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
14
Oct 20
Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent
The National Coordination Center of Territorial Ethics Committees for clinical trials on medicines and medical devices (“National Coordination Center”) has drawn up guidelines for the collection of informed consent (“Guidelines”) for participation in clinical trials, pursuant to Legislative Decree No. 211 of June 24, 2003 and Regulation (EU) 536/2014.
14
Oct 20
The Italian Data Protection Authority publishes Frequently Asked Questions and Infographic on the Electronic Health Record
On September 14, 2020, the Italian Data Protection Authority (“Garante”) published on its website a set of Frequently Asked Questions (“FAQ”) and an Infographic on the main characteristics of the Electronic Health Record (“EHR”).
13
Oct 20
Ecommerce of medicines: the European Court of Justice states the applicability of certain restrictions imposed by a Member State destination of ecommerce upon a provider established in another Member State
On October 1, 2020, the European Court of Justice (“ECJ”) issued a very interesting judgment in a case between a company incorporated under Netherlands law that operates both a dispensing pharmacy established in the Netherlands and a website specifically targeting French customers and associations representing the professional interests of pharmacists in France.
