Regulatory     NSNR(O)    


About our NSNR(O) workshop

The context

More than minimally manipulated human cells have been triggering an extensive environmental review by ECCC in addition to that done by HC with the CTA. Human cells, especially those used in autologous therapies (one’s own cells) should never trigger review as new organisms, since by scientific definition human cells cannot be an organism on their own, nor may they be incorporated into a different species and thrive. These excessive and repetitive requirements generate tremendous paperwork and require additional nonsensical research that is wrought with redundancies with that completed for HC. They deter industry investment in Canada and delay the launch of new Canadian cell & gene therapy-based clinical trials.

 

Why it matters

• Over 90% of the Network Partners from the ISCT Canadian Pavilion are impacted by the NSNR(O), as well as 100% of CellCAN’s CMFs.
• Where multiple options exist, industry sponsors are choosing to invest in jurisdictions where such delays and excessive redundancies do not exist (e.g. Japan). In effect, these overbearing regulations are a source of resource wasting.

 

What we are doing

In collaboration with BIOTECanada, CellCAN organized a workshop at the Biologics and Genetics Therapeutic Directorate (BGTD) at HC to discuss overdue changes to the NSNR(O). Sixteen senior-level decision makers were invited to represent various stakeholders from the cell and gene therapy manufacturing sector, including academic and industrial CMFs and biotech and biopharma companies as a united voice, expecting actionable outcomes from the meeting with 15 government regulatory stakeholders from the BGTD, NSN (HC), Science Policy Branch (HC), Innovation, Science and Economic Development (ISED), ECCC and Public Health Agency of Canada (31 participants in all).

As a unified stakeholder group, 8 suggested changes were proposed to the government stakeholders that could be implemented at the level of the Act, Regulations, Guidelines and Policy (from most difficult change requiring legislative modifications to the most easily adaptable and rapid change implementation).

 

The results to date

Government stakeholders recognized the tremendous burden that the NSNR(O) place on sponsors and agreed that it was never the intent of the Act to capture human cells (especially for autologous therapies), but these technologies did not exist when the Canadian Environmental Protection Act was passed in 1999.

Members of the BGTD, NSN and ECCC agreed that requiring full environmental assessment at initial clinical trial application was a Policy that could be changed so it is required only at the full market authorization stage (after later phase clinical trial) when substantial safety data has been collected, rather than at the beginning when no such data has been generated. This change had the most traction and both stakeholder groups have taken steps to implementing the adoption and dissemination of this newly changed Policy.

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