AMR High-Level Meeting Draft Declaration / Australia and Canada engage on Pull models!

Dear All,

Greetings from Porto (Portugal) where we’ve just ended the 2024 edition of the ESCMID-ASM Developer’s Meeting .. a superb congress with contributions from EMA, FDA, young investigators, older investigators, and points between. I enjoyed meeting so many of you this week!

Three items today, all on the path to next week’s United Nations General Assembly High-Level Meeting on AMR. 

First up is the political declaration that will be ratified at the HLM. At 15 pages, it is a lot to absorb — you’ll want to page through it a couple of times to grasp the whole.

As an orientation, its 106 paragraphs are divided across 7 chapters: (I) Governance; (II) Financing; (III) Access; (IV) Co-ordinated Multisectoral Response (Human Health, Agriculture & Human Health, Environment); (V) Research and Development, Training, Innovation and Manufacturing; (VI) Surveillance and Monitoring, (VII) Follow-up.

As you go along, watch for these paragraphs (screenshots of all are below my signature):

• Paragraphs 5 and 6 are good summaries of the cost(s) of AMR:
  • “… in 2019, 4.95 million deaths were associated with drug-resistant bacterial infections, including 1.27 million deaths directly attributable to bacterial antimicrobial resistance, …”
  • “… globally, antimicrobial resistance could result in US$ 1 trillion of additional health-care costs per year by 2050 …”
• Paragraph 24 calls for national action plans to be in place globally by 2030
  • “Ensure, by 2030, that all countries have developed or updated and are implementing multisectoral national action plans …”
  • This timing would align with an update of the current SDGs (Sustainable Development Goals) at the end of the 2030 Agenda for Sustainable Development
• Paragraph 30 re-iterates the important call for an independent panel on evidence: “Invite the Quadripartite organizations to establish an independent panel for evidence for action against antimicrobial resistance in 2025 …”
• Paragraph 53 reinforces the value of diagnostics and laboratory systems: “Enhance the appropriate, prudent and responsible use of antimicrobials across sectors through better valuation of and investment in innovative, rapid, effective, validated and affordable diagnostics and laboratory systems …”
• Towards the end, paragraph 89 calls for delinked mechanisms: “Recognize the important role played by the private sector in research and development of innovative medicines and continue to support voluntary initiatives and incentive mechanisms that separate the cost of investment in research and development from the price and volume of sales …”
• Finally, the closing para 106 calls for another HLM in 5 years (2029); as noted above, an SDG update would be needed in 2030

In short, comprehensive coverage of everything we’d expect. I do wish the call for delinked mechanisms was a bit crisper, but I can only imagine the wrangling that went into this language. 

And on the theme of delinked mechanism (drum roll, please!), we have some exciting news for the 2nd and 3rd stops on today’s tour … both Australia and Canada are both going to push towards incentive models!

• Tour Stop #2: As I hope you’ll recall, Canada commissioned a major review of the issue of Pull incentives
  • See this 8 Sep 2023 newsletter entitled “Canada says, ‘Let’s pull together!’ in a major new report”
  • Following on from this, we now have a “Pilot project to make more antimicrobials available in Canada”
  • The available details are limited, but we are told
    • “Canada’s Antimicrobial Economic Incentives Pilot Project will run for 3 years. It will start in the 2024 to 2025 fiscal year and end in the 2026 to 2027 fiscal year.
    • “The pilot project will use an incentive program to help secure access for antimicrobials in Canada that address priority unmet public health needs for people in Canada.
    • “To create a more attractive marketplace for antimicrobials, incentives could, for example, change the revenue model for antimicrobials and help support applications for market authorization.
    • “This new incentive model also aims to encourage antimicrobial stewardship practices.”
  •  
  • Hopefully, this is going to look a lot like the UK subscription model with scaling appropriate to Canada’s size and situation. 

 Tour Stop #3: In parallel, Australia have released an updated Health Technology Assessment (HTA) plan entitled “Accelerating Access to the Best Medicines for Australians Now and Into the Future.”

• In the summary of its recommendations (page 18 of the .pdf), we find Recommendation 21: Approaches to incentivise the development of health technologies that address antimicrobial resistance (AMR) which …
  • Recommends that the Australian Government develop an HTA policy that would lead to the design of “a flexible reimbursement policy for antimicrobial products.“
  • And recommends that the Australian Government should in the “short term, develop, implement and assess the effectiveness of a pilot subscription fund for novel antimicrobials. The model should be guided by international examples but tailored for the Australian setting.”
• Net, this feels like an earlier stage of the process than in Canada … some analysis will be done but the direction of travel is towards delinked Pull.

Exciting! We could wish for more details and more certainty, but even having this conversation is SUCH  a big step forward. With thanks to all for their work and with all best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Selected paragraphs from the draft political declaration: