EU Council Recommendation adopted! But what does it mean?

Dear All,

During their recent turn to hold the EU presidency (1 Jan to 30 Jun 2023), the Swedes have steadily pushed AMR as one of their top priorities. As part of this, Sweden used their most recent presidency to release a motion to adopt a Council Recommendation on fighting AMR. Here are the parallel links that you need to follow the plot:

  • The new Council Recommendation on fighting antimicrobial resistance. Note in particular
    • Push! Article 28: “Support research and technological innovation with push incentives for the detection, prevention and treatment of infections in humans caused by antimicrobial resistant pathogens…”
    • Pull! Article 30: “Contribute to the design and governance of a Union multi-country pull incentive scheme in order to improve innovation, the development of new antimicrobials and access to existing and new antimicrobials…”
    • Pull together! Article 31: “Pool resources, take collaborative actions, financially contribute to the implementation of the pull incentive scheme, and commit to participate in the network…”
  • More on Pull: Background on proposed transitional implementation mechanism for pull incentives in Europe
    • Because of differing legal & regulatory structures, different countries need different pull mechanisms!
    • For Europe, this means that a 2-step process is needed to achieve pan-EU Pull.
    • For details on the EC approach, start by reading this newsletter from May. This Pink Sheet article gives a good summary as well!
    • More broadly, this is the domain of the UK (NHS) pilot and the PASTEUR Act. For an introduction to Pull, try this newsletter and this Fireside Chat, both from May 2023.
  • More on Push: Recent reports on the need for (more!) Push incentives (more details an all of these below my signature)

So, now back to the Council Recommendation and its path to adoption. We can see from the first few pages that the initial proposal was reviewed over several days in May. After tweaking some wording, the updated proposal was sent to and adopted by the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council of 13 June 2023Adopting the European Commission’s recommendation was listed as the first major result of the meeting!

Now that they have adopted the recommendation, it will be published in the Official Journal of the European Union. So, what does any of this mean? Although not legally binding, this adoption will make waves over the coming years in the EU Member States. 

How will it make waves? Well, Member States can be held accountable to implement actions they themselves encouraged so we can expect further measures from Sweden in future. The hope is then that other members of the EU see Sweden’s example and then create their own similar initiatives. We can also expect to have a progress report — if you go to the end of the recommendation, you can see that the Council “…HEREBY WELCOMES THE COMMISSION’S INTENTION TO Report to the Council four years after adoption on the follow-up given to this Recommendation.”

In short, Sweden is continuing to show its leadership in AMR. By using its 3rd EU presidency to position the EU as a leader in fighting AMR and by setting in place mechanisms to track progress, the hope is hoping that other countries will follow their example. Impressive … and as a history refresh, it was during Sweden’s previous presidency (2nd half of 2009) that a fateful workshop was held in Stockholm. Entitled “Innovative incentives for Effective Antibacterials,” this was the key starting point for the all the truly global discussions on ensuring we have adequate antibiotics that have happened since. For more on this foundational workshop, see details on the Incentives page of AMR.SolutionsGo Team Sweden! 

There is clearly still a lot of work to be done globally, not just within the EU. To quote Jakob Forssmed, Swedish Minister for Social Affairs and Public Health, “We cannot afford to ignore the deadly threat that drug-resistant microorganisms pose to human health.” Well said and I fully agree! Let us hope others are also inspired to take similar action!

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://13.43.35.2/blog/. All opinions are my own.

(1) European Commission’s study on bringing AMR medical countermeasures to the market (April 2023)

  • “There is a broad agreement that push funding should complement the pull models above, acting where the pull models are least efficient: in the early phases of development.”
  • “There is relative consensus on the need to provide additional push funding, in a range between USD 250 and USD 400 million on an annual basis, and at a global level … This range corresponds to what is necessary for reinvigorating the pipeline in conjunction with the pull incentives. While it is not clear exactly how many new products would be brought to the market thanks to this additional funding, there is agreement that this amount would contribute significantly to improve innovation in this market.”
  • “Our study shows that non-dilutive financial support at this stage is the preferred option by almost 80% of respondents covering industry, academia, organisations, and associations actively engaged in the AMR space.”
  • “Incubators and accelerators are playing an important role in improving the assertiveness of AMR drug development process globally.”

(2) New WHO report highlights progress, but also remaining gaps, in ensuring a robust pipeline of antibiotic treatments to combat antimicrobial resistance (May 2023)

  • “The small biotech companies and research groups developing the most promising pre-clinical antibacterial R&D projects need additional push funding to replenish a weak clinical pipeline.”
  • “An analysis based on data from the Global AMR R&D Hub’s Dynamic Dashboard plus other sources estimated how much funding and investments can be expected in the coming ten years for antibacterial R&D from private investors, G7 countries and the European Commission (EC), initiatives like CARB-X and the AMR Action Fund, plus others. It then compared this amount to what would be needed to sustain a pipeline delivering at least six ‘high impact’ antibiotics over the next decade. The preliminary results draw renewed attention to a significant funding gap in the pre-clinical stages of R&D. This is particularly worrying because, as highlighted by WHO, the pre-clinical pipeline is where the most promising and innovative R&D projects are. Yet, these projects are often led by financially vulnerable product developers (mostly small or even micro biotech companies). Accelerating the most promising R&D projects in pre-clinical development will provide much needed replenishment of a weak clinical pipeline.”

