Government Action

The UK commits to a delinked antibiotic purchase model!

Dear All: Wow! It’s happened! As reported this morning in The Times and The Guardian among others, the UK will announce at Davos that it is committing to a 20-year vision and initial 5-year plan to combat AMR. The plan includes actions to reduce infection rates, to reduce antibiotic use, and most importantly for this audience to find a path to delinked

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Draft EMA antibacterial guidance: Analysis

Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the

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The UK jumps in with a subscription model for antibiotics!

Dear All: We had hints back in January that this was coming (see this post), but now it is really happening! In brief, UK’s NHS will test the world’s first subscription-style payment model in which payments delinked from volume are used to incentivise pharmaceutical companies to develop new drugs for resistant infections. Below my signature, I’ve

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NHS England antibiotic procurement pilot project: Update webinar on 25 Mar 2020

Dear All, This email was just today received from the team leading the NHS England antibiotic procurement project (go here for a prior newsletter describing the project): Dear Stakeholders, In November 2019, we held a stakeholder webinar to share our response to the comments raised in targeted engagement  and to outline proposals for the procurement process.

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Your vote counts! Support the UN proposal for an AMR-focused Sustainable Development Goal (SDG) Indicator

Dear All, Your vote counts! The UN’s Inter-Agency and Expert Group on Sustainable Development Goal Indicators (IAEG-SDGs) is conducting an open consultation on proposals it is considering including in the 2020 Comprehensive Review and is seeking the global community’s comments on these proposals (link to summary web page). The 17 SDGs were adopted in 2015 and are really driving

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Lord O’Neill’s 10 steps to control AMR, two years on / G20 calls for action

Dear All: About two years ago, Lord Jim O’Neill led the UK AMR review to its 7th and final report and proposed these 10 steps as the fundamental basis for controlling AMR: A massive global public awareness campaign Improve hygiene and prevent the spread of infection Reduce unnecessary use of antimicrobials in agriculture and their dissemination into the environment Improve global surveillance of drug resistance and antimicrobial consumption in humans and animals

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Ready, set, go! AMR appropriations in the US FY2025 budget

Dear All, If you follow US politics, you will know that the USG (US Government) is beginning its appropriations process for FY2025 (Federal Year 2025). In preparation, a letter calling for AMR-related funding has been drafted by the Infectious Diseases Society of America (IDSA), AdvaMedDx, American Society for Microbiology (ASM), Association for Professionals in Infection Control

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The road to UNGA 2024 is paved with … reports!

Dear All, We’re now well into the run-up to the HLM (High-Level Meeting) on AMR during UNGA 2024 (the UN General Assembly, September 2024, see the 15 Apr 2023 newsletter for details). In preparation, reports providing data to support policy and decision-making are continuing to appear. Today, for example, GCOA and IDSA released their report entitled “2024

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EMA-FDA-PMDA action + Podcasts (CDD, Pew) + NEJM on non-inferiority

Dear All: Several updates today, all on the theme of good things to know or share! First, EMA, FDA, and PMDA are continuing to meet and have released a summary of their third tripartite meeting. The key message is alignment: alignment on trial designs for key indications, alignment on pediatric programs, and alignment on single global development programs! This is

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FORWARD Act, PREVENT Act, new NIAID RFP!

Dear All, Our US government colleagues have been busy! Three things back-to-back: First, the FORWARD Act (Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2022”) was introduced in the US Senate on 13 Jan 2021 as S.3498 by Sens. Kelly, Sinema, and Feinstein. You’ve got to admire the acronymics! The Senate bill is the

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