Cost Recovery Under the Self-Care Framework

Discussion Paper Release – April 2019

Discussion Paper by Shawn Buckley

Published April 2019

Health Canada is moving forward with the Self-Care Framework which will repeal the Natural Health Products Regulations and regulate natural health products under a single set of regulations with chemical non-prescription drugs and cosmetics.

 

Health Canada has made it clear that once NHPs are regulated with chemical non-prescription drugs as Self-Care products, that natural health companies will be charged fees for licensing (i.e. there will be cost recovery). Health Canada’s rationale is that they cannot continue to charge the chemical drug companies fees, and not charge natural health companies fees, when both are under the same regulations with the same requirements for licensing.

 

Cost recovery threatens the accessibility of NHPs in Canada by potentially pushing small and medium sized NHP manufacturers out of business, and by driving up the costs to consumers of products that remain on the market.

Action Needed Now

We are asking you to educate yourself by downloading and reading this Discussion Paper.

Excerpts From The Discussion Paper

  • “Once the Natural Health Product Regulations are repealed, Health Canada will have no choice but to charge the fees found in the Fees in Respect of Drugs and Medical Devices Regulations. Natural health products are exempted from the Fee Regulations. Once natural health products are “Self-Care” products, the Fee Regulations will apply.”

  • “To offer an understanding of current fees, some common hypotheticals are set out below. Using those hypotheticals, under the current Fees in Respect of Drugs and Medical Devices Regulations there are the following fees… fees for the processing of product licences. The fees range significantly from $355,579 to $19,921.”