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

An Act to amend the Food and Drugs Act

This bill was last introduced in the 41st Parliament, 2nd Session, which ended in August 2015.

Sponsor

Rona Ambrose  Conservative

Status

This bill has received Royal Assent and is now law.

Summary

This is from the published bill. The Library of Parliament often publishes better independent summaries.

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.

Elsewhere

All sorts of information on this bill is available at LEGISinfo, provided by the Library of Parliament. You can also read the full text of the bill.

September 27th, 2018 / 10:15 a.m.
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President and Chief Executive Officer, Canadian Organization for Rare Disorders

Dr. Durhane Wong-Rieger

First of all, we want to make sure we do not have the barriers that the proposed reforms to the PMPRB would have, and that is to discourage countries from coming in.

I think we want to talk about having a national program that would allow us to bring in all of those patients. The numbers are small, so we're not going to be able to....

Most of these drugs have to come into specialty clinics, so we have a proposal for a rare disease strategy that would also include centres of excellence. They would include the ability to do what we call a life-cycle approach. We can bring in the drugs. We can identify early on, as we're bringing them in, which patients are going to be immediately eligible—like those with ALS—and which ones are not at all going to be eligible, set up a monitoring program for them to have access to it, and then over time, as we are learning from those patients who are on it....

In the old days, we would call it post-market monitoring. As Cathy talked about, under the new bill, Bill C-17, we can enforce those kinds of post-market monitoring programs that we can learn from.

We have a lot of tools at our disposal and, quite frankly, we do not necessarily need to invent them. We can look at some of the model programs we've put together. Canada knows how to do this. We already have these kinds of monitoring programs with very specific drugs, but we want to be able to make that the standard, make it so we can do it nationally, which we don't necessarily do well, and then not wait until we've gone through two more years of negotiations before we implement it.

We know how to do it. We just need to make sure we put that template in place and have the specialty clinics that are there also able to support the use of them, and, as she talked about, the administration of them, and the ongoing data collection to make sure they're used appropriately and, at the end of the day, price readjustment.

September 27th, 2018 / 9:30 a.m.
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Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health

Catherine Parker

You are correct that in 2012 the Minister of Health announced that Canada was going to proceed with the development of an orphan drug framework for Canada. We advanced a significant amount of work under that project. Most notable was the enactment of Bill C-17, Vanessa's law, which gave the regulator under the Food and Drugs Act many more powers that would be useful, especially in the rare disease space.

At that time we also considered going forward with a specific set of regulations. We decided on a change of course in this respect. We had conversations and dialogue with our international regulatory partners on some of the challenges they face because they had specific legislation for orphan drugs. We ultimately decided not to proceed with specific regulations, but through a regulatory review of drugs and devices initiative, we incorporated new processes and new pathways that could be very valuable for the approval of orphan drugs and also for some other products.

May 30th, 2016 / 5:15 p.m.
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Conservative

Colin Carrie Conservative Oshawa, ON

Dr. Tamblyn, I think that's a great idea on the adverse drug events. I mentioned Vanessa's Law and the safety component. What kind of doctor uptake and buy-in are you getting with this adverse drug reaction reporting? Do you have an update on how things are going with Vanessa's Law?

Professor Herder, do you?

May 30th, 2016 / 5:15 p.m.
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President and Chief Executive Officer, Canadian Organization for Rare Disorders

Dr. Durhane Wong-Rieger

That means that a lot of these drugs come in with conditional approvals, and that's really important. I think the conditions, as you say, under Vanessa's Law, allow us to be able to hold companies accountable. But the other thing is to engage the patient community, because we get a lot of push-back that says, gee, what if we've started drugs, and we have stop criteria, and the patients don't want to come off them—

May 7th, 2015 / 5:10 p.m.
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Deputy Minister, Department of Health

Simon Kennedy

Yes, I can certainly assure the member that the Health Canada funding as regards water and safe water...and in the specific case of Health Canada our role is around testing. There are other elements that belong to Aboriginal Affairs, and so on, but certainly that funding continues and is not lapsing.

If I could just for a moment come back on Vanessa's Law, there is an injunction power under the legislation that would allow us to step in very quickly if there was an issue around advertising. I just wanted to close the loop on that.

May 7th, 2015 / 5:10 p.m.
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Deputy Minister, Department of Health

Simon Kennedy

Thank you very much for the question.

There's a variety of quite powerful provisions that have come into force under Vanessa's Law, and unfortunately I'm not able to cite the specific one with relation to advertising or how it applies, but I could come back to the committee.

For example, under the rules now we're able to have the courts impose penalties including jail time and fines of up to $5 million per day instead of the current $5,000 per day. Drug companies are compelled to revise labels to reflect new risk information, including updates for health warnings for children. Recalls on unsafe products require stronger surveillance. There's a very wide range. This is a law with very strong teeth.

My apologies, I'm trying to remember but I don't have at my fingertips the specific provisions on advertising. I think the general principle is that we're going to look at being a lot tougher on these kinds of violations in the future.

May 7th, 2015 / 5:05 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Okay I'll be fast.

Mr. Kennedy, last year at the Toronto airport I came in one night and there were these advertisements, these big, high signs about eight feet high, in bright colours, you couldn't miss them, and they said, “Humira”. Now, I know disease awareness advertisements are allowed under the current law, but this isn't a disease awareness advertisement, this is a drug advertisement.

It has the name of a very expensive drug that costs about $22,000 a year for treating rheumatoid arthritis, juvenile arthritis, and Crohn's disease. The reason they're not supposed to advertise prescription drugs is that they all have dangers and a doctor should be deciding. No one should make a decision to take a prescription drug without consulting an expert first. The adverse effects from Humira are that it can cause cancer and it can cause tuberculosis. It's definitely not a decision that you want to make while you're walking by with your suitcase in an airport.

What can we do under Vanessa's Law, or what can you do or what do you intend to do to stop drug companies from planting seeds in people's heads to try to get around their doctors so that they decide to take a drug before they know anything about it?

May 7th, 2015 / 4:35 p.m.
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NDP

Murray Rankin NDP Victoria, BC

Thank you very much.

Thank you very much, officials, for being here. As I said earlier I appreciate it. I'd like to first talk about off-label use of drugs as an issue. That is the misleading advertising for unapproved uses of drugs. The International Journal of Risk and Safety examined how Health Canada regulates and enforces Canadian drug advertising. It reviewed complaints for a decade between 2000 and 2011, and it concluded that Health Canada was not doing enough.

The official opposition asked an order paper question that revealed Health Canada received 359 complaints about pharmaceutical advertising, but didn't levy a single fine in response. They wrote letters and Health Canada “worked with them to achieve compliance”. There are big fines under the amendments of Vanessa's Law to the Food and Drug Act, big fines of $500 million and so forth, but if you don't enforce them why would anybody take it seriously?

We appreciate your having to work with companies to achieve compliance, but if there are no teeth in the rules prohibiting it, why are they ever going to comply or ever going to do the right thing? If you just get a warning letter, what does it matter?

May 7th, 2015 / 4:20 p.m.
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Conservative

Terence Young Conservative Oakville, ON

—but Vanessa's Law gives a place for them to go where something will be acted on.

May 7th, 2015 / 4:15 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Thank you, Minister, for joining us today, and to everyone else who came.

Before I ask my question, I would like to congratulate you and Health Canada on the anti-drug online and television ads, which we saw, which you commissioned. I thought they were very effective. Obviously, they would get the viewer's attention. It appeared as if they were slanted toward young people, which is very important, before they decide to try drugs, so they are aware that they would be very bad for their health. I thought they were excellent so I wanted to congratulate you on them.

As you know, Minister, drug safety issues have been a focus of my life for many years, so I was very pleased to have had the opportunity to take part in our review of Vanessa's Law. We ensured that the final wording of the bill addressed long-standing issues that drug safety experts have been raising for years about the lack of transparency by Health Canada.

When we're drafting legislation on issues as important as drug safety, it's absolutely essential that we listen to the experts and accept good advice when it is offered. Your openness to hearing that advice has strengthened the bill, and I believe it will serve to strengthen our drug safety system for years to come.

We have now had the law passed for some time. I know that a number of measures are undergoing consultation to ensure that the details are implemented effectively; in other words, we're going to get it right. Can you please provide some additional details to the committee about the continuous monitoring of the development of these powers that have been put in place?

May 7th, 2015 / 3:45 p.m.
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Simon Kennedy Deputy Minister, Department of Health

Thanks, Minister.

On this particular case, the original submission was made under the access to information rules. The ministry is obliged to apply the access law, which does require a number of exemptions for business information and so on.

With new authorities under Vanessa's Law, there is this other avenue we can use to make information available where there is a health or safety threat. We've spoken to the researcher in question, and we sent him a fairly detailed letter to explain the process to make an application under Vanessa's Law. That conversation is going on and our hope would be to be able to move through that avenue to deal with the issue.

May 7th, 2015 / 3:45 p.m.
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Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

I sympathize with his experience.

Under Vanessa's Law, the intention is to make clinical trial information available, but still to some extent—and for legal reasons obviously—protect confidential business information. Our intention under Vanessa's Law—and it's my belief—is that we should be sharing as much as we possibly can.

On that specific one, I think that's still under way, but I know Simon is working on that.

May 7th, 2015 / 3:45 p.m.
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NDP

Murray Rankin NDP Victoria, BC

I appreciate that.

As you speak of transparency, that takes me to Vanessa's Law, to which you made reference earlier.

Toronto doctor, Nav Persaud, made an information request to Health Canada to get clinical trials on a pregnancy drug, an anti-nausea drug called Diclectin. He tried that three and a half years ago. He finally got 359 pages, 212 of which were completely redacted or censored.

In March, after Vanessa's Law came in, he resubmitted the request for all of the 359 pages, and so far has been given nothing. I got that as recently as two days ago in a letter. The clinical trial data was something that was to be made available, as I understood it, under Vanessa's Law. His experience has been entirely frustrating.

May 7th, 2015 / 3:40 p.m.
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Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

First of all, let me say it's important that we remember this tragic event that happened in the 1960s, reflect upon the good work of this committee around Vanessa's Law, and remember why it's so important that we have strong drug safety laws in this country.

Our government has very deep sympathy for what happened. While this happened in the sixties, I offered our government's and all Canadians' public regret and apologies to those who were affected by thalidomide. We know we can never undo the pain and suffering that people have experienced.

I had an opportunity to meet a few times with Mercedes Benegbi, who is the head of the Thalidomide Victims Association of Canada. As you know, we did announce $180 million to be distributed among the survivors. I'm pleased to say that we've been able to get out the $125,000 tax-free lump sum immediately to survivors. The reason we worked very quickly is that it will take us some time to get the yearly pension set up with the other $168 million we have. Also, we have an extraordinary medical assistance fund. We're in the middle of working out the details of that.

May 7th, 2015 / 3:30 p.m.
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Edmonton—Spruce Grove Alberta

Conservative

Rona Ambrose ConservativeMinister of Health

Thank you very much, Mr. Chair, and thank you to the committee. I want to thank all of you for the work you do on the health committee. I know many of you are passionate about the issues of health, and I thank you for your commitment to that.

I'm joined by Simon Kennedy, Health Canada's new deputy minister; Krista Outhwaite, our newly appointed president of the Public Health Agency of Canada; and Dr. Gregory Taylor, whom you've met before, Canada's chief public health officer. I know he'll be here for the second half. You might want to ask him about his trip to Guinea and Sierra Leone to visit our troops and others who are working on the front dealing with Ebola. I'm sure he'll have some great things to share with you.

Michel Perron is here on behalf of the Canadian Institutes of Health Research. He's also new. Last time I know you met Dr. Alain Beaudet.

We also have Dr. Bruce Archibald, who's the president of the Canadian Food Inspection Agency. I think you've met Bruce as well.

Mr. Chair, I'd like to start by sharing an update on some of the key issues that we've been working on recently. I'll begin by talking about Canada's health care system, the pressures it's facing, and the opportunities for improvement through innovation. I will then highlight some recent activities on priority issues such as family violence and the safety of drugs in food.

According to the Canadian Institute for Health Information, Canada spent around $215 billion on health care just in 2014. Provinces and territories, which are responsible for the delivery of health care to Canadians, are working very hard to ensure their systems continue to meet the needs of Canadians, but with an aging population, chronic disease, and economic uncertainty, the job of financing and delivering quality care is not getting easier.

Our government continues to be a strong partner for the provinces and territories when it comes to record transfer dollars. Since 2006, federal health transfers have increased by almost 70% and are on track to increase from $34 billion this year to more than $40 billion annually by the end of the decade—an all-time high.

This ongoing federal investment in healthcare is providing provinces and territories with the financial predictability and flexibility they need to respond to the priorities and pressures within their jurisdictions.

In addition of course, federal support for health research through the CIHR as well as targeted investments in areas such as mental health, cancer prevention, and patient safety are helping to improve the accessibility and quality of health care for Canadians.

But to build on the record transfers and the targeted investments I just mentioned, we're also taking a number of other measures to improve the health of Canadians and reduce pressure on the health care system. To date we've leveraged over $27 million in private sector investments to advance healthy living partnerships. I'm very pleased with the momentum we've seen across Canada.

Last year we launched the play exchange, in collaboration with Canadian Tire, LIFT Philanthropy Partners, and the CBC, to find the best ideas that would encourage Canadians to live healthier and active lives. We announced the winning idea in January: the Canadian Cancer Society of Quebec and their idea called “trottibus”, which is a walking school bus. This is an innovative program that gives elementary schoolchildren a safe and fun way to get to school while being active. Trottibus is going to receive $1 million in funding from the federal government to launch their great idea across the country.

Other social innovation projects are encouraging all children to get active early in life so that we can make some real headway in terms of preventing chronic diseases, obesity, and other health issues. We're also supporting health care innovation through investments from the Canadian Institutes of Health Research. In fact our government now is the single-largest contributor to health research in Canada, investing roughly $1 billion every year.

Since its launch in 2011, the strategy for patient-oriented research has been working to bring improvements from the latest research straight to the bedsides of patients. I was pleased to see that budget 2015 provided additional funds so that we can build on this success, including an important partnership with the Canadian Foundation for Healthcare Improvement.

Canadians benefit from a health system that provides access to high-quality care and supports good health outcomes, but we can't afford to be complacent in the face of an aging society, changing technology, and new economic and fiscal realities. That is why we have been committed to supporting innovation that improves the quality and affordability of health care.

As you know, the advisory panel on health care innovation that I launched last June has spent the last 10 months exploring the top areas of innovation in Canada and abroad with the goal of identifying how the federal government can support those ideas that hold the greatest promise. The panel has now met with more than 500 individuals including patients, families, business leaders, economists, and researchers. As we speak, the panel is busy analyzing what they've heard, and I look forward to receiving their final report in June.

I'd also like to talk about another issue. It's one that does not receive the attention that it deserves as a pressing public health concern, and that's family violence. Family violence has undeniable impacts on the health of the women, children, and even men, who are victimized. There are also very significant impacts on our health care and justice systems.

Family violence can lead to chronic pain and disease, substance abuse, depression, anxiety, self-harm, and many other serious and lifelong afflictions for its victims. That's why this past winter I was pleased to announce a federal investment of $100 million over 10 years to help address family violence and support the health of victims of violence. This investment will support health professionals and community organizations in improving the physical and mental health of victims of violence, and help stop intergenerational cycles of violence.

In addition to our efforts to address family violence and support innovation to improve the sustainability of the health care system, we have made significant progress on a number of key drug safety issues. Canadians want and deserve to depend on and trust the care they receive. To that end, I'd like to thank the committee for its thoughtful study of our government's signature patient safety legislation, Vanessa's Law. Building on the consultations that we held with Canadians prior to its introduction, this committee's careful review of Vanessa's Law, including the helpful amendments that were brought forward by MP Young, served to strengthen the bill and will improve the transparency that Canadians expect.

Vanessa's Law, as you know, introduces the most significant improvements to drug safety in Canada in more than 50 years. It allows me, as minister, to recall unsafe drugs and to impose tough new penalties, including jail time and fines up to $5 million per day, instead of what is the current $5,000 a day. It also compels drug companies to do further testing and revise labels in plain language to clearly reflect health risk information, including updates for health warnings for children. It will also enhance surveillance by requiring mandatory adverse drug reaction reporting by health care institutions, and requires new transparency for Health Canada's regulatory decisions about drug approvals.

To ensure the new transparency powers are providing the kind of information that Canadian families and researchers are looking for, we've also just launched further consultations asking about the types of information that are most useful to improve drug safety. Beyond the improvements in Vanessa's Law, we're making great progress and increasing transparency through Health Canada's regulatory transparency and openness framework. In addition to posting summaries of drug safety reviews that patients and medical professionals can use to make informed decisions, we are now also publishing more detailed inspection information on companies and facilities that make drugs. This includes inspection dates, licence status, types of risks observed, and measures that are taken by Health Canada. Patients can also check Health Canada's clinical trials database to determine if a trial they are interested in has met regulatory requirements.

Another priority of mine is tackling the issue of drug abuse and addiction in Canada. There's no question that addiction to dangerous drugs has a devastating and widespread impact on Canadian families and communities. In line with recommendations from this committee, I am pleased that the marketing campaign launched last fall by Health Canada is helping parents talk with their teenagers about the dangers of smoking marijuana and prescription drug abuse. The campaign addresses both of those things, because too many of our young people are abusing drugs that are meant to heal them.

Our government also recognizes that those struggling with drug addictions need help to recover a drug-free life. From a federal perspective, of course, we provide assistance for prevention and treatment projects under our national anti-drug strategy. We've now committed over $44 million to expand the strategy to include prescription drug abuse and are continuing to work with the provinces to improve drug treatment.

I've now met and will continue to meet with physicians, pharmacists, first nations, law enforcement, addictions specialists, medical experts, and of course parents to discuss how we can collectively tackle prescription drug abuse.

Finally, our government continues to make very real investments to strengthen our food safety system. As only the latest example, I recently announced a five-year investment of more than $30 million in the CFIA's new food safety information network. Through this modern network, food safety experts will be better connected, and laboratories will be able to share urgently needed surveillance information and food safety data, using a secure web platform. This will put us in an even better position to protect Canadians from food safety risk by improving our ability to actually anticipate, detect, and then effectively deal with food safety issues. This investment will continue to build on the record levels of funding we've already provided, as well as the improved powers such as tougher penalties, enhanced controls on E. coli, new meat labelling requirements, and improved inspection oversight.

In conclusion, those are just some of the priorities that will be supported through the funding our government has allocated to the Health portfolio. This year's main estimates, notably, include investments for first nations health, for our ongoing contribution to the international response to the Ebola outbreak in West Africa, and the key research and food safety investments that I have already mentioned.

I'll leave it at that. If committee members have any questions, my officials and I would be very pleased to answer them. Thank you.

January 27th, 2015 / 5:15 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Thank you.

This committee just completed a study of Vanessa's Law, which is now the law of Canada and is all about transparency and openness with regard to keeping Canadians safe when using prescription drugs. That will empower researchers, doctors, and even patients to get the information they need to keep themselves safe or keep their patients safe. What has the PMRA done to increase transparency and openness to help keep Canadians safe?

December 9th, 2014 / 3:30 p.m.
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Karen Proud President, Consumer Health Products Canada

Thank you very much.

Good afternoon, Mr. Chair and ladies and gentlemen of the committee.

My name is Karen Proud and I am the president of Consumer Health Products Canada. For those of you who don't know us, we're the trade association that represents the companies that make evidence-based over-the-counter medications and natural health products. These are products you find in medicine cabinets in every Canadian home. From sunscreens and vitamins to pain relievers and allergy medications, people use consumer health products to maintain their health and manage their minor ailments. This is a fundamental part of self-care that is vital to the health of Canadians and to the sustainability of our health care system.

I'm very pleased to be here today to speak in support of Bill S-2 and want to thank the committee for the opportunity.

In our opinion this bill is important in two ways. It provides express authority for departmental regulatory authorities to utilize an important tool in the drafting toolbox where currently there exists ambiguity. More importantly, it creates efficiencies and flexibilities within the regulatory process that are necessary to keep pace with the rapid rate of change in the regulatory environment.

The bill also contains a number of safeguards that have been put in place to ensure that the use of these new authorities is in line with current regulatory practices. While we certainly support safeguards related to ensuring accessibility and maintaining official languages, we would call into question the limitations that this bill imposes on regulatory authorities when it comes to referencing documents they produce internally.

As it stands today, this bill would not allow departments to use dynamic references for documents they produce themselves or produce with a person or body in the federal public administration. We think this is a bit short-sighted. Our members' products are currently regulated under the Food and Drugs Act. The act, which was amended in 2012 through the budget implementation bill, Bill C-38 and again this past fall with Bill C-17, gives the Minister of Health the authority to incorporate by reference any document, regardless of its source, either as it exists on a particular date or as amended from time to time. The Safe Food for Canadians Act, which passed in November 2012, has similar broad authorities for incorporation by reference.

It may surprise the committee to hear that we fully support providing regulatory authorities with these broad authorities under the proper circumstances. Under the Food and Drugs Act, our members rely on the fact that the department can incorporate by reference documents that it produces, which change over time. For example, the “Compendium of Monographs” is a document produced by Health Canada and incorporated by reference into the natural health products regulations. It allows new product applicants to reference the data contained in the monographs to support the safety and efficacy of their products rather than providing evidence for ingredients that are already known to be safe and efficacious when used under the conditions specified in the monographs. This significantly reduces the regulatory burden for industry and helps speed the evaluation of applications without compromising safety and efficacy requirements.

One of the biggest challenges with regulation is to maintain flexibility within the system to adapt to changing environments, so why tie the hands of regulators? Why not, instead, ensure that they have the tools they need and create a system of checks and balances to ensure that these tools are used responsibly? We recommend removing the limitations that are contained in Bill S-2 but ensuring that there is proper oversight so that these authorities, both in this bill and as they exist in other legislation, are used consistently and in the spirit in which they were intended by Parliament.

Specifically, we ask that the Treasury Board Secretariat be tasked to immediately develop guidance in the form of a cabinet directive that must be followed by departments when exercising the authority to incorporate by reference. We would also suggest that the Standing Joint Committee on Scrutiny of Regulations broaden its mandate to look not only at regulatory instruments but at the departments' adherence to Treasury Board guidance. With these two things in place, we feel departments will have access to an important regulatory tool with the proper oversight.

While I understand that the clause-by-clause review of this bill will take place immediately following this round of testimony, I do hope that you will consider our proposals. I look forward to any questions you may have.

Thank you.

Opposition Motion—Survivors of thalidomideBusiness of SupplyGovernment Orders

November 27th, 2014 / 4:25 p.m.
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NDP

Libby Davies NDP Vancouver East, BC

Mr. Speaker, I certainly appreciate the support from the hon. member. I would agree with him that the real heroes are the incredibly strong advocates, the thalidomide survivors who have had the courage to speak out and to be visible. They have brought forward this incredible tragedy of what is happening 50 years after to full public light. For sure, the Globe and Mail article from last Saturday was pretty amazing.

We should also thank a public relations firm called Campbell Strategies, a former member of Parliament. People at that firm have been working truly pro bono with the Thalidomide Survivors Task Force for about a year and a half on this issue. We all recognize it is really hard to bring something forward and get that kind of national attention. When it happens and things come together, it is very powerful. That is what has happened. The very important role and ongoing work that Campbell Strategies has provided in supporting the thalidomide survivors with a communications strategy has helped them to bring this story forward.

The member mentioned Bill C-17. He also mentioned that in Europe clinical trials are fully disclosed. He is correct; that is the situation.

We debated Bill C-17 in the House and it was passed unanimously. In committee, the NDP brought forward probably 23 amendments, several of which were about full disclosure in clinical trials. Whether the trials are positive or negative, our belief is that we need to have full transparency and disclosure. This information is often used by researchers and it is often information that is used in other clinical trials. That kind of full and public disclosure is really important. Unfortunately, all of those amendments were defeated. The bill itself is a very important step forward, but I would agree with him that we still have more work to do on this file.

Does the member believe it is critical to have public oversight of these kinds of issues in terms of drug safety? We never want to see a repeat of what happened with the women who took thalidomide, thinking it was a safe drug. This kind of oversight is very critical.

Opposition Motion—Survivors of thalidomideBusiness of SupplyGovernment Orders

November 27th, 2014 / 1:50 p.m.
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Richmond Hill Ontario

Conservative

Costas Menegakis ConservativeParliamentary Secretary to the Minister of Citizenship and Immigration

Mr. Speaker, I will be splitting my time today with my colleague, the member for Huron—Bruce.

I want to begin by saying that nobody who is not a thalidomide survivor or a relative or a friend of a survivor can begin to comprehend the pain and suffering the thalidomide tragedy caused. Nothing can ever undo the pain and suffering inflicted. It is a tragedy that made governments around the world fundamentally rethink how they protect their citizens' health and safety.

The government in Canada too learned from this tragedy. The tragic event from the 1960s reminds us why we need to take drug safety so seriously. Since that time, we have collectively resolved that Canadians deserve nothing less than one of the safest drug approval systems in the world.

As parliamentarians, we continue to strive to strengthen patient safety in this country. We continue to make changes to the drug safety system to enhance its rigour and reduce the risk that this kind of terrible event could occur again. That is why this House so recently united to support Bill C-17, Vanessa's law. It is too often that we experience terrible events like the impact of thalidomide from its use in the early 1960s and, more recently, the death of Vanessa Young to call us to action.

In the case of Vanessa's law, all parliamentarians recognized Health Canada's need for appropriate authorities to ensure that unsafe products are identified and dealt with quickly. We recognized how important it is for regulators to be given the tools they need to protect Canadians from unsafe drugs.

In the wake of the thalidomide tragedy, laws were enacted to require manufacturers to file more detailed submissions with Health Canada, the federal regulator, to receive authorization before a new drug could be marketed. These submissions contain substantial information and data about the drug's safety, effectiveness, and quality, as well as warnings and precautions about side effects.

Products with an identified risk, such as the potential to cause birth defects, or products that are used in vulnerable populations, such as children or pregnant women, are treated as high-risk products and are subject to increased scrutiny, monitoring, and risk mitigation.

These were critical changes to the drug safety system; however, it became apparent that addressing safety concerns at the pre-market stage was not enough. Health Canada needed the tools to take appropriate action if a serious risk was identified after a drug was on the market. That is why all parties in this House and in the other place endorsed Vanessa's law, which received royal assent on November 6 of this year.

This legislation will protect Canadian families and children from unsafe medicine by enabling the Minister of Health to require health care institutions to report serious adverse drug reactions and to report incidents related to medical devices, to recall unsafe products, to apply to the courts to impose tough new penalties for unsafe products, to provide the courts with discretion to impose even stronger fines if violations were caused intentionally, to compel drug companies to revise labels to clearly reflect health risk information, and, finally, to compel drug companies to do further testing on a product, including when issues were identified with certain at-risk populations.

