15
Oct 20
EMA launches public consultation on the draft Guideline concerning registry-based studies
Last September, the EMA published its draft Guideline on registry-based studies (“Guideline”). This draft Guideline is currently open for public consultation: stakeholders may post comments until December 31, 2020.
15
Oct 20
Clinical trials: new rules for conflict of interests
The regulation on conflict of interest in clinical trials was recently amended by Article 11-bis of Law Decree No. 34 of May 19, 2020 (Decreto Rilancio), as amended by Law No. 77 of July 17, 2020.
15
Oct 20
Foreign investment control in the life science sector: the scope of the Italian Government’s powers also in the context of the current COVID-19 pandemic
Some recent cases in the news, as well as steps taken to increase the regulatory powers of the government in the current emergency situation via the Decreto Liquidità[1], have prompted us to draft this overview of measures that provide the government with special powers that it may exercise to prohibit or impose conditions upon extraordinary corporate transactions of foreign parties involving Italian target companies (known as the Golden Power) operating, among others, in the life sciences sector.
15
Oct 20
Italian Competition Authority says that the rules on the remuneration of health care services provided by pharmacies are anti-competitive
The Italian Competition Authority once again criticizes the introduction of legislative provisions that reserve only to pharmacies the provision of certain public health services paid by the NHS
