La ricerca di soluzioni diagnostiche e terapeutiche per far fronte all’emergenza pandemica da Covid-19. Il ruolo propulsivo dell’Agenzia europea per i medicinali: profili giuridici e regolatori

Looking for diagnostic and therapeutic solutions to face Covid-19 pandemic emergency. The propulsive role of the European Union: legal and regulatory issues

Abstract

After some preliminary considerations on the nature of the public health emergency situation generated by the Covid-19 pandemic and on the role and remit of responsible European institutions and bodies, the essay will focus on the initiatives taken by the European Medicines
Agency (EMA) to foster clinical research and development and to speed up availability of vaccines and other medicinal products for the prevention and treatment of Corona virus disease. Consideration will be given to the initiatives taken by the EMA to foster international
cooperation between medicines regulatory authorities in countering the global Covid-19 pandemic. Limits and conditions for either off-label or compassionate use of already available medicinal products, pending the availability of vaccines and in order to address otherwise unmet patients’ needs, will also be addressed.