Access Delayed, Access Denied

Book excerpt: PR: the date at which the first public reimbursement of the new drug is recorded in the formularies of each federal, provincial, and territorial drug program. [...] For the purposes of this report, the global development time for new medicines is assumed to be a function of factors outside of Canada's control; therefore, the time associated with this segment is presented for completeness but is not the focus of the main policy discussion in this paper, nor is it part of the overall wait time for access to new medicines measured here. [...] In Canada, the time patients spend waiting for government approval of a new drug is measured from the date the drug manufacturer's application for approval is recorded or filed in the Central Registry (CR) of Health Canada's Therapeutic Products Director- ate (TPD) or Biologics and Genetics Therapies Directorate (BGTD) following the comple- tion of clinical testing. [...] Since 2004, the equivalent authority to approve pharmaceutical and biological medicines in the United States has fallen under the Department of Health and Human Services (HHS), with the Center for Drug Evaluation and Research (CDER), a part of the Food and Drugs Administration (FDA). [...] The delay in this segment is measured from the date at which Health Canada issues a NOC for a new drug to the date at which the first public reimbursement (PR) of the same drug is recorded in the formularies of each federal, provincial, and territorial drug program.