A group of experts from the DRIVE-AB project has introduced a new plan to boost the fight against antimicrobial resistance in the EU and EEA. This pan-European proposal aims to establish a strong incentive model for the development and accessibility of new antimicrobials — a move that could provide support for drug developers like Norwegian Adjutec Pharma.
Adjutec Pharma is a pharmaceutical start-up derived from research in antibiotic products at the University of Oslo. The company’s vision is to provide novel solutions to the imminent threat posed by antimicrobial resistance (AMR), a problem that is increasingly undermining modern medicine.
The AMR situation has received widespread politicial recognition with initiatives set in motion around the world. One such initiative is DRIVE-AB, a collaboration between 15 public and 7 private partners from 12 European countries. It focuses on responsible antibiotic use, public health priorities, and developing economic models for antibiotic innovation.
New initiatives to foster development
In an effort to invigorate the development of new antibiotics and combat the escalating threat of AMR, DRIVE-AB alumni have put forward a proposal for a pan-EU/EEA Pull Incentive model, drawing from the successes and ongoing efforts within and outside the European Union.
As the foremost active example, the UK’s NHS is driving a project, that has expanded from a test case into a broader implementation phase. This project serves as a beacon for the proposed pan-EU/EEA incentive, emphasising the necessity of a sustainable economic model that decouples antibiotic sales from their development, thereby promoting innovation without encouraging overuse.
The UK’s initiative does not stand alone. The PASTEUR Act in the United States and other early-stage projects in Canada and Japan reflect a growing international consensus on the need for economic models that encourage the development of new antimicrobials.
Aiming for revenue guarantees
Within the EU, a landmark recommendation during the Swedish Presidency in June 2023 has called for a comprehensive approach to AMR, suggesting a union-wide pull incentive scheme to spur innovation. This scheme could potentially include revenue guarantees, market entry rewards, and milestone payments, offering a multi-faceted financial stimulus to pharmaceutical companies.
DRIVE-AB´s newly proposed plan seeks to revitalise the development and accessibility of antimicrobial agents within the EU/EEA by establishing a flexible revenue guarantee system coordinated by the Health Emergency Response Authority (HERA). The scheme promises to incentivise innovation and ensure that public health and clinical needs are met by financially rewarding the creation and distribution of high-value new antimicrobial agents and prioritising access to essential generic antimicrobials.
Tiered valuation system
In short, the proposal contains a tiered valuation system managed by the European Medicines Agency (EMA) to categorise new agents into high, medium, low, or no reward categories, with a separate tier for priority generics. The participation in the program would be voluntary, with each member state making a predetermined financial commitment and maintaining their normal procedures for pricing, procurement, and reimbursement.
The proposal suggests an annual reward system, where any given agent is eligible for yearly amounts of between 15 to 120 million EUR, depending on their tier. At the end of each year, member states will fulfil their financial commitments by compensating the difference between actual sales of the agent and the predetermined financing amount.
Balancing act between new and existing treatments
The plan is ambitious in its breadth and depth, seeking not only to address immediate clinical and public health challenges but also to foster a sustainable environment for antimicrobial innovation. The tiered valuation system, in particular, reflects a nuanced approach to balancing the cost and value of new and existing treatments. The proposal’s alignment with prior work and global needs signals a thoughtful and strategic response to the complex issue of antimicrobial resistance.
Despite these positive developments, challenges remain. The European Commission’s proposal for a temporary mechanism of transferable data exclusivity vouchers has met with legislative hurdles, with the concept being removed from the pharma legislation revision. The ongoing negotiations and upcoming European Parliament elections in June 2024 present potential delays for these incentive structures to take effect.
Potential game changer
The precise details of the proposed pan-EU/EEA Pull Incentive are up for debate, but the initiative as a whole could be a game-changer, particularly for companies like Adjutec Pharma, dedicated to developing novel antimicrobials. The model promises to create a more predictable market, mitigate the financial risk associated with the development of new drugs, and ultimately, offer a more robust response to the global AMR crisis. BioStock will make sure to follow up on the story and its potential implications for drug developers in this important field.Innehållet i BioStocks nyheter och analyser är oberoende men BioStocks verksamhet är i viss mån finansierad av bolag i branschen. Detta inlägg avser ett bolag som BioStock erhållit finansiering från.