Health committee  I think it's important to keep in mind a couple of things. One is that there are these international agreements that create minimal requirements around intellectual property. You have to have a patent system. You have to put into place, as you say, measures to protect data. But they don't necessarily determine what your patent system looks like and what the requirements in your particular country for patenting are.

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 chain that have pharmaceuticals, if they have them in their hands and there's a recall on that particular drug, they're subject to that recall as well.

Health committee  Thank you for the question. I think it's critical to think about transparency in terms of the institutional picture that Health Canada presents, compared with other regulators. Just thinking about it on its own, it clearly does not necessarily have as many resources as would be helpful to deal with some of these issues.

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 they have to craft and massage and at the resources that will take, yes, that is scary, and they may never get those resources.

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

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 work as a result, as was the case in a contraceptive pill, which they may not include in the definition of “harm”.

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 in the last year or so.

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 following up on those particular conditions.

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 fix this part of the bill.

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 result per se because they stopped the trial, when does that become reportable?

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 it's necessary to protect the public, so a public interest exception, and I would make the argument that it is absolutely the case that we have to have this information.

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, which has been happening for years and years in other countries, it's really at the risk of being a pyrrhic victory.

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 comply with registration requirements pursuant to the tri-council policy statement, but that doesn't capture trials that are privately funded, conducted by private research organizations, which is fairly common in Canada.

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 be included: the number of patients, those who withdrew from the trial, the different kinds of outcomes they are looking for in the trial, the design of the trials.