Natural Health Product (NHP) regulations – Update Leave a comment
by John Stan and Kelly Kitchen
ACTION… ACTION… and more ACTION… creates… CHANGE!
As you are all aware, last year HC submitted a proposal for Cost Recovery Fees that will be imposed on the Natural Health Product (NHP) industry. These initial fees were outrageous, and a grassroots response across Canada was immediately initiated. We are pleased to report that the combined efforts from TCM/Acupuncturists, the members of the Health Food Industry coordinated by the Canadian Health Food Association (CHFA), and other industry stakeholders has got Health Canada’s (HC) attention! HC received over 350K physical postcards and letters. They also had 4,696 responses on their online submission form and other emails and correspondence from associations and stakeholders.
We can guarantee that HC knows this is an issue of high public concern. On March 27th, 2024 HC published a revision to the Cost Recovery Program that included an amendment to their fee structure and a ramp up period for these new fees over 7 year period. While we (the public) did get their attention and they have returned with a counter-proposal, we still feel it is unacceptable. Here is the link to the full revised proposal:
In essence, while the new fees are much lower at the beginning of the 7-year ramp-up schedule, they still amount to an axe blow to the TCM industry. Here is an example:
The original proposed “Right to Sell” fee, per product was 542.00. A typical TCM supply company can hold anywhere from 300 to 1000 NPNs. The original cost to companies for just the right to sell to you would be a yearly fee ranging from $162K to $542K (depending on how many licenses the supplier held).
The new cost proposed is to start year 1 at $154.00, and then over 7 years increase to $317.00.With this new cost, not even calculating the other fees an importer has to deal with, would be anywhere between $46K to $154K (depending on how many licenses a company has) in the first year. This amount would then continue to rise over the 7-year period to peak at 95K to 317K (again depending on how many licenses a company has).
If all a company had was one or two licensed products and they sold thousands of these per year, the fees are not too bad. But, for the TCM industry and other Western Herbal companies with hundreds of plant species in their pharmacopeia, the dollar amounts are overwhelming. The consequence is that products will have to be dropped which will result in fewer choices for clinicians and fewer still for patients.
With this new proposal, HC has given our industry 30 days to reply. The new deadline to respond is April 25, 2024. This is less than 3 weeks away. There has been a request for an extension on the deadline, but HC has not yet formally responded to this.
We attended a meeting held by the CHFA with HC in Vancouver on April 3. Information from this meeting is summarized below:
- The CHFA reports that there are multiple drivers in effect that will change the course of how NHPs will be controlled over the next years. The top-level drivers will be which political party will win the next election in October 2024. The Conservative Party of Canada has clearly outlined their position on this, stating they feel NHPs are being over regulated and they would immediately work towards dialing back regulatory control over NHP’s. The NDP have reflected support of the NHP industry’s concerns but have taken no steps to push for less control and no cost recovery. The Liberals are on high alert and know this is a wedge issue that could tip the balance of winning or losing in the next election, but still have not influenced HC to change course.
- A further report from the CHFA stated that the grass roots campaign to fight these costs and other over-the-top regulatory changes (Vanessa’s Law, Label changes) have amounted to HC sitting up and taking notice. The CHFA states that HC is banking that our industry will back down after we see the reduction in fees. The fact they offered these revisions demonstrates we are having an impact. The conclusion at the meeting was, we cannot back down now!!! A continued multi-pronged effort must be maintained to keep an increasing slow burn of fire at the heels of the regulators. This includes in-person calls with MPs, personal physical letters to the Health Minister and MPs and emails. With enough heat, they will have to re-visit their strategy of over-regulation and the elimination of Cost Recovery.
- We also heard a report from an agency that monitors Adverse Events (AE) for Natural Health Products across the USA and Canada. They reported that AE are very low and are considered minor. The types of events reported are stomach upset, loose stool, headache, nausea, and skin irritation. With this type of data, there is no justification for over-regulation, and we as practitioners must use this as a point of reference.
