Ajankohtaista kansainvälisestä yhteistyöstä

1. Ajankohtaista kansainvälisestä
yhteistyöstä
Taneli Puumalainen
Osastopäällikkö
Sosiaali- ja terveysministeriö
26.04.2024

2. Suomen sosiaali- ja terveydenhuollon varautuminen
 Kokonaisturvallisuuden malli – lähtökohtana kansallinen varautuminen
 STM johtaa ja koordinoi
 AVIt, Valvira, Fimea, STUK, TTL, THL tarjoavat tilannekuvaa, asiantuntijapalveluja ja
valvontaa
 HVK – materiaalinen valmius, yksityisen, kolmannen ja julkisen sektorin yhteensovitus
 Hyvinvointalueet/YTA –alueet, kunnat
 Pohjoismainen yhteistyössä tehtävä varautuminen
 EU:n yhteinen varautuminen rajat ylittäviin terveysuhkiin
 NATO maiden yhteinen sotilas- ja siviilipuolen terveydenhuollon varautuminen
ja resilienssityö
 WHO ja globaali terveysturvallisuusyhteistyö
 Pandemiasopimusta ja kansainvälistä terveyssäännöstöä (IHR) koskevat neuvottelut

3. EU DG for Health Security
 1992 EU Civil Protection and Humanitarian Aid Operations department - DG ECHO
 Emergency Response Coordination Centre (ERCC)
 EU Civil Protection Mechanism
 2019 rescEU stockpiles
 2014 DG for Health and Food Safety - DG SANTE (1999-2014 DG SANCO)
 2022 Health security framework of European Health Union
 Regulation of Serious Cross-Border Threats to Health
 Regulations for extended mandates of ECDC and EMA
 2021 Health Emergency Preparedness and Response Authority – DG HERA
 6/30 billion euro funding from EU4Health, Horizon Europe and Civil Protection Mechanism
 EU strategic independence - medical countermeasures (MCM), critical medicines, RescEU medical
stockpiles, joint procurement agreements, agreements for ever-warm vaccine production, R&D

4. HERA Risk Assessment – Most important threats to
human health (2022)
1. Pathogens with high pandemic potential, notably due to their transmission mode,
likelihood to meet a sensitive population (e.g. meeting a population with minimal pre-existing
immunity), with high potential to cause high morbidity and mortality, and for which EU
preparedness and response in the area of Medical Counter Measures (MCM) is needed.
2. Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental
or deliberate release.
3. Antimicrobial resistance (AMR) includes high priority pathogens which pose one of the
greatest risk to human health with an annual estimate of 1.27 million deaths globally

5.  Protect public health!
 Early warning – the regulation establishes a system for early warning and quick sharing of
information
 Coordination – it sets up a way for all EU MS to work together in different phases:
prevention, preparation and response to a health crisis
 Preparedness – it obliges all EU MS to be ready – have plans and resources in place to
respond effectively
 Response – it tells EU MS what actions to take during a health crisis and how countries
should cooperate, share resources, make decisions together
 Solidarity – it promotes EU solidarity – EU countries will help each other
The Regulation on serious cross-border threats to
health 2022/2371 –– key features

6. Alert
notification
Situation awareness &
risk assessment
Incident
management
Preparedness
 EWRS is organised in modules
 Notification of alerts and selective exchange
 Interlinking with Alert and Information Systems
 Selective exchange for contact tracing and MEDEVAC
 Crisis management and response
 Situation awareness and risk assessment
 Incident management (coordination of response measures)
 Risk communication
 Preparedness planning and reporting
 Simulation exercises (EU and national)
Early Warning and Response System

7.  Protect public health!
 Early warning – the regulation establishes a system for early warning and quick sharing of
information
 Coordination – it sets up a way for all EU MS to work together in different phases:
prevention, preparation and response to a health crisis
 Preparedness – it obliges all EU MS to be ready – have plans and resources in place to
respond effectively
 Response – it tells EU MS what actions to take during a health crisis and how countries
should cooperate, share resources, make decisions together
 Solidarity – it promotes EU solidarity – EU countries will help each other
The Regulation on serious cross-border threats to
health 2022/2371 –– key features

8. Reporting and assessment of plans (Art 7, 8 and 9)
Implementation of
prevention,
preparedness and
response plans at
national level
Discussion with
Health Security
Committee
EU/EEA country’s
report
Art. 7
Commission’s report
to Health Security
Committee
Reporting with
general
recommendations
ECDC
Recommendations
Discussion with
MS
EU/EEA country’s
action plan
ECDC
assessment
Art. 8
3
year
cycle
3
year
cycle
Commission report
to European Parliament and the
Council
Art. 9

9. • June 10-14 2024
• ECDC, WHO and Member State experts
• Technical areas to be evaluated:
• Surveillance system
• Laboratory capacity
• Health crises management
• Antimicrobial resistance
• One Health cooperation
Assessment of Finnish health preparedness plans
-> Draft report with recommendations
-> Comments and corrections
-> National Action Plan
-> Publication
-> Re-evaluation every 3 years

10. EU approach to stockpiling
 a stockpile is defined as the supply of an item kept for future use in case there
is a sudden increased demand or lack of availability. The concept of
stockpiling includes the identification, purchase, storage, management and
distribution of the medical items or products.

