ExpectedOutcome:
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. The partnership will be firmly anchored within the framework of the European Health Union package[1] that aims to improve the EU's capacity in the vital areas of prevention, preparedness, surveillance, risk assessment, early warning, and response. In this regard, synergies and close collaboration with the European Health Emergency Preparedness and Response Authority (HERA) and other relevant European Commission services need to be ensured.
The partnership’s activities are expected to be key enablers of the EU Global Health Strategy[2], notably its guiding principle 5 to boost global health research and guiding principle 7 to strengthen capacities for prevention, preparedness and response, particularly to expand and strengthen European and global research partnerships including clinical trial networks that can be pivoted to address new and emerging pathogens.
Proposals under this topic should aim for delivering results that are directed, tailored towards, and contributing to all of the following expected outcomes:
- The EU offers a valued network of clinical trial sites that have the capacity to implement well-coordinated large-scale multi-country quality trials in different target populations, which are able to smoothly transition to public health interventions relevant for cross-border health threats in response to a public health emergency;
- Relevant EU and national entities, the scientific communities and networks, policymakers and funders enhance their collaboration and coordination for strengthened research on pandemic preparedness and response, forming a strong and structured ecosystem with shared evidence, tools and methodologies cutting across sectors;
- Research funders, policymakers, relevant EU and national entities, and the research community recognise and close rapidly relevant research and related infrastructure gaps and break existing silos on pandemic preparedness research and response;
- Healthcare authorities, regulatory authorities, policymakers and other stakeholders use the research results to develop evidence-based strategies and policies for pandemic preparedness and response, and deploy good practices to European countries and regions, and beyond whenever relevant;
- The research community at large benefits from and uses an improved comprehensive knowledge framework integrating the EU, national/regional data and information infrastructures to improve transnational research in the area of pandemic preparedness and response;
- The EU is strengthened as an internationally recognised actor for pandemic preparedness research and response, as such substantially contributing to global cooperation and coordination.
Scope:
The COVID-19 pandemic uncovered the challenges that European health care systems face in detecting, preventing, combatting and managing outbreaks of infectious diseases in a coordinated manner. It also illustrated the need for stronger preparedness and networks for research and timely clinical trials and observational studies, for more timely availability of medical countermeasures, such as vaccines, therapeutics and diagnostics, as well as more appropriate non-pharmaceutical interventions and adequate communication strategies in terms of fighting mis/disinformation and fostering appropriate behaviours. Furthermore, it showed how unilateral research initiatives may lead to a fragmented, inefficient research landscape.
At the same time, the relentless work of the research community that has led to availability of several COVID-19 vaccines in record time highlighted the critical importance of collaborative R&I to respond rapidly to emerging health threats.
Therefore, transformative investments in research for pandemic preparedness are needed at European level. Stronger collaboration and coordination between European actors, including the appropriate infrastructures and networks, are an important prerequisite for improving EU’s pandemic preparedness and stepping up our contribution to global cooperation in this area.
This should be done through a partnership that promotes:
- improved coordination and cooperation to adjust research and innovation agendas on national and European levels (and contributing globally), as essential part of the pandemic preparedness planning and implementation activities;
- coordination and prioritisation of a comprehensive research response to a health emergency, from basic research for better understanding of pathogens with pandemic potential to the development or adaptation of medical countermeasures, as well as effective non-pharmaceutical interventions (NPI) and/or public health and social measures (PHSM), and using an integrated One Health approach;
- the consolidation and further development of ever-warm EU-wide networks and infrastructures for clinical research, controlled trials and observational studies for public health interventions, such as EU-wide vaccine and treatment trials, PHSM/NPI trials or cohorts;
- the provision of robust and timely scientific evidence to inform sound public health decision-making in response to a public health emergency;
- the use of agreed data standards[3] to safely collect, store, link and manage FAIR[4] data and to exploit the full potential of the generated data for modelling and in-silico methods for epidemic surveillance, clinical trials and observational studies, among others.
The partnership should strengthen the European Research Area by supporting excellence in innovative research, capacity building, programmes for development of talent, widening the engagement of countries and sectors not yet involved.
The partnership should endorse a pandemic preparedness Strategic Research and Innovation Agenda (SRIA) based on the work of the CSA BE READY and prepare for the management of the research response during a crisis, by strengthening the collaboration between relevant partners and the alignment of related investments. The partnership will consider the impact of environmental, climatic issues and patterns in relation with the emergence and spread of health threats to better understand how these increase the risk for emerging infectious diseases, and how this should be integrated into the research done using a One Health approach.
