The Council of Canadian Academies (CCA) is pleased to announce it has been asked by the National Research Council to undertake an assessment on somatic gene and engineered cell therapies.
A multidisciplinary expert panel will be appointed in the coming months to address the following question:
What are the key legal/regulatory, ethical, social, and policy challenges specific to the approval and use of somatic gene and engineered cell therapies in Canada?
Gene and engineered cell therapies hold great promise for treating rare genetic disorders, as well as chronic diseases, such as cancer. However, these therapies raise a number of challenges including regulatory barriers, equity in access to treatment, and affordability.
Somatic gene therapy alters or eliminates genes that cause disease in a patient without imparting these changes to future generations. This assessment will examine the challenges related to approval and use of these therapies, focusing on the latter stages of therapy development including drug approval, market introduction, and use.
“This area of science has its share of ethical, legal, and social issues” said Eric M. Meslin, PhD, FCAHS, President and CEO of the CCA. “We look forward to convening the multidisciplinary expertise needed to address this important question, to inform the NRC.”