Regulatory revisions for cell therapy in Canada.

          Nowadays, cell therapy is continuously progressing to reach its potential. The therapy aims to improve the quality of life of healthy people, and the treatment of severe rare diseases. However, given the complexity and ongoing development of cell therapy, in 2019 the Canadian government revised the regulations on cell therapy to emphasize the safety of patients, the effectiveness of treatment, and importantly the promotion of industrial development.

          The safety and efficacy of cell therapy involves many regulations, including:

1. Food and Drugs Regulations

2. Medical Device Regulations

3. Safety of Human Cells, Tissues, and Organs for Transplantation Regulations.

          Under these three regulations, the definition of cell therapy varies according to the type of treatment. In 2019, Health Canada, the Canadian health organization, adjusted the definition of cell therapy to make it clear and consistent.

          Cell therapy, regardless of whether the cells are autologous or allogenic, is a drug. By definition, a drug is “any substance or mixture of substances manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms” (Caulfield and Murdoch 2019).

          Under the Food and Drugs Act, cell therapy is a type of drug. Thus, it needs approval from the federal government prior to treatment. In addition, Health Canada has issued a warning about the risks of cell therapies that do not get approval from the government. Under the precise regulation, it allows the Canadian government to better control and regulate the use of cell therapy through regulatory compliance.

          The implementation of the regulations consists of the clear public communication of Food and Drugs regulations through multiple forms of announcement. The government uses simple, easy to understand language for patients from all walks of life. The announcement covers a comprehensive range of cell therapy and processes, not merely for approval of cell therapy processes but also those that do not receive certification from Health Canada. Furthermore, apart from clear announcements, Health Canada has started sending warning letters to unproven cell intervention therapists and clinics about the revocation of licenses. Health Canada has also started public dissemination of information on both the effectiveness and safety of approved therapies.

          The development of the cell therapy industry is the primary responsibility of the Competition Bureau. One of the bureau’s primary duties is enforcing compliance with regulations on prohibiting the advertisement and promotion of cell therapy. The regulations focus on the prohibition of providing false or manipulatively beneficial information to cell therapists, such as overstating the efficacy of cell therapy. Advertising and public promotion of cell therapy efficacy need to be backed by scientific research on such therapy. These regulations will result in the creation of a qualified supply of cell therapy, ultimately promoting only the provision of potent and safe therapy. In turn, the cell therapy industry will provide beneficial services to patients and society. 





 

References
Caulfield, Timothy, Murdoch, Blake (2019). Regulatory and policy tools to address unproven stem cell interventions in Canada: the need for action. BMC Med Ethics 20, 51. https://doi.org/10.1186/s12910-019-0388-4    
Zarzeczny Amy. (2019) The Future of Stem Cell Research and its Clinical Translation in Canada: Exploring Questions of Governance and Policy Options. In. Advances in Experimental Medicine and Biology. Springer, New York, NY