EFPIA, the European Federation of Pharmaceutical Industries and Associations, is concerned about a decision by the Italian health authority to allow the reimbursement of off-label treatments for economic reasons when on-label alternatives are available. The 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 bevacizumab in its decision to reimburse the drug for use in the eye, despite the fact that on-label treatments currently are available to Italian patients. EFPIA opposes this decision as it undermines the European regulatory framework, potentially compromising patient safety and creating legal uncertainty.
Richard Bergström, director general EFPIA, said, “Almost five decades ago the pharmaceutical regulatory framework was created, and 20 years ago the EMA was established, to preserve the highest standard of patient safety in Europe. We are concerned about efforts by E.U. member states creating secondary, national marketing authorizations for economic reasons that undermine the E.U. regulatory framework and could potentially put patients at risk.
“Yesterday’s decision by AIFA questions the E.C.’s competence to authorize new medicines. To preserve the high standards of patient safety in the E.U., healthcare bodies should adhere to E.U. law and refrain from promoting off-label use for economic reasons. These medicines have not been tested and assessed to the same stringent standards for the off-label indication, putting patients’ health and safety at risk for the sake of cost savings.
“Promotion of economic driven off-label use will discourage pharmaceutical companies from undergoing the costly and time-consuming authorization process for new indications if public authorities favor off-label use of other, cheaper medicines which have not undergone the same stringent safety and efficacy assessment.”