AMR.Solutions

Pull incentives in Europe: Next legislative steps

Dear All (Deeply wonkish alert! Settle in! Great stuff here!):

For today, we have a deep dive into the ongoing work in the EU to develop a set of realistic pull incentives using our best understanding to date of realistic choices. If the idea of Pull (and Push) is new to you, please check out this high-level written explainer or this YouTube explainer. And if you are already fluent in Push-Pull, the 13 April 2025 newsletter (“Most current global summary of Pull incentives”) might be of interest.

With respect to the EU’s initiatives, you will hopefully know that the EU have been working towards Pull incentives. As background, here a few places to start reading:

  • 2 May 2023 newsletter: “European Commission: Proposed Pull incentives!” This one provides a good overview of the initial TEV-based structure.
  • 4 Dec 2023 newsletter: “Pan-EU/EEA Pull incentive: A proposal by DRIVE-AB alumni!” This one advances the conversation by describing a flexible revenue guarantee that could work for Europe.
  • And these two cover the UK’s model:

 
To add to this, we have today a Q&A with Deepali Patel, MPH, Director of International Policy at the AMR Action Fund. Deepali is an expert on the EU legislative process and has been steadily teaching me its inner workings. I was recently able to (again) sit down with her for conversation during the 3rd Health Economics Conference at the Toulouse School of Economics and thought sharing her explanations would be helpful to everyone. So, and without further ado, here we go!

— 
John: What is the state of play in Europe for Pull incentives?

Deepali: As you know, the G7 has committed to enacting policies to incentivise R&D of antimicrobials. For the European Union, including France, Italy and Germany, this is being approached through the General Pharmaceutical Legislation (GPL).

Under its policy framework, the EU has three decision-making bodies. The European Commission (EC or ‘the Commission’) is the executive that proposes laws, in this case the proposal for the revised GPL in April 2023. This proposal went to the European Parliament (EP), which represents the people, and the Council of the European Union (‘the Council’), which represents the member states. Each of them has their own process to review the legislation, make their amendments and adopt their version of the legislation.

The EP adopted their version in April 2024, and the Council adopted its version in June 2025.

This now triggers a negotiation between the three bodies (the EC, the EP, and the Council), through meetings called ‘trilogues’, which started this month. Through these meetings, the three parties come to a compromise on a single version of the legislation and then respectively undergo their formal approval procedures.

The GPL includes, amongst many things, an incentive for AMR R&D referred to as a ‘transferable data exclusivity voucher’ (TEV). Per the Commission’s proposal, the TEV provides for a 12-month extension of data exclusivity. When the developer of an antibiotic that meets certain conditions successfully obtains marketing authorisation, a TEV can be granted. The developer can choose to use the voucher on its own product or sell the voucher to someone else to use on a different product (again, under certain conditions).

— 
John: OK! The EC, EP, and Council are off into the trilogues. So, please tell me more about GPL (General Pharmaceutical Legislation) and why it is relevant?  

Deepali: The General Pharmaceutical Legislation governs the regulatory framework for pharmaceuticals in the European Union. It sets standards on quality, safety and efficacy to guide authorisation of medicines, and promotes the pharmaceutical sector. The GPL contains a Regulation (which sets binding rules across the EU) and a Directive (which sets out a common goal that must be achieved, but it is up to member states to determine how). The last update of the GPL was in 2004.
Because the Regulation is binding at EU level, it was seen as a natural home for an incentive for novel antimicrobials.

— 
John: Ah! So now tell me more about the idea of TEVs (transferable data exclusivity vouchers) and how this idea has been proposed as part of the GPL.
 
Deepali: Yes, after 20 years, the GPL is being revised and modernised. The legislative process started in April 2023, when the European Commission issued its proposal for the revision of the GPL, as part of the ‘pharmaceutical package’. It includes a revised Directive, Regulation and a proposal for a Council Recommendation on AMR. Shortly thereafter, the Council adopted the Recommendation, and the European Parliament also issued a Resolution on AMR.

After an extensive review of various options, the Commission designed and proposed the TEV. As mentioned, this voucher would be granted to the marketing authorisation holder (MAH) of a novel antimicrobial meeting a specific set of requirements. Per the Commission’s proposal, the voucher would extend regulatory data protection by 12 months. And as noted, it is ‘transferable,’ meaning the MAH can sell the TEV to another company to be applied to another product already on the market.

