Health Committee on June 5th, 2014

[The Chair, Conservative, Ben Lobb]

Good morning, ladies and gentlemen. Welcome and thank you for coming to the committee meeting this morning.

We're studying Bill C-17. We have the minister and officials with us. The minister will be with us for the first hour and then we'll continue on with the officials. If we have 15 minutes for committee business at the end, we'll do that.

Welcome, Minister. Welcome, officials. We'll allow you to start. You have 10 minutes or thereabouts for your opening remarks and then we'll go into our rounds of questions.

[Rona Ambrose, Conservative, Minister of Health]

Thank you, Mr. Chair.

It's great to be here. I'm going to ask Anne, David, and Supriya to introduce themselves quickly.

[Anne Lamar, Acting Assistant Deputy Minister, Health Products and Food Branch, Department of Health]

How do you do. I'm Anne Lamar. I'm the acting assistant deputy minister of health products and food branch at Health Canada.

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

Good morning, I'm David Lee. I'm the director of the office of legislative and regulatory modernization within the branch.

[Dr. Supriya Sharma, Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health]

Good morning. I think I have the longest title of anyone here. I'm the acting associate assistant deputy minister of the health products and food branch and also the senior medical adviser for the branch.

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

Thank you, again, Mr. Chair and committee members.

I'm pleased to be here today to speak to the protecting Canadians from unsafe drugs act, or Vanessa's law.

This important legislation will make a difference in the health and safety of all Canadians. I commend the committee for studying it. I know you will ensure that it receives the focus it deserves.

I would like to state at the outset that I'm appearing before you with an open mind. I know there are many parties interested in making this piece of legislation better. I look forward to the recommendations from the committee.

I am the minister responsible for this bill, but I do believe that all political parties and all members of Parliament have an interest in ensuring the safety of the drugs that we rely on for our health. I look forward to the study by the committee and potential amendments to this legislation.

As you know, this bill is actually named after Vanessa Young, who tragically died of a heart attack while on a prescription drug that was later deemed not safe and actually was removed from the market.

Stories like this remind us all of the very serious consequences pharmaceutical drugs can have, and of course of the need for all governments to ensure we have the strongest possible safety systems in place in order to prevent other families and patients having to suffer such a terrible loss.

I'm also pleased that Terence Young is here not only as a committee member but also very much as a subject-matter expert on this issue. I appreciate all the work he has done to get us to this place.

Colleagues, what it comes down to is this. Canadian families expect when they go to a pharmacy or a hospital that the drugs they receive are safe, that they're of high quality, and that they're effective in treating their condition. They expect that government will ensure that unsafe products are quickly identified and appropriate action is taken, including, if necessary, their removal from the marketplace.

Canada does have one of the most rigorous drug approval systems in the world for pharmaceuticals and medical devices. This system ensures, as far as possible, the safety of these products before they are marketed.

However, once these products are on the market, my department has very limited ability to gather information about these products and to take action when a problem arises. This is largely because the laws in this area have not been substantially updated in over half a century to reflect the post-market realities of drugs and medical devices.

Because of the problems with the current legislation, as Minister of Health I use the example that I have the authority to recall a bag of Doritos, but I don't have the authority to recall an unsafe drug from the market.

When there is a safety concern and a drug should not be on the market, we have no option other than to negotiate with the manufacturer in the hope that it will voluntarily come to the right decision. I find this unacceptable.

Vanessa's law will enable us to order a manufacturer to take immediate action to recall a product if it poses a serious or imminent risk to human health. Health care institutions are also not currently required to report adverse drug reactions. There exists no authority to order label changes on packaging if we feel additional information or studies are required.

In this bill's development, we spoke with representatives from patient safety organizations, the provinces and territories, and industry. All of their input was invaluable in developing this bill. There was an overwhelming consensus that stronger drug and medical device safety tools are absolutely necessary.

