Italy

Italy launches urgent tender for the supply of 400 kg of medical cannabis: New opportunities for cannabis producers

Roberta Errico

For the second time, the Italian Ministry of Defence has launched an open tender for an urgent need of cannabis for therapeutic purposes by the Florence Pharmaceutical Chemical Plant. The estimated reference price of the tender is EUR 1,520,000 (net of VAT) for 400 kg, which represents an average of EUR 3.8 per gram. This Read More

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

Eveline Van Keymeulen

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

Eveline Van Keymeulen

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

Eveline Van Keymeulen

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