8. Health, Demographic Change and Wellbeing

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Annex 11

Horizon 2020

8. Health, demographic change and wellbeing

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Table of contents

Introduction

Call - Better Health and care, economic growth and sustainable health systems

Overall mission statement

1.1 Personalised medicine

SC1-BHC-01-2019: Understanding causative mechanisms in co- and multimorbidities

SC1-BHC-02-2019: Systems approaches for the discovery of combinatorial therapies

SC1-BHC-03-2018: Exploiting research outcomes and application potential of the human microbiome for personalised prediction and prevention of disease

SC1-BHC-04-2018: Rare Disease European Joint Programme Co-Fund

SC1-BHC-05-2018: International flagship collaboration with Canada for human data storage, integration and sharing to enable personalised medicine approaches

SC1-HCO-01-2018-2019-2020: Actions in support of the International Consortium for Personalised Medicine

SC1-HCO-02-2018: Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework

SC1-HCO-04-2018: ERA-NET to support the Joint Programming in Neurodegenerative Diseases strategic plan (JPND)

1.2 Innovative health and care industry

SC1-BHC-07-2019: Regenerative medicine: from new insights to new applications

SC1-BHC-09-2018: Innovation platforms for advanced therapies of the future

SC1-BHC-10-2019: Innovation Procurement: Next generation sequencing (NGS) for routine diagnosis

SC1-HCO-05-2018: Strengthen Regulatory Sciences and support for regulatory Scientific Advice

1.3 Infectious diseases and improving global health

SC1-BHC-13-2019: Mining big data for early detection of infectious disease threats driven by climate change and other factors

SC1-BHC-14-2019: Stratified host-directed approaches to improve prevention, treatment and/or cure of infectious diseases

SC1-BHC-15-2018: New anti-infective agents for prevention and/or treatment of neglected infectious diseases (NID)

SC1-BHC-16-2018: Global Alliance for Chronic Diseases (GACD) 1

SC1-BHC-18-2019: EU-CELAC collaboration for research on non-communicable diseases

SC1-BHC-19-2019: Implementation research for maternal and child health

SC1-BHC-21-2018: Research on HIV, tuberculosis and/or hepatitis C in patients with mono-, co-infections or comorbidities in the contest of the collaboration between the European Union and the Russian Federation

SC1-HCO-06-2018: Establishment of an International Network of Research Centres addressing governance challenges in the research response to infectious threats

SC1-HCO-08-2019: Creation of a European wide sustainable clinical research network for infectious diseases

SC1-HCO-09-2018: Building international efforts on population and patient cohorts

SC1-HCO-10-2018: Coordinating European brain research and developing global initiatives

SC1-HCO-11-2018: Strategic collaboration in health and care research and innovation between EU and China

1.4. Innovative health and care systems - Integration of care

SC1-BHC-22-2019: Mental health in the workplace

SC1-BHC-23-2018: Novel patient-centred approaches for survivorship, palliation and/or end-of-life care

SC1-BHC-25-2019: Demonstration pilots for implementation of personalised medicine in health care

SC1-BHC-26-2018: HTA research to support evidence-based healthcare

SC1-HCO-12-2018: Innovation in health care - a CSA towards using pre-commercial procurement and public procurement of innovative solutions in health care systems

1.5 Decoding the role of the environment for health and well-being

SC1-BHC-27-2018: New testing and screening methods to identify endocrine disrupting chemicals

SC1-BHC-28-2019: The Human Exposome Project: a toolbox for assessing and addressing the impact of environment on health

SC1-HCO-13-2018: Setting the priorities for a European environment and health research agenda

Conditions for the Call - Better Health and care, economic growth and sustainable health systems

Call - Digital transformation in Health and Care

Overall mission statement

SC1-DTH-01-2019: Big data and Artificial Intelligence for monitoring health status and quality of life after the cancer treatment

SC1-DTH-03-2018: Adaptive smart working and living environments supporting active and healthy ageing

