FEAM Forum Summary

1 ͳͷƒ”…ŠʹͲʹͳ

The FEAM European Biomedical Policy Forum in partnership with the Wellcome Trust A stronger crisis preparedness: The European Health Emergency Response Authority (HERA)

‘”—”‘—†–ƒ„Ž‡†‹•…—••‹‘Ǧ‡‡–‹‰—ƒ”›

Š‡ ‡†‡”ƒ–‹‘‘ˆ—”‘’‡ƒ…ƒ†‡‹‡•‘ˆ‡†‹…‹‡ȋ Ȍƒ†‡ŽŽ…‘‡ƒ”‡…‘•—Ž–‹‰™‹–Šƒ

range of stakeholders to produce recommendations for the European Commission’s proposal for

ƒ ‡ƒŽ–Š ‡”‰‡…› ”‡’ƒ”‡†‡•• ƒ† ‡•’‘•‡ —–Š‘”‹–› ȋȌǤ • ’ƒ”– ‘ˆ –Š‹•

…‘•—Ž–ƒ–‹‘ǡ —”‘’‡ƒ‹‘‡†‹…ƒŽ‘Ž‹…› ‘”—‡„‡”•ƒ†‘–Š‡”‹–‡”‡•–‡†’ƒ”–‹‡•

…ƒ‡–‘‰‡–Š‡”–‘†‹•…—••–Š‡’”‘’‘•ƒŽ•Ǥ––‡†‡‡•‹…Ž—†‡†‹†—•–”›ǡ…‹˜‹Ž•‘…‹‡–›ǡƒ†

’ƒ–‹‡–‰”‘—’•ȋˆ—ŽŽƒ––‡†‡‡Ž‹•––ƒ’’‡†‹šͳȌǤŠ‡ˆ‘ŽŽ‘™‹‰“—‡•–‹‘•™‡”‡†‹•…—••‡†„›–Š‡

‰”‘—’ǣ

What gap could HERA fill and what needs to be in place for it to succeed?

Š‡”‡™ƒ••‘‡†‡„ƒ–‡‘HERA’s ambitionǡƒ†™Šƒ–‹•ƒ…Š‹‡˜ƒ„Ž‡‰‹˜‡–Š‡•…ƒŽ‡‘ˆˆ—†‹‰

ƒ˜ƒ‹Žƒ„Ž‡Ǥ‘‡ƒ––‡†‡‡••—‰‰‡•–‡†•Š‘—Ž†–ƒ‡ƒ„”‘ƒ†ƒ’’”‘ƒ…Š–‘’”‡’ƒ”‡†‡••ƒ†

”‡•’‘•‡ǡ™Š‡”‡‘–Š‡”•–Š‘—‰Š–‹–™ƒ•‘”‡ˆ‡ƒ•‹„Ž‡–‘•–ƒ”–™‹–Šƒ‘”‡Ž‹‹–‡†•…‘’‡‹–‡”•

‘ˆ Š‡ƒŽ–Š –Š”‡ƒ–•ǡ ’ƒ”–‹…—Žƒ”Ž›ƒ•’‘Ž‹–‹…ƒŽ•—’’‘”–ƒ› …Šƒ‰‡ǤŠ‡”‡ ™ƒ•ƒ‰”‡‡‡– –Šƒ–ˆ‘”

–‘•—……‡‡†ǡ‹–‡‡†‡†significant and sustained fundingƒ†‹–™‘—Ž†‡‡†–‘™‡ƒ–Š‡”

