SHARP Joint Action Work Package 4 lead, François Esmyot, Conseiller Expert pour les Affaires internationales at the French Ministry of Solidarities and Health, provides a useful background and overview of how the activity of SHARP Joint Action supports the vision for the EU health union.
The new EU law on serious cross-border threats to health
The EU and its member states coordinate and cooperate in the field of health security and medicines safety. While health is a national competence, the EU has the competence to support, coordinate and complement national actions.
Monitoring, early warning, preparedness and response measures to combat serious cross-border threats to health are essential elements to ensure a high level of health protection in the European Union.
On 23 June 2022, the Council and the European Parliament reached a provisional agreement on the new EU law on serious cross-border threats to health. This is the final building block for the European Health Union, protecting Europeans against health threats.
The regulation seeks to strengthen and broaden the EU’s abilities to both prepare for, and respond to, health threats like deadly pandemics.
It requires member countries to prepare reports on their state of preparedness and allows the ECDC to carry out evaluations. The regulation also allows the Commission to declare EU-level health emergencies, which trigger expanded monitoring and response capabilities, including the joint procurement of medical countermeasures.
In this way, the European Commission is building an EU Health Union to protect the health of its citizens; prepare for future pandemics; and improve health resilience through coordination on serious cross-border health threats.
Progress made on the key elements of the legislative package for an EU health union
First proposed by the European Commission in November 2020, in the context of the Covid-19 crisis, The legislative package included four key elements:
Reinforcement of the mandate of the European Medicines Agency (EMA) adopted by the Council on January 25, 2022
This mandate will allow the EMA to mitigate and closely monitor shortages of medicines and medical devices during major events or public health emergencies and to facilitate faster approval of drugs that may treat or prevent a disease causing a public health crisis.
The creation of a new European Health Emergency Preparedness and Response Authority (HERA) set up by a Commission decision in September 2020 for non-crisis mode and by a regulation for crisis mode adopted in December 2021
HERA will anticipate potential health threats and crises, through the collection of intelligence and the strengthening of the necessary response capacities. In the event of an emergency, HERA will ensure the development, production and distribution of countermeasures.
Reinforcement of European Centre for Disease Prevention and Control (ECDC) mandate (adopted by the Council on 6 December 2021).
The strengthened ECDC mandate includes:
- Strengthen its collaboration with Member States
- Strengthen the rapid digitisation of integrated surveillance systems
- Strengthen its capacity for anticipation and forecasting
- Develop EU prevention and response plans against future epidemics and capacities for an integrated rapid response to epidemics and outbreaks
- Provide non-binding recommendations for risk management
- Implement, mobilize and deploy a European Task Force for rapid intervention to support the response in Member States and third countries
- Strengthen the monitoring and evaluation of the capacities of national health systems to diagnose, prevent and treat communicable diseases
- Strengthen epidemiological surveillance via integrated systems allowing real-time surveillance
- Strengthen its cooperation with third countries and its collaboration with the WHO.
The regulation on serious cross-border threats to health (SCBTH) political agreement reached on 23 June 2022
This is the final pillar of the foundation for a stronger European Health Union and strengthened preparedness and response planning, and sets out the rules for an improved, flexible and integrated surveillance system.
It also increases the capacity of the Union and its Member States to do accurate risk assessments and take targeted response actions, including joint procurement of medical countermeasures, such as vaccines and therapeutics. Key elements of this regulation include:
- The establishment of a “public health alert at Union level”, which, once declared by the Commission, will allow the implementation of emergency measures (including the activation of “emergency mode” of HERA)
- The establishment of rules for a reinforcement and integration of the epidemiological surveillance system at Union level, supported by improved data collection tools and artificial intelligence
- The establishment of common rules regarding the surveillance of new pathogens and the transmission of health systems data and other data relevant to the management of cross-border threats
- Strengthening the role and coordination of the Health Security Committee
- The development of a Union preparedness and response plan (which will be drawn up by the Commission) and requirements for correspondence to national plans, together with a framework for preparation of reports and audits of national plans
- Periodic evaluation of national preparedness and response plans by ECDC (and the formulation of recommendations by ECDC based on its evaluations). ECDC will develop procedures and standards for these assessments and conduct them
- The implementation by the Commission of capacity building activities for health personnel in crisis preparedness and response
Arrangements for the designation and funding of EU reference laboratories in the field of public health (under the aegis of ECDC)
The provisional agreement highlights the relevance of the SHARP Joint Action
The purpose, objectives and deliverables of the Joint Action, established pre-pandemic, contribute to EU Health Security. The COVID-19 pandemic reinforced the importance of coordination among European countries to protect people’s health and boost preparedness for new, cross-border health threats.
Within the context of the EU Health Union the joint action’s deliverables remain in synergy/ alignment with the new legislative framework for EU Health Security.