SC1-DTH-05-2019: Large scale implementation of digital innovation for health and care in an ageing society

SC1-DTH-07-2018: Exploiting the full potential of in-silico medicine research for personalised diagnostics and therapies in cloud-based environments

SC1-DTH-08-2018: Prototyping a cloud-based standardised Personal Health Record/Electronic Health Record for Europe

SC1-DTH-09-2019: Scaling up the univocal Identification of Medicinal Products

SC1-DTH-10-2019-2020: Digital health and care services

SC1-DTH-11-2019: Large Scale pilots of personalised & outcome based integrated care

SC1-HCC-01-2018: Supporting investment in smart living environments for ageing well through certification

SC1-HCC-02-2019: Support for the large scale uptake of open service platforms in the Active and Healthy Ageing domain

SC1-HCC-03-2018: Support to further development of international cooperation in digital transformation of health and care

SC1-HCC-04-2018: Digital health and care services – support for policy, strategy and (early) adoption

SC1-HCC-05-2018: Support to a Digital Health and Care Innovation initiative in the context of Digital Single Market strategy

Conditions for the Call - Digital transformation in Health and Care

Call - Trusted digital solutions and Cybersecurity in Health and Care

Overall mission statement

DT-ICT-12-2019-: Smart and healthy living at home

SU-TDS-01-2018: Toolkit for assessing and reducing cyber risks in hospitals and care centres to protect privacy/data/infrastructures

SU-TDS-02-2018: Raising awareness and developing training schemes on cybersecurity in hospitals

Conditions for the Call - Trusted digital solutions and Cybersecurity in Health and Care

Other Actions 2018-2019

1. Subscription fee: Human Frontier Science Programme Organisation

2. Studies, activities of the Scientific Panel for Health, conferences, events and outreach activities

3. External expertise

4. Grant to the Global Alliance for Chronic Diseases

5. Fostering transnational cooperation between National Contact Points (NCP) in the area of health, demographic change and well-being: follow-up project

6. Expert group for the impact assessment of the planned Commission communication on infectious diseases

7. Expert groups for the assessment of scenarios for public-public and public-private partnerships

8. Subscription fee: World RePORT international health research database

9. Mobilisation of research funds in case of Public Health Emergencies

CALLS and OTHER ACTIONS for 2020

Call - Better Health and care, economic growth and sustainable health systems (continued in 2020)

Draft content for 2020

Other Actions for 2020

1. Subscription fee: Human Frontier Science Programme Organisation

2. Horizon Prize on novel solutions to reduce the spread of AMR in the environment

3. Surgical care in resource-poor settings

4. Exemplary application of personalised medicine approaches at a local or regional level

5. Novel tool(s) to limit the use of test animals in biomedical sciences and safety testing

6. Implantation of smart medical devices to (re-) establish neural &/or neuronal function

7. Mobilisation of research funds in case of Public Health Emergencies

Call - Digital Transformation in Health and Care

Draft content for 2020

Call - Trusted digital solutions and Cybersecurity in Health and Care

Draft content for 2020

Budget

Introduction

Policy drivers

The specific objective of the 'Health, demographic change and well-being' societal challenge 1 (SC1) is to improve the lifelong health and well-being of all. Lifelong health and well-being for all - children, adults and older people - high-quality, economically sustainable and innovative health and care systems, as part of welfare systems, and opportunities for new jobs and growth are the aims of the support provided to research and innovation in response to this challenge. SC1 implements several Commission priorities, including:

• The pursuit of the 2030 Agenda for Sustainable Development and its Sustainable Development Goals (SDGs), in particular the SDG3 on 'Good Health and Well-being'. All activities developed in this work programme will support the SDGs;
• The agreement reached during COP21[1] and future COP agreements and the goals of the Ostrava declaration on environment and health. Several actions of this work programme will contribute to the climate action;
• The Digital Single Market, and its relevance for the digital transformation of health and care. The Digital Single Market will support in particular patient-centred integrated care and personalised medicine, leveraging the potential of digital technologies and data analysis to improve detection of health risks, early diagnosis and treatment of rare and chronic diseases, as well as advance early detection of infectious diseases outbreaks, and faster drug development;
• The implementation of the expected new EU Action Plan on Antimicrobial Resistance;
• The support and implementation of the expected legislative initiative on Health Technology Assessment

Beyond well-being, health is also instrumental in social policies and socio-economic sustainability.

