Under Article 3.1 of Legislative Decree no. 23/1998, a doctor, when prescribing medicinal products to patients, must follow the therapeutic indications, methods and the routes of administration provided in the Marketing Authorisation granted by the A.I.F.A.

Nevertheless, under Article 3.2 of the Decree, a doctor may, under his own responsibility and after having acquired the prior informed consent of the patient, prescribe a medicinal product for therapeutic indications, methods and routes of administration different from those actually authorised. This “off-label” use is permissible whenever the doctor considers that the patient cannot be usefully treated with the registered indications and provided that this “offlabel” use conforms to guidelines or scientific literature at an international level.

Article 1, paragraph 796, letter z) of Law no. 296/2006 (the 2007 Italian Budget Law) has narrowed down the “off-label” use of medicinal products in Public Hospitals and Healthcare Institutions. Article 3.2 of the above Decree will no longer apply to the systematic use in Public Hospitals, Healthcare Institutions, etc., of pharmacological therapies funded by the Italian Health Service (“HIS”). Moreover, the “off-label” use cannot be made, outside the terms and indications authorised by the same HIS, as a therapeutic alternative for patients suffering from pathologies for which pharmaceutical products containing specific indications for treatment have been authorised. Such therapies will be allowed solely in the ambit of the clinical trials.

By 28 February 2007, the Regions must adopt provisions relating to Local Health Authorities, Hospital Authorities and other health authorities aimed at the identification of persons liable for implementing the above mentioned provisions and also with regards to administrative liability for damages to the Inland Revenue Service. Until the date on which the regional dispositions come into force, such liability is attributed to the Healthcare Director of Local Health Authorities, Hospital Authorities, etc.