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)
  • EC study on AMR medical countermeasures to the market (April 2023)
  • WHO/Global AMR R&D Hub’s report to G7 Finance and Health Ministers (May 2023)
  • Swedish EU Presidency policy paper (June 2023)
  • This is the domain of CARB-X, Novo REPAIR Impact Fund, AMR Action Fund — all projects that have made / are making a huge difference — we need to keep funding them!

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 2023. Adopting 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.Solutions. Go 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://amr.solutions/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.”