Vanessa's law has also introduced new transparency measures that when in force will require Health Canada to make both positive and negative regulatory decisions publicly available, as well as the reasons for those decisions. These reasons will include a clear statement of benefits a drug may confer, the harmful side effects that some patients may experience, and areas where there are gaps in knowledge.

Transparency regulations will enhance the current transparency requirements in Bill C-17 by placing an obligation on drug companies to disclose more clinical trial information publicly.

Canadians will also be consulted during the regulatory development process about the types of information that could be made available.

As an example, clinical databases show what clinical trials are taking place in Canada for drugs that treat a particular disease or condition. They also provide information about a point person who can provide information for that particular clinical trial. Going forward, a clinical trial registry could indicate whether a trial has been conducted or if it has been terminated prematurely. At the conclusion of a trial, a registry could provide a summary of the results.

The information could be important to patients and health care providers in making treatment decisions. It could be helpful to academic researchers in doing further assessments relating to patient safety. It could stimulate thinking about new areas for research.

In developing Vanessa's law, the government consulted broadly with patients and experts about how to best update Canada's drug safety laws. The new measures substantially strengthen the safety and oversight of therapeutic products throughout their life cycle. They improve Health Canada's ability to collect post-market safety information and ensure strong and active oversight once a drug is on the market. Equally important, they improve the department's ability to communicate important safety information to Canadians and their health care providers.

I will continue my remarks after question period.

Opposition Motion—Survivors of thalidomideBusiness of SupplyGovernment Orders

November 27th, 2014 / 1:10 p.m.
See context

Conservative

Wladyslaw Lizon Conservative Mississauga East—Cooksville, ON

Mr. Speaker, thalidomide is a word that resonates in Canadian cultural history. It is one of those words that one only has to hear, say, or read to evoke immediate and strong feelings. It has gone down in our collective national memory as a mark of human suffering. It is a sad symbol of scientific and governmental failure.

Canadians have a profound faith in the capacity of modern science to improve their quality of life, and this faith is justified. Scientists and researchers keep developing new effective medicines to treat and heal disease. Canadians expect their governments to protect them from unsafe drugs, and this is an expectation that has largely been fulfilled. Over the decades, Canada has enjoyed one of the best drug safety systems in the world.

However, science and governments can fail. Thalidomide is one of those failures. From both sides of the House today, we have heard terrible stories of the shattering human toll of the catastrophic failure that was thalidomide. We have also been reminded that while thalidomide is an awful lesson of history for the survivors, it is very much their present and their future.

As a government, we can help the victims of this tragedy, and I am proud today to stand in support of this motion. I am also pleased to hear that the Minister of Health will be meeting with the victims and is actively reviewing the proposal put forward by the Thalidomide Victims Association of Canada.

Today I want to talk about another aspect of this tragic failure, and the solution so that it does not happen again: transparency and openness. More specifically, I want to talk about the significant steps that the Minister of Health has taken to further enhance the culture of transparency at Health Canada.

The victims of thalidomide never had a chance. Their mothers never had any warning and never saw it coming. Although there was a heated debate at the time within international scientific and regulatory communities about the safety of thalidomide, this concern was never shared with the public. As a result, expectant mothers suffering from morning sickness, and their doctors, were denied the chance to make an informed choice about whether to use thalidomide.

By approving the drug, Canadian regulators took what they viewed at that time as being a justified risk on behalf of potential victims without telling them about it. Many things have changed since thalidomide, but one thing that has not and likely never will is the fact that all drugs come with risks and benefits. The choice that still faces any drug regulator is the determination, based on sound science, of whether the benefits of taking a given drug outweigh the potential health risks to patients.

What has become unacceptable to Canadians, especially post-thalidomide, is for our regulators to restrict the public availability of information about drug risks. It is unacceptable to convey the false impression that such topics are best left to qualified experts in government, industry, and the health professions.

Mr. Speaker, you and I, and most Canadians, may not be scientists, but we have a right to know all that we can about the drugs we are taking, the good and the bad. At the end of the day, it is our lives, our health, and it should be a choice. That means we deserve an informed choice based on best information available to us at the time.

In the years since thalidomide, Health Canada has taken an expectation of transparency to heart. Today the department makes more drug safety information available to Canadians than ever before, so they can make informed decisions for themselves and their families. Every year, the department issues hundreds of health product risk communications, by way of public warnings, public advisories, information updates, and foreign product alerts.

This includes product recalls, as well as changes to drug labels that are required to inform Canadians about any new and emerging risks of using a particular drug. These communications are widely disseminated to media and health professionals. Health Canada also requires that drug makers publicly communicate any new drug product risks.

The department now posts the drug product database on the Internet, where Canadians can find the list of risks and benefits of any approved drug or publicly available product. It has also created the Canada vigilance adverse reaction online database. Here, Canadians can find out about adverse reactions that have been reported to the department.

Increasing the availability of information to Canadians is a fundamental pillar of the Minister of Health's openness and transparency framework at Health Canada.

When our government took office, it was clear that the level of transparency at Health Canada had improved significantly from the days of thalidomide, but we felt it could do more and do it better. We particularly felt that information that Health Canada shares with the public needed to be easier to understand and more accessible.

We directed the launch of the recalls and safety alerts database. It provides Canadians with one-stop access to the latest risks information on all food and consumer products, including health products. The framework and action plan shows Canadians the concrete and incremental steps that we are taking to improve their access to timely, useful, and relevant health and safety information.Each year, Health Canada will issue a report on how it has performed against those commitments. This too will be posted online, on Health Canada's transparency page.

Each year, Health Canada performs numerous reviews of the safety of specific approved drugs. These are done when the department receives scientific evidence that a new risk is emerging and needs to be assessed, to see if the approved uses of a drug need to be changed to help protect patients. Sometimes during these reviews, a risk is confirmed and requires additional safety action by the regulator, but this is not often the case.

Before the announcement on the framework, the finding of these studies was typically made available only by way of access to information requests. Under the framework, a commitment was made to post public summaries of drug safety reviews proactively. This has made Canada a world leader in communicating this kind of drug safety information.

This House has heard a good deal today about Bill C-17, known as Vanessa's law. Its passage is a quantum leap forward for drug safety in Canada.

We all know that this bill was inspired by another tragedy, the death of the daughter of our colleague, the member for Oakville. She died while using medication that she did not know was unsafe. I am inspired by the hon. member's example and honoured that he is in our caucus. I am proud that our government has delivered a concrete legislative response to the suffering of his family and other families like his.

To send a message that a government is serious about becoming more transparent and putting the health and safety of Canadians first, there were amendments introduced to Bill C-17 that added transparency provisions. The transparency measures introduced in Vanessa's law will also place an obligation on therapeutic product authorization holders to ensure that information concerning any clinical trials is made public.

I want to close by acknowledging that none of these measures alleviate the current suffering of thalidomide victims. It is only to highlight how our government has taken to heart the lessons that thalidomide has taught about the importance of transparency and openness about drug safety to Canadians.

I look forward to hearing how the Minister of Health is engaging the Thalidomide Victims Association of Canada and how we might support the victims in their plight.

Opposition Motion—Survivors of thalidomideBusiness of SupplyGovernment Orders

November 27th, 2014 / 12:15 p.m.
See context

Conservative

Patrick Brown Conservative Barrie, ON

Mr. Speaker, the member for Northumberland—Quinte West has made his life in public safety, and this falls into that category. This is all about public safety.

I want to touch on Bill C-17, Vanessa's law, which was raised by my colleague. It is important to recognize what this legislation will do. It is a step forward for patient safety and for public safety. Bill C-17 will bring in mandatory recall powers, so that we will not have to negotiate with big pharma companies; mandatory reporting of serious adverse drug reactions; tough new fines and jail time for companies that put Canadians at risk; and transparency for drug approvals and clinical trials. These are all critically important steps forward.

Obviously the tragic events in the 1960s remind us of why we need to take drug safety seriously. Let us be clear. Nothing can ever undo the pain and suffering inflicted on these individuals. That is why it is so important that we get it right, so this never happens again. That is why it is important that we use every power and tool within government's regulatory powers to make sure we have the proper framework in place to protect patients.

Opposition Motion—Survivors of thalidomideBusiness of SupplyGovernment Orders

November 27th, 2014 / 12:05 p.m.
See context

Conservative

Patrick Brown Conservative Barrie, ON

Mr. Speaker, I first want to congratulate the member for Oshawa on his very thoughtful remarks. We are certainly fortunate to have a parliamentary secretary who is so engaged on the topic.

It is impossible to stand today to speak about the thalidomide tragedy and not be moved. It is a story of an unspeakable tragedy of distraught parents, and children born with challenges that most of us cannot begin to comprehend. This is a tragic event from the 1960s that reminds us of why we need to take drug safety so seriously.

Nothing could ever undo the pain and suffering that was inflicted. It is a story that changed the way we regulate drugs in Canada. It opened our eyes to the fact that while drugs can bring many benefits, by curing diseases, reducing symptoms, and prolonging lives, they can also carry tremendous risks. It also serves as a constant reminder that we as parliamentarians must do all that we can to strengthen patient safety in Canada. That is why I am very pleased to hear that the Minister of Health will be meeting with thalidomide victims and working co-operatively with them to determine what government can do to support them.

Canada now has one of the safest drug systems in the world, and our government recently strengthened that even further, giving royal assent to Bill C-17, Vanessa's law. Protecting patients is a shared responsibility, one that also rests with fellow legislators in the provinces and with provincial health departments, individual health care professionals and administrators, the colleges that regulate medical practice and other professional organizations, key partners like the Canadian Patient Safety Institute, and the Drug Safety and Effectiveness Network, and last, of course, the manufacturers of drugs.

The thalidomide tragedy of the 1960s, like no other event before or since, has impressed upon us what a truly enormous responsibility that is. While the quest for new cures is vital, it is equally important that we do everything in our power to ensure that drugs that reach the market do not cause harms that outweigh their benefits. That is why all parties in the House and in the other place united to unanimously support Vanessa's law, and why so many stakeholders and individuals endorsed that legislation.

Although many steps have been taken previously to strengthen Canada's drug safety system, we all recognize that the Minister of Health and Health Canada did not have adequate powers to protect patients from drugs that were found to be unsafe once they were on the market We, as legislators, acted decisively to provide the new tools to address this gap.

I would like to take some time today to focus on how Vanessa's law will enhance patient safety, how it will reduce the risk of tragic events like those associated with thalidomide, and how it will help Canadians to make informed decisions about the drugs they are taking.

Vanessa's law will ensure that knowledge about approved drugs and medical devices continues to be gathered and shared with the public once products enter the market. This is important because clinical trials can only tell us about how a drug will affect a particular population, the population it was tested on. They do not tell us how the drug will affect everyone who might take it once it is on the market.

When a company submits an application for market authorization to Health Canada, reviewers analyze the results of all tests and studies that are submitted. If the product is safe, effective, and of high quality, the department will give the company a licence to market a drug in Canada for a particular use. However, once products reach the market, Health Canada's ability to gather knowledge about them has traditionally been limited, and its ability to take action when problems arise has also been limited. That is why there are new provisions in Vanessa's law that represent a game changer.

Let me take a moment to describe some of them and why Vanessa's law is so crucial. One important new provision is that Vanessa's law will give the Minister of Health the ability to set the terms and conditions on an authorization and to make those terms and conditions publicly available. What this means is that, as part of the authorization, Health Canada will be able to ask a pharmaceutical company to continue to gather information in the real world, after the product reaches the market, and to make the results of the information gathering public so that Canadians and their health care providers have easy access to them.

For example, Health Canada may require the company to gather information about the impacts of a drug on patients with multiple medical conditions. Health Canada could require a company to monitor and assess the effects of drugs on patients with impaired kidney function. This may or may not have been studied in the initial clinical trial, and the approved label would indicate that.

However, this information may prove to be important as we gather real-world experience and see some patients with impaired kidney function and how the drug affects them. It may become apparent that there is no difference in the benefits and harms experienced by patients with impaired kidney function.

However, should it become clear that there may be a cause for concern, Health Canada will be able to compel the manufacturer to conduct active safety surveillance or conduct a new study specifically to address the issue. The information about what activities the manufacturers are being compelled to undertake will be made public. It will be a transparent system so that prescribers and patients will know what actions are being taken. Vanessa's law also provides the Minister of Health with the power to compel a label change for a drug and to make that information publicly available to Canadians. In the past, most companies have agreed on a voluntary basis to undertake a label change. Sometimes, however, protracted negotiations have been required, and sometimes, those negotiations were not successful. The new powers provided by Vanessa's law have changed that, so if adults or children are taking a drug, they will be able to access this new information. This will allow us, as Canadians, to make informed decisions in consultation with our health care providers.

However, not all new information comes from tests, studies, or the ongoing proactive monitoring of a drug. Sometimes, adverse events are completely unexpected and only identified through a rigorous adverse drug reaction reporting system. This reflects the reality I mentioned before, that patient safety is a shared responsibility. That is why Vanessa's law included mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions. Simply put, serious adverse drug reaction reports from manufacturers, health care institutions, health care professionals, and the public often provide the first clue about an emerging drug safety issue.

To date, adverse drug reactions have been under-reported in Canada. It has only been mandatory for companies to report adverse drug reactions related to their products. It was recognized that it is critical that we increase the reporting of adverse drug reactions so that Health Canada could take quick action when a problem is detected and share the knowledge rapidly with health care professionals and, most importantly, the public, in order to prevent further harm.

Sometimes, it may be necessary to remove a drug or particular batch of the drug from the market. Other times, it may be appropriate to change the label of a drug so that health care practitioners are aware of the new information when they make their prescribing decisions. In other situations, it may be most appropriate to require the company to conduct some active monitoring to gather further information.

I mentioned earlier the important work done by the Canadian Patient Safety Institute and the Drug Safety and Effectiveness Network. The Canadian Patient Safety Institute works with governments, health organizations, leaders, and health care providers to inspire improvements in patient safety and quality care. It acts as an advocate and catalyst for improvements in patient safety, and it invests in and brokers policy and system changes to protect the health of Canadian patients. As Health Canada works to roll out the new authorities provided in Vanessa's law, either immediately or through developing regulations, these organizations will be able to provide advice.

Nothing can undo the pain and suffering endured by the thalidomide survivors and their families, and it is truly tragic. However, with the passing of Vanessa's law, federal regulators have important new tools to enhance on-market drug safety. The legislation is a very real step to reducing the risk that similar tragedies will occur in the future, and it represents a very important federal contribution to the shared goal of patient safety in Canada.

Opposition Motion—Survivors of thalidomideBusiness of SupplyGovernment Orders

November 27th, 2014 / 11:50 a.m.
See context

Oshawa Ontario

Conservative

Colin Carrie ConservativeParliamentary Secretary to the Minister of the Environment

Mr. Speaker, I will be splitting my time with the member for Barrie. I am pleased to have the opportunity today to take part in this very important discussion about thalidomide and to pay tribute to the 12,000 babies in 46 countries who were born with malformations.

Like all Canadians, I am saddened to know that only some 8,000 of these babies made it past their first birthday. Let me assure the House, as has already been expressed by other members on this side of the House, that we will be supporting the motion today.

Many of my colleagues are contributing to this debate by bringing forward varying perspectives, sometimes their own personal stories or experiences, to this very important issue. However, if the best predictor of future behaviour is indeed past behaviour, it is important to consider the historical perspective of the regulatory framework in our country.

It is important to consider what was in place in the late 1950s and the early 1960s, and how this framework has evolved since then. The thalidomide experience caused the government to overhaul the Canadian drug regulatory framework. As a result, Canada has one of the safest and most rigorous drug approval systems in the entire world. The system is continuously evolving and improving as we find new ways to better protect the health of all Canadians.

These changes include the very recent improvements brought forward through Bill C-17, known as Vanessa's law. This bill, brought forward by the Minister of Health received royal assent earlier this month.

Canadians can rest assured that I am fully conscious of the fact that whatever improvements have been made since the thalidomide tragedy, they are of no relief whatsoever to the victims, their families, and friends. Nothing can ever undo the pain and suffering inflicted.

That being said, I feel it is very important to look back at the history of our regulatory framework. The history of federal oversight of foods and drugs in Canada started some 150 years ago and predates Confederation. Oversight was initially confined to ensuring that food and drugs were not adulterated.

The Proprietary or Patent Medicine Act of 1909 was the first legislation to register medicines. Although limited in scope, that act was the beginning of this country's legislative protection of the public against drugs administered without medical supervision. This regime prevailed until 1920, at which time the Food and Drugs Act was introduced. This followed the establishment of a federal Department of Health the previous year.

By the late 1920s, regulations developed under the Food and Drugs Act established specific requirements for the licensing of drugs. At that time, the Minister of Health had the authority to cancel or suspend a licence if these requirements were violated.

A significant reworking of the food and drugs regulations did not begin until 1947, but it laid the foundation for the regulations that are in place today. By 1951, and as is still the case today, manufacturers were required to file new drug submissions prior to marketing their drugs. As I said, that has not changed. However, the required content of these submissions has since changed significantly.

It is under that regulatory regime that thalidomide was first approved for sale in Canada to treat sleeplessness and morning sickness. More specifically, it was approved in November 1960 under the brand name, Kevadon, and again in October 1961 as Talimol.

In 1962, the drug was withdrawn from the Canadian market when it was discovered that it caused birth defects when taken during pregnancy. However, by then a lot of damage had already been done.

As I said previously, approximately 12,000 babies in 46 countries were born with malformations. In Canada, it is estimated that more than 100 Canadian families were impacted. The tragic circumstances surrounding thalidomide's removal from the market in the 1960s prompted a complete revision of the Food and Drugs Act and the food and drug regulations. These revisions were made to strengthen Health Canada's regulatory oversight and data requirements for new drug submissions.

The government asked the Royal College of Physicians and Surgeons to appoint a special committee to review new drug procedures under the Food and Drugs Act. The intent was to critically review the act and associated regulatory powers in order for Health Canada to more effectively carry out its purpose and to protect the public.

In December 1962, new legislation was introduced that substantially broadened Health Canada's powers. For the first time, Health Canada was given the authority to enact regulations respecting the distribution or conditions of distribution of drug samples; the prohibition of sale of certain drugs; the methods of preparation, manufacture, preservation, packing, labelling, storing, and testing of new drugs; and the sale or conditions of sale of any new drug. In January 1963, a complete revision of the Food and Drug Regulations concerning the sale and distribution of new drugs was finalized, and new regulations were arrived at in October 1963. These revisions imposed strict safety requirements. For the first time, manufacturers were required to produce “substantial evidence of the clinical effectiveness of the new drug”, including clinical case reports and in vitro studies, in addition to the previous safety requirements.

At the time that thalidomide was initially authorized, the package of information related to the drug was limited, contained in only a small binder of data. Now the volume of data received by Health Canada for the review of a new drug can fill several hundred binders, with safety, efficacy, and quality-related data.

Given the observations noted by the special committee in the 1960s, drug distribution was also an important issue to be addressed in revising the Food and Drug Regulations. The situation was brought into focus when it was disclosed that the greatest distribution of thalidomide was to the medical profession, as free samples to give to patients. Reports also surfaced that individuals were taking delivery of these unsolicited samples and selling them to wholesalers, pharmacists, and others. The Food and Drug Regulations were therefore amended to discourage excessive and unsolicited sampling, through maintenance of complete distribution records by manufacturers.

Today, the post-thalidomide 1960s revisions of the Food and Drugs Act and the Food and Drug Regulations regarding Health Canada's regulatory responsibilities, the new drug submission requirements, as well as the distribution and sampling of prescription medicines, remain substantially the same. As science has evolved, the revised framework has allowed Health Canada to require appropriate and fulsome studies to support drug approvals. Through the Food and Drugs Act and its regulations, Health Canada regulates the safety, efficacy, and quality of pharmaceutical drugs. The pharmaceutical drugs program involves pre-market review, post-market surveillance and compliance, and, of course, enforcement.

As I mentioned earlier in my remarks, the most recent substantive revision to the Food and Drugs Act, completed earlier this month, is the recently adopted Bill C-17, Vanessa's law. This legislation enables Health Canada to better respond to drug safety issues and improve patient safety related to prescription and over-the-counter drugs, vaccines, gene therapies, cell tissues and organs, and medical devices. It includes new measures to strengthen safety oversight of therapeutic products over their life cycle. These measures are intended to improve Health Canada's ability to collect post-market safety information, take appropriate action when a serious health risk is identified, and help ensure that drug safety information is available to Canadians. As well, these measures serve to promote greater confidence in the oversight of therapeutic products by increasing transparency and improving safety of their use.

In Canada, manufacturers must now file a submission with Health Canada and receive authorization before a new drug can be marketed. These submissions contain substantial information and data about a drug's safety, effectiveness, and quality, as well as side effects, warnings, precautions, and contraindications. Health Canada also continues to enhance its post-marketing surveillance and assessment of programs for health products. Comprehensive evaluations include information from post-marketing surveillance, on a global scale, to determine whether the benefits of a marketed drug continue to outweigh its risks.

The 1960s thalidomide tragedy highlighted the need to reform Canada's drug approval process, and prompted a modernization of the Food and Drugs Act and underlying regulations, which has shaped today's drug regulation standards in Canada. The drug review process continues to evolve and improve, but five decades after the thalidomide tragedy, the initial legislative reforms brought about by the result of this sad chapter in our history continues to underpin Health Canada's legislation and practices.

I look forward to hearing about the minister's constructive meeting with the Thalidomide Victims Association of Canada and what support we can offer these victims.

Opposition Motion—Survivors of thalidomideBusiness of SupplyGovernment Orders

November 27th, 2014 / 10:30 a.m.
See context

Mississauga—Brampton South Ontario

Conservative

Eve Adams ConservativeParliamentary Secretary to the Minister of Health

Mr. Speaker, I am pleased to say that the government will be supporting the motion today. It is certainly a very emotional issue.

No incident has had a greater impact on the drug safety system in this country than the authorization of thalidomide in the 1960s. The terrible consequences for the pregnant women who used the drug and the children who were born to them sparked major changes in the way Canada approaches drug approvals and surveillance. The modern system that protects Canadians so well today is one of the enduring legacies of this dark chapter in drug regulation.

What we can never forget, and what we have heard loudly and clearly, is that the past is not over for the victims. Thalidomide survivors are still coping with daily struggles that most of us will never fully understand or have to go through. As their physical struggles grow greater and the mental strain of an uncertain future weighs even heavier upon them, the dedication and perseverance these individuals demonstrate every single day of their lives is incredibly moving. The number of challenges they have to face day in, day out from the moment they wake up to the time they go to bed is unimaginable. The physical, mental, and spiritual toll is immense and tiring.

Individually they have shown so much strength, and the fact that they have come together to form an association that does so much good work and helps so many people is admirable.

The government recognizes that the hardships they face are now growing. The physical toll that aging takes on all of us is greatly magnified for them. For instance, simple things like standing up for extended periods or walking for a few minutes have become a real challenge for the majority of thalidomide victims. These activities cause them extreme pain. Many are also now at an age when their parents, often their primary caregivers, have either passed on or can no longer look after them.

The struggles victims face every day have become greater than they have ever been before. According to the Thalidomide Victims Association of Canada, everyday chores and simple tasks that we take for granted, such as eating, getting dressed, cleaning homes, or brushing teeth, have all become daily challenges.

The majority of victims require modifications to their vehicles and to their homes and clothing to allow them to have a decent quality of life. This costs money, and every one of us can understand how quickly these expenses can add up. Let us think about how costly it is to renovate a standard kitchen. Now let us think about how much more expensive it would be if the kitchen would have to be customized in proportion so that the cupboards and counters could be reached to perform daily tasks.

In order to help victims overcome the many limitations they face every day, the Thalidomide Victims Association of Canada has developed an accommodation program tailored to each member's needs. This leadership deserves to be recognized. According to the association, the objective of this program is to ensure that every Canadian thalidomide victim is able to maintain and develop their autonomy in performing various daily activities and to enable them to participate in community activities.

Thalidomide victims have continuously shown determination, strength, and perseverance by having jobs and raising families of their own, but they are worried about their future. They want to talk about their needs, and we are here to listen.

My colleague, the Minister of Health, told the House on Tuesday that she is committed to having that discussion with the Thalidomide Victims Association of Canada in person and to reviewing the association's proposal. This will be an opportunity to listen, to share, and to explore what has been done in other jurisdictions also facing these types of challenges.

For members' reference, the Thalidomide Victims Association of Canada was founded by Randolph Warren in the late 1980s. It was formed to help coordinate the advocacy of thalidomide victims in securing compensation for the tragedy in the 1960s. The association worked closely with the War Amputees of Canada to lobby for a compensation package for victims, a package that was provided in 1991. Over the last few years, we have seen more and more countries compensate thalidomide victims. For many countries, this is the first step they have offered to survivors.

In 1991, Canada provided what was presented at the time as a one-time compensation package to victims. This government recognizes that the needs of thalidomide survivors then were markedly different from what they are today. We as a government are ready to discuss what more can be done to meet the very specialized ongoing needs of these victims.

Members of the House will know that thalidomide was originally sold in the early 1960s in Canada to treat morning sickness in pregnant women. What emerged were thousands of tragic stories in Canada and worldwide that sparked a sea change in the way we approach the approval of new drugs in Canada.

It is impossible to tell how many pregnancies ended in miscarriage because of the complications caused by the drug. Many other children died soon after birth, causing emotional devastation to parents and families. Those children who survived faced, and are still facing, difficult lives because of the birth abnormalities associated with the drug. Indeed, nothing can ever undo the pain and suffering that has been inflicted.

Canada was not the only country affected by this tragedy. Around the world, 12,000 children in 46 countries were born with birth defects caused by thalidomide. It is estimated that only 8,000 survived past their first birthday, which is truly a tragic outcome, and the number of survivors in Canada today is less than 100.

Our country is not alone in needing to find ways to address the needs of thalidomide survivors. We can learn from what other countries have done to address the ongoing needs of their citizens facing similar growing health concerns. As the Minister of Health indicated this week, our government will have that conversation with the Thalidomide Victims Association of Canada.

While it is difficult to fully understand the daily challenges of thalidomide victims, it is all too easy to comprehend how this group of people has more reasons to be distrustful of the drug safety system than anyone else. They and their families have paid a terrible price for a system that failed to do the job it was supposed to do, and yet thalidomide survivors have done something truly incredible: they have worked to make current drug approval systems even better, and they have persevered.

The Thalidomide Victims Association of Canada played an extraordinary and unprecedented role many years ago in the review and approval of the thalidomide product in the United States as a treatment for multiple forms of cancer. At various times over the years, the group has shared its experience in participating in that process with Canadian regulators. The group was also consulted before Health Canada's decision in 2010 to approve thalidomide for multiple myeloma.

Their involvement in the approval of thalidomide in the face of the tragedy in their lives and in the lives of their families must have been incredibly difficult, but as they have done throughout their lives, they persevered. Their participation in the process has helped ensure that all possible precautions are taken and that drugs are used safety.

