Why the EU’s Antibiotic Revenue Guarantee Scheme Stalled – and how to fix it

Bringing life-saving antibiotics to market is a paradox: doctors depend on them, yet are trained to use them sparingly. This creates a difficult business equation, where every step from development to commercialisation is fraught with challenges. Even with positive clinical results and regulatory approval, these crucial treatments often only reach a small number of countries and at a slow pace. In smaller countries, the cost of registering, marketing and supplying the product can often be unsustainable for companies given restricted sales, leaving patients without access when they need it most.

Meropenem-Vaborbactam, for example, approved in 2018, is currently only available in twelve EU countries, and Cefiderocol had fully launched in just four countries two years after its approval. Both are vital treatments for life-threatening, multidrug-resistant infections including hospital-acquired pneumonia and intra-abdominal infections. There have also been cases of products being launched and then later being withdrawn from those markets due to unsustainable sales volume and revenue.

A revenue guarantee to improve access to antibiotics

To address these access challenges, in 2023, the EU’s Health Preparedness Response Authority (HERA) launched an initiative to improve antibiotic availability: a pilot revenue guarantee scheme for important, recently approved, on-patent antibiotics. Such a scheme would see companies commit to launch their products and maintain supply in all participating Member States, making it available within a clinically relevant timeframe. In return, HERA would guarantee any short falls in revenue below an agreed threshold. Through discussions with Member States, industry and civil society, HERA narrowed down a list of potential products and offered a first of its kind agreement to the selected manufacturer to provide a revenue guarantee for their antibiotic.

The agreement was structured as a “service” contract between the European Commission and the participating company, with the service being a guarantee of ongoing supply. This approach elegantly addresses antibiotic access with the contract sitting as a layer on top of regular national purchasing routes, with no doses of the product procured centrally, leaving pricing and reimbursement as a Member State competency. The initiative was funded through EU4Health with a total budget of €40M split over a timeframe of 49 months. This budget would be used to top-up revenue shortfalls if collective sales fell below the agreed value. Additionally, and within the scope of the €40M, a small payment can also be allocated to cover the costs of maintaining supply, even if the minimum sales revenue was reached.

Figure 1: Revenue guarantees ensure that even with low sales volumes antibiotics can be maintained on market

For a country to participate in the scheme, they must go through procedures to make the product available within their national system. Additionally, both the company and country commit to reporting their sales to HERA to allow the top-up payments to be calculated. Our understanding is that the guaranteed revenue was to be a pre-agreed amount per country, per year (e.g. €500K revenue guarantee one country, €200K in another) rather than an overall total.

Encouragingly, 23 countries initially signed up to participate in the scheme. However, despite the promise of this approach to improve patient access, it has yet to be realised. HERA offered tender contracts to three separate companies, apparently in series as only one contract was available, but ultimately no agreement was reached and the budget expired at the end of 2024.

Overcoming the challenges

We are encouraged to hear that this scheme will be revisited in the future and, in consultation with various stakeholders, believe that the following should be considered to present the best opportunity for success:  

●     Debrief and lessons learned – A formal consultation with all stakeholders, including pharmaceutical companies who felt unable to sign the contracts, should be conducted to gather lessons learned and refine the scheme for future iterations

●     Increase the financial value - It is important to note that this scheme was never intended to drive new antibiotic development, only to secure access to existing products. But even for that purpose, a more substantial and enduring funding model is essential. €40M over a 4-year period to cover over 20 countries is very limited and is unlikely to prove an appealing prospect for industry in the long term. With the negotiations on the Multiyear Financial Framework underway, it may be worth exploring ways to scale up financing.

Financial viability varies significantly by product and country, and greater industry transparency on revenue needs could help ensure sustainable access. This could include making counterproposals of what they can do for a fixed revenue guarantee. Finally, working within the constraints of a fixed budget, the number of countries could be reduced to focus mainly on small countries with limited market attractiveness and commercial viability.

●     Flexibility within negotiations and contracting – Revenue guarantee schemes are still new territory for both government and industry, making close collaboration essential. The UK’s antimicrobial subscription model, a comparable initiative in mechanism but larger in financial size, benefited from extensive dialogue during its pilot phase, allowing a co-creation between companies and the government. It has been indicated that the timelines and negotiations around the HERA revenue guarantee scheme were challenging, with the process moving quickly to a fixed tender for the first companies who were involved. However, Menarini, the final company offered a contract, appears to have had flexibility in negotiations on key items and short timelines were the main issue.

The contract also required manufacturers to finalise national access arrangements within a certain timeframe, which could be perceived as a significant risk to companies as it is not entirely within their control. It is understandable that public procurement regulations may restrict some aspects of what is possible, however, future versions should prioritise more time and flexibility within negotiations.

●     Product and country selection - While the scheme aimed to secure supply in existing markets and encourage expansion, some companies may have been restricted by pre-existing licensing deals or rollout plans. One option to overcome this challenge is to prioritise very recently approved products or those nearing market entry. However, a low financial payout risks sending a weak market signal to developers and investors. Alternatively, deals could be sought with a smaller number of Member States where the product is not yet available, or where it faces a high risk of market withdrawal.

●     Define success and scale-up plans - This scheme represented a pilot, and it is unclear what would have been defined as success and what this would have led to. Addressing antibiotic access requires both immediate action and long-term planning. To ensure lasting impact, a roadmap for scaling up the scheme, with more products and stronger financial backing, should be developed alongside any pilot programme. This will allow a full scheme to launch quickly if the pilot proves effective.

Revenue guarantee schemes show great promise in ensuring antibiotic innovation and access. These early attempts are essential steps toward ambitious, lasting, and sustainable solutions. We commend HERA and HaDEA for their work under tight timelines and budgets, as well as the companies willing to engage in these difficult negotiations. We look forward to a renewed effort in 2026 and hope that it will deliver not just a successful pilot, but a scalable, long-term model for ensuring antibiotic access across Europe.

Transparency: Whilst we have worked hard and consulted widely to ensure the accuracy of this article, there may be errors in some of the details as limited information is available. If you spot any then please flag them to us and we will issue an update. All errors are the authors own.