Good morning.
This time around, I will be making my presentation in French.
As a pharmacist, I believe the product licensing problem stems from a dispute surrounding the scientific data. There was an attempt made to impose a pharmaceutical model on products the use of which has nothing to do with the pharmacological model of one molecule—one receptor—one effect. We're talking here about extraordinarily complex products. A single plant can contain several active ingredients. When we're dealing with complex products—and Mr. Creber alluded to this—we're getting into a complex area where stakeholders tend to get completely confused by all the regulations.
Pharmaceutical products are patented products. The patent guarantees a protected market which makes return on investment possible and generates revenues to cover the cost of the research required by Health Canada. The problem with small companies—and in Canada, barring exception, companies that make natural products are small—is that they simply do not have the resources, whether it be to obtain scientific data or to keep pace in terms of financial and human resources. A number of small companies are thinking about closing their doors because of the cumbersome legislative requirements.
As I've already said, I'm a pharmacist and from my vantage point, I see both sides of the issue. When reviewing this whole question, it is very important to look beyond the people who are armed with university degrees, however knowledgeable and amazing they may be, and look to people with genuine ability in the area of product formulation. These people know why a given ingredient is used in a product, but they do not rely solely on lists. They also have practical skills that cannot be acquired in a classroom. They understand why a particular formula must contain a certain ingredient, or why another formula is totally harebrained, despite the accompanying scientific data.
One example I have for you is Red Bull, the leading energy drink on the market. To my knowledge, this product received the first ever NPN licence awarded in Canada. The pharmacological file on this product is extensive. However, is the safety of the product guaranteed? Has any follow-up been done with young people? Has anyone checked to see what happens when the product is combined with alcohol, or what the effects can be from an overdose or from chronic use of the product? No one has looked into this. I repeat, this is a well made, legitimate product, but it may not be as safe a product as it should be. You can read about this in my notes. I have made copies for everyone.
Do we need the same protective criteria for totally new, synthetic, biotechnology compounds as we do for organic echinacea tea formulated by the local herbalist? Of course, there will be a product monograph for the echinacea. However, when two plants, or native plants are combined and there is no product monograph, the poor herbalist will not have the resources to complete the file. The product will therefore be lost.
Summing up, I have to admit that the NHPD has done a very admirable job indeed. The creation of a third category is a first of its kind, or almost, in the world. This initiative deserves to be supported because in my estimation, natural products are neither drugs nor food substances. They fall into both categories.
Thank you.