A Letter to Denise Savoie, MP, about Bill C-51
Jon brought to my attention this morning a speech given by Denise Savoie, the NDP MP for Victoria, to the House of Commons on 1 May objecting to Bill C-51. Below is a portion of her speech, followed by an e-mail that I sent to her office.
The provisions in the bill are worrisome because among the modifications proposed by the bill are radical changes to key terminology, for example, replacing the word “drug” with “therapeutic products” throughout the bill and therefore bringing the natural health industry under the scope of the Food and Drugs Act and Health Canada. This far-reaching change would give the Minister of Health broad powers to regulate all natural health and plant derived products and, in the process, restrict access to these products for Canadians.
Up to 60% of the natural health products currently on the market would be outlawed as a direct result of the enactment of Bill C-51. This would remove a lot of choices for Canadians.
From some of the many letters I have received, there is one from a medical doctor who says, “I’m a medical doctor and a doctor of Chinese medicine living and working in Victoria. I’m becoming concerned that the new Bill C-51 introduced by the health minister might affect the public’s and my patients’ access to natural health products in Canada”.
Indeed, the clauses in this bill would have a serious limiting effect.
It is not by succumbing to the big pharma lobby that we will achieve balance in better regulating natural health products. That is an important piece: we must have a better balance. Perhaps we can do it by creating a third category. This something that the natural health industry has been calling for. Instead of buckling under to the big pharmaceutical lobby, it would simply have its own category, by itself, and regulations that do achieve that balance.
Another comment I have received which has concerned me is the following: “I and my family are opposed to Bill C-51 as it will restrict access and increase prices of natural health products we use regularly”. I think we are all aware that right now Canadians are having a more difficult time. Our economy is in decline. Many people are struggling to make ends meet and are using natural health products to stay healthy. Increasing the prices at this time would certainly not be helpful.
Another comment from one of my constituents states: “Regulations of natural health products should be separate from pharmaceuticals”. This is something that I think we will be asking the committee to look at.
Dear Ms Savoie:
I have just read on your website your speech to the House dated 1 May 2008 concerning Bill C-51. I note in your speech your concern for the health of your constituents and your support of their right to access natural health products (NHPs). I am therefore surprised that the position you take in your speech is contrary to the facts and to the real mitigation of your concerns.
I have no ties to either the NHP or pharmaceutical industries, and I have found all of the information below readily available on the Health Canada website.
You say in your speech that Bill C-51 is:
replacing the word “drug” with “therapeutic products” throughout the bill and therefore bringing the natural health industry under the scope of the Food and Drugs Act and Health Canada.
Although the term “therapeutic products” is being introduced to the Food and Drugs Act by Bill C-51, it is not a new term in Health Canada’s regulations. See Access to Therapeutic Products: The Regulatory Process in Canada. The term collectively refers to drugs, NHPs and medical devices. Bill C-51 continues to require therapeutic products to comply with the regulations that apply to each product’s specific class (i.e., NHP regulations for NHPs). Bill C-51 does not require NHPs to comply with drug regulations. As well, contrary to what you said, NHPs have always been under the regulatory purview of Health Canada, and since 2003, specific regulations for NHPs have been in force.
You say in your speech that:
“Regulations of natural health products should be separate from pharmaceuticals”. This is something that I think we will be asking the committee to look at.
In fact, NHPs have been regulated separately from both food and drugs since 2003 and, subsequent to Bill C-51, will continue to be so.
Perhaps a quick review of the background of NHP regulations will help. The House of Commons Standing Committee on Health met with the NHP community in 1997-8 and collaborated on a regulatory approach for NHPs. The Committee produced the report Natural Health Products: A New Vision in November 1998 with 53 recommendations. The Minister of Health at the time, Allan Rock, accepted those recommendations and began a process to implement them over time. In line with these recommendations, the following NHP regulations have been established and are currently in force:
- Natural Health Products Regulations (SOR/2003-196) in June 2003
- Regulations Amending Certain Regulations Made under the Food and Drugs Act (SOR/2007-288 and SOR/2007-289) in December 2007
When Bill C-51 requires NHPs to comply with therapeutic product regulations, these above regulations are the ones to which NHPs must comply.
It is important to remember the extent to which the NHP community – that is NHP users, producers, distributor, practitioners and advocates – have participated with policy makers in the development of the NHP regulatory approach and subsequent NHP regulations. The inspiration of the New Vision report was a report from the Advisory Panel on Natural Health Products (APNHP), which was made up of NHP community representatives; the Standing Committee on Health heard from a broad spectrum of witnesses from the NHP community in producing the New Vision report; and Health Canada is currently being advised by an Expert Advisory Committee (EAC), which comprises many NHP professionals and practitioners. It would also be interesting to see how many employees of Health Canada’s NHP Directorate have some type of professional NHP or Complementary and Alternative Medicine (CAM) background.
If you have any doubt about the influence of these NHP advocates, I recommend that you read the New Vision report. You will quickly see that the report is very supportive of the CAM philosophy that you advocate and of the desire to give people access to safe, high quality and effective NHPs.
If you wish to refresh yourself on the regulations to which NHPs must comply, both before and after Bill C-51, I recommend reading the following list of guidelines provided on the Health Canada website:
- Access to Therapeutic Products (2006)
- Natural Health Products Compliance Guide, version 2.1 (2007)
- Product Licensing Guidance Document, version 2.0 (2006)
- Compendium of Monographs, version 2.1 (2007)
- Clinical Trials for Natural Health Products (2005)
- Evidence for Safety and Efficacy of Finished Natural Health Products, version 2.0 (2006)
- Evidence for Homeopathic Medicine, version 2.1 (2007)
- Labelling Guidance Document, version 2.0 (2006)
- Guidance Document: Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products) (2006)
Again, NHPs must comply with the regulations described in these Guides, not to the regulations in force for drugs. Bill C-51 will not substantially change this situation, except as may be required by the incorporation of progressive licensing. These NHP regulations are in line with the recommendations of the New Vision report and were developed in collaboration with the NHP community.
Finally, I am surprised by your quote that:
Up to 60% of the natural health products currently on the market would be outlawed as a direct result of the enactment of Bill C-51.
Based on the context of that line in your speech, you are implying that, by imposing drug regulations on NHPs (according to you), this will be the outcome. I believe that you have taken this statistic from the legal review of Bill C-51 circulated by Shawn Buckley, president of the NHP Protection Association (NHPPA) in which he observed that “currently roughly 60% of natural health product license applications are failing.” This statement means that 60% of NHPs submitted for product licensing under the current NHP regulations have failed. Have you checked that this is an accurate statistic? If it is, are these “failures” severe, irrecoverable problems or minor rejections that require further information or minor corrections to their submissions prior to approval? More importantly, does this not mean that the NHP industry, which helped developed the regulations to which they are now held, must answer for their poor performance in not meeting those regulations?
The product licensing regulations have been established to ensure the safety, quality and effectiveness of NHPs. People have a right to have health products that are safe to consume, that contain the ingredients listed, that are produced under high quality conditions, and that will produce the treatment effects that are claimed. As you say in your speech, “[i]t is important for Canadians to have clear information about the health product they take.” That is exactly what the product licensing, labelling and advertising regulations do with respect to NHPs.
If, in fact, 60% of NHPs are not substantially meeting the NHP product licensing requirements, shouldn’t the responsible governmental action be to investigate why the NHP industry is not living up to its responsibilities to provide sufficient and accurate submissions rather than to lower the regulatory standard for them and put Canadians at risk?