Thank you.
Evidence of meeting #32 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A video is available from Parliament.
Evidence of meeting #32 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A video is available from Parliament.
June 5th, 2014 / 9:40 a.m.
Conservative
James Lunney Conservative Nanaimo—Alberni, BC
Thank you, Minister and officials, for being with us today.
Minister, I think a lot of people would be surprised to learn from your earlier remarks that it's been nearly 50 years since patient safety legislation has been significantly updated. This seems to be a worldwide phenomenon that there are great gaps in the information on safety and effectiveness of drugs used in real-world settings. More information is needed on the safety and effectiveness of pharmaceuticals when used by the diverse patient populations, and outside the controlled, experimental environment of clinical trials.
I was wondering if you would be able to elaborate for the committee on how Health Canada currently undertakes post-market surveillance activities. What kind of improvements are here in Bill C-17, in Vanessa's law?
9:40 a.m.
Conservative
Rona Ambrose Conservative Edmonton—Spruce Grove, AB
I'd be happy to outline the current approach. It does demonstrate a contrast with what Vanessa's law hopes to deliver.
As I mentioned in my opening remarks, we do need to recognize, and I fully believe, that Canada does have one of the most rigorous drug approval systems in the world for drugs and medical devices.
This system does ensure, as far as possible, the safety of these products before they're marketed. Before a pharmaceutical product reaches the market it must satisfy strict safety, efficacy, and quality evidence requirements.
Health Canada's team of scientists thoroughly review and evaluate all of the evidence that is provided. Once they've determined that the benefits of the pharmaceutical product outweigh the risks, the department will issue an authorization allowing the pharmaceutical product to be legally available for Canadians to use under specific conditions.
However, and that's where Vanessa's law comes in, once these products are on the market, we currently have limited ability to gather information about these products and to take action when a problem arises.
When Health Canada does issue a market authorization to allow a pharmaceutical product to reach the Canadian market, the department monitors these products to detect any new risks.
This work includes the collection and evaluation of adverse drug reaction reports submitted by industry, patients, caregivers, and health care professionals. We also have a review of periodic safety updates that are submitted by manufacturers, an analysis of information gathered from various sources such as medical and scientific literature, other regulatory agencies internationally, and manufacturers.
You can see that we're doing the best we can possibly do with the powers we have, and that does go quite far, but as many members of the committee know, in the bill before you today there is room for improvement. The scientists and those who work on this issue relish the thought of having more authority and more powers to be able to act in this area.
It was only recently that I announced that Health Canada would start posting summaries of after-market drug safety reviews on its website, which was a great initiative. These reviews provide a plain language description to Canadians with respect to what was assessed, what Health Canada discovered, and what action it took.
This new approach allows the department to share information gathered from the scientific literature, health care professionals, the manufacturers, and other international regulators. These drug safety summary reviews make Health Canada an international leader in the transparent posting of this kind of information, now ahead of both the United States and the European Union.
However, as I've said, Canada's overall safety system for drugs is based on legislation that is over 50 years old now, and lags behind many international regulatory counterparts.
While we've taken action to strengthen post-market drug safety, we still do not have key legislative authorities or tools needed to efficiently further protect the health and safety of Canadians. Vanessa's law will provide us with that. It will provide us with the legal weight to help better protect the health of families.
For example, as we already discussed, adverse drug reactions to pharmaceutical products are estimated to account for one quarter of emergency room visits in our hospitals, and most adverse drug reactions are vastly under-reported.
This is why, as I've said, Vanessa's law includes measures that will require mandatory adverse drug reaction reporting from health care institutions. It will also give our government the tools needed to recall a drug or require a label change.
I will use the example of Diane-35. People ask why this takes so long. Journalists are asking why it is taking so long for us to come out with the action we promised on Diane-35. A lot of it was because we had to negotiate with the manufacturer and that took months.
In this instance, now that we have these authorities, we don't have to negotiate. We were able to take the action we wanted to take on Diane-35. We had a checklist and worked with the associations that were involved with the drug to disseminate very good information to physicians to make sure they were not prescribing Diane-35 off label, and the manufacturer did cooperate with us. It did take us a number of weeks, even months, to be able to reach that point.
That's just one example of why it's important that we have these authorities, so that Health Canada not only has the information but they have the weight, then, to act on it as quickly as possible.
I do think this legislation will make a great deal of difference in the lives of Canadians, but also for the department. They look forward to having these extra tools to do their jobs.
9:45 a.m.
Conservative
The Chair Conservative Ben Lobb
Thank you very much.
That concludes this portion of the meeting. It's over an hour that we've had with the minister this morning.
Thank you very much, Minister, for your time.
9:45 a.m.
Conservative
The Chair Conservative Ben Lobb
We're going to suspend for a minute to allow the minister to leave and to also allow any other departmental officials who are going to join us to come to the table.
9:50 a.m.
Conservative
Rona Ambrose Conservative Edmonton—Spruce Grove, AB
Good luck with your deliberations on the bill. I appreciate it.
