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.

[Walter Robinson]

Another area of focus critical for business stability and confidence is safeguarding confidential business information. In June this House passed Bill C-17, which modernizes Canada's Food and Drugs Act. To be clear, we support the principles, objectives, and direction of Bill C-17, as it essentially codifies the manner in which our members already work with Health Canada to ensure and promote patient safety. However, we are concerned about last minute amendments made to the bill prior to its passage by the House, which deal with the standard for disclosing confidential business information or CBI.

As currently written, CBI in the bill is understood broadly to include business information that is not publicly available. It is information that has economic value to a business or its competitors but may not be related to patient safety. Rx and D is strongly supportive of providing the Minister of Health with specific powers to respond to the threats to the health of Canadians, which may include circumstances where it is essential to disclose CBI to address an imminent and serious risk to human health without notice or consent. Indeed, this is the approach in the Canada Consumer Product Safety Act and the Human Pathogens and Toxins Act. The threshold in both of these acts permits disclosure only when the risk is serious and imminent. Using these acts as benchmarks, we think the language in Bill C-17 is problematic and imprecise. It is also inconsistent with the benchmark used by the FDA and the EMA. We have amendments that we can talk to you about during our closing our remarks.

Health

[Libby Davies, NDP, Vancouver East, BC]

Mr. Speaker, the minister still has not explained her inaction.

Just think about it. For the past eight years, Canadians and the NDP have been calling for better drug safety measures, including in Bill C-17, yet today Health Canada is still unable to stop the sale of a dangerous drug in Canada.

What steps will the minister take to fix this situation? The health of Canadians is on the line. When is she going to take responsibility?

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

[Terence Young, Conservative, Oakville, ON]

Mr. Speaker, there have been consultations with respect to the final stages of Bill C-17, Vanessa's law, and I believe you would find the unanimous consent of the House for the following motion. I move:

That, notwithstanding any Standing Order or usual practices of this House, Bill C-17, An Act to amend the Food and Drugs Act, shall be deemed concurred in at the report stage and deemed read a third time and passed.

(Bill C-17. On the Order: Government Orders:)

June 13, 2014—Report stage of Bill C-17, An Act to amend the Food and Drugs Act—the Minister of Health.

Health

[Eve Adams, Conservative, Parliamentary Secretary to the Minister of Health]

Mr. Speaker, I have the honour to present, in both official languages, the fifth report of the Standing Committee on Health in relation to Bill C-17, An Act to amend the Food and Drugs Act.

The committee has studied the bill, and has decided to report the bill back to the House with amendments.

[The Chair, Conservative, Ben Lobb]

That concludes Bill C-17.

Mr. Young, did you have a point?

[Terence Young, Conservative, Oakville, ON]

Bill C-17 represents the biggest change in 20 years, a major, major change, and—

Business of the House

[Peter Van Loan, Conservative, Leader of the Government in the House of Commons]

Mr. Speaker, I am pleased to have another opportunity to respond to the Thursday question from the hon. member for Burnaby—New Westminster.

I know how proud he claims to be about showing up to work. In fact, though, the New Democrats seem to have a spotty record on that. Last evening, that very member rose to speak to our government's bill to protect our communities and exploited persons—that is Bill C-36—and after one whole minute he moved to adjourn the House. He said we should all go home. Maybe that is the parliamentary equivalent of taking one's ball and wanting to go home when one is unhappy with how things are going in another meeting.

In any event, we did all dutifully troop into the House to vote on that at 6 p.m. However, what was very revealing was that only 61 of those 98 New Democrats stood in their places to vote. A few of them were missing their shifts, oddly. We did not find that on the Conservative side. In fact, we just had two votes in the House, and the number of New Democrats who were not standing in their places was very similar to that.

Therefore, when I ask myself who is not showing up for work, I can say it is not the Conservatives not showing up; it is, in fact, the New Democrats.

However, following the popular acclaim of last week's Thursday statement, I would like to recap what we have actually accomplished in the House since last week in terms of the legislative agenda.

Bill C-37, the riding name change act, 2014, which was compiled and assembled through the input of all parties, was introduced and adopted at all stages.

Bill C-31, the economic action plan, act no. 1, was adopted at both report stage and, just moments ago, at third reading.

Bill C-24, the strengthening Canadian citizenship act, was concurred in at report stage.

Bill C-20, the Canada-Honduras economic growth and prosperity act, was passed at third reading. Of course, the NDP tried to slow down its passage, but Conservatives were able to get around those efforts, as I am sure the 50 New Democrats on vigil in the House last night fondly appreciate, and we were able to extend our hours because there were, again, not even 50 New Democrats here in the House to stand in their places to block that debate as they wanted to, so we did finish the Canada-Honduras bill that night and were able to vote on it.

The government's spending proposals for the year were adopted by the House, and two bills to give these plans effect, Bill C-38 and BillC-39, were each passed at all stages.

Bill C-22, the energy safety and security act, was reported back from committee, and several other reports from committees were also tabled. As I understand, we will see Bill C-17, the protecting Canadians from unsafe drugs act, reported back from the health committee in short order.

Finally, this morning we virtually unanimously passed a motion to reappoint Mary Dawson as our Conflict of Interest and Ethics Commissioner.

Sadly, though, the New Democrats did not heed my call last week to let Bill C-32, the victims bill of rights act, pass at second reading. We were treated, sadly, to only more words and no deeds from the NDP.