’‘Ž‹–‹…ƒŽ…›…Ž‡•ǤŠ‡ˆ—–—”‡”‡Žƒ–‹‘•Š‹’„‡–™‡‡‡„‡”–ƒ–‡•ƒ†™ƒ••‡‡–‘„‡

…”‹–‹…ƒŽ–‘‡•—”‡national commitmentƒ†ƒ†Š‡”‡…‡–‘’‘Ž‹…›”‡…‘‡†ƒ–‹‘•Ǥ

––‡†‡‡• ‘–‡† –Šƒ– ˆ‘” –‘ •—……‡‡†ǡ ‹– —•– Šƒ˜‡ ƒ mandate for decision-making –‘

‡•—”‡‹–…ƒ”‡•’‘†“—‹…Ž›‹ƒ…”‹•‹•Ǥ™‘—Ž†ƒŽ•‘”‡“—‹”‡–‡…Š‹…ƒŽ‡š’‡”–‹•‡ǡƒˆ‘…—•‘

„‡‹‰ ’”‘ƒ…–‹˜‡ ”ƒ–Š‡” –Šƒ ”‡ƒ…–‹˜‡ǡ ƒ† •–”‘‰ •–ƒ‡Š‘Ž†‡” ”‡Žƒ–‹‘•Š‹’• –‘ •—……‡‡†Ǥ ‘‡

ƒ––‡†‡‡•„‡Ž‹‡˜‡™‘—Ž†„‡‘•–„‡‡ˆ‹…‹ƒŽƒ•ƒsingle point of contactˆ‘”ˆ—†‹‰

’”‡’ƒ”‡†‡••ƒ†”‡•’‘•‡–ˆ”‘”‡•‡ƒ”…Šƒ††‡˜‡Ž‘’‡–ǡ–‘ƒ—ˆƒ…–—”‹‰ǡ–‘’—”…Šƒ•‹‰

ƒ††‡Ž‹˜‡”›Ǥ—’’Ž›…Šƒ‹•™‡”‡ƒŽ•‘‡–‹‘‡†ƒ•‹’‘”–ƒ––‘‹˜‡•–‹ǡ–‘„‡ƒ„Ž‡–‘”ƒ’‹†Ž›

‘„‹Ž‹•‡‡†‹…ƒŽ…‘—–‡”‡ƒ•—”‡•ƒ…”‘••†‹ˆˆ‡”‡–‰‡‘‰”ƒ’Š‹‡•Ǥ

‘‡ƒ––‡†‡‡••‡‡ƒ•ƒ‘’’‘”–—‹–›ˆ‘”ƒŒ‘‹‡†Ǧ—’horizon scanningˆ—…–‹‘ƒ…”‘••

–Š‡–‘‹†‡–‹ˆ›ˆ—–—”‡Š‡ƒŽ–Š–Š”‡ƒ–•ǡ‹…Ž—†‹‰‹’”‘˜‡†…‘‘”†‹ƒ–‹‘ƒ…”‘••—”‘’‡ƒŠ‡ƒŽ–Š

†ƒ–ƒ •›•–‡•ǡ ‹ –Š‡ …‘–‡š– ‘ˆ –Š‡ ’Žƒ‡† —”‘’‡ƒ ‡ƒŽ–Š ƒ–ƒ ’ƒ…‡Ǥ –Š‡”• ”ƒ‹•‡† –Š‡

‹’‘”–ƒ…‡ ‘ˆ –ƒ‹‰ ƒ One Health ƒ’’”‘ƒ…Šǡ –‘ …‘•‹†‡” Š—ƒ•ǡ ƒ‹ƒŽ• ƒ† –Š‡‹”

‡˜‹”‘‡––‘‰‡–Š‡”ǡ’ƒ”–‹…—Žƒ”Ž›‹–Š‡…‘–‡š–‘ˆ‡‡”‰‹‰œ‘‘‘–‹…†‹•‡ƒ•‡•Ǥ

‘‹–‘”‹‰ healthcare workforce capacity ƒ† shortages in medical counter-measures

ƒ…”‘••–Š‡™ƒ•ƒŽ•‘…‘•‹†‡”‡†ƒ‹’‘”–ƒ–ˆ—…–‹‘ˆ‘””‡•’‘•‡Ǥ

ANNEX 3:

FEAM Forum Summary

ANNEX 3. 30

2

What could we learn from other organisations and previous health crises?

