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

9:15 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

Thank you, Supriya.

To your question, Dr. Bennett, on the low-risk products, on natural health products, to be frank, I struggled with this one because I thought everyone should be under the legislation, but the reality is and the case was made from the natural health products community that their products are low risk.

My discussion with them was....

9:15 a.m.

Liberal

Carolyn Bennett Liberal St. Paul's, ON

May I just say that on the study of natural health products, it's one thing to be a natural health product from a reputable company, but I think what we were worried about is if you find out that Sleepytime Tea has Valium in it, or if echinacea actually has ephedrine in it, you have the ability—

9:15 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

Yes.

9:15 a.m.

Liberal

Carolyn Bennett Liberal St. Paul's, ON

—to remove that in terms of it not being accurately labelled. But if something has a contaminant in it or.... I think there is some concern about....

Do you believe you already have that power?

9:15 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

We are regulating natural health products now, as you know. In terms of capturing them under Vanessa's law in adverse drug reactions, their belief is they are low risk, and so they shouldn't be treated as pharmaceutical products.

What I will say is if someone goes to the hospital with an adverse drug reaction, the reality is it doesn't matter what they have used. They are going to tell the physician what it was, and it will be captured.

9:15 a.m.

Liberal

Carolyn Bennett Liberal St. Paul's, ON

You don't even have to say how much sugar is in it. That pink water that actually is full of sugar, a diabetic may not even know they shouldn't be drinking that.

9:15 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

On labelling, that's not.... Vanessa's law is about adverse drug reactions and about patient safety. Obviously, natural health products are regulated, and we are able to change labels on them, and we deal with health claims made by naturopathic or natural health product manufacturers.

Again, I think you should ask the experts that question when they come to committee. Ask them if there is an adverse reaction from a natural health product whether this legislation is enough to cover that.

9:15 a.m.

Liberal

Carolyn Bennett Liberal St. Paul's, ON

In terms of how you will communicate with physicians....

9:15 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

Diane-35 is an example. We had 40% off-label prescribing with Diane-35. Not only had we sent numerous Health Canada warnings to physicians, we also did a checklist to....

9:15 a.m.

Liberal

Carolyn Bennett Liberal St. Paul's, ON

Do you have an ability to do that other than through the—

9:15 a.m.

Conservative

The Chair Conservative Ben Lobb

Ms. Bennett.

9:15 a.m.

Liberal

Carolyn Bennett Liberal St. Paul's, ON

—College of Physicians and Surgeons?

9:15 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

We have a number of ways we communicate. I can ask Anne to give you a list of all of the different ways in which we communicate through associations beyond just the College of Physicians and Surgeons. We can communicate directly, but, yes, we have a number of ways.

Anne, if you want to expand on it....

9:15 a.m.

Conservative

The Chair Conservative Ben Lobb

Thank you very much.

Moving right along, we have Mr. Wilks, for seven minutes, please.

9:15 a.m.

Conservative

David Wilks Conservative Kootenay—Columbia, BC

Thank you very much, Mr. Chair.

Before I ask my question, I've heard from time to time that sometimes those of us in the back seats of the House of Commons can't make a difference. I believe my colleague, Mr. Young, has proven that wrong, and that he will make a significant difference in the lives of millions of Canadians in years to come. So thank you for that.

Minister, I appreciate your being here today.

You made mention of the competence and transparency in regard to the health care system. Can you provide the committee with some additional details on what Health Canada is doing to provide Canadians with the information they need to make informed health decisions? How will Vanessa's law give Canadians the information they need to make informed decisions about the use of therapeutic drugs and medical devices? Would you be able to provide the committee with some examples of these transparent measures?

9:20 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

Sure. Thanks so much.

The fact is that Canadians do expect more information from Health Canada when it comes to patient safety issues. This legislation is incredibly important, but the current legal framework that we have is outdated. Just like every Canadian, I expect more. We expect to have that kind of information at our fingertips, and we expect the regulator to be able to make decisions when they're confronted with clear information that a drug is negatively impacting Canadians.

We know that 83% of Canadians are online now. They expect access to accurate information. They want it quickly and they want it easily. This is especially true when it comes to health and safety information. In most cases we will purchase over-the-counter medications or pay a visit to the doctor to receive prescribed medication. Along the way, we will read the label or receive information from a pharmacist about the proper dosage, when to take the medicine, and how to take it. We may also read or receive information about any side effects or other health warnings of which we should be aware. But the reality is that we sometimes do not get all of the information that we should, and the information can be confusing for people to follow.

