Technical Briefing on Pull Incentives for the European Parliament (26 Sep 2025)

Dear All (and with thanks to Frédéric Peyrane for leading on this newsletter):

You will know that we eagerly watching the work in the EU on implementing a set of pull incentives based on use of  ‘transferable data exclusivity voucher’ (TEV), also referred to as a  ‘transferable exclusivity extension voucher’ (TEEV). In brief, the concept is that a TEEV would be granted upon approval of a new, important antibiotic. The TEEV could generate income to compensate the developer of the antibiotic by being applied to extend the period of marketing protection of another drug (it could also be sold).

• For a more detailed update on the state of legislative play, see the 20 Jun 2025 newsletter (“Pull incentives in Europe: Next legislative steps”) in which Deepali Patel and I have a Q&A on the current state of play.
• For a wonkish dive into the economic logic behind a TEV/TEEV, see the 2 Oct 2022 newsletter (“How hard (and how) to Pull? Net value of Pull via a TEEV”) which reviews at length a report on the economics of  this approach using the lens of the STEDI values of new antibiotics.

Excitingly, the BEAM Alliance, AMR Action Fund, and Novo Nordisk Foundation convened a technical briefing on pull incentives and the TEV/TEEV concept at the European Parliament on 26 Sep 2025. The briefing consisted of 5 segments, each 30-40 minutes in length; a copy of the agenda is here. The videos from the five sessions are now posted:

1. Defining “Priority Antimicrobials”: The Missing Link for Effective PULL Incentives (Video)
   1. Speakers: Marco Cavalieri (EMA) and Sophie (Cooper (UK NICE)
2. The Future of the TEE Voucher in EU Pharma Package (Video)
   1. Speakers: Pierre Dubois (Toulouse School of Economics), Tim Wilsdon (Charles River Associates), and Henry Skinner (AMR Action Fund)
3. The Milestone Prize: A Smart Way to Boost AMR Innovation—or a Gamble? (Video)
   1. Speakers: Enrico Baraldi (Uppsala University) and Marc Gitzinger (BEAM Alliance, BioVersys)
4. Can a Subscription Model Fix Europe’s Antimicrobial Crisis? (Video)
   1. Christine Ardal (NIPH, EU-JAMRAI 2), Jean-Baptiste Perrin (EC DG HERA), and David Glover (NHS England)
5. Could Transferable Priority Review Vouchers (TPRV) Work in Europe? (Video)
   1. David Ridley (Duke University) and Stefan Schulz (MSD)

Expanded notes on each session are found below our signatures, but the (lightly paraphrased) titles of the sessions are a clear guide to their content and you will also note the leading roles of the speakers. 

Well done to the organizers of the event … seeing this conversation more forward is very exciting!

All best wishes, Frédéric and John

Frédéric Peyrane | General Secretary | BEAM Alliance. frederic.peyrane@beam-alliance.eu. All opinions are my own.

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.


=== Extended details on the content of the videos ===
 
1. Defining “Priority Antimicrobials”: The Missing Link for Effective PULL Incentives (Video)

The success of PULL incentives—designed to drive new antimicrobial development—depends on one critical, often overlooked step: clearly defining eligibility for “priority antimicrobials.” Yet, the conversation around what qualifies as meaningful innovation remains surprisingly limited. Below are the key takeaways from a discussion with Marco Cavalieri (EMA) and Sophie (Cooper (UK NICE):

• Expert-Led Criteria: The EMA is ready to help, as criteria must go beyond the WHO Priority Pathogens List. Factors like safety, ease of use, and clinical impact are essential.
• Lessons from the UK: The UK’s subscription model uses a scoring system that balances unmet needs, drug profile, and health system impact. A comprehensive list of criteria is required for the score to better reflect the drug’s full value.
• Pan-EU Potential: A unified EU framework is possible, and it must provide early clarity to attract investment.

Summary: Even a multi-billion-dollar incentive will fail if it rewards the wrong products or is inaccessible. Getting eligibility right requires collaboration among clinicians, researchers, and policymakers—with the EMA playing a central role.

