Presentation at the 20th NMFP meeting held on 4-5 June 2019 at ECDC in Stockholm, Sweden.

1. Microbiology
Focal
Points
Meeting
Frank Van Loock
DG Health and Food Safety
Health Threats and Preparedness

2. Overview of planned actions
• Health Programme (SANTE)
• Health Cluster in Horizon Europe (R&I)
• DG DEVCO
• DG GROW
• DG HOME
• DG EMPL
• DG CNECT

3. Proposed Future of Health Programme
• Health strand is integrated in the European
Social Fund Plus (ESF+) 2021-2027:
• One of the main aims: strengthen crisis
preparedness, management and response in the
EU to protect citizens against cross-border health
threats
• Foreseen: in crisis, costs incurred in non-
associated countries may be considered
exceptionally eligible if justified for countering
the spread and protection of EU citizens.
Health Programme

4. Joint Actions QUANDHIP & EMERGE
• JA QUANDHIP
• Aimed at linking and consolidating the objectives of 2
European networks: The European Network for Highly
Pathogenic Bacteria and the European Network for BSL 4
Laboratories
• JA EMERGE
• Enabled an efficient response to serious emergent and
re-emergent cross-border events by reinforcing the
existing EU network of BSL 3 and BSL 4 laboratories
which are already active in the field of identification of
dangerous bacterial and viral human pathogens.
Health Programme

5. Joint Action SHARP
• JA SHARP: Strengthening IHR Implementation and
Laboratory Capacities
• JA as follow-up on previous JA QUANDHIP/EMERGE
• This JA is led by THL (Finland)
• to improve preparedness and response planning for serious cross-border
threats and the implementation of IHR in EU Member States, EEA and
neighbouring countries, in view of the EU and the global emergency
preparedness context
• to improve the core functions of public health laboratories, by the
coordination, in collaboration with ECDC, of a reference network
of European microbiology laboratories specialised in highly
pathogenic or newly emerging pathogens to improve laboratory
capacity
Health Programme

6. Joint Action SHARP
• WPs
- IHR Core capacity strengthening and assessment
- Preparedness and response planning
- Laboratory preparedness
- Training and local exercises, exchange of working practices
- Chemical safety and chemical threats
- Case management and infection prevention and control
preparedness
- +Sustainability, Communication, Evaluation work packages
Health Programme

7. Joint Action SHARP
• Laboratory Preparedness:
• EQAs
• Diagnostic approaches including Next Generation
Sequencing (NGS), Antimicrobial susceptibility
testing (AST) and basic diagnostics for institutions
with lower resources
• Laboratory Biorisk Management
Health Programme

8. Joint Action on AMR
• Upcoming Joint Action on Laboratory capacity
and AMR surveillance: designated reference
laboratory support structure
• provide capacity-building support to national and local
laboratories with the overall aim to:
• further strengthen coverage, timeliness and usability of AMR
surveillance at local, regional and national levels
• early warning and targeted control of AMR in compliance with
the new EU AMR case definitions
• provide an evaluation of the AMR containment activities to
inform the longer term strategic development of this area
Health Programme

9. Horizon Europe
• Commission proposal for a research and
innovation programme for seven years (2021-
2027)
• Aims to:
• Strengthen the EU’s scientific and technological
bases
• Boost Europe’s innovation capacity,
competitiveness and jobs
• Deliver on citizen’s priorities and sustain our
socio-economic model and values
DG Research &
Innovation

10. Horizon Europe
Specific objectives of the Programme
Foster all forms of innovation and
strengthen market deployment
Strengthen the impact of R&I
in supporting EU policies
Support the creation and diffusion
of high-quality knowledge
Optimise the Programme’s delivery for impact in a strengthened ERA
Strengthening the European Research Area
Reforming and Enhancing the European R&I systemSharing excellence
Pillar 1
Open Science
European Research Council
Marie Skłodowska-Curie Actions
Research Infrastructures
Pillar 3
Open Innovation
European Innovation Council
European innovation ecosystems
European Institute of Innovation
and Technology
Pillar 2
Global Challenges and
Industrial Competitiveness
• Health
• Inclusive and Secure Society
• Digital and Industry
• Climate, Energy and Mobility
• Food and natural resources
Joint Research Centre
Clusters
DG Research &
Innovation

11. Horizon Europe – Health pillar
• Urgent need for R&I on new therapies, vaccines and
diagnostics, alternative to antibiotics
• R&I orientation to support activities aiming at better
methodologies and diagnostics
• Strengthen R&I expertise, human capacities and know-how
for combating infectious diseases in the EU
• Development and validation of effective intervention for
better surveillance, prevention, treatment and crisis
management of infectious disease threats.
• DG SANTE co-Chair
DG Research &
Innovation

12. Collaboration Commission-Agencies
• MoU aiming to increase cooperation between
Agencies (CPVO, ECDC, ECHA, EFSA, EMA) and
the Commission (DG RTD, DG SANTE)
• in order to foster the impact of Horizon Europe in
relevant EU policies, in particular by framing a
coherent contribution to and engagement of EU
agencies in Horizon Europe activities
DG R&I - SANTE

13. Medilab Secure Project –
extended for 3 years
• Consolidation of a Laboratory Network on the
emerging viruses that are pathogens for humans
and/or animals : Improve VBDs surveillance, One
Health networking, Capacity building
• 55 laboratories and public health institutions as
network members from non-EU-MS
• 5 partners in EU-MS
DG Development
Cooperation

14. IVD Medical Devices
State of play
• Publication of the IVD regulation in the OJ the 5th of May 2017
• Date of application: 26 May 2022
• Coordination group established
• Adoption of secondary legislation (Implementing acts) ongoing,
e.g. Common Specifications
• Guidance to be drafted to facilitate implementation of the
Regulation (e.g. classification, performance evaluation studies,
companion diagnostics…)
DG Growth

15. Protection of workers
• Revision of Directive 2000/54/EC on the
protection of workers from risks related to
exposure to biological agents at work
• Too high requirements might undermine the
capacity to respond to health threats
• Move to risk-based approaches
DG Employment

16. WHO Biosafety Manual
• Revision of the Laboratory Biosafety Manual: 4th
edition released mid-2019
• Most important change: the factor that
determines the biosafety level of the laboratory
will no longer be the risk category of the
microorganism
• Shift in focus from pathogen-based to risk-based
approach
DG Employment

17. Security Union
• Joint Criminal-Epidemiological Investigations
EU/US Workshop on 10-11 April 2019
• With DG SANTE, DG HOME, FBI, Europol, CDC, ECDC, RKI
and BKA
• To discuss preparedness against chemical, biological,
radiological and nuclear security risks
DG Home

18. E-Health
• Digital Single Market strategy (2015)
• Commission’s Communication on the
Transformation of Digital Health and Care (April
2018)
• First pillar: Secure access to health data and
healthcare providers can exchange them across
the EU
• Second pillar: Connected health data to advance
research, prevention and personalized health and
care
• Third pillar: Digital tools to foster citizen
empowerment and person-centred care
DG CNECT / SANTE

19. E-Health
• Activities in the second pillar:
• Decentralized European Infrastructure to federate
access to health data
• 1 Mio genomes declaration signed by 20 MS
• Pilot actions for rare and infectious diseases, real
world data
• ECDC public health microbiology strategy 2018-
2022: laboratory methods and eHealth initiatives
DG CNECT / SANTE

20. Digital health
• Digitalisation of health care is increasing thanks
to the digital revolution
• DG CONNECT to support the development of
digital health care with DG SANTE
• Looking for input from NMFPs on ways to
assist in the digitalisation process
DG CNECT / SANTE