Special Access Denied: A Case Study of Health Canada's Special Access Program.

This paper examines the ethical probity of Health Canada's Special Access Program (SAP). The SAP is designed for patients with life-threatening conditions who require "emergency" access to drugs that are not authorized for use in Canada when conventional therapies have failed. We argue that the SAP inappropriately uses the tenets of evidence-based decision-making in situations where evidence-based decision-making is unfeasible. The SAP should abandon its pretence of evidence-based decision-making and adopt a transparent process in which the values guiding decisions are explicit and corrigible. We recommend the ethical principles of autonomy, non-maleficence, beneficence and justice.