Reforming Canada’s Special Access Programme (SAP) to improve access to off-patent essential medicines

Abstract

Many essential medicines, including basic drugs such as albendazole, do not have approval to be marketed in Canada. Instead, they are only available through a federal government mechanism: the Special Access Programme (SAP). SAP was designed as a mechanism to provide emergency access to new drugs not yet authorized for sale, not for proven medicines that appear on the World Health Organization (WHO) Model List of Essential Medicines. Because it was never intended or designed to fulfill this function, SAP creates needless access barriers that inhibit timely and effective care, particularly for patients with tropical, parasitic, and other infectious diseases. Regulatory changes to resolve this problem are readily achievable and should be prioritized.