—
John: Ok, so we have a revised GPL proposal from the EC with a TEV in it. Can you further describe the job of the other two institutions?

Deepali: Bear with me a minute as this will be a bit wonky. The Commission is the executive branch of the European Union, and it also retains the (almost) sole right to propose legislation, though other institutions can request the Commission to do so. This is different, for example, from the US, where only Congress can introduce legislation.

The European Parliament consists of members (MEPs) who are directly elected by the people. Unlike most parliaments, it has only one ‘house’, but its structure is familiar: MEPs organise into committees to first review legislation before bringing it to the full plenary for formal votes.

The Council is the body that represents the member states in the legislative process. It is led by a Presidency anchored by a member state, rotating every 6 months. Poland currently holds the presidency and will hand over to Denmark on 1 July. Sometimes the Council is compared to the Senate in the US, which is not quite the same (the Council is not directly elected, for example). A closer comparison would be if the US had a ‘council of governors’ from each state that has as much say in approving legislation as Congress does.

— 
John: So how do the EP and the Council come up with their own versions of the GPL? And, you mentioned that the EP and the Council both have approved versions already – how do these dots connect?

Deepali: In the EP, the committee responsible for the legislation assigns a rapporteur whose role it is to create the first draft of the EP’s amended version. The rapporteur also collates all the proposed amendments from other committee members. Once the committee has a version with broad approval, it goes to the full plenary for a vote. The EP adopted its version in April in 2024.

At the same time, and separately, the Council also reviews the text and develops its own version. It works through groups known as ‘working parties’ covering technical details. The final decision is taken at political level in the Committee of Permanent Representatives (COREPER), which is comprised of the ambassadors or deputy ambassadors of each member state in Brussels. The COREPER voted at the beginning of June 2025 to give the Presidency (currently held by Poland) the mandate to initiate the negotiations on behalf of the Council with the EP.

— 
John: Yow! OK, so now we have three versions of the GPL. You’ve hinted at something called ‘the trilogues’ – is this where they the resolve the differences?

Deepali:  Yes, exactly so. Each institution has a text that they will use as a negotiating stance, and this kicks off the next step which is called the ‘trilogues.’ During the trilogues, the Commission mediates discussions between the EP and the Council, acting as an ‘honest broker.’  The meetings are informal, with the purpose of identifying a provisional text that both parties then send back to their respective institutions for formal adoption.

— 
John: So how long will these trilogues take? Are there many differences between the texts?

Deepali: Trilogues can take many months or longer, as there are many differences to resolve. For AMR specifically, one difference is that the Parliament’s version includes other mechanisms beyond the TEV, including milestone payments and a subscription model. So, the co-legislators will need to decide whether to retain other mechanisms.

There are other key differences as well, which could be further described in another newsletter! But some of these include: the number of vouchers that will be issued (10? 5?), the year in which a voucher can be used (first 4? Year 5?), the length of the extension of data protection (6 months? 12?), and which products would be eligible (must be novel class? Must address a multi-drug-resistant organism?). All of these will need to be resolved in the trilogues. In theory, nothing is final in the legislation until there is a single text that all parties have adopted.

— 
John: OK! Well, that it is VERY encouraging! As I wrote on 2 May 2023: “This is the fruition of the conversation that the community has been building ever since Sweden’s ground-breaking 2009 conference (“Innovative incentives for Effective Antibacterials” from which we have a pre-meeting report on policy options, a brief post-meeting report, a complete post-meeting report, and the post-meeting 1 Dec 2009 European Council Resolution that concluded with the call to the commission to “within 24 months, develop a comprehensive action-plan, with concrete proposals concerning incentives to develop new effective antibiotics…” that helped catalyze TATFAR, the ND4BB project, and more), the 3-year DRIVE-AB project as one element of ND4BB, the UK AMR Review and then testing via the UK NHS procurement pilot, the debates in the US about the PASTEUR Act, and so much more.”

And, it is also encouraging to see hints that momentum is building. Swedish Health Minister Acko Ankarberg Johansson and Minister for Social Affairs and Public Health Jakob Forssmed (new vice-chair of the Global Leaders Group on AMR jointly posted a blog on LinkedIn that comes out strongly in favor of the TEV concept: “The decision made today includes a completely new incentive, a so-called Transferable Data Exclusivity Voucher (TEV). Many countries have been against a voucher, but Sweden has fought hard to ensure that this remains in the negotiations. In the negotiations, Sweden has also passed a definition for which products may be eligible for a voucher.”

