Farmaci orfani: tensioni negoziali tra interesse pubblico e concorrenza
European Health Union: Commission publishes open public consultation on the European Health Data Space
European Delegation law to implement the Medical Devices Regulations
On April 23, Law No. 53 of April 22, 2021, “Delegation to the Government for the transposition of European directives and the implementation of other European Union acts,” was published in the Official Gazette (“Delegation Law”).
Clinical Trial Regulation: Clinical trial EU Portal and Database, essential for the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022
Software as Medical Device
The European Commission has published an interesting infographic showing which logical path should be followed in order to understand whether a software can be qualified as a medical device.
Pay-for-delay: The Court of Justice clarifies the scope of “by object” restrictions and “potential competition” in patent settlement cases
On March 25, 2021, the Court of Justice of the European Union ruled on appeal in the Lundbeck case, confirming the previous judgement of the General Court that upheld the decision of the European Commission on pharmaceutical “pay-for-delay” agreements.