The scope of the partnership should encompass:
- basic research to accelerate the acquisition of knowledge on the biology of pathogens with epidemic or pandemic potential, their transmission and interaction with humans, animals and plants, in particular in view of emerging threats to human health. The initial focus should be on pathogens with high epidemic or pandemic potential for the EU, such as those included in the list of priority diseases of the World Health Organization (WHO), with particular attention to those meeting the criteria identified by HERA[5];
- preclinical research aimed at better understanding of human diseases caused by pathogens with epidemic or pandemic potential and testing of related medical countermeasures;
- clinical research to support the generation of novel solutions, in particular the development (phase I to phase III) of medical countermeasures, e.g. vaccines, diagnostics, therapeutics and digital solutions, to prevent or mitigate outbreaks from pathogens with epidemic or pandemic potential, in line with the mission of HERA and the ACT EU initiative[6];
- a key feature should be the consolidation and further development of an ever-warm network of clinical trial sites[7] applying the same quality standards and ensuring a baseline of continuous clinical trial activity across a wide and diverse range of clinical trial sites, to allow for a rapid clinical trial response in case of an epidemic or pandemic. This includes the development of criteria for a clinical trial site to be considered as ever-warm;
- the development, testing and validation of new methods and tools, including those based on artificial intelligence and computer modelling, to improve surveillance and diagnosis and control of the spread of pathogens with epidemic or pandemic potential;
- the conduct of public health and social sciences and humanities (SSH) research for the development and robust evaluation of appropriate non-pharmaceutical interventions/public health and social measures and effective communication strategies at all phases of a public health emergency;
- the consolidation and/or development of infrastructures, platforms and networks necessary for fast and timely start of the response research, capitalising on previous investments and existing infrastructures supporting collaboration, trans-boundary access and provision of services, such as provided by ISIDORe[8] or ECRIN[9].
- capacity building through networking and training of researchers, to share knowledge and good practices also with EU and national entities, policymakers and funders.
It is intended to implement the partnership in two phases. The activities in the first phase should mainly focus on:
- the way clinical trials are set up and conducted in the EU to address public health emergencies, including new approaches such as computer modelling and in-silico clinical trials.
- this will require coordination mechanisms to support prioritisation of emergency trials, improved mechanisms to identify and rank promising compounds, mobilising EU and Member State funding mechanisms, and measures to help speed up contracting of clinical trial sites during emergencies and in preparedness time. For this purpose, close collaboration with the EMA and its Emergency Task Force, National Competent Authorities, Ethics Committees, and the European Commission should be ensured.
- this includes the consolidation, integration and further expansion of EU-wide network of ever-warm clinical trial sites, building on earlier made investments such as Vaccelerate[10], Ecraid[11] and EU RESPONSE[12]. It is expected that the partnership will develop a sustainable solution to ensure the long-term viability of adequate European clinical trial networks for a timely public health emergency response, which cover key target populations and have a suitable geographic spread.
- implementing joint calls for transnational proposals to foster transnational research in the other areas in the scope of the partnership.
- developing the roadmaps for the implementation of the remaining activities foreseen by the partnership.
The second phase of the partnership is expected to build on this first phase, to further develop and consolidate what has been achieved and implement the roadmaps developed for remaining activities as outlined in the scope, with the possibility of expanding to new partners.
The total indicative budget for the partnership is up to EUR 100 million and subject to the effective implementation of the commitments made by the members of the consortium. The Commission envisages to include new actions in its future work programmes to provide continued support to the partnership for the duration of Horizon Europe.
The expected duration of the partnership is 7 to 10 years with the first phase having a duration of 2 to 3 years.
General principles
As general principles, the partnership will:
- promote an inclusive membership and balanced geographic representation, open to third countries and other relevant stakeholders;
- promote data sharing, data standards and data-based digital tools, and align with EU-wide initiatives on open access and FAIR[4] data, artificial intelligence and virtual human twins;
- pay specific attention to the gender and sex dimensions, as well as representativeness of different population groups including young people and vulnerable groups;
- foster the development and use of trustworthy artificial intelligence[14], in all its three dimensions (lawful, ethical and robust);
- ensure synergies and explore collaborations with other relevant activities at EU and international level.
