title: It's time for change; commentary in response to feature article by Halpin et al.
abstract: It is essential that we re-examine the way new drugs for life-threatening illnesses are assessed and regulated. The time taken to approve lifesaving medicines for general use outside of clinical trials is prohibitively slow; people are needlessly dying. The bioethics community should be at the forefront of change. In particular, the rigid adherence to Evidence Based Medicine (EBM) has become irrational. New regulatory frameworks are being proposed, including that of adaptive licensing. Whereas the current model uses a one-point-in-time, all-or-nothing system of regulation, adaptive licensing allows for progressive access to a new drug during the approval process. Indeed this may be the first instance where the contemporary practice of EBM needs to be abandoned due to inherent inefficiencies. In response to the inefficiencies of the current system, a collaboration of stakeholders has established NEWDIGS (NEW Drug Development ParadIGmS). The Feature Article by Halpin and colleagues, on which this Commentary is based, gives a sophisticated survey of relevant bioethical issues. In addition this Commentary outlines a novel bioethical model to align with proposed new regulatory frameworks: a distributive-benefit-at-equilibrium model.
authors.affiliation: Human Psychopharmacology, Swinburne University, Melbourne, Victoria, Australia Public Health and Preventive Medicine, Monash University.
authors.forename: Michael
authors.initials: M
authors.lastname: Keane
mesh_terms: D019317:Evidence-Based Medicine; D006801:Humans; D008004:Licensure
keywords: Clinical Trials; Ethics