Health committee  Thank you, Chair. Thank you for the privilege of appearing before you today. l'm a legal scholar with expertise in intellectual property law. Given time constraints, l'm going to focus solely on the issue of transparency, which Bill C-17 does not address. l have two themes, each

Health committee  I'll speak to the specific issue, if I may, of that provision on trade agreements. The current wording of the statute is that it's a power to make regulations in respect of the trade agreements and the opening language of the clause is, “without limiting the powers conferred els

Health committee  I'm not sure if I quite understand the question. Are you asking with respect to clinical trials as a whole or the information around clinical trials that you thought, by virtue of a commitment to transparency, were asking to be made transparent?

Health committee  I might defer to Joel and Janice for some of the particulars, but what I can say that I think is helpful is that there's been a lot of work to define the particular elements. The World Health Organization has sort of done some work that has led to a minimal set of information to

Health committee  I guess I would simply echo that—I thought you were asking specifically about registration as a starter—other kinds of information are critical to get out as well. There's such a course of support for transparency right now that if we limit it to clinical trial registration, whic

Health committee  Clinical trial sites have to receive approval from the government to have a trial conducted there, but they don't necessarily have to comply with any registration requirements. It depends on that site, where it's being conducted in Canada. Publicly funded researchers have to com

Health committee  That's my view. Under trade agreements, Canada is required to put into place measures to protect data, essentially, which might capture, or some would argue does capture, safety and effectiveness data around a drug. But there are two exceptions to that commitment. One is where i

Health committee  That's a great really specific question. I think the amendments I envision would certainly capture negative results, although I think some very careful thinking would have to be done in defining what a negative result is. I'm trying to capture all results, but if you don't have a

Health committee  I share the view that it's not clear to me that they are inherently less risky. For that reason, I think they should be regulated very carefully. I think it's more of a strategic consideration in some ways, as my friend just intimated, although I'm not sure it's that difficult to

Health committee  Perhaps I can speak first. I think the point Professor Gibson was making was around restrictive interpretation of harm or injury. Her point was that without clear guidance, harm or injury encompassed products that had been mislabelled or mispackaged and that therefore wouldn't w

Health committee  I think there have been other examples where there hasn't been quick action by the regulator because there's been a dispute or a discussion about whether the harm is clearly owing. Diane-35 was another medication that's commonly used to treat acne that has received some attention

Health committee  I think it's essential to do a couple of things. One is to ensure that any such conditions placed on a licence to market a drug and to keep doing post-market studies be made publicly known so that others can both hold the company to account and the regulator to account to be foll

Health committee  Absolutely. Bill C-17 is strong as it stands. It could be made really strong if the amendments are included.

Health committee  Absolutely, but it's not clear to me that fewer resources means less transparency. I think it might mean the opposite. But specifically, disclosure of clinical study reports—these are things that are provided by the company—if Health Canada is looking at this as something that

Health committee  Yes, I do. That was in the paper that Joel, Janice, Elaine, and myself, and Barbara Mintzes published. That was one of the points we thought should be addressed in the bill, simply to make it absolutely plain that other corporate actors in the production chain and distribution