5
Feb 20
Who can request authorization to advertise medicines? Answers from the AGCM
The Italian Competition Authority (hereinafter the “AGCM“) recently expressed an opinion and addressed a recommendation to the Ministry of Health (the “Ministry”) regarding the parties entitled to request authorization to advertise medicinal products to the public (resolution No. AS1628 of December 9, 2019
12
Dec 19
Pharmaceutical trademarks: the proof of genuine use and proper reason for non-use
In its decision issued on 3 July 2019 in Viridis, Case C-668/17 (the “Decision”), the Court of Justice of the European Union (“CJEU”) ruled that the lengthy time necessary to complete a clinical drug trial is not a proper reason to prevent the prematurely registered trademark from being revoked for non-use.
4
Dec 19
Under what circumstances may an incumbent associate with a competitor in a public tender? The ICA provides useful guidance in the field of plasma derivatives.
In January 2018, the Italian Competition Authority (AGCM, or “ICA”) launched an investigation for a possible breach of Article 101 TFEU against two international manufacturers of blood-based pharmaceuticals – Kedrion S.p.A (“Kedrion”) and Grifols Italia S.p.A (“Grifols”) – for participating as a joint venture in a public tender (issued by a contracting authority acting on behalf of a group Italian regions, “Intercent-ER”) to collect blood and plasma, to produce plasma derivatives and to deliver these to the Italian National Health System (NHS).
17
Oct 19
The ranitidine case: a test for the new class action?
On September 20, 2019, the Italian Medicines Agency (AIFA) ordered the withdrawal of several batches of medicine containing Ranitidine, which is produced by the pharmaceutical laboratory SARACA LABORATORIES LTD in India.
15
Oct 19
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”).
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).
