • 10. Our tools in action 66 signatory investors: $8.7 trillion AUM
  • 12. Antibiotic resistance There are two alternative pathways to acquire resistance: • Random changes in the bacterial DNA produces resistance by chance • Incorporation of resistance genes from other bacteria or bacteriophages.
  • 14. Antibiotic resistance Source: Nature Chemical Biology; 2007; 3: 541-548. Antibiotic deployment Antibiotic resistance observed
  • 15. Appropriate Access to antibiotics Although antibiotic use has increased in the last 15 years in countries like India... Access to Medicines Availabil ity Accessi bility Accepta bility Quality
  • 16. ...the burden of disease for infectious diseases keeps being high. Appropriate Access to antibiotics Source: Institute of Health Metrics and Evaluation Multicausal issue: • Lack of WASH and infection prevention and control policies. • Lack of access to appropriate treatment.
  • 17. What’s the Industry’s role in combating Antimicrobial Resistance?
  • 18. Industry’s role in AMR Market failure • Externalities: • Societal benefit: using antibiotics prevents infection from spreading. • Societal loss: using antibiotics can foster resistance. • Imperfect information: Resistant infection? When will resistance emerge? Viral or bacterial infection? Are new antibiotics going to be used? • RISK.
  • 22. • Davos Declaration. January 2016. • Industry Roadmap for Progress on Combating Antimicrobial Resistance. September 2016 Industry’s role in AMR
  • 24. • A new tool to map how pharmaceutical companies are responding to the rise of antimicrobial resistance • Pharmaceutical companies, generic medicine manufacturers, biopharmaceutical companies • Independently funded by the UK and Dutch government The Antimicrobial Resistance Benchmark
  • 25. What the Benchmark does on the role and responsibilities of pharmaceutical companies, to guide company action on AMR within companies, governments and investors. covering priority areas in R&D, Manufacturing & Production and Stewardship & Access
  • 27. • Impact on Media The Antimicrobial Resistance Benchmark
  • 29. Research & Development • How pharmaceutical companies fill the pipeline with new antimicrobials • Considering priority pathogens as defined by CDC and WHO lists. • Not only the quantity, but also how they promote access & stewardship and how they collaborate with other stakeholders
  • 30. A.2 R&D pipeline New medicines and vaccines are needed to curb AMR. Ideally, companies spend a substantial amount of their R&D investments on antimicrobial R&D, having large pipelines with novel/innovative drug candidates and new vaccines. Scope: R&D project selected based on priority pathogens lists (WHO & CDC) Assessment: • Pipeline size (distinction between preclinical vs. clinical) • Novelty (WHO definition) • Vaccines How is this relevant to AMR? What does good look like? Indicator development
  • 31. Few novel clinical- stage projects targeting priority bacteria • The 20 R&D-based companies together develop 9 novel candidates and 14 vaccines • 6 out of 9 are developed by biopharmaceutical companies
  • 32. Manufacturing & Production • How pharmaceutical companies ensure the production of antibiotics does not contribute to resistance • Two aspects • Companies release waste into the environment with antibiotics/antibiotic-resistant bacteria • Manufacturing of substandard products.
  • 33. B.1 Environmental Risk Management Active antibiotic ingredients in the wastewater can accelerate the development of antibiotic resistance in bacteria. Pharmaceutical companies should limit antibiotic discharge to a degree that is under the Predicted No-Effect Concentration (PNEC) for its own manufacturing sites, third party manufacturing sites and external waste treatment plants. The company: 1. Has an environmental risk management strategy in place 2. Performs audits on the implementation of its strategy 3. Sets antibiotic discharge limits How is this relevant to AMR? What does good look like? Indicator development
  • 34. Depth and breadth of environmental risk- management strategies vary widely • Six large research-based pharmaceutical companies are leading this areas by including the most elements in their strategy. • Generic medicine manufactures mainly focus their strategies on their own manufacturing sites.
  • 35. Access and Stewardship Stewardship: Ensuring medicines are used appropriately Access: Ensuring medicines are Available and Accessible
  • 36. Supporting HCP Education How is this relevant to AMR? What does good look like? Indicator development Results Increasing HCP’s knowledge is key to reduce misuse •Ensure that HCPs receive the most updated epidemiological data and guidelines It was a controversial topic during the stakeholder consultation •Controlling conflict of interest, content development. •Companies have expertise and knowledge that can be shared. Takes into account two general variables: •Conflict of Interest mitigation. •Type of content delivered •Additional variables GSK SOAR: General Conflict of Interest mitigation strategy (don’t pay HCPs, outsource selection procedures, etc.). •Johnson & Johnson: stakeholder engagement and unrestricted educational grants.
  • 39. Thank you Access to Medicine Foundation www.accesstomedicinefoundati on.org www.amrbenchmark.org @AtMIndex // @AdrianATM90 aruiz@accesstomedicinefounda