Health Committee on May 8th, 2008

[Patrick Brown, Conservative, Barrie, ON]

For the regulations.

[James D'Astolfo]

I think mandatory reporting and compliance should be enforced. I think companies should be responsible and conduct clinical trials in terms of their products. We also believe in education of the public and making sure the public is aware of what they're taking. Consumers have a choice in terms of what kinds of products they take, but they have to be informed that there are clinical trials out there that support the effectiveness of those products.

[Patrick Brown, Conservative, Barrie, ON]

Is enforcement currently adequate, in your opinion, Peter or Trueman?

[Trueman Tuck]

Basically, what happens is that.... I'll confess, from Health Canada's point of view, I'm a criminal, because I have a family business, Tucksdiscountvitamins.com. I import from the U.S. kava kava, alcarnatine, which is on schedule F, and our group of small businesses that has included Truehope, Strauss, Bell Lifestyle, BIE.... We have a group of businesses. Four of our businesses have faced Health Canada in massive criminal trials over the last five years. Our small businesses have invested over a million dollars in legal fees to basically tell Health Canada that if they can't convict us of a criminal offence in front of a jury, they have no federal jurisdiction so they should leave us alone.

In the U.S., the Dietary Supplement Health and Education Act.... We did a study. If you go to New York State, you have about 70,000 products on the market. So when they started these illegal health regulations.... We complained, by the way, for three years that within REGS--the scrutiny of regulations committee--these are illegal and outside the criteria, and that committee hasn't heard any of this in three years either.

[Patrick Brown, Conservative, Barrie, ON]

Peter, do you have a comment on that as well?

[Peter Helgason]

Well, I kind of get it. Are the regulations strict enough? I would go back to the Direct Sellers Association's point that somehow often the goalposts are moving, so what's sufficient on one submission.... I will apologize. I hang out with way too many PhDs and lawyers. That said, these are people who are experts in their own fields, and they see that what they did last time is rejected the next time and they're scratching their heads trying to figure out why.

Then there's an exceptionally complex bureaucratic process that you have to go through. You know, you wait in line, wait in line, wait in line, punt it to the back, and before you can even ask your question as to why you were punted to the back of the line, you have to wait in line for six months to a year again.

The other part of the regulatory impact is something that was brought up here, a herbal sleep product that was spiked with benzodiazepines. Something I was surprised to learn, and I think most lay people would be surprised to learn, is that about 75% of the prescription drugs on the market are actually derived from plants. There is a sub-branch of science called ethnobotany where drug companies hire scientists to go out in the wilds and study indigenous cultures to find out what cool plants they use, and then they isolate molecules from those plants, run them through the clinical trial and patent process and have very profitable products.

Well, when you sell a natural herb that that product is extracted from, when you run a mass spec or a high-pressure liquid chromatograph on it, yes, that molecule is there. That's where it came from. But it has been patented by someone else. So it's a complex issue.

[The Vice-Chair, Liberal, Lui Temelkovski]

Ms. Wilkie, could you make a short comment, as we're wrapping up.

[Anne Wilkie]

Thank you.

Just in terms of compliance, it's very difficult to go out there. The industry is desperately trying to comply with the regulations now. But the way the regulations were written, as of January 1, 2004, when they came into effect, all 50,000 products on the market had to be licensed—unless they had DIN numbers. And as you heard, four years later, the NHPD say they are still wading through a huge volume and backlog of submissions.

So to go out there and proactively enforce the regulations and look for NPNs is not doing anybody a service.

And the industry wants those licences as desperately as the consumer does. They are in a very tenuous position right now, but they are aggressively trying to comply with the regulations.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Mr. Brown, and thank you to all of the panellists. This concludes our meeting today.

The meeting is adjourned.