That includes physicians being trained to prescribe the drug appropriately and patients being properly informed of the risk. It is an incredible part of the legacy being left by the victims of thalidomide that patients with multiple myeloma now have access to this very important treatment. From great tragedy can come positive change. Thalidomide victims know this and have been active participants in improving the drug safety system so that Canadians are better protected.

Our colleague, the hon. member for Oakville, also understands this. His daughter Vanessa tragically died of heart attack while taking a prescription drug that was later deemed not safe and removed from the market. Bill C-17, which was recently passed with all-party support in the House and Senate, was named Vanessa's law in her honour. The act gives the Minister of Health new tools with which to identify potential safety risks related to medications and stronger powers to make sure the problems that are identified are dealt with quickly and effectively.

Before their products are authorized for sale in Canada, drug manufacturers are required to do extensive research and provide substantial evidence to Health Canada in their application, demonstrating that the drug is safe and effective. In spite of this, once medications are being used by a wide range of actual patients, we know that new safety risks can emerge.

Although clinical trial groups are structured to represent as broad a range of patients as possible, they can never truly capture every variable imaginable and every vulnerable group. Even with our best efforts and the best research available, there will always be some factors that will only emerge once the drugs are being used by actual patients, perhaps those coping with other conditions at the same time.

That is where the life-cycle approach to drug safety comes into effect. The life-cycle approach means that Health Canada's role as a regulator is ongoing.

Vanessa's law gives the Minister of Health new powers and tools that will make that ongoing regulatory role more effective. Since most serious adverse reactions to drugs result in hospitalization, a new adverse reaction reporting requirement for health care institutions will give the minister new insight into these events. Regulations are being developed to support this requirement, which will allow the regulator to reach into the health care system and extract data to provide a better window on what is happening in the real world with patients.

Other powers under Vanessa's law that have come into force immediately have given the minister the ability to take action promptly if and when new risks to health are identified. Vanessa's law gives the Minister of Health greater power over the removal of therapeutic products from the marketplace when they present imminent or serious risks to the health and safety of Canadians. Until now, Health Canada has worked within the restrictions of the older Food and Drugs Act to persuade companies to remove drugs from the market if they are found to be unsafe. Most of the time this approach has been successful, although it sometimes takes longer than any of us would like. On a few rare occasions it has not worked and the minister did not have the power to force or withdraw these products. With the passage of this new law, if the force of law is needed, the minister now has the power to act without having to undertake any negotiations with pharmaceutical companies while potentially dangerous drugs remain on the market.

Vanessa's law also gives the government new tools to ensure that risks associated with drugs are well-communicated. Many risk situations are better addressed through improved labelling rather than complete market withdrawal. Previously, Health Canada only had the ability to negotiate label changes with manufacturers. With the new law, manufacturers will be required to comply, and to do so within prescribed timelines. If Health Canada does not have all of the information it needs to assess the safety of a drug on the market, the minister now has the power to compel anyone holding that information to share it with her in order to protect the health of Canadians. In the event that the information simply does not yet exist, Health Canada can also require new studies to be conducted. All of these things together will vastly improve Health Canada's ability to assess and take targeted action where it is needed the most.

Vanessa's law will also help to improve the ability of Canadians to make decisions about their health by ensuring that information about authorized drug clinical trials is made public to all Canadians in a consistent and timely manner. This will also be achieved through new regulations that are currently being developed.

I also want to highlight that this government's commitment to an open government is longstanding. It is part of the overall efforts to foster greater accountability, to provide Canadians with more opportunities to learn and participate in government, and to drive innovation and economic opportunities. I am pleased to say that our Minister of Health has made transparency and openness a key priority during her mandate.

The decisions taken by this government impact the day-to-day lives of Canadians and we acknowledge they have the right to understand how and why we make those decisions. All Canadian families want that level of discussion. Canadians want to feel meaningfully involved and consulted within the decision-making process. We have listened to Canadians and have provided what we believe are the right tools to ensure fairness, openness and transparency.

Health Canada plays an important role in being open and transparent, and continues to prioritize the protection of health and safety among Canadians. Greater transparency and openness with Canadians strengthens the trust in our regulatory decisions. Canadians can see for themselves that Health Canada continues to make regulatory decisions based on valid evidence. The credible, timely information Health Canada provides is absolutely vital in helping Canadians to make informed choices for themselves and their families.

Since the thalidomide tragedy, Canada and other countries have also invested in research. The Canadian Institutes of Health Research and the Public Health Agency of Canada both actively support research related to improving health of mothers and babies, as members will hear later today.

Today, we are focusing our discussion on a tragic event that took place over 50 years ago but has never been forgotten. It is a tragic event that has terribly affected the lives of thalidomide victims and their families.

I would like to reiterate that our Conservative government recognizes the challenges that thalidomide victims face each and every day. We are already reviewing their proposal and we look forward to meeting with them very soon. The health and safety of all Canadians is a priority for our government. That commitment, of course, includes the victims of thalidomide, who have already suffered far too much.

We are ready to listen and to ensure that everyone is heard and included.

Opposition Motion—Survivors of thalidomideBusiness of SupplyGovernment Orders

November 27th, 2014 / 10:05 a.m.
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NDP

Libby Davies NDP Vancouver East, BC

moved:

That, in the opinion of the House: (a) full support should be offered to survivors of thalidomide; (b) the urgent need to defend the rights and dignity of those affected by thalidomide should be recognized; and (c) the government should provide support to survivors, as requested by the Thalidomide Survivors Taskforce.

Mr. Speaker, first I would like to start by saying that I will be sharing my time with the member for Saint-Bruno—Saint-Hubert.

I am very honoured to rise in the House today to speak to this very important and historic motion from the NDP.

The motion before us calls on the government to right the wrong of the tragic consequences that took place, when, in 1961, the Government of Canada approved the sale of thalidomide as a safe drug for the treatment of morning sickness for pregnant women. It is so important today that we speak out collectively and with one voice, as Parliament, to understand and to address this urgent and tragic issue.

I would like to thank the member for Outremont, the leader of the official opposition, for agreeing to and giving his full support to this motion being brought forward today. I would also like to thank members from all sides because we now know that the government will be supporting this motion with a slight amendment. I am very thankful for that. We have had a lot of discussion. It is historic and important that today we will be speaking in this debate, and we will be bringing forward the visibility of this issue. I hope that on Monday we will be voting on this motion and that it will be a unanimous vote.

On Tuesday, I had the honour to be joined, with my colleague from Saint-Bruno—Saint-Hubert, by two members of the thalidomide survivors task force. Mercédes Benegbi and Josée Lake came from Montreal to join us in a press conference, where they spoke and shared some of their experiences of what it has been like, over more than 50 years, to be a thalidomide survivor. It was very moving to hear their words and to hear them speak about their deeply personal experience, and of the experience of 95 survivors in Canada. Hearing what they had to say is a day that I will not forget.

I am also very thankful that the people at The Globe and Mail decided to focus on this issue. We saw the original story that they did last Saturday, which was a very comprehensive piece. It gave us the history and background, and brought us to the current situation today, with so many survivors living in pain and suffering and with great financial hardship. To me, it was one of those moments when a whole bunch of things came together. We have to recognize that the thalidomide survivors have for 50-plus years been living in a way that has been quite invisible.

It is a story that we are aware of. I remember when we debated Bill C-17 in the House, on drug safety, a bill that we supported. I remember that when I debated that bill in the House, I mentioned the history of thalidomide. I did not know then that a few months later we would actually be debating the issue of thalidomide. There is some continuity here, and some historical importance to what we are doing. Of course, drug safety in this country is critically important, and although we would have liked to see some improvements to it, the bill that was passed a few months ago was a very important bill.

When we look at history and see what has taken place in this country around drug safety, and we look at this terrible tragic situation that took place in the early 1960s, it is so compelling. It speaks to the core of why we are here. As parliamentarians and legislators, we need to pay attention and ensure that there is proper regulatory oversight for drug safety.

When this drug was first brought on to the market in the early sixties, it was deemed to be safe. The tragedy is that when the story began to unfold and the consequences began to be known about women who had miscarriages and babies being born with terrible deformities, Canada was very slow to react. It took decades, right up until 1991, for there to be even some discussion around compensation.

If we look at the amount of compensation that was given in 1991, we can see how terribly inadequate the small settlements were to the survivors. It really did nothing to help them. They even had to sign gag orders that they would not speak out afterward. The small settlements they got in no way dealt with the long-term effects of what they were dealing with.

We know today that the consequences of thalidomide have left people dealing with very severe and debilitating pain. It has taken 50 years of work, which has taken a toll on them, not only emotionally and financially, but of course physically. Many of the survivors are now suffering from nerve damage and painful wear and tear on their bodies. It has caused enormous challenges for them, including the loss of the ability to use their limbs to care for themselves, and damage to their spines and joints, which severely limits their mobility. It has impacted on their ability to gain employment. It means that they have often had to depend on others for very basic tasks, such as using the toilet, dressing, preparing meals, doing all of the daily things we take for granted.

Fifty years later, with this group of people who are aging, the health consequences of what they face have become even more serious. It is critical that we not lose more time. There are only 95 thalidomide survivors left in Canada. I believe there were originally about 120 people; some have already died. As these survivors age, their health and financial needs will only grow.

Time is of the essence, and it is very important that we take a stand today and that Parliament speak out. New Democrats call on the government to right the wrong and immediately sit down with the survivors task force to begin the work to arrive at a just settlement for the survivors. That is what this motion would accomplish if it is passed. I want to stress that time is of the essence. We cannot lose another day, week, or year.

There are some precedents in terms of what other countries have done. For example, the government in the United Kingdom is providing regular payments to survivors. Germany offered a one-time lump sum payment. The thalidomide survivors task force is asking the government to sit down and work with it in creating a program that would provide a one-time payment to address people's immediate needs, as well as ongoing payments that would assist individuals based on their own individual circumstances. It is something that needs to be done based on individual needs.

I have had a lot emails over the last couple of days, and I want to refer to one from a former colleague, Penny Priddy, who was a member of Parliament for Surrey. She wrote:

It was the summer of 1963 and I was working at HSC/Sick Kids in Toronto. Her name was “Maria”. She was about a year old. [...]

“Maria” was born without arms. [...] Her legs were not able to support any weight. Her mother had taken thalidomide. [...]

Given what we know, I expect her life was filled with challenges and barriers that required a strength that many of us cannot begin to imagine. [...]

Thank you...for listening to the voices of all of the Marias' who were victims of a system that was so rushed to get a questionable drug to market that they did not consider the unthinkable legacy that they were creating for its smallest citizens.

Today, with this motion, we have an opportunity to right that wrong, and I thank all members of the House who will be supporting it.

HealthAdjournment Proceedings

November 26th, 2014 / 7:40 p.m.
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Liberal

Francis Scarpaleggia Liberal Lac-Saint-Louis, QC

Mr. Speaker, a glaring lack of federal oversight exists in a little known but nonetheless important aspect of our health care system. I am referring to the reprocessing and reuse of medical devices designed and intended for single-use only.

The federal government has undisputed jurisdiction for regulating the manufacture of both pharmaceutical products and medical devices. I have already asked the government why it has been remiss in regulating drug compounders, those entities that are not strictly speaking drug manufacturers or pharmacies as the oversight and regulation of the latter is the responsibility of the provinces and the former of Health Canada.

In regard to the reprocessing of singe-use medical devices, in 2004 the Auditor General urged Health Canada to consider regulating these devices in the same manner as it regulates new medical devices. However, the department concluded that the Food and Drugs Act, from which the medical devices regulations derive their authority, was not intended to apply to the use of a device after its sale.

The issue was subsequently raised by a witness at the health committee last spring during the committee's hearings on Bill C-17, Vanessa's Law.

Suddenly, this past July, Health Canada announced that it was encouraging, although apparently not requiring, reprocessors to apply for and obtain a licence for reprocessed single-use devices in Canada. The government went on to say that one reprocessor had, in fact, obtained a licence from Health Canada for one reprocessed single-use device out of 200 or so in commerce in Canada. This device was a non-invasive device, an inflatable compression sleeve, which is clearly not an example of the riskiest reprocessed single-use device.

Why will the government not act decisively and follow the Auditor General's 2004 recommendation to begin strict regulatory oversight of the market for reprocessed single-use medical devices?

What prompted the government to move away from its earlier view, that it lacked jurisdiction in the matter, to a more confused position that reflects a half-hearted commitment to ensuring the safety of patients undergoing invasive procedures with reprocessed devices?

November 20th, 2014 / 11:05 a.m.
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Conservative

Rona Ambrose Conservative Edmonton—Spruce Grove, AB

Thank you, Mr. Chair.

It's great to be here in front of the health committee.

I want to start off by thanking you for all of the good work that you're doing. Thank you for the invitation to discuss supplementary estimates for the health portfolio.

We have a number of officials here that many of you know already: Alain Beaudet, from the Canadian Institutes of Health Research; of course, Bruce Archibald, who's here from CFIA; George Da Pont, our deputy minister from Health Canada; Gregory Taylor, our chief public health officer; and Krista Outhwaite, our newly appointed deputy minister for the Public Health Agency.

I'm going to provide just a short update to committee members on Canada's response to the Ebola outbreak in West Africa, as that I believe would prove helpful to all of you.

As many of you know, this outbreak is the most severe and complex the world has seen in 40 years of combatting the virus. The humanitarian, social, and economic impacts will be felt long after the virus is contained. Canada has been at the forefront of the international response to this outbreak, and has been since April. We are contributing funds, expertise, and equipment. To date we have committed over $65 million in health, humanitarian support, and security interventions. I'm pleased to report to the committee that 57 million dollars' worth of this funding has now been disbursed. This funding has gone to support the United Nations, the World Health Organization, UNICEF, and many others to improve treatment and prevention, improve health capacity, save lives, and support the basics such as nutrition.

Our efforts are directed at bringing an end to this outbreak, treating patients, assuring the availability of essential services, preserving stability, and preventing outbreaks in surrounding countries.

We've also now donated and delivered over 2.5 million dollars' worth of personal protective equipment to West Africa that was requested by the WHO, including 1.5 million pairs of gloves, two million masks, over 480,000 respirators, and over 1,000 beds and blankets. The Public Health Agency also has deployed our mobile laboratory again to Sierra Leone to provide rapid diagnostic support and infection control testing, and we're currently awaiting further direction from the WHO on where our second mobile lab can be deployed.

In addition to Canada's invention of an experimental Ebola vaccine, which is currently undergoing clinical trials, we've generously donated the Canadian Ebola vaccine, in the amount of 800 vials, to the World Health Organization in Geneva. This vaccine is a fine example of Canadian scientific innovation. It's our hope that if found to be safe and effective, it will be used in West Africa to help stop this outbreak.

To support this goal, we've recently launched a Canadian phase one clinical trial for the vaccine, led by the Canadian Immunization Research Network in Halifax at the Canadian Centre for Vaccinology in the IWK Health Centre. This trial will support concurrent trials elsewhere in the world by determining if lower dosages could be just as effective as higher ones, potentially multiplying the amount of doses in each vial. While there has never been a case of Ebola in Canada, we must of course continue to be prepared and take every precaution necessary.

I've now spoken with health ministers from across the country several times and we've held, I think, three meetings. Our chief public health officer is in regular contact with medical officers in provinces and territories, I think now meeting almost twice a week for a number of months. In the event of an Ebola case, the Public Health Agency is ready to support the provinces and territories by deploying our Ebola rapid response teams. These five teams are made up of a team lead, a field epidemiologist, an infection control expert, a biosafety expert, a laboratory expert, a communications expert, and a logistics expert, and they would be deployed immediately to support any local public health systems that would need our support.

Transport Canada is also supporting the Public Health Agency by having planes readily available to deploy at a moment's notice. These planes are also stocked with emergency supplies, including protective equipment, like masks, gloves, and gowns. Our government is also providing additional funding to support Ebola preparedness and response capacity here in Canada to further support the provinces. This includes, of course, the $27.5 million that will be directed towards domestic preparedness. This amount includes just under $25 million to support further research and development of Ebola medical countermeasures. This means more money for research of the Canadian Ebola vaccine and monoclonal antibodies.

Funding has also been set aside to support infection control training and equipment, and to deploy additional quarantine officers at Canadian airports.

We've also launched an online Ebola information campaign designed to help raise public awareness about the disease and its risks, through social media such as Facebook and Twitter. As we combat the disease, we need to fight the stigma around it. Canadians need to know the facts about Ebola, how the virus is transmitted, its symptoms, and any other information that will help them manage their fears of contracting this disease.

Of course, we are making a strong contribution to international efforts abroad and working together to prepare here at home. We are strengthening coordination across the federal, provincial, and territorial governments, and other important agencies, and doing everything possible to protect Canadians and fight the disease.

On a different subject, I'd like to commend and thank all of you for your thoughtful study of Bill C-17, Vanessa's Law. In addition to the many months of consultations—

November 6th, 2014 / 1:55 p.m.
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Conservative

The Acting Speaker Conservative Barry Devolin

I have the honour to inform the House that a communication has been received as follows:

Rideau Hall Ottawa

November 5th, 2014

Mr. Speaker,

I have the honour to inform you that the Right Honourable David Johnston, Governor General of Canada, signified royal assent by written declaration to the bills listed in the Schedule to this letter on the 5th day of November, 2014, at 5:26 p.m.

Yours sincerely,

Stephen Wallace

Secretary to the Governor General and Herald Chancellor

The schedule indicates that royal assent was given to Bill C-10, An Act to amend the Criminal Code (trafficking in contraband tobacco); Bill C-17, An Act to amend the Food and Drugs Act; Bill C-36, An Act to amend the Criminal Code in response to the Supreme Court of Canada decision in Attorney General of Canada v. Bedford and to make consequential amendments to other Acts; and Bill C-501, An Act respecting a National Hunting, Trapping and Fishing Heritage Day.

October 7th, 2014 / 4:20 p.m.
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Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Walter Robinson

Through you, Mr. Vice-Chair, to Mr. Keddy, in the context of our presentation today, in terms of a driving an innovation environment that fosters Canadian competitiveness, the stability and predictability of the Canadian business climate is important for life sciences investors and, I would dare say, for some of the other industries that are represented across the table today. Your question goes specifically to Bill C-17. We testified before the House health committee and before the Senate last week. Bill C-17—and I know this is not the place for it, but with respect to the question—is trying to do two things, and doing neither very well. One is to ensure that the minister has the right to disclose clinical trial information, emerging trends, and things that are of a serious or imminent risk, in the interests of the health and the promotion of the safety of Canadians. We fully agree with that. But the bill also defines confidential business information. That stuff is proprietary. It may not be intellectual property on the molecule or the biological...but it speaks to issues of proprietary manufacturing processes, packaging, and a variety of other things that Mr. Fleming and other members have to disclose to Health Canada to get a notice of compliance in order to get a medicine approved as safe and clinically effective. We're just trying to ensure that the patient safety data, the stuff that is needed, has to be there.

In the other areas, they need notice and consent because those do have a competitive advantage, and Minister Fast, with the global markets action plan, is out there speaking about Canada's brand. The late Minister Flaherty and the current minister speak to Canada's brand as a stable and predictable place to do business. That's what we're trying to get at.

October 7th, 2014 / 4:20 p.m.
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Conservative

Gerald Keddy Conservative South Shore—St. Margaret's, NS

Thank you very much for that answer.

Mr. Fleming and Mr. Robinson, I just want to try to get this straight. You talked about the obvious need we have in Canada to harmonize our IT sector with the global economy and the rest of the world and the modernization of the Food and Drugs Act, Bill C-17, which was an attempt to do it. Yet you're concerned about two different issues.

You have patent protection, and we understand what patent protection is. That gives you roughly 20 years of protection, and after that it's out there in the mainstream and anyone can copy it. But most companies also have proprietary information, which is not patented. There is no protection for that proprietary information. Are you suggesting that there needs to be some type of built-in mechanism to have protection for proprietary information?

October 7th, 2014 / 3:30 p.m.
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Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

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.

HealthOral Questions

September 19th, 2014 / 11:25 a.m.
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NDP

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)Routine Proceedings

June 16th, 2014 / 3:30 p.m.
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Conservative

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.

HealthCommittees of the HouseRoutine Proceedings

June 13th, 2014 / noon
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Mississauga—Brampton South Ontario

Conservative

Eve Adams ConservativeParliamentary 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.

June 12th, 2014 / 3:40 p.m.
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Conservative

The Chair Conservative Ben Lobb

That concludes Bill C-17.

Mr. Young, did you have a point?

June 12th, 2014 / 3:35 p.m.
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Conservative

Terence Young Conservative Oakville, ON

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

Business of the HouseRoutine Proceedings

June 12th, 2014 / 3:25 p.m.
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York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader 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, the Safeguarding Canada’s Seas and Skies Act, at third reading; Bill C-8, the Combating Counterfeit Products Act, at third reading; Bill C-12, the 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, the Port State Measures Agreement Implementation Act, at second reading; and Bill S-4, the Digital Privacy Act—which I understand we will receive shortly from the other place—at second reading.

Vanessa's LawStatements By Members

June 12th, 2014 / 2:10 p.m.
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Conservative

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 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.

June 12th, 2014 / 1:45 p.m.
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Conservative

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.

June 12th, 2014 / 1:25 p.m.
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NDP

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.

June 12th, 2014 / 1:20 p.m.
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Conservative

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.

June 12th, 2014 / 12:15 p.m.
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Conservative

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.

June 12th, 2014 / 12:05 p.m.
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Conservative

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.

June 12th, 2014 / 11:55 a.m.
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NDP

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.

Time Allocation for Vanessa's Law--Speaker's RulingPoints of OrderRoutine Proceedings

June 12th, 2014 / 11:10 a.m.
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Conservative

The Speaker Conservative Andrew Scheer

I am now prepared to rule on the point of order raised on May 30, 2014, by the House leader of the official opposition regarding the validity of a notice of time allocation with respect to Bill C-17, an act to amend the Food and Drugs Act.

I would like to thank the House Leader of the Official Opposition for having raised the question, as well as the Leader of the Government in the House of Commons and the member for Oxford for their contributions.

The House leader of the official opposition argued that the consultation required pursuant to Standing Order 78(3), had never taken place and therefore, the Chair should rescind the notice for time allocation for Bill C-17. Furthermore, it was his contention that there was no need for the government to resort to time allocation at all since the bill had been on the order paper for six months yet had received virtually no debate to date.

The Leader of the Government in the House of Commons confirmed that, although the contents of confidential House leaders’ meetings could not be revealed, agreements had been proposed to the House Leader of the Official Opposition and his staff. Notice of time allocation was then given only once it was evident that no agreement could be reached.

Through this point of order, the Chair is being asked to stand in judgment of two things, the first being whether or not there were consultations such that the conditions of Standing Order 78(3) were satisfied. The second is whether the time that the House had debated Bill C-17 was sufficient enough to warrant the use of time allocation.

House of Commons Procedure and Practice, second edition, on pages 669 to 670, states that:

The Speaker has stated that the wording of the rule does not define the nature of the consultations which are to be held by the Minister and representatives of the other parties, and has further ruled that the Chair has no authority to determine whether or not consultation took place nor what constitutes consultation among the representatives of the parties.

As recently as March 6, 2014, the Deputy Speaker addressed this very issue when, on page 3598 of Debates, he reminded the House that:

The nature of the consultation, the quality of the consultation, and the quantity of the consultation is not something that the Chair will involve himself in. That has been the tradition of this House for many years. What the Chair would have to do, in effect, is conduct an extensive investigative inquiry into the nature of the consultation. That is not our role, nor do the rules require it.

Therefore, it remains a steadfast practice that it is not the role of the Speaker to determine whether consultations have taken place or not.

With respect to the amount of debate a bill must receive before notice of a time allocation motion can be given, the Chair is being asked to render a decision on a matter over which there are no explicit procedural rules or practices, and thus, over which it has no authority. Rather, it is the House that retains that authority and therefore must continue to make that determination as to when and if a bill has received adequate consideration.

Accordingly, notice of time allocation for Bill C-17 was valid when it was given. I thank all members for their attention.

June 12th, 2014 / 10:20 a.m.
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Conservative

The Chair Conservative Ben Lobb

Welcome back. We're back in session.

We'll start going through the clause by clause portion of Bill C-17. We have the departmental officials at the table, at the ready, if there are any questions. So feel free to ask questions or for clarification.

In addition to that, similar to what we did for Bill C-442, the Lyme disease bill, we'll take our time and make sure everybody knows exactly what clause and what amendment we're talking about, so everybody feels good about what they're voting on.

There's lunch at the back and recognizing the fact that everybody wants to pay attention to the clauses and the amendments and to which way to vote, we can suspend at some point, when the committee feels like it, for five to 10 minutes, just to have a quick lunch so that everybody can stay focused on the clauses and the amendments, if that's okay with everybody.

We have two legislative clerks here to help us along the way if we have any technical questions. Karin is also still here as our analyst.

If everybody's ready to go, we'll get at it.

Similar to the case with the Lyme disease bill, the title and the preamble will wait until the end, and we'll get right at it.

(On clause 2)

We have amendment CPC-1. On that, I'll say that if this amendment is adopted, so will be amendment CPC-2 since they are consequential. Would somebody like to talk about the amendment?

Ms. Adams.

June 12th, 2014 / 10:05 a.m.
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Director, Government Relations and Public Affairs, Canadian Pharmacists Association

Jeff Morrison

It tends to be lower.

We would argue that if that were the case, that the risk is significantly lower, then by including NHPs within the bill, there's probably not a lot they would need to worry about. However, the risk still does exist.

I think what Bill C-17 does is to acknowledge that there is risk with all medication, that there needs to be processes in place to address that risk and identify it. Therefore, by putting it in—and I'll pass it over to my colleague in a moment to finish off the response—you are essentially covering the range of possible risk associated with consumption of any of these products. It's probably better to put them in than not.

June 12th, 2014 / 9:55 a.m.
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Helen Long President, Canadian Health Food Association

Thank you. Joining me today is Carl Carter, our director of regulatory affairs and policy development.

It's with great pride that I appear before you today as president of the Canadian Health Food Association. CHFA is Canada's largest trade organization dedicated to the natural health and organic products industry.

As MPs, you should also have pride that Canada has a robust natural health product sector contributing $3 billion annually to the Canadian economy. CHFA represents over a thousand predominantly small and medium-sized businesses across Canada. Our members include manufacturers, retailers, importers, and distributors of natural health and organic products, and these can include foods, vitamins and supplements, herbal products, and more.

As members of the committees know from your own constituents, over 70% of Canadians use natural health products to improve the quality of their lives. The majority of Canadian families consume NHPs as part of a balanced healthy lifestyle and our sector has worked hard to ensure that Canadians continue to have access to these safe and effective products. CHFA members across the country applaud the Standing Committee on Health for their important work on Bill C-17 and its specific targeted focus on drug safety. CHFA fully supports the government's approach in this bill.

