Government Action

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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FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

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EMA Network Strategy to 2025: Action on AMR / Comments due 4 Sep

Dear All, We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges

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UK Pilot Antibiotic Subscription Model: Two candidate antibiotics chosen!

Dear All, Breaking news! Prior newsletters (initial and follow-up) have discussed the UK’s innovative antibiotic subscription pilot (aka, “Netflix for antibiotics”). In brief, the UK intends to identify two innovative antibiotics suitable for being purchased via a delinked model in which the payment to the innovator is a fixed annual fee rather than a per-use

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UK Antibiotic Subscription Pilot: Post-webinar FAQ document

Dear All, Kevin Outterson and I recently shared our analysis of the NICE/NHS England pilot of an antibiotic procurement subscription model (link to that newsletter). The NICE/NHS team have now released a post-webinar FAQ document. Here is the link to the document … and I’ve also added the link to the initial webpage (cited just above) discussing

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NHS England Antibiotic Procurement Pilot: Call for applications!

Dear All, As has been discussed in recent newsletters (link), the UK National Institute for Health and Care Excellence (NICE) and NHS England launched a joint project July 2019 to test a payment model for antibiotic products, based on a product’s value to the NHS, rather than how much is used. This goal of the

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UK Antibiotic Subscription Pilot implies Pull Incentive of up to $4b across the G20

Note that there is a follow-up newsletter that covers a post-webinar FAQ. After reading this newsletter as introduction, please go here for the follow-up newsletter. Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Prior newsletters have covered the antibiotic evaluation procurement pilot being run by NICE and NHS England (go here for the

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Horizon Europe 2021-2027: Initial AMR-focused calls now posted!

Dear All (and with thanks to Arjon van Hengel for co-authoring), As was discussed in newsletters dated 28 Nov 2020 (a general announcement) and 29 Apr 2021 (comments by Stella Kyriakides), the EU has announced an ambitious Pharmaceutical Strategy with initiatives that includes development of Pull incentives for antimicrobials among a number of other topics (see the 28

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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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MTEC: A funding source for anti-infective projects that (also) have military uses

Dear All, I have recently become aware of MTEC (Medical Technology Enterprise Consortium), a 501(c)(3) nonprofit organization designed to accelerate the translation of medical technologies into solutions that prevent and treat injuries and restore the health of United States military personnel.  MTEC is a public-private collaboration between the U.S. federal government and the businesses and

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