––‡†‡‡•”‡…‘‰‹•‡†–Šƒ–™Š‹Ž‡–Š‡”‡™ƒ•—…Š–‘Ž‡ƒ”ˆ”‘ ‹‘‡†‹…ƒŽ†˜ƒ…‡†‡•‡ƒ”…Š

ƒ†‡˜‡Ž‘’‡–—–Š‘”‹–› ȋBARDAȌǡ–Š‡—”‘’‡ƒ…‘–‡š–—•–„‡–ƒ‡‹–‘…‘•‹†‡”ƒ–‹‘Ǥ

Š‡„—†‰‡–ˆ‘”‹•—…Š•ƒŽŽ‡”–Šƒƒ†–Š‡—”‘’‡ƒ‹‘˜ƒ–‹‘Žƒ†•…ƒ’‡‹•

†‹ˆˆ‡”‡–Ǥ–ƒ‡Š‘Ž†‡”•”‡ˆŽ‡…–‡†–Šƒ–…‘—Ž†„‡‘”‡–”ƒ•’ƒ”‡–ǡƒ†–Š‹•™ƒ••‘‡–Š‹‰

–Šƒ–…‘—Ž†„‡ƒƒ††‡†ƒ†˜ƒ–ƒ‰‡ˆ‘”Ǥ–”ƒ•’ƒ”‡…›ǡ–Š‡”‡™ƒ•ƒŽ•‘ƒ•—‰‰‡•–‹‘–Šƒ–

…‘—Ž†ƒ†‘’–‘’‡•…‹‡…‡’”‹…‹’Ž‡•–ˆ‘””ƒ’‹†‹ˆ‘”ƒ–‹‘•Šƒ”‹‰†—”‹‰ƒ…”‹•‹•ƒ†–‘

’—„Ž‹•Š’—„Ž‹…Ȁ’”‹˜ƒ–‡…‘–”ƒ…–•Ǥ

”‘–Š‡COVID-19 pandemicǡƒ––‡†‡‡•‘–‡†–Šƒ–ƒ‡›‰ƒ’‹–Š‡—”‘’‡ƒ”‡•’‘•‡Šƒ•

„‡‡–Š‡‹••—‡‘ˆƒˆˆ‘”†ƒ„‹Ž‹–›ƒ†ƒ……‡••–‘‡†‹…‹‡•ƒ†–Š‹•—•–„‡ƒ‡›…‘•‹†‡”ƒ–‹‘ˆ‘”

ǤǦͳͻŠƒ•ƒŽ•‘†‡‘•–”ƒ–‡†–Š‡‡‡†ˆ‘”•‘Ž‹†ƒ”‹–›ƒ†…‘‘”†‹ƒ–‹‘ƒ…”‘••–Š‡

„Ž‘…Ǣƒ–‹‘ƒŽ‹•–‹…ƒ’’”‘ƒ…Š‡•Šƒ˜‡•‘‡–‹‡•…‘–”ƒ†‹…–‡†‡ˆˆ‘”–•ƒ––Š‡’ƒǦŽ‡˜‡ŽǤ–™ƒ•ƒŽ•‘

‘–‡†–Šƒ––Š‡HERA IncubatorŠƒ•„‡‰—–‘•‡––Š‡†‹”‡…–‹‘‘ˆ–Š‡„”‘ƒ†‡”’”‘’‘•ƒŽ•

ƒ†–Š‡”‡™‹ŽŽ„‡‹’‘”–ƒ–Ž‡••‘•–‘Ž‡ƒ”ˆ”‘‹–•‹’Ž‡‡–ƒ–‹‘Ǥ

‘‡•–ƒ‡Š‘Ž†‡”••ƒ‹†–Šƒ–™Š‹Ž‡–Š‡”‡ƒ”‡ƒ›Ž‡••‘•–‘„‡Ž‡ƒ”‡†ˆ”‘–Š‡ Innovative Medicines Initiative (IMI)ǡ–Š‹•’—„Ž‹…’”‹˜ƒ–‡’ƒ”–‡”•Š‹’Šƒ•ƒŽ•‘Š‹‰ŠŽ‹‰Š–‡†‹••—‡•‘ˆ‹•–”—•–

towards the private sector and that HERA could help to rebuild this relationship. Also, while IMI’s

