Italy
Excessive pricing practices in the pharmaceutical sector – NCAs’ scrutiny continues
02 August 2019 - Posted by: Nele De Backer
Last week, the Belgian and Italian consumer associations Test Aankoop/Test Achats and Altroconsumo filed complaints with their respective national competition authorities, alleging that the pharmaceutical group Biogen is abusing its dominant position by charging excessively high prices for the medicine Spinraza, which it has the exclusive right to market as an orphan drug until 2029. › Read More
20 June 2019 - Posted by: 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?
18 April 2018 - Posted by: 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
15 February 2018 - Posted by: 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
24 October 2017 - Posted by: 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