RAPS: An Argument for Emergency Authorization during Public Health Crises
When a public health crisis like Ebola emerges, public health officials need the flexibility to respond quickly and effectively. But as a new paper in the journal Public Library of Science - Medicine (PLoS Medicine) argues, many countries currently have in place regulatory hurdles which would delay access to experimental new emergency treatments during such crises. Many global healthcare product regulators have in place provisions designed to speed access to healthcare products, including accelerated pathways for products that treat or diagnose rare diseases. These so-called orphan products are often approved based on less clinical data than a typical product would require. Some regulators also provide measures for the “ compassionate use” of unapproved products in cases where a patient lacks any alternatives. This type of use is usually applied in situations where a patient faces at serious or life-threatening risks without treatment.