Bill C-17 (Historical)

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)

An Act to amend the Food and Drugs Act

This enactment amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things,
(a) strengthen safety oversight of therapeutic products throughout their life cycle;
(b) improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and
(c) promote greater confidence in the oversight of therapeutic products by increasing transparency.

Concurrence in Vote 1--Senate

[Dan Albas, Conservative, Parliamentary Secretary to the President of the Treasury Board]

Mr. Speaker, normally I am happy to have the opportunity to participate in a debate, but not today. Today, in this case, I will be rising to oppose a motion denying the allocation of resources for the Senate. In other words, I will not be supporting the motion that opposes funding for the Senate.

I expect that was the point by the member opposite in creating this motion, because the member knows the role of the Senate in our Constitution. Once a bill leaves this place, it must pass through the other place before it ultimately can receive royal assent. In essence, the member opposite is suggesting to shut down the ability to pass laws, to amend laws and to change legislation, because without the Senate, the way our Constitution is structured, that would be the final result.

I suppose that a do nothing approach is favourable to the NDP. After all, if nothing were to change, the New Democratic Party would not have to oppose everything. I have problems with that, and I would like to provide an example for the chamber as to why that is.

Recently, in this place, we debated Bill C-17, otherwise known as Vanessa's law, a long overdue, much needed bill that would better protect Canadians from dangerous drugs by ensuring that our democratically elected Minister of Health and Health Canada could have the power to recall dangerous drugs and not just the huge pharmaceutical corporations, as is the current case.

One of my weekly member of Parliament reports was focused on Vanessa's law. I am pleased to share with the House that the response from my constituents was overwhelmingly in support of the bill. Even my local NDP and Liberal friends were strongly supportive of the bill. As we know, the NDP in the House supported Vanessa's law as well, even if they filibustered the debate in debating how they agreed with it. I suspect when the New Democrats heard from their constituents back home, they heard much the same message that I heard. That is likely why they did an about-face in sending that bill forward late last week.

Imagine if bills like Vanessa's law could not ultimately become law because they could not pass through the other place. This is the kind of nonsense the NDP is proposing in this motion today.

I am not naive to the fact that there are many Canadians who are strongly opposed to the Senate. The problem is that the NDP likes to pretend that it has a magic wand and can simply wish the Senate away. Our own Supreme Court has confirmed that simply is not the case. The NDP knows this and yet it continues to play a political game that we can simply make the Senate disappear when, in fact, we cannot.

If the NDP truly wants a constitutional debate on the Senate, it should simply say so. Let us be clear that there are many non-partisan support staff that make that Senate run, no different than the assistance we here receive and benefit from in this place. The NDP members, with this motion, in effect, is suggesting that none of them get paid, or perhaps they are suggesting that they possibly work for free. Is the member for Winnipeg Centre also proposing to hand out pink slips to all the support staff in the Senate?

If there were lawsuits from de-funding the Senate, would the member for Winnipeg Centre ask his friends in the union movement to cover the costs of those lawsuits, as he did his own? I suspect not. This is the same NDP that has no problem using tax dollars in NDP satellite offices, the same NDP that is happy to use taxpayer-funded staff in these satellite offices, but apparently does not think there should be taxpayer-funded staff in the Senate. This just does not reconcile.

The Canadian Senate, rightly or wrongly, was conceived as an institution to provide sober second thought in legislative scrutiny. It was also conceived as an institution to provide regional representation, as evidenced by the regional divisions of the Senate.

Disagreement with the Senate is nothing new to Canadians and, I would suggest, has been occurring since July 1, 1867, and has continued ever since.

As I am sure all members are well aware, a plethora of Senate reform proposals have been put forward over a number of decades. In most cases, proposals have called for an injection of democratic legitimacy into the appointment process, as well as the changes to the distribution of senators among the provinces, and also changes to the power of the Senate itself.

One of these reform initiatives was the triple-E Senate proposal that came out of Alberta during the 1980s. Triple-E stands for elected, equal, and effective. This should not be confused with the Liberal leader's vision of a triple-E Senate, which is a Senate of the elites, by the elites, and for the elites.

