It really depends on the data requirement. Essentially what's happened is that only large multinational companies are capable of, one, using GMO technology, and, two, bringing something to market. But it costs millions of dollars for one variety. If you look at something like corn, there's a 25% turnover every year in the varieties that are on the market because after four years, farmers don't want that four-year-old variety. Corn, canola and soybeans are really the example where innovation is the strongest as far as R and D is concerned, but it costs millions of dollars.
Essentially what happens is if CFIA and Health Canada determine you need to do a pre-market assessment, you have to do field trials. You have to have confined field trials to grow it all out. It really depends on the data package, the data submission. The actual cost of making the submission is not that high. It's what comes with it. They'll say you need to generate data on this, and data on this. These are lengthy reports, multi-hundred page reports.
Where it really becomes difficult is there's no clear path to when this is going to be over: “When is my assessment done? When am I approved or rejected?” That makes it really difficult for a company to commercialize, to say they want to invest $6 million to get this variety to market. They have no idea when they'll be able to plant that and actually start getting a return on investment.
It does depend on the particular situation, but it has essentially created a system where only six to seven major multinationals play in that PNT space. Smaller companies might license from them but they certainly don't have a four-person team in regulatory affairs to steward their innovation through the process.