On 27 January, the European Commission launched the consultation on the European Health Emergency Preparedness and Response Authority, HERA for short. The consultation, which main aim is to issue a legislative proposal on the new authority by the end of this year received 154 responses from a wide range of stakeholders.
EUCOPE took the opportunity to provide its view and considerations on the matter.
Overall, we do understand the reasons of this proposal and the issues that the new Authority would be supposed to tackle. The COVID-19 pandemic caught all the Member States, and not only them, unprepared to face this new health threat. However, we also assisted to great cooperation, solidarity, and a sense of responsibility.
The pharmaceutical industry stepped up, collaborated, and successfully joined forces with public institutions to tackle together an unprecedented situation. Hence, we have outlined in our response that, in order to enforce health emergency preparedness, the EU should start from building on the lesson learnt, on the strategies that became more and more refined over time, on the current instruments and digital tools that help to promptly identify the new coronavirus.
As also many other respondents highlighted, the HERA’s role and responsibilities are not quite clear, and it is blurry how the new entity would complement and create synergies with the work of already existing EU and national institutions.
As a matter of fact, this consultation came right after the consultations on the empowerment of the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). As these proposals have the objective of extending the mandate of the two existing Agencies to better monitor, prevent and timely mitigate pharmaceutical and medical device shortages, to swiftly identify and map cross-border health threats, the proposal of establishing an additional authority with very similar powers makes the system confusing.
As the objective, as stated in the inception impact assessment, is to address the challenges that the Member States cannot efficiently and effectively address on their own, concerning preparedness, management, and response to cross-border health threats, the European Union should enhance the capacity of its existing Agencies and streamline the reporting systems, rather than increasing the administrative burden with additional entities.
Please read here our official response.
February 26, 2021