The original triple-E proposal laid the basis for many of the proposals that ensued in the years that followed and found its way into constitutional discussions that took place during the 1980s and 1990s, the most notable being the Meech Lake constitutional accord and the Charlottetown constitutional accord.

The Charlottetown accord would have resulted in a fundamentally changed Senate. The Senate would have been elected with an equal number of senators per province, with some limitations on the power of the Senate to avoid deadlock. The rejection of the Charlottetown accord in the 1992 referendum significantly reduced the prospects for fundamental constitutional reform for many years, and serious discussion of the Senate largely disappeared from the national debate.

As members will know, not long after the 2006 election, when our government first introduced Bill S-4 in the Senate, the bill would have limited senators' tenure to a renewable term of eight years. Bill S-4 gathered a great deal of support and was endorsed by the Senate Special Committee on Senate Reform, as well as by a number of constitutional experts.

Let us not forget that it was the opposition parties that united in their refusal to support meaningful Senate reform, as was proposed in Bill S-4. This led to the introduction of Bill C-7, the Senate reform act, in 2011. Bill C-7 would have implemented a nine year, non-renewable term for senators, as well as a voluntary framework for provinces to implement Senate appointment consultation processes of their own. However, that was not to be, and now we must all live with and respect the decision of the Supreme Court in this matter.

The court said that Senate abolition would require the support of Parliament and the legislative assemblies of each province. In doing so, it has given the Senate the highest level of protection that can be achieved under our amending procedures. I would point out for the member for Winnipeg Centre that his proposal to effectively abolish the Senate by withdrawing its funding would not conform to the court's decision in its Senate reform reference.

I would also like to point out that it is unlikely that all of the provinces agree with the position of the member for Winnipeg Centre. I would further submit that one thing most of the provinces do appear to agree on is that the Senate is not the top priority of provincial concern.

I would like to make this clear. I am not looking to defend the institution that we call the other place. That is not the role of members of the House. However, we now have a reference to the Supreme Court of Canada on Senate reform and the release of the court's opinion this spring. It remains to be seen what the ultimate impact of the court's opinion will be on the future for reform.

However, the subject of this potential constitutional debate is not one that any member of this place should take lightly. The reality is that the member for Winnipeg Centre is trying to do an end run around with his motion.

I understand the NDP's frustration, and at times I am certain we all wish we had a magic wand to make our challenges magically go away. However, what the member for Winnipeg Centre has proposed, as we know, is not how this issue will be resolved.

Before I close, I would like to share a few personal thoughts on this issue. Since I have come to this place, I have worked with senators. I have worked with senators on the Senate-House of Commons Standing Joint Committee for the Scrutiny of Regulations. I worked with the Senate on the passage of my private member's bill on the interprovincial movement of wine. This work seldom is covered by the media. However, I can state first-hand that it is important work and that the Senate takes a different perspective on these issues. I mention this because we all know that there are a handful of members from the other place who have become household names for a variety of different but not flattering reasons. However, there are also many good people who do good work on behalf of Canadians in the other place.

Many of us may not like the historic structure of the other place and the role it plays in our governance. However, dislike of an institution we disagree with does not alleviate our constitutional obligations to work with that institution. Regardless of what the NDP thinks, the Senate is part of the process of how we pass laws.

I need not remind the NDP that we are legislators. To deny or otherwise disable part of the very process involved with changing legislation would in effect compromise the work we do on behalf of Canadians. If the NDP seeks to disable our ability to pass, amend, or change laws as legislators, then perhaps it is time it ceased to be the opposition. I frequently hear the NDP members propose private member's bills, suggest amendments, and even propose to change laws, should they ever form the government. None of that can happen without bills passing through the Senate. It is in our constitution.

Either the New Democratic Party is kidding Canadians, or perhaps it is just kidding itself. Either way, like the Senate or not, those who came long before us did a very good job of ensuring that the other place is very much part of how we pass bills into law. To undermine this process undermines the work we do as legislators, and I cannot and will not support this motion presented by the NDP tonight. I certainly will be happy to vote in favour of the estimates put forward.