After an extensive and thorough review in 1998, this very House of Commons Standing Committee on Health concluded, as number one of its 53 recommendations, that NHPs are not drugs and should not be legislated as such. In line with this recommendation, NHPs have been regulated since 2004 under the natural health product regulations and these regulations are among the most rigorous and advanced in the world. Simply put, we support the exclusion of NHPs, as defined in the natural health product regulations, from Bill C-17. It's just common sense. Vitamins are different from pharmaceuticals and we commend the government for recognizing the relative low-risk profile of NHPs.

I am proud to highlight for committee members that NHPs are subject to extensive legislation and regulation in Canada, much more, for example, than in the U.S. According to Health Canada's most recent quarterly report, over 85,000 product licence applications have been submitted over the 10 years since the regulations were put into effect, and some 52,000 product licences issued. This is not a rubber stamp process. Before an NHP is authorized for sale, a company must complete a product licence application that is reviewed by the natural health products directorate. This is an entire section of approximately 100 staff dedicated to NHP safety. An application must demonstrate that the product is safe, effective, and high quality. Each application must provide information about the product, including medicinal and non-medicinal ingredients, evidence supporting any health claims, product labelling, and information about the manufacturing site. Many are unaware of, or perhaps take for granted, the lengthy pre-market assessment process required for NHPs. In addition, all NHPs licensed for sale in Canada must comply with Health Canada's good manufacturing practices and the natural health product regulations require a site licence issued by Health Canada to demonstrate compliance.

GMPs are a system designed to ensure NHPs are packaged, manufactured, stored, and monitored appropriately to ensure high-quality products are available to Canadians. All NHPs that have been assessed by Health Canada for safety, effectiveness, and quality have an NPN or natural product number on the label, which a consumer can easily find. It is worth noting again that Health Canada is a global pioneer in the regulation of natural health products and in pre-approval requirements of a product being sold in Canada. In contrast, the U.S. has a post-market system that clearly lags behind Canada in consumer safety of NHPs.

The licensed NHP database is a public, fully transparent government database of licensed products, approved label copy, claims, warnings, and the name of licence holders. Consumers, retailers, and medical professionals can and do consult the site regularly.

Serious adverse reactions to NHPs licensed for sale in Canada are rare. Health Canada monitors the safety profile of all products sold in Canada to ensure consumer safety. In addition, the marketed health products directorate provides a reporting and review framework for any adverse events to medicines or NHPs experienced by Canadians. NHP regulations under section 24 expressly require companies to report serious adverse reactions to the minister. As noted, Health Canada does not approve all NHP applications it receives and routinely requests additional safety information, formulation changes, or additional warnings.

Consumers and health care practitioners are encouraged to report any suspected adverse reactions to Health Canada through the online reporting system. Through this system, we know that adverse reactions to NHPs are rare, especially in comparison to pharmaceutical drugs. Information collected from adverse reaction reports is assessed to determine the most appropriate measures for risk management and intervention. When there are any changes to the conditions of use for a product, or if a product is withdrawn altogether, this information is conveyed to Canadians through communications, such as advisories online and other resource materials.

We commend the government for recognizing the relative low-risk profile of NHPs. In line with the Standing Committee on Health's 53 recommendations, in 1998, NHPs are not drugs, and they should not be treated as such.

Thank you.

June 12th, 2014 / 9:50 a.m.
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Jeff Morrison Director, Government Relations and Public Affairs, Canadian Pharmacists Association

Thank you, Mr. Chair, and good morning to the committee. Thank you to the Standing Committee on Health for the invitation to appear this morning. My name is Jeff Morrison. I'm director of government relations and public affairs with the Canadian Pharmacists Association. With me—I'm very happy—is Barry Power, a pharmacy consultant with CPhA, an adjunct assistant professor at the school of pharmacy with the University of Waterloo, and a pharmacist himself.

As you know, CPhA is the national association representing the pharmacist profession in Canada.

Drug safety is a priority for the Canadian Pharmacists Association and for all pharmacists in Canada. Although it is not possible to completely eliminate all risks associated with the use of prescription drugs, pharmacists spend a lot of time counselling patients on the appropriate and safe use of the drugs they are taking. That is why the CPhA supported the general spirit and thrust of Bill C-17, Vanessa's Law, when it was introduced by the minister in December 2013.

In particular, the CPhA supports the bill's intent to increase penalties for unsafe products and to provide Health Canada with new powers to recall unsafe products and to compel companies to do further testing on a product when issues are identified with certain at-risk populations, as well as the requirement for drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children.

However, there are some concerns and outstanding questions we have with regard to the bill. Although these questions and concerns may be addressed during the regulatory development process, we still wish to raise them with the committee this morning.

First, the bill provides a blanket exemption for natural health products. As NHPs are medicinal products and have the ability to cause harm, and given that Health Canada and several provinces state that between 60% to 70% of therapeutic products consumed by Canadians are in fact NHPs, the CPhA feels that NHPs should be included within the scope of the bill.

Second, the bill mandates the need for adverse drug reporting by stating the following, which I'm sure you know:

A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.

However, this clause raises several questions that frankly the bill doesn't clarify.

For example, what is a prescribed health care institution? Is a pharmacy a health care institution? Will the downtown community health centre, of which I was the president, be considered a health care institution?

It would be helpful to specify the definition of a prescribed health care institution that is required to provide information.

Also, what is a serious adverse drug reaction? How is that to be defined? For example, is it necessary to report a well-known but serious reaction? All health care professionals know of many of the serious adverse reactions caused by chemotherapy, for example, during cancer treatment. Would they be expected to report these? Where do we draw the line between what is to be reported and what is considered well-established fact? Again, clarification within the bill would be useful.

Also, what will happen with this information? Will it be analyzed? Will all the information that is reported be made publicly available? If so, how so? As pharmacists we believe that Health Canada should be transparent in the provision and aggregation of the information it receives from this mandatory reporting, but at present, the legislation as written is unclear on whether this information will be properly analyzed and shared with health practitioners and with Canadians.

The same issue regarding transparency can also be applied to the bill's requirement that the minister may order the manufacturer to conduct additional assessments and tests of a questionable product or drug in regard to health and safety. The legislation states that the results of these tests will be provided to the minister. However, there is no allowance currently in the bill for providing that information more publicly, including to pharmacists, other practitioners, and Canadians. As you can probably guess, we feel it should.

Last, the bill also states that this reporting requirement “shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens”. However, this clause would appear to be at odds with the reality of the situation on the ground.

By its inclusion in the bill, the requirement for prescribed health care institutions to report adverse drug reactions will impose additional administrative burdens. Although technological solutions can and should help, the fact remains that additional human resources will be required to collect and provide this data. If the definition of prescribed health care institution is broad in scope—as I mentioned earlier, we don't have that—then the administrative requirements will likely increase. As a result, we're uncertain about how the bill can reconcile what would appear to be two contradictory goals of, on the one hand, increasing reporting, but on the other hand, without imposing administrative burdens.

In short, Mr. Chair, the Canadian Pharmacists Association is very supportive of Bill C-17. Given pharmacists' preoccupation with safe and effective use of medications, the CPhA believes the legislation is a step in the right direction. However, as I've outlined, we feel that there are clauses within the bill that could benefit from greater clarity and certainty in terms of how they will be applied.

Thank you, Mr. Chair.

We are ready to answer the committee's questions.

June 12th, 2014 / 9:30 a.m.
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Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Walter Robinson

I would start by noting that many aspects of Bill C-17 already codify the manner in which Rx&D member companies have been interacting with Health Canada and other regulatory bodies, not only here in Canada but similarly with Health Canada's peer agencies, for a long time.

Regarding the issue around the specific article you mentioned—and I think that had to do with Dr. Lexchin and a few other journalists—you were cut off before when listing some of those products. As I noted, I can't speak to individual product issues. It would be best to address the companies to speak to those. From reading about it and from the research, I can tell you that some of those recalls were voluntary. They were not mandatory recalls. The companies themselves pulled them from the market.

You had a very clear question around plain-language labelling. I'd like to ask my colleague Keith McIntosh to speak to the things we've done around that and the things we've urged Health Canada to do. Some of these things have the best weight of suasion with regulatory authority.

June 12th, 2014 / 9:30 a.m.
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Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Keith McIntosh

First I would note that we support the authorities that are proposed in Bill C-17 to provide the minister with the authority to compel label change or to compel a recall if that thoughtful dialogue isn't conclusive.

I think that reasonable scientific debate is a valid exercise, and I know that our members have patient interest at heart when they have that debate, regarding what the label should contain or when to conduct a recall. I think if we only require a mandatory recall or a mandatory label update, the regulator is not necessarily the most rapid vehicle. The manufacturer is in the best position to initiate one of those changes quickly.

June 12th, 2014 / 9:10 a.m.
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Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Walter Robinson

Through you again, Mr. Chair, we followed the testimony closely. There are four things that cover our conduct in Canada.

First is the Food and Drugs Act, the law of the land. As we've noted, we support the improvements proposed before this committee in Bill C-17. Second is our code of ethical practices. When it comes to the distribution of information and promotion, we are also guided by the parameters of the Pharmaceutical Advertising Advisory Board, or PAAB, and Advertising Standards Canada.

There is a great degree of rigour in the context of what our members can do. Again, by law and by our code, we can promote only the approved indication and label.

June 12th, 2014 / 8:55 a.m.
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Nancy Abbey Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies

Good morning.

On behalf of MEDEC, I want to thank the health committee for providing me with the opportunity to be here today.

My name is Nancy Abbey, and I am the executive director of the MEDEC Reuse of Single-Use Devices Task Force.

MEDEC is the national association representing the medical technology industry in Canada. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our publicly funded health care system.

The industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities, and we have sales of over $7 billion per year.

We are committed to supporting the growth of a strong and vibrant medical technology industry that contributes to Canada's innovation economy.

Our member companies are fully supportive of Bill C-17, an act to amend the Food and Drugs Act, in order to improve patient safety by introducing important measures that will strengthen safety oversight and improve reporting of serious adverse events.

We have an opportunity to work together to further strengthen this legislation. Unfortunately, in the time we have today, I will not be able to review with you the full list of our recommendations, but they are contained in appendix 1 of our submission. I do, though, want to focus on two of our recommendations that would address a long-standing medical device issue that warrants particular attention by the committee, which is the reason I asked to appear before you today.

This issue is the reuse and reprocessing of single-use medical devices and the fact that there is no federal regulatory oversight regarding this practice, a fact that raises serious concerns regarding patient safety. It's important that I briefly outline this issue for you.

In an effort to save money, hospitals in Canada are reusing medical devices that are licensed by Health Canada for single use only. This practice is widespread. In 2008 the Canadian Agency for Drugs and Technologies in Health, better known as CADTH, reported that 28% of hospitals in Canada and 42% of hospitals with over 250 beds were reprocessing single-use devices either in-house or through a third party reprocessor.

Single-use devices are not designed, validated, or licensed to be disassembled, cleaned, reassembled, and reused, and doing so can jeopardize their performance, safety, and effectiveness.

In 2014 the vast majority of hospitals that are using reprocessed single-use devices are doing so by outsourcing this activity and signing contracts with third party reprocessing companies. The fact is there are no third party reprocessing companies for single-use devices based in Canada. This has resulted in a situation of hospitals across the country shipping used devices, licensed for single use only, to U.S.-based companies for reprocessing without any federal regulatory oversight of the reprocessors and the devices that are then being shipped back for use in our Canadian hospitals.

This is a long-standing issue.

In March 2004, over 10 years ago, the Auditor General of Canada recommended that Health Canada take action, such as regulating the reprocessing of single-use devices, to manage the health and safety risks related to the reuse of single-use medical devices.

The Health Canada Scientific Advisory Panel on Reprocessing of Medical Devices and the Canadian Orthopaedic Association have repeatedly called for Health Canada to regulate this activity.

Health Canada has concluded that the Food and Drugs Act, from which the medical device regulations derive their authority, is not intended to apply to the use of a device after its sale; therefore, Health Canada does not have the authority to regulate the reprocessing of single-use devices by hospitals or third party reprocessing companies.

Health Canada has been unable to take action given the current Food and Drugs Act and medical device regulations. With Bill C-17, there is an opportunity to change this situation.

Why are amendments important? Canada's medical device regulations require original equipment manufacturers to present substantive evidence of a device's safety, effectiveness, and quality prior to being given authorization to sell and market a device for its intended use in Canada. There are also specific requirements for documenting and reporting adverse events, with clear guidance on how to issue a recall should the situation warrant such action.

Third-party reprocessing companies are not required to comply with Canada's medical device regulations, a fact that raises important concerns regarding Health Canada's role in ensuring patient safety. For instance, Health Canada does not require third party reprocessing companies to submit any safety, effectiveness, or quality data for the devices they are selling and/or shipping back for use to our Canadian hospitals. Third party reprocessing companies are also not required to maintain any records of reported problems related to a device, nor are they required to report adverse events to Health Canada. They are also not required to provide a proposed strategy to the health minister as to how a device recall would be conducted and a proposed plan to prevent a recurrence of the problem.

Amendments to Bill C-17 provide an opportunity for Health Canada to be granted the authority to regulate reprocessed single-use devices and address these important patient safety concerns. It is our recommendation that Health Canada regulate third party reprocessing companies as manufacturers in the context of Canada's medical device regulations, as has been the case in other countries, including the United States.

We're recommending that amendments be made to section 30 of the act, as this is the section addressing regulation-making authority for therapeutic products, including medical devices.

With regard to the bill, our first recommendation is to modify the regulation-making power in proposed paragraph 30(1.2)(a) to include reprocessing as a listed activity in respect of which authorizations may be issued.

Our second recommendation is to add a subsection—adding to proposed subsection 30(1.2)—providing for the authority to make regulations requiring that reprocessors of devices licensed for single use obtain therapeutic product authorizations in respect of those reprocessed devices.

It's important to point out to committee members that neither of these recommendations would actually require Health Canada to regulate, but would grant them the option to regulate both the reprocessing companies and reprocessed devices without dictating when or in what matter. The decision before you today is a relatively easy one. Time would allow the right regulations to be developed. Without these amendments, however, that discussion about how to regulate couldn't take place.

I want to be clear on the benefits of your making these amendments to Bill C-17 to strengthen patient safety. There would be clear, appropriate requirements for evidence to demonstrate that reprocessed devices will perform as intended and are safe for patients when used by a trained health care professional. There would be the ability to ensure that patients, doctors, industry, and other stakeholders have access to clear information about the medical devices they use. Very importantly, it would allow for rapid identification of adverse events and ensure coherent and timely action in the event a recall is required.

In summary, MEDEC wants to reiterate its full support for Bill C-17. It is important to MEDEC members that patients and health care providers have confidence in the safety of our health care system. We all benefit when public trust is at its highest. Bill C-17 helps to build that public trust and grow Canadians' confidence in our health care system. We believe these amendments can address a long-standing issue and enhance this important piece of legislation to further improve patient safety.

Over the years, I have talked with many government officials about this issue. There is always an interest in seeing a sample of a single-use device that is currently being reprocessed, so today I've brought with me a harmonic scalpel. This is a device that is used during surgery to cut and seal tissue. On the back you can see what a fully assembled harmonic scalpel from the original equipment manufacturer looks like. On the reverse are the individual components that would actually happen as part of a resterilization. The reverse shows you the individual components when it's disassembled and what would have to happen in order for it to be then reprocessed and come back.

I'll pass it around for you to see it, if you would like.

Thank you for your time. I would be pleased to answer any questions.

June 12th, 2014 / 8:55 a.m.
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Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Walter Robinson

Rx&D members seek to meet or exceed all legal and regulatory requirements regarding safety, product quality, and the information that is provided to patients, their families and healthcare providers.

In conclusion and in reviewing your work today, we are encouraged by your commonality of passion and the solidarity of your commitment to patient safety. We share this number one priority. We look forward to your questions on specific aspects of Bill C-17 during today's session, and we'll be active participants during the gazetting and comment process if it's passed into law. At the beginning of our remarks, we noted that we support Bill C-17 and we sincerely urge Parliament to pass it into law.

Thank you.

Thank you for your attention.

June 12th, 2014 / 8:50 a.m.
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Walter Robinson Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Mr. Chair and honourable members, thank you for inviting Rx&D to appear before Bill C-17 today.

My name is Walter Robinson. I'm vice-president of government affairs at Rx&D, and I'm joined by my colleague, Keith McIntosh, our senior director of scientific and regulatory affairs.

By way of background, Rx&D is the national trade association that represents 55 research-based pharmaceutical companies and members who discover, develop, and deliver innovative medicines and vaccines to Canadians. To be perfectly clear we support Bill C-17.

Legislative and regulatory modernization of the Food and Drugs Act that enhances and promotes patient safety is good public policy. We have been consistently supportive of these efforts and those of previous governments.

By way of background as well, we invest over $1 billion each year into Canada, with approximately 75% of this amount directed to over 3,000 clinical trials across the country. As you have heard before, clinical trials are required to bring safe, innovative, and effective medicines, vaccines, and devices to the Canadian marketplace. These trials are conducted in highly controlled, monitored, and regulated settings. The successful completion of trials provides the confidence to bring new drugs and procedures into clinical practice. Clinical trials also provide hope to patients and their families who have failed on or do not respond to conventional therapies.

We are proud of our long-standing partnerships with the Canadian Institutes of Health Research (and its predecessor, the Medical Research Council of Canada) and various provincial and para-public agencies.

But our most important contribution is working together to better the lives of all Canadians. It is here where the proper diagnosis, appropriate prescribing, and optimal utilization of medicines enable health system sustainability by reducing the need for physician visits, unnecessary hospitalizations, or avoiding costly and invasive surgical procedures.

Our industry is also on the front lines of health care provision with our federal and provincial partners in the delivery of vaccination campaigns. And we play a key role in supporting provincial health system strategies, such as primary care reform, age in place efforts, and community delivery of health care through pharmaceutical and other services.

As we have highlighted to this committee before, our members' activities are guided by a clear code of ethical practices. Acceptance of and adherence to this code in letter and in spirit are mandatory conditions of membership in Rx&D.

Rx&D and its members support Bill C-17, as I have stated, and other related efforts to improve patient safety across all stages of the development, approval, and use of all therapeutic products. And we agree with you that Health Canada must have a modern, efficient, and effective compliance and safety regime, a regime that is world-leading in its scope and receives the confidence of Canadians.

We also note that prior to any specific powers now proposed in Bill C-17, which essentially codifies the way we have been working with government, Rx&D members work closely with Health Canada to recall products, update or change labels, and implement any other important safety-related actions, either of their own accord or these warranted by Health Canada.

The foundation of any decision or regulatory intervention must be evidence-based and arrived at through rigorous scientific inquiry and standards.

Critical to this line of inquiry is a fulsome exchange of information among manufacturers, Health Canada, health care professionals and, increasingly, Canadian patients.

We pledge to work with the government, parliamentarians, and all stakeholders to make Bill C-17 and its adoption, if passed into law, as clear, efficient, and effective as possible. We would also suggest that the committee consider a number of aspects to further enhance and strengthen patient safety within Bill C-17. These include improving the exchange of information around reporting adverse events, which we support; encouraging and promoting the consistent dispensing of approved Canadian labels in pharmacy settings for innovative and generic medicines; additional oversight regarding counterfeit medications; and at a more practical level, more collaboration with international regulators such as the U.S. FDA, the European Medicines Agency, and their peers. As you heard in testimony before this committee, in several aspects they are further ahead than Health Canada on present safety regimes.

Every product has benefits and, yes, risks that are determined on the best available information and scientific practices. These benefits and risks are studied throughout a product's life cycle, and as the committee is aware, the vast majority of developmental therapeutic products fail for a wide variety of reasons, including unacceptable safety profiles, lack of efficacy, or situations where established risks clearly outweigh the benefits of a given therapy. Only one of 10,000 molecules in study ever makes it to market and to patients.

Vigorous and continuous attention to safety is a fundamental part of the development process from the early stages of drug development through to the entire life cycle of product even after discontinuance or product withdrawal. As other experts have testified before you, this process can span 30 to 50 or more years.

June 12th, 2014 / 8:45 a.m.
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President, Canadian Generic Pharmaceutical Association

Jim Keon

Thank you, Mr. Lobb.

Welcome everyone. Thank you for the opportunity for Canada's generic pharmaceutical industry to contribute to your study of Bill C-17, Vanessa's law. Thank you for accommodating our need to appear via video conference this morning.

I am Jim Keon, the president of the Canadian Generic Pharmaceutical Association. I'm joined today by Jody Cox, our vice-president for federal and international relations.

I'll say just a couple of words about the CGPA, the Canadian Generic Pharmaceutical Association. We represent companies that specialize in the research, development, and production of high-quality generic medicines, fine chemicals, and new chemical entities. We are Canada's primary pharmaceutical manufacturers and exporters and are among the top research-and-development spenders across all industrial sectors. The generic pharmaceutical industry employs more than 12,000 Canadians in highly skilled scientific and manufacturing positions and operates large life sciences companies in Ontario, Quebec, and all of Canada.

The generic pharmaceutical companies have an essential role in Canada's health care system. Generic pharmaceutical products provide safe and proven alternatives to more expensive brand-name prescription drugs. In 2013 alone, the use of generic prescription medicines saved governments, employers, and consumers approximately $13 billion. Today, four or five prescriptions for generic medicine can be filled for the cost of one brand-name prescription. We are proud of the fact that two out of every three prescriptions in Canada are now filled with generic medicines.

Generic drugs are approved for sale by Health Canada and are identical or bioequivalent to the brand-name version. Each product must also meet the rigorous and internationally accepted standards established by the Food and Drugs Act and its regulations. Generic medicines are required to have the same quality, purity, efficacy, and safety profile as branded drugs.

By the time a generic version is licensed for sale in Canada, the drug has generally been on the market for between 12 and 15 years in Canada and other jurisdictions, and the safety profile of the drug is generally well established. Even so, Canada's generic drug companies take our responsibilities with respect to patient safety very seriously. For us, patient safety is paramount.

I'd like to make a few comments on the bill.

On behalf of the association and our member companies we would like to congratulate member of Parliament Terence Young for championing Bill C-17 and the minister for bringing it forward.

In general, the CGPA supports Bill C-17. We note that it is enabling legislation and that many of the finer details will be provided for in regulation, which we will of course follow very carefully. I will briefly address a few certain aspects of the bill.

First, I will address the new powers for the minister. Bill C-17 provides several new powers to the Minister of Health. They give the minister expanded powers to obtain safety information, modify labelling, recall drugs or take other corrective actions, and obtain a court injunction on 48 hours' notice or no notice at all in the event of a perceived health risk.

During their testimony to the committee, the minister and Health Canada officials pointed to a specific instance where it was felt that undue delays were created in negotiations with a manufacturer. In most instances, however, manufacturers voluntarily comply with the requests from our Canadian drug regulator, Health Canada. The CGPA is of the view that a thoughtful, risk-based dialogue between the manufacturer and the regulator generally brings out the best outcome for patient safety. As such, it is our view that a voluntary approach is appropriate and should be maintained. That said, we do support the minister having the ultimate power as a last resort.

Next is adverse drug reactions, ADRs. There is no question that information is a key component of assessing the risks associated with a medicine. While drug companies have had a mandatory reporting requirement for many years, the health care professionals who are the primary point of contact for patients have had no such obligation. As such, the CGPA supports a mandatory requirement for prescribed health care institutions to report adverse drug reactions. This new requirement will help to narrow an important information gap and will improve both the quality and quantity of ADR information available.

We have a comment about post-market surveillance. As previous witnesses have testified, Health Canada has been moving towards a life-cycle approach to drug regulation for several years.

While the current regulatory scheme focuses on drug review prior to and leading to market authorization, the amendments allow the minister to order a manufacturer to “compile information, conduct tests or studies or monitor experience in respect of the therapeutic product”.

While CGPA welcomes this approach, we look forward to consulting with Health Canada on the specific details of the regulation and guidance that will be associated with these changes. In particular we recommend that the regulations and guidance specifically clarify any shared duties or actions between generic and brand manufacturers of the same drug. I'm going to stop here, Mr. Chair.

In conclusion I would like to reiterate our support for the bill, and Jody and I will be pleased to answer any questions you may have this morning.

Thank you.

June 12th, 2014 / 8:45 a.m.
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Conservative

The Chair Conservative Ben Lobb

Good morning, ladies and gentlemen. We're continuing our study of Bill C-17.

We have a full schedule here today, so we'll get right at it. We have a number of witnesses here for the first hour, and then we'll have some for the second hour. As we always do in these meetings, we'll try to start with our guests who are here by video conference.

Can you guys hear us okay?

Federal Framework on Lyme Disease ActPrivate Members' Business

June 11th, 2014 / 6:10 p.m.
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Green

Elizabeth May Green Saanich—Gulf Islands, BC

, seconded by the member for Vancouver East, moved that the bill be read the third time and passed.

She said: Mr. Speaker, I would like to express my heartfelt thanks to all those who supported my bill. We can accomplish a lot when we work together in a non-partisan way.

I would particularly like to thank the Minister of Health, who supported this bill. She shared her opinions and was extraordinarily understanding. I also want to thank her team.

I have to thank, in particular, the member for Honoré-Mercier, because, in the spirit of non-partisanship, she gave up her slot today, June 11, so that this bill, which has received such widespread support from all corners of the House, could proceed through report stage, third reading, and make its way to the Senate. I am very grateful that Senator Janis Johnson is prepared to take it forward so that we can get this help to the people who need it most.

All members in this place are now much more familiar than they were with the threat of Lyme disease. This bill will not solve all our problems, but it will take us a long way forward. So many members spoke passionately in this place about the importance of the bill. I want to particularly thank members on all sides of the House. The hon. member for South Shore—St. Margaret's gave a passionate speech about the difficulties of diagnosis and what he sees happening in Nova Scotia. My friend, the hon. member for Victoria, talked about our friend who lives in his riding but works with me, Chris Powell and her daughter Nicole Bottles, who testified in committee.

The hon. member for St. Paul's gave me time in committee so I could ask questions, which I otherwise could not have done. There have been so many acts of kindness. It is unusual for a private member's bill to have been seconded initially by the hon. member for Thunder Bay—Superior North with the Green Party, seconded at the next stage by the hon. member for Oakville, a Conservative, who has himself stood on an important issue in Bill C-17, which I hope we can also pass expeditiously, Vanessa's law. Today I am honoured that the health critic for the official opposition, the hon. member for Vancouver East, would be my seconder.

I also want to thank the Parliamentary Secretary to the Minister of Health for her help. I know I will forget people as I keep thanking everyone. The hon. member for Sault Ste. Marie offered early help and support. Everybody on all sides of the House, including the health critic for the Liberal Party, have been unstinting in their willingness to help the bill pass, to get through amendments and clause-by-clause in committee. This bill is now called a federal framework on Lyme disease. It has the support, as I have said, of Health Canada.

