Government Action

Reform of EU pharmaceutical legislation: Public consultation now open!

Dear All, As was discussed in these prior newsletters, the EU has announced an ambitious Pharmaceutical Strategy with initiatives that include development of Pull incentives for antimicrobials among a number of other topics (see the 28 Nov 2020 newsletter for the full list): 28 Nov 2020 (a general announcement) 29 Apr 2021 (comments by Stella Kyriakides) 24 Jun 2021 (RFPs

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Let’s make a pull incentive happen in the US during the 116th Congress!

Dear All: I’ve written a lot about the need for pull incentives, preferably delinked (some papers to read, comments by TATFAR, highlights from Davos 2018, and the UK commits to trying delinkage).  Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress. The essential document can be

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Updated EMA antibacterial guidance: Draft released for public consultation

Dear All: Dated 19 Dec 2018 and marked as released for public consultation on 14 Jan 2019, EMA has 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 have not yet had a chance to study in detail and will

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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 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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WHO-FAO-OIE-UNEP survey on a multi-stakeholder AMR platform

Dear All (this newsletter experiments with an Executive Summary/Details format; let me know what you think),  (Executive Summary)  As a further support for implementation of recommendations from the UN Interagency Coordination Group on Antimicrobial Resistance (IACG AMR), the Tripartite Plus (WHO-FAO-OIE-UNEP) are seeking to create a Partnership Platform that will “engage institutions representing states, markets and

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Ex-US new antibiotic access: Multi-year delays, even in Europe!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Post-newsletter addendum: A slide deck that summarizes the data from the paper is now available. We talked in a 22 Mar 2021 newsletter about ensuring access to new antibiotics and you should take a moment to refresh your memory of its discussions of

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21st Century Cures v2.0 — PASTEUR Act is embedded!

Dear All, Building on the success of the 21st Century Cures Act passed in 2016 and springboarding from a concept paper published in Science, U.S. Reps. Diana DeGette, D-Colorado, and Fred Upton, R-Michigan, have today introduced the 21st Century Cures Act v2.0! Here are the links you need: Discussion draft of the Cures 2.0 bill Cures 2.0

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