Thank you, Mr. Chairman.

The members of Food, Health & Consumer Products of Canada produce most of the natural health products sold in Canada and the vast majority of over-the-counter medicines also used by Canadians in the practice of self-care. Self-care empowers Canadians to play a greater role in the management of their own health and, in so doing, frees up resources in our health care system to deal with more complex health issues.

Bill C-368 is about a vital Canadian industry, but it's also about a very important part of health care at a crucial time for our struggling health care system. FHCP members greatly appreciate this committee's interest in Health Canada's NHP program, and we agree with virtually all stakeholders that this program, right now, is struggling. Along with the concerns raised by the Auditor General that the committee has already heard about, NHP authorization and site licensing operations are both severely backlogged, at times threatening product launches and even expansion into foreign markets.

The committee has heard a lot about these issues, along with industry's significant concerns about the labelling regulations and cost recovery. These are the problems that are blocking access to NHPs and keeping our members up at night, but Bill C-368 addresses none of those problems.

It's impossible to frame our response to Bill C-368 without reference to Health Canada's self-care framework. The framework emerged from the original debates around Vanessa's Law in 2014. The concern at the time was that it would anchor over-the-counter medicines to the prescription drug framework while leaving natural health products in a separate legislative framework, despite the fact that both categories sit side by side on store shelves and are used by Canadians without the supervision of a health practitioner. The government of the day responded to those concerns with the consumer health products framework, which sought to create a risk-based regulatory system for both product categories separate from the prescription drug regulations.

Since then, the framework has been a source of both promise and frustration. After rebranding in 2016 as the self-care framework, and a series of cross-Canada consultations in 2017, the framework was reorganized into a three-phase project in 2018. First, it proposed new labelling rules for NHPs modelled on previously passed rules for OTC products. Second, it proposed crucial regulatory modernization for OTC medicines to simplify market authorization pathways and provide innovation incentives. Finally, the third phase of the framework would bring NHPs into this modernized framework, including the simpler product application pathways and innovation incentives; it would implement cost recovery and apply Vanessa's Law.

FHCP was alarmed by that proposed plan, because we knew that the OTC rules had been a disaster for industry and for consumers. Nonetheless, the technical discussions on regulatory modernization promised meaningful new efficiencies and innovation incentives, and industry worked hard with the department to move that crucial piece forward.

Then the pandemic hit, and progress on the framework came to a halt. In 2022, those labelling regulations were approved and implementation timelines were set. Less than a year later, the NHP cost recovery proposal was put forward, and Bill C-47 brought NHPs in under Vanessa's Law. The promised regulatory reforms originally targeted for 2019 were characterized as “to be determined” sometime in 2025, or beyond.

At that point, the idea that the self-care framework was about separating self-care products from prescription drugs was hard to defend. All measures undertaken to that point had simply moved NHPs closer to the prescription drug framework. Discussions around broader regulatory modernization had virtually disappeared.

One of the great ironies of this whole process is that the problems identified in the 2021 Auditor General report are all things that the framework would have addressed had it been completed in the original time frames. Simplified product approval pathways, originally proposed under the framework, would have improved consumer access and been much more efficient for industry. They would have also freed Health Canada resources from pre-market approvals, which the AG found robust, and allowed them to be applied to post-market enforcement, which the AG identified as lacking. That, in turn, would have permitted the development of a realistic cost recovery proposal that would generate sustainable funding for Health Canada without punitive costs to industry.

That brings us to today's debate. FHCP and its members appreciate this committee's genuine interest in the sector. However, passing Bill C-368 would not be without risks for industry and wouldn't solve the real, immediate challenges our sector faces. What both consumers and industry need is the modern consumer health product framework that was promised in 2014.

Thank you, Mr. Chairman. Ms. Kramchynsky and I are looking forward to your questions.