Vanessa's law will give our government the tools needed to ensure that drugs are safe and that strong measures are taken when concerns are raised. It will require health care institutions to report serious adverse drug reactions and medical device incidents. It includes tougher penalties to better reflect the serious nature of violations.

The measures included in Vanessa's law will provide the power to order drug or medical device manufacturers to make changes to the label or package of a drug or medical device. This will speed up the communication of important safety information and prevent harm to Canadians and their families who rely on these products.

When a consumer buys a drug at the pharmacy, the drug is accompanied by the manufacturer's label on which there is information on the safe use of the drug and warnings about the negative effects. Sometimes the information and warnings are not sufficient or clear enough.

When the labels are not clear, the patient's health may be in danger. Currently, when my department becomes aware of a safety problem that requires a new warning on a label, we contact and try to convince the manufacturer to add this new warning to the label.

This process can take a long time, since we have to rely on the manufacturer to take action to change it. Meanwhile, the patient's health continues to be in danger. Again, this situation is unacceptable and it must change.

Vanessa's law will provide the power to compel information and require companies to perform additional tests and studies on products. For example, I would be able to compel further studies on a drug that was designed for adults but was routinely causing adverse reactions in children.

Vanessa's law also introduces tough new fines for those who do not comply with these measures. It allows for significant penalties, including jail time, on companies that sell unsafe drugs in Canada.

The current fines and penalties simply do not reflect the severity and the nature of offences that can occur. Previously, the fine was $5,000 per day. To put this into perspective, this is the same amount that a person can be fined for littering under some municipal bylaws. That will now change to $5 million per day. For any company that intentionally misleads Health Canada, or recklessly harms a Canadian, the law will also provide the courts with the discretion to impose even higher fines and jail terms where they find it justified.

Before concluding, I would like to state once again that I am open to amendments to this bill. I've listened to the debates in the Commons, media commentaries, and heard directly from doctors and patients, and of course patient safety experts, since we introduced the bill.

I think it's clear that improvements can be made that address elements including transparency in clinical trials, disclosure of regulatory actions, and confidential business information. I think the committee is in a good place to put forward well-informed amendments that will make this bill even better. I have consulted widely, and feel these amendments will be very helpful.

In closing, let me again state that our government has listened to the experts. We agree with health care professionals that we need a strengthened drug safety system. Drug safety is not an issue that should become, in any way, a victim of partisan games and rhetoric. I thank the committee for approaching it in this fashion. I know that Canadians expect this issue will be taken very seriously as this committee studies Vanessa's law.

Thank you, Mr. Chair.

[The Chair, Conservative, Ben Lobb]

Thank you, Minister.

That concludes the opening remarks. We'll open it up for our first round of questioning, starting with Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Thank you very much, Chairperson.

Thank you to the minister for appearing here today.

It's good to hear your comments about the bill. I know that you've put a lot of work into the bill. It's a very important bill. As you noted, there's been support in principle from all the parties in the House, because I think we all recognize that drug safety and the provisions in the bill are long overdue. In fact, I would remind us that it was as far back as 2011 that the Auditor General, in his report, flagged this issue as something that needed attention.

Minister, I have been a bit perplexed about the process here. Recently we had charges made, allegations, that this bill was being held up, when in actual fact it just had a very few hours of debate in the House at second reading. Of course, second reading, looking at the bill in principle, is very important. Members wanted to speak in the House. The government basically sat on the bill for six months.

I wonder if you could tell us why the government didn't move on this bill for six months and is now apparently trying to create a political crisis around this bill, that it has to be rushed through at the last minute, when really it's been sitting there for six months and not being called for debate. We could have debated it, have it go through committee, send it back to the House and it probably would have been passed by now if the government had moved on it. Could you respond to that please?

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

When Vanessa's law was introduced, I did have high hopes for its quick passage, given the support that it received by all parties in the Commons. I know you yourself said that it was a step in the right direction. I also received correspondence from several members, from all parties, who believe that this is a very important bill and urged me to secure passage of Bill C-17, which is Vanessa's law, as quickly as possible.

