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European Health Emergency Response Authority

Public health

The COVID-19 pandemic demonstrated the need for coordinated EU level action to respond to health emergencies. It revealed gaps in foresight, including demand/supply dimensions, preparedness and response tools. A European Health Emergency Response Authority is a central element for building the European Health Union with better means to strengthen EU preparedness and response to serious cross-border health threats, by enabling rapid availability, access and distribution of needed countermeasures.

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Public consultation

ID: 12870

Lobbying Activity

47 responses

Consultation response

European Federation of Pharmaceutical Industries and Associations, 23 Feb 2021

COVID-19 has demonstrated the need for the EU to ensure a robust, resilient and agile ecosystem to anticipate and effectively manage pandemics and their consequences. EFPIA and Vaccines Europe (VE) welcome the European Commission’s ambition to create a Health Emergency and Response Authority (HERA)…

Medicines for Europe seeks seat on HERA Board and supply chain reforms

MEDICINES FOR EUROPE, 24 Feb 2021

The organization requests industry representation on the HERA Board and legal framework for voluntary cooperation during shortages. They call for improved data analysis, robust modeling for inventory planning, and a structured process to assess emergency medicines lists. They demand financial incentives for manufacturing capacity and regulatory reforms encouraging maintenance of older medicines.
This would reduce their compliance burden and secure financial incentives for maintaining idle manufacturing capacity.

Consultation response

MedTech Europe, 24 Feb 2021

MedTech Europe agrees with and welcomes the Commission’s analysis of the vulnerabilities in European health preparedness and crisis response for cross-border health threats highlighted by the COVID-19 crisis, as well as the structural weaknesses which are the underlying contributing factors to…

Consultation response

European Disability Forum, 24 Feb 2021

The European Union and all its Member States have ratified the United Nations Conventions on the Rights of Persons with Disabilities (CRPD). This international treaty creates specific obligations relevant for the EU and all Member States in the European Health Union Package and the new EU health…

Consultation response

EuropaBio, 24 Feb 2021

1. Introduction: Hera has a critical role to play in public health and better crisis preparedness to address cross-border health threats and improving crisis management capacity. It should learn lessons from ongoing initiatives world-wide, including BARDA and collaborate where suitable with wider…

Consultation response

SANOFI, 24 Feb 2021

The Covid-19 pandemic has demonstrated the need for governments, institutions, and companies to react rapidly and effectively to major, unforeseen disruptions. Thus, strengthening the European capacities to address cross borders health threats and deliver integrated responses is of utmost…

Consultation response

Johnson Johnson, 24 Feb 2021

The COVID-19 pandemic has shown that the EU needs to strengthen its preparedness and response to serious cross-border health threats. Johnson & Johnson (J&J) welcomes the Commission’s proposal of creating HERA to prepare for future pandemics by enabling stronger surveillance, risk assessment and…

Consultation response

Koninklijke Philips, 24 Feb 2021

On behalf of Philips thank you for the opportunity to comment on the HERA Inception Impact Assessment. Please see our feedback attached. Philips is ready to step up as an effective and reliable partner to establish and support HERA’s mandate.

Consultation response

GSK, 24 Feb 2021

As a global, science-led healthcare company with a commitment to innovation to help prevent and treat infectious diseases, GSK welcomes the Commission’s vision to strengthen the EU’s pandemic preparedness and response to serious health threats like emerging viruses and drug-resistant bacteria.…

Consultation response

European Public Health Alliance, 24 Feb 2021

The COVID-19 pandemic has shown that Europe has paid the price of not being prepared in the biomedical research & innovation (R&I) front. Moreover, the lacking supply and grossly inequitable global access to Covid19 vaccines is a stark reminder of why such fundamental public health questions must…

Consultation response

DSW (Deutsche Stiftung Weltbevoelkerung), 24 Feb 2021

We welcome the proposal of a full end-to-end Authority responsible for streamlining EU initiatives on medical countermeasures for serious cross-border threats to health (policy option 3). OBJECTIVES HERA’s objectives should be aligned with the achievement of the Agenda 2030, in particular, the…

Consultation response

Association of the European Self-Care Industry, 24 Feb 2021

EUROPEAN HEALTH RESPONSE: GETTING TOGETHER TO BETTER PREPARE AESGP supports the proposed Better Regulation approach which integrates an impact assessment to accompany the legislative proposal for the establishment of a European Health Emergency Preparedness and Response Authority (HERA). AESGP…

Consultation response

AnimalhealthEurope, 24 Feb 2021

Please find full submission attached. Thank you for the opportunity to comment on this legislative initiative. AnimalhealthEurope is contributing to this consultation as a key stakeholder in the animal health sector, and in the context of the close inter-relation between human health and animal…

Consultation response

Helmholtz-Gemeinschaft Deutscher Forschungszentren e.V., 24 Feb 2021

The attached statement addresses the research and innovation aspects of the proposed legislation, which are evidently a prerequisite to overcoming any health challenge. Helmholtz welcomes the focus on long-term solutions for these complex threats to the health of European citizens. Science-based…