— 
2. The Future of the TEE Voucher in EU Pharma Package (Video)

As trilogue negotiations on the EU’s General Pharmaceutical Legislation (GPL) progress, the Transferable Exclusivity Extension Voucher (TEEV) remains a focal point—but its effectiveness hangs in the balance. Below are the key points shared by Pierre Dubois (Toulouse School of Economics), Tim Wilsdon (Charles River Associates), and Henry Skinner (AMR Action Fund):

• Predictable & Cost-Effective: Unlike cash prizes, TEEV avoids free riding and delivers value, especially in imperfect generic markets.
• Investor-Friendly: Aligns with typical 5–10 year investment cycles, offering a clear path to returns.
• Broad Support: Backed by SMEs, industry, and investors for its ability to spur innovation, particularly in antimicrobials and oncology.
• Challenges Ahead: New constraints—like the “blockbuster” clause (€490M turnover cap) and “EU-first” registration rule—risk diluting its impact. These add complexity without addressing core needs, and may even penalize valid projects facing development hurdles.

Summary: TEEV isn’t perfect, but its predictability makes it a powerful tool for driving R&D. To keep it effective, policymakers should minimize constraints and pair it with complementary incentives to meet the EU’s fair share goals.

— 
3. The Milestone Prize: A Smart Way to Boost AMR Innovation—or a Gamble? (Video)

Most AMR breakthroughs today come from SMEs, but bringing new antibiotics to market is risky and expensive. Enter the milestone prize. a financial reward for hitting key R&D milestones such as completing Phase 1 trials. The prize is designed to encourage early progress early but it does not ensure funding will be adequate for later phases. The strengths and risks of prizes were discussed by Enrico Baraldi (Uppsala University) and Marc Gitzinger (BEAM Alliance, BioVersys):

• Products may never reach the market: Setting up target product profiles and a pipeline coordinator could help anticipate which products have the best chance (provided the latter can thoroughly monitor any drug development in the world).
• To be part of EU fair share, the milestone prize must be accessible to any developer: which source of EU funding could be used?
• It is tempting to require the developer to use the prize for further development: but then, that’s PUSH funding and the impact on the size of the PULL at market entry is limited.

Summary: We need more evidence before writing this into EU law. The idea is compelling, but the details are tricky.

— 
4. Can a Subscription Model Fix Europe’s Antimicrobial Crisis? (Video)

The subscription (or revenue guarantee) model is the most talked-about “pull” incentive for antimicrobial innovation. But scaling it up in the EU is a major challenge as health policy remains a national competence and the bloc lacks the authority to enforce a unified approach. Critical insights were shared by Christine Ardal (NIPH, EU-JAMRAI 2), Jean-Baptiste Perrin (EC DG HERA), and David Glover (NHS England), including:

• Impactful incentive mechanisms are needed to attract investment in truly impactful antimicrobials.
• DG HERA’s incentive pilot aimed to procure new antibiotics with 24-hour antimicrobial availability across EU member states, but hit roadblocks that led to closure of the tender with no awardee. Although the process received generally favorable feedback, concerns that frustrated the process arose from procedural complexity, budget, and confidentiality. Possible solutions include simplified methods for hospital-level access and budgeting to fully cover the cost of launching in all EU member states.
• The UK’s success started with political agreement, then a Memorandum of Understanding. England leads evaluations, and other UK nations opt in based on the results.

Summary: An EU-funded revenue guarantee could work if incentives are strong enough to justify the registration effort in Europe’s fragmented market. It could also complement the Transferable Exclusivity Extension (TEE) voucher, ensuring fairer benefits.

—
5. Could Transferable Priority Review Vouchers (TPRV) Work in Europe? (Video)

The US introduced TPRV in 2007 to spur innovation in neglected and rare paediatric diseases. To date, over 80 vouchers have been issued and prices around $100M. TPRV have been considered as a pull incentive to reward new antimicrobials in the revision of the EU pharmaceutical package. David Ridley (Duke University) and Stefan Schulz (MSD) discussed the question of the applicability of the TPRV to antibiotics:

• TPRVs could be implemented at EU level—just like TEEVs.
• The EU is not the US: Regulatory hurdles, national HTAs, and existing schemes like PRIME may limit their impact.

Summary: While TPRVs have driven progress in the US, their success in Europe is not guaranteed. Overall, TEEVs would offer less uncertainty and a more predictable value.