ESIP first reaction to the new EU Health Package on preparedness to cross-border threats

On November 11 the Commission released a package of three legislative proposals on Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats. The proposals are a new Regulation on serious cross-border threats to health, and two Regulations on reinforced roles for the European Medicines Agency (EMA) and for the European Centre for Disease Prevention and Control (ECDC). The three initiatives are accompanied by a Communication on Building a European Health Union.

Overall the initiatives aim at improving the EU crisis preparedness and response mechanism to common cross-border health threats, in order to better protect citizens’ health, further equip the EU and Member States in future pandemics and overall increase healthcare resilience across the Union. 

The proposed Regulation on cross-border health threats aims at reinforcing the EU health security framework. It would complement and coordinate Member States’ actions in the context of public health emergencies, repealing decision No 1082/2013/EU on serious cross-border threats to health.The European Centre for Disease Prevention and Control would be empowered to run better risk analysis and audit national surveillance plans, which will receive financial support from the new EU4Health budget. The European Medicines Agency would be mandated with stronger powers for monitoring and mitigating shortages of medicines and medical devices, as well as for coordinating clinical trials.The Commission also announces future consultations on a new EU Health Emergency Preparedness and Response Authority (HERA), which would support the EU capacity to respond to cross-border threats not limited to pandemics. Find more information in the Commission’s new webpage on the European Health Union.

As a first reaction to yesterday’s announcements, ESIP circulated a press release welcoming the recent EU proposals to strengthen the crisis-preparedness mechanism. ESIP supports a European unified approach to tackle cross-border crises, that respects Member States’ competences in the field of health on the one hand and avoids fragmentation while boosting cooperation and solidarity on the other

ESIP welcomes the proposals to improve the ECDC surveillance system, as well as to strengthen the role of the EMA in monitoring and mitigating medicine shortages. Regarding clinical trials, ESIP recognises the need to boost the swift market entry of effective treatments and vaccines in times of crisis. Nevertheless, the highest levels of safety and transparency need to be ensured, also regarding to the use of data. With a view to the proposal for a new Regulation on cross-border health threats, ESIP takes note of the proposed medical countermeasures, several of which correspond to the recommendations set out in the position paper on medicines shortages available here, namely common stockpiling and the reinforcement of the joint procurement mechanism.

ESIP will further elaborate its views on the EU health competences also in light of the upcoming Conference on the Future of Europe. Read our press release here.

 Photo: © European Union 2019 - Source : European Medicines Agency