- HC had three representatives scheduled to speak at this meeting. They offered a very short (45-minute) overview of their activities to the stakeholders present in the room. In summary, each official outlined that HC was trying to improve their services for licensing new NHPs and that they are trying to improve their Site License renewal times. They also shared that their revised fee schedule is up for public commentary and that the date April 25th was a deadline for reply. They said they were considering an extension to this deadline but did not commit to one. During this particular part of their presentation, they clearly confirmed that are committed to a cost recovery process.During the question period, they deflected an attendee’s comments on why Cost Recovery was even being proposed. As stated by this attendee, our tax dollars pay for Government employee salaries. With low AEs and a very compliant industry, the attendee asked why does HC feel it needs to hire more employees to audit and police an already co-operative and low-risk industry. Her forceful and common sense questions to the HC panel resulted in only uncomfortable smiles and no clear answers.In fact, it was amazing and upsetting to us present in the room, that these HC officials spent thousands of dollars to fly themselves out from Ottawa to BC the night before the meeting, offer us only 45 minutes of their time and then claim they had no time for further interactions and were rushing to catch a flight back! This is so disrespectful in our opinion to the hard-working providers of quality NHP products and the practitioners offering patients with healthy alternatives. This, thief in the night, fly in and out strategy is reflective of a noticeable shift in the NNHPD strategy from a collaborative effort of Government and Industry working together to ensure public safety, to one of a paternalistic, enforcement approach that assumes we are all bad players and herbs and vitamins are not real medicine.
Where do we go from here… Phase two – the bigger push
As our title states ACTION… ACTION… and more ACTION… creates… CHANGE! This is in essence what we have to do. If you care about having personal choices for the type of health care you receive and the types of natural health products you use, then ACTION is your moniker word for the next few months! Change is a result of persistent interventions. Just as we know a patient can’t just take herbs for one day to have an effect on a long-term health problem, or we don’t develop new muscle strength with one visit to the gym, the same is true when engaging with a self-aggrandized regulatory agency to inspire it to make a change in their policy direction. The heat and intensity have to be strong and continuous.
Here are our suggestions:
1. Respond to HC’s request before the deadline by filling in the survey:
https://healthcanada.qualtrics.com/jfe/form/SV_a2ZCxwYgfgWqQwS?Q_Language=EN
- The survey will ask for a response to their new proposed fees in a box that offers you a limit of 5000 characters including spaces. This gives you a range of 750 – 1250 words in general. To give you an idea to this point roughly 8,000 characters and 1,350 words have been typed, so you have some space to get your point across.
- If you are a TCM practitioner – reflect the safety of TCM herbs and their historical safe use.
- Reflect that your materia medica has hundreds of substances. Imposing costs in addition to the costs your current supplier is currently being burdened with by managing regulatory concerns, is unreasonable and unnecessary to your supplier and you as a healthcare provider
- Reflect that your access to a constant and varied supply of ingredients is essential to the needs of your patients.
- Reflect that bankrupting the supply chain of products in the NHP industry will only further burden the current medical industry, which in many ways is relieved in part by the services you offer to patients and your access to NHPs.
2. Engage Your Local MP house and place of business
- Call and ask for a meeting with your MP.
- Reflect in the meeting that you are following up on the HC Cost Recovery proposal for NHPs.
- State or re-iterate that the new fees and the 7-year ramp-up period are still unacceptable as your TCM supplier will not be able to maintain the full range of the products you normally use.
- Reflect that you want to be shown the data that demonstrates NHPs are causing harm and the millions of users in Canada are at risk. Ask the MP to put in a request to the government for such data that specifically outlines harms or AE caused by NHPs. State you would like a copy of this. (note if they don’t provide you with anything over the next two or three months, then in reality no such data is available, or it is not reflective of the need for excessive regulatory control). In this instance use this as a case in point with your MP and encourage the MP to challenge her/his party to reject any further regulatory pressure put on the NHP industry.
- Consider the issues that are in the forefront for you in the next election. If the right to access NHPs is one of them, then share this with your MP. Votes are high-level motivators for government.
3. Continue to encourage your patients to reflect their concerns to the government.
- Have them write their MP or the Health Minister
- Email them this link to the SOS campaign being sponsored by the CHFA https://chfa.ca/en/Advocacy/NHPs
- Ask them to read the page and focus on the section “How You Can Help”, tell them there are several tools in that section that they can easily use. Ask them to participate with these tools as much as they can.
- Over multiple visits, keep talking about their engagement on this issue. Gently encourage some action if they voluntarily report they haven’t done anything yet. Make a note in your files if they did or not. We found that gentle reminders are effective, but you may also need to back off in asking if they clearly say that they will do something but after two or three inquiries they report that they did not. Some people will just say yes and do nothing. But, for many, a gentle reminder works wonders.
We thank you for taking the time to read this notice. Some things are important and require time and effort!
Thanks for being a change agent, and we will report back to you as news unfolds.
Sincerely,
John and Kelly