‹˜‡•–‡–ˆ‘…—•‡•‘’”‡Ǧ…Ž‹‹…ƒŽ•–ƒ‰‡”‡•‡ƒ”…Šǡ…‘—Ž†–ƒ‡ƒ‘”‡‡†Ǧ–‘Ǧ‡†ƒ’’”‘ƒ…Š

–‘†‡˜‡Ž‘’‹‰‡†‹…ƒŽ…‘—–‡”Ǧ‡ƒ•—”‡•ǡ–‘‡•—”‡’”‘†—…–†‡˜‡Ž‘’‡–Ǥ

How could HERA work in practice?

Š‡”‡™ƒ•ƒŽ‘–‘ˆ†‹•…—••‹‘ƒ„‘—––Š‡”‘Ž‡‘ˆ public private partnershipsȋ•Ȍ‹Ǥ

‘‡”‡ˆŽ‡…–‡†–Šƒ–…‘—Ž†’”‘˜‹†‡ƒ‡™‘†‡Žˆ‘”—”‘’‡ƒ•–‹…Ž—†‹‰‘”‡‘ˆƒ

ˆ‘…—• ‘ ’”‘†—…– †‡˜‡Ž‘’‡– ƒ† †‡’Ž‘›‡–ǡ ”ƒ–Š‡” –Šƒ ’”‡…‘’‡–‹–‹˜‡ ”‡•‡ƒ”…ŠǤ –Š‡”•

‘–‡†‹†—•–”›…‘—Ž†‘˜‡ƒ™ƒ›ˆ”‘–Š‡‘†‡Žȋ™Š‡”‡‹†—•–”›ƒ‹Ž›’”‘˜‹†‡•‹Ǧ‹†

…‘–”‹„—–‹‘•Ȍ–‘‹…”‡ƒ•‡”‹•Ǧ•Šƒ”‹‰Ǥ‡šƒ’Ž‡‘ˆƒƒ…–‹˜‹–›…‘—Ž†’—”•—‡–‘•Šƒ”‡”‹•

ƒ† ‹˜‡•–‡–• ™ƒ• –Š‡ —•‡ ‘ˆ †˜ƒ…‡† —”…Šƒ•‡ ‰”‡‡‡–•ǡ ™Š‹…Š Šƒ˜‡ „‡‡ —•‡† –‘

…‘ŽŽ‡…–‹˜‡Ž› ’”‘…—”‡ Ǧͳͻ ˜ƒ……‹‡• ƒ† ”ƒ’Ǧ—’ ‹†—•–”‹ƒŽ …ƒ’ƒ…‹–‹‡• ‹ —”‘’‡Ǥ – ™ƒ•

”‡…‘‰‹•‡†–Šƒ–™Š‹Ž‡™‹ŽŽ‡‡†–‘”‡ƒ‹ƒ––”ƒ…–‹˜‡–‘‹†—•–”›’ƒ”–‡”•ǡ‹–•…”‡ƒ–‹‘…‘—Ž†

„‡ƒ‰‘‘†‘’’‘”–—‹–›–‘‡•–ƒ„Ž‹•Šƒ‡™•‘…‹ƒŽ…‘–”ƒ…–„‡–™‡‡’Šƒ”ƒ…‡—–‹…ƒŽƒ†Ž‹ˆ‡•…‹‡…‡

‹†—•–”‹‡•ƒ†•‘…‹‡–›ƒ†’ƒ–‹‡–•Ǥ

Š‡”‡™ƒ•ƒŽ•‘ƒ”‡…‘‰‹–‹‘–Šƒ––Š‡public element‘ˆ‹•…”‹–‹…ƒŽƒ†…‘—Ž†„‡…‘”‡–‘

‡•—”‡‹–•‹†‡’‡†‡…‡ƒ†–”ƒ•’ƒ”‡…›Ǥƒ”–‹…‹’ƒ–•ƒŽ•‘”‡…‘‰‹•‡†ƒ‡‡†ˆ‘”’—„Ž‹…‹–‡”‡•–

•ƒˆ‡‰—ƒ”†• ‹ ƒ‰”‡‡‡–• ™‹–Š ‹†—•–”›ǡ ‹…Ž—†‹‰ –Š‡ ‡‡† –‘ ‡•—”‡ –Šƒ– ’—„Ž‹… ˆ—†‹‰ ‹•

”‡ˆŽ‡…–‡† ‹ –Š‡ ˆ‹ƒŽ ’”‘…—”‡‡– ƒ† ’”‹…‹‰ ‘ˆ ’”‘†—…–• ”‡…‡‹˜‹‰ ˆ—†‹‰Ǥ ƒ˜‹‰

’‘Ž‹–‹…ƒŽ ‹†‡’‡†‡…‡ ™ƒ• …‘•‹†‡”‡† ‹’‘”–ƒ– –‘ ‡•—”‡ ƒ……‘—–ƒ„‹Ž‹–› ƒ† –‘ ‡•–ƒ„Ž‹•Š

†‹•–ƒ…‡ ™Š‡ •‡––‹‰ ‘„Œ‡…–‹˜‡• ‘– Ž‹ƒ„Ž‡ –‘ …Šƒ‰‡ ™‹–Š ’‘Ž‹–‹…ƒŽ …›…Ž‡•Ǥ ‘‡ ƒ––‡†‡‡•

