‘Therapeutic Alternatives’: Procurement Rules for Drugs with Same Indication but without Equivalence Certification Released According to the Balduzzi Law:

摘要

In Italy, a national law issued in 2012 has drastically modified the procurement rules for running local tenders in the field of drugs with ‘similar’ clinical indications. According to this law, tenders involving these drugs are subjected to a pre-authorization that the National Medicines Agency (AIFA) must release to certify that the different agents included in the same lot of the tender are equivalent with one another in terms of effectiveness and safety. Since this represents a profound change in comparison with the past, operational difficulties in managing tenders have rapidly emerged at local level immediately after the new law. Also AIFA must face a difficult challenge because the turnaround times for the response have become critical as well.