Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

The European Federation of Pharmaceutical Industries and Associations (EFPIA) says it is concerned about a decision by the Italian health authority, which allows the reimbursement of off-label treatments for economic reasons when on-label alternatives are available.

The trade organization calls on the European Commission to ensure member states adhere to the European regulatory framework and that financial considerations do not take precedence over regulatory decisions.

On June 9, the Italian Medicines Agency, AIFA, endorsed the off-label use of cancer drug bevacizumab in its decision to reimburse the drug for ophthalmic use. All this, despite the fact that on-label treatments are currently available to Italian patients, the EFPIA said. The EFPIA opposes this decision as it undermines the European regulatory framework, potentially compromising patient safety and creating legal uncertainty.