The Decree Law of 6 July 2012, No. 95 (the so-called "Spending Review" decree), as converted into the Law of August 7, 2012, No. 135, introduced significant changes to the healthcare, pharmaceutical and biomedical industries.
Requirement of indication of active ingredient in prescriptions: A doctor who treats a patient for the first time for a chronic disease, or for a new episode of disease that is not chronic, for the treatment of which there multiple equivalent medicines, is required to indicate in the receipt of the National Health Service only the name of the active ingredient of the drug. If the doctor considers a specific product based on the same active ingredient to be indispensable, she must provide a brief statement of her reason.
Purchase of goods and services: The law imposes a reduction of 5% in the cost of contracts already in place for the supply of health care goods and services (excluding pharmaceuticals). The reduction took effect from 7 July 2012, the date of entry into force of the Decree Law, and will last for the duration of the contracts, except for medical devices for which it will last until 31 December 2012. From 2013 a specific cost cap will be put into place to moderate the growth in costs for that sector.
The law provides for a reduction in contract volumes and the corresponding total prices, but does not seem to allow the government to request a reduction only of total prices while leaving quantities unchanged.
In this regard, Assobiomedica has complained of a widespread practice by the public administration of interpreting the rule in question as a mere discount, without implementing the corresponding cut in the amount of supplies required. A clarification from the legislature or the adoption of an interpretative circular is expected.