Health committee  The closest you come to experimental drugs is if you're enrolled in a clinical trial, in which you would be part of the process of discovering...but by the time it's being put into you, it's pretty much sure that it's going to be safe. The question is, what's the dosage and how much can the patient withstand?

Health committee  If it has been approved. Usually the FDA or the European medical community has approved it as well. We're not talking eye of the newt type of stuff here.

Health committee  Perhaps you could define “experimental drugs”.

Health committee  Sure, but just to be clear, by that time, and we're talking about probably in 10 to 15 years, it will have gone through a very rigorous testing process in labs where you use probably rats, but also then you have to go through clinical trials. There are three different phases of clinical trials in human beings to make sure these drugs are absolutely safe and efficacious for patients.

Health committee  You're entirely correct that other countries do have them. We've seen success in some, but some of them reduce their costs by just eliminating some of those therapies. They just say they're not going to pay for those therapies and take them right off, and the patients never get access to them.

Health committee  Absolutely.

Health committee  Thank you, Mr. Chair. Thank you for the question, Ms. Harder. I think your question points out something really important: it's not necessarily the therapy; it's the people. People are very complex. They react differently to different molecules, to different treatments. Mr. Keon's point is correct.

Health committee  It absolutely could; it depends on how it's designed. The complexity of our industry is one where you have small innovators that have a great idea and they're trying to move it forward, but they need partners. They need investors. A lot of those partners and investors come in the large multinational companies that are doing business here.

Health committee  The system is in place to do that already. It's working in a very healthy way. On the small molecule side, you have the patent protection that allows the generics to come in. We're moving to the same sort of system for the complex biologics. That's already there. In a pharmacare system, I think the challenge is going to be—and you were pointing this out in your remarks—that if you move uniquely to one type, whether it's a generic or you limit access to a number of different innovative medicines, you're creating a marketplace that's not competitive with other marketplaces.

Health committee  Certainly you've touched on an important part of this, which is that these are new, are ground-breaking, are game-changers, and they're lifesavers. They're also expensive; there's no question. When you're in the biologics space, you're into a very different game. You require some fairly significant infrastructure to create the therapy, so there is an expense there.

Health committee  I'm glad you were able to clarify that, Mr. Chair.

Health committee  Thank you Mr. Chair On behalf of the BIOTECanada members, thank you to the committee for giving us the opportunity to speak today about these very important issues. I'll briefly introduce our industry. Biotechnology is a pretty broad envelope. It includes health biotechnology, but also for BIOTECanada we have members that are in the industrial, agricultural and environmental space.

International Trade committee  They're essentially catching up. Let's put it that way. We're talking about a two-year restoration period for patent term restoration. In Europe, it's five years. In the U.S., it's five years. It's trying to keep pace with them. It's not exactly five years, but it's better than what we had before, which was nothing.

International Trade committee  Canada would be unique. We were the only country.... I'm sorry, Brazil, India, and China, I think, are the other countries that don't have it, but in the OECD we were quite unique in that we didn't have anything in place already.

International Trade committee  Yes, we're definitely ahead of those countries. There are other factors at play in those countries, but more importantly, I think, it keeps pace with the EU, the U.S., Japan, and other jurisdictions where biologic innovation certainly is taking place.