11. Layered stockpiling system
Low probability – high impact threats
High probability – low impact
Global -level
NATO?

12. rescEU medical –varastokapasiteetit ovat osa EU:n
yhteistä varautumista
 15 jäsenmaata rakentaa / jo
ylläpitää medical-varastoja
 Sisällöt vaihtelevat, mm.
 Lääkkeitä
 Suojavarusteita
 Laitteita (mm. hengityskoneita,
infuusiopumppuja)
 Hoitotarvikkeita
 100% EU-rahoitus, hankkeistettu
toimintamalli
 Komissio päättää käytöstä
 Varastojen uudistaminen,
lisääminen tai
uudelleensuuntaaminen EU -
vaalien jälkeen prioriteettien
mukaisesti

13. Suomen rescEU varastot - lääkkeet
 rescEU 1 = CBRN varasto, käynnistetty 1.1.2023
 Kemiallinen-, Biologinen-, Säteily ja Ydinuhkien vasta-aineet
 66 lääkevalmistetta, yli 30 % erityisluvallisia
 rescEU 2 = Medical varasto, käynnistetty 1.1.2024
 kipu, anestesia, ensihoidon ja mikrobilääkeresistenssin lääkkeet
 43 lääkevalmistetta, paljon erityisluvallisia
 rescEU 1 on ensimmäinen hanke, jossa jäsenmaat (Suomi ja Ranska) hankkivat
lääkkeitä EU:n yhteisiin valmiusvarastoihin.
14.5.2024 13

14. rescEU-varastojen hyödyntäminen Suomessa
 Varastot on tarkoitettu hyödynnettäväksi jos omat voimavarat eivät riitä tilanteen hallintaan
 Terveydenhuollossa palvelujärjestelmän kuormittuminen ja toimintojen akuutti vaarantuminen,
esimerkiksi seuraavissa tilanteissa:
 Viruspandemia tai muu yleisvaarallisen tartuntataudin leviäminen
 Lääkkeiden saatavuuden vakava häiriö tai kulutuksen äkillinen kasvu
 Säteilyyn, kemiallisiin tai biologisten tekijöihin liittyvät vaaratilanteet (CBRN)
 Sosiaali- ja terveydenhuollon tukemiseen tilanteissa, joiden seurauksena on syntynyt vakavia ja suuria
henkilövahinkoja – esimerkiksi suuronnettomuus, terroristinen teko, aseellinen konflikti
Tarve arvioidaan ministeriössä kentältä tulleen tilannekuvan pohjalta. Varsinaisesta materiaalin
käyttöönottopyynnöstä ja materiaalisisällöstä päätetään sisäministeriössä, joka välittää
avunpyynnön Komissiolle.

15. Addressing medicine shortages in the EU
 New legislative proposal for medicines
 Incentives, notification of shortages, legal requirements for availability in all MS
 Critical Medicines Alliance – a new platform
 Union list of critical medicines
 Vulnerability analysis
 Critical Medicine Act?
 Joint procurement
 Stockpiling
 International dimension
Communication_medicines_shortages_EN_0.pdf (europa.eu)

16.  Protect public health!
 Early warning – the regulation establishes a system for early warning and quick sharing of
information
 Coordination – it sets up a way for all EU MS to work together in different phases:
prevention, preparation and response to a health crisis
 Preparedness – it obliges all EU MS to be ready – have plans and resources in place to
respond effectively
 Response – it tells EU MS what actions to take during a health crisis and how countries
should cooperate, share resources, make decisions together
 Solidarity – it promotes EU solidarity – EU countries will help each other
The Regulation on serious cross-border threats to
health 2022/2371 –– key features

17. 17
EU Health Emergency Coordination
Integrated political crisis response

18. https://cdn.ceps.eu/wp-content/uploads/2024/02/CEPS-InDepthAnalysis-2024-04_Health-emergency-response-governance.pdf

19. KIITOKSIA!

20. Health security framework of European Health Union
1. REGULATION (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25
January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and
management for medicinal products and medical devices
2. REGULATION (EU) 2022/2370 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23
November 2022 amending Regulation (EC) No 851/2004 establishing a European centre for
disease prevention and control
3. REGULATION (EU) 2022/2371 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of
23 November 2022 on serious cross-border threats to health and repealing Decision
No 1082/2013/EU
4. COUNCIL REGULATION (EU) 2022/2372 of 24 October 2022 on a framework of measures for
ensuring the supply of crisis-relevant medical countermeasures in the event of a public health
emergency at Union level

21. 21
Regulation 2022/2371 on serious cross-border threats to
health
 Health Security Committee
 Prevention, preparedness and response (PPR) planning
 Joint Procurement of medical countermeasures
 Emergency research and innovation
 Epidemiological surveillance and monitoring
 Network for epidemiological surveillance
 Early Warning and Response System (EWRS)
 Risk assessment
 Coordination of response
 Recognition of a public health emergency at Union level
 EU reference laboratories for public health
 Network for substances of human origin
 Advisory Committee on Public Health Emergencies