”‡ˆŽ‡…–‡†–Šƒ–™‹ŽŽ‡‡†–‘ ƒ˜‹‰ƒ–‡’‘Ž‹–‹…ƒŽƒ†ƒ”‡––‡•‹‘•™Š‹Ž‡ƒ‹–ƒ‹‹‰‹–•

autonomyǤ

3

––‡†‡‡• ƒ‰”‡‡† –Šƒ– •Š‘—Ž† ’‘•‹–‹‘ ‹–•‡Žˆ ™‹–Š‹ –Š‡ European and international ecosystemǢ‹–•Š‘—Ž†‘–„‡‹•‘Žƒ–‡†ǡƒ†ƒ›‡†‹…ƒŽ…‘—–‡”‡ƒ•—”‡•…”‡ƒ–‡†–Š”‘—‰Š

•Š‘—Ž†„‡‰Ž‘„ƒŽŽ›ƒ……‡••‹„Ž‡Ǥ

Acknowledgments

FEAM warmly thanks the participants for their contribution to the discussion, the Wellcome Trust for its support, in particular Catherine Guinard for moderating the event, Amelia Dearman and Erika Loggin for drafting its summary report.

REFERENCES 32 1. President von der Leyen on the COVID-19 outbreak (europa.eu)

2. State of the Union Address by President von der Leyen (europa.eu)

3. https://ec.europa.eu/info/sites/info/files/communication-european-health-union-resilience_en.pdf 4. communication-hera-incubator-anticipating-threat-covid-19-variants_en.pdf (europa.eu)

5. Global leaders unite in urgent call for international pandemic treaty (who.int)

6. Given the absence of a formal definition for pandemic, the European Commission should also carefully consider whether to rely on the definition of a Public Health Emergency of Internation-al Concern (as per the InternationInternation-al HeInternation-alth Regulation of the WHO), or on a broader definition of cross-border epidemic. Clearly agreeing on a definition will facilitate earlier action by HERA.

