Finance committee  We didn't allude to it, Mr. Cullen. On the story that I think you're referring to, I don't believe that any.... Rx&D; has not formally asked for that. It was a study commissioned by the Council of Canadian Academies on the need for pediatric clinical trials and the subpopulation.

Finance committee  We're looking at the study, and in general, yes, in the context that if there's an opportunity to have rigorous Health Canada-approved trials to ensure that the medications that doctors are prescribing to children and to other subgroups as well.... The Senate committee has studied a lot of this.

Finance committee  Through you, Mr. Vice-Chair, to Mr. Keddy, in the context of our presentation today, in terms of a driving an innovation environment that fosters Canadian competitiveness, the stability and predictability of the Canadian business climate is important for life sciences investors and, I would dare say, for some of the other industries that are represented across the table today.

Finance committee  At the end of the day, the protection and promotion of the safety of Canadian patients is the top priority, for us as well as for Health Canada. And as long as that takes precedence over all other priorities, no dual mandate exists.

Finance committee  Merci, monsieur le président. Through you to Mr. Caron. Very quickly, as we pointed out in our submission, the promotion of health and patient safety is not incompatible with innovation for the FDA. It is not incompatible with the role of innovation for the European Medicines Agency.

Finance committee  Thank you, Mr. Chair. My name is Walter Robinson, and I'm the vice-president of government affairs for Rx and D. I'm joined by Mark Fleming, the director of federal affairs and health policy at Janssen, the pharmaceutical companies of Johnson and Johnson, who also serves as vice-chair of our national affairs committee.

Finance committee  Another area of focus critical for business stability and confidence is safeguarding confidential business information. In June this House passed Bill C-17, which modernizes Canada's Food and Drugs Act. To be clear, we support the principles, objectives, and direction of Bill C-17, as it essentially codifies the manner in which our members already work with Health Canada to ensure and promote patient safety.

Health committee  Through you, Mr. Chair, to Dr. Lunney, as we had a conversation earlier, I won't speak to specific products, but the therapeutic class I know very well. I take two PPIs a day for a hiatus hernia, because they are avoiding an unnecessary and invasive surgical procedure that is 50% effective, not 100% effective.

Health committee  Many of those products are now in the generic realm and have lost their market exclusivity, which comes back to the point that I made earlier in my testimony. It is about how we're in a continuum here of health care of proper diagnosis, appropriate prescribing, optimal use, real-world surveillance, and measuring outcomes to move us back to a virtuous circle of medicine—which you know well as a physician—back to proper education and diagnosis.

Health committee  There are trials during and after a drug's lifecycle. Before it is put on the market, during the clinical trials, there is a safety program. There is— real world evidence that we collect, Those are the requirements of regulatory bodies like Health Canada or the FDA. After the end of a drug's lifecycle, we have to keep providing information that it is not harmful for 25, 30 and even 50 years.

Health committee  Yes. Both. Under the legislation, Canada's Medical Technology Companies and the Canadian Generic Pharmaceutical Association are required to do that. Let me continue in English. By law, we've always been required to report adverse events. We have safety studies in the clinical phase and in the regulatory approval phase.

Health committee  I would start by noting that many aspects of Bill C-17 already codify the manner in which Rx&D; member companies have been interacting with Health Canada and other regulatory bodies, not only here in Canada but similarly with Health Canada's peer agencies, for a long time. Regarding the issue around the specific article you mentioned—and I think that had to do with Dr.

Health committee  I can't speak, again through you, Mr. Chair, to individual products. The question is more of a broader policy question. I appreciate that, and I can speak to recent examples where you're seeing more global recalls or voluntary withdrawals of product. I'll ask Keith if he has anything further to add on that—and he did want to answer the other question, because it was an important one, on plain language labelling.

Health committee  The ones that are approved by Health Canada, which are our trials, are already public.

Health committee  They're publicly.... There is a portal on the Health Canada website today with those trials.