Introducing HERA, the European Health Emergency preparedness and Response Authority, the next step towards completing the European Health Union

Author (Corporate)
Series Details COM (2021) 576
Publication Date 16/09/2021
Content Type

Summary:

Communication published by the European Commission on 16 September 2021, setting out the mission and reasoning behind the establishment of a European Health Emergency preparedness and Response Authority (HERA) in the context of the European Health Union.

Further information:

As the COVID-19 (coronavirus) pandemic unfolded across the world, the European Commission put forward in November 2020 an agenda aimed at building a European Health Union. A Communication was later published in June 2021 addressing early lessons from the sanitary crisis, which highlighted the need for special arrangements in place to better react in times of health crisis. It showed that the pandemic revealed vulnerabilities in the European Union's health preparedness for and response to public health emergencies.

A new Health Emergency preparedness and Response Authority (HERA) is set up to strengthen the European Union's ability to prevent, detect, and rapidly respond to cross-border health emergencies, by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures. Its establishment takes place within the structure of the European Commission as a shared resource for Member States and EU alike, also allowing for a swift operationalisation, flexibility in its organisation and mobilisation of the Commission's existing powers, tools and programmes. It also builds on the work already carried out in the framework of the HERA Incubator, launched in February 2021.

This Communication was published by the European Commission on 16 September 2021 in the context of the annual State of the European Union (SOTEU) address, and alongside a draft Council Regulation setting out the emergency framework regarding medical countermeasures. A Commission Decision establishing the HERA was also adopted together with the Communication.

Source Link https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2021:576:FIN
Related Links
Commentary and Analysis
Wikipedia: Health Emergency Preparedness and Response Authority https://en.wikipedia.org/wiki/Health_Emergency_Preparedness_and_Response_Authority
The Lancet: Correspondence, May 2021: HERA: a new era for health emergency preparedness in Europe? https://doi.org/10.1016/S0140-6736(21)01107-7
FEAM: Activities, 13/05/2021: EU Health Emergency Preparedness and Response Authority (HERA) must define role in global preparedness ecosystem https://www.feam.eu/eu-health-emergency-preparedness-and-response-authority-how-should-the-eu-prepare-and-respond-to-future-cross-border-health-threats/
Medicines for Europe: News, 16/09/2021: HERA must address outstanding weaknesses in EU pharma framework to be successful https://www.medicinesforeurope.com/news/hera-must-address-outstanding-weaknesses-in-eu-pharma-framework-to-be-successful/
European Patients Forum: News, 16/09/2021: The new European Health Emergency preparedness and Response Authority (HERA) https://www.eu-patient.eu/news/latest-epf-news/2021/the-new-european-health-emergency-preparedness-and-response-authority-hera/
Van Bael & Bellis (VBB): Insights, 17/09/2021: European Commission Launches European Health Emergency Preparedness and Response Authority https://www.vbb.com/insights/european-commission-launches-european-health-emergency-preparedness-and-response-authority
Politico, 17/09/2021: HERA isn’t the hero Parliament wants — or the game-changer Council fears https://www.politico.eu/article/hera-eu-commission-health-emergency-preparedness-response-authority/
European Movement (Ireland): Just the Facts, 21/09/2021: HERA – The European Health Emergency preparedness and Response Authority https://www.europeanmovement.ie/just-the-facts-hera/
EPHA, 01/10/2021: HERA: will the EU lead global action against pandemics? https://epha.org/hera-will-the-eu-lead-global-action-against-pandemics/
European Industrial Pharmacists Group (EIPG): Business & Policies, 22/10/2021: First steps of the HERA Authority and comments from industrial and medical associations https://eipg.eu/first-steps-of-the-hera-authority-and-comments-from-stakeholders/
EFPIA: News & Events, 17/11/2021: EFPIA and Vaccines Europe position on the European Health Emergency preparedness and Response Authority (HERA) https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/efpia-and-vaccines-europe-position-on-the-european-health-emergency-preparedness-and-response-authority-hera/
BEUC: Publications, December 2021: The health emergency preparedness and response authority (HERA): a consumer perspective https://www.beuc.eu/publications/beuc-x-2021-109_the_health_emergency_preparedness_and_response_authority_hera_a_consumer_perspective.pdf
League of European Research Universities (LERU): News, 07/12/2021: HERA and European research-intensive universities: close cooperation is imperative to tackle health emergencies in Europe https://www.leru.org/news/hera-and-european-research-intensive-universities-close-cooperation-is-imperative-to-tackle-health-emergencies-in-europe

News
Euronews, 16/09/2021: European Commission launches new department for preparing and responding to health emergencies https://www.euronews.com/2021/09/16/european-commission-launches-new-department-for-preparing-and-responding-to-health-emergen
Science Business, 16/09/2021: Commission launches health emergency authority with promise of €30B funding https://sciencebusiness.net/news/commission-launches-health-emergency-authority-promise-eu30b-funding
Reuters, 17/09/2021: EU launches health crisis body to prepare for future pandemic https://www.reuters.com/world/europe/eu-launches-health-crisis-body-prepare-future-pandemic-2021-09-16/
EUObserver, 28/09/2021: MEPs 'disappointed' at observer-status at new EU health body https://euobserver.com/coronavirus/153043
Science Business, 07/10/2021: MEPs call for closer scrutiny of EU’s €6B health emergency authority https://sciencebusiness.net/news/meps-call-closer-scrutiny-eus-eu6b-health-emergency-authority
EurActiv, 03/11/2021: Health NGOs ask Commission to reconsider “crucial aspects” of HERA https://www.euractiv.com/section/health-consumers/news/health-ngos-ask-commission-to-reconsider-crucial-aspects-of-hera/

Official
EUR-LEX: C(2021)6712: Commission Decision establishing the Health Emergency Preparedness and Response Authority https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32021D0929(02)
European Parliament: Legislative Train Schedule: European Health Emergency preparedness and Response Authority (HERA) https://www.europarl.europa.eu/legislative-train/theme-promoting-our-european-way-of-life/file-european-biomedical-research-and-development-agency
European Commission: Priorities 2019-2024: European Health Union https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en
European Commission: Better Regulation: Have Your Say: European Health Emergency Preparedness and Response Authority (HERA) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12870-European-Health-Emergency-Preparedness-and-Response-Authority-HERA-_en
European Commission: Press Release, 16/09/2021: European Health Emergency preparedness and Response Authority (HERA): Getting ready for future health emergencies https://ec.europa.eu/commission/presscorner/detail/en/ip_21_4672
European Commission: Questions and Answers: European Health Emergency preparedness and Response Authority – HERA (16 September 2021) https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_4733
S&D EP Group: Newsroom, 16/09/2021: S&Ds: Commission’s Health Emergency Preparedness and Response Authority (HERA) proposal is insufficient to face future health threats https://www.socialistsanddemocrats.eu/newsroom/sds-commissions-health-emergency-preparedness-and-response-authority-hera-proposal
Renew Europe EP Group: News, 16/09/2021: Renew Europe insists that Parliament should have a say on HERA https://www.reneweuropegroup.eu/news/2021-09-16/renew-europe-insists-that-parliament-should-have-a-say-on-hera
EPP EP Group: Newsroom, 11/11/2021: Emergency preparedness needs parliamentary oversight https://www.eppgroup.eu/newsroom/news/emergency-preparedness-needs-parliamentary-oversight

Subject Categories
Subject Tags ,
International Organisations