EU Position Paper on AMR: Opportunities Beyond The General Pharmaceutical Legislation

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Executive Summary

The EU is approaching a critical juncture in its response to antimicrobial resistance (AMR). With efforts around the world stalling, it remains one of the few regions with the technical ability, financial mechanisms and industrial base to be the world leader in novel antimicrobial development. However it is currently lagging behind. Both the recently published Life Sciences Strategy and Medical Countermeasures Strategy propose that Europe needs a toolbox of measures to support the development of new antimicrobials and address antimicrobial resistance. Whilst measures within the General Pharmaceutical Legislation(GPL) will prove a useful starting point, they are seen by the commission as one of a suite of measures to adequately stimulate development. In the coming months the Union now has a rare window of opportunity: to turn this recognition into action.

The Critical Medicines Act, provides the legal basis for coordinated procurement and revenue guarantees whilst facilitating access for small member states; Joint Clinical Assessment, presents an opportunity to establish a streamlined mechanism for recognising and rewarding the true value of antibiotics as well as significant risk of delaying their assessment. The Biotech Act, could provide the financing and innovation support needed to mobilise capital. Dedicated funding within the upcoming 2027-34 Multi-annual Financial Framework (MFF) is essential to lay the foundation for ensuring adequate resources in the upcoming years to catalyse Europe to meet its ‘Fair Share’ through a number of schemes including revenue guarantees model.

Introduction

The European Union is approaching a critical juncture in its response to antimicrobial resistance (AMR). With global efforts stalling, Europe remains one of the few regions with the scientific expertise, industrial base and financial mechanisms to lead in developing new antimicrobials. Yet it is not currently seizing that opportunity.

Both the Medical Countermeasures Strategy and the Life Sciences Strategy (Figure 1) recognise the need for a toolbox approach, a coordinated set of measures spanning legislation, regulation and financing to reinvigorate antimicrobial innovation and ensure sustainable access. Crucially, Section 3.1 of the Medical Countermeasures Strategy calls for “improving access to AMR products by developing innovative economic models, including revenue guarantee or other forms of financial pull incentives and joint procurement,” as well as “targeted calls to speed up innovation to address high-risk bacterial and fungal pathogens.”

Figure 1 EU Policy Strategy for Antimicrobial Innovation

Figure 2. Critical Policy Windows for AMR Action (2025-2026)

The Commission itself acknowledges that the measures in the General Pharmaceutical Legislation (GPL) will not be sufficient to address the market failure for new antibiotics. The GPL is a first step as part of a broader set of actions that must now be developed and implemented.

As shown in Figure 2, several upcoming initiatives will shape Europe’s health and industrial agenda, including the Critical Medicines Act (CMA), the Biotech Act, HERA’s work plan and the shaping of the 2028–34 Multi Annual Financial Framework (MFF). Each provides an opportunity to operationalise this toolbox approach in ways that we explore within this paper. This is a narrow but decisive window. Without clear prioritisation by the Commission and Parliament, Europe risks once again acknowledging AMR’s urgency without acting at the necessary scale, undermining both its credibility and its ability to deliver its “fair share” of global antimicrobial innovation and access.

Critical Medicines Act

The Critical Medicines Act aims to strengthen the security of supply and availability of medicines across the EU. Critical medicines are defined as: “a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients” with the key criteria of being able to a) treat a serious condition and b) having a limited availability of appropriate alternatives. Beyond critical medicines which are selected by the EMA, the act also creates a new category of Medicinal Products of Common Interest (MPCIs), these are defined as ‘a medicine, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure availability and accessibility to patients in the necessary quantities and presentations’. Novel antimicrobials are specifically highlighted within the act as being eligible for MPCI status.

Demand Side Measures (Articles 19-22)

Once designated as MPCIs, novel antimicrobials become eligible for the Act’s demand-side measures. Article 19 is particularly significant, as it requires Member States to establish national programmes to support the security of supply of critical medicines. As the Regulation states: “Such programmes may also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures” (Article 19). This creates a legal basis for Member States to adapt pricing and reimbursement frameworks with security of supply in mind, rather than purely therapeutic or cost-effectiveness criteria. In practice, it allows both (a) prioritisation or acceleration of reimbursement for MPCIs, recognising them as medicines of European strategic interest, and (b) higher or more innovative reimbursement models where necessary to guarantee availability. Crucially, the Act makes clear that these programmes apply “without prejudice to Articles 107 and 108 TFEU” (state aid laws)  and the Commission has issued guidance on how state aid rules apply. This ensures that innovative reimbursement models, such as subscription-style, multi-annual contracts, can be deployed by Member States without breaching EU competition law.

