Oltre la pandemia: nuove norme nell'Unione europea per affrontare le emergenze sanitarie

Beyond the pandemic: new rules in the European Union to deal with public health emergencies The experience gained during the pandemic has shown the need to coordinate the activity of Member States to ensure timely and adequate interventions to better protect public health. Over the last few years, this has led the European Union to adopt a series of measures and to propose legislative initiatives to better deal with future health emergency situations. These include the establishment of the new Health Emergency Preparedness and Response Authority (HERA), new rules to prevent and address drug shortages, and the proposal for a new legislative package to reform the rules applicable to the evaluation and marketing of medicines, which, among many other innovations, introduces the possibility of applying for a temporary emergency authorisation in order to promptly make available medicinal products needed to treat new and unknown diseases (as it was the case with SARS-CoV 2) where there is no alternative therapeutic solutions available on the market. The willingness shown by the Member States to jointly confer decision-making powers on the European Union has made it possible, during the recent pandemic, to overcome the limits of art. 168 TFEU which, in the field of public health, allow the European Union to intervene only to complement national policies.