I have received a great deal of correspondence, and a number of phone calls, regarding Bill C-51.  It is understandable that the misinformation which has been circulated about this legislation, would be of concern. I have spoken with the Health Minister about these issues and he 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 which have been expressed. 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.

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 have posted an explanation of the above-mentioned amendments, and background documents including commonly asked questions on C-51 on my website at www.leonbenoit.ca for your information.

I do want to emphasize that 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.  Canadians have clearly expressed the desire to recognize NHPs as a unique category of products under the Food and Drugs Act.  Currently, NHPs are considered to be a subset of "drug" within the definition of the Food and Drugs Act.  In order to clearly recognize that NHPs are distinct from foods and drugs in legislation, the Government proposes that a definition of “natural health product” be introduced into the Bill. NHPs would be recognized separately from drugs under the definition of “therapeutic product”. These proposed changes would allow for continued access to NHPs and support Canadians in making informed decisions about their health care.

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.  

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 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, and my above-mentioned website, for information.

Bill C-51 and Natural Health Products

• Bill C-51 will not affect the way natural health products are regulated in Canada. These products will continue to be regulated under their own unique set of regulations, namely the Natural Health Products Regulations, which came into force in 2004.
• Natural health products are considered to be generally low-risk but they are not “no risk”, and Canadians continue to need assurances about the quality and safety of the products they use. Currently, under the Natural Health Products Regulations, those wishing to sell natural health products with a health claim must obtain a product license. This would continue to be the case under Bill C-51.
• The Natural Health Products Regulations already recognize that natural health products are different from drugs, and that the evidence requirements for drugs are not appropriate to natural health products. Bill C-51 does not change this, and in fact supports different requirements for different types of products, based on risk.
• Bill C-51 will not convert natural health products into prescription products. Canadians will continue to have the same access to natural health products that are safe, effective and of high quality.
• Similarly, Bill C-51 does not change the scope of the regulated activities specific to natural health products, which are already identified in the Natural Health Products Regulations. These regulated activities are: manufacturing, packaging, labelling, importation and distribution of natural health products for sale.
• The activities of natural health product practitioners continue to fall under provincial jurisdiction, as they do now. Personal use of products by consumers is also not affected by Bill C-51.
  

• Strengthened compliance and enforcement activities in Bill C-51 will apply to all products, including food, and will be based on the degree of risk to human health and safety. They do not change the current approach to natural health products, which will continue to be guided by the Compliance Policy for Natural Health Products and the Health Products and Food Branch Inspectorate’s Policy - 0001. Any future decision to take action will be based on the same risk-based principles that are used today: the higher the risk posed by a product, the more immediate the compliance and enforcement action.
• Compliance and enforcement measures in Bill C-51 respect the Charter rights of Canadians. For example, if entry to a private home were required, the inspector would have to either have the consent of the owner or, after making a compelling case to a judge, obtain a warrant to enter. There is nothing in Bill C-51 that changes this.
• Updates to the Food and Drugs Act will not result in more compliance and enforcement action taken for regulated products, including natural health products. A modernized Food and Drugs Act will allow for more effective compliance and enforcement activities to be undertaken by providing Health Canada the authority to act based on the product’s level of risk.
• The fact is that the compliance and enforcement authorities of the Food and Drugs Act are over 50 years old and need updating. We lag significantly behind other parts of the world in this area, especially in the US, Europe and Australia.
• The compliance and enforcement proposals support our ability to respond to risks, regardless of the product type – they will not result in more enforcement action being directed at natural health products or any other product.