To ensure coherence and complementarity of activities and leverage knowledge and investment possibilities, the partnership is expected to establish relevant collaborations with the relevant European Commission services, with other Horizon Europe projects, partnerships (institutionalised and co-funded) and missions as set out in the working document on ‘Coherence and Synergies of candidate European partnerships under Horizon Europe’[15] as well as to explore collaborations with other relevant activities at EU and international level. On top of this, the proposal should consider synergies with EU programmes, including but not limited to EU4Health[16], the Digital Europe Programme (DIGITAL)[17], the European Social Fund Plus (ESF+)[18], the European Regional Development Fund (ERDF)[19], InvestEU[20], the Recovery and Resilience Facility (RRF)[21] and the Technical Support Instrument (TSI)[22].
When defining calls for proposals, the partnership needs to consider the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
The partnership should create synergies with the European and Developing Countries Clinical Trials Partnership (EDCTP) currently in its third iteration as Global Health EDCTP3[23] Joint Undertaking, that brings together 15 countries from Europe and 25 countries from sub-Saharan Africa. EDCTP is already funding adaptive clinical trial networks spanning African and European countries and a Clinical Trials Community Network[24] The partnership should also contribute to help achieve the goals of GloPID-R[25], the coalition of research funders that invests in research to improve pandemic preparedness & response.
The partnership is open to all EU Member States, as well as to countries associated to Horizon Europe and will remain open to third countries wishing to join. Applicants should describe in their proposal the methodology for their collaboration and the aims they want to achieve with this kind of collaboration. Cooperation with international organisations, private sector and non-European institutions and experts may be considered.
Governance
The partnership’s governance structure should enable an upfront strategic steering, effective management and coordination, daily implementation of activities and ensure the use and uptake of the results. The governance should involve key stakeholders and interested parties, including but not limited to the research and innovation community, public health authorities, patients and citizens, health and care professionals, formal and informal care organisations, innovation owners, and relevant EU entities, including the European Commission, the European Centre for Disease Prevention and Control and the European Medicines Agency.
Resources
The proposal should pool the necessary cash and in-kind resources from the participating national (or regional) research programmes, in order to:
- sustain and further develop the EU-wide networks and infrastructures for clinical research, and in particular a network of ever-warm clinical trial sites by running continuous preparedness trials in relevant target populations;
- implement joint calls for transnational proposals resulting in grants to third parties. Financial support provided by the participants to third parties is one of the activities of this action in order to be able to achieve its objectives;
- conduct capacity building activities;
- implement any other activities, coordinated between (a group of) partnership members, that contribute to the achievement of the partnership’s objectives. Research projects resulting from coordinated national calls could be envisaged in this context as well.
[1]https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en
[2]https://health.ec.europa.eu/system/files/2023-03/international_ghs-report-2022_en.pdf
[3]Without prejudice to the ones set by the Clinical Trials Regulation EU No 536/2014
[4]See definition of FAIR data in the introduction to this work programme part.
[5](1) rapid transmission mode, (2) likelihood to reach a sensitive population, for example persons with minimal pre-existing immunity and (3) their high potential to cause high morbidity and mortality
[6]https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/accelerating-clinical-trials-eu-act-eu. Under ACT EU, a concrete roadmap will be established for improved regulatory approval of clinical trials during public health emergencies.
[7]An ever-warm clinical trial network ensures a baseline of continuous clinical trial activity across a wide and diverse range of trial sites, which allows the rapid adaptation (‘pivoting’) of the trial in case of an epidemic or pandemic.
[8]https://isidore-project.eu/
[9]https://ecrin.org/
[10]https://vaccelerate.eu/
[11]https://www.ecraid.eu/
[12]https://eu-response.eu/
[13]See definition of FAIR data in the introduction to this work programme part.
[14]https://op.europa.eu/o/opportal-service/download-handler?identifier=d3988569-0434-11ea-8c1f-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=
[15]https://research-and-innovation.ec.europa.eu/system/files/2020-10/ec_rtd_coherence-synergies-of-ep-under-he.pdf
[16]https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en
[17]https://digital-strategy.ec.europa.eu/en/activities/digital-programme
[18]https://ec.europa.eu/european-social-fund-plus/en
[19]https://ec.europa.eu/regional_policy/funding/erdf_en
[20]https://investeu.europa.eu/index_en
[21]https://commission.europa.eu/business-economy-euro/economic-recovery/recovery-and-resilience-facility_en#the-recovery-and-resilience-facility
[22]https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/technical-support-instrument/technical-support-instrument-tsi_en
[23]https://www.globalhealth-edctp3.eu/
[24]https://www.ctcan.africa
[25]https://www.glopid-r.org/