7. Pharma strat and EU AMR action plan

8. https://www.nato.int/cps/en/natolive/topics_49156.htm

9. https://ec.europa.eu/info/research-and-innovation/research-area/health-research-and-innovation/

ebola/ebola-research-and-innovation-strategy_en

10. https://www.ecdc.europa.eu/sites/default/files/documents/ECDC-Strategy-2021-2027.pdf 11. https://www.who.int/research-observatory/analyses/rd_blueprint/en/

12. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31411-2/fulltext#%20 13. https://carb-x.org/

14. https://ec.europa.eu/info/sites/info/files/proposal-regulation-cross-border-threats-health_en.pdf 15. https://www.who.int/neglected_diseases/diseases/zoonoses/en/

16. https://ec.europa.eu/health/antimicrobial-resistance/eu-action-on-antimicrobial-resistance_en 17. https://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/COV-19/A_Guidance_

for_animal_health_laboratories_1April2020.pdf

18. https://theconversation.com/lutte-contre-le-coronavirus-mais-ou-sont-passes-les-veteri-naires-137279

19. https://academie-veterinaire-defrance.org/communiques-de-presse/realisation-des-tests-covid-19-p ar-les-structures-veterinaires

20. https://www.europarl.europa.eu/RegData/etudes/BRIE/2020/646123/EPRS_

BRI%282020%29646123_EN.pdf

21. https://www.ecdc.europa.eu/en/about-us/how-we-are-governed/management-board 22. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761

23. https://ec.europa.eu/health/advisorypanel_covid19_en https://www.lshtm.ac.uk/newsevents/

news/2021/professor-peter-piot-appointed-special-advisor-president-european-commission 24. https://ec.europa.eu/health/international_cooperation/overview_en

25. “Team Europe” - Global EU Response to Covid-19 supporting partner countries and fragile popula-tions - European External Action Service (europa.eu)

26. https://vaccelerate.eu/

27. https://www.prepare-europe.eu/

28. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016ME/TXT&-from=EN#d1e826-13-1

29. https://ec.europa.eu/international-partnerships/sdg/good-health-and-well-being_en

30. https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-on-line-pledging-event-hosted-by-the-european-commission

31. https://wellcome.org/reports/equitable-access-health-technologies-lessons-covid-19 32. communication-eu-africa-strategy-join-2020-4-final_en.pdf (europa.eu)

33. https://ec.europa.eu/info/research-and-innovation/strategy/goals-research-and-innovation-policy/

open-science_en

34. https://ec.europa.eu/health/human-use/strategy_en

35. Little-known drug manufacturer gets big contract for COVID-19 response

REFERENCES:

BOX 1:

I. https://www.sciencedirect.com/science/article/pii/S016885102030107X; https://www.bmj.com/con-tent/368/bmj.m1075.full

II. https://link.springer.com/chapter/10.1007/978-3-030-51791-5_44

III. https://voxeu.org/article/how-strengthen-european-industries-leadership-vaccine-research-and-in-novation

CASE STUDY: US Biomedical Advance Research and Development Authority (BARDA):

I. https://www.phe.gov/about/barda/Pages/default.aspx II. https://www.phe.gov/about/aspr/Pages/aspr-fy2021-bib.aspx

III. https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/

BOX 3:

I. https://ec.europa.eu/health/funding/eu4health_en BOX 4:

I. https://ec.europa.eu/commission/presscorner/detail/en/ip_21_641 II. https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_642 BOX 5:

I. https://ec.europa.eu/info/sites/info/files/proposal-mandate-european-medicines-agency_en.pdf II. ii https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761#footnote44 BOX 6:

I. https://ec.europa.eu/info/files/proposal-extend-mandate-european-centre-disease-preven-tion-and-control_en

BOX 8:

I. https://ec.europa.eu/international-partnerships/topics/eu-global-response-covid-19_en II. WBT Team Europe | Capacity4dev (europa.eu)

Im Dokument How should the EU prepare and respond to future cross border health threats? (Seite 29-34)