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.

On the agenda

MPs speaking

Also speaking

Anne Lamar  Acting Assistant Deputy Minister, Health Products and Food Branch, Department of Health
David Lee  Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Supriya Sharma  Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health

10 a.m.

Conservative

The Chair Conservative Ben Lobb

Okay, Ms. Davies, we're over time. Thank you, though.

Ms. Adams, go ahead.

10 a.m.

Conservative

Eve Adams Conservative Mississauga—Brampton South, ON

Mr. Chair, I'd like to split my time with Mr. Lunney.

I have a question regarding the birth control pills that made headlines recently, both Alesse and Diane-35. Do you feel that the legislation and the definitions within the current proposed legislation go far enough to enable Health Canada to recall products like Alesse or Diane-35?

The issue with Diane-35 was that it was off-label use and people were taking it for far too long. With Alesse the issue was that there were really ineffective medications in the pack, so basically placebos. People thought they were taking a prophylactic and there was no use in taking it and some unwanted pregnancies ensued.

Do you feel this legislation would allow you to circumvent that type of problem or to act speedily should something like that happen again?

10 a.m.

Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Dr. Supriya Sharma

There are a number of parts of the legislation that would have helped in both those situations.

The first part is really what we talked about in terms of the recall. Again, for the vast majority of companies when Health Canada said they would like a recall, they do recall. The issue is if we don't get that consent, if they don't want to recall. Again, down to the patient level.... This gives us the authority to say they must recall. That's one part of it.

The other part of it really speaks to getting information around off-label use. Again, off-label use certainly is within the purview of practitioners. They need to be able to make decisions for their individual patients. What the legislation does is it gives Health Canada the authority to get information on off-label use.

If there is an off-label use out there that's potentially introducing risks, then we have the ability to ask a company to study it, to get information and then to use that information to make changes to the label or to communicate to people so that when they're actually making decisions about their health they are doing that with the benefit of all the information that they need.

10 a.m.

Conservative

Eve Adams Conservative Mississauga—Brampton South, ON

Some have raised the concern that currently this legislation would only allow Health Canada the power to recall a therapeutic product if it presents a serious or imminent risk of injury to health. In the case of Alesse, for instance, where the drug was simply ineffective or a placebo, that was not how Health Canada interpreted it. They didn't consider that a serious adverse health consequence. They deemed that a lifestyle impact.

I go back to my question. Do you feel as though this legislation gives you broad enough powers to act in the interests of Canadian patients and consumer safety?

10 a.m.

Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health

David Lee

We've taken this question up and really searched carefully through the language, the threshold that you need to use for recall, and we absolutely think that, looking at Alesse, we would be able to effect recall on the language that we've proposed. A failure to work in that case would also constitute grounds for a recall. We have run that through our assessment.

10 a.m.

Conservative

Eve Adams Conservative Mississauga—Brampton South, ON

Perfect. I think Canadians want to know that we're not going to get bogged down in definitions, but that we have the ability to act immediately for the benefit of Canadian consumers.

10 a.m.

Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health

David Lee

That's what we would do.

10 a.m.

Conservative

Eve Adams Conservative Mississauga—Brampton South, ON

Thank you.

Mr. Lunney.

10 a.m.

Conservative

The Chair Conservative Ben Lobb

You have 40 seconds.

June 5th, 2014 / 10 a.m.

Conservative

James Lunney Conservative Nanaimo—Alberni, BC

Nearly 10 years ago I raised an issue about deaths in the hospital. Currently there are an estimated 1,400 deaths per year with C. difficile in the hospitals...common classes of medications, proton-pump inhibitors, acid suppressants.... I was told then that CNISP, the nosocomial infection surveillance program, would get to the bottom of it, but amazingly, they did not collect the data on the meds they were on at admission. I understand we're working now to get that corrected, and they're going to actually collect the data. That would be very helpful.

I have a question that maybe you can answer, and I'll direct this to Dr. Sharma.

Labels...there are warning devices out there. There's a fact sheet on C. difficile. In 2004 when I raised it the first time, there was a great two or three paragraphs at least explaining the biological plausibility and why taking people off these meds might be an important way to reduce the risk, 40% to 270% we now know, of contracting an infection that could take your life. The warnings got weaker. After the DSEN, the drug safety and effectiveness network, reported just a short time ago confirming the concerns I've been raising for 10 years, amazingly, PHAC moved to take the warning, even the one liner, off the three-page fact sheet on C. difficile.

Can you explain how that's possible?

10 a.m.

Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Dr. Supriya Sharma

In terms of the Public Health Agency of Canada report or the fact sheet, I think you would probably have to direct that to them. If there's a question for Health Canada, I'd happily be able to take that.

10 a.m.

Conservative

James Lunney Conservative Nanaimo—Alberni, BC

I would assume you would sort of talk to each other and I thought one of you perhaps was involved with PHAC.

However, the warnings were weaker. We need strong regulatory response on that. I understand we're going to have much better tools now, but I'm talking about the tools that were available to communicate to doctors that were a little more cumbersome. It seems to many that the fact that tools were missing meant that people were actually not collecting data or they were looking the other way to avoid problems.

10:05 a.m.

Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Dr. Supriya Sharma

Certainly the provisions in the bill, as we mentioned, give us more flexibility in terms of collecting data. It really comes down to two parts of it. One is that there are powers in the bill that actually ask companies to do reassessments. You can have a situation that's going on for a period of time; you can have one look at the data, but that may not be sufficient. It's really looking at that body of data, being able to drill down, and being very specific to look for specific issues.

The other part of it is to then ask for new data, whether it's studies or whether it's new information that needs to come to bear to make those decisions. I think when you have more information, then we can do the analysis and we can make sure, as we do and endeavour to do, that the labels reflect exactly the state of information that—

10:05 a.m.

Conservative

James Lunney Conservative Nanaimo—Alberni, BC

I've been putting information for 10 years in front of Health Canada, and there's no action.

10:05 a.m.

Conservative

The Chair Conservative Ben Lobb

Mr. Lunney, your time is up, sir.

Mr. Young, you're up for five minutes.

10:05 a.m.

Conservative

Terence Young Conservative Oakville, ON

Thank you very much, Mr. Chair.

In October 2013 Marit McKenzie of Calgary died of a blood clot in her lungs after taking Diane-35, which is one of the newer generations of birth control pills, for acne. She was preparing for her school formal. This use was not proven safe and effective; it was off-label use prescribed by her doctor. Tragically, because she bought it at Shoppers Drug Mart, she had no safety warning of blood clots and so she died. Shoppers Drug Mart is recorded in the Toronto Star as saying they didn't issue a warning because they didn't want to frighten consumers about rare adverse effects, so they robbed her of the opportunity to make an informed decision.

By law in Alberta, the maximum damages Shoppers or the drug company would have to pay for such a loss is $85,000. So in normal risk management practices why would they warn patients? It hurt sales, and if something terrible happens, they only have to pay $85,000 anyway.

I joined the minister recently to announce the transparency framework, and the media took a mixed approach. They gave credit that it was a good idea, for example, in the Toronto Star, but then they criticized it because all drug reviews weren't going to be published right away, which I thought was very unfair. This is a huge change. If drug reviews for Diane-35 had been published and open, I suspect Marit Mackenzie would have had a proper safety warning and might have decided to not take Diane-35 at all.

Could you please comment on the transparency framework, on the change of publishing drug reviews, and why it makes sense to publish the ones for which there is not an established safety profile, the newer drugs, or one that appeared to have a risk, rather than go to the trouble of printing all of them now? A drug review can be up to 10,000 pages, and then it has to go for translation. There's a tremendous cost and timeframe to do that. Would you comment on the fact that—I hope you agree with me—it makes sense to publish the ones where there's an apparent risk first and then go to the others?

10:05 a.m.

Acting Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Anne Lamar

Thank you for the question.

As you are aware, the minister has made her intention known that we will be publishing drug summaries moving forward, as well as making the full reports available upon request. We are trying to provide information that is meaningful to the people who are requesting and looking for that information. The drug summaries, for example—because as you've noted, the reports themselves are very, very dense and technical—will provide very, very plain language information that will be available to everyone, and particularly consumers, so they have a very good understanding of what the implications of using that drug may be, and of course they will then be able to discuss that with their practitioner.

On the other hand, in the consultations we've been doing with all of our stakeholders, we do know there are other groups, academics, for example, that are very, very interested in seeing the more fulsome reports of our safety assessments. We are committed to making those public. Of course we have to be mindful of potential information that we may need to redact, but really our goal is to make those as public as possible, with minimal oversight in terms of what would be removed from those reports.

10:05 a.m.

Conservative

Terence Young Conservative Oakville, ON

I assume you have the resources to make that happen.

10:05 a.m.

Acting Assistant Deputy Minister, Health Products and Food Branch, Department of Health

10:05 a.m.

Conservative

Terence Young Conservative Oakville, ON

Ms. Lamar, could you please describe how Vanessa's law will make drugs safer for children in Canada?

10:10 a.m.

Acting Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Anne Lamar

I'm going to ask Mr. Lee to take that on, given his familiarity with the bill.

10:10 a.m.

Conservative

Terence Young Conservative Oakville, ON

Of course.

10:10 a.m.

Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health

David Lee

This is where a number of clauses in the bill can really work together very valuably.

You can start with approval. There is a section in the proposals that would allow us to put conditions on authorizations, so to plan out what to look for as a drug goes out. If it's not approved for kids initially, we can put in some measures that we want to see if we think it's going to be used in that population.

If we start to see something, we will also be able to ask for further tests and studies, which could include monitoring who's being prescribed the drugs. It would be a utilization study. Again, if we see anything of concern, we can ask for signals to be confirmed. They can come in and do a reassessment—

10:10 a.m.

Conservative

Terence Young Conservative Oakville, ON

Could you explain to the committee what a signal is?

10:10 a.m.

Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health

David Lee

Oh, sorry.

If we start to see adverse events occurring and we see that kids are being harmed, then we can pick that up and try to understand it and figure out if it's the drug and if we need to do something, and we can use these powers to very immediately get at that analysis and do a reassessment. Then we can either go to suspension or indicate to the community of practice not to use it in that community, which we call a contraindication, and we can really make sure that message gets out there to change prescribing behaviour.