The Real "Hot" Issue of the Week

May 12, 2008

Often the grandstanding and political posturing on issues by politicians on Parliament Hill fails to generate even a single phone call from you and your friends to any of my offices.  What did get a lot of calls and activity this week was Bill C-51, relating to Natural Health Products (or NHP’s).  As a user and a fan of NHP's I can tell you I gave this legislation very close scrutiny and tough questioning to the Minister of Health when he brought it to us in draft form. Upon receiving the feedback he then reworked the bill to deal with the concerns and then introduced it in its present form.

However, as my constituents, I take seriously the concerns which many of you have brought to me this week in e-mails, calls and personal visits to my offices.
I compiled as carefully as possible a list of the key specific issues you have raised.  Many of the ones you brought forward have also been brought to Minister Clement’s attention from others.  I have asked my colleague for specific responses to each one based on the legal and scientific realities of the Bill.

Here is what he has said to date…The legislation is designed to ensure access to safe, effective Natural Health Products, not to keep them from Canadians.  There are many cases of adulterated Natural Health Products, such as the pills ‘Sleepees’ that were the subject of national media stories, and Canadians want us to make sure they’re safe.  Products that make health claims must be regulated; otherwise they can be sold as foods.  Natural Health Products are already a separate category in the regulations of the Food and Drugs Act. They are not regulated as drugs, and Bill C-51 won’t change that.

In response to claims that Bill C-51 will remove 75% of NHPs from the market through the use of strict risk/benefit standards he responds that 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.

It has also been reported that 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.  That too 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.

One constituent had heard that the use of the term ‘therapeutic product’ in Bill C-51 is intended to move NHPs fully into the drug category.  This is of course a false representation. 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.

With regard to the claim that new powers around recalls, enforcement, fines and penalties are specifically targeting the NHP industry, this is incorrect and misleading.  These powers apply to all product classes regulated under the Act, are not directed to any single group and will 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. 

Folks, as the Bill moves to debate and study in the House of Commons I will monitor it closely to make sure your points are fully dealt with. Let's keep in close touch on this one. I want NHP's to be safely in place for you and for me.