These are the amendments that were passed in Bill C-47
Sections 500 to 504:
Amendments to the Food & Drug Act
500 The definition therapeutic product insection 2 of the Food and Drugs Act is replaced by the following:
therapeutic product means a drug or deviceor any combination of drugs and devices; (produit thérapeutique)
This all means that they are going to put NHP’s under the same regulations as pharmaceutical drugs.
Talking Points to MPs & Health Minister
1. Reduced Access – Industry experts estimate that approximately 80% of NHP’s will disappear from the market over the next two years. This is because NHP companies are much smaller than pharmaceutical companies and do not have the financial ability to pay the excessive regulatory fees that are being proposed. These businesses will either be forced to close entirely or move to the USA where regulation is more appropriate for NHP’s.
2. Loss of Businesses – The NHP companies are exponentially smaller than the pharmaceutical companies and will be unable to withstand being charged the proposed fees for increased regulation. These businesses will close or move to the USA where regulations is more appropriate for NHP’s.
3. Loss of Jobs – As the NHP companies close their doors or move to the USA, many jobs will be lost. This will impact those who work directly for the NHP company, but also those who retail these products. If there is no product to sell, there is no job to be had. Many practitioners, especially herbalists and naturopaths, depend on NHP’s as a key revenue generator. These industries will be especially negatively impacted.
4. Increased demand on Healthcare services – As Canadians become less able to access NHP’s, they will be forced to access the public healthcare system.This will increase demand on an already overwhelmed system.
5. Increased demand for doctors – As Canadians become less able to access NHP’s, they will be forced to access physicians to get pharmaceutical drugs to manage their healthconcerns. This is especially dangerous for those individuals who have been using NHP’s because of sensitivity or intolerance to pharmaceuticals. For some, this may be life threatening. Doctors are already in short supply with many Canadians unable to even get a family doctor. This will result in reduced access to care for Canadians.
6. Increased wait times – As Canadians are more and more unable to manage their own health,they will be forced to access the pubic health system. As 70-80% of individuals use NHP’s, this may result in a substantial increase in demand for public health services and thereby an increase in wait times for care. Pain clinics are already experiencing wait times that extend beyond 6 months. Taking away NHP’s that help to mitigate pain is just one example of how devastating this will be to the health and wellbeing of Canadians.
7. Increase in non-complaint product coming into Canada – When effective and safe products become unavailable in Canada, NHP users will seek out other sources of product. This opens up the market to unregulated, potentially unsafe products being used. We can expect an increase in adverse outcomes as well as increased demand on the healthcare system because of this.
8. No patents, no incentive for innovation, loss of research – The high fees being proposed for innovative product development will quash any incentive or motivation for research and development. This means less options for Canadians, less jobs for Canadians, and less access to innovative products.
9. Increase in product price – The excessive fees being proposed will be passed on to the consumer. The NHP companies will have no other way to pay these fees, other than by raising the cost of their products. This again will limit access as any NHP’s that do survive in the new highly restrictive Canadian market will be so expensive, the majority of Canadians will be unable to afford them. People can barely afford groceries right now. The unintended increase of cost of NHP’s means fewer people will be able to manage their own health.
10. Reduction in new products – The excessive regulatory fees being proposed are not manageable by most of the NHPcompanies. There is a proposed application fee of almost $60,000.00 for an innovative product, with no guarantee that the application will be approved. As well, there is no patent protection for NHP’s. That means if one company pays to develop an innovative product, once it is approved, another company could make the exact same product at a fraction of the cost because it would no longer be considered ‘innovative’. Few companies will take that kind of financial hit when there is little to gain from the work.
11. Loss of existing products – NHP companies are a fraction of the size of pharmaceutical companies, with a fraction of the income. ONE pharmaceutical company – Pfizer – made $100.3 Billion in 2022. The entire NHP industry in Canada – ALL companies combined – is expected to make approximately $8.16 Billion in 2023. This demonstrates the exponential inequity of applying the same regulatory fees for NHP’s as for pharmaceuticals. NHP companies can’t afford to pay fees to keep products on the market. Industry experts predict we will lose about 80% of NHP’s over the next two years.
12. Summary of proposed regulatory costs – https://gowlingwlg.com/en/insights-resources/articles/2023/health-canada-cost-recovery-natural-health-product/ This isa good article that speaks to the proposed regulatory fees that are to beapplied to NHP’s.
Health Canada Proposal highlights
• A Canadian NHP manufacturer of non-sterile product would have to pay Health Canada $23,071 each year for a site licence. An importer, importing from as few as a single foreign site, will pay $20,035 each year for a site licence.
• Site amendments, for actions as simple as adding a single warehouse, would pay an additional $4,784.
• Applicants submitting a Class III PLA would pay a minimum of $7,209 and could cost as much as $58,332 depending on the type of application and whether a product would fall under a new, mystery category of application deemed a “Class IIInovel application.”
• Product licence amendments for something as simple as modifying a daily dose, adding an age group or modifying a test tolerance would start at $7,209 and range up to $23,333.
• Licence holders will be charged an annual right to sell fee of $542 for every single NPN they hold.
• The proposal is open for consultation as of May 12, 2023 and will remain open for only 75 days to provide comments. **Extended to August 10, 2023 – 90 days**
• Health Canada is targeting an implementation date of April 1, 2025 to begin charging these fees. The start date, however, is not fixed and can be implemented at anytime by government decision.
Resources
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Gowling News – Summary of The Proposed Costs
Senate Discussions
Natural Health Product Protection Association
NHPPA Discussion Papers
New proposed changes to Natural Health Product (NHP) regulations – Eastern Currents
Proposed Fee for Natural Health Products
Health Canada Website