We did work in that direction. I will simply say that sometimes the work we do is caught up by.... The House leaders do the work that they do. I will just say at this point that, yes, there were exchanges between House leaders as to when this bill should move forward. I'll just leave it at the fact that I'm glad that we have now seen the bill unanimously supported by all parties to move to committee. I'm glad to see that happen.

[Libby Davies, NDP, Vancouver East, BC]

Thank you.

I guess we can take it that the government House leader, who controls the House agenda, for whatever reason made a decision to wait on this bill for six months. I'm glad we are dealing with it now, and I'm sure the committee will go through the bill very carefully. We have witnesses to hear and I think they're going to be pretty good witnesses. We'll go through the bill clause by clause.

If I have some more time I would like to ask a couple of general questions.

As you've noted, you are open to amendments, which we very much appreciate. One of them has to do with the issue of overall transparency and the question of drug safety. We have to begin at the beginning and go right through the process.

There's the question of transparency in clinical trials, for example, the need to publish both positive and negative regulatory decisions, the need for Health Canada to publish the rationale for decisions they make concerning whether drugs are approved for sale or refused for safety reasons. I think the whole issue of transparency and people needing to know, whether it's the general public or whether it's researchers or clinicians in the field, is being raised about whether or not the bill could do a better job, and also including the results of clinical trials, including post-market studies and adverse drug reactions reported by drug manufacturers.

There are some elements of that in the bill, but we wonder whether it could go further. I wonder if you could give us a general response as to whether or not that's an area that could be looked at in ensuring greater transparency and greater reporting so we have the full spectrum from beginning to end.

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

Sure, I'd be happy to.

I've made transparency in our regulatory decisions a priority at Health Canada. Quite a bit of work has already been undertaken in our transparency framework that we launched a few months ago. I'm proud we're moving in that direction, but as I said, I'm open to amendments. On regulatory transparency, in particular, I think that properly written amendments to Vanessa's law to require public disclosure of safety decisions would provide clarity to Canadians on how and why Health Canada takes certain actions.

I know some drug safety experts have considered the importance of transparency for both negative and positive decisions made by drug regulators. The committee may also want to consider that element, should it have thoughts on how best to improve Health Canada's transparency for decision-making. Again, I think this is a good opportunity to put forward amendments in that respect and around clinical trials, obviously. I've commented on that. I think this bill already takes us in the right direction and puts us ahead of some jurisdictions, but I'd like us to work on a bill that puts us ahead of all jurisdictions when it comes to transparency of drug safety.

Again, I'm open to amendments, both on the clinical trials and on the transparency of regulatory decisions.

[Libby Davies, NDP, Vancouver East, BC]

Thank you very much. I appreciate that response.

There's one other area of the bill. A number of people have written in, and maybe you won't have time to address this, but we'll certainly ask your officials in the next round, regarding what's in and what's out in the bill in terms of the new definition of a therapeutic product.

Some of us, and maybe all of us, have received a very graphic picture of over-the-counter products, some of which would be in the definitions in the bill and some of which would not be. I think we're going to have to...or maybe it's just a better explanation, but on the face of it, there are certainly some questions about what the definition means and what's included and what's excluded.

That's going to be another area that we obviously need to look at and clarify.

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

Sure.

I could go into the definition in the bill, but it sounds as if you're more interested in what's in and what's out. I'll ask David, who did a great deal of the work drafting the legislation, to speak to what's in and what's out.

[David Lee]

Mr. Chair, technically what's in is both drugs and devices and what's excluded is natural health products as it's defined in those regulations. We are certainly looking at some products that would apply under the drug definition, like disinfectants, and so on. Again, that's also part of our regulatory road map as we work on regulations under the act as well, so we can speak to that.

[The Chair, Conservative, Ben Lobb]

Okay, thank you very much.

That concludes your round, Ms. Davies.

