The Portuguese Society of Diabetology (SPD) has described Infarmed’s decision to allow continuous glucose monitoring sensors to be prescribed as generics as an “unprecedented clinical setback.” In a statement released today, the society warned that the measure could endanger the safety and quality of life of thousands of people with diabetes in Portugal. The dispute stems from an information circular issued in April, in which Infarmed said the prescription model for these medical devices should change and that generic models could replace established commercial brands. Infarmed defended the move by arguing that generics can improve access to health technologies and that the wider availability of blood glucose monitoring sensors offers a practical alternative to traditional monitoring methods. The SPD countered that these systems are not interchangeable like medicines, because each sensor has distinct clinical features such as accuracy, reading and interpretation algorithms, calibration needs, compatibility with insulin pumps and digital health platforms, and customizable alarms. It also said the choice of sensor must take into account the patient’s condition, daily life, literacy and ability to use technology, and argued that Spain, France, Germany, and Italy have not adopted undifferentiated prescription models. The Order of Doctors (OM) also called on Infarmed today to revoke the decision, saying it poses a “real danger” to patient safety and cannot be justified by treating complex medical devices as if they were generic medicines.