I will share with the House things that I did not know when I first put this bill forward at first reading almost two years ago exactly. The Public Health Agency of the Government of Canada testified before the health committee that this is one of the fastest-growing infectious diseases in Canada. The evidence from the federal Public Health Agency is that it thinks by the year 2020 Canada could be experiencing 10,000 new cases of Lyme disease every year.

Every step we take in 2014 to put in place national approaches that work federally, provincially, and territorially for better education and better prevention so that people can avoid getting Lyme disease in the first place by knowing what to look for, by avoiding ticks, moving to better diagnoses, working with the doctors across this country, is crucial. The support of the Canadian Medical Association for this bill, the College of Physicians and Surgeons, and the Canadian Lyme Disease Foundation has been absolutely essential. All of these expert bodies recognize that this is a very complicated disease, very difficult to diagnose, and that we should no longer stand for any one of our friends, neighbours, or relatives to have to go to the United States for expensive treatment.

We do not want to hear any more stories from our own constituents who had to sell their homes to be able to afford the treatment that we can provide here in Canada through a federal framework on Lyme disease. Ultimately, we need much better research. I have mentioned a couple of times how indebted I am to the hon. Minister of Health. Funds have been put in place by Health Canada without being tied to this bill, because, of course, a private member's bill cannot put forward funds.

I will close now with the most deep and heartfelt thanks to all in this place tonight and every day. God bless them.

Concurrence in Vote 1--SenateMain Estimates, 2014-15

June 10th, 2014 / 9:05 p.m.
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Conservative

Dan Albas Conservative Okanagan—Coquihalla, BC

Mr. Speaker, again, the NDP continues to believe that its magical thinking will pan out in a way that supports Canadians.

That particular member, regardless of whether it is a discretionary or a statutory item, will vote in opposition, because the NDP ultimately opposes this government's agenda of low-tax policies that will help us grow our economy, create more jobs, and create long-term prosperity.

I understand that the member has certain ideas about the Senate and about whether it should be funded, but this government stands clear. We want to see a strong parliamentary agenda. We want to see things like Bill C-17, Vanessa's law, which I mentioned, go forward, because they are in Canadians' greatest interests.

Concurrence in Vote 1--SenateMain Estimates, 2014-15

June 10th, 2014 / 8:45 p.m.
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Okanagan—Coquihalla B.C.

Conservative

Dan Albas ConservativeParliamentary 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. Yet, 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.

June 10th, 2014 / 10:40 a.m.
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Professor, School of Health Policy and Management, York University, As an Individual

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.

June 10th, 2014 / 10:20 a.m.
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Vice President and Chief Operating Officer, Institute for Safe Medication Practices Canada

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.

June 10th, 2014 / 10:20 a.m.
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Prof. Matthew Herder

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

June 10th, 2014 / 10:15 a.m.
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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.

June 10th, 2014 / 10:10 a.m.
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NDP

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?

June 10th, 2014 / 10:10 a.m.
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Conservative

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.

June 10th, 2014 / 10:10 a.m.
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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.

June 10th, 2014 / 10:05 a.m.
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Professor, School of Health Policy and Management, York University, As an Individual

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.

June 10th, 2014 / 10:05 a.m.
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Vice President and Chief Operating Officer, Institute for Safe Medication Practices Canada

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?

June 10th, 2014 / 10:05 a.m.
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Conservative

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.

June 10th, 2014 / 9:55 a.m.
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Conservative

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?

June 10th, 2014 / 9:50 a.m.
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Liberal

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?

June 10th, 2014 / 9:50 a.m.
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Professor, School of Health Policy and Management, York University, As an Individual

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.

June 10th, 2014 / 9:35 a.m.
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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.

June 10th, 2014 / 9:20 a.m.
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Sylvia Hyland Vice President and Chief Operating Officer, Institute for Safe Medication Practices Canada

Mr. Chair, members of the committee, and staff, thank you for giving me the opportunity to be here on behalf of ISMP Canada.

I would like to state our strong support for Bill C-17,, the protecting Canadians from unsafe drugs act, also known as Vanessa's law.

ISMP Canada is an independent, not-for-profit organization established in 2000 to analyze incidents of preventable harm from medications, to identify system improvements, and to work collaboratively to advance medication safety.

One of the key elements in Bill C-17 is a stronger requirement for reporting by health care institutions of serious adverse drug reactions and medical device incidents that involve drugs. We believe that this will better identify drug-related risks.

Repeated research has shown that harm from medications happens more frequently than practitioners and the public realize. A study in 2008 found that more than one in nine emergency department visits are due to drug-related adverse events, of which 68% were thought to be preventable. The research, along with experience, has shown that in many cases harm can be prevented and patients can be protected, but only if we as health care providers and administrators are aware of the problems.

One of the ways we become aware of the problems is through a robust reporting system. The value of improved reporting will be more information to better evaluate a drug's benefit-to-risk ratio. With adverse event or adverse reaction reporting, anyone can make a report. One report can make a difference and ultimately impact on the way that health care is provided.

Our organization works closely with hospitals, and we know that reporting is taking place on a voluntary basis. There is a growing culture of safety and a growing awareness of the value of reporting. We also know that the reporting of harm from medications is variable. The bill provides impetus to build on existing infrastructure, create more consistency, and adopt standardized approaches so that the quality of data collected can improve.

A readiness for this bill exists. It is our experience that when there is recognized value, additional work on the part of practitioners or organizations will not be a barrier to implementation. There is a level of awareness that, if enacted, this legislation will not only promote reporting but will spark more collaboration at the provincial and national levels.

With this bill we have an opportunity to identify best practices for reporting and for coordinating existing systems to provide adverse drug reaction data to Health Canada. There will be opportunity to link this work through such advancing technologies as the electronic health record and thereby continuously improve data capture on the use and safety of medications.

As well, analysis and interpretation of data will improve. One of the limitations of the current system for voluntary reporting by practitioners in hospitals is that it is not possible to infer or project the probability of specific harms. This can be improved with mandatory reporting. In other words, voluntary reports of severe and unexpected cases of harm from medications help to detect new risks and can provide early warning. However, increasing the number of reports through a mandatory process in hospitals will also help to identify trends and will better support continuous evaluation of a drug's benefit-to-risk balance.

Our organization works closely with consumers and patients, and it is our experience that most consumers and patients are under the impression that mandatory reporting already exists. This bill helps us to live up to their expectations. Ultimately, this bill will help ensure that practitioners, together with patients, have enough information to make an educated decision about drug treatment.

A second key component of the bill is strengthening safety oversight by providing Health Canada with increased authorities.

Health Canada's life-cycle approach to drug safety oversight recognizes the need for continuous evaluation of the use of a drug and its benefit-to-risk balance in the real world experience. The bill empowers Health Canada to require licence holders to conduct assessments, compile information on product use, conduct tests or monitor experience, take preventative measures, and monitor the effectiveness of such measures.

Pharmacovigilance activities are now being viewed more broadly as relating to not only adverse reactions that inform the inherent benefit-to-risk ratio of the drug molecule itself but also the preventable adverse events that inform health care system improvements, practice improvements, and label improvements.

For example, following analysis of medication errors, which by their nature are preventable harms from medication, we have worked with manufacturers and Health Canada to improve package label design, so that critical information is the most prominent information, rather than, for example, emphasis placed on branding or marketing. In this way, we can increase the probability that important information will stand out and also reduce the risk for error.

The authorities provided in the bill will allow greater influence on the unique considerations for the package and its label, the product monograph, the package insert, and the patient information provided. With the evolution of medication safety, we now know much more about designing labels for safety, designing labels and packages with the end user in mind, and utilizing human factors expertise to help ensure optimal representation of information and reduce risk of error.

There is a tension between the safety science and the many efforts to market, brand, and sell a product. The two can be at odds. It is important that Health Canada be positioned to assert safety over marketing, safety over branding, and safety over sales. We need to have Health Canada in a position to demand quick action when the safety of Canadians is at risk.

I acknowledge that there have been pharmacovigilance advances and successful safety initiatives accomplished within the limitations and constraints of the current Food and Drugs Act.

Many manufacturers have moved quickly to improve product problems when compelling information for change has come forward, but not always. By enabling a prompt response to identified risks, such as requiring a label change or to make new safety information available, or ordering a product recall, we believe that the safety of patients is enhanced.

Again, as we work with consumers and patients, we often find that they are under the impression that Health Canada already has the authorities outlined in the bill. The bill helps us live up to their expectations.

In summary, the components of Vanessa's law encourage collaboration and system improvement for reporting of serious adverse drug reactions. The bill aligns Health Canada authority with expected accountability and responsibility.

The bill has undergone extensive study and consultation, and it meets the test of reasonableness. We are grateful for this chance to encourage the standing committee to move forward with Bill C-17.

Thank you again, Mr. Chair, and members of the committee, for this opportunity. I look forward to our discussions and the next steps.

June 10th, 2014 / 9:15 a.m.
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Professor Matthew Herder Assistant Professor, Faculties of Medicine and Law, Health Law Institute, Dalhousie University, As an Individual

Thank you, Chair.

Thank you for the privilege of appearing before you today. l'm a legal scholar with expertise in intellectual property law. Given time constraints, l'm going to focus solely on the issue of transparency, which Bill C-17 does not address. l have two themes, each with a few specific points that l want to touch upon. I'll conclude by reading five key provisions that l think should be added to the bill.

My first theme is to make evidence and regulatory work transparent.

First, amend Bill C-17 to make registration of all clinical trials, from phase one to phase four, as well as other investigational studies and the reporting of all such study results, mandatory for all new drugs and new indications for existing drugs that are submitted for regulatory approval, whether those submissions are successful or not.

Second, empower the Minister of Health to disclose clinical study reports. Access to clinical study reports and the data they contain can be critical to understanding the quality of the evidence behind a given drug.

A study published just last week in the British Medical Journal comparing clinical study reports with published information regarding duloxetine, a commonly prescribed treatment for major depressive disorder in Canada, concluded, “Clinical study reports contained extensive data on major harms that were unavailable” from other sources.

The optimal procedures for sharing clinical study reports are the subject of live debate. For that reason, defining the procedures by which clinical study reports should be made available by way of regulations is appropriate. But vesting the minister with the authority to make them available is critical.

Third, require the minister to publicly report all decisions, including product approvals, refusals, suspensions, and recalls, and the reasons behind those decisions. Patients, physicians, researchers, indeed drug manufacturers and other regulators would benefit from knowing how the regulator is interpreting the evidence. In time, this will improve the quality of the regulator's decision-making and Canadians' confidence in it.

Fourth, attach real penalties to non-compliance with transparency requirements. Despite clear penalties backed by the force of law, in the United States compliance has been less than adequate. According to one study, 78% of trials registered on ClinicalTrials.gov failed to provide results within the statutory one-year timeframe.

I therefore suggest a modified enforcement strategy. As is done in the U.S., Bill C-17 should make failure to comply with registration and results reporting subject to monetary fines. However, Bill C-17 should also tie results reporting to market approval.

Bill C-17 already includes an amendment to the Food and Drugs Act that would require manufacturers to comply with any terms or conditions attached to the market approval. This power should not be used only on occasion. Rather, that new power should be used in every single drug approval where results reporting is, at the time of market authorization, still incomplete. Where the regulator rejects a drug or a new indication for an existing drug, and the results reporting requirement has not been fulfilled—it has to be within six months—manufacturers should incur an additional monetary fine.

The second theme is to make it absolutely clear that transparency trumps commercial claims.

Here's my first point. Subclause 6(6) of Bill C-17 proposes a modification to subsection 30(3) of the current Food and Drugs Act. The proposed change opens the door to limiting the powers contained in the act in order to implement trade agreement articles relating to intellectual property. This proposed amendment should be deleted from the bill. The federal government's responsibility to protect the welfare of Canadians should not be reduced by trade objectives.

On my second point, and this is my last point, claims by manufacturers that certain information is proprietary—that is, confidential business information or trade secrets—has long been the central barrier to transparency. However, consistent with its international obligations, Canada's food and drug regulations already protect data against unfair commercial use, providing eight years of data exclusivity to innovative drugs on top of any available patent protection. Nevertheless, it is received wisdom within Health Canada that information about drug safety and effectiveness cannot be disclosed. Consequently, Bill C-17 must make it plain that the regulator has the power to disclose that information.

People have given up their bodies and taken on serious, even life-threatening, risks to help generate that information. It is not for the companies to own in secret, and the regulator has to be free to disclose it.

To conclude, here are five provisions that should be added to Bill C-17, in light of the foregoing.

First, all clinical trials and other investigational studies involving a therapeutic product shall be registered on a publicly accessible, searchable database before participant recruitment begins, in accordance with the regulations. As well, the minister shall not issue a market authorization in respect of a therapeutic product unless any clinical trials and other investigational studies involving said therapeutic product were registered in accordance with this provision, whether or not those trials and other investigational studies were carried out in Canada.

Second, all clinical trials and other investigational studies involving a therapeutic product shall report the results thereof on a publicly accessible, searchable database within one year of the completion of the trial or study, in accordance with the regulations. As well, where the results of one or more completed trials or investigational studies associated with the therapeutic product have not been reported in accordance with this provision prior to market authorization, the minister shall require as a condition of market authorization that such results be reported in accordance with this provision within six months of the date of market authorization. Finally, in the event that a therapeutic product is not granted a market authorization by the minister, the manufacturer shall report the results of all clinical trials and investigational studies in accordance with this provision within six months of the date of the minister's decision not to grant market authorization.

Third, the minister may publicly disclose clinical study reports in accordance with the regulations.

Fourth, the minister shall disclose in a publicly accessible, searchable database, information about therapeutic product authorizations, including any terms or conditions associated with a therapeutic product authorization, indication changes, refusals, suspensions, and recalls, and the reasons for each such decision.

Fifth, the minister, in fulfilling the foregoing provisions, shall publicly disclose information regarding the safety and effectiveness of a therapeutic product, including adverse drug reactions, which it receives from manufacturers, health-care institutions, and other persons. As well, information referred to in this provision shall not be used by a manufacturer for unfair commercial purposes as described by the regulations.

Those are the provisions I suggest are essential to add in their entirety to the bill for it to achieve its full promise.

Thank you.

June 10th, 2014 / 9:05 a.m.
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Professor Elaine Gibson Associate Professor, Health Law Institute, Dalhousie Schulich School of Law, As an Individual

Thank you. I apologize in advance. We were originally scheduled to be here until 9:45 and I'll have to leave shortly before 10:00, so I won't be here for the full two hours.

It's an embarrassment to our nation that Health Canada does not at present have the power to recall a pharmaceutical product from our market. I urge the committee members to rectify this omission by ensuring the passage of Bill C-17. You will thereby play an important role in helping to protect the safety of Canadians.

That said, there are a number of ways in which Bill C-17 can and should be enhanced. Others on this panel are speaking to the critical matter of transparency. I'm not going to address this. I'm going to outline three other measures that I urge you to embrace. These measures are simple, straightforward, and I hope, easy to comprehend. I'm happy to take questions after.

I'm even going to give you the suggested wording for the amendments that I propose. Despite how basic they are, these measures have the potential to dramatically improve patient safety, which is, as you know, the intended aim of the bill before you.

Here they are. First, expand the application of Bill C-17 to ensure that it applies to all holders of therapeutic product authorizations. Second, incorporate a greater range of adverse events. Third, exempt Health Canada from liability for measures taken in good faith.

I'll go through these one-by-one.

First, expanding the application of Bill C-17. The language at present generally refers to holders of therapeutic product authorizations. However, the specific provision on ability to recall refers only to sellers of products. The production and distribution of pharmaceuticals is complex and may involve several companies. Not all holders may be sellers.

For example, a company holding the authorization may license product sales to a different company and therefore not fall within the definition of seller. The recall provisions in the bill should be amended to capture all entities in the production chain and should specifically refer to the holders of therapeutic product authorizations.

Second, incorporate a greater range of adverse events. The language of the bill at present refers to injury and to harm. You may recall the incident last year regarding packaging of the birth control medication Alysena. Health Canada initially took the view that the problem with the packaging, potentially leading to numerous pregnancies in Canada and having resulted now in multiple claims of unwanted pregnancy and lawsuits, did not constitute a serious adverse health consequence.

They eventually accepted that if a particular woman should not get pregnant specifically for medical reasons, this would constitute such an adverse consequence, but not simply if she was opting not to get pregnant; i.e. taking the birth control pill for non-medical reasons.

In other words, pregnancy was and is, I assume in the interpretation of Health Canada, a lifestyle choice and not a serious adverse event.

The wording of Bill C-17 should be altered to incorporate language that envelopes situations of product mislabelling or mispackaging. Suggested wording is as follows, “For greater clarity, an adverse drug reaction includes but is not limited to circumstances in which the therapeutic product does not have its intended effect due to mislabelling or mispackaging of the product”.

An adverse drug reaction includes circumstances in which the drug does not have its intended effect due to mislabelling or mispackaging of the product.

Third, exempt Health Canada from liability for measures taken in good faith. Last and perhaps most importantly, the Minister of Health or her designate need to be able to exercise the powers outlined in Bill C-17 with impunity, provided that they act in good faith. Tort liability is in my view a marvellous mechanism for accountability and I would not usually be arguing for immunity on the part of government from its actions; however, consider this.

Pharmaceutical companies are among the most powerful corporations in the world. The total revenue of the Government of Canada for 2012-13 was $257 billion. The total revenue of the top 10 pharmaceutical corporations combined was over $400 billion in 2013. The total revenue of the top 50 pharmaceutical corporations was $610 billion in 2012. The incentive on the part of pharmaceutical corporations to commence lawsuits is high. In recent years they have engaged in illegal activities, and faced and absorbed fines for these illegal activities in the billions of dollars with barely a blink in their ability to continue functioning. It's not exactly David and Goliath, the Government of Canada versus pharmaceutical corporations, but you get the idea. To restate the basic facts I just outlined, Canada's total government revenue was $257 billion. The top 10 pharmaceutical companies' is over $400 billion.

I'm concerned that Health Canada will be impeded in its ability to execute the functions outlined in Bill C-17 for fear of lawsuits that could place a serious dent in our economy. Take the example of a precautionary recall of a product from the market in light of concerns followed by evidence accumulated by the corporation that the recall proved not to be necessary in the end. One can well imagine a lawsuit by the seller for sales lost during that period of recall. A primary means to ensure that Health Canada can vigorously pursue its mandate to protect Canadians is to amend Bill C-17 to incorporate a clear exemption from liability.

What would such an exemption look like? Here's some draft wording for example. The clerks have copies of this and you can get it after.

The government is not liable in respect of any loss or damage caused or resulting, directly or indirectly, by or from,

(a) the enactment of (specified sections of) this Act or a regulation or standard made under these sections of this Act, or

(b) anything done or omitted in the exercise or performance or purported exercise or performance of a power or duty conferred under this Act or regulations unless the person who brings the action proves that the person exercising or performing or purporting to exercise or perform the power or duty was not acting in good faith.

What is good faith? It's acting not with maleficent or evil aim, in other words, acting positively in a moral sense. Then if this measure is enacted, the government is immune from lawsuits for its actions in this regard.

In conclusion I urge you to promote the passage of Bill C-17 along with the specific enhancements that I'm recommending. The stated aim of the bill is to protect Canadians from unsafe drugs. These measures will ensure that the bill, once it becomes law, will live up to its lofty name. Members of this committee are uniquely poised to play a positive role in protecting Canadians and I encourage you to do so.

June 10th, 2014 / 8:50 a.m.
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Professor, School of Health Policy and Management, York University, As an Individual

Dr. Joel Lexchin

I want to thank the standing committee for the opportunity to appear today.

I teach health policy at York University and work as an emergency physician at the University Health Network in Toronto. I've been analyzing, talking about, and writing about pharmaceutical policy for over 30 years, and I'm the author or co-author of about 140 peer-reviewed articles on these topics.

My testimony is going to focus on three issues: first, the need to ensure that any post-market studies are carried out in a timely manner; second, the problems with clinical trials conducted by companies making the products being tested; and finally, the need to improve on the amount of information that Health Canada discloses after it has approved a new drug.

In discussing the first issue, I'll examine the situation regarding the notice of compliance with conditions policy. For the second, I will use the results of a recent systematic review that looks at the results and conclusions of trials funded by drug companies, and those trials that receive funding from other sources. And for the third issue, I'll draw on a study that I and a graduate student recently published, that looked at the quantity and quality of information that's disclosed in the summary basis of decision documents that Health Canada releases after it approves a new drug.

With regard to the notice of compliance with conditions, this is a policy that was adopted back in 1998, and the goal was—and here's a quote from Health Canada—to provide patients suffering from “serious, life-threatening or severely debilitating diseases or conditions” with earlier access to promising new drugs. This is where surrogate markers have suggested that these products offer “effective treatment, prevention, or diagnosis of a disease or condition for which no drug is presently marketed in Canada”, or significantly improve efficacy or significantly diminish risk over existing therapies.

One example of a surrogate marker would be that a drug shrinks the size of a cancer tumour. In return for getting a notice of compliance with conditions, companies have to commit, in writing, to undertake confirmatory studies—that is, studies that definitively establish efficacy—and then submit these results to the therapeutic products directorate at Health Canada. If these post-marketing trials do not provide sufficient evidence of clinical benefit, the notice of compliance with conditions could be revoked and products removed from the market. Health Canada will also issue a notice of compliance with conditions for a new indication for an existing product.

Since this policy was adopted in 1998, Health Canada has issued a total of 60 notices of compliance with conditions for either new active substances—these are molecules that have never before been marketed in Canada—or new indications for existing drugs. Out of these 60, seven were either revoked, suspended, not fulfilled, or removed, which leaves 53. Out of those 53, 28 have been fulfilled and 25 have yet to be fulfilled.

A table that I've provided in this brief shows that it took six years for four or more of these 28 to be fulfilled, and of the 25 that have yet to be fulfilled, 15 have been on the market for more than six years. Some have been on the market for as long as 12 years, which means that these drugs are being prescribed by doctors, being taken by patients, and nobody really knows either how well they work, or if they work at all.

Health Canada provides no information that's publicly available as to the status of the clinical trials that are supposed to be undertaken to fulfill the conditions for which these products were licensed.

The second topic is trials funded by drug companies. About 80% of all clinical trials are funded by pharmaceutical companies.

I recently participated in a Cochrane Collaboration review that looked at the results and conclusions of trials funded by drug companies and those that received their funding from other sources. Just as a brief bit of background, the Cochrane Collaboration is an independent, non-profit, non-governmental organization consisting of about 31,000 volunteers in more than 20 countries. It was formed to organize medical research information in a systematic way to facilitate the choices that health professionals, patients, policy-makers, and others face in health interventions according to the principles of evidence-based medicine.

Our review, which was published two years ago, found that studies that were sponsored by drug and device companies more often had favourable results and conclusions than those that were sponsored by any other source. The findings were consistent across a wide range of diseases and treatments. Specifically, we found that if a study was sponsored by a company, the results were 2.15 times more likely to be positive and the conclusions 2.67 times more likely to be positive than if any other source—charities, hospitals, universities, CIHR—had funded the trials. This indicates that the mere fact that drug companies are sponsors of the trials creates a bias that they're likely to be positive. If the committee wants a copy of this review, I'd be happy to provide an electronic copy.

Finally, with regard to the summary basis of decision documents, this is an initiative that Health Canada started as of January 1, 2005. This is a document that's issued after a new drug or medical device is approved, and it explains the scientific and benefit-risk information that was considered prior to approving the product. Of particular interest to people like me, who are health care professionals, is the section of the summary basis of decision document that contains a description of the pre-market clinical trials that were examined by Health Canada and a summary of the final risk-benefit assessment of the product. Health Canada's position is that as a result of the summary basis of decision documents, Canadian health care professionals and patients will have more information at their disposal to support informed treatment choices.

Recently a graduate student of mine and I examined all 161 summary basis of decision documents that looked at a total of 456 clinical trials that Health Canada had examined between January 1, 2005, and the end of April 2012. We looked particularly at the information that was disclosed about the safety and efficacy of the drugs. We were interested in information about the characteristics of the patients who participated in the trials and about the risks and benefits of the drugs.

For the characteristics of the patients, we looked at information about age, sex, whether the patients were in hospital or were outpatients, and how the patients were chosen for inclusion in the trial.

For the risks and benefits of the drugs, we looked at information about how long the study ran, the statistical significance of the results, whether the drug was compared to a placebo or another drug, what percentage of patients withdrew from the trial, and if there was any difference between the withdrawal rates for people who were taking the new drug and the withdrawal rates for people who were taking either the placebo or the comparator drug.

Here are some of the results we found. The number of summary basis of decision documents that fully reported on the sex of the patient was 32 out of 161. The number of documents that fully reported on the age of the patients was 53 out of 161.

The number of documents that reported on how long the trials ran was 90 out of 161. The number of documents that reported on how many people withdrew from the trials was four out of 157. Four of the documents couldn't be analyzed for this issue. The number of documents that fully reported on differences between withdrawal rates for people taking the new drug and people who were taking either the placebo or the comparator drug was one out of 154.

Our conclusions were:

Overall, clinical trial information in SBDs is presented in a haphazard manner, with no apparent method to its presentation....at least one-third of the potential information about patient trial characteristics and the benefits and risks of tested treatments is missing.

I would be happy to provide an electronic copy of this study to the committee.

Based on the foregoing information, I have two recommendations for changes in Bill C-17.

First, if Health Canada requires post-market trials for drugs, then it has to report on a regular basis, probably annually, on the status of those trials. For instance, are they delayed, and if so why? When are they expected to start? Are they in progress, and when are they expected to be completed? If they are completed, what were the results?

Second, Health Canada should ensure that all of the results of clinical trials dealing with the safety and efficacy of a new drug are made publicly available within one year of completion of the trial, after they have redacted any information that might identify any individual patients.

Finally, I think that Health Canada needs to institute a mechanism of separating the funding of any post-market study from the conduct of the trial. What I'm suggesting is that the company that has committed to undertake the trial give the money to do that trial to CIHR. CIHR would then select the researchers, who would design and undertake the trial; those researchers would analyze the results of the trial independent of the company, and the results of the trials would be made public.

Thank you very much for listening to me.

June 10th, 2014 / 8:45 a.m.
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Prof. Janice E. Graham

Thank you very much for this opportunity to contribute to your study of Bill C-17

I'm going to focus today on why I think amendments to the bill are needed to address openness and transparency of clinical trials data and the decisions surrounding the approval of drugs by Health Canada.

I became interested in the transparency of safety and efficacy data almost 20 years ago while working as a research fellow on a phase four clinical trial. The manufacturer who sponsored our study selected the positive results from our database, ignoring the not-so-positive cases in order to argue for inclusion of that drug into the provincial formulary. I was appalled at the manipulation and wondered how mediocre drugs get approved in the first place given their cost to our health care system.

