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

Excessive pricing of medicines and antitrust: not a great week for Aspen

Emilio De Giorgi

This week Aspen received two pieces of bad news. On 13 June, the South African Competition Commission (SACC) announced the opening of an investigation against Aspen for its suspected excessive prices in the provision of certain cancer medicinal products (Leukeran, Alkeran and Myleran). The following day, the Italian administrative court of Lazio rejected the appeal Read More

Advertising to the public of all non-prescription medicines (not just OTCs) now permitted in Italy

Roberta Errico

The Italian Council of State (Italy’s highest administrative court) has recently clarified the scope of permitted advertisement to the public of medicinal products in Italy: by its decision No. 2217 of 12 May 2017, it confirmed the admissibility of the promotion to the public of all non-prescription medicines (NPMs, also known with the acronym “SOP” Read More