Health Canada’s Non-Prescription and Natural Health Products Directorate (NNHPD) held two separate consultation sessions last week to discuss the proposals they are developing as part of the Government’s “red tape” reduction initiative for both non-prescription drugs and natural health products.
The fact that NNHPD held two separate consultations spoke volumes about their inability to recognize that “like” products need to be treated in a “like” manner and their continued insistence on applying “fixes” and “patches” to an outdated regulatory model rather address the systemic issues. For anyone who has been around Health Canada for some time, NNHPD’s response to the Government’s “red-tape” reduction initiative sounded much like what they were saying over a decade ago – a decade in which NNHPD was NOT able to complete the Self-Care Framework modernization which they were responsible for leading.
Of immediate significance to our sector was that NNHPD’s emphasis in both sessions was on products at the higher end of the risk profile with little or no recognition of the regulatory inefficiencies and needs for low-risk cosmetic-like drugs and NHP’s. The message here was quite clear to the CA delegation – which included staff and committee chairs – that there is nothing much in this process for our products.
CA made clear in both consultations that although cosmetic-like drugs and NHP’s represent some 6.5% of the products they regulate and so are not likely a “priority” for red tape reduction efforts by NNHPD, we will not be silent and will continue to continually raise our concerns and issues to NNHPD and well as to higher echelons within Health Canada and the Carney government. Our aim – as we made abundantly clear to NNHPD officials – is to have cosmetic-like drugs and NHP’s removed from the Drug and Natural Health Products Regulations and placed under enhanced Cosmetic Regulations. This would meaningfully reduce red tape for our products and provide the unified, modernized, and efficient approach to regulation which has been the Government’s stated intent for over a decade under the Self-Care Framework initiative. It would also encourage innovation, manufacturing, and business growth in our sector.
For NNHPD, removing our 6.5% of products from their pre-market approval process would surely help to reduce the workload which led them to impose a two week “pause” this December in processing applications so to allow them some time to catch-up with their backlog. We would hope that NNHPD will come to appreciate the benefit our “carve-out” proposal and so be able to support and promote it within Health Canada.
CA’s “carve-out” strategy for cosmetic-like drugs and NHP’s is based on the what has already been achieved – and approved by Parliament – in Appendix 1 of the Cosmetics Annex of the Canada-United States-Mexico Agreement (CUSMA) of 2022. It was in this agreement that Canada recognized that there are products that can be both defined as “cosmetics” as well as “drugs” or “natural health products”, and being low risk in nature, require a more appropriate level of regulation that that provided for higher risk drugs or NHP’s as well as a consistency in approach for like products. Although several specific regulatory changes were included in CUSMA, Cosmetics Alliance is now proposing that Health Canada builds on this model using the products specifically defined in CUSMA and regulate through a more appropriate, risk-based, post-market, model under an enhanced Cosmetic Regulation.
This change would effectively eliminate much of the red tape with which companies now deal, enhance our ability to bring new and innovative products to market, and provide a more efficient (and effective) regulatory model.
As such, Cosmetics Alliance will be pursuing this approach through the Government’s red tape reduction process as well as through the CUSMA review. It should be noted that the only regulatory modernization that was achieved for any product sector under Health Canada’s Self-Care Framework was with respect to our products and it came through the CUSMA negotiations and the inclusion of Appendix 1 of the Cosmetics Annex. This included the elimination of “quarantine and confirmatory re-testing” for cosmetic-like drugs (with a then estimated saving ~$100K/year/SKU), and the elimination of the ban on “sampling” for cosmetic-like drugs and NHP’s such as toothpaste and sunscreen.
Pursing this regulatory approach will be a high priority for Cosmetics Alliance, and our Team will keep you updated as our efforts progress.