Exciting times! Again, MANY thanks to Deepali for making time to get all this down in writing — VERY helpful indeed!

All best wishes, John & Deepali

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.

Deepali Patel, BSFS, MPH | Director, International Policy | AMR Action Fund | Deepali.Patel@amractionfund.com

Current funding opportunities

  • Vivli’s 2025 AMR Surveillance Data Challenge has extended its application deadline to 15 June 2025. To participate, please visit: https://amr.vivli.org/data-challenge. See also this 20 April 2025 newsletter.
  • The AMR Industry Alliance is again offering a Stewardship Prize of 10,000 CHF to recognize innovative approaches to combating AMR in low-to-moderate-income countries. This year’s prize focuses on utilizing diagnostics in stewardship efforts. Applications are due by 1 Sep 2025. Go here for details and to apply.
  • NNF (Novo Nordisk Foundation) have announced their “Challenge Programme 2026 – Unravelling the Pathways of Human Invasive Fungal Diseases. The call seeks applications from EU-centered consortia (global partners are possible) for research in 4 areas: (i) fungal virulence factors, (ii) host-pathogen interactions, (iii) mechanisms of anti-fungal resistance, and (iv) fungal disease markers. Applications are due by 8 Oct 2025. Go here for details. 
  • ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews. 
  • CARB-X will have two calls during 2025 that span two areas: (i) Small molecules for Gram-negatives (the focus is on Pseudomonas aeruginosa) and (ii) Diagnostics for typhoid (the focus is diagnosis of acute infections in 60 minutes or less). See this 26 Feb 2025 newsletter for a discussion of the call and go here for the CARB-X webpage on the call. The first cycle is now closed (it ran16-30 April 2025); the 2nd round will be open 1-12 Dec 2025.
  • BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has a 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world! See also this newsletter for further comments on the BAA and its areas of interest.
  • HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more details.
  • The AMR Action Fund is open on an ongoing basis 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.
  • 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
    • 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.
    • Antimicrobial Resistance Research and Innovation in Australia is an actively updated summary that covers Australia’s AMR research and patent landscape. It is provided via collaboration between The Lens (an ambitious project seeking to discover, analyse, and map global innovation knowledge) and CSIRO (Commonwealth Scientific and Industrial Research Organisation, an Australian Government agency responsible for scientific research). Lots to explore here!
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-X, C-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).

John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers, the small meeting format of BEAM’s AMR Conference and GAMRIC (formerly, the ESCMID-ASM conference series) creates excellent global networking. IDWeek and ECCMID are much larger meetings but also provide opportunities for networking with a substantial but focused audience via their Pipeline sessions. Hope to see you there!

  • 1-3 Oct 2025 GAMRIC, the Global AMR Innovators Conference (London, UK). Formerly the ESCMID-ASM Joint Conference on Drug Development for AMR, this meeting series is now in its 10th year and is being continued under the joint sponsorship of CARB-X, ESCMID, BEAM Alliance, GARDP, LifeArc, Boston University, and AMR.Solutions. The ongoing series will continue the successful format of prior meetings with a single-track meeting and substantial networking time (go here to see details of the outstanding 2024 meeting).
    • Registration is now open and the preliminary agenda can be found at that same link (https://www.gamric.org/). The meeting will be limited to approximately 300 attendees, so please be sure to register promptly to avoid disappointment! 
    • The abstract submission window (same link as registration) runs until 13 June.
    • Application for travel grants (same link as registration) are accepted through 2 June.
  • [Note call for IDWeek 2025 Pipeline presentations] 19-22 Oct 2025 (Georgia, USA): IDWeek 2025, the annual meeting of the Infectious Diseases Society of America. Go here to register. For those who would like a substantial opportunity to present a product (see also ECCMID), note the call for applications to present at an IDWeek Pipeline Session; go here to submit an application for your compound or diagnostic.
  • 3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference. Sponsored by the BEAM Alliance, the 9th AMR Conference has just concluded and it’s again been an excellent meeting! Please mark your calendar for next year. You can’t register yet, but details will appear here! 
  • [Note that ESCMID’s Pipeline Monday will again occur in 2026] 17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. You can’t register yet, but you can go here for details on the outstanding 2025 meeting. For those who would like a substantial opportunity to present a product (see also IDWeek), I also know that the meeting schedule will again include Pipeline Monday; go here to see details from 2025.

