PROTECTING OUR RIGHTS TO NATURAL PRODUCTS

In May 2023, Health Canada issued a proposal (Bill C-47) detailing cost recovery for natural health products (NHPs), including Chinese herbal medicines. It mandates various additional fees, such as application fee, licensing fee, and right to sell fee. There are also questions around the incentive to pay almost $60,000 to apply for an NHP approval, when most formulas cannot be patent protected.

We are very concerned at the attempt by Health Canada to overburden the Natural Health Product industry with excessive costs thereby reducing many of our clients’ access to products that they have relied on for years. This proposal will result small and medium-sized businesses to not able to offer the NHPs or compounding chinese herbal prescriptions anymore or to be forced to pass down the additional high cost to the consumers.

This all means that they are going to put NHP’s under the same regulations as pharmaceutical drugs.

WE DO NOT WANT THESE AMENDMENTS TO BE ENACTED. WE WANT THEM REPEALED.

 

We are writing this letter to get you all as a consumer/practitioner to voice out our concern together and oppose to this proposal. What you can do:

  1. There is a new petition that has come out that is supported by an MP.  That means the federal government must address it if it gets enough signatures. Click here or the blue button.
  2. The public survey is open until AUGUST 10th, please submit your concern online here.On the second paragraph of the page “Join in: How to Participate” –> Select/Click “Use the Online Form”
  3. Talk, call, or write a letter to your local MPs or the new Health Minister. We understand life can be too busy and hectic, you can go to Eastern Currents website and download the letter template and modify as you need.HonourableMark HollandMinister of Health

    Health Canada

    Address Locator 0900C2

    Ottawa ON K1A 0K9

    hcminister.ministresc@hc-sc.gc.ca

    HELP TO WRITE LETTERS:

    Free Mail – No Postage Required:

    Government Mail Free of Postage allows for mail to be sent for free to and from:

    •         The Governor General

    •         The Speaker or Clerk of the Senate or House of Commons

    •         The Parliamentary Librarian or the Associate Parliamentary Librarian

    •         Member of Parliament (MP)

    •         Members of the Senate

    •        Members of the House of Commons (see the Parliamentary mailings using Neighbourhood Mail™ section)

    •         The Conflict of Interest and Ethics Commissioner or Senate Ethics Officer

    •         The Director of the Parliamentary Protective Service

    •         The Parliamentary Budget Officer

    The mail is sent for free if both the sender and receiver are in Canada.

  4. Engage and educate your family, friends, and networks to this critical issue and ask them to do the same. Share the links, share the templates of the letter, etc.

CITCM believes in uniting voices with other groups and is currently working on these collaborations. In the meantime, we all are encouraged to continue to educate ourselves on these regulatory changes, regularly talk to your elected officials, and keep email contact with us. Follow our updates and let us know of any questions or support you may need.

Keep scrolling for more detailed information and impacts of this bill.

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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)

  • 501 (1) The Act is amended by adding thefollowing after section 21.‍32:Definition of therapeutic product21.‍321 Despite the definition therapeutic product in section 2, in sections 21.‍31 and 21.‍32 therapeutic product means a drug or device or any combination of drugs and devices, but does not include anatural health product within the meaning of the Natural Health Products Regulations.

    (2) Section 21.‍321 of the Act is repealed.

  • 502 (1) Section 21.‍8 of the Act is renumbered as subsection 21.‍8(1) and is amended by adding the following:Definition of therapeutic product(2) Despite the definition therapeutic product in section 2, in subsection (1) therapeutic product means a drug ordevice or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations.

    (2) Subsection 21.‍8(2) of the Act is repealed.

    Transitional Provision

    Authorizations and licences

  • 503 The definition therapeutic product authorization in section 2 of the Food and Drugs Act also includes(a) an authorization, including a licence, that was issued, before the day on which this section comes into force, underthe regulations made under that Act and that authorizes, as the case may be, the import, sale, manufacture, packaging or labelling of a natural health product, within the meaning of the Natural Health Products Regulations as those Regulations read immediately before that day; or(b) an authorization, including a licence, that would fall within paragraph (a) if the authorization were not suspended.

    Coming into Force

    Order in council

  • 504 (1) Subsection 501(2) comes into force on a day to be fixed by order of the Governor in Council.Order in council(2) Subsection 502(2) comes into force on a day to be fixed by order of the Governor in Council.

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 costshttps://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
———
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

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