How SHARP Joint Action contributes to these ongoing and planned EU actions on health security in the European Union
The work of SHARP Joint Action strengthens implementation of Decision 1082/2013/EU, supporting the EU level preparedness and responses to health threats and the implementation of the International Health Regulations (2005). The Joint Action implements actions mentioned in Annex 1 of the Annual Work plan 2018 of the EU Health Programme 2014-2020. Through the Joint Action, the member and partner states and the Union’s common ability to prevent, detect and respond to biological outbreaks, chemical contamination and environmental and unknown threats to human health will be strengthened
Special efforts are employed to fill gaps that have been or will be identified in countries that have biggest gaps in the capacity required for full IHR capability.
Alignment of SHARP Joint Action within the EU health union legislative package
SHARP JA mainly aligns with, and contributes to the implementation of the ECDC, SCBTH and HERA regulations. The following table summarizes the specific areas.
|Field||Aspect of legislative package for an EU health union||Alignment/possible contribution from SHARP JA|
|Laboratory preparedness and responsiveness||Network of EU reference laboratories under ECDC mandate and SCBTH regulation||SHARP JA maintains and runs the EMERGE network which comprises a European network with about 40 diagnostic laboratories focused on risk group 3 bacteria and risk groups 3 and 4 viruses. EMERGE provides a common, coordinated and effective response to infectious disease outbreaks at EU level and abroad. EMERGE network could contribute to implement ECDC’s mandate for a network of EU reference laboratories.|
|Development and access to medical countermeasures (MCM)||HERA’s mandate is to ensure the development and access to relevant MCM. To this end, the capacity to evaluate new diagnostic methods for high threat pathogens is essential, with a view towards ensuring manufacturing capacities||SHARP JA maintains and runs the EMERGE network where state of the art and new diagnostic methods for high threat pathogens are evaluated.|
|Fight against Antimicrobial resistance (AMR)||AMR is identified as one of the priority threats at EU level. HERA is mandated to address this threat by ensuring access to adequate countermeasures.||SHARP JA implements optimized, fast and reliable methods for detection of antimicrobial resistances in wild type strains of RG3 bacteria sets breakpoints for all substances used for therapy of these agents and develops guidelines for therapy of patients suffering from infections caused by highly pathogenic bacteria using first-line drugs and in case of antimicrobial resistances. The network of experts from across member states established through the JA could contribute to the implementation of tasks related to AMR in HERA’s work plan.|
|Strengthening IHR core capacities||SCBTH calls for strengthened national Preparedness and Response capacities||SHARP JA works towards strengthening national Preparedness and Response capacities, with a focus on low GNI countries.|
|Improve external evaluation process||SCBTH calls for Periodic evaluation of national preparedness and response plans by ECDC (and the formulation of recommendations by ECDC based on its evaluations||SHARP JA works towards increasing knowledge about the practicalities and added value of external evaluation processes (JEE, AAR, SPAR). Valuable lessons learned could contribute to ECDC development of procedures and standards for these assessments.|
|Cross-border cooperation||EU health union call for strengthened cross-border cooperation||SHARP JA works towards strengthening cross-border cooperation, notably in terms of patient and health personnel transfer. Valuable lessons learned could contribute to better cross-border preparedness and response planning.|
|Preparedness and Reponses Planning||SCBTH calls for the development of a Union preparedness and response plan (PRP) to be drawn up by the Commission. Plus, requirements for correspondence to national plans via a framework for preparation of reports and audits of national plans||SHARP JA has developed tools to identify core elements of an integrated multi-sectoral preparedness and response plan (PRP). These insights could usefully contribute to Union and national PRPs.|
|Training and capacity building||SCBTH calls for the implementation by the Commission of capacity building activities||SHARP JA has developed cross-sectoral basic and advanced training materials (based on ECDC and WHO material), to improve capacity in IHR implementation for serious cross-border health threats in the JA partner countries. These materials could contribute to the EC mandate in this regard.|
|Chemical safety and chemical threats||HERA aims to address a range of threats including Chemical, Biological, Radiological or Nuclear (NRBC) threats.||SHARP JA aims to strengthen preparedness and response to cross-border chemical health threats within MSs and across the EU and can contribute to HERA’s action in this regard.|
|Case management capacities||Union prevention, preparedness and response plans will include cross-border and interregional preparedness elements to support aligned multi-sectoral, cross-border public health measures, including capacities for specialised treatment||SHARP JA aims to improve clinical and biorisk management, hospital preparedness and response to high-consequence infectious diseases. A mapping of existing facilities is underway. This could usefully contribute to the Union PRPs.|
François Esmyot is an expert in international health security. He graduated as a medical doctor from the University of Cambridge and holds degrees in public administration and epidemiology. He has close to ten years’ experience in health security at the international level. He was involved in the management of the Ebola Epidemics in Guinea (2014) and DRC (2018). He has worked on several technical assistance projects including in Mongolia (Covid-19 response) and in the Indian Ocean region on strengthening IHR implementation.