Health committee  Thank you, Mr. Chair. I'll point out first that the language “business proprietary information” doesn't quite match up with the definition of “confidential business information”. That may be the intent of this wording. Could I get that as a clarification?

Health committee  Okay. There is a motion already, a CPC motion, that allows regulations to be made to clarify when something is not confidential business information or ceases to be. With that regulation-making power, it provides the necessary ability for the Governor in Council to make any regu

Health committee  Mr. Chair, the proposal here was being made because in each of the grants related to the Governor in Council, the language is being modernized and made consistent. So you'll see this in each grant of power to the GIC to make regulations. That's all that was being changed here.

Health committee  Thank you. I don't want to fulfill your prediction, but we do worry. We walked through this to see what kind of regulations could be made. You would have to have a prohibition on the receipt of a gift of a certain nature, then you'd have to make a rule that says you have to repo

Health committee  It really matters whether, in making regulations under this section, Health Canada would be enforcing rules on the interchange between companies and physicians, for example, for which there are some rules already governing advertising and promotion. It's a little unclear to us wh

Health committee  Thank you for the explanation. When you're making regulations under this kind of section, because it is up under the criminal head.... Usually the recipe you have to use is that you make a prohibition—make something criminal—and then sort of allow it. Around things like best pr

Health committee  I should mention that I'm just here as a departmental official, and the legal counsel is beside me. We're both David K.

Health committee  On this, there is a supporting ability to make regulations related to what will be at the legislative level to compel registration of clinical trials. It's the prescribed information in the prescribed time and manner. That would cover all of this. Your point about observational

Health committee  Thank you, Mr. Chair. There is an important principle of transparency around the conditions of an authorization, which is certainly very important in the regulatory cycle. If a drug is approved and there are conditions to conduct further studies on market, there is an interest

Health committee  I would begin with the observation that putting in the refusal criteria when a company applies to get on market is already something that the minister can do, or the GIC can do, under the current act. We can, in regulation, stipulate grounds of refusal without having this as an a

Health committee  Mr. Chair, the idea that you make the provision of information connect the registration of clinical trials with the validity of a market authorization.... There's a lot to look at there. A market authorization allows a drug to be given to a patient. These are often very needed.

Health committee  Thank you, Mr. Chair. In contemplating the difficulty you sometimes see with devices, if you have an MRI in a hospital, for example, to recall it, you don't want to pull it out of the hospital. It would be a great expense, among other things. That's why, in proposed subsection

Health committee  I have very great respect for all of them, but you need to look at the definition of “sell”. I think what was not raised in that discussion, which is very important to cover, is that “a person who sells”—and that is defined in the act—is somebody who either sells for money or dis

Health committee  It's basically to show who can be ordered to do further tests and studies or label changes, for example. It's usually identifying a group of people who are the regulated parties. That's usually the drug companies or the warehouses that move the product and that hold an establishm

Health committee  There are two powers here. One is that if there is a risk of injury, the minister can disclose very broadly—so to consumer groups, publicly. There's also an ability in proposed paragraph 3(3)(c) to give it to.... Researchers would fall into proposed paragraph 3(3)(c), a person wh