Between 2001 and 2006, I conducted extensive anthropological research at Health Canada's regulatory authorities. I was observing drug evaluations, regulatory activities, and decision-making. Also, I participated in progressive licensing consultations with Health Canada and I chaired their expert advisory committee on the special access program.

Concerns and recommendations that our committee made in 2008 about the role and fit of regulatory modernization were never made public and several apply to the recommendations for Bill C-17.

In 2004, Health Canada received the Code of Silence award from the Canadian Association of Journalists as the most secretive government department for denying access to drug databases that could harm or kill Canadians. The CAJ charged that commercial interests trumped Canadians' health. Regulatory capture, a term that gets used by all sides to accuse a regulatory authority of favouring the interests of one stakeholder over another, can happen in any sector. It's non-partisan.

The ability of Health Canada's regulatory evaluators and independent reviewers to do their job is challenged when assessing partial and incomplete data. I do not wish to criticize the dedicated work carried on by Health Canada's regulators. They work under considerable structural and financial constraints. Hiring just a few more evaluators in 2004 and 2005—while I was doing my research there—enabled the directorates to move out of years of backlog.

Improvements in recent years have made Health Canada's activities and reports more readily accessible. But these still remain weak instruments, lacking important details about the research design and methodologies, data, critical appraisal, and the assessment that would ensure unbiased results and analyses. While Health Canada's reviewers use many mechanisms to arrive at their decisions, including bilateral consultations with the sponsor and ongoing clarification of their questioning during reviews, I suggested there remains an essential role for independent appraisal that requires open access to the clinical trial data and to Health Canada's decision-making.

As a case in point, Health Canada's assessment of the stem cell therapy Prochymal left more questions than answers. In 2012, Canada became the first country to conditionally approve Prochymal for the treatment of acute graft-versus-host disease in children. Approval was based on very encouraging data showing clinically meaningful responses provided by the sponsor. The U.S. FDA wasn't convinced though and denied approval of that drug. The manufacturer, Osiris, planned to use Prochymal for the treatment of many other diseases, opening the door to multiple off-licence indications.

The fact that the panel recommended a warning for the product monograph to say, “The long term effects of Prochymal® in growing children are unknown“ would, I hope, have alerted the marketed health products directorate to a ticking time bomb.

Based on limited and unpublished clinical trial data, Canada's decision to approve Prochymal was lauded as a huge achievement by the financial and drug development communities. Canada was seen to be signaling a shift, that they were open to industry for faster access, more than for the safe drugs that Canadians need as promised in the 2003 throne speech.

Health Canada's summary basis of decision-making for Prochymal presented a confused picture of the criteria and proceedings that allowed its approval. Data from two unpublished studies were used to arrive at the decision, and one didn't even meet statistical significance for the critical end point. I quote from the summary basis of decision-making:

To date, only preliminary evidence exists to indicate a potential therapeutic value for Prochymal; however, so far, Prochymal has not exhibited worrisome toxicity and has shown a relatively benign safety profile.

I submit to you that so does a placebo and the evidence was that this trial was based on only 28 days of clinical research.

HPFB's own consultations say that the summary basis of decision documents do “not contain enough detailed information about clinical trials including study participants, results and harms to truly allow consumers and health care providers to make informed choices.”

In a business article titled “How to Tell When a Drug Company Fibs About Clinical Trial Results”, Adam Feuerstein wrote:

Osiris Therapeutics “disappeared” important data when the company announced results...from a mid-stage study of its stem cell therapy Prochymal in heart attack patients.

Regulation works well when it takes nothing for granted and has multiple, iterative mechanisms to control for potential gaps. The good regulator wears both a belt and suspenders. I don't think any of us wants Canadian regulators caught with their pants down. I cannot afford a ticking time bomb—none of us can. Bill C-17 does not go far enough in ensuring independent, systematic review of all clinical trial data. Steps to ensure access to clarifications and consultations between industry sponsors and regulators, and the details in rationale for drug approval, approval with conditions, refusal, and suspended or recalled drugs, are not included in the present draft of Bill C-17. Neither is budgetary commitment to provide the resources for the enhanced regulatory activities that modernization will need to meet obligations to Canadians for the safety and efficacy of therapeutic health products. Without budgetary commitment to carry out these extra activities, provisions in the act will be futile.

Regulatory modernization has swept across nations. It's intended to keep pace with our political neighbours in terms of policy, economy, and science and technology, but it can also be an opportunity for clinical trialists and regulators to adopt new, more robust methodologies. While Bill C-17 will enhance the recall powers of the health minister, it puts no emphasis on enhancing the capacity and capability of Health Canada with the precautionary buffer of independent review and access to decision-making.

Instead, regulatory modernization has pushed for post-market surveillance and follow-up for conditionally approved drugs, many of which should be stopped at the gate. With quicker access to these drugs, Canadians risk becoming phase four clinical trial guinea pigs who are not protected by the careful controls in traditional phase one, two, and three clinical trials.

Without the benefits of independent, open and transparent access to clinical trial results, the authorization and approval of the use of medications remain an ethically unjustifiable black box. Bill C-17 will serve all Canadians better if it can address this gap. As the journal Nature points out:

Greater openness about clinical-trial data should help to speed up drug development, provide independent assessments of drug safety and efficacy and increase trust in industry science.

It's a win-win for us all.

Thank you.

June 10th, 2014 / 8:45 a.m.
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Conservative

The Chair Conservative Ben Lobb

Good morning, ladies and gentlemen. We're continuing our study on Bill C-17. We have a number of witnesses today, so we might as well get right at it.

First of off, we'll start with our guest who's on teleconference this morning.

Ms. Graham, can you hear us okay?

Business of the HouseOral Questions

June 5th, 2014 / 3:10 p.m.
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York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader of the Government in the House of Commons

Mr. Speaker, I will start with the concept of the very strange proposition put forward by my friend. He uses this concept of shifts and believes there is some perverse obligation on the part of the government that, if the opposition wishes to filibuster the production of new laws and delay their production, we somehow have an obligation to match them step for step in extending that process. His comparison is with ordinary Canadians. He said that ordinary Canadians should not produce a product at the end of the day at work; they should take two, three, or four days to get the same thing made. That is his idea of getting things done. That is his idea of how ordinary Canadians can work. I think that says something about the culture of the NDP and the hon. member. I will let members guess what culture that is. It is a culture that does say we should take two or three times longer to get something done or to get to our destination than we possibly can.

We on this side are happy to make decisions to get things done for Canadians. In fact, that is exactly what we have been doing. Since I last rose in response to a Thursday question, the House has accomplished a lot, thanks to our government's plan to work a little overtime this spring.

I know the House leader of the official opposition boasts that the New Democrats are happy to work hard, but let us take a look at what his party's deputy leader had to say on CTV last night. The hon. member for Halifax was asked why the NDP agreed to work until midnight. She confessed, “We didn't agree to do it.” She then lamented, “We are going from topic to topic. We are doing votes. We are at committees. They are really intense days. We're sitting until midnight.”

On that part, I could not agree more with the deputy leader of the NDP, believe it or not, but with much more cheer in my voice when I say those words, because we think it is a good thing. These are intense days. We are actually getting things done. We are actually voting on things. We are actually getting things through committee. For once, we are going from topic to topic in the run of the day.

Let me review for the House just how many topics, votes, and committee accomplishments we have addressed since the government asked the House to roll up its sleeves.

Bill C-24, the strengthening Canadian citizenship act, was passed at second reading and has even been reported back from the citizenship committee.

Bill C-10, the tackling contraband tobacco act, was concurred in at report stage and later passed at third reading.

Bill C-31, the economic action plan 2014 act, no. 1, was reported back from the finance committee.

Bill C-27, the veterans hiring act, was passed at second reading.

Bill C-20, the Canada-Honduras economic growth and prosperity act, was concurred in at report stage.

On the private members' business front we saw:

Bill C-555, from the hon. members for West Nova in support of the seal hunt, was passed at second reading.

Bill C-483, from my hon. colleague, the member for Oxford, cracking down on prisoners' escorted temporary absences was passed at third reading.

Bill C-479, from the hon. member for Ancaster—Dundas—Flamborough—Westdale, on improving the place of victims in our justice system was passed at third reading last night.

Progress is not limited to Conservative initiatives. The Green Party leader's Bill C-442, respecting a Lyme disease strategy, was reported back from committee yesterday.

The hon. member for Timmins—James Bay saw a motion on palliative care pass.

We have also seen countless reports from committees reviewing the government's spending plans, as well as topics of importance to those committees.

This morning we even ratified the appointment of an officer of Parliament.

Finally, I do want to reflect on the accomplishment of Bill C-17, the protecting Canadians from unsafe drugs act (Vanessa's law), which members may recall me discussing in last week's Thursday statement. It finally passed at second reading. However, this did not happen until the NDP relented and changed its tune to allow the bill to go to committee. It was the first time ever that we had an expression from the New Democrats when we gave notice of intention to allocate time in which they said, “We don't need that time; we're actually prepared to allow a bill to advance to the next stage”. I think, by reflecting on the fact that those dozens of other times the NDP did not take that step, we could understand that they did not want to see a bill advance; they did not want to see progress made. That lets Canadians understand quite clearly why it is we need to use scheduling and time allocation as a device to get things done in the face of a group that thinks the objective is to fill up all possible time available with words rather than actual votes and getting things done.

It is clear that our approach is working. We are getting things done in the House of Commons and delivering results for Canadians.

Perhaps I might be overly inspired by the example of Vanessa’s Law, but I do want to draw the attention of the House to Bill C-32, the Victims Bill of Rights Act.

So far, we have seen three days of debate on second reading of the bill, but “debate” is actually not accurate. What we have witnessed is speech, after speech, after speech—most of them from New Democrats—offering platitudes of support for the idea of getting that bill to a committee where it could be studied. What I want to know is, why will they not just let it happen? Victims of crime want to see meaningful action, not just kind words.

Suffice it to say that I will need to schedule additional time for discussion of this bill. Perhaps the NDP will let it pass after a fourth day of talk.

This afternoon, we will continue with the report stage debate on Bill C-31, our budget implementation bill. When that concludes, we will turn to Bill C-20, to implement our free trade agreement with Honduras, at third reading. If time permits, we will continue the third reading debate on Bill C-3, the Safeguarding Canada's Seas and Skies Act.

Tomorrow morning, we will start the report stage debate on Bill C-24, which makes the first modernization of the Citizenship Act in 35 years. After question period, I will call Bill C-32, the Victims Bill of Rights Act, to see if the NDP is ready to deliver results, not talk.

Monday morning, we will continue the third reading debate on Bill C-20, if more time is needed, and then resume the second reading debate on Bill C-18, the Agricultural Growth Act. After question period, we will get back to the Strengthening Canadian Citizenship Act.

Tuesday shall be the eighth allotted day when the NDP will have a chance to talk, and talk, about a topic of their own choosing. At the end of the night, we will have a number of important votes on approving the funds required for government programs and services and pass two bills to that end.

On Wednesday, we will debate our budget bill at third reading, and then we will start the second reading debate on Bill C-36, the Protection of Communities and Exploited Persons Act, which my seatmate, the Minister of Justice, tabled yesterday.

We will continue the debates on Bill C-36 and Bill C-24, if extra time is needed, on Thursday. After those have finished, and on Friday, we will resume the uncompleted debates on Bill C-3, the Safeguarding Canada's Seas and Skies Act, at third reading; Bill C-6, the Prohibiting Cluster Munitions Act, at report stage; Bill C-8, the Combating Counterfeit Products Act, at third reading; Bill C-18, the Agricultural Growth Act, at second reading; Bill C-26, the Tougher Penalties for Child Predators Act, at second reading; Bill C-32, the Victims Bill of Rights Act, at second reading; and Bill C-35, the Justice for Animals in Service Act (Quanto's Law), at second reading.

To make a long story short, we have accomplished much in the House over the last week, but we still have much left to do, which inspires me to note that in the week ahead I have to take my automobile in for maintenance. At that time, when I take it to the dealership, I hope one person will work on it for an hour, get the job done, and then return it to me at a reasonable cost. I do hope I am not told, “There are still many more employees who have not had a chance to have a shift working on your car as well, so we are going to keep it here another three days and give everybody a turn to work on your car.” I hope the dealership will do as Conservatives do: get the job done and then deliver me the product.

HealthOral Questions

June 5th, 2014 / 3 p.m.
See context

Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, this morning I was pleased to take part in the beginning of the health committee study of Bill C-17, Vanessa's law.

I was pleased that we could get the study under way and would like to thank the NDP members for finally conceding to allow the bill to be referred for study after their initial attempts to slow its progress through this House.

To ensure that the official opposition remains mindful of the importance of this legislation, I would ask the Minister of Health to please inform the House, once again, about the important measures that it contains to protect the health and safety of Canadians.

June 5th, 2014 / 9:40 a.m.
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Conservative

James Lunney Conservative Nanaimo—Alberni, BC

Thank you, Minister and officials, for being with us today.

Minister, I think a lot of people would be surprised to learn from your earlier remarks that it's been nearly 50 years since patient safety legislation has been significantly updated. This seems to be a worldwide phenomenon that there are great gaps in the information on safety and effectiveness of drugs used in real-world settings. More information is needed on the safety and effectiveness of pharmaceuticals when used by the diverse patient populations, and outside the controlled, experimental environment of clinical trials.

I was wondering if you would be able to elaborate for the committee on how Health Canada currently undertakes post-market surveillance activities. What kind of improvements are here in Bill C-17, in Vanessa's law?

June 5th, 2014 / 9:40 a.m.
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Acting Assistant Deputy Minister, Health Products and Food Branch, Department of Health

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.

June 5th, 2014 / 8:55 a.m.
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Conservative

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.

June 5th, 2014 / 8:50 a.m.
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Conservative

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.

Time Allocation for Vanessa's LawPoints of OrderGovernment Orders

June 2nd, 2014 / 4:35 p.m.
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York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader of the Government in the House of Commons

Mr. Speaker, I am rising in relation to the point of order raised by the hon. House leader of the official opposition made on Friday afternoon.

I was quite prepared to see the House advance Bill C-17. I was prepared to leave it at that and take the victory for what it was and move on. However, since the hon. member for Burnaby—New Westminster confirmed at that time that he wished to continue with his point of order, I do want to supplement my hon. friend's intervention on it.

First, I did want to make this point, that the NDP House leader told the House that the hon. member for Oakville made comments in the House, “With the government leader's full endorsement and encouragement”. I appreciate my counterpart's sense that my powers are all-seeing, all-knowing, and all-powerful. However, I can assure the House that in this case my hon. friend from Oakville proceeded entirely on his own initiative in the comments on Bill C-17 that he made, as every MP has the right to do.

That being said, I do wish to congratulate the hon. member for Oakville for his very successful efforts. I am proud of him as a colleague for having taken the initiative, even if I cannot share in any credit or blame for his having done so. His persistence last week in seeing the bill through to committee clearly paid off, given that the NDP did change its tune late on Friday afternoon on this matter.

Turning to the substance of his point of order, the opposition House leader claims that the time allocation notice, which I gave on Thursday evening in relation to Bill C-17, the protecting Canadians from unsafe drugs act, should be rescinded because he alleges there were no consultations on the bill.

As the deputy government whip said on Friday, our party does not reveal the content of the discussions of the House leaders' meetings.

It is common knowledge around here that the recognized parties' House leaders and whips, their deputies, and staff gather every Tuesday afternoon to discuss upcoming parliamentary business, along with the Clerk or her representative in attendance. Some weeks, such as last week, the House leaders will even gather for a second meeting. That is on top of the innumerable exchanges that take place by email, informal meetings, and phone conversations among these various actors.

Last week's House leaders' meeting would have been held on the heels of the NDP's Tuesday filibuster of Bill C-17, when it has been the expectation and hope of all other parties that the second reading debate would wind up that morning.

Astute observers of the business of the House would conclude that it was not in isolation that I gave time allocation notices on Thursday evening for Bills C-17 and C-27. Indeed, I only gave those notices once it had become obvious that no agreement for a time allocation motion under Standing Orders 78(1) or 78(2), let alone any other firm agreement, could be reached among the required parties with respect to those two bills.

I can absolutely assure the Speaker and the entire House that both myself and my staff did put proposals on Bill C-17 to the NDP House leader and his staff, both verbally and in writing, last week. I have no difficulty whatsoever in assuring the Speaker that the requirement for consultations contemplated in the standing orders was fulfilled.

As to what that requirement is, I would refer the House leader of the official opposition to a ruling of the Deputy Speaker on March 6, 2014, at page 3598 of the Debates, in response to a point of order raised by the previous NDP House leader, where he opened by making reference to page 667 of the House of Commons Procedure and Practice, second edition:

This is what is required when one of these notices is brought forward: The notice in question is to state that the agreement could not be reached under the other provisions of the rule and that the government therefore intends to propose a motion... The hon. government House leader, when he rose in the House yesterday, preceded his presentation of the motion with the following words:

Mr. Speaker, I would like to advise that agreements could not be reached under the provisions of Standing Orders 78(1) or 78(2)... That is all that is required by the Standing Orders. The nature of the consultation, the quality of the consultation, and the quantity of the consultation is not something that the Chair will involve himself in. That has been the tradition of this House for many years. What the Chair would have to do, in effect, is conduct an extensive investigative inquiry into the nature of the consultation. That is not our role, nor do the rules require it. Therefore, I am rejecting the request for the point of order.

In this case, while I might welcome such an investigations and Canadians, I can assure the House, would be most interested in its findings and I would be most satisfied for them to receive those, I do also understand the policy rationale for not conducting them. That is a policy rationale of encouraging full-ranging negotiations without a concern for potential investigations like that.

Finally, I would like to note the significance of the point of order raised by the opposition House leader. He has, however, inadvertently, given Canadians an insight into how the NDP approaches the business of managing the progress of legislation in the House of Commons.

The NDP members make a great deal of fuss every time the government makes use of time allocation to ensure MPs can get to vote on a bill. The NDP members keep track of how often it happens and make a big deal about that statistic. I have been heard to remark myself that often they seem to enjoy compelling us to run up that statistic.

Why does that happen? The NDP has now finally told Canadians why it happens. In raising this point of order it has asked that a notice of time allocation be rescinded or withdrawn on the basis that it is not necessary. The NDP is prepared to allow the bill to advance. This is the very first time the NDP has done that, the very first time it has told the House that it is prepared to advance a bill and thus that a time allocation motion need not be moved. Never before, since this Parliament began, some three years ago, has it taken this step. Never on any of those many occasions when New Democrats stood up to denounce the use of the scheduling device of time allocation have they pre-empted that step with a statement that they are willing to advance a bill. This, however unintended by the NDP, has given Canadians a valuable insight into the approach of the NDP and why, as a result, the government makes use of the standing orders provisions to bring some certainty to the scheduling of debates and votes.

I hope, however, that this marks the beginning of a new approach by the NDP and not merely an unusual exception to the rule, brought on by the very effective comments of the hon. member for Oakville on the matter of Bill C-17.

I hope that we will see many more occasions where the NDP makes it clear that it is prepared to see a bill advance and, as such, resorting to Standing Order 73 is not required. There are several such notices on the order paper. I invite the NDP to advise the House which of those bills it is prepared to see advanced. Such a gesture would be welcome, and I am prepared to assure the House leader of the opposition it will be received in a non-partisan and co-operative manner.

Either way, I wish to thank the opposition House leader for having done a service in revealing to Canadians how it is that the NDP approaches debate in the House. This revelation will, I am sure, help to inform the views of all those who follow the work we do.

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

May 30th, 2014 / 1:05 p.m.
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Oshawa Ontario

Conservative

Colin Carrie ConservativeParliamentary Secretary to the Minister of the Environment

Mr. Speaker, following the comments of the opposition House leader, I hope that we can get unanimous consent for the following:

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, be deemed to have been read a second time and referred to the Standing Committee on Health.

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

May 27—Second reading and reference to the Standing Committee on Health of Bill C-17, An Act to amend the Food and Drugs Act—Minister of Health

Time Allocation for Vanessa's LawPoints of OrderGovernment Orders

May 30th, 2014 / 12:50 p.m.
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NDP

Peter Julian NDP Burnaby—New Westminster, BC

Mr. Speaker, I am rising in response to a point of order concerning the time allocation motion that the House received yesterday in relation to Bill C-17.

As you know, yesterday the Leader of the Government in the House of Commons stood and announced his intention to move a time allocation motion for Bill C-17. There has not been much debate about the bill in the House because all of the parties support it. Even more important is the fact that all of the parties are prepared to send the bill to committee.

As members also know, the short title for the bill is “Vanessa's Law”, in honour of the tragic death of Vanessa Young, who was the daughter of the member for Oakville. However, this week, I am very sad to say, that member levelled unfounded and partisan comments against the opposition for so-called delaying the bill. Given the prominence of the attacks from the government in question period and the members' statements lineup, it is clear he was doing this with the government leader's full endorsement and encouragement.

The problem is that the only reason the bill was not been sent to committee months ago was that the government House leader did not consider it important enough to qualify for debate. He, of course, sets the agenda for what bills are called and he is responsible for asking other parties to help expedite legislation when he wants to.

At the beginning of December, the bill was tabled in the House. The sad truth is that in the nearly six months since this proposed law was tabled, there have been only 60 minutes of debate in March and then a couple of hours of debate this week. In fact, in the March discussion, we moved on to another bill before the third party even had an opportunity to speak.

Questions need to be asked about why the bill has not been brought forward to committee, and here is a good example. With almost an hour left in government orders, the government has asked to move forward to private members' legislation. It could have brought Bill C-17 forward for debate at this time.

The problem is that we have never been asked, not once at any of the meetings we have had with the government House leader. One cannot say that one does not have agreement if one has never asked the question.

The government House leader actually has my cellphone number, although it is telling to note that I do not have his. I have been meeting with him regularly, and we have told him very clearly that Bill C-17 can to go committee without time allocation. The reality is that he has not asked me because he seems to want to play political games rather than deal with the fact that we want some debate on the bill before it is sent to committee.

Therefore, Mr. Speaker, I am asking you to rescind that notice of time allocation given under Standing Order 78.3 because the government House leader simply has never asked us the question in the many opportunities he has had in the last few months.

We do not want to set a precedent around the use of time allocation, and the Conservatives have used it so abusively already. Sometimes they have asked us the question, but in this case, the question was never asked. The government seems to want to play political games with this bill rather than work with the opposition so we can improve upon it in committee and move it back into the house.

Bill C-17—Notice of Time Allocation MotionProtecting Canadians from Unsafe Drugs Act (Vanessa's Law)Government Orders

May 29th, 2014 / 9:35 p.m.
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York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader of the Government in the House of Commons

Mr. Speaker, I must advise that agreement could not be reached under the provisions of Standing Orders 78(1) or 78(2) with respect to the second reading stage of Bill C-17, an act to amend the Food and Drugs Act.

Under the provisions of Standing Order 78(3), I give notice that a minister of the crown will propose at the next sitting a motion to allot a specific number of days or hours for the consideration and disposal of proceedings at the said stage of the said bill.

Business of the HouseGovernment Orders

May 29th, 2014 / 3:25 p.m.
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York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader of the Government in the House of Commons

Mr. Speaker, first let me start by acknowledging the support shown on Tuesday night for our motion to have the House work hard for all Canadians to ensure that we have a productive, hard-working, and orderly House of Commons. It was not just this side of the House that voted for this ambitious plan to let MPs reach decisions on many important issues, and I want to thank the Liberal Party for agreeing to join Conservatives in rolling up their sleeves this spring.

I know my hon. friend has a different definition of what our work is here in the House of Commons. He believes that our work here is to filibuster and fill every moment possible with as many speeches as possible to avoid decisions being made. I have encountered one or two Canadians who think the problem with politicians is too much talk and not enough action. Now we know where they get that impression.

On this side of the House, we are committed to action, we are committed to delivering results, and we are committed to decisions being made and to people participating in votes and making decisions on behalf of their constituents at home. That is why we need debates to also come to a conclusion so we can make those decisions and so we can have those votes.

Last night, for example, we had a great debate on Bill C-24, the strengthening Canadian citizenship act. That is our government taking steps to modernize the Citizenship Act for the first time in some 35 years. What is even better, we just had a vote and a decision. Every single member, not just a dozen or so who might have spoken for a few hours but every single member of this House, got to have a say on behalf of his or her constituents and got to make a decision and advance a bill through the legislation process. That is what it is really all about.

Earlier this week, on Tuesday morning—before we adopted the government's ambitious work plan—a number of New Democrats expressed their support for Bill C-17, Vanessa's law. However, they did not walk that talk.

The honourable member for Chambly—Borduas said, “we do recognize the urgency [of this matter]”. Nevertheless, seven other New Democrats then got up after him to block this bill from going to committee. Among them was their deputy leader who said, “I also hope that the bill will go to committee quickly...”.

I wish that the New Democrats listened to their deputy leader. It would be disappointing to think that the NDP might be using Vanessa's law as a political hostage by filibustering it as a means to avoid debating other bills.

I would not want to ascribe such cynical motives to the House Leader of the Official Opposition, and I trust this is not a preview of how he wishes to approach the business of the House for the forthcoming three weeks, when Canadians actually expect us to accomplish things for them.

Looking forward to these three weeks to come, I am pleased to review the business the government will call in the coming days.

This afternoon, we will carry on with the second reading debate on Bill C-22, the energy safety and security act. Once that has concluded, we will take up Bill C-6, the prohibiting cluster munitions act, at report stage. If time permits, we will get back to third reading and passage of Bill C-3, the safeguarding Canada's seas and skies act.

Bill C-10, the tackling contraband tobacco act, will be considered tomorrow at report stage and hopefully at third reading as well.

After the weekend, we will consider Bill C-20, which would implement our free trade agreement with the Republic of Honduras, at report stage.

Following Monday's question period, we will consider Bill C-27, the veterans hiring act, at second reading. That will be followed by second reading of Bill C-26, the tougher penalties for child predators act.

On Tuesday morning, we will start second reading debate on Bill C-35, the justice for animals in service act. The hon. member for Richmond Hill spoke a couple of nights ago about this wonderful bill, Quanto's law, which will have a chance to be considered, thanks to having additional debate time in the House. Since I cannot imagine New Democrats opposing this bill, the only question is how many speeches will they give supporting it, and of course, how will giving more speeches make this bill become law sooner.

Following question period, we will resume debate on Bill C-20, on Canada-Honduras free trade, as well as Bill C-17, the protecting Canadians from unsafe drugs act, which I discussed earlier, Bill C-32, the victims bill of rights act, and Bill C-18, the agricultural growth act.

On Wednesday, we will start the second reading debate on Bill C-21, Red Tape Reduction Act. After private members' hour, we will begin report stage of Bill C-31, Economic Action Plan 2014 Act, No. 1, which underwent clause-by-clause study at the Standing Committee on Finance this week.