Next up for seven minutes is Ms. Adams.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

Thank you very much, Minister, for appearing before us today. I know you have been extremely diligent and have shown great leadership in advancing this file.

All Canadians feel vulnerable going to their doctor or to their hospital when they're ill or their children are ill. We rely on the expertise of medical professionals to prescribe the best possible medicine for ourselves and for our family members.

What is tragic is to eventually find out that information that would have, perhaps, provided for a better outcome could have been available and made available to families and individuals.

I genuinely want to commend the minister for coming forward and for showing great openness in advancing this legislation, in coming to our committee and saying that she's extremely open to listening to amendments that would make for more transparent legislation. We share your desire to become global leaders when it comes to patient safety.

Minister, currently hospitals and health care institutions are not required to report serious adverse reactions. I know that doctors are certainly very busy when they're in the hospital, and so on. Could you explain to us what this legislation would bring about, how we would strengthen patient safety in requiring hospitals and health care institutions to report on adverse drug effects?

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

Thank you very much for that question.

You've raised an important point. It is the case that reports on adverse drug reactions are essential pieces of information for drug regulators. It's essential that Health Canada receive that information, that it be high-quality information, that it be clear, and that it be comprehensive so we can ensure that we have the appropriate knowledge to take action.

We are all aware that drugs are powerful chemical and biological substances. They can have both positive and negative effects, but also unwanted side effects, so the issue of adverse drug reactions is an important one. Currently, only drug companies and sponsors of clinical trials must report serious adverse reactions to Health Canada. That obviously is important information for us to have because it allows us to take action with the aim of preventing such effects from recurring.

We know that a significant number of Canadians who are admitted to hospital each year suffer from very serious adverse drug reactions. However, reports of these drug reactions are not always shared with Health Canada. As the regulator, that seems like a gap we need to close, which is what we want to do with Vanessa's law.

Indeed, while adverse drug reaction reporting to Health Canada has been on the rise over the last five years, it's still estimated that less than 10% of all incidents are reported. So you can see the need for closing this gap. This under-reporting of critical drug safety information is a very serious concern. It limits our ability to identify potential safety issues at an early stage and then, of course, to take quick action to prevent further harm to patients.

Of course, we see hospitals as being the unique entities and institutions to identify and report these incidents. Although most drugs are prescribed by family doctors and used outside of a hospital setting, the truth is that when there's a really serious interaction, people usually go to the hospital or take their children to the hospital. It makes sense to us that this would be where we would focus our efforts.

We already know that adverse drug reactions are under-reported. Vanessa's law would give us the tools needed to improve the collection of this information. Although some tools, such as electronic reporting, have already been developed to encourage health care institutions to provide this information, it's still not enough. This is why we've introduced these measures to require certain health care institutions to report serious adverse drug reactions and serious medical incidents directly to Health Canada.

Better reporting by health care institutions will ultimately lead to a reduction in preventable harm to patients. We know that many emergency room visits are related to serious adverse drug reactions and that many of these are actually preventable. If we have the information and the ability to take action to prevent harms from occurring in the first place, not only will this lead to the safer use of drugs, but it will also free up valuable hospital resources.

We understand that all of us rely on the health care system. This is why we've increased transfers to health care. We also recognize, and we are acutely aware, how busy health care institutions are. We believe that Vanessa's law does not impose any unnecessary burdens on our health care system. I mention this because it was one of the issues raised with me by the provinces and territories.

I have to tell you that the provinces and territories are very supportive of this legislation, very supportive. They are looking forward to working with us on the implementation, more so on an institutional basis, to make sure hospitals understand what their requirements and obligations are. We look forward to working on that.

We will obviously be developing the regulations in consultation with the provinces and territories. Those will then set out exactly for them what information they are required to report, which health care institutions will have to report, and how that information will be reported and in what timeframe. We've made a lot of progress with them already to date.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

Thanks, Minister.

