Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization procedure and (iii) regulate the transitional period for evaluation activities
How Covid changed telemedicine in Italy: Current status and next steps
In Italy, the Covid-19 pandemic rapidly accelerated implementation of telemedicine, which then was named one of the top priorities in the National Recovery and Resilience Plan. Mission No. 6 of that plan (Health) earmarks EUR 1 billion for the development of telemedicine to provide healthcare locally.
Patent monopolies and the pandemic emergency: Obstacle or opportunity?
The outbreak of the Covid-19 pandemic generated extensive debate regarding equitable access to vaccines and medical treatments. In this framework, discussion of the role of patents in health care came to the fore: Are patents a resource, or are they instead an obstacle to the widespread protection of public health during a pandemic emergency?
Clinical trials and sanctions in relation to Regulation 2014/536, national rules, and contract standards
The European rules on drug trials do not include provisions for sanctions, but instead leave it up to Member States to outline an effective sanctioning framework.
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
IRCCS reform: Upcoming changes with regard to research
The regulation of Scientific Institutes for Research, Hospitalization, and Health Care (“Istituti di Ricovero e Cura a Carattere Scientifico,” “IRCCS” or “Institutes”) is undergoing a major transformation in Italy.