Certainly we believe that the modernization of the regulatory frameworks has provided some tools that can make that happen.
You need to look at where the different barriers are. In some cases companies don't come, because these drugs have been around for a long time, and there's no new evidence in terms of how well they work. If you have a process that says, “We need to have you submit evidence based on clinical trials on how these work”, these companies are saying, “I'm not going do a clinical trial for Canada; we have 20 years of evidence, in terms of real-world usage.” That hasn't been enough sometimes to get them to get an NOC.
That's number one. We need to be able to accept real-world evidence the same as the FDA does, to say, “Okay, that can happen”.
The second thing we need to look at is that in some cases these companies aren't coming in because it costs a lot. This is a generic drug by this time. They're making peanuts on it. In fact, sometimes they're making less than peanuts on it, because it's lower than their costs. Now they would have to pay an application fee of how much in order to get this drug approved. After it gets approved, we have companies that are caught in a loop that they must now submit to CADTH in order to get it reimbursed. Well, hello, it's already being reimbursed as an SAP drug. Now we want them to pay 70-some thousand dollars to get us to reapprove it. We're not going to negotiate a price, so why would they do this?
We put in these bureaucratic obstacles that do not need to be in there. I just had a company that called me again and said, “Can you please just get Health Canada to accept the IND that we have in the States, developed for a clinical trial? Do not make us write a separate protocol for you. I have five babies that are waiting for treatment. Can we not do this right away?” I'm kind of thinking that it should be able to do it, but we haven't been able to figure out how to remove those kinds of barriers. It can be done, but I think we need to have an even more enlightened approach.
I don't fault the individuals who are there. I really have huge respect for everybody who was here at this table. They work with us as hard as they can. Good God, we keep throwing land mines in their path and tell them to keep jumping.
I think this is the challenge, and at the reimbursement end as well. This is a problem for us. We have companies.... Actually, let's talk about the drug Cystagon. The company brings it in. It's been here for years. They have a certain price, and now we're saying to them, “We'd like you to have an NOC on it so that we can get it out of the SAP.” They're saying that in order to do that, they are going to have to raise the price of the drug. Then, we have one province—I won't tell you which one; I should tell you which one it is—that says, “Oh, you've raised the price of that drug. We don't want to reimburse it any longer, because it used to be cheaper.” Now we have to intervene with the province, to say this is ridiculous.