ESIP welcomes a European unified approach to tackle cross-border health threats that avoids fragmentation and respects national health competences. A coordinated approach should be extended to other long-term cross-border challenges beyond pandemics.

The Regulation on a reinforced role for the EMA would strengthen the EU crisis management framework through a reinforced system for monitoring and mitigating shortages of both medicines and medical devices. It would also promote the timely development of high quality, safe and efficacious medicinal products with the potential to address public health emergencies.

ESIP welcomes the establishment of the Executive Steering Groups responsible for preparing lists of crisis-relevant medicinal products and medical devices, that should be limited in time and in terms of subject matter to specific incidents. Cooperation bewteen all relevant actors is welcomed and ESIP supports mandatory participation in a coordinated electronic reporting system to ensure better monitoring of potential and actual shortages. 

While welcoming the provision of scientific advice and support to clinical trial protocols by the Agency, ESIP highlights that quality, safety and efficacy must always remain the key priority and that real-world data (RWD) should be used as a complementary source of evidence.

The Regulation on serious-cross border threats to health would strenghten EU preparedness and response planning, epidemiological surveillance, early warning and risk assessment as well as better coordinated response at EU level.

Regarding preparedness, ESIP welcomes flexible guidance from the Health Security Committee (HSC) that considers and respects national responsibilities in public health. Based on the recommendations from the paper on medicines shortages, ESIP recommended an evidence-based evaluation of supply to prevent shortages and the strenghtening of the joint procurement mechanism.

When it comes to surveillance, ESIP welcomes the use of digital tools to exchange data and monitor health hazards, in compliance with the European Data Protection Regulation (GDPR). As part of the ECDC reinforced mandate, ESIP also welcomes the proposal to create an EU network of reference laboratories, whose guidance would alleviate pressure on healthcare systems and promote the functioning of the single market.

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