Interruption in the marketing of medicines: AIFA provides clarifications to MAHs on their communication duty
On October 9, 2019, the Italian Medicines Agency (“AIFA”) issued an information notice to provide useful information to medicine marketing authorisation holders (“MAH(s)”) on the obligation to notify AIFA of any temporary or permanent interruption in the marketing of medicines (“AIFA Note”).
New criteria for the negotiation of prices for medicines
On August 1, 2019, the Ministry of Health announced the approval of a Ministerial Decree, issued in agreement with the Ministry of Economy and Finance, which sets new criteria for the price negotiation procedure between the medicine marketing authorisation holder (MAH) and the Italian Agency of Medicines (AIFA) in order to establish the price for medicines that will be reimbursed by the National Health Service (NHS).
Excessive pricing abuses in the pharmaceuticals sector: complying with a cease-and-desist order. The Italian case of Aspen v AGCM
On 29 September 2016, the Italian Competition Authority (the AGCM or ICA) fined the Aspen Group (Aspen) €5m for a violation of article 102(a) of the Treaty on the Functioning of the European Union.
The EU Court of Justice holds that colluding to disseminate information constitute a restriction of competition “by object” (Roche / Novartis)
On January 23rd, 2018, the ECJ delivered its preliminary ruling on the Roche/Novartis v. Commission case (C-179/16), concerning the compatibility of an agreement entered into between Roche and Novartis with Article 101 TFEU.