Health committee  Mr. Chair and honourable members, thank you for inviting Rx&D to appear before Bill C-17 today. My name is Walter Robinson. I'm vice-president of government affairs at Rx&D, and I'm joined by my colleague, Keith McIntosh, our senior director of scientific and regulatory

Health committee  Rx&D members seek to meet or exceed all legal and regulatory requirements regarding safety, product quality, and the information that is provided to patients, their families and healthcare providers. In conclusion and in reviewing your work today, we are encouraged by your c

Health committee  Through you, Mr. Chair, I thank Ms. Davies for the question. I would point out that our code of ethical practices in chapter 16 shows how we work in concert with the Food and Drugs Act regulations that are already in place for the distribution of clinical evaluation packages, or

Health committee  Through you again, Mr. Chair, we followed the testimony closely. There are four things that cover our conduct in Canada. First is the Food and Drugs Act, the law of the land. As we've noted, we support the improvements proposed before this committee in Bill C-17. Second is our c

Health committee  As you've heard, and as we noted in our testimony, about 75% of our activity in this country is in clinical trials. That mirrors about 75% to 80% of global activity of the pharmaceutical industry funding clinical trials. It's in our interest to do so, to bring new medicines to pa

Health committee  There are a variety of things. I would also—very succinctly, Ms. Adams—point you to the work of your colleagues in the Senate. The Standing Senate Committee on Social Affairs, Science and Technology is lead by your esteemed colleague Dr. Kelvin Ogilvie, whom I know many of you

Health committee  Through you, Mr. Chair, to the honourable member, to start, I commend your work on patient safety. As I pointed out earlier in our remarks, all clinical trials that are conducted in Canada by industry must be registered with Health Canada, and we need to report the adverse event

Health committee  Through you, Mr. Chair, to the honourable member. It is true that adverse events happen with medication. One of the things we pointed out, and which we believe could be improved in the bill, is that when adverse events occur, we would like to see not only a notification to Healt

Health committee  I'll defer to my colleague, Mr. McIntosh, who has a much more detailed knowledge of that aspect of the act.

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.

Health committee  As I understand it, yes. Could I add, though, that one of the challenges—and I refer back to the work done in the Senate committee—is that these are global trials involving multiple companies, multiple countries, 5,000, 10,000, or 12,000 patients, and multiple sites across Canad

Health committee  Through you, Mr. Chair, to the honourable member, I cannot comment on specific product decisions or specific company dialogue. I can speak at a policy level with respect to risk-based communications. I'm going to ask my colleague Keith McIntosh to walk us through what some of th

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. Re

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 any