11
Oct 19
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).
2
Oct 19
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.
8
Jun 19
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.
7
Jun 19
Regulations on the shortage of medicines in the Draft law converting the “Calabria” Law Decree
On May 3, 2019, Law Decree No. 35 of April 20, 2019 (the “Calabria Decree “) entered into force. The Calabria Decree includes significant provisions relating to the shortage of medicines.
6
Jun 19
Artificial intelligence software: FDA news
On April 2, 2019, a discussion paper describing a proposal for a regulatory framework for modifications to Artificial Intelligence-based medical devices that are already on the market, was published by the Food and Drug Administration (FDA), in view of the future formulation of guidelines that relate to this issue.
5
Jun 19
Breaking news on the supplementary protective certificate for medicinal products
On June 11, 2019, Regulation (EU) 2019/933 (“Regulation 2019/933”), amending Regulation (EC) No 2009/469 (“Regulation 2009/469”) concerning the supplementary protection certificate (“SPC”) for medicinal products, was published in the Official Journal of the European Union.
