| Popis: |
“Special” or “expanded” access schemes permit the use, outside of clinical trials, of drugs or devices that have not yet been licensed or approved for marketing in a particular jurisdiction. Special access raises important and difficult questions, reflecting tensions between competing interests and values. This article explores similarities and differences between special access schemes in the United States, Canada, and Australia, focusing on areas closely connected with the controversies highlighted in the literature and where the comparison can provide insights for regulatory reform. These jurisdictions differ particularly with respect to how the regulations can be used to protect clinical trials and product development processes, whose authorisation is needed for special access use, and how ethical concerns, such as informed consent, are addressed. The requirements for data collection and reporting are similar, with all three countries appearing to be uncertain about the utility of information collected from special access use. |
