Thank you very much, Mr. Chair. And thanks to the panel for having me out to speak. I appreciate it.
Most of you likely have not heard of us or our company. Just to give you some brief background, at risk of sounding like an infomercial, which I don't want to do, we're a contract research organization founded in 2002. We've been federally incorporated since then. We have four divisions at our company: a human clinical trials division, a product analytics division, a human diagnostic division, and a regulatory consulting division. It's important to note that we don't do any work with pharmaceuticals. We do only human-based work on non-pharmaceutical, active ingredients used in the food, beverage, cosmetic, and natural health product sectors.
We've been involved in whole or in part with approximately 250 Health Canada-approved health claims across those categories. Sometimes we're doing the entire process for the sponsor; sometimes we're doing a small part of it. We've been involved with roughly 250 of these.
One of the key topics I was asked to speak on was whether the federal government should fund research in Canada in the agritech/agrifood sector, and how should it be funded? I'm going to speak to that today.
Interestingly, alongside this, in March 2009, Health Canada published a food health claim relationship monograph. It was intended for food and beverage companies and agriculture and agrifood companies so that they could look at how they could substantiate a health claim for their products. What we're talking about is the direct interface between a product and the consumer.
AAFC, in response to this monograph, came out with an RFP through the MERX system. There were six of these RFPs, and as part of the response to the RFPs, we were asked, as one of the bidders, to put in place our decision tree for choosing which six sectors we were going to concentrate on and how did those six sectors relate to the body of evidence in the literature.
We won five of those six RFPs. We have long since completed those. Two of those six have gone to expert panel review, and one of the two, thus far, may have some really interesting new health claims associated with the product area.
When we conduct a systematic review, what we do is look at the entire body of evidence out there. We establish parameters for the inclusion and exclusion criteria for choosing the publications that will be used to substantiate the claim. We then determine which ones will be used and why. In one particular instance, using our criteria for which publications were going to be used for the five groups we were looking at, this is what happened. After title, abstract, and full-text filtering of 14,658 unique references on this particular agrisector category, which is a significant one for the agriculture sector in Canada, we were able to use 59 publications. That was after having started with 14,000. There were 45 intervention studies, one observational study, and 13 meta-analyses, which are systematic reviews or authoritative statements. These are documents that are in the public domain.
When you look at that, there are roughly 14,600 studies that, from a Health Canada health claim substantiation perspective, are unusable, and from an AAFC perspective, based on the monograph, are unusable. So it really comes down to what the expectation of outputs are for AAFC, for Health Canada, and for the Government of Canada.
To me, in terms of how research is funded, the reason so many of these studies were rejected was that they were not powered properly. For instance, if you want to power a study properly for cholesterol lowering, you need two groups, minimally, for a double-blind, placebo-controlled trial, and you need 45 subjects. If you don't have 45 subjects, it won't produce statistical significance. You don't have a publication, and you don't have good stats in terms of proving a health claim relationship between a particular food and cholesterol lowering.
They didn't have enough subjects. They didn't have enough groups. The end point they were looking at wasn't reflected in the duration of the trial. For all these reasons, we see time and time again lots of good money chasing after flawed trial design.
From our perspective, as it relates to AAFC and Health Canada and growing agrifood sectors across the country, there are two key opportunities that work synergistically.
The first one is the health claim opportunity. I can tell you first-hand that when Health Canada puts a stamp on a substantiated health claim for a Canadian product that's tied to Canadian agriculture, it improves market share domestically and internationally. I've had tons of feedback from multinationals all the way down to very small companies in this regard. To me, that's a key output.
Oftentimes, taxpayers' money goes to fund trials through various mechanisms that are designed in a flawed way that won't even produce the results. Even if they're favourable or positively trending results, it won't produce the results to substantiate a claim to get Health Canada's approval. That is a big flawed area in terms of a gap analysis.
The second is the intellectual property that's produced. It's often very difficult for food and beverage companies to get intellectual property around a formula in this industry. Where they can get some IP protection is on source, which goes back to livestock and crop. Tied to their source, and unique sources, product-specific data is incredibly important for IP protection in order for them to grow their sector and market share domestically and internationally. They can do that through a health claim.
In terms of patent filings, and trademark filings around brands, this is where you think of the Millennium asparagus crop as one where you could potentially tie specific outcomes to a substantiated Canadian agrifood sector and turn that into a domestic and international growth story for that market group.
For me, as it relates to all of this, if the Government of Canada is interested in these two opportunities and interested in these outputs as a tangible outcome from funding research through Health Canada and AAFC dollars, there has to be a threshold for minimum trial design, or time and time again you end up with the scenario that I've outlined above. This isn't one that I picked out of many; this situation occurred across all five areas we looked at on behalf of AAFC.
However, if the Government of Canada is interested in basic investigative research with no parameters on trial design in terms of the commercialization pathway, very early investigative work exclusively, which is how the funding model is set up now, whether it's funded through marketing boards, growers' groups, or university-based or university quasi-based organizations and associations, then the status quo is sufficient.
If you're looking for these outputs specifically to enhance Canadian agriculture, there have to be some parameters around how these trials are designed. These are the ones that are published. Think of all the money that's gone into trials that journals have rejected because they're not properly designed. If you think of all that investment and what it's actually producing, I think the return on investment is far too low and could be a lot higher.