A week from today, on Thursday next, we will continue debating our budget implementation bill. Ideally, I would also like to see us finish third reading of the bill on the free trade agreement between Canada and the Republic of the Honduras that day.

Finally, any remaining time available to us that evening will be spent on the bills on which the NDP will be able to offer more, remarkably similar speeches confirming, time after time, their support. Although I appreciate their supportive attitude towards many parts of our government's legislative agenda, it would be great if they would let all members of Parliament have their say, in an ultimate expression of democracy and to help us move from mere words to actual deeds, so that all of us can tell our constituents that we have actually accomplished something on their behalf.

Business of the HouseGovernment Orders

May 29th, 2014 / 3:25 p.m.
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NDP

Peter Julian NDP Burnaby—New Westminster, BC

Actually, Mr. Speaker, the member would have been right if he was not talking about speakers. He is wrong. Speakers actually show up in Hansard, so Canadians who are interested can go online, look at Hansard, and see how many members spoke.

The point I was going to make was that there were a number of speaking spots that Conservatives did not show up for. They did not even show up for their shifts. For most Canadians, if they do not show up for their shifts, they do not get paid. For the first two nights, a number of Conservative MPs did not even show up to speak for their constituents. Therefore, after two nights, we can see very clearly that New Democrats show up to work, they fight for their constituents, and they speak out for Canadians every night in the House of Commons, whether it is midnight or 9 p.m.

I still have some questions for my colleague, the Leader of the Government in the House of Commons.

First, the government has just moved another time allocation motion. This is the 66th time. How sad. How many times in the coming days will the government use its majority to impose closure or time allocation?

Second, we debated Bill C-17 for a few hours this week. It was introduced in the House in December 2013, and the government refused to debate it for six months. When will the government hold another debate and a vote on that bill? Those are my two questions.

May 29th, 2014 / 9:45 a.m.
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Green

Elizabeth May Green Saanich—Gulf Islands, BC

That gives me another chance to thank your side of the House, and particularly Terence, for bringing forward Bill C-17, because we shouldn't always believe what the pharmaceutical industry tells us. We should rarely believe it.

Bill C-24—Time Allocation MotionStrengthening Canadian Citizenship ActGovernment Orders

May 28th, 2014 / 4:50 p.m.
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Green

Elizabeth May Green Saanich—Gulf Islands, BC

Mr. Speaker, I wish we could be having the kind of conversation that would reflect the honesty of what is going on in this place, which would mean that I was not addressing my question through the Speaker to the hon. Minister of Citizenship and Immigration but to the puppet masters in the various leaders' offices who have decided that the House is going through the charade of late night sittings until midnight in the absence of the kind of trust and political consensus we should have been building in this place to allow us to avoid long debates on bills on which we completely agree, such as Bill C-17, to get it to committee and not take up our time in speeches, and allow us to have the kind of debate that this particular bill really requires.

If we had the kind of respect across the House that should be the job of all parliamentarians, we would not be sitting until midnight in a farcical exercise to prove we are working hard, because we are not going to be working smart by the end. I know what happened last June when we worked every night until midnight. Late night sittings do not advance the kind of parliamentary performance that our voters deserve.

I do not know if my hon. colleague would agree with me, but would it not be better if the House leaders were able to work together so we could focus our time deservedly on this bill and move up the passage of the ones on which we all agree?

HealthOral Questions

May 28th, 2014 / 2:55 p.m.
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Oak Ridges—Markham Ontario

Conservative

Paul Calandra ConservativeParliamentary Secretary to the Prime Minister and for Intergovernmental Affairs

Mr. Speaker, I want to take just a moment to recognize and thank the member for Oakville for his tireless efforts on this and the obvious passion that he brings to this file.

He is absolutely right, Bill C-17 has the support of all members of this House. Yesterday, shamefully, the NDP played partisan political games in delaying this before it could go to the health committee.

The NDP members need to answer to those Canadians, the millions of Canadians who are waiting for this bill to be passed. They have to stop playing partisan political games and work with us to make sure this bill gets passed.

Let me assure the member, his family, and the millions of Canadians who are relying on this that this side of the House will do everything in our power to make sure this gets passed.

HealthOral Questions

May 28th, 2014 / 2:50 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, Bill C-17 has the support of every party in this House. When passed, it would empower the Minister of Health to, among other things, order dangerous drugs off the market without delay and require reporting of serious adverse drug reactions.

This bill is, without exaggeration, a matter of life and death for Canadians who may suffer serious adverse drug reactions in the coming months. The minister has stated that she is open to amendments to further strengthen the bill.

Can the Parliamentary Secretary to the Prime Minister and for Intergovernmental Affairs please tell us why this legislation has not yet been referred to the health committee?

Vanessa's LawStatements By Members

May 28th, 2014 / 2:20 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, Bill C-17, Vanessa's law, would help identify potentially dangerous drugs and ensure the quick recall of unsafe drugs. It would require reporting of serious adverse drug reactions, so doctors and patients are aware of new risks, and it would introduce tough new fines for companies that put Canadians at risk.

The Minister of Health has even declared that she is open to amendments to further strengthen this bill. I cannot believe that New Democrats have chosen to stonewall its passage. They wasted hours yesterday talking about how important this bill is, but when asked to fast-track it, they simply refused. I pleaded with six NDP members yesterday in the House to request their House leader to get Bill C-17 to committee as soon as possible. Every one of them refused or ignored me entirely.

This legislation would save lives. We need to get it passed. The NDP will have to answer to Canadian patients for this inexcusable delay. The NDP should stop playing political games with patient safety.

Extension of Sitting HoursGovernment Orders

May 27th, 2014 / 5 p.m.
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NDP

Françoise Boivin NDP Gatineau, QC

Mr. Speaker, what an odd debate. I listened with interest to the speech by the hon. member for Burlington. He is the chair of the committee and I am the vice-chair.

I found some of his statements peculiar. The fundamental problem with the motion presently before the House is not the fact of staying until midnight. The NDP team has a reputation for hard work. Anyone who wants to entertain themselves by visiting my Facebook page would see that the people of Gatineau are actually advising me to slow down because they are worried about my health. Perhaps they are right, considering the flu I have at the moment. We in the NDP work very hard. A number of bills, for example, are before the Standing Committee on Justice and Human Rights, so that they can be debated in the House or in committee. It is not the work we are afraid of.

The cat is out of the bag. There are issues that our Conservative friends want to talk about, and they want to speak about them at length. Had I been asked, I would have said—before they even rose to speak—that I expected to see a great many Conservatives rise to speak in the House about Bill C-32. Why? Because it is an opportunity for the Conservatives to give Canadians the impression that they have been dealing with this issue—and this issue alone—for weeks, months and even years. They are the ones who stand up for victims. We are all deadbeats and have washed our hands of the problem. That is not true, though. Now, when workers’ rights were at stake, the Conservatives wanted to cut debate short.

The member said that nine bills had been passed and that he is embarrassed to return to Burlington. What I would say to him is that he is absolutely right to be embarrassed; the Conservatives did nothing with their majority aside from getting nine bills passed, and they had to resort to time allocation motions to ram the bills through. There is something not quite right with this government. The Conservatives are averse to debate. They do not like hearing opinions that do not coincide with their own. When the Conservatives too often hear something they disagree with, a red light suddenly goes on. We have had to debate many a time allocation motion. I do not know how many times I have taken part in debates in the House or how many speeches I have made expressing my dissatisfaction with the fact that we have been stripped of our right to speak.

The Conservatives made mention of Bill C-13. I am fortunate to be the NDP justice critic and to have had the opportunity to voice my opinion regarding this omnibus bill, right after the minister spoke. This is no small bill; on the contrary, it is approximately 50 pages long and has an impact on numerous other pieces of legislation. It does address the issue of cyberbullying, as the government likes to point out, but it goes much farther, so far that the committee is being flooded with requests for meetings. We hear all manner of experts warning us to be careful. That is what is missing in the House.

The Senate is referred to as a chamber of sober second thought, but we were not elected to this place in order to abdicate our duty to think. Members have a responsibility to be present in the House to voice and stand up for the opinions of their constituents. Canadians expect us to go about our work in an intelligent and thoughtful manner, to take the time to properly analyze bills. I am in favour of debating this bill in the House and referring it to committee for further consideration. More often than not, bills are analyzed at lightening speed.

The Conservatives will say that the House was given an opportunity to debate Bill C-13, the bill on cyberbullying, and thank God, especially given the time allocation motion that was foisted upon us so as to ram the bill through to committee.

Suddenly, things became urgent. Why urgent after the death of Rehtaeh Parsons, and yet not after the death of Amanda Todd? That was a question a witness asked us. The notion that the government would somehow need to act urgently does not really cut it with me; these things are more politically driven than they are concrete. It is a bit worrisome.

Bill C-13 is large and contains a number of disturbing provisions. When considered alongside the remarks made by the Conservative committee members, it leads me to believe that the Conservatives will not be very receptive to the many amendments proposed by expert witnesses. If past events are any indication, I am not very optimistic. Still, I am an optimistic woman by nature.

In light of this, I have trouble believing it when the government tells us, hand on heart, that its goal is to work harder. Working harder, for a Conservative, does not necessarily mean working more effectively and harder. It simply means that members end up working until midnight in order to discuss all the bills before the House, including those bills that have not been studied for an eternity.

For example, there is Bill C-2 on safe injection sites; Bill C-3 on marine transportation; Bill C-6, which implements the Convention on Cluster Munitions; Bill C-8 on counterfeit products; and Bill C-10 on contraband tobacco, which we finished studying in committee such a long time ago that I will have to reread all my material. Indeed, since then, we have studied so many other topics that I have almost had enough time to forget all about it. We will resume studying this bill at report stage. We could have covered it a long time ago. I have been waiting for some time for this stage to be completed in the House. Everything will have to be done over. It is a colossal waste of time for everyone concerned. There is also Bill C-11 on the hiring of injured veterans. If there is a category of people in our society who have huge needs, it certainly is our veterans.

Suddenly, the Conservatives are going to try and push all this through at once. The member for Burlington has done the math when it comes to the number of hours, and the government is going to try and give us a few hours for each bill. Then the government turns around and calls itself a champion of hard work. Well done, champion.

There is also Bill C-17, Vanessa’s law, about drug safety, an extremely important bill that must be debated; Bill C-18, concerning farm regulations; and Bill C-20, concerning the Canada-Honduras agreement, which is at report stage. I no longer even remember when I gave my last speech on that subject. It has already been a heck of a long time. The Conservatives have been in no rush, but all of a sudden, they are in a rush.

We will examine Bill C-21, concerning red tape for small businesses. The junior Minister of Tourism is travelling all over Canada to talk about the importance of eliminating red tape everywhere, while this bill is stuck in some office or other. It could have been debated a long time ago.

There is Bill C-22, concerning oil, gas and nuclear liability, and Bill C-24, concerning the Citizenship Act. These are bills that are announced to us with great fanfare at big press conferences, but then they stagnate and we do not see them again.

There is Bill C-26, about sexual predators. I expected that one would move quickly, because the Conservatives told us we had to work on this issue quickly. There is also Bill C-27, about hiring veterans in the public service. It is extremely important, I repeat, because it concerns a category of people in our society who have needs that are just as important.

Then there is Bill C-32, about the victims bill of rights. I think it is the reason why this government’s Motion No. 10 has no credibility at all. For a full year, I was treated to one press conference after another. If it was not the Prime Minister, it was the Minister of Justice with his senator from the other side. They told us they were going to work very hard, listen, set up panels and do everything we could wish for, and then they brought forth a charter that was denounced by many people, starting with victims, because they expected a lot more. That may be why the Conservatives kept their charter hidden for some time.

Apart from the minister, one Liberal and myself, no one has yet spoken on this subject. I am going to make a wager with my colleagues in the House. I expect there will be a time allocation motion on this. The Conservatives are going to rend their garments and plead that it is urgent, that it is extremely important and that it must be passed immediately, or the opposite will happen, because they will want to talk to us about it for hours on end. It becomes part of their narrative.

Every Conservative member wants to go back to their riding and have their householder and the excerpt from their speech in the House, which they made to show that they are protecting victims’ rights.

In the NDP, we want to talk about important issues and show that we could do even better than Bill C-32, specifically by amending it. We want to talk about the proposals made by the federal ombudsman for victims of crime. In fact, Bill C-32 does not contain a large percentage of her recommendations. A balance has to be struck. For every Conservative who speaks, the New Democrats will also speak.

When we want to talk about something, it is not important. That is the message we constantly get in the House, and, perhaps because we are approaching the end of the session, it is becoming extremely annoying, to put it mildly and stay within the bounds of parliamentary language.

It is appalling to see that people who are elected to represent the residents of their riding are silenced as often as we are by this government. We get told they are not interested. I have also heard the member for Burlington say—and I am going to talk to him about it again, in fact, at the Standing Committee on Justice and Human Rights—that sometimes we just need to go and read because members all read pretty much the same thing.

If the people of Gatineau think the same thing as the people of Laval, I think it is important that this be pointed out. Who has more right than whom to speak in the House on a particular bill? There is something indecent about wanting to constantly silence people.

Sometimes, I tell the members opposite that they should stop imposing time allocation motions and motions to get things done, as they like to say. I very much liked the expression my colleague used yesterday, when he talked about motions that are “a licence for laziness”.

This is unpleasant. If they had taken the time spent on debating those motions and instead used the time to finish the debate on the bill that they were trying to stop from being debated, we would probably have finished. The fact is that not all members in the NDP caucus or the Liberal Party or the Green Party or whatever colour you like necessarily wish to speak.

However, if the government limits the speaking time of a single member who wishes to speak, we cannot claim to be living in a democratic system. That is what is known as the tyranny of the majority. I believe we have to stand up against that, loud and clear. Every time that happens here, we are going to speak out against it, in every way possible.

We are told that we could perhaps go faster. I listened to the Minister of Foreign Affairs say that, and what he said made sense, in some respects. The way that Manitoba and the NDP government operate makes sense. Those consensus-based approaches make sense.

Quebec managed to pass a bill on a very sensitive issue, end-of-life care, with the agreement of all parties. There was an election, and the members all agreed to reinstate the bill once the election was over. That is being discussed.

The problem here is that the people on the Conservative benches are not talking to the opposition parties. All they talk about is strategies. We keep wondering who is going to pull a fast one on us. They use roundabout tactics such as counting how many MPs are in the House, catching them off guard, and forcing a party leader to go testify before a committee. This is unprecedented—and they say they are democratic.

Then the Conservatives get all offended when we say that Motion No. 10 is total nonsense. This is not about giving us more time. This is about taking all of the bills—there are more on the agenda than have already been passed, and that took much longer than the amount of time we have between now and June 20—and making us think they are giving us more time. They are not giving us a thing. I do not believe in Conservative gifts, and nobody in Canada should believe in any Conservative gift whatsoever.

The truth is that the Conservatives are going to shove their agenda down our throats because they could not get through it in a mature, parliamentary, by-the-rules way. They could have said that the House leaders would discuss it and try to see if some of the bills were more palatable or if we could agree to pass some of them more quickly. Then the real committee work could have started.

It is true, for Bill C-13, we had a lot of witnesses. However, I am not yet ready to give a seal of approval to the government in power, indicating that the bill has been studied in depth, because we still have the entire amendment stage. I believe that what the other side wants to accept is under so much remote control that the committee is not really doing the work. Instead, the higher-ups are dictating to our colleagues opposite what they have to do, while at the Standing Committee on Justice and Human Rights, we are trying to bring out the best in the bill.

I have not even mentioned the upcoming Bill C-35, dealing with service animals. Bill S-2 deals with statutory instruments and may not seem like much. However, it is a very significant bill that is going to change an entire way of doing things in terms of regulations. We know that regulations have an impact on the everyday lives of our fellow Canadians in all kinds of areas: the environment, transportation, health and what have you. This is a real concern. I bet that we will analyze it very quickly. That concerns me.

The fact that we are extending our hours until midnight does not encourage any belief on my part that we will be having constructive debates followed by more productive work in committee. That is why the Conservatives have this problem with credibility. We are not the only ones saying so. When their measures are challenged in court, the Conservatives get slammed.

I will take a deep breath and take a little time to say that perhaps we should review our way of doing things. Our friends in the House may not know this, but the bill on prostitution may well be coming our way next week. We hear whispering in the corridors that the government wants the bill passed. It is huge, though, since it comes as a response to a Supreme Court of Canada decision. Everyone in the House knows that passing the bill will not be easy because there are people on all sides of that issue. I would bet that we are going to have just a few hours of debate before they pitch it—to put it very nicely—to the Standing Committee on Justice and Human Rights. We can expect a hot and heavy summer on that one.

Extending the sitting hours until midnight just to work harder is one more tactic that is just like their time allocation motions, closure motions and any other kind of motion they can think of. It is part of the Conservatives' bag of undemocratic tricks. They will force these tricks on the House, but not on themselves, as ministers. Based on how the motion is written, I think it will be quite humourous. It will be interesting to see how many of them will be here in the House to happily participate in the debates on all the topics I mentioned, instead of at a cocktail party. That is why it is extremely important that we amend this motion.

Seconded by the hon. member for LaSalle—Émard, I move:

That the motion be amended by deleting all the words after the word “place” and substituting the following:

(b) when a recorded division is demanded in respect of a debatable motion, including any division arising as a consequence of the application of Standing Order 61(2), but not including any division in relation to the Business of Supply, Private Members’ Business, or arising as a consequence of an order made pursuant to Standing Order 57,

(i) before 5:30 p.m. on a Monday, Tuesday, Wednesday or Thursday, it shall stand deferred until the time immediately before the time provided for Private Members’ Business at that day’s sitting,

(ii) after 5:30 p.m. on a Monday, Tuesday or Wednesday, it shall stand deferred until the time immediately before the time provided for Private Members’ Business at the next day’s sitting,

(iii) after 5:30 p.m. on a Thursday, or at any time on a Friday, it shall stand deferred until 6:30 p.m. on the following Monday.

Extension of Sitting HoursGovernment Orders

May 27th, 2014 / 4:50 p.m.
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NDP

Anne-Marie Day NDP Charlesbourg—Haute-Saint-Charles, QC

Mr. Speaker, I listened carefully to the hon. member's speech and frankly, I am astonished. This is about being for or against democracy. If he could, would he go straight to the checkout without buying groceries, so to speak?

The party opposite would like to pass the bills in a hurry. I, for example, have had no opportunity to speak to Bill C-17, Vanessa's law, so how are the people in my constituency supposed to know that the bill exists? They will know if I can speak to it and that finds its way into social media and the press. If not, they will never know what is in the bill, unless the hon. member comes to my region to talk about it. This is a way in which one can express oneself.

Can the hon. member tell me where the blame lies in all this? In the fall, we began this session of Parliament late. How many weeks have we lost? How many times has the government prorogued Parliament? If the government had not wasted time and limited members' speaking time, perhaps we would not be in this situation today.

Perhaps the hon. member is running out of steam. Perhaps he is getting fed up with being a member of Parliament. Perhaps he would like to do something else in life. Perhaps he prefers the open road to open debate as a way of giving people information. However, we feel that it is important to fulfill that role here.

Motion that debate be not further adjournedExtension of Sitting HoursGovernment Orders

May 27th, 2014 / 3:30 p.m.
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Conservative

Peter Van Loan Conservative York—Simcoe, ON

Mr. Speaker, I know this is an issue in which the hon. member has taken a great interest for obvious reasons and has been a champion. It is fair to say that if it was not for his leadership and initiative we would not have the opportunity to be debating this particular bill on the floor of the House of Commons today.

What was disappointing to me today was, contrary to what we had been led to believe, certainly it was the impression I had this morning, we did not succeed in getting the debate to a conclusion today. This is one of the difficulties we find. We debated the number of speakers people have put up. According to the NDP, there was some virtue in the fact that they have had more speakers in the evenings, even though the statistics are quite different than that when we look at the fullness of debate.

Our approach is to let those who feel passionately about it have their say, allow the debate to occur, but also allow a decision to be made, allow a vote to happen, allow a bill to proceed to the next stage.

This is an important bill. These extended hours will give us the opportunity to get it to the next stage because clearly simply relying on the good faith of the opposition to allow it to proceed to the next stage is not sufficient. That is why we have to sometimes take unusual steps with our process to allow that to happen. Members should keep in mind that we are only talking about getting it to second reading in the House of Commons.

I often take school visits and school groups through the stages of getting a bill adopted. I explain that it has to go to committee to be studied, to have witnesses heard, and then be put to a vote. It then comes back to the House for report stage and to be voted on there. There will then be a further debate in the House at third reading and be put to a vote. I then say, “Is it a law now?” They all say yes. Then I say, “No. Guess what? It then has to go to the Senate for all the same things all over again”. Then they realize that there are indeed many hurdles and safeguards.

If we want to get bills passed, if we want to get changes in place and get Bill C-17 in place, it requires a real commitment from all of us to put our shoulder to the wheel and get things done. That is what this motion would allow us to do on Bill C-17 and a number of other bills that are before us that Canadians want to see us deliver results on.

Motion that debate be not further adjournedExtension of Sitting HoursGovernment Orders

May 27th, 2014 / 3:30 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, the question is regarding Bill C-17, Vanessa's law. I am trying to understand what these extended hours will mean with respect to Bill C-17.

As the House knows, Vanessa's law will, among other things, empower the Minister of Health to order dangerous drugs that are harming Canadians off the market immediately, change labels, give better safety warnings, and so forth.

The timeliness of this bill is important. For example, we know that there are hundreds of patients in Canada who suffer serious adverse drug reactions daily. That is what this bill is designed to address. If this bill is passed sooner, without a word of exaggeration it will save lives. It will protect Canadians from serious adverse drug reactions.

I did not count how many NDP members spoke in support of the bill today. I think it was 10 or more. The New Democrats are supporting the bill in principle. They want to get it to committee to talk about amendments. I would love to get it to committee to talk about amendments, but we did not get the direction or agreement from the NDP House leader today to send it to committee. We need to do that soon in order to get it through committee, passed in the House of Commons, and sent to the Senate for consideration before the end of June.

Therefore, I would ask the government House leader this. What do these extended hours mean with respect to Bill C-17, Vanessa's law?

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

May 27th, 2014 / 1:45 p.m.
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NDP

Carol Hughes NDP Algoma—Manitoulin—Kapuskasing, ON

Mr. Speaker, we are having a wholesome debate today.

I want to reiterate what the bill is actually about. Bill C-17 would bring in the following measures. It would allow the government to recall drugs or order the distributor to take corrective actions to remedy the problem with the drugs. The government could order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. The minister could order a review of the drug and to be reported back to the minister. People will be quite surprised by the fact that this cannot get done at this point. It would give the Governor-in-Council new powers to create regulations as needed for labelling and authorization criteria. It would require manufacturers to communicate risks associated with their drugs that have come up in other countries. It would impose new fines for keeping unsafe product on the market, up to $5 million per day, and could include jail time, with a stronger penalty if the manufacturer knowingly erred.

A lot of Canadians would be surprised to find out that these measures are not in place at this point in time. It is evident that we need a comprehensive drug plan so all Canadians can be assured their medications are safe for use and so they have access to plain language information about why their medications are safe, including the testing process and medication labelling.

We have heard over and over again at the health committee, when I sat on it a few years ago and today, whether it is GMO or anything else, that people want to see the labelling. They want to be informed, contrary to what the government sometimes thinks. Sometimes it thinks people are not paying attention to what is being said in the House. It thinks people are not paying attention to the bills. Canadians are paying attention.

While we support the legislation, more needs to be done to improve the drug safety measures. We will be proposing amendments to improve the bill. I understand the Liberals are also looking at proposing amendments as well. This is why we should not be rushing bills through. These issues date back many years. In 2011, the Auditor General warned that consumers were not receiving safety warnings about pharmaceutical drugs fast enough because Health Canada was slow to act on potential issues that it identified. That was one of the reasons the Auditor General brought forward.

Fast track now to 2014, three years later, and we are just getting this. If the government is saying that this was such a critical issue, why did it not bring it forward? If the Liberals are saying that this is such a critical issue, why did they not bring it forward when they had 13 years to do it?

I forgot to mention earlier, Mr. Speaker, that I will be splitting my time.

Certainly the NDP is looking at proposing amendments to improve the bill when it reaches committee. In the meantime, it is important to have a healthy debate in the House so we can get the ideas forward, so people can be more educated about what is going on and what the government is putting forward. It is a great bill. Why do we not want Canadians to know about it just by having the debate in the House and being able to hear from other witnesses as they may want to choose to have their words heard at committee, whether it is by writing a submission or being called as a witness?

Sometimes the government will put in place some type of advertising. This is basically what has happened here. It indicates it is taking care of the well-being of Canadians, but as we can see, the bill shows there was a big void. We know, for the most part, when we send something to committee, and my colleague spoke to this a little while ago, the Conservatives still have a majority on the committee and all too often they are just eager to pass legislation without proper amendments. Because the amendments are coming from the opposition, they sometimes think that they are not noteworthy.

Therefore, we want to ensure that people are aware of the proposition and of the changes and concerns we have with legislation. That is why we are having this debate today, so more people are aware of needed amendments and whether the government acts on those.

The Auditor General also found there were gaps in transparency that were keeping Canadians in the dark about Health Canada's drug safety work. Unlike many other countries, Health Canada also does not make information on clinical trials public.

I have a sister who was diagnosed with Alzheimer's at the age of 50. She was on a clinical trial. We would have liked to have known what those results were at the end of the day and more information about that.

If information on clinical trials are public, they would show the health risks and side effects associated with the drug during its testing phase. All Canadians should be made aware of what those are. I also think the scientific community is looking at this as well. It does not want to be kept in the dark. The information needs to be passed on in a public way.

When it comes to providing Canadians with the information they need, Health Canada has been slow to react as of late. It took a full week before the voluntary recall of Alysena 28 was communicated to Health Canada and made public. Guess what happened with that? Many women were exposed to unwanted pregnancies. Now there is a class action lawsuit against Apotex for the faulty birth control pills.

The United States stops these medications from going forward. In Canada, we hear about these medications being taken off the market, yet we continue administering them to Canadians. We need to react a little more swiftly and we need to pay attention to what is going on. While Canadians are Canadians and U.S. citizens are Americans, they are all people and it affects them the same way.

Currently drugs can be prescribed without knowing what effects they can have on children, seniors, or nursing women because Canada and other countries do not share the information they collect on the particular effects of drugs and they do not ask drug companies to share it. That is extremely important.

It is not just the NDP that is calling for amendments to the bill.

Dr. Joel Lexchin, who is the drug safety policy expert at York University, calls Bill C-17 a step forward for Canada's drug safety legislation. We basically have said the same thing.

Dr. Lexchin has also expressed concerns that the legislation would not go far enough and that Canadians would still not know enough about the evaluation process that determines whether medications would be safe enough to be sold in Canada.

