Sure. I think it's important to point out that the situation of Procysbi and Cystagon was rare. It's very unusual that you would have two products coming through the special access program for one rare disease or that you have two products with a very different price.
The consideration under the regulations for the special access program is that we verify whether it's a serious and life-threatening condition. Have the products that are available on the market been considered, tried and failed or considered and not available or not suitable? Is there evidence on its use, safety and efficacy?
When Procysbi came on the market—it's the same molecule; one was extended release and one was immediate release—there was no clear medical reason at the time to say that Procysbi wouldn't be a suitable alternative. The special access program does not consider cost in its review. If you're looking for the reason why a product may be unavailable, cost is not considered. In fact, we're often not aware of what the cost is.
When Procysbi came on the market, the program had no idea at all what the price was going to be. It's not a conversation we're involved with. It's not part of the statutory purpose in the Food and Drugs Act that the special access program consider cost. In fact, their concern would be, if we went in that direction, that it would have an impact on market authorizations in general. It would introduce an unpredictability in the country in the sense that, if an innovator company wants to market a product and goes through the costs of doing research and development, the cost of marketing and the cost post-market, and there is a possibility that the special access program will provide access to a cheaper product that has not gone through extensive safety, quality and efficacy, you might destabilize whether innovator companies will come to Canada, because they have no guarantee of a secure market. It's not something that we—