Italy

Can the Italian healthcare system process sensitive personal data without explicit patient consent?

Emilio De Giorgi

On 27 March 2018, a draft of the legislative decree (Draft Decree) that is expected to replace the Italian Privacy Code following the entry into force of the EU General Data Protection Regulation (GDPR) was published.  The Draft Decree anticipates important novelties regarding the way in which medical facilities will have to handle the processing Read More

Italian reform of clinical trial rules out of the starting blocks

Marco de Morpurgo

Today, Italian Law 3/2018 – mandating the governement to reform the Italian clinical trial rules – entered into force.  The Italian government now has 12 months to revise the regulatory framework applicable to clinical trials conducted in the country.  The legislative mandate to the government includes an alignment of the Italian clinical trial rules with the Read More

Italian Regions cannot recommend against use of costly medicines – says highest administrative court

Roberta Errico

A recent decision by the Italian Council of State (CS) comes as welcome news for the innovative pharmaceutical industry as it sets important boundaries to the initiatives that regional authorities can take in the attempt to limit public pharmaceutical expenditure under the increasing pressure of their budgetary constraints. The CS has firmly stated that the Read More

Italy unlocks corporate investments in retail pharmacies

Marco de Morpurgo

On 29 August 2017, significant regulatory changes allowing corporate entities to own retail pharmacy businesses will enter into force in Italy.  The new measures bring attractive opportunities for corporate investors, opening to new business models for Italian pharmacies that already exist in other EU countries, such as corporate-owned pharmacy retail chains.  To date, Italian law Read More

Italian Medicines Agency warns MA holders of products imminently subject to ‘sunset clause’

Marco de Morpurgo

Last Friday, the Italian Medicines Agency (AIFA) published a warning to marketing authorisation (MA) holders concerning the imminent invalidity of certain MAs in application of the ‘sunset clause’ (Warning). Article 38 of the Italian Medicines Code, implementing Article 24 of the EU Medicines Directive in Italy, provides that an MA ceases to be valid if Read More