Legal, Ethical, Social, and Policy Dimensions of Somatic Gene and Engineered Cell Therapies

With a commitment to renewing its research programs, the National Research Council (NRC) has developed a challenge program in the area of health, and specifically, in gene and engineered cell therapy. The challenge program will provide seven years of support for developing disruptive technologies to enable affordable gene and engineered cell therapies for chronic diseases and rare genetic disorders affecting Canadians. The NRC, with its wide ranging and multidisciplinary expertise and capabilities in the science of cell and gene therapy, and in technology transfer, will work with stakeholders and collaborators to help unify the value chain for gene and engineered cell therapy from discovery to commercialization.  In support of this program, the NRC requires assistance in assessing the legal/regulatory, ethical, social, and policy (LESP) dimensions specific to the approvals and use of somatic gene and engineered cell therapies. A better understanding of the LESP dimensions of somatic gene and engineered cell therapy will enhance the NRC’s ability to anticipate challenges and successfully navigate the Canadian ecosystem for developing, regulating, commercializing, and delivering gene and engineered cell therapies. These therapies hold much promise for treating rare genetic disorders as well as chronic diseases such as cancer. These therapies also raise a number of challenges including regulatory barriers, fairness in access to treatment, social acceptance, post-market surveillance, patient safety, and the sustainability of business models.