Thank you, Mr. Lee.
Evidence of meeting #26 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
Evidence of meeting #26 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
12:50 p.m.
Conservative
Ron Cannan Conservative Kelowna—Lake Country, BC
Thanks. I know they do that with the children as well.
Thank you very much.
12:50 p.m.
Conservative
May 1st, 2008 / 12:50 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
Thank you, Madam Chair.
Thank you for the presentations today. I know we have very little time.
I'm interested in pursuing the reference that was brought up earlier regarding counterfeit drugs and how we are, to the best of your knowledge, checking for counterfeit drugs to ensure that patients are getting the right drug in terms of the relationship to adverse drug reactions.
Mr. Fraser, would you comment?
12:50 p.m.
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
With respect to counterfeit drugs, they are not really provincial jurisdiction, but I know that the colleges will often have processes and policies in place so that if something is reported to them, they may elevate it through, I suspect, to Health Canada.
12:50 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
Mr. Lee, what about doing spot checks in pharmacies to find and identify counterfeit drugs?
12:50 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
My colleagues from the inspectorate would best answer that question for you, but I've certainly done enough briefings alongside them to know they are doing a lot of work at the border, and they've been very involved with us in working out the new policies. They also deal with colleagues in the RCMP, for example.
So there has been a lot of good discussion on this topic, but I'm less than qualified to do justice to the question.
12:55 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
Perhaps you could help to facilitate that information being forwarded to the committee for our report.
12:55 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
Yes, absolutely.
12:55 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
As well, Mr. Fraser, is your working group going to be providing recommendations for our committee's work, or can you?
12:55 p.m.
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
The working group has been putting forward some recommendations, but again, those are still being discussed through some of the ministers, so they won't be presented to this committee.
12:55 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
I think it would be very helpful if we could have that type of information. I know that the FPT ministerial task force on the NPS hasn't submitted a report here since 2006. Are we missing one? Should we be expecting one?
12:55 p.m.
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
There have been some discussions and recommendations under way, but again, those are still under discussion and we're waiting for direction from ministers on the next steps. So those are still in the formative stage.
12:55 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
Finally, Madam Chair, I'd like to ask if our witnesses believe that progressive licensing will improve or reduce consumer safety in terms of drugs for Canadians.
12:55 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
That is the absolute intent. It is actually to make sure that not only can we do that at the pre-market stage, but also that we can do it as the therapy goes out. We recognize that it's a complex job, but that's why we're trying to put in very good supervision.
12:55 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
I'm asking this because the United States has identified difficulties they've had with this process. I think they may not use the same terminology, but they have had difficulties with compliance by industry, I believe.
12:55 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
Yes. Well, they've been making a lot of changes as well. Again, we're not saying that progressive licensing is fast-tracking; rather, progressive licensing describes the way we generally market-authorize a drug, and there's no reduction in standards here.
We're adding to the post-market, because you can only know so much when you first authorize a drug, and then when it moves out into the community of use, you can start to see things that you wouldn't see in a clinical trial. We want to make sure we have really good tools that are very enforceable and effective in communicating, because it's not just enforcement that matters, but also that we're actually communicating well with health care professionals and the consumers and patients who are taking a drug.
12:55 p.m.
Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
I would just add that in the American example, they have just obtained new legislative authorities as well. I think these just came into effect in 2007. This also affects their tools vis-à-vis post-market authorities.
12:55 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
We've been talking a lot with our colleagues in the FDA to learn from them, because we want to advance the best model that we can. Similarly, the Europeans have been very helpful to us in showing us what's worked for them as they've modernized.
12:55 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
So this proposed new approach will not reduce any safety mechanisms at the pre-market stage?
12:55 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
No, no, it will not. It will maintain the very high standard that we have.
12:55 p.m.
Conservative
The Chair Conservative Joy Smith
I want to thank the witnesses. We've had a very, very interesting dialogue today and some really good questions and answers. I appreciate this very much.
But I understood that Health Canada was going to bring forward a schematic of post-market activities. Could that perhaps be provided to the clerk so that we could distribute it to all the members? Is it possible to have that?
12:55 p.m.
Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Yes, I think so. We'll go back and check, but I think that should be okay.