The contribution to Focus Areas will be EUR 186.50 million for 'Digitisation' and EUR 71 million for 'Security Union'.

Challenges and opportunities

Europe faces rising and potentially unsustainable health and care costs, mainly due to the increasing prevalence of chronic diseases, to an ageing population requiring more diversified care and to increasing societal demands. Health research and innovation also face new challenges stemming from the emergence of new research paradigms and methodologies to address increasingly complex medical and health challenges, including growing awareness of the influence of external environmental factors, and in view of worldwide competition. The world, including Europe, is confronted with increasing migration, climate change and new threats of emerging infectious diseases. Furthermore, health inequalities and access to health and care also constitute major challenges for our societies. Europe needs to innovate to develop smart, scalable and sustainable solutions in order to overcome these challenges and must grasp every opportunity for leadership. Technology and innovation continue to offer such opportunities at an accelerating pace.

Diseases need to be addressed at global level. Therefore the many SC1 research priorities include an international dimension, mainly through multi-lateral initiatives (such as in the areas of rare diseases, chronic diseases and infectious diseases). In this regard, recent outbreaks infectious diseases such as Ebola, Zika, SARS and MERS-CoV demonstrated that cross-border epidemics are a major threat for the health and prosperity across the world. Threats need to be swiftly identified and at a much earlier stage, before developing into a public health emergency (PHE). Under WP 2018-2020, research investment in measures that better detect and foresee these potential epidemics will be stepped up so that preparedness and surveillance can further improve. This includes the swift mobilisation of research funds to address a public health emergency independently recognised by the Commission[2].

Social sciences and humanities research is employed, and sex differences and gender aspects are addressed where relevant. SC1 integrates the principle of responsible research and innovation, including ethics, in all its activities.

In line with the 'Three Os' strategy of promoting Open Science, Open Innovation and being Open to the World' and with the European Open Science Cloud initiative, this work programme promotes an 'Open Science' approach in all topics. Grant beneficiaries under this work programme part will engage in research data sharing by default, as stipulated under Article 29.3 of the Horizon 2020 Model Grant Agreement (including the creation of a Data Management Plan). Participants may however opt out of these arrangements, both before and after the signature of the grant agreement. More information can be found under General Annex L of the work programme. Above and beyond the default requirements on Open Access to Research Data in Article 29.3 of the Model Grant Agreement, applicants are encouraged to demonstrate plans for data management and in particular FAIR (findable, accessible, interoperable and reusable) data sharing.

Applicants are required to include specifications in their proposal on how timely data sharing will be ensured to allow for an appropriate use in public health and research. This is of particular relevance for projects related to emerging infections and public health emergencies. Public health emergencies may include, but are not limited to the following: Public Health Emergencies of International Concern (PHEIC) according to the World Health Organization, public health emergencies under Decision 1082/2013/EU or under applicable national frameworks and regulations.

For clinical studies, the 'Open Science' approach requires (i) the registration of the study prior to the enrolment of the first patient in a registry that is part of the WHO Registry Network[3], and (ii) in line with the WHO 'Joint statement on public disclosure of results from clinical trials'[4] the disclosure of the study results by posting to the results section of the registry and by journal publication within 12 months from primary study completion.

The use of European health research infrastructures (including e-infrastructures) is also encouraged when appropriate, e.g. research infrastructures established as a European Research Infrastructure Consortium (ERIC) or identified on the roadmap of the European Strategy Forum on Research Infrastructures (ESFRI). Projects submitting a data management plan are invited to identify the existing European research data infrastructures that may be used and how these may be mobilised, in particular for long-term data curation and preservation.