Last year, as you know, we took important steps to help Canadians better understand medicine. As a result, our plain language labelling initiative is set to make prescription and over-the-counter labels and safety information easier to read and understand. Through the introduction of a standardized format for information on drug labels, this includes what's called a drug facts table.

In addition, the plain language labelling regulations will advance key safeguards, such as requiring labels to be in plain language, requiring that companies include contact information on labels so that users can report problems and adverse drug reactions, requirements for manufacturers to provide mock-ups of labels and packages for our review, and requirements for manufacturers to provide evidence that drug names will not be confused with other authorized products.

Canadians are already familiar with the nutrition facts table on food. Many report using this information to make informed decisions when choosing healthier foods. It makes sense then that we would have a similar tool to help Canadians make equally informed decisions when it comes to choosing the right medications and over-the-counter drugs.

Vanessa's law will build on the successes of the plain language labelling initiative by enabling new ways for our government to collect more information to provide to Canadians.

First, it will require a mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions. The knowledge gained by Health Canada through this reporting will help us to inform Canadian patients about any safety concerns or risks more quickly and more transparently.

Second, it will authorize Health Canada to compel manufacturers to make a label or packaging change when it's needed to alert patients and prescribers about a potential side effect or other health risk that only becomes known after the product is on the market. This will also expedite the communication of important safety information by Health Canada to prevent harm to Canadians who rely on these products.

Third, Vanessa's law will authorize Health Canada to compel manufacturers, when necessary, to provide more post-market information about their products. Companies may be required to gather ongoing evidence of the product's benefits and risks, to conduct new tests and studies, perhaps on specific populations, or to undergo a product reassessment. For example, as I mentioned, I would be able to compel further studies on a drug for adults that was routinely causing side effects in children.

Of course, information is power, and we are committed to gathering the information that Health Canada needs to ensure that Canadian patients and caregivers are empowered to make the most informed choices about their drug and medical device decisions. The measures in Vanessa's law will build on other efforts that we've undertaken to make more data and information available to Canadians than ever before.

For example, the department's Healthy Canadians website and social media channels give Canadians important up-to-date health and safety information, written in plain language. More than five million Canadians have visited these online sources. Canadians also have access to Health Canada's online databases, including a drug product database that provides information about all approved drugs. Our recalls and safety alerts database is another critical resource to learn more about the possible risks associated with health, consumer, and food products. Vanessa's law will help us to add valuable information to these trusted sources.

Canadians also need to understand that when they are using therapeutic drugs and medical devices, they need to know how to use them. They need clear, plain language information on the drug label to make the right choices for themselves and their families, and they need access to it transparently and in a timely way. They also need assurance that the regulator of therapeutic products has the ability to gather information throughout the life cycle of these products.

The plain language labelling initiative and our commitment to regulatory transparency and openness are important steps forward to meet the information expectations of Canadians. Vanessa's law will provide the necessary legal authorities for us to ensure that labels and information contain the most accurate information for Canadians to use to make informed decisions for themselves and their families.

9:25 a.m.

Conservative

David Wilks Conservative Kootenay—Columbia, BC

Thank you very much.

9:25 a.m.

Conservative

The Chair Conservative Ben Lobb

You are right on seven minutes. Congratulations.

9:25 a.m.

Conservative

David Wilks Conservative Kootenay—Columbia, BC

Thank you.

9:25 a.m.

Conservative

The Chair Conservative Ben Lobb

Next up is Mr. Morin. He has five minutes. I'm pretty sure everybody can speak both official languages, but if you can't, this would be a good time to put in your earpiece.

Go ahead, sir.

June 5th, 2014 / 9:25 a.m.

NDP

Dany Morin NDP Chicoutimi—Le Fjord, QC

I will start with English.

Minister, good morning.

9:25 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

Good morning.

9:25 a.m.

NDP

Dany Morin NDP Chicoutimi—Le Fjord, QC

You just mentioned all the different consequences of this law. Would you estimate that there will be a great deal of burden on the companies producing therapeutic products if they have safe products? What kind of burden do you think this will have on those companies?

9:25 a.m.

Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

What kind of burden...?

9:25 a.m.

NDP

Dany Morin NDP Chicoutimi—Le Fjord, QC

Do you think it will put a lot of burden on those companies that say that they produce safe therapeutic products?