Working Session of the Parliamentary Group against Antimicrobial Resistance - New Incentives for Antibiotic Development
The latest working session of the Parliamentary Group against Antimicrobial Resistance took place on Sept. 24th and focused on the implementation of the new EU pharmaceutical legislation and the question of how the development and availability of new antibiotics can be secured long term. Germany’s position was a key topic of discussion as well.
Dr Franziska Kersten MP, Co-Chair of the Parliamentary Group, emphasized the need to discuss what role Germany should play in the further development of the Transferable Exclusivity Voucher (TEV) and the Voluntary Subscription Model (VSM), in their potential national implementation, and in the development of a European financing framework for antibiotics.
A particular focus was placed on the incentive mechanism provided under the new European legal framework: the TEV, which ideally should be complemented by the VSM (see also the DNAMR Policy Paper). The two instruments pursue different approaches:
The TEV provides a regulatory market incentive in the form of an additional period of market exclusivity or data protection for another medicinal product, thereby generating additional revenue.
The VSM, by contrast, provides a direct economic pull incentive by guaranteeing remuneration for the availability of an antibiotic that is not directly dependent on actual sales volumes. The European Commission is currently working on guidelines for the further development of the VSM. A key question is which Member States will participate and how such models will be designed on a national level. Given the differences between healthcare systems across the EU, this is a complex task.
Subscription Models as an Economic Pull Incentive
Marc Gitzinger of the BEAM Alliance outlined the economic challenges involved in developing new antibiotics. In order to slow the emergence of new resistances, antibiotics should be used as sparingly as possible. This necessarily limits the potential sales volume and therefore the commercial revenue that can be generated. To nevertheless ensure continued investment in the development of new antibiotics, pull incentives such as TEVs and subscription models are needed to complement existing research funding instruments (push incentives).
Gitzinger referred to the positive experience with the UK model. Under this approach, the National Health Service (NHS) pays the manufacturer a fixed annual fee, similar to a subscription (“Netflix model”). The level of payment is based on the societal value of the antibiotic as assessed by the independent National Institute for Health and Care Excellence (NICE), rather than on sales volume. In return, the manufacturer commits to ensuring reliable supply of the product in the quantities required. Following a pilot programme involving two antibiotics, the model was expanded in 2024. It now applies across the UK, is open to additional products and provides for significantly longer contract periods.
Insights from the UK and International Models
Louise Norton Smith of the product development partnership CARB-X, who previously worked as a civil servant in the UK government, provided an overview of the UK subscription model as well as other push and pull incentives in the G7 countries.
The UK model demonstrates how predictable remuneration for the availability of important antibiotics can be structured without creating incentives for inappropriate use. The remuneration can also be differentiated according to the clinical relevance of a new antibiotic. At the same time, the discussion showed that subscription models cannot replace other measures, such as research funding, clinical development infrastructure and reliable conditions for market entry.
Germany’s Role
A substantial part of the discussion focused on the question of what position Germany should assume regarding the new European incentive instruments and what Germany can contribute to further the development of the VSM. There was broad agreement that the effectiveness of the new instruments will depend on their specific design and implementation. The Parliamentary Circle considered it particularly important that the German Federal Ministry of Health (BMG) work closely with the other stakeholders involved, including research-based pharmaceutical companies. The absence of a BMG representative in the meeting was unanimously regretted.
Tara Hadviger from the office of MEP Timo Wölken provided an update on the current status of the European legislation. From the perspective of the European Parliament, the legislative work has been completed. Her office welcomed the fact that TEVs have been established. It is now up to the individual Member States to define and design complementary VSMs.
Stephan Albani MP, Chair of the Parliamentary Circle, referred to the challenging federal budget situation and the resulting limited financial room for manoeuvre. This makes it all the more important to clarify at an early stage what options and measures are available at the German level. All participants agreed that Germany should participate in the VSM.
Diagnostics and Antibiotic Stewardship
Annika Jöcker of the German Association of Diagnostics Manufacturers (VDGH) highlighted the importance of targeted diagnostics for antibiotic stewardship. She called for diagnostics to be taken into account in the further development of subscription models.
Next Steps
For the next steps, closer dialogue with the BMG was considered particularly important. Stephan Albani MdB intends to engage with the BMG and propose that the issue be discussed within the Parliamentary Group against Antimicrobial Resistance. Representatives from financial policy and healthcare payers may also be involved in further discussions.
The discussion on Germany’s position and role in the further European development of the VSM will continue. Looking at other Member States may also provide useful insights: countries such as Italy, Spain, Sweden and the Netherlands are already considering how the new European incentive instruments could be implemented at national level.
Source: News of the German Network against Antimicrobial Resistance (Deutsches Netzwerk gegen Antimikrobielle Resistenzen, DNAMR), in German