Consultation response

Association Internationale de la Mutualité, 24 Feb 2021

The pandemic has shown that “more Europe” is an opportunity. However, the prerequisite is that real solidarity between the states and their people is actually put into practice and not only vocalized. The EU with its institutions must succeed in communicating real joint action and its benefits to…

Consultation response

European Brain Council, 23 Feb 2021

COVID-19 has served as a sharp reality check for public health systems. Developing a European HERA can be the first steps in the vital attempt at building a stronger European Health Union, with improved preparedness to respond to cross-border health threats which can translate into increased…

Global Health Advocates calls for independent EU health agency

GLOBAL HEALTH ADVOCATES, 24 Feb 2021

The group wants an independent agency excluding industry from governance. They demand public ownership of research and transparent contracts.
This approach ensures public investments lead to affordable, accessible medical products.
Pharmaceutical companies would lose their policy influence and control over patents.

Consultation response

European Healthcare Distribution Association, 22 Feb 2021

GIRP would like to express its appreciation for the opportunity to comment on the establishment process of HERA. We consider HERA to be an important means to effectively and efficiently manage an EU approach to current and future health crisis. We support forming HERA in line with policy option…

Consultation response

Pharma Deutschland e.V, 24 Feb 2021

The BAH welcomes the European Commission's efforts to address the weaknesses in European health preparedness and crisis response to severe cross-border health threats revealed by the COVID-19 pandemic. We understand the intention to facilitate coordinating activities along the entire value chain…

Consultation response

European Social Insurance Platform AISBL, 24 Feb 2021

The European Social Insurance Platform (ESIP), representing statutory social security institutions in the EU, Switzerland and the UK, supports EU action to improve the European crisis preparedness and response mechanism to common cross-border health threats and particularly the system of medical…

Consultation response

League of European Research Universities, 24 Feb 2021

Two pivotal advocacy, educational, and research promoting networks from European Universities - the League of European Research Universities (LERU) and the European Global Health Research Institutes Network (EGHRIN) jointly would like to provide their views on the Commission's perceptions and…

Consultation response

European Federation of Nurses Associations, 15 Feb 2021

Preparedness is essential to prevent any future crises. Planning and having fit-for-purpose policies and procedures in place will help to ensure that the EU Member States can respond to any upcoming crisis and save lives when emergencies occur. This includes coordination with the EU Member States…

Consultation response

Federation of Veterinarians of Europe, 24 Feb 2021

The Federation of Veterinarians of Europe (FVE) very much welcomes that establishment of the European Health Emergency Preparedness and Response Authority, with a mission to strengthen the EU’s preparedness and response in terms of medical countermeasures for serious cross-border threats to health,…

Consultation response

The European Association of Hospital Pharmacists, 24 Feb 2021

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the Inception Impact Assessment for the European Health Emergency Preparedness and Response Authority (HERA).

Consultation response

Valneva, 24 Feb 2021

Valneva very much welcomes the Commission’s initiative to create a European Health Emergency Preparedness and Response Authority (HERA). The current pandemic has shown that Europe needs more and better coordination in order to respond to cross-border health crises and to establish well in advance…

Consultation response

Stichting Health Action International, 24 Feb 2021

Health Action International (HAI) appreciates the opportunity to offer our reaction to the proposed European Health Emergency Preparedness and Response Authority. We welcome the political support for public-funded R&D and we fundamentally we agree there is a need to move away from overuse of…

Consultation response

The European Society of Intensive Care Medicine, 24 Feb 2021

From the European Society of Intensive Care Medicine (ESICM) point of view, it was evident that one of the lessons learned from the first wave of the pandemic was that the EU needs a clear blueprint for all countries to follow in times of crisis. Once the PPE went scarce, ventilators weren’t found,…

Consultation response

Grifols, S.A., 24 Feb 2021

Grifols welcomes the opportunity to provide input on the inception impact assessment for the establishment of HERA. Grifols recent experience working with governments around the world, including BARDA in the U.S., to develop therapeutics for COVID-19 demonstrates the important role such an agency…

Consultation response

European Blood Alliance, 23 Feb 2021

The European Blood Alliance (EBA) agrees with the context, problems, issues and objectives identified in the Inception Impact Assessment (IIA). The EBA highlights that the EC response must be flexible and generic for all major crisis not just pandemics. The risks to the EU and its member states…

Consultation response

Biomedical Alliance in Europe, 24 Feb 2021

BioMed Alliance supports the intention to establish HERA and welcomes the inception impact assessment. We believe that with the necessary support, it may effectively address both current and future health threats, provide long-term horizon scanning and focus on unmet medical needs. The COVID-19…

Consultation response

ReAct - Action on Antibiotic Resistance, 24 Feb 2021

ReAct – Action on Antibiotic Resistance is pleased to see the proposed ambition for HERA to have a mandate that allows it to act and intervene throughout the entire life-cycle of a drug from early-stage discovery, to production, distribution and patient access. Such an end-to-end approach is…

Consultation response

Emergent, 24 Feb 2021

Emergent BioSolutions applauds the Commission’s intention to set up a European Health Emergency Preparedness and Response Authority (HERA), and appreciates the opportunity to provide initial feedback. Please see attached letter for further details.