I know you've been working collaboratively with not only the provinces and territories but also with the leading minds, the experts and the patient groups, on this file. Can you give me a sense of the feedback you've been receiving from those patient groups?

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

We've received very positive feedback, particularly in the area of adverse drug reactions. We're essentially building a new system across the country of reporting. It's one that is obviously much more thorough, much more comprehensive, and much more consistent. I do believe that all of those who are involved in the health care system feel strongly that this needs to be done and are supportive.

After the bill passes, then we move to the regulations, which will impact the institutions themselves. We'll work with them on how they'll report and we'll make sure that hopefully we have the most consistent type of reporting across the country.

At the end of the day, the important thing here is that we have a huge gap. As I said, we think we're collecting at this point only around 10% of adverse drug reactions across the country. That's not nearly enough. If the regulator doesn't have that kind of information, how can we make the appropriate decisions on the safety of drugs? On that issue alone, the issue of adverse drug reaction reporting, this piece of legislation will make a huge difference for the safety of Canadians. I'm very excited that we're moving forward with this, as are the many, many stakeholders who care about patient safety and as are the provinces and territories. They know that this is a way we can collaborate. We're the regulator. They have the information. We look forward to closing that gap so that we can provide better safety information to patients and to physicians.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

You must be very proud. This is critical legislation, and you've done outstanding work.

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

Thank you.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

Ms. Bennett, you're up for seven minutes, please.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Thank you for coming, Minister.

I have three questions. The first is with regard to the issue you raised around prevention. When we did the post-market surveillance study at this committee, it was very clear that in future, with personalized medicine, we can sort out that certain people have genetic predispositions to a certain drug interaction or to an adverse reaction. In the science around the definition of serious risk or injury or harm, how will the department determine whether it's a number of people with a serious predisposition to a problem or whether it's a general problem for which the drug must be recalled for the public good?

Second, as my colleague was asking, could you explain your thinking on why toilet bowl cleaners are included in this because it's a disinfectant, but natural health products are not?

Third, I think we know, whether it's trying to talk to physicians about SARS or whether it's trying to talk to physicians about recalls, that the time that elapses before Health Canada makes a decision and it actually gets out to the doctors is.... From the time when you make your decision, I may have in my office been prescribing this drug for three weeks before I get the letter from Health Canada. In 2014 do you think Health Canada has the resources or the systems in place to actually communicate with the front-line providers to tell them they have to stop prescribing this today, and not when...?

I can remember one situation when I was up all night delivering a baby, and it was on the news that a drug had been recalled. One of my patients, who'd been watching the news, came in and asked me the next morning what I thought about that drug being removed from the market. I wouldn't have known about it if my astute patient hadn't filled me in.

Those are the three things that I would like to know about in terms of whether those are areas for amendments.

[Rona Ambrose, Conservative, Edmonton—Spruce Grove, AB]

On the question of prevention and how Health Canada will assess whether or not it's a predisposition or a general harm, I'll ask Dr. Sharma if she would answer that for you.

[Dr. Supriya Sharma]

Absolutely. In terms of the definition of serious, it is dependent on the situation. As you know, for an individual patient an adverse reaction can be quite serious...for a group of patients, because they are predisposed to that. The bill actually allows us to collect that type of information.

It's really important to understand when a product goes on the market it can be used for a variety of different purposes in a variety of different populations. Right now we do rely on the companies to come in with that information.

In terms of the new provisions, the bill allows us to ask for specific studies, specific analysis, specific information to come in. That helps us look at that analysis and then decide whether or not changes need to be made.

The changes can run the gamut of communicating to help practitioners and patients, making warnings more prominent on the label, adding warnings to the label, or it could go all the way to requiring that product to come off the market.

Now if you have a serious adverse event that affects a small group of people, you don't want to limit that access for everyone. Based on what the adverse reaction is and what we're seeing, we need to have the tools, the flexibility, to make the appropriate risk decisions.