  Upcoming meetings of interest to the AMR community:

  • 19-23 June 2025 (Los Angeles): ASM Microbe, the annual meeting of the American Society for Microbiology. Go here for details.
  • 10-11 Sep 2025 (Ghent, BE): Organized by a group at Ghent University in collaboration with the ESCMID Study Group for Non-Traditional Antibacterial Therapy (ESGNTA), the Phage Protein Meeting is an interdisciplinary conference dedicated to advancing the field of phage proteins for infection control that seeks to bring together academic researchers and professionals working with phage proteins such as phage lysins, tail fibers, tailspikes, depolymerases, and tailocins. Note that the focus here is on phage proteins rather than phage themselves. Go here for details and to register.
  • 12 Sep 2025 (Ghent, BE): The 10-11 Sep 2025 meeting just above is followed in Ghent on 12 Sep by the 4th annual meeting of BSVoM (Belgian Society for Viruses of Microbes). This meeting is broader than therapeutics, providing an “interdisciplinary perspective on virus of microbes, ranging from basic research to industrial developments and clinical use.” Go here for details.
  • 10-13 Sep 2025 (Lisbon, Portugal): 6th ESCMID Conference on Vaccines. Go here for details.
  • [NEW] 15-19 Sep 2025 (virtual): US CDC-sponsored the 9th Annual Fungal Disease Awareness Week (FDAW). Daily themed events include “Think Fungus” on 15 Sep, “Fungi are everywhere” on 16 Sep, and “Fungal diseases and drug resistance (19 Sep). Signup for the Mycotic Diseases Branch newsletter to stay updated.
  • 1-3 Oct 2025 GAMRIC, the Global AMR Innovators Conference (London, UK; formerly the ESCMID-ASM Joint Conference on Drug Development for AMR). See list of Top Recurring meetings, above..
  • 11-19 Oct 2025 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance) … and 2025 will be the 9th year for this program. Patrice Courvalin orchestrates content with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications are being accepted from 20 Mar to 21 Jun 2025 — go here for more details.
  • 17-20 Sep 2025 (Porto, PT): 14th International Meeting on Microbial Epidemiological Markers (IMMEM XIV). Go here for details.
  • 9-13 Nov 2025 (Portland, OR, USA): ASM Conference on Biofilms. Go here for details and to register.
  • 18-24 Nov 2025 (global, multiple locations): World Antibiotic Awareness Week (WAAW) is convened annually on 18-24 Nov by WHO with national events (e.g., CDC’s US Antibiotic Awareness Week (USAAW); ECDC’s 18 Nov European Antibiotic Awareness Day) occurring around the globe. Details will follow as events become visible.
  • 19-22 Oct 2025 (Georgia, USA): IDWeek 2025. See list of Top Recurring meetings, above.
  • 29-31 Oct 2025 (Bengalaru, India): ASM Global Research Symposium on the One Health Approach to Antimicrobial Resistance (AMR), hosted in partnership with the Centre for Infectious Disease Research (CIDR) at the Indian Institute of Science (IISc). Go here for details and to register.
  • 28-30 Jan 2026 (Las Vegas, NV, USA): IDSA and ASM have announced a new US-based meeting series entitled IAMRI (Interdisciplinary Meeting on Antimicrobial Resistance and Innovation) and described as a “forum for collaboration and exploration around the latest advances in antimicrobial drug discovery and development.” You can’t register yet (further details anticipated June 2025) but you can go here to see general details about the new meeting.
  • 3-4 Mar 2026 (Basel, Switzerland): The 10th AMR Conference sponsored by the BEAM Alliance. See list of Top Recurring meetings, above.
  • 8-13 Mar 2026 (Renaissance Tuscany Il Ciocco, Italy): 2026 Gordon Research Conference (GRC) entitled “Antibacterials of Tomorrow to Combat the Global Threat of Antimicrobial Resistance.” A Gordon Research Seminar (GRS) will be held the weekend before (7-8 Mar) for young doctoral and post-doctoral researchers. Space for the GRS and the GRC is limited; for details and to apply, go here for the GRC and here for the GRS.
  • 17-21 April 2026 (Munich, Germany): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.

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