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The COVID-19 pandemic has exposed significant European vulnerabilities in preparing for and responding to cross-border health threats. Member States have struggled to strategise health services planning and delivery, effectively manage supply chain disruptions or ensure the equitable distribution of medical devices and medicines. 

In response, as part of the European Health Union proposal 2020, the European Commission held a public consultation on establishing a new European level health authority: the European Health Emergency Preparedness and Response Authority (HERA). 

EFA participated in the consultation, representing the voice of patients living with allergy and airways diseases. Stakeholders were asked to comment on current EU competencies and what they hoped to see, regarding:

  • Development, manufacturing and deployment of medical countermeasures
  • Threat and Risk Assessment
  • Development and financing
  • Impacts, role, scope and coordination within the exiting institutional context

Development, Manufacturing and Deployment of Medical Countermeasures

EFA identified a strong need to improve the EU framework on developing, manufacturing and deploying medical countermeasures, including medicines, medical devices and other goods and services addressing cross-border health threats. The COVID-19 pandemic has exposed disruptions to supply chains resulting in shortages of medicines and devices, a lack of coordination among Member States increasing health inequalities, a propensity for Member State protectionism and isolation, and disruption to other essential healthcare services. EFA believes future and ongoing crises such as climate change will reveal similar vulnerabilities.

Therefore, we believe HERA would add significant value to the EU framework by centralising efforts and establishing an early warning system. 

EFA highlighted key challenges for HERA including assessing and maintaining quality and continuity of care during times of crisis. Notably, HERA should be able to demand analysis of healthcare delivery and planning during an emergency and ensure that all Member States have equal access to medical countermeasures. 

EFA stressed the importance of a central authority to anticipate market failures and tackle disruptions and shortages in supply chains. 

Threat and Risk Assessment

EFA noted that current EU capacity for anticipating of health risks and supply chain disruptions are sub-optimal and should be strengthened through HERA authority. The EU should consider leveraging its existing financial instruments to facilitate HERA objectives and clarify which instrument would be responsible for addressing each threat. 

EFA also perceived that the scope of risk assessment was too narrow and should include regulations that address hazard and intentional Chemical, Biological, Radiological and Nuclear (CBRN) threats including environmental risks. 

Development and financing of HERA

EFA welcomes methods to increase EU capacity to intervene and fill gaps in investment, research and development of medical countermeasures in cases of extreme emergency and scarcity. EFA supports investments via public-private partnerships.

In order to facilitate rapid development of medical countermeasures in times of crisis, HERA should establish pre-arranged emergency contract networks, streamlining EU manufacturing initiatives. 

Impacts, role, scope and coordination of HERA within the exiting institutional context

Urgent needs upsetting the status quo have prompted the development of a central health authority such as HERA. As such, EFA noted that its establishment can only have a positive effect.  

EFA supports HERA’s role in becoming the leading EU agency responding to health threats, with the authority to coordinate all other relevant organisations. Broader EU coordination in this manner is necessary to establish a meaningful and impactful European Health Union.

EFA Priorities and Collaboration with HERA

As the voice of over 200 million people living with allergy, asthma and chronic obstructive pulmonary disease (COPD) in Europe, EFA would be delighted to engage in a sustained partnership with HERA as stakeholder.

EFA urges the European Commission to prioritise addressing health threats, avoiding disruption of other essential health services and addressing the increasing evidence suggesting links between climate change and adverse health outcomes. 

The public consultation period closed 12 May 2021. Commission adoption is planned for third quarter 2021.

Read EFA's response to the consultaiton here.

Read how HERA would help advance our Breathe Vision 2030 here.