In addition, if at least three Member States request it, the Commission may facilitate joint cross-border procurement (Article 21), and if at least nine Member States request it, the Commission may procure MPCIs directly on their behalf (Article 22). Together, these provisions already provide the legal hooks to structure multi-annual revenue guarantees, delinked from sales volumes—for example, subscription-style contracts that pay for predictable access and resilience obligations rather than units sold. Clarifying in the legislation that revenue guarantees are an appropriate tool for MPCIs such as novel antimicrobials would ensure this potential is realised. Such a scheme would secure sustainable availability for patients, reduce commercial uncertainty for suppliers, and signal that Europe has mechanisms in place to support access once products exist. Joint procurement in particular may be most useful as an access and equity tool for smaller Member States, which cannot independently sustain subscription contracts but can pool demand to obtain predictable supply. In practice, these mechanisms should be seen as stabilising access tools, while reinforcing the need for a dedicated EU-level pull incentive to bring new antimicrobials to market in the first place such as those that the General Pharmaceutical Legislation intends to provide.

Strategic Projects

Strategic Projects, as defined in the Critical Medicines Act, are EU-supported initiatives designed to secure the long-term supply of medicines on the Union List of Critical Medicines through actions such as diversifying manufacturing, strengthening supply chains, and enabling EU co-financing. Although the act frames Strategic Projects primarily around medicines on the Union List of Critical Medicines, novel antimicrobials designated as MPCIs should be treated as medicines of equal strategic importance. Extending Strategic Projects to antimicrobials would recognise AMR preparedness as an overriding public interest, giving Member States the possibility of direct financing and the possibility of EU co-financing whilst also remaining compliant with state aid rules. 

AMR-focused SMEs face a “second valley of death” marked by low uptake at launch, difficulties with staffing, and risk of investor withdrawal. Designating them as a strategic project could unlock coordinated State aid flexibility and access to EU and national financing tools. This could co-fund post-approval costs such as manufacturing, post-approval clinical trials and pharmacovigilance, and ensure sustainable market presence of priority antimicrobials across the EU.

Joint Clinical Assessment

The Joint Clinical Assessment (JCA), created under Regulation (EU) 2021/2282 on Health Technology Assessment, was introduced to harmonise the evaluation of medicines across the Union by producing a single EU-level assessment of comparative clinical effectiveness. While this is an important step forward, antimicrobials require special consideration. Their unique clinical and societal value does not fit neatly within conventional HTA approaches, and under the current schedule they would not be assessed until at least 2030. Such a delay risks slowing coordinated European action at a time when supply is already fragile. More fundamentally, leaving it to national HTA bodies to adapt their methodologies case by case will almost certainly prove fragmented and slow. Without a central steer on how to value antimicrobials, Member States are likely to struggle to align approaches, delaying both access and procurement. By providing that steer, the JCA could play a decisive role in accelerating uptake and enabling novel antimicrobials to benefit from EU-level mechanisms such as joint procurement under the Critical Medicines Act.

The implementation of the JCA is staggered:

• January 2025: Mandatory for all new oncology drugs and Advanced Therapy Medicinal Products (ATMPs).

• January 2028: Expands to include all orphan drugs (for rare diseases).

• January 2030: Expands to cover all other new drugs that go through the centralized EMA approval process.

The JCA process is overseen by the EU HTA Coordination Group, which draws lead and co-assessors from national agencies to prepare draft assessments that are then adopted collectively. These evaluations focus narrowly on comparative clinical effectiveness, while economic value and pricing assessments remain the responsibility of Member States. For antimicrobials, this approach presents a methodological difficulty: ethical and practical considerations mean that non-inferiority rather than superiority trials are used, yet their results can be difficult to interpret within traditional HTA frameworks.

Recognising this, it will be important for the Coordination Group to remain attentive to the distinctive features of antimicrobial evidence and to their wider societal contributions- preserving treatment diversity, providing insurance against resistance, and enabling other forms of care. These dimensions are often overlooked in standard HTA. Tools such as multicriteria decision analysis could help make them more explicit, ensuring that the full value of novel antimicrobials is captured when their turn in the JCA process comes.

In order to benefit from the provisions of the Critical Medicines Act, such as joint procurement, products must first undergo JCA. On the current timeline, novel antimicrobials would not be assessed until at least 2030, delaying coordinated procurement at a time when uptake across Europe is already uneven and many Member States have no reliable access to new antibiotics. More seriously, by 2030 the pipeline itself may have all but collapsed: without decisive intervention, there may be virtually no novel products left to assess. In that scenario, the JCA risks arriving too late to make any meaningful contribution. Options should therefore be explored either to expedite their inclusion in the JCA process or to provide funding for early JCA assessments that enable more nuanced product evaluations and coordinated procurement before 2030. Without such measures, Europe risks having the right mechanisms in place only once there are no products left to use them on.

Multi-Annual Financial Framework (MFF) & European Competitiveness

Despite the introduction of a limited number of national pull incentives and the likelihood of a Transferable Exclusivity Voucher being adopted within the GPL, the EU has not secured a funding mechanism of sufficient scale to correct the antimicrobial market failure. The Multiannual Financial Framework (MFF), the EU's seven-year budget that translates policy priorities into funded programs, offers the critical window to change this. This makes the establishment of a dedicated, high-level budget line providing funding for an adequately sized pull incentive to drive innovation in the 2028–2034 Multiannual Financial Framework necessary and timely. We estimate that the required funding for this would be €2 -3 billion[1} to top-up national sales and create a sufficient incentive. Most importantly, Member States have already called for a centrally funded EU pull incentive for antimicrobials. The logical next step is to ensure that such central funding is provided through the MFF.

