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.
Liberal
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
That hasn't been the mandate of this working group. A lot of the working group itself is focusing more on the fact that there is a lot of research happening out there in the field when you're looking at post-marketing surveillance or post-market studies, so how do you collaborate and form networks of those studies?
On the progressive licensing framework, we've been speaking to Health Canada individually, as jurisdictions, through some of the consultations they've been doing, and that has been through a different vehicle. It has not been through the national pharmaceutical strategy.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
In a federal-provincial partnership, if it's not your group, who would deal with advice on progressive licensing, advice on counterfeit drugs, and so on? Surely there has to be a forum to have those kinds of conversations with the provinces and territories.
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
Right. So each province has an intergovernmental affairs section within their ministry. The linkages between the federal government and Ontario would be through the Ministry of Health for Ontario, of which I can speak specifically, and then they will seek out who the correct people are. So for a progressive licensing framework, that would be me and my team of individuals.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
But all your colleagues from all the provinces and territories don't sit down with the feds and say, “What should we do on progressive licensing?” Is it all done one by one?
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
We have done it as a group. The directors of the public drug programs typically sit down with Health Canada to understand what the framework is about. We had a meeting within the past six months to understand what the potential approach was going to be.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
That sounds pretty one way. Were you not asked what you thought it should be?
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
It was difficult because they were still preparing their regulations, so we couldn't comment. Now that the bill has been introduced, I haven't heard of plans for the directors to provide input as a collective group, but one-way dialogues are happening between the individual jurisdictions and Health Canada if there are concerns.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
So we have a bill on progressive licensing, but the provinces haven't been asked what they think about progressive licensing.
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
We have been asked about progressive licensing as a concept, but since the bill was introduced we haven't been asked to comment specifically on the contents of the bill.
Conservative
The Chair Conservative Joy Smith
I'm sorry, Dr. Bennett, your time has run out.
Thank you, Mr. Fraser.
Mrs. Davidson.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Thank you very much, Madam Chair.
Thank you very much for being here and presenting.
It's nice to see you again, Dr. Carleton.
I want to ask Dr. Law a couple of questions about vaccines and the surveillance around them. I think we've heard that almost all of the post-marketing surveillance activities lie within Health Canada, but I think your Public Health Agency is responsible for the marketing surveillance of preventative vaccines. What mechanisms are in place for the coordination and ongoing communication between the two departments?
Interim Director, Vaccine Preventable Diseases Prevention and Vaccine Safety, Public Health Agency of Canada
It's interesting that historically both drugs and vaccines were with Health Canada when the agency was still with Health Canada as the Laboratory Centre for Disease Control. Then drugs were separated off and vaccines stayed where they were originally, with the Laboratory Centre for Disease Control. That's just some historical perspective.
We do the post-marketing surveillance for preventative human vaccines. The biologics and genetic therapies directorate, which is part of Health Canada, are the pre-market regulators, but they also have post-marketing responsibilities. One thing that's different about vaccines and some biologics versus other drugs is that every new lot of a vaccine has to be studied and given a release for marketing, and BGTD does that.
We interact with BGTD on a number of different committees. They have a committee for risk management, so when an issue comes up related to a vaccine we sit at that table and work with them. We have our National Advisory Committee on Immunization, and they sit at the table there. The committee provides expert recommendations on vaccines and updates vaccine safety information as part of the immunization guide. Different technical documents are produced when a new vaccine comes out--statements on the vaccine.
We run a vaccine vigilance working group. It is a federal-provincial-territorial committee that has members from all the provinces and territories, with a co-chair from the provinces and a co-chair from us. It looks specifically at vaccine vigilance, develops the form we use for reporting, and works on national case definitions and standard national operating procedures for adverse event reporting. We work with the provinces and territories in conjunction with them, and BGTD sits at that table.
We also have an advisory committee on causality assessment. It looks at the serious adverse events, some of which have been mentioned. They include deaths, hospitalizations, anything that prolongs hospitalization, anything that's life threatening, and anything that causes residual damage or potential congenital defects. We pull those reports and, to the extent possible, review them. We can't always get all the information we need for a committee to review them. BGTD sits at that table as well.
So those are all formal interactions. Then we have a number that are informal, ad hoc, as needed, when an event comes up, like the Gardasil deaths that were reported. They weren't Gardasil deaths; they were deaths following. They were temporal associations that were reported to EMEA. When we got that information, we met with our colleagues at BGTD. So we work with them very regularly--not every single day, but several times a week.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
How are the warnings sent off to the physicians and the people who need them? Is that a cumbersome process, or does it follow the same process as Health Canada's?
Interim Director, Vaccine Preventable Diseases Prevention and Vaccine Safety, Public Health Agency of Canada
It's fairly similar, but BGTD would mainly take the lead. As the regulator, they have the mandate to do that, but we work with them when it comes to vaccines.
