Better regulatory actions on Natural Health Products, not more
August 2023 Position on Health Canada and NNHPD proposed changes to NHPs
Since June of 2023, there have been a number of issues that targeted the NHP stakeholders that are attacking the diversity of the Canadian health culture and could result in a devastating loss of NHPs and choice of alternate medicines and small and medium-sized NHP businesses. The issue and our asked are listed below for your reference.
Issue 1: NHPs are relatively safe, when compared to over-the-counter medication. This was covered by the 1998 Parliamentary Heal Committee Report. The resulting NHP regulation has made NHPs safer. There is no need for additional regulatory measures.
Issue 2: According to the legal opinion we received, section 500 of Bill C-47 which makes NHPs one Governor in Council repeal away from being regulated as drugs. If section 500 was not included in Bill C-47, we would not raise the concern.
Issue 3: Impact analysis on cost structure incomplete. I used the product and site licensing database and calculated that the top 5 licensed Traditional Chinese Medicine importers had to pay an annual fee of about 500,000 dollars from 0 today. Health Canada could have done the impact analysis and told each company how much they must pay and obtain their feedback. In addition, after the proposed fee, many small businesses will be forced to close due to the high fees, would that lead to even higher fees? Please tell us what the impact is like in 5 years and 10 years. How many products will remain in the market from the 120000+ today? How many sites will remain in the Canadian market?
Issue 4: The cost technical analysis pointed out that the US supplements (consider food) neither do not have to pay any fee on an import site nor obtain products licensing and most importantly – no fee for the “right to sell”. The Health Canada fee proposal is going to put the entire Canadian NHP industry at a disadvantage.
Issue 5: NHPs are groups or systems for many branches of unique traditional medicines e.g., vitamins and minerals (100+ products), TCM (400-800 products), Ayurvedic (300 products), homeopathic (500+ products) etc. They are part of Canadian traditions; government financial support shall be implemented accordingly just like Agriculture and Canadian media industries!
Issue 6: The Auditor general did not include the relative safety of the NHPs into consideration in the 2021 report. NHP safety is much higher than even products like acetaminophen (Toronto Star report of 68 death per year between 2000-2011). The effort to regulate NHPs shall be much less than that of acetaminophen. Do lower risks, and lower spending on regulation make sense to Health Canada?
Issue 7: The proposed fees will drive consumers to buy NHPs from the US (amazon.com). Health Canada is introducing additional risks to Canadians from unapproved foreign products. NHP safety overall will deteriorate from today because the number and diversity of Canadian products will reduce dramatically, and prices will go up significantly. No amount of fees would be able to allow NNHPD to stop most of the online NHP orders from the US!
Issue 8: Kill the health diversity, innovation, choices, and assets that the current NHP regulating system has created – currently, Canada is considered one of the world leaders in NHPs.
What shall be done?
The following Five points summarize what should be done to better regulate NHPs.
- Educate all Canadians to ensure that they do not support repealing the NHP exemption and let them know that it is critical to the diversity of alternative medicines for Canadians and the livelihood of many Canadian businesses.
- The costing model behind the fee proposal included many inefficiencies within the NNHPD of Health Canada since 2020. Health Canada shall use existing licensing infrastructure, streamline site and product licensing, and use the cost savings to enhance enforcement.
- If changes are necessary, consider aligning some of our regulatory activities with the US. This guarantees that Canadian NHPs are safe, effective, diverse, competitive and affordable to Canadians.
- Full impact analysis shall be done! Using the site and product licensing database, NNHPD of Health Canada shall calculate how much the annual fees are due for each licensed company. Take the list and present them to the companies and the Canadian government. Collect their feedback. I have made a few calculations using the same data; the fee proposal is asking most small businesses to pay annual fees of $40,000+ to $500,000 from $0 today. This is unacceptable.
- Forster NHP diversity, resist attacking the current relatively safe regulatory environment. NNHPD cannot just look at its own cost and try to spread it around, try to protect the value Canada has created in the past 20 years!
August 2022 Cyctek Inc. presented in the 1st International Conference on Traditional Chines Medicine Tele-Healthcare
Topic: Canadian Traditional Chinese Medicine Regulatory Framework as a component of Tele-healthcare
Topic in Mandarin: 加拿大中药法规概述 Traditional Chinese Medicine Regulatory environment in Canada