Europe’s future prosperity and autonomy depend on staying globally competitive by leading in innovation, resilience and strategic technologies, an ambition set out in the European Competitiveness Fund within the upcoming MFF. With a proposed financial envelope of €234.3 billion for 2028–2034, the Fund is to be established as the EU’s flagship instrument to enhance competitiveness by consolidating fragmented programmes, scaling up investment across the innovation cycle and strengthening resilience in critical sectors. As the proposal makes clear, it will support “health, biotech, agriculture and bioeconomy” including ‘availability and accessibility of medicinal products(...)and other medical countermeasures’ (p38 ECF) and contribute directly to the EU’s Medical Countermeasures Strategy(p5). Antimicrobial resistance fits squarely within this scope: resistant infections undermine workforce productivity, inflate healthcare costs and expose Europe’s dependence on fragile global supply chains for essential medicines. Ensuring a sustainable pipeline of effective antimicrobials is therefore not only a public health imperative but also a strategic investment in competitiveness, protecting productivity, driving biotech innovation and reinforcing strategic autonomy. While antimicrobials are not blockbusters in the market sense, they can be“systemic blockbusters” in economic terms: without them, routine care, advanced therapies, and Europe’s wider life sciences industry cannot function.

AMR also embodies the COMPASS principles on which the Competitiveness Fund is built. It requires concentration on a strategic health priority with cross-border implications; orientation towards resilience and security by strengthening preparedness against one of Europe’s most predictable health threats; and modernisation of Europe’s biotech and pharmaceutical sector through support for cutting-edge antimicrobial innovation. It offers performance with measurable societal and economic benefits, from reduced healthcare costs to improved workforce productivity. A centrally funded pull incentive strengthens autonomy by reducing reliance on fragile external supply chains for essential medicines. It achieves simplification by replacing fragmented national or EU initiatives with a single, coherent mechanism. And it creates synergy with wider EU frameworks, including the Life Sciences Strategy and the Medical Countermeasures Strategy.

Biotechnology Act

The forthcoming European Biotech Act is its public consultation stage and aims to strengthen Europe’s competitiveness in biotechnology by reducing time-to-market for innovative products, improving access to risk-tolerant financing, supporting biomanufacturing capacity, building skills, and facilitating the use of data and AI. While its scope is broad, the Act has clear relevance to AMR. Novel antimicrobials, diagnostics, vaccines, and microbiome-based therapies are biotech innovations that face exactly the challenges the Act seeks to address: slow and costly regulatory pathways, limited mid-late-stage investment, insufficient manufacturing capacity in Europe, and underuse of AI and data in discovery.

For antimicrobials, improved regulation combined with regulatory sandboxes under the Biotech Act could be transformative for advancing the development of novel antimicrobials. Current approval models often demand large-scale randomized controlled trials, which are impractical for rare resistant infections. Improved regulation  would ideally accelerate the use of innovative methodologies such as platform trial designs, early conditional approvals and real-world evidence, including natural history trials that track how patients with resistant infections fare on existing treatments to provide a comparator for new drugs. This approach would give smaller antimicrobial developers a faster and more affordable path to market, while still ensuring that regulators gather the data needed for long-term safety and effectiveness monitoring. Additionally this would offer opportunities to improve regulatory pathways for or innovative approaches to antimicrobials such as phage therapy where regulatory approaches are not yet well defined.

Beyond regulatory streamlining, the Biotech Act offers opportunities to strengthen the wider AMR ecosystem. Dedicated risk-tolerant financing instruments could help companies bridge the gap from early push funding into scale-up and manufacturing, complementing initiatives like CARB-X, GARDP and the AMR Action Fund. Traditional financial instruments have thus far  proven ill-suited for novel antimicrobial development, which faces the dual challenge of long development timelines and inherently low returns on investment. Incentives for biomanufacturing could be directed to secure antimicrobial production capacity within the EU, reducing dependency on external suppliers. Provisions on skills development could fund targeted training programmes in antimicrobial R&D, regulatory science, and biomanufacturing. Furthermore,  positioning antimicrobials within the Act’s strategic security lens would further reinforce their role as dual-use technologies critical to Europe’s resilience and complement the EU ambitions laid out in Readiness 2030.

Conclusion

To date EU has shown commendable foresight in recognising the weaknesses of the antibiotic pipeline and in investing substantial political and economic capital to address this market failure, what is still required are the final legislative and financial measures, to bring the system fully into effect. Completing this work will deliver lasting rewards: safeguarding European health security and delivering on the Union’s capacity to act decisively and lead competitively on the global stage.

[1} Over the 7 year period of the MFF, targeting 6 new antibiotics. This assumes a global pull incentive of $363M/year, as per best academic estimates, sales in line with current EU estimates and that these products are also rewarded with a transferable exclusivity voucher, in line with current proposals in the GPL. Calculations available here.