The programme should allow for further building of clinical research infrastructure and evidence with regard to efficient and validated models of organisation of complex networks such as European Reference Networks of healthcare providers established by Article 12 of Directive 2011/24/EU[5].

Actions included in this work programme may also gain more impact and scope by envisaging synergies with the European Structural and Investment Funds (ESIF) in this field. It is therefore recommended, where relevant, to seek concrete synergies with ESIF in smart specialisation priorities within the EU regions.

Funding schemes

In order to address these objectives and challenges, societal challenge 1 (SC1) implements a comprehensive strategy covering the whole innovation cycle. SC1 supports multidisciplinary and translational approaches, aiming at the integration of new knowledge generated in pre-clinical, clinical and public health settings. It deploys all Horizon 2020 instruments:

• Research and Innovation Actions (RIA)
• Innovation Actions (IA)
• Coordination and Support Actions (CSA)
• Innovation Procurement (Pre-Commercial Procurement, PCP, and Public Procurement of Innovative Solutions, PPI)
• The SME instrument
• Public-public partnerships (ERA-NET Cofund, European Joint Programme Cofund)
• Inducement prizes

SC1 also builds strong links and synergies with Joint Programming Initiatives (JPIs), with activities undertaken by the Innovative Medicines Initiative 2[6] (IMI2), the European and Developing Countries Clinical Trials Partnership 2[7] (EDCTP2) and the Active and Assisted Living Joint Programme 2[8] (AAL2). Topics in this work programme also respond to the priorities of the European Innovation Partnership on Active and Healthy Ageing[9] (EIP-AHA).

Call - Better Health and care, economic growth and sustainable health systems

H2020-SC1-BHC-2018-2020

Overall mission statement

This call will aim at reconciling better health and healthy ageing with the need to develop sustainable health and care systems and growth opportunities for the health and care related industries. The scope of the call may range from prevention, diagnosis, stratified approaches, predictive toxicology, the development of novel and repurposed therapeutic approaches, including medical technologies and advanced therapies, cohorts and registries-based research, to integration of care and systemic digital solutions for health and ageing well. It aims to translate new knowledge into innovative applications and accelerate large-scale uptake and deployment in different health and care settings, making health and care systems and services more accessible, responsive and efficient in Europe and beyond.

Research areas to be addressed under this priority will implement and provide the evidence base for global and EU policies, including the 2030 Agenda for Sustainable Development and its Sustainable Development Goals (SDGs, in particular the SDG3 on 'Good Health and Well-being'), the Digital Single Market, the implementation of the Ostrava declaration of the Sixth Ministerial Conference on Environment and Health, the cross-border healthcare directive (and its support to the European Reference Networks), the Commission Communication on upgrading the single market (and its proposed health technology assessments initiative), and the Council Conclusions on Personalised Medicine and on Pharmaceuticals.

This Call will be implemented through 5 main priorities:

1. Personalised medicine
2. Innovative health and care industry
3. Infectious diseases and improving global health
4. Innovative health and care systems - Integration of care
5. Decoding the role of the environment for health and well-being

1.1 Personalised medicine

Mission statement:

This priority will aim at moving towards personalised health and care solutions to benefit citizens. It will generate and translate knowledge on disease aetiology and technological innovation into personalised health and care solutions. Areas of application include chronic, rare and communicable diseases. This priority targets any type of population, including children, the ageing population or high-risk groups. Relevant links with the European Reference Networks will be sought. Research under this priority will also attempt to develop an understanding on the economic impact and the health system transformation potential of personalised medicine.

The expected key impact of this priority is improved health outcomes for the citizens. Additional impacts are to: (i) establish Europe as a global leader in personalised medicine research; (ii) support the personalised medicine science base through a coordinated approach to research; (iii) provide evidence to policy makers of the benefit of personalised medicine to citizens and healthcare systems. The International Consortium on Personalised Medicine will be instrumental to achieve these aims.