November 6, 2020 -- Gene therapies offer great benefits to patients but could strain healthcare budgets and exacerbate existing treatment inequities in Canada, according to an expert panel that was commissioned to write a report by the Council of Canadian Academies (CCA).
In Canada, two gene therapies for cancer treatment (Novartis' Kymriah and Gilead's Yescarta) and one for treatment of a rare neuromuscular disease (Biogen's Spinraza) have received marketing authorization, with many others being evaluated in clinical trials.
The arrival of somatic gene therapies has prompted an active global discussion about the merits and challenges of their approval and use. The National Research Council of Canada asked the CCA to examine key legal, regulatory, ethical, societal, and policy challenges specific to the approval and use of somatic gene and engineered cell therapies in Canada.
The report is titled "From Research to Reality: The Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada."
"Rapid scientific advances mean potentially life-changing treatments are approaching the clinic at an accelerated pace," said Janet Rossant, PhD, chair of the CCA's expert panel. "These new therapies, however, pose a number of challenges in terms of their introduction into the Canadian healthcare system and ensuring access to those who would most benefit."
Main findings of the report include:
"The approval and use of gene therapies challenges payers, regulators, industry, patients and families," said Eric Meslin, PhD, president and CEO of the CCA. "This report covers many of these challenges as well as possible paths forward and will help to support evidence-informed decision making in Canada."
Do you have a unique perspective on your research related to gene and cell therapy research? Contact the editor today to learn more.