An example of that is what happened in Alberta recently when there were six allergic reactions--anaphylactic-like reactions. Because of the mumps outbreak, there was a campaign to try to make sure adults had had at least two doses of mumps-containing vaccine. In conjunction with that, several thousand adults were immunized, and there were more possible serious allergic reactions than you would expect to see. That was reported to us. We engaged BGTD and got additional information, but ultimately it was BGTD that decided to quarantine the lot. So that's a fairly major action that doesn't happen very often, but it was taken by them in collaboration with us.
Conservative
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Thank you, Madam Chair.
Thank you for being here with us.
Dr. Carleton, thank you for being back with us again. Like Mr. Thibault, I find that the approach that you are presenting to committee members is interesting. I would like to go back to the comments you made in your preliminary remarks. As I understand it, the vast majority, if not all, of the medications on our shelves as a result of our pre-market process are safe. If the medications produce adverse reactions, they are, in many cases, because of the presence of genes in some individuals that are not found in others, on whom the medication has no undesirable effects at all.
If that is the case—you can correct me if I am wrong—are we not avoiding the essential if we do not consider the genetic aspects of the entire post-market process?
Senior Clinician Scientist, Child and Family Research Institute, BC Children's Hospital, University of British Columbia
Avoiding the essential what...? I'm not sure I understand the last part of your question.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Are we not overlooking the most important element, that is, the individual who receives the medication and who is different from someone else? If we study medications during their post-market process and overlook all the genetic factors, are we not going round in circles and thinking that everyone is the same?
Senior Clinician Scientist, Child and Family Research Institute, BC Children's Hospital, University of British Columbia
Exactly. For the most part, the comments you make are accurate. The issue is what specifically puts individual patients at risk of a serious reaction. If there are genetic variants in certain individuals that put them at risk, they could be responsible for many of the reactions that currently occur with biologics and drugs.
In the example I provided the last time about codeine, there was a duplication of a specific gene responsible for converting codeine into its active form in the body--morphine--and another genetic variation. Instead of converting morphine into an inactive form that was excreted by the body, it converted it into another active form of morphine that increased its effect on the brain, and therefore its effect on bodily function. That is what killed a child in Ontario, as we reported in The Lancet medical journal, I believe in 2006.
So human genetics is definitely at play here in terms of response, and how we uncover those genetic differences is important in all of this post-market debate. One of the concerns I have is that just collecting reports on individuals who experience reactions isn't enough; we need a control group. One of the things that research is quite clear about is the need to look at another group of people that don't experience a reaction and understand what makes them different from the people who do experience them.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
I have two more questions about that. First, since it seems so important to move forward in the genetic field, is there support in your program, which seems to be costing $1.5 million, for moving further and faster? Would that put as many drugs as possible under the genetic microscope?
Second, does the government consult you about studying the post-market process when the time comes to draft new legislation?
Senior Clinician Scientist, Child and Family Research Institute, BC Children's Hospital, University of British Columbia
We don't have enough funding to do all of the work we could do. We're working in a very small environment now. We're working in children's hospitals across the country on very specific targeted therapies, we're looking at reactions that have been in existence for a long time that cause a lot of morbidity and mortality, and we're trying to solve these problems one patient and one drug at a time. We need more funding and we need to expand the work that we're doing further.
I had a very positive meeting with Health Canada about progressive licensing in the middle of March. We spent three hours together talking a little bit about what opportunity this new framework would present for these kinds of issues, in terms of improving surveillance and improving our ability to produce safer drugs. I think the framework provides an opportunity.
The question now is whether we seize that opportunity and actually make safer drugs for Canadians and the rest of the world. I believe that's what Canada actually can provide.
Conservative
The Chair Conservative Joy Smith
Mr. Cannan was next, but I see he's not available right now. So we'll go to Ms. Wasylycia-Leis first, and then go back to Mr. Cannan.
Ms. Wasylycia-Leis.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Thank you very much.
One of the recommendations we've been receiving from folks during these hearings is that there has to be something to compel pharmaceutical companies to immediately and efficiently give information to the government regarding adverse reactions. I just want to check where that is and how obligatory it is with respect to your proposal.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
Again, I would just caution that I can speak to the broader policy discussions we've been having.
What we've identified is that the requirement for adverse drug reaction reporting is certainly down in the regulations right now. It appears in the architecture of the act in several places. It can occur as a term and condition for a standard authorization, and that's through the regulation-making process. As for how you actually bundle those together, I'm sure the committee has heard a lot about periodic safety update reports, which bundle together and summarize those reports to make them useful. That, too, becomes an ongoing requirement, and its frequency can be set out and determined around the therapy.
So as to your earlier point about not burdening health care professionals and others with therapies on which we don't need as much reporting, you can index those. So that's really the concept we're advancing there. So it does occur in a number....
I would point out that you also need to require information in study form, because just having ADRs can't get us where we need to go.