9:53 a.m.
Conservative
The Chair Conservative Ben Lobb
We'll get back at it. We're going to continue with our questions.
To lead off this round, we have Ms. Davies for five minutes. As we know, in the meeting today we're going to go until 10:30, and then we have some committee business.
You don't have any prepared comments; you're just going to take questions. Is that right?
9:53 a.m.
A voice
That's right.
9:53 a.m.
Conservative
9:53 a.m.
NDP
Libby Davies NDP Vancouver East, BC
I'm trying to focus the questions on material that started coming to us in anticipation of witnesses being heard, in order to get your reaction, at least in general, to what we might be hearing at committee. I think the committee is of a mind that should it be required, we could call you back later, based on what we've heard from witnesses, because there might be some clarification needed.
I have a couple of questions. First, it's very clear that the minister can recall something. What about suspension? It seems to me that the bill doesn't really address the issue of suspension. Was there consideration made of the need to have suspensions as well? Also, how would you see it differently from a recall? That's one question.
On the other question, we did get some information just very recently from MEDEC, which is the medical technology association. I haven't read all of the info that they put out, because we just got it yesterday, but they are concerned about the fact that the bill doesn't address single-use medical devices, which they say is quite a problem. Devices are manufactured and are intended for one use, but apparently what really happens out there is that they are reused and reused, including by hospitals. There's that issue as well. I wonder if you had contemplated that being covered in the bill in terms of single-use medical devices.
Those are the two questions right now.
9:55 a.m.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Mr. Chair, on the first issue about suspension, when putting in measures at either the legislative or regulatory level, you need to look at what the instrument does. Recall is introduced at the act level. Suspension is something that Health Canada can do under the current regulations. It really has to do with how the authorization works. As Health Canada approves a product out on the market, it does so with a threshold. It looks at the product and it says that the benefits outweigh the risks and the chemistry is okay.
If we see something that gives us concern, then we can reach for a suspension, and that will still be effective under this current set of proposals. You're really looking for.... If we start to see that there's a serious risk introduced and the drug shouldn't be sold anymore, then we can invoke suspension. Recall, though, is also where you need to reach into the market and pull the product back from the market or correct it.
9:55 a.m.
NDP
Libby Davies NDP Vancouver East, BC
Just to be clear, then, a suspension doesn't necessarily mean that the product can no longer be sold?
9:55 a.m.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
No. Suspension does mean that it can't be sold anymore. The authorization allows you to sell. There's a prohibition in law that says that you don't sell unless you have an authorization.
9:55 a.m.
NDP
Libby Davies NDP Vancouver East, BC
A suspension would be that you can in effect take it off the market for a period of time while there is further clarification and testing, whereas with a recall it's just gone. You take it off presumably for good, or...?
9:55 a.m.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Yes. Recall is usually when we need to reach into the market and say something is so dangerous right now we need to remove it from supply. It usually comes back to the manufacturer usually from pharmacy and from retail. That's different from suspension. Suspension just says don't sell any more into the system.
9:55 a.m.
NDP
9:55 a.m.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Usually when there's a suspension we will advise the whole drug system and people will appreciate that there is a stop. Sale includes distribution, so technically speaking, you shouldn't see more of the drug going out to any one particular patient when we suspend.
Having said that, sometimes it is so dangerous you really need to remove it from pharmacy shelves and that would be recall.
9:55 a.m.
NDP
Libby Davies NDP Vancouver East, BC
No, I get that. It was just more the suspension element that I wasn't quite so clear on.
What about in terms of the single-use medical device?
9:55 a.m.
Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health
We are talking about the reuse of single-use devices. If it sounds like an oxymoron it's because it is.
The idea from our perspective is that if a product is for single use there should be good reasons that it's for single use and it should be labelled as such. We do have symbols on medical devices and wording on medical devices for products that are for single use.
Sometimes those products that are for single use are then reused, reprocessed, and refurbished. Some of those are legitimate. For example, in a hospital if you have surgery that's taking place and you have a number of total knee replacements and you open up different sizes. If you don't use them they can be re-sterilized and used again.
The concerns that are coming now is if you actually send it off to a facility and they somehow change that device, so it's not longer that same device, or there might be new risks that are introduced.
From Health Canada's perspective, if a product can be safely reused and reprocessed, then the company that manufactures it is in that unique position to know all about that product and to be able to tell us this is how it should be reused or reprocessed and that should be on the label.
9:55 a.m.
NDP
Libby Davies NDP Vancouver East, BC
They're not under the bill. These devices are not within the definition of these therapeutic products. Is that correct?
9:55 a.m.
Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health
They are.
9:55 a.m.
Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health
They are. The concerns that we have right now are.... For example, let's say we have a product that's for single use and it's going out and it's being reused and there are concerns about that. We don't have a way to then compel the manufacturer to study that or to change the label to reflect that. That would be included in the bill.
The concerns that we have, though, are that the product should be used based on the label and we should have information that we can see in Health Canada to assess how they should be used, whether it's for single use or for reprocessed devices.