OTTAWA - Dear constituent :
Thank you for your correspondence regarding Bill C-51. I appreciate being made aware of your concerns and indeed have spoken to the Health Minister about these issues. The Minister has clarified that many of the areas being discussed are not being portrayed accurately by media and others. However, he did indicate that, in other areas, he will consider revising the legislation to deal with concerns that you have mentioned. Certainly, as someone who has used Natural Health Products myself for many years, I do not want to make these products more difficult to access, nor to have their prices skyrocket, and I will not allow this to happen.
I do want to emphasize that many apprehensions are based on a misunderstanding or misrepresentation of the Bill. Bill C-51 is designed to ensure access to safe, effective Natural Health Products (NHPs), not to keep them from Canadians. It is part of our strategy to ensure that food and products that are available on the Canadian market are safe for consumers. I want to emphasize that Natural Health Products are not regulated as food or as drugs; they have been regulated as a unique category since 2004. Bill C-51 does not contemplate any changes to the Natural Health Products Regulations.
For your information, the Natural Health Products Regulations can be found at http://laws.justice.gc.ca/en/showdoc/cr/SOR-2003-196///en?page=1.
Another area where completely false information about the Bill is being claimed is regarding possible searches of private property. Again, those who either have not read the legislation or are deliberately ‘fearmongering’ have alleged that C-51 allows for ‘warrantless searches.’ This is absolutely untrue. If an inspector needed to enter private property (which includes businesses), they would have to have the owner’s consent or, after making a compelling case to a judge, obtain a warrant to enter. There is nothing in Bill C-51 that changes this. There is one slight exception to this rule as some manufacturing sites may not be situated on public roads or beside public spaces. The Bill contains a provision that would permit inspectors to cross private property to gain access to a manufacturing site. This provision does not, in any way, permit an inspector to
enter a private home or business without consent or a warrant.
I also want to clarify the term ‘therapeutic product’ in the legislation. This term is general in nature because it includes drugs, natural health products, medical devices, veterinary drugs, as well as blood and blood products. They all share one common element: they claim to enhance human health, and Canadians rely on them to do that. When a health claim is made, it needs to be tested in order to ensure public safety.
There has been some misunderstanding regarding the approach of the government toward Natural Health Products. It is very important to understand that the legislation now before the House of Commons requires that compliance and enforcement measures be gauged to the degree of risk of the product. On products of low risk, which includes most Natural Health Products, pharmaceutical standards of evidence are not required. On the other hand, the legislation also requires vigilance to ensure that tainted products are found and recalled, that what is on the label is actually in the bottle, and that health claims are supported by evidence.
Many misleading, inaccurate claims have been made by those who have not taken the time to familiarize themselves with the legislation. In fact, the Minister held recent cross-country consultations following the tabling of C-51 and, as a result of the feedback he received, has proposed several amendments which will clarify the Act’s intent. As he stated in a letter to the Chair of the Standing Committee on Health:
“Bill C-51 is an important piece of legislation that would modernize the Food and Drugs Act and better protect Canadians by modernizing our safety system for health products and food.
“Concerns have been raised about Bill C-51 and its potential impacts on natural health products (NHPs). Many of these concerns arise from misinformation about a complex piece of legislation.
NHPs will not be regulated as pharmaceutical drugs, access to NHPs will not be limited, and inspectors will not be able to enter homes or businesses without permission or a warrant.
“The proposed amendments I would like to bring forward for consideration at Committee stage would clarify the Government’s intent to maintain a separate regulatory framework for NHPs, to highlight that the information required for licensing of NHPs is different than for drugs, and that inspectors must exercise their powers reasonably.”
I am taking the liberty of enclosing an explanation of the above-mentioned amendments, for your information and I would also encourage you to visit http://www.healthycanadians.ca/pr-rp/facts-c51- fiches_e.html where commonly asked questions are answered.
For your convenience, some of the most common questions/myths are addressed below.
Access to Products
MYTH: Bill C-51 will remove 75 per cent of NHPs from the market through the use of strict risk / benefit standards.
FACT: This is completely false. Bill C-51 was specifically drafted in order to allow for increased flexibility to regulate products proportional to their relative risk. The Bill specifically recognizes that different product classes have different standards of evidence. As such, the standards of evidence for NHPs, which allow for a full range of evidence from traditional use to full clinical trials, will remain unchanged.
Definition of Sale
MYTH: The definition of sale and distribution of NHPs within Bill C-51 will impact the practitioner / patient relationship with regard to the practices of compounding and will prevent caregivers from distributing NHPs to patients.
FACT: No, this is false. The relationship between practitioner and patient, specifically with regard to the activity of compounding falls under provincial jurisdiction, relating to the definition of “practice of medicine”. Therefore, the federal government cannot legislate in this area. Furthermore, the concept of “distribution” in Bill C-51 refers only and specifically to cells, tissues and organs and will not apply to the caregiver / patient relationship when it comes to NHP distribution.
Regulating NHPs as Drugs
MYTH: Use of the term “therapeutic product” in Bill C-51 is intended to move NHPs fully into the drug category.
FACT: This claim is false and misleading. The term “therapeutic product” is an umbrella definition applied not only to NHPs and drugs but to veterinary drugs, medical devices, cells, tissues and organs, blood and vaccines. Under this Bill, NHPs will continue to fall under their own unique set of regulations and the provisions for
safety, efficacy and quality (including GMPs) that will continue to be appropriate to the relatively low risk profile of this class of products.
Increased Compliance and Enforcement Powers
MYTH: The increased powers around recalls, enforcement, fines and penalties are specifically targeting the NHP industry.
FACT: This is incorrect, and misleading as these powers apply to all product classes regulated under the Act and are not directed to any single group. These new powers bring Canada up to par with other international regulators. Without this Bill, Canada will remain unable to require recall of products even in situations when there are clear health and safety concerns.
Increased Fines and Penalties
MYTH: NHP companies will be subject to multi-million dollar fines for minor infractions which will result in the bankruptcy of many companies.
FACT: While fines under the new Bill have increased, the highest fines will be applied only for the most severe contraventions. A minor contravention would not be treated in the same manner as an incident that has significant impacts on the health and safety of Canadians.
In the future, under a modernized Food and Drugs Act, the numbers and variety of Natural Health Products will continue to grow, and Canadians can be confident that they will always be able to access innovative, safe and effective Natural Health Products.
I hope the above information clarifies the actual contents of the Bill. I have also attached a document which further details the background to C-51 and its effects, for your interest. I will continue to provide updates to those who have expressed interest and/or concerns about C-51 as the legislation moves through the House of Commons and the Senate. Please watch my quarterly publication, Voice from Vegreville-Wainwright, for information.
Again, I do appreciate the opportunity to discuss this issue further and hope you will continue to advise me of your concerns.
All the best,
Leon Benoit, MP
