Health Committee on June 5th, 2014

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

First of all, I would say that I am sure those who are in the health care business take safety very seriously as a community. It's not just their own product. They should, I hope, support ongoing efforts to make the regulatory framework and the legal framework for patient safety legislation stronger. I hope that all companies do.

We believe, in terms of red tape, if that is your question, that the proposed changes will have a limited impact on the day-to-day business of industry, as companies are already responsible for meeting similar requirements in other countries.

As I indicated before, what I believe we're doing is closing a gap that needs to be closed. We see this approach in other jurisdictions. Many of these companies operate internationally, and so they are familiar with this kind of regulatory environment.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Thank you, Minister. I agree with you. That is why I believe, if I can go back to natural health products, that this law would not put any new heavy administrative burden on the natural health product manufacturers.

Are you still insisting that even those low-risk products should not be included in this law? As you said, the burden of this law will not be cumbersome for companies that say they produce safe products.

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

I'll leave it up to you to question the experts on that. The recommendation to me was that those are considered to be low risk. The pharmaceutical industry and the pharmaceutical and prescription products are what this law applies to. Again, I'll leave it up to the committee to ask those questions further and probe on that issue.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Okay.

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

I think Anne wants to say something. I can tell she is—

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Perhaps she can do so in the second hour.

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

Sure.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Before moving to the second question, I would say again that the administrative burden will be quite low, so I believe that the natural health product companies could also be under this law.

Minister, my other question is, how will you ensure that there are enough resources to report adverse drug reactions and to coordinate the information once it has been received?

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

This is a priority for the government. We will ensure that we have the resources available to implement the legislation.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Can you expand a little more on that? As Dr. Bennett has said, the ramifications are nationwide. It is, needless to say, a complex system. You said that you seem to be prepared. Can you expand more?

[Anne Lamar]

Yes, there are a couple of points that I would make in terms of our resources. The short answer is yes, we have the resources to implement the new authorities.

In terms of the reporting, the department has been continuing to invest in really updated IT infrastructure and platforms that enable us to do more efficient reporting, a sort of e-reporting, which also lessens the burden to industry in that regard.

We will also be using new technologies to mine data more efficiently and be able to access the information more rapidly. We think, in fact, we'll be moving to a more efficient system. In addition to that, we'll be working very closely with the provinces and the territories to ensure that we are leveraging the systems they currently have in place as well, so not to duplicate those over again.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Thank you.

[The Chair, Conservative, Ben Lobb]

Thank you, Mr. Morin.

Next up we have Mr. Young for five minutes.

[Terence Young, Conservative, Oakville, ON]

Thank you, Chair.

Minister, when the safety of patients is at stake, Canadians expect strong measures in place to ensure appropriate action taken by regulators. Currently in Canada the penalties that can be levied against wealthy companies that put Canadians at risk are the equivalent of a slap on the wrist.

Existing levels of fines and penalties in the Food and Drugs Act reflect the age of the legislation and not the multi-billion dollar pharmaceutical industry that Health Canada regulates. If I can just give some examples from my own research, I have a list here of the who's who of the pharmaceutical industry, what we call big pharma, the biggest companies.

These are companies that parents trust, that have safe drugs for their children, themselves, and aging seniors, and that have, in fact, committed criminal offences in the United States and paid fines. No one ever seems to go to jail. I've never heard of anyone going to jail. I'll just give you some examples.

GlaxoSmithKline, in July 2012, paid a $3-billion fine for illegally promoting packs of Wellbutrin and Avandia. Now illegal promotion is not just that they put up too many billboards. Illegal promotion means they told the doctors, or they somehow made the doctors believe, that the drug was safer or more effective than it was, or that it was appropriate to prescribe it off label for uses for which it hadn't been proven safe. When drug companies promote off label and illegally, people die. A lot of people die. GlaxoSmithKline paid $3 billion in 2012 for illegal promotion of Paxil, Wellbutrin, and Avandia.

Merck paid $1.6 billion from 2008 to 2012 for giving kickbacks to health care providers to get them to prescribe their drugs.

Eli Lilly paid $1.3 billion in 2009 for illegally promoting Zyprexa, so that doctors thought it was effective for Alzheimer's with zero evidence that it helped Alzheimer's patients. In fact, it increased their risk of death by 200% to 300%.

Novartis paid $422.5 million in 2010 for off-label promotion of Trileptal.

Forest Labs paid $313 million in 2010 for off-label promotion of Levothroid and Celexa.

The list goes on: Allergan, Elan, Johnson & Johnson—$81 million in 2010. AstraZeneca, Abbott, Sanofi-Aventis.... This is just back to 2008. This has been going on since the late 1990s.

Can you please provide the committee with some additional details on how Vanessa's law addresses this reality with regard to fines and penalties? Do you feel that these new fines and penalties alone will serve to deter wrongdoing in the world of profit-driven big pharma companies?

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

First, let me thank you for all the great work you've done to advance this issue and for being such an amazing patient safety advocate. We're really thankful to have you on committee as this bill goes through. Thank you very much to MP Young.

Obviously, you know full well the consequences of adverse drug reactions and I do think it is so critical that Vanessa's law provides for much higher penalties and even jail time, because we do have to recognize, as you say, the serious impact of adverse drug reactions on our communities.

