The debate continues on off-label use, which is permitted by some governments for the sole purpose of reducing the costs of national health care. After Italy, even France is preparing to implement similar legislation and the EFPIA has intervened citing Italy in a judgment at the European Court of Justice. The Director-General of EFPIA has stated that the association, which bring together companies and associations in the pharmaceutical sector, considers the offlabel use as an attack on the European authorization system, which works to protect innovation and the health of patients.
EFPIA have stressed that the conduct of the Italian Medicine Agency is justified only by the extreme pressure to curb spending, and as other European countries are preparing similar interventions, it is necessary to run for cover. The spokesperson for the association was ultimately concerned about the issues being discussed at a European level, not only the off-label use, but also, for example, the intent to infringe patents with compulsory licenses. EFPIA has finally made it clear that it is not opposed
to the off-label use of certain drugs, particularly in therapeutic areas such as CNS, in which the mechanism of the disease is not always clear, but this cannot become an instrument for governments to cut spending on pharmaceuticals. The most striking case is that relating to the authorized treatment for age-related macular degeneration, replaced by another less expensive treatment and
devoid of indications for this pathology.
Controversy over off-label use continues
