Collaborating with the existing community of global AMR stakeholders, the BEAM Alliance is engaged in the process of bringing forward tangible policies and incentives for the discovery and development of novel antimicrobial therapies and diagnostics in Europe.
To find out more, watch our video presenting our main messages:
Position papers on specific topic are regularly released to support and inform the discussions.
Reinvigorating the AMR R&D field
The innovation ecosystem, mainly composed of Small and Medium Enterprises (SMEs), is in a difficult situation. BEAM Alliance regularly takes the pulse of innovators to highlight the difficult situations they face.
BEAM’s SMEs Barometer – First edition, 2023 (Link)
Financial incentives are needed to help both implementation of R&D actions (PUSH) and fixing the broken market for AMR-related products (PULL). The implementation of appropriate PUSH and PULL financial incentives is a crucial factor to enable industry to retain a focus on developing innovative AMR solutions.
On the PULL side, and along with the encouraging pilot actions being run in Sweden and in the United Kingdom, the BEAM Alliance welcomes the European Commission’s Pharmaceutical Strategy, which recognises the development of novel antimicrobials as a prime example of unmet medical needs. Short-term solutions must be fostered in parallel to long-term incentive reforms, and the specific challenges faced by SMEs in the AMR field have to be considered.
2023.10: Reaction paper on The ENVI Committee Draft Report on the Proposed Pharmaceutical Regulation (Link)
2023.10: Reaction paper on The Proposed Revision of the General Pharmaceutical Legislation (Link) 2023.06: Reflection paper on Possible Pull Mechanisms available through DG HERA – Pitfalls to avoid (Link) 2023.05: Statement: The Proposal for a Council Recommendation to combat AMR (Link)
2023.03: Reflection paper calling for a fair evaluation of the Transferable Exclusivity Extension (TEE) voucher (Link) 2023.02: Reflection paper on Features of a Right Pull Incentive Mechanism for Europe (Link)
2022.12: BEAM Alliance’s reaction to the ‘non-paper’ issued by 14 Member states on antimicrobial market incentives (Link)
2022.01: Reflection paper on Pull Incentive Mechanisms suitable for SMEs developing AMR Products in Europe (Link) 2021.04: Reflection paper on the Roadmap towards the Revision of the Pharmaceutical Legislation (Link) 2021.02: Reflection paper on HERA’s Impact Assessment (Link) 2021.01: Reflection paper on the EU Pharmaceutical Strategy (Link) 2020.08: Call for Urgent Action on the Reimbursement Models for Life Saving Antibiotics (Link) 2020.07: Reflection paper on the EU Pharmaceutical Strategy Roadmap (Link) 2019.11: Incentivising Sustainable Response to the Threat of AMR (Link)
On the PUSH side, significant progress has recently been made (e.g. CARB-X, BARDA, AMR Action Fund initiatives). Nevertheless, although SMEs now represent the vast majority of the AMR innovation pipeline, they only receive a tiny portion of the public funding available (c.a. 20%). Funding instruments should be more aligned with SMEs’ needs.
August 2020: Reflection paper on the AMR Action Fund (Link) March 2019: Supporting Financial Investments towards AMR R&D (Link)
Expanding the vision of AMR innovation
It is recognised that the rising threat of antimicrobial resistance is not going to addressed by a single approach. A range of innovative approaches are being investigated to aid in the fight against resistant bacteria, going beyond the traditional MIC-driven antibiotic model. Currently there is poor recognition of the contribution these diverse approaches can deliver to infection management and healthcare outcomes. To better inform on the diverse and differentiated nature of these products the BEAM Alliance is proposing a categorization of antimicrobial features to better fit with patient’s needs. This work is developed by a dedicated task force (named BTF-E).
April 2019: A New Vision for AMR Innovation to Support Medical Care (Link) The 6 Ways Innovative Products Address Patients Needs to Combat AMR (Link)
Raising awareness on the critical role of diagnostic
The BEAM Alliance is advocating for an impactful inclusion of diagnosis as part of the global AMR solution. Molecular, ID and phenotyping diagnostic (Dx) tests are already available and diagnosis procedures seem fully aligned with stewardship policies and guidelines. However, the availability of funding and investment leveraging the market uptake of new AMR-related Dx is very low, jeopardizing the development of future solutions. A combination of economic, scientific or practical reasons contribute to the current situation and they need to be identified, understood and addressed.
The BEAM Alliance is in a unique position to support policies and incentives to address the identified issues, especially in Europe, ensuring the adoption on new Dx tools to combat AMR. BEAM’s current network and know-how will help leverage European-based innovative SMEs in the Dx space to address the challenges around AMR and evolve viable strategies for implementation. A dedicated task force is being coordinated to approach the issues in an open and innovative way. We are keen to hear from stakeholders that wish to contribute and help shape our response to this challenge.
2023.09: Reflection paper on The Issues Faced by SMEs Developing Innovative AMR Diagnostics (Link)
Supporting SMEs at EU and at national level
Since its inception (see the first position papers below), the BEAM Alliance has been advocating for a better understanding of SMEs’ needs both at the EU and at the national level. For the latter, a dedicated task force (named BTF-National) has been set up with a view to adapting the message for each national context and to encourage local interactions.
2017 BEAM Position Paper (Link) 2015 BEAM Position Paper (Link)