HARNESSING THE PROMISES OF CELL THERAPY, REGENERATIVE MEDICINE, AND GENE THERAPY IN QUÉBEC, CANADA

• Published in: Cytotherapy (Oxford, England) England), 2024-06, Vol.26 (6), p.S114-S115
• Main Authors: Delisle, J., Fournier, D., Santerre, K., Rochette, S., Zawati, M.H., Dumont-Lagacé, M., Turcotte, S., Guertin, J.R., Vermette, P., Tremblay, J.P., Parisotto, M., Beauséjour, C., Gélinas, J., Petropoulos, L., Dieudé, M.
• Format: Article
• Language: English
• Subjects: Ethics; Production capacity; Regulations
• ISSN: 1465-3249; 1477-2566
• DOI: 10.1016/j.jcyt.2024.03.215

The last decade has witnessed tremendous progress in cell therapy (CT), regenerative medicine (RM), and gene therapy (GT). However, these advances come with their own set of challenges and opportunities, which may vary among jurisdictions depending on infrastructures, laws, regulations, access to funding, and socioeconomic, political and cultural aspects. In September 2023, a virtual symposium was held on the opportunities and challenges of CT, RM, and GT in Québec, Canada. The symposium brought together scientists, manufacturers, and experts in law, pharmacoeconomics, and regulatory affairs. This work reports on the discussions held during this symposium, with the aim of guiding the development of new policies for CT, RM, and GT treatments in Québec and within the Canadian ecosystem. The comments from three panels were grouped into seven strategic orientations that reflected dominant views among panelists. The orientations were that: (1) an ethical framework must be developed around CT, RM, and GT to enable fair and timely access to treatments for all; (2) governments should spur private and public research investments in CT, RM, and GT; (3) regulatory awareness may be improved among developers through outreach approaches (initiated by the regulator) and early consultations (initiated by developers); (4) the regulations governing the development of CT, RM, and GT products could be streamlined and further adapted to the needs of these emerging products; (5) the skill sets of developers should be mobilized to foster the development and production of CT, RM, and GT products in the academic and industrial setting, and the training of Québec's workforce could be better aligned with industry and population needs; (6) Québec should ensure that the province's production and health care capacity are aligned with current and future needs in CT, RM, and GT products, considering the rapidly evolving landscape of CT and RM; (7) ongoing efforts to reform the current reimbursement framework could be continued in Québec's public, single-payer health care system. This symposium provided guidance for addressing current limitations and taking advantage of opportunities in CT, RM, and GT in Québec. We surmise that other jurisdictions face challenges similar to those discussed in this symposium. The global CT, RM, and GT community should therefore share experiences to promote the optimal development and access to these promising therapies.