Turning to the business ahead, I am currently anticipating the following debates. This afternoon and tonight, we will finish the debate on Bill C-36, the Protection of Communities and Exploited Persons Act, at second reading. That will be followed by third reading of Bill C-24 and second reading of Bill C-35, Justice for Animals in Service Act (Quanto's Law).

Tomorrow morning, we will debate Bill C-24, if necessary, and Bill C-18, Agricultural Growth Act, at second reading. After question period, we will get back to Bill C-32, and give the NDP one more chance to send the victims bill of rights to committee.

The highlight of Monday is going to be the report stage of Bill C-6, the Prohibiting Cluster Munitions Act. Tuesday’s feature debate will be Bill C-2, the Respect for Communities Act, at second reading. Wednesday will see us finish third reading, I hope, of Bill C-6. During the additional time available those days—in addition to Thursday and Friday of next week—I will schedule any unfinished debates on Bill C-18, Bill C-32 and Bill C-35.

I will also try to schedule debates on Bill C-22 and Bill C-17, as well as other bills, such as Bill C-3, Safeguarding Canada's Seas and Skies Act, at third reading; Bill C-8, Combating Counterfeit Products Act, at third reading; Bill C-12, Drug-Free Prisons Act, at second reading; Bill C-21, Red Tape Reduction Act, at second reading; Bill C-26, Tougher Penalties for Child Predators Act, at second reading; Bill S-2, Incorporation by Reference in Regulations Act, at second reading; Bill S-3, An Act to amend the Coastal Fisheries Protection Act, at second reading; and Bill S-4, Digital Privacy Act—which I understand we will receive shortly from the other place—at second reading.

Vanessa's Law

[Terence Young, Conservative, Oakville, ON]

Mr. Speaker, Bill C-17, Vanessa's law, will help identify potentially dangerous drugs and ensure the quick recall of unsafe drugs. It contains tough new patient safety measures, and the health committee is currently working very well on amendments that will make this bill even stronger.

I have been pleased to see the co-operation of all parties at committee to get its legislative study of Vanessa's law done today, and we hope to see it reported back to the House as soon as possible. If this spirit of co-operation continues, it is within our power to see Bill C-17 pass in this House before the summer.

Our discussions today have been fruitful, and I hope to see this goodwill continue to ensure that this important patient safety legislation becomes law as soon as possible. I am willing to work. Our committee is willing to work. Let us get the job done.

[The Chair, Conservative, Ben Lobb]

Welcome back.

We're continuing with our examination of Bill C-17. We're working right through.

We left off last time on amendment CPC-10. On that amendment to clause 6, we have Mr. Wilks.

[Libby Davies, NDP, Vancouver East, BC]

Thank you, and sorry for the mix-up.

In NDP-5.1, we're suggesting that clause 6 be amended by adding after line 30, on page 6, the following:

(c.l) respecting the registration of clinical trials and investigational tests involving human subjects and specifying the period within which the results of those clinical trials and investigational tests must be provided to the Minister.

Again, this comes out of the testimony that we heard from, I think it was Professor Herder. We believe that this amendment would add the range of clinical trials and observational studies to the mandate of Bill C-17, and give the Governor in Council the power to make regulations about clinical trial registration.

All investigational studies, including not just phase 1 to 4, but also observational studies, should be registered and otherwise subject to transparency. In fact, we did hear from our witnesses that the importance of observational studies is becoming more evident. They are more likely to be used in the future, particularly in the context of rare diseases.

I think this adds a better range, in terms of the clinical trials and observational studies to be added to the mandate of the bill.

[Terence Young, Conservative, Oakville, ON]

Bill C-17 empowers the minister to order the publication of a whole range of things, and one of them is drug reviews. Another one is the initial grant of the NOC powers.

I'd like to ask the counsel to comment on that one as well, please.

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

Thank you, Mr. Chair.

I'd like to move that the health committee extend its current meeting, suspending at 1:45 and resuming at 3:30, for the purpose of clause-by-clause consideration of Bill C-17, and that the committee continue sitting until clause-by-clause consideration of Bill C-17 is complete, or 11:59 p.m., whichever comes first.

[Terence Young, Conservative, Oakville, ON]

Chair, under Bill C-17 the minister will have all kinds of new powers to direct pharmaceutical companies to issue new documents, new warnings, new safety warnings to clarify things, and to go back and retest a drug, etc.

Currently the Department of Health makes product monographs all publicly available on the Health Canada website. A monograph is a factual statement. It's the statement that the pharmaceutical companies provide to Health Canada to get their first notice of compliance. They're required to update it on occasion. It describes the properties, claims, indications, and conditions of use for a drug and all the other information, including reference to studies. Anyone, any independent researcher anywhere in the world, can have access to that document, just by going on the Internet, to draw their own scientific conclusions.

In fact, under Vanessa's law, the minister has committed to publishing drug reviews. For the first time, drug reviews for drugs that are on the market will be available to any scientist in the world who wants to examine that documentation, as they can in other countries.

This proposed motion would require the minister to actually do an independent review when there's already been a review. Drug monographs are approved by Health Canada in the first place.

In that sense, this would be redundant.

[Libby Davies, NDP, Vancouver East, BC]

We have NDP-2.2, which is dealing with the same situation, again we're trying to give greater certainty to how this legislation reads. I move that Bill C-17 be amended in clause 3 by adding after 40 on page 3:

(2.1) For greater certainty, if the Minister makes an order under paragraph (1)(a) in respect of a therapeutic product, that therapeutic product must be withdrawn from the market.

Again, it follows on the same point that was raised by MEDEC in terms of larger equipment. I heard what Mr. Lee says, but I'm still moving this amendment.