Consultation response

Association Mieux Prescrire, 23 Feb 2021

We welcome the opportunity to contribute to this first round of consultation on the establishment of a European Health Emergency Preparedness and Response Authority. The Covid-19 pandemic has illustrated the need for enhanced EU action and coordination in response to cross-border health threats.…

Consultation response

Erasmus Universitair Medisch Centrum Rotterdam, 24 Feb 2021

European Health Emergency Preparedness and Response Authority (HERA) should have two main focus areas: pandemics and disaster preparedness. In addition, particular attention should be given to the important links between pandemic and disaster preparedness. Both in methodologies, as in cascading…

Consultation response

EIT Health, 24 Feb 2021

The COVID-19 public health emergency highlighted the need for a proactive approach to health emergency response in Europe. EIT Health therefore welcomes the European Commission’s ambition to create a Health Emergency Preparedness and Response Authority (HERA) to ‘advance science and trigger…

Consultation response

The Global Alliance for TB Drug Development, 23 Feb 2021

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster acting, and affordable tuberculosis drugs. It is part of a group of Product Development Partnerships (PDPs) which aim to address existing market failures by linking the public, private, and…

Consultation response

European Safety Federation, 22 Feb 2021

The idea of such an authority has its merits. However, lessons learned from the COVID-19 pandemic show clearly a lack of knowledge of all aspects (including EU law) by existing agencies and authorities (both EU and national member states). For this initiative to be effective it is essential that it…

Consultation response

PATH, 24 Feb 2021

Please see attached file. PATH has been dedicated to advancing health equity through technology for more than 40 years. We work in more than 70 countries to transform bold ideas into sustainable solutions that improve health and wellbeing for all. We develop, introduce, and advance vaccines, drugs,…

Consultation response

Knowledge Ecology International Europe, 24 Feb 2021

Whilst calls for better coordination in the EU pandemic response are welcome, HERA must put the global right to health, rather than regional biosecurity concerns, at its heart. Rapid operationalisation, as demanded by global public health needs, must not and need not come at the cost of ossifying…

Consultation response

Avicenna Alliance -, 24 Feb 2021

The Avicenna Alliance supports the Commission’s ambition to conduct horizon scanning to anticipate threats, identify countermeasures, generate and disseminate knowledge of the responses against cross-border threats. Computer Modelling and Simulation (CM&S) is decisive to identify and understand…

Consultation response

, 24 Feb 2021

DNDI is a not-for-profit research organization that develops new treatments for neglected patients. In response to the Covid-19 pandemic DNDi has launched the ANTICOV clinical trial novel discovery projects, is a member of the ACT Accelerator and COVID-19 Clinical Research Coalition. Just as…

Consultation response

HIMSS Europe, 24 Feb 2021

HIMSS and PCHA welcome the Commission’s intention to create the Health Emergency Preparedness and Response Authority (HERA) as a standalone body. Such a step would ensure EU preparedness as well as be a key element in establishing a stronger European Health Union, a revamped cross-border health…

Consultation response

Seqirus, 24 Feb 2021

The COVID-19 pandemic has demonstrated the need for a well-coordinated and resilient preparedness and response ecosystem to allow health emergencies with pandemic potential, such as influenza, to be addressed effectively. As one of the world’s largest influenza vaccine providers and a global…

Consultation response

, 24 Feb 2021

The BEAM Alliance welcomes the HERA initiative and believes that the establishment of HERA would indeed be of high value to increase the level of preparedness at EU level and reduce the massive impact of future pandemics. Indeed, beyond SARS-Cov-2, more viruses are (re-)emerging. Antimicrobial…

Consultation response

MUTUA MBA SOCIETA' DI MUTUO SOCCORSO SOCIETA' COOPERATIVA PER AZIONI, 24 Feb 2021

Spettabile Commissione Europea, siamo entusiasti di poter intervenire sull'iniziativa legislativa di creazione di un'Autorità Europea volta a fronteggiare l'emergenza sanitaria, in quanto, come società di mutuo soccorso, sin dall'inizio della pandemia da COVID 19, siamo stati attivi nella ricerca…

Consultation response

European Children's Hospitals Organisation, 23 Feb 2021

Please find attached the input of the European Children's Hospitals Organisation (ECHO).

Consultation response

Europharm Small and Medium Size Companies, 20 Feb 2021

Abstract Europharm SMC Position Paper Europharm SMC is the official European Association representing Small and Medium Sized pharmaceutical companies in the EU. Europharm SMC supports and defends the interests of its members, in achieving a legal and political framework compatible with the…