End 2022, ReAct Europe initiated the project REMAAP (Revisiting Effective Models to Advance the Antibiotic Pipeline) to find ways how to best reinvigorate the antibiotic pipeline with a public health interest in focus. Now the REMAAP initiative is publishing a new Expert Policy Brief: Identifying key bottlenecks in the early stages of antibiotic R&D and exploring public and not-for-profit solutions. In this article you find the brief and five takeaways from a two-day expert workshop held 7-8 November 2022, including suggested ways forward.
The burden of antibiotic resistance is steadily increasing worldwide, accounting for 1.27 million deaths in 2019. Meanwhile, compared to other therapeutic areas, the antibiotic development pipeline is poorly populated. This has been the situation for over 30 years. With increasing bacterial resistance to existing antibiotics, an effective global response to antibiotic Research & Development (R&D) is urgently needed.
More of the same is not the answer
The existing market-based Research & Development model is neither appropriate nor effective for developing antibiotics. It is undoubtedly clear that more of the same will not be the answer. Instead, increased public leadership should test new alternative models in order to overcome challenges in an efficient and public health needs-driven way.
The REMAAP initiative
By building evidence and collective understanding around the key challenges and needed solutions for antibiotic development, the Revisiting Effective Models to Advance the Antibiotic Pipeline (REMAAP) initiative aims to identify the role and purpose of publicly funded and not-for-profit models and entities in tackling the vulnerabilities in the antibiotic pipeline.
To generate interest and commitment
The initiative aims to generate interest and commitment amongst governments, other policymakers and funders to take strong leadership and concrete steps to support solutions where public and not-for-profit models and entities play a key role.
15 senior experts
The workshop 7-8 November comprised of:
- 15 senior leading experts, academics, and members of civil society
- representing nine countries
- from the field of antibiotic R&D.
While the workshop aimed to take an “end-to-end” approach to antibiotic Research & Development (from discovery to patient access), specific attention was given to the early stages of antibiotic Research & Development in the first workshop. This focus was also reflected in the multidisciplinary expertise of the participants, ranging from microbiology, chemistry, infectious diseases, as well as academics with backgrounds in economy and history.
5 key takeaways from the brief
1. Increase governmental ownership of the issue & political leadership required to address the R&D challenges
- Governments should seek to deepen their understanding of the complexity of the antibiotic R&D processes, the constraints of the current market model and the consequences for public health, as well as the key role that public funders can play. This should enable governments to increasingly engage in and own the processes and problems, and thereby also more effectively contribute to the solutions.
- Global alliances and ensuring representation of low- and middle-income countries when developing solutions is paramount for sustainability in access to and stewardship of new antibiotics.
2. Strengthen global coordination and exchange of knowledge & expertise
- New and existing early stage research funding and structures should demand and enable knowledge- and data sharing (including of failing compounds and assays) between experts, as well as providing support and incentives for researchers to take their research to the next phase.
- Existing actors in the field such as ENABLE2 (preclinical research), CARB-X (funder of pre- and early clinical R&D) and GARDP (predominantly focused on late stage clinical R&D and access) operating in different R&D stages should be better and more sustainably supported. Alignment and collaboration between their respective mandates should be strengthened.
- To overcome the fragmentation problems a sustainably funded centralised coordination entity or hub (for example a network of R&D centres or a consortium of existing actors to coordinate research and discovery) to retain expertise, equipment, and potentially funding should be considered. LMICs partners need to be part of such an entity to ensure global health needs are met and access to the end product is planned for.
3. Provide longer-term, sustainable, targeted and coordinated funding
- To yield better results funding must be made long-term and predictable to maintain expertise, structures and institutional memory in the field incl. by funding entities rather than short-term projects.
- Acting as “honest brokers”, a consortium of funders (governments and organisations) can coordinate funding efforts to identify gaps, and require more collaboration and information exchange between research groups.
- Funders should include conditionalities to ensure global access to end products and data sharing, also covering early stage funding. Further exploring of where such conditions are best placed to require public health friendly IP management such as licensing (e.g. through a licence and access pool) and use of open knowledge systems is needed.
- Alternative academic incentives to that of publication in scientific journals should also be introduced via a new coordination entity, designed to promote knowledge- and data-sharing (inclusive of failed projects), with the aim to solve the most critical scientific problems.
4. Expand the use of public and not-for-profit models in discovery and early stages of R&D
- The role of public and not-for-profit entities should be expanded into the discovery and preclinical phases of antibiotic R&D, and should be supported by additional pooled funding from philanthropists and governments including from LMICs to broaden ownership.
- A cost and efficiency comparison between not-for-profit pathways and other ways to finance drug development (e.g. through incentives to the private pharmaceutical sector) would be beneficial.
5. Build stronger regional institutions and networks
- Strengthen collaboration and support for new and existing regional institutions and networks such as regional CDCs (Africa CDC, the emergent ASEAN CDC, etc.) involved in antibiotic R&D and responsible for identifying local needs, coordinating clinical trials, networks of manufacturers, regulatory procedures, procurement, production, as well as integrated stewardship policy guidance.
- Additionally, production, with proper conditions, could be out-licensed to middle income countries with production capacity to create ownership.
- Multiple regions can operate in parallel and in collaboration in a “trans-regional” global model and regional coordination bodies can be expanded for building capacity to create an end-to-end knowledge for antibiotic R&D.
The underlying causes and effects of the various challenges are often intertwined and directly linked to the poor outcomes of current R&D investments and efforts. Going forward it is necessary to focus on tackling the challenges in the early stages to improve final outcomes of antibiotic R&D.
Relevant political processes where these challenges should be addressed include:
- Global processes which can address antibiotic R&D and access constraints e.g. the UN General Assembly High Level Meeting on AMR in 2024, and within the development of the WHO “Pandemic Accord”.
- Regional policy development and funding investments in antibiotic R&D, for example revision of pharmaceutical legislation in the EU and establishment of bodies like the European Health Emergency Preparedness and Response Authority (HERA) to develop medical countermeasures for pandemic preparedness.
- National policy frameworks, initiatives, action plans and investments.
The Swedish EU presidency High Level Meeting on AMR on 6-7th of March provided an important opportunity for discussions among member states and experts on the EU’s future role in antibiotic R&D. As further deliberations will follow in the coming months, ReAct calls attention to the need for enhanced coordination, targeted financing and knowledge sharing, to address the bottlenecks in early stages of antibiotic R&D, and to build on publicly funded and not-for profit models and entities.
Affordably, sustainably and equitable accessible antibiotics – to everyone in need
The overarching goal of antibiotic R&D should be that effective antibiotics become affordably, sustainably, and equitably accessible to everyone in need. Whether or not this will happen depends on how drug development is financed and coordinated. Policy makers at global, regional and national level will have to set a new direction for antibiotic R&D, provide more leadership and be willing to test new waters.
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