I support the motion put forward by the government so that it can have supply, but I stand opposed to the notion by the NDP.

I would like to thank all members of the House for taking the time to hear my comments this evening. I appreciate and look forward to their questions.

[Dr. Joel Lexchin]

I definitely do.

For instance, if we have evidence of widespread off-label use of drugs, Bill C-17 would then allow the minister to require companies to undertake additional studies so we can gain better information about whether or not that off-label prescribing is or is not appropriate.

Currently, the estimates are that 70% of all of the off-label prescribing is not backed up by good scientific data. That doesn't mean, as you pointed out, that off-label prescribing is bad for people; it just means that we don't know. We need to be able to have the requirements to get that information to decide whether this off-label prescribing is good or not.

However, another provision we need to consider is that although Health Canada collects data in its adverse drug reaction reports about whether or not the drug has been prescribed on or off label, when that information is provided to them, that is not part of the online database. People don't really know how often adverse reactions are linked to off-label prescribing. That could be quite easily corrected by giving Health Canada the resources, or requiring Health Canada to post on its public database whether or not the drug was being prescribed on or off label.

[Sylvia Hyland]

I agree more can be done, and I think maybe we need to do it in a staged approach. My concern is that amendments could delay getting some of these key authorities in place sooner, so that's my only concern. I think there's always room to improve. There will always be ongoing improvement that's going to be needed, and there'll be more changes needed to the Food and Drugs Act. But I'm not sure we want to delay implementing some of these key components of Bill C-17.

I liked hearing that there's agreement that it's a very strong bill.

[Prof. Matthew Herder]

Absolutely. Bill C-17 is strong as it stands. It could be made really strong if the amendments are included.

[Prof. Matthew Herder]

Perhaps I can speak first.

I think the point Professor Gibson was making was around restrictive interpretation of harm or injury. Her point was that without clear guidance, harm or injury encompassed products that had been mislabelled or mispackaged and that therefore wouldn't work as a result, as was the case in a contraceptive pill, which they may not include in the definition of “harm”.

With the definitions that are in Bill C-17 and with the additional wording that she proposed for circumstances in which they may not work because of mislabelling or mispackaging, the bill would capture other things as well as adverse drug reactions—the more traditional kinds of harm.

I'm not sure that I have squarely addressed your question, but I think we're there in terms of what has been offered.

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

I am very happy about that.

Thank you for giving me the opportunity to speak my native language.

My first question is for Mr. Lexchin and Mr. Herder. Other witnesses may also make comments on this.

Earlier, we spoke about a contraceptive pill which, according to the old definition which is not included in Bill C-17, meant that a pregnancy was considered to be the consequence of a life choice. So, according to the new definition we find in the bill before us, are there other concrete examples of medications which were mistakenly classified?

In other words, will the new definition solve other situations we may have seen in Canada, aside from the contraceptive pill which was used as an example previously?

[Terence Young, Conservative, Oakville, ON]

Mr. Chair, I have a point of order.

Professor Gibson made a really brief remark on natural health products, and I could tell she wanted to say more. I wonder if we could ask the clerk to write to Professor Gibson to ask her if she wouldn't mind submitting further remarks in addition to her brief comments on the record about natural health products and Bill C-17.

[Prof. Janice E. Graham]

Thank you. It's a very good question, Mr. Wilks. Thank you for asking it.

I was researching at Health Canada when the natural health products directorate was brought into being. At that point in time, Canada was a world leader, and it remains a world leader in having a natural health products directorate. Unfortunately, and I will say it here, they caved to industry pressure—and I'm talking about the natural health products industry—and removed issues of efficacy from approvals. So unlike biologics and pharmaceuticals, NHPs or natural health products don't actually need to have the stamp of showing that they are an efficacious agent.

Mostly people were worried about safety, and I share all of my colleagues' concern that many of the natural health products aren't all that safe. This is something that is recognized everywhere in the world.