The bill does introduce new fines for those who do not comply with important safety measures. It allows for significant fines and penalties for companies that sell unsafe drugs in Canada. As you point out, right now the fine for companies who put Canadians at risk is simply not reflective of the realities of the harms that they cause. A fine of $5,000 per violation is a drop in the bucket for many companies that can generate profits of literally hundreds of millions of dollars. With this amendment the fine will change to up to $5 million per violation. In addition to this, the proposed law will also give the court discretion to impose even steeper fines, with no limitations imposed through legislation, and up to two years of jail time if companies break the law intentionally.

I do think that Canadians will support this legislation. They expect that the drugs they purchase from the pharmacy or from store shelves should be safe for the use of their families. I do think by introducing these tough new fines for companies who put Canadian families at risk, we will ensure that companies that break the law will pay the price for compromising this trust and putting the health of Canadians at risk.

It is an unfortunate reality that there are always a few who choose to engage in unethical behaviours, suppressing negative research and withholding vital safety information in order to increase their profit margins, but if these companies were to be convicted today, the punishment for their crimes would fall woefully short of meeting the severity of the risks.

Through Vanessa's law, a company that intentionally provides Health Canada with false information, fails to adhere to conditions of sale, fails to recall a product when ordered, or fails to revise a label as requested, will be in violation of the law and will face very stiff new penalties. The increased fines and penalties are also consistent with those found in our other consumer-based legislation, such as the Canadian Consumer Product Safety Act and the Safe Food for Canadians Act.

Vanessa's law also proposes an injunction power to permit the minister to apply to the court to order a person to stop doing an action related to an offence. This new authority will prove helpful in preventing future contraventions and in dealing with cases where ongoing non-compliance creates a risk to health. If an injunction is not complied with, the regulated party would be in contempt of the court and the court could then impose a fine or imprisonment. These measures will allow the government to take more effective action against those who jeopardize the safety of Canadians.

I think the updated powers go a great distance further than what we have today to protect Canadians from unsafe drugs.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Minister, I'd like to come back to a question that my colleague, Dr. Morin, raised.

Although one could say that there's a measure of responsibility for the pharmaceutical companies that are producing these drugs, and that's very important, at the end of the day, as I see the legislation, it's actually Health Canada, your department, that has to do the heavy lifting in terms of seeing this process through. For example, it gives you the power to call for more studies. It gives you the power to actually make a recall, to require labelling, to do follow-up.

You're not going to do that on your own. You have to have experts who are helping you do that. I do want to say that nothing would be worse than passing this law only to find that we actually don't have the resources within the department to undertake the levels of work and the further research that might be required to actually put this law into effect.

There have been cuts at Health Canada, so I think it would be very helpful for the committee to know, for example, what additional resources your department will be able to draw on in order to actually implement and enforce this bill, assuming that it is passed by the House.

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

Let's remember that Health Canada is doing a lot of this work today in terms of assessing the safety of drugs, going through the drug approval process. We have many hundreds of experts, researchers, physicians, who work on our staff, who are doing these assessments. What we're talking about in terms of the drug approval process is making those assessments more transparent, easier to understand, more available to Canadians. Obviously, that takes some resources, but it's about doing our work differently.

In terms of collecting the information from institutions and then ensuring that we can assess that information, again, we do those assessments on an ongoing basis.

I don't know, Dr. Sharma, but maybe you want to explain how it is we do a drug safety assessment. We do these things today. What we want is more information—

[Dr. Supriya Sharma]

Yes.

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

—and more information will help us do our work and make sure that we have more comprehensive information about any particular drug when we're looking at the post-market analysis.

[Libby Davies, NDP, Vancouver East, BC]

The reason it's very important is that the Auditor General's report in 2011 clearly referred to the time lag for people actually getting information. In fact, he said that two years is too long, so already we have a problem.

I don't know whether or not now, since 2011, the time lag has improved, but to me it's a really serious question. If the information isn't getting back to people about the adverse reactions, about what the problems are in terms of drug safety review, then really the bill is not doing the job it should do.

I think we need some very specific markers on this to demonstrate to us that the recommendations from the Auditor General are being met, and that there will be serious improvements in terms of drug safety review and the timeline that it takes.

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

Sure, and Anne wanted to make a comment about the timeliness.

[Anne Lamar]

In reference to the AG report from 2011, obviously, Health Canada took those recommendations very seriously. We've completed, actually, the majority of the action items that were recommended. We can certainly provide more follow-up details to the committee on that.

I think that what is being proposed in Bill C-17 is actually completely in line with the OAG report. In fact, we have already started, as the minister alluded to, to move some of our priorities, change the way we are doing our business. I referred to some of the efficiencies that we find around electronic reporting, with large IT systems that help us to manage that information.

You also referenced a time lag in terms of information coming in and being able to provide a signal assessment. Again, that will be enabled and be even stronger with new systems. I think as well with the fact that we won't need to be negotiating on some of the authorities like recall, for example, where it does take more time for us to get information out to the public, we will see ourselves saving time in that regard. Our capacity to communicate, to take that information and communicate it externally to Canadians, to pharmacists, to practitioners who need it, I think will clearly be enabled.

[Libby Davies, NDP, Vancouver East, BC]

You mentioned that you could provide the committee with information about what steps have been taken to meet the recommendations of the Auditor General from 2011. I'd like to take you up on your offer and ask that you provide that information to the committee, Ms. Lamar. Could you do that?

[Anne Lamar]

Yes.