(3) Swedish Presidency’s policy paper “How can the EU support sustainable innovation and access to effective antibiotics?: Policy options for existing and new medicines” (June 2023)

  • “While there has been substantial investment in push incentives over the last decade (see section 2), as of 2023, the majority of expected investments in antibacterial therapeutic R&D over the coming decade is either concentrated in the basic science research or the later stages of advanced clinical development. This means there remains a very significant funding gap for early-stage product development, a period during which SMEs are particularly vulnerable to experiencing financial difficulties.”
  • “This preliminary analysis does demonstrate the significant funding gaps during the early stages of product development, which are likely to be responsible for many antibiotic candidates not continuing to later clinical stages of development.”
  • “There is a strong argument for the EU to also consider increasing funding for push incentives alongside implementing pull incentives, as well as to join other G7 governments in supporting antibiotic pipeline coordinators to distribute this push incentive funding with responsibility for oversight of antibiotic candidates under development, identification of unmet needs for funding, and the provision of platforms to share technical support and expertise among antibiotic developers.”

Current funding opportunities (most current list is here)

  • [NEW] The AMR Industry Alliance has announced that applications are again open for its annual Stewardship Prize. The Alliance began the Stewardship Prize in 2021 to identify and support innovative approaches to combatting antimicrobial resistance in low-to-moderate-income countries — the winning application receives CHF 10,000. Applications close September 1, 2023; go here to see past winners and here to apply. 
  • The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
  • BARDA’s long-running BAA-18-100-SOL-00003 offers support for both antibacterial and antifungal agents. This BAA has offered 4 deadlines/year since 2018 … check the most current amendment for details.
  • INCATE (Incubator for Antibacterial Therapies in Europe) is an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
  • These things aren’t sources of funds but would help you develop funding applications
    • AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
    • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-XC-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
  • In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).


Upcoming meetings of interest to the AMR community (most current list is here):

  • 3-5 Jul 2023 (Tours, France): 9th Symposium on Antimicrobial Resistance in Animals and the Environment (ARAE). Sponsored by INRAE (French National Research Institute for Agriculture, Food, and Environment, itself a merger of merger of INRA, the French National Institute for Agricultural Research, and IRSTEA, the French National Research Institute of Science and Technology for the Environment and Agriculture), this conference has been running since 2005. Go here for details.
  • 4-6 Aug 2023 (Bangkok, Thailand): The regional Medical Mycology Training Network Conference by ISHAM’s Asia Fungal Working Group is set to feature both hands-on workshops and clinical sessions for all those managing and working with invasive fungal infections. Go here for details. 
  • 19-22 Sep 2023 (Boston, USA): ASM-ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent development focused meeting … highly recommended! Go here for details and to register. 
  • 7-15 Oct 2023 (residential, Annecy, France): ICARe, the Interdisciplinary Course on Antibiotics and Resistance. Now in its 7th year, this course is a deep-dive into the world of antibiotic development. Intense, rigorous, and HIGHLY recommended. Seats are always limited … apply sooner rather than later! Go here for details.
  • 11-15 Oct 2023 (Boston, USA): IDWeek 2023, the annual meeting of the Infectious Diseases Society of America. Go here for details and to register. 
  • 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
  • 6-7 Feb 2024 (online): Antimicrobial Chemotherapy Conference. This is an annual, free of charge conference that is co-organized by GARDP and the British Society for Antimicrobial Chemotherapy (BSAC). Details to follow — for now, just mark your calendar.
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details.

Share

ENABLE-2 funding now includes Hit Identification & Validation

Dear All, I wrote on 25 Aug 2023 about the ENABLE-2 program and its support for hit-to-lead compound development. As a reminder, that program is focused on molecules with the potential to be direct-acting therapies for one or more of the following priority pathogens: ESBL-producing/carbapenem-resistant Enterobacteriaceae (E. coli, K. pneumoniae), P. aeruginosa, A. baumannii, methicillin-resistant S. aureus, or vancomycin-resistant E. faecium. Adding to that program, there is now an ENABLE-2

NIAID/DMID thinking for FY2026: Antibacterials, Phage, and Antifungals

Dear All, NIAID’s DMID (Division of Microbiology and Infectious Diseases) recently held a council meeting during which they proposed program concepts that encompassed both antibacterial therapies (including phage) as well as antifungal therapies for funding in FY 2026 (the year that would run from 1 Oct 2025 to 30 Sep 2026). There is no guarantee that

WHO Antibacterial Pipeline Review: Update thru 31 Dec 2023

Dear All, WHO have released an update through 31 Dec 2023 of their ongoing series of antibacterial pipeline reviews! Here are the links you need: The report: 2023 Antibacterial agents in clinical and preclinical development: an overview and analysis and a press release about the report. Infographics: Key facts and recommendations from the 2023 antibacterial agents in clinical

The (confusing!) language of AMR: ChatGPT tries to help!

Dear All (Wonkish alert! Not technical but lengthy … so settle in and enjoy the ride!): Regular readers will know of my fascination with language: e.g., this 20 Feb 2020 newsletter entitled “Language Matters: CRE vs. CPE; SDD vs. I; And MDR, XDR, PDR, UDR vs. DTR.” How about that for acronymics taken to Olympian

Scroll to Top