I was in West Africa last month and watched a little boy writhing on the ground after he had to have a terrible abscess removed without painkillers, because the nurse in this tiny clinic without electricity recognized that these kids were coming in and.... People first go to what in Canada is the medicine cabinet or to what anywhere else is the local herbalist and pick up whatever they have. When they finally go as a last effort to the emergency ward, the emergency people can't treat them, because they don't know what they've taken.

I think the issue of natural health products would very easily derail all of our interests in getting the amended Bill C-17 forward, but I would like to leave it off for now, because we want to see Bill C-17 amended and approved.

[Dr. Joel Lexchin]

I certainly think we need more information about natural health products. I work in an emergency department. When people come in and they say they're taking various natural health products, I really have no idea of, one, the inherent risks associated with those products, and two, how those products interact with any prescription drugs that those people may be taking.

I'm not alone. I think most of my colleagues are in the same position. We definitely need more information about the safety of these products. But I think one of the things that killed Bill C-51 was the opposition from the natural health products community. I would hate to see Bill C-17 killed because of that same kind of opposition. I think we need to move forward with better regulation of natural health products. But I agree that I think it can be done at a later date.

[Sylvia Hyland]

I'm not sure the risks are lower. Our position is the understanding that the inclusion of natural health products in the more complex bills cause them not to move forward and be enacted. Bringing that into this bill might actually slow down the great work that's already been started. So maybe the natural health products do need to be dealt with, but in the future...to take Bill C-17 and take this first step forward. So I do think they will need to be looked at, but I'm not sure we need to bring them in right now to Bill C-17.

Does that help?

[David Wilks, Conservative, Kootenay—Columbia, BC]

Thank you.

Thank you, Mr. Morin.

I wanted to touch upon a couple things, and unfortunately, one of our witnesses left. One of the things that was brought up was the natural health products that were not included in Bill C-17 due to their low risk profile and the fact that they're already adequately regulated.

Ms. Hyland, do you agree with the approach, given the inherent low risk of natural health products? Perhaps I could listen to Professor Herder and Dr. Lexchin, and Janice Graham, who is online as well.

We'll start with Ms. Hyland.

[Terence Young, Conservative, Oakville, ON]

That's a terrific example.

Can you please comment on drug disasters? I wanted to ask you, if Bill C-17 had been law throughout the 1990s and clinical data had been published throughout the 1990s, how many or what drug disasters could have been avoided?

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

If we passed Bill C-17 without the amendments, without strong amendments that have been suggested, would we be laggards? What I guess I'm getting at is whether this bill is simply a placebo, or is it going to make substantial progress anyway? Would we still be behind the United States and Europe, in terms of transparency, if we passed the bill without the amendments that you and others are suggesting?

[Dr. Joel Lexchin]

If you compare us with the United States and the EU, right now we're a distant third in terms of transparency. With the passage of Bill C-17, with the amendments that have been suggested, I think Canada would be leading both the U.S. and the EU. Right now, though, we're not doing very well in terms of transparency, disclosure of information.

[Prof. Matthew Herder]

I'll speak to the specific issue, if I may, of that provision on trade agreements.

The current wording of the statute is that it's a power to make regulations in respect of the trade agreements and the opening language of the clause is, “without limiting the powers conferred elsewhere in this act”, or something essentially to that effect, so that you can create regulations to deal with these trade commitments, but they don't undermine or shape the powers that are already in the statute outside of that set of regulations.

Under the proposed amendment, in Bill C-17, the language is, “Without limiting the power conferred” in this section, so that means, by implication, that implementing those trade agreements or commitments around those trade agreements around intellectual property, could shape powers elsewhere in the legislation. That's my interpretation of the effect of that wording. That's very subtle. It does not necessarily shape those powers. It just creates the possibility of doing that in the name of trade and respecting particular articles in NAFTA and the TRIPS agreement around intellectual property.

I hope that clarifies it. The first time I read the bill, I didn't catch it. It's very subtle language, but I think it's important and it opens the door to sort of fettering responsibilities or powers that are in the legislation around recalls, things in the name of patient safety or transparency. It could, in theory, certainly be tempered by virtue of that new wording.