Let us hear what else he has to say on what needs to be improved in the legislation. I hope the colleagues across are listening to what needs to be improved because these are some of the amendments that the NDP will be bringing forward at committee.

He says that the new drug safety law should require that when the minister makes a decision about a product needing additional testing or that a product should be withdrawn, that all of the documentation used in making that decision should be made public. All of the safety and efficacy effectiveness information about a product that was generated either in the testing phase or once the drug was on the market should be publicly available, including periodic safety update reports. How important is that? It is extremely important.

He also says that the minister should be able to make decisions without prior consultation with the company involved, and those are important to note. All too often we find that the big corporate entities have the government in their pockets. Therefore, this would certainly put that to rest. When a company is required to do additional testing, there should be an annual report about the status of that additional testing. Additionally, the complete results of those additional tests should be public.

He further says that if companies are required to do additional testing, then the companies should turn over the funding to do that testing to a neutral third party, for example, the Canadian Institutes of Health Research. The CIHR should be responsible for selecting the researchers to do the testing and the data should be analyzed completely independent from the company.

This is about the safety of patients and Canadians.

The government can go on and on about doing some advertising, but until it takes action such as some of the amendments that have been suggested here, we will not get that perfect bill that could provide more security to Canadians. We know over and over again when the government has done advertising. We can look at the economic action plan. We can look at Twitter feed amount it actually puts in. What really matters is to ensure we have proper legislation that will protect Canadians.

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

May 27th, 2014 / 1:30 p.m.
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NDP

Élaine Michaud NDP Portneuf—Jacques-Cartier, QC

Mr. Speaker, I am very pleased to join my colleagues in the debate on this important bill, Bill C-17.

The debate we are having in the House today is also very important. I have heard Liberal members questioning the fact that NDP members are rising in the House to take a stand on Bill C-17 and propose solutions. I have heard Conservative backbenchers yelling for us to send the bill to committee.

I think they have forgotten what has been happening in committee since the Conservatives won a majority. The Conservatives say publicly that they are open to amendments and discussions with the opposition parties to try to improve bills, but when it comes time in committee to actually consider amendments proposed by the opposition to try to improve the bills, the Conservatives insist on meeting in camera and systematically oppose any idea that comes from the opposition, even if that idea was shared time and time again by various subject matter experts, groups and Canadians who expressed their views to members from all parties.

The NDP believes it is important to take the time to publicly propose in the House the amendments we would like to see made to Bill C-17 in order to correct the flaws that still exist in this bill. No bill is perfect when it is sent to committee after second reading in the House. I have been here for three years and I have never seen a perfect bill come out of the House at second reading, and I am sure that other members who have been here longer have not either.

This is where we begin thinking about the bill and we take the time to debate it. Quite frankly, I find it unfortunate to hear my colleagues from the other parties saying that we are wasting our time, that we should send the bill to committee and that we should trust the committee members who will examine it. I would like to have such blind trust in the government, which holds a majority on every committee, but to date, I have seen virtually no evidence of its good faith.

Unfortunately for the Conservatives, it is our responsibility to take the time to discuss the bill in the House at second reading. it contains some good elements. We in the NDP know full well that we will not be able to come to a perfect result in the debates here at second reading. It will be very difficult to achieve that result in committee, but we still have some ideas to put forward that were raised on a number of occasions by experts whom we consulted and who provided their opinions on the matter.

As some of my colleagues have mentioned, Bill C-17 deals with a very important issue, namely drug safety. The changes that will be made to the current legislation are long-awaited. So this is a good first step in the right direction. The bill before us today would allow the government to require the recall of drugs or to order distributors to take corrective action in respect of their products. It would also allow the Minister of Health to order a manufacturer or importer to modify the label on a product in order to provide the most current information possible on side effects and health risks associated with the drug in question.

Bill C-17 would also allow the Minister of Health to order that a drug be tested and the results sent to the minister, and to require manufacturers to update the information available in Canada about any health risks associated with their products, even if those risks have been identified outside Canada.

While information is available in other countries, and while scientists have conducted research and there are documented cases of problems caused by taking certain drugs or by drug interactions, this literature is not distributed in Canada. Therefore, Canadians have to do their own research if they want to be informed. This appalling situation is frankly incomprehensible. This is one of the most important improvements that must be made to the bill as presented to us today.

We in the NDP are pleased to see that the government has finally listened to the pleas of doctors, health professionals, and representatives from the area and from the NDP. Our health critic, the hon. member for Vancouver East has been questioning the government for a very long time. She has been putting pressure on the government to finally take steps to correct the shortcomings in the current bill.

We are pleased to see a result, and we support the bill at second reading. We want the bill to go to committee so that it can be studied in greater detail and so that the necessary amendments can be made.

However, we believe that the bill still does not go far enough. There are still a lot of flaws. Every year, 150,000 Canadians suffer serious reactions after taking prescription drugs. That is a significant number, and these people still do not have access to all the information they need and do not have all the means they might have to protect themselves. Among these 150,000 Canadians, seniors are five times more likely than the rest of the population to be hospitalized as a result of an adverse drug reaction.

According to a 2013 study by the Canadian Institute for Health Information, one in 200 seniors was hospitalized as a result of an adverse drug reaction, compared to one in 1,000 for the rest of the Canadian population.

Before I became an MP, I spent some time as an information officer for the Régie de l'assurance maladie du Québec. I regularly answered questions from people, mainly over the phone. We had to explain how Quebec's public health insurance plan and public drug insurance plan worked. The NDP would like to see such a plan implemented Canada-wide. However, that is a topic for another debate.

I also regularly spoke to seniors who called in for information on the price of medications or on how the public drug insurance plan worked. They also had a lot of questions about the drugs they were taking. I did not have the ability to answer them, since I am not a pharmacist or health care professional. However, I could see that our seniors were distressed because, over the years, they had been prescribed more and more drugs for various reasons and they did not always have the information they needed. Furthermore, the information on labels is rather complex and not necessarily very clear. When someone is taking 6, 8 or 10 drugs at the same time for various health problems, it is very important for that person to have access to clear, accurate, up-to-date information, regardless of the source. Whether the information is from an international source or the research was conducted in Canada, it should be provided to Canadians. We hope to see that happen soon.

In my riding of Portneuf—Jacques-Cartier, the population is aging. I am concerned about how the lack of up-to-date information is affecting people at present. I am truly worried about how this could affect the health of the seniors I represent and the general population.

The NDP has called for various amendments that we would like to see made to Bill C-17. First, we would like to ensure that best practices for prescribing drugs are adopted by physicians. We want to ensure that Canadians are prescribed the most appropriate drugs in appropriate quantities.

We are hearing more and more about overmedication, whether of our seniors or our veterans who need psychological or physical help and who are prescribed many drugs that are more or less effective. The vast majority of our population could benefit from major enhancements to drug safety.

The NDP would also like to see public disclosure of the results of clinical trials, which does not currently happen. This information will be held by Health Canada, but will not be available to the general public. Canadians do not have the right tools to determine the possible effects of different medications on themselves and on their health.

Unfortunately, I do not have enough time to speak about the various improvements that the NDP would like to make to Bill C-17. I will simply mention once again that we are very proud to support the bill at second reading stage. However, we hope that the work in committee will be done in good faith and that we will truly be able to focus on Canadians' health and safety and enact the best possible bill to protect our citizens.

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

May 27th, 2014 / 1:15 p.m.
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NDP

Jasbir Sandhu NDP Surrey North, BC

Mr. Speaker, I will be splitting my time with the member for Portneuf—Jacques-Cartier.

It is a pleasure to rise today on behalf of my constituents of Surrey North to speak to Bill C-17. Before I do, I would like to say that I had a chance to attend a graduation ceremony last night at Queen Elizabeth Secondary School where 310 young people graduated. I want to congratulate them and their parents for a job well done. It just so happens that Queen Elizabeth is my former school. I graduated from there many years ago. I took the red eye so I could speak to this important bill this afternoon.

Bill C-17 is a step in the right direction toward tackling a far-reaching problem. After years of pressure from the NDP, health care practitioners, and health care organizations, I am glad to see that the government is finally taking action to address many issues related to drug safety. However, while the bill is a definite step in the right direction, it does not go far enough in addressing some of the key gaps in Canadian drug safety legislation.

I am sure that all of my colleagues in the House would agree that all Canadians deserve to have the information they need to make informed decisions about their health care. Furthermore, I am sure we can all agree that all Canadians expect their health care providers to have all the information necessary to make the best decisions possible about the care they are providing, including information related to the medications they are prescribing. In reality, Canadians and their health care providers are being left in the dark when it comes to important decisions related to their health care. I can provide numerous examples for the House.

In 2011, the Auditor General warned that consumers were not receiving safety warnings about pharmaceutical drugs fast enough, because Health Canada is slow to act on potential issues it identifies. People sometimes have to wait more than two years before Health Canada completes a drug safety review of a product already on the market and before it provides updated information on the risks. This is a backwards process. Canadians deserve to have full information about pharmaceuticals before they make the choice to use them. One of the most basic principles we teach our children is to think before they act. The process Health Canada follows right now seems to encourage the exact opposite of that: use a pharmaceutical first and think about the potential consequences or side-effects later. This needs to change.

It is an unacceptable statistic that most risks associated with prescription drugs are identified after they are introduced to consumers. Almost one-fifth of new active substances approved by Health Canada between 1995 to 2010 were later given serious safety warnings. This further illustrates the backwards process currently being followed.

If that does not provide enough proof that drug safety legislation needs to be urgently strengthened, then let us look at the major drug safety incidents we witnessed in 2013.

How about the diluted chemotherapy drugs given to over 1,200 patients in Ontario and New Brunswick? How about the recall of the birth control pill Alysena 28? It took a full week before this recall was issued, and in the meantime, many Canadian women were exposed to unwanted pregnancies. If that is not enough, five other popular birth control pills were recalled and had serious safety warnings issued about them. The list goes on, but I think members are beginning to see a pattern here.

Canadians deserve better. They deserve to be presented with the full information they need to make informed decisions about their health. They should be able to trust that they will be protected from drugs that would put their well-being at risk.

It is for all these reasons that I, along with my colleagues, am glad to see this bill. Bill C-17 is a good step toward the comprehensive drug safety plan Canada so badly needs. Canadians should have assurance that their medications are safe for use, and they should have access to plain-language information on why their medications are safe.

Bill C-17, in its current form, would allow the government to recall drugs or order the distributor to take corrective action to remedy a problem with a drug. It is a scary thought that up until now, Canada has not had mandatory recalls for drugs. This means that even if a drug posed serious health risks to Canadians, the government could not force the manufacturer to remove it from the Canadian market. This aspect of the bill would give the government the power to protect Canadians when drug safety issues arise.

Bill C-17 would also give the Minister of Health the power to order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. It would also require manufacturers to update Canadian information about the risks associated with a drug, even if the safety risks were discovered in another country. These are all important steps on the road to ensuring that Canadians have as much information as possible about the drugs they are about to use.

However, while we on this side of the House support the legislation, there is still more that needs to be done to improve drug safety in our country. This legislation still leaves many gaps that must be addressed.

For example, although Bill C-17 would improve labeling, it would not set up better communications systems between doctors, pharmacists, and patients for communicating and reporting risks. Likewise it would not increase access to public information about drug trials, additional drug testing, and why medications are or are not considered safe. While it would include provisions regarding reporting adverse drug reactions, there is no mention of a follow-up by Health Canada to these reports.

There are more steps that need to be taken and more issues that need to be addressed to create the comprehensive drug safety plan that is needed in our country. Comprehensive drug safety legislation should include optimal prescribing practices to ensure that drugs are used only when medically necessary and for the correct reasons and that negative side effects and drug interactions are avoided as much as possible.

Canadians also deserve access to clinical trial results. The reporting of all trial results, both good and bad, would lead to better-informed health care decisions. Although since 2007 Health Canada has encouraged clinical trial sponsors to make their data available, it has no authority to compel this transparency, which is a vital component of a comprehensive approach to drug safety.

I am glad to see this critical step toward improving drug safety being taken. Bill C-17 has the potential to benefit all Canadians in a concrete way and to especially benefit vulnerable populations, such as children and seniors. The bill, in its current form, lays the groundwork for even more concrete measures to be taken to strengthen our drug safety legislation. It is my sincere hope that the government will carefully consider amendments that my colleagues will be proposing at committee that will strengthen the bill.

I would like to talk about that a little bit. We have seen over the last two or three years that the government has brought in legislation that has gone to committee stage. We have seen over and over that the opposition has made concrete, valid amendments. Unfortunately, the Conservatives do not seem to want to take any sort of advice, either from the opposition or from experts who have testified before the committees. I would urge the Conservatives to take into consideration amendments that will be offered at the committee stage to further improve this very important measure.

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

May 27th, 2014 / 1:05 p.m.
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Liberal

Francis Scarpaleggia Liberal Lac-Saint-Louis, QC

Mr. Speaker, I take special interest in federal policies, legislation, and the regulations that govern the pharmaceutical sector. The western part of Montreal, a great part of which falls in the riding of Lac-Saint-Louis, includes many brand-name pharmaceutical companies and medical equipment suppliers that together employ a great many of my constituents. As a result, I am fortunate to be regularly kept apprised of issues impacting this industry. Constituents also contact me to share their concerns about matters like the cost of drugs and drug safety.

Liberals support sending Bill C-17 to the health committee for review and improvement. Whether the government agrees to important amendments at committee will signal whether it truly takes the safety of Canadians with respect to pharmaceutical products seriously.

Incidentally, I applaud the member for Oakville who has been relentless in pressing for enhanced drug safety in Canada. I have been witness to his interventions at health committee and can attest to his tenacity and expertise on the issue.

Bill C-17 however is a delayed response to an issue that has demanded our focused attention going back to the very beginning of the Conservative government's mandate.

A key pillar in the national pharmaceutical strategy launched in 2004 was “Strengthening evaluation of real-world drug safety and effectiveness” to strengthen surveillance of prescription drugs.

An earlier attempt to address the issue, Bill C-51, languished on the order paper when the government, violating its own fixed date election law, triggered the 2008 election. That was six years ago. Canadians would like to know what has taken the government so long to address such a vital issue.

Let me get to the bill. What would Bill C-17 do? The bill applies to prescription and over-the-counter drugs, vaccines, gene therapies, and medical devices. The main features of Bill C-17 are as follows:

First, the bill would require mandatory reporting by health care institutions, presumably meaning hospitals, of adverse drug reactions in patients so that the government may know whether to re-evaluate a drug's safety.

Second, the bill would empower the government to order recalls of unsafe drugs without first entertaining representations from the manufacturer or being obliged to negotiate the recall with the manufacturer, provided the Minister of Health “believes that a therapeutic product presents a serious or imminent risk of injury to health...”. Astonishingly, the government does not already possess this authority when it comes to therapeutic products like drugs. On the other hand, the federal government currently has the power to recall bad toys, tools, cleaning supplies, clothing, and food, something it does with varying degrees of efficiency, but not unsafe drugs. Currently, drug recalls are at the discretion of the manufacturers and distributors. This is hard to believe but true.

Third, not only would Bill C-17 give the government the power to recall drugs, it would create stronger penalties for the marketing of unsafe pharmaceutical products, including jail time and new fines of up to $5 million per day instead of the current $5,000.

Fourth, the bill would authorize the Minister of Health to order a person to provide the minister with any information in the person's control regarding a therapeutic product that the minister believes “may present a serious risk of injury to human health” and that “the Minister believes is necessary to determine whether the product presents such a risk”.

Fifth, the bill would also authorize the Minister of Health to require label or packaging changes if the minister “believes that doing so is necessary to prevent injury to health...”.

Finally, the bill would allow the minister to order therapeutic authorization holders to conduct assessments and provide the results to the minister and in order to improve understanding about a product's effects on health and safety, compile information, conduct studies and tests, or monitor experience regarding a therapeutic product.

The bill is seen to have some important loopholes that compromise its ultimate effectiveness.

First, the definition of “therapeutic product” does not include a natural health product within the meaning of the National Health Products Regulations.

Furthermore, stakeholders are concerned about what constitutes a “prescribed health care institution” under the bill. Does this definition only mean hospitals or does it include clinics and doctors in family practice?

Also, the bill raises the real-life distinction between sellers of therapeutic products and holders of drug authorizations, underscoring the fact that in the complex modern marketplace, they may be different entities.

Incidentally, a therapeutic product authorization is:

....the authorization that permits the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storing and testing of a therapeutic product.

As an example of the distinction, and to quote an article in the Canadian Medical Association Journal:

...the company holding the market authorization may...license distribution to another company.

An historic example shows us why the distinction is significant and why there is a need for the bill to cover both sellers and those with authorization. When, in the 1960s, thalidomide was suspected of being harmful, manufacturers eventually withdrew the drug after some negotiation with Health Canada, the kind of negotiation this bill would presumably no longer require. However, free samples, the primary form of the drug's distribution, were still sitting in doctors' offices across the country. Health Canada did not have the legal authority to control or contain this problem.

The power the bill gives to the minister to recall or suspend drugs appears limited to sellers only. According to the CMA Journal, the health minister:

...should be explicitly empowered to issue suspensions and recalls to both types of “persons”.

Another issue related to the question of the federal government's capacity to fully protect Canadians from unsafe drugs has to do with whether it has the financial and human resources to ensure that drugs important to Canada are manufactured under strict quality control standards, along with ensuring quality control in manufacturing facilities in Canada.

We know that the government has been cutting in areas related to environmental protection and health protection, whether at the Canadian Food Inspection Agency or Health Canada. For example, budget 2012 cut 275 positions from the health products division at Health Canada, the group responsible for monitoring the safety and efficacy of prescription drugs.

Constituents have spoken and written to me because they have been concerned about conditions abroad in plants that manufacture drugs, often generics. Their concerns have often followed news of recalls of drugs such as Ranbaxy's atorvastatin calcium, the generic version of Pfizer's Lipitor.

For example, a 20 milligram tablet was recently found in a sealed bottle marked for 10 milligram tablets of the drug, resulting in a 64,000 bottle recall. This situation followed another episode, where glass particles were found in other batches of this same generic Lipitor.

As a result of such incidents, the U.S. FDA has apparently increased its presence abroad with a view to auditing certain facilities. What is Health Canada doing? Does it have the resources, financial and human, to do anything? Is it working with the FDA?

Whether in the U.S. or Canada, we need drug monitoring systems that catch problems before unsafe products are in consumers' hands and bodies.

This bill is obviously a good step in the right direction, but we have to ensure that any loopholes that would compromise its efficacy are closed. This can be done at the health committee. We also have to ensure that the government, quite apart from this bill, commits the funding necessary to guarantee that we have a safe drug system in Canada. It obviously has to work with the FDA and other international partners in the process of doing so.

Again, I congratulate the member for Oakville for his assiduous efforts in this area. I look forward to seeing what happens to the bill in committee.

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

May 27th, 2014 / 12:50 p.m.
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NDP

Denis Blanchette NDP Louis-Hébert, QC

Mr. Speaker, today, we are talking about Bill C-17, An Act to amend the Food and Drugs Act. My first comment is that it is about time.

Finally, society will be able to better protect people. Finally, the government will have the power to order drug recalls. Finally, the government will have the power to order manufacturers to change the drug labels to include the side effects of a drug. Finally, the government will be able to order the assessment of drugs. Finally, the government will be able to require manufacturers to keep the available information up to date. It is about time.

When profit hangs in the balance, I do not believe in voluntary approaches. Earlier, my colleague talked about the Walkerton tragedy. We could also talk about the XL Foods recall. There are also heartbreaking examples related to the train derailment in Lac-Mégantic last year.

Good health is the most precious asset of every member of the House and everyone watching. We even wish people good health at the beginning of a new year. That is why I believe that this bill is a step in the right direction. I believe that we must move forward with this bill, but that we must also examine it carefully.

Basically, the bill explains that better coordination is needed when it comes to health administration. That is why this bill is a step in the right direction. We need a broad view of health and a comprehensive approach to pharmaceuticals to serve human beings. That is what we need.

In my riding, there is a company that tests drugs . Not to name names, but it is called inVentiv Health Clinics. I have had the pleasure of visiting this company, which conducts clinical research. I learned about the importance of the clinical trials conducted by pharmaceutical companies. In this era of globalization, clinical trials are conducted throughout the world, including in Canada. The unfortunate part is that the rigour of these tests varies from company to company and from country to country.

Legislation such as this, which requires manufacturers to take more responsibility, may ensure that clinical trials are more rigorous. It may also bring contracts that are currently being awarded to foreign companies back to Canada. This would be advantageous for Canadian companies and could be a positive effect of the bill. We would therefore be able to provide higher drug assessment standards for Canadians, including during the clinical phase.

We also have to talk about production quality and the distribution chain for drugs. We cannot remain silent about how drug shortages are managed. We also have to talk about transparency. A number of my colleagues have talked about transparency and how important it is. More and more, the world of pharmaceuticals is unbelievably complex. The pharmaceutical industry faces major challenges in coming up with new medications to improve our health, our children's health and our neighbours' health. Managing that complexity is increasingly difficult. That is why doctors and pharmacists, the people we trust when we have health problems, must have at hand all possible information about the products they are prescribing.

They want the best for us, we want the best for ourselves, and everyone wants to be healthy. Given the complex environment of medications today, increased transparency of course will help the specialists to make the best decisions possible, which is what each and every one of us wants. Clearly, to get an overall picture of medications, we have to look at both sides of the coin.

Very briefly, I would like to talk about experimental treatments. A young mother in my constituency suffers from ovarian cancer that no longer responds to traditional treatment. As much as we want to protect all Canadians from side effects and from frankly obscure studies through this bill, we also want to help this mother of two in my constituency who wants access to experimental drugs that have not gone through all the clinical trials and all the testing. I mention this because I feel it is important for us to understand the degree of complexity the world of medications has reached today.

That is why I am pleased that we are discussing this bill. That is also why I feel that we need to take the time to debate it properly and consider it as a first step towards better use of medication in our society. That is also why I am speaking about the importance of a comprehensive examination of the use of medication. I do not think we should be looking at one aspect at a time in order to fix a minor problem and then moving on to try and coordinate all the various aspects. That usually does not work very well.

I am therefore asking the House to continue studying this bill, but to do so in a comprehensive way so that we can avoid making this a technical process when it should be a holistic one.

We want to look at the complexity of the issue, but to do that we need an overall plan. We need to be able to inform our specialists, but Canadians also need to know what they are getting themselves into when they are taking medication. Taking something for a headache is fine. However, sometimes even taking too much of a certain medication for a headache can have severe side effects.

We need to be able to give people the tools so that they can have an intelligent conversation with their specialist. That specialist must have relevant information and be able to recognize how various medications interact with one another. That is especially important for seniors. The more medications someone is taking, the more important it is to know how those medications interact.

That is why we think this is a step in the right direction. In committee, we will propose amendments that call for more transparency. We also want to see a better communication system between the various stakeholders so that each one of us and every professional has the tools required to make the best decision possible.

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

May 27th, 2014 / 12:50 p.m.
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NDP

Lysane Blanchette-Lamothe NDP Pierrefonds—Dollard, QC

Mr. Speaker, earlier, my colleague said that there had been consultations and that several groups supported Bill C-17. However, I think we must set the record straight.

It is true that several associations say that Bill C-17 is a step in the right direction. However, they have reservations and say that this bill does not go far enough.

If I am not mistaken, the Canadian Nurses Association, for one, says that it hopes that experts in the field will be consulted to ensure that stronger and more meaningful action is taken. It is good that the players in the field want to be consulted and taken into consideration.

Does my colleague also think that this should be given serious consideration in committee?

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

May 27th, 2014 / 12:50 p.m.
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Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, I would like the member to please consider going to his House leader now and asking his House leader to arrange to have Vanessa's law, Bill C-17, sent to committee today.

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

May 27th, 2014 / 12:35 p.m.
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NDP

Philip Toone NDP Gaspésie—Îles-de-la-Madeleine, QC

Mr. Speaker, I have the honour to rise today to speak to Bill C-17, An Act to amend the Food and Drugs Act, or Vanessa's law, as we call it in the House.

I will be sharing my time with the hon. member for Louis-Hébert.

By all accounts, this bill deserves our support, at least for further debate in committee. Even though the fundamental and necessary steps have been taken, there are some gaps. My colleague was clear about that.

Let us talk about the bill. Why would we need this bill? Something that happened recently in New Brunswick effectively illustrates the need for this bill. It happened in Ontario as well. Diluted chemotherapy drugs had been administered. If I recall correctly, more than 1,000 patients received these substandard diluted drugs. The patients involved deserved a lot more information than was available at the time.

There needs to be transparency. The more information that patients, citizens, pharmacists, and doctors have, the better. We need to have reliable information. I do not want Canada to become like the United States where drugs are marketed to be sold at a profit for the pharmaceutical company.

The goal is to put Canadians' health first. To have good health, there is nothing better than self-defence. The individual should have the choice. I think my colleagues on the government side might very well understand that, fundamentally, it is an individual choice to know what drugs might best protect us. That choice is made in co-operation with pharmacists, doctors, and the government, who have the information and should ensure transparency.

We are talking about co-operation between experts in the field and the individual who must choose what is best. There needs to be information. The problem now is a lack of transparency. The bill before us today raises a lot of questions, namely whether the transparency that will be there once this bill is passed will be adequate. People want to make informed decisions. Canadians have less and less confidence in their government. They are wondering whether the government is providing them with the necessary information.

There is talk of letting 28,000 federal public servants go. We know full well that this will have an impact on services. Many scientists have been fired, as have front-line employees who took phone calls from people looking for information. The government needs to be there to provide services to the public. Taxpayers have paid for this piece of legislation before us and they should benefit from it. When bills are introduced by the government without sufficient funding, and there are not enough people to study and enforce them, then there is not enough information to share with Canadians.

The fundamental problem I have with this government is that it does not understand the correlation between government resources and sharing information with Canadians or being transparent with them.

That is exactly why I feel this must go to committee. We need to look at the lack of resources. Federal resources are constantly being cut. Tax credits are constantly being increased for companies that do not need them, such as banks. Those companies are benefiting tremendously. I think that they are capable of paying their own experts.

When it comes to fundamental issues such as health, medication options, and choosing medical services they rely on, Canadians often lack the necessary information and have to do their own research.

We want to see better collaboration with pharmacists. They are open; they want to talk about products. Unfortunately, even after this bill is passed, pharmacists will not have enough information to properly explain the merits of each medication to their clients.

Clinical trials will be no more transparent than they were before. Pharmacists will not know the results of clinical trials conducted by the companies, which are often private. Pharmacists try to have confidence, but open and public transparency is the best way for companies to gain their trust.

Unfortunately, this bill does not do enough to ensure this transparency and collaboration that in a democracy are vital to making informed decisions. Should the bill be defeated for that reason? I believe it deserves to be sent to committee for further debate. That way, the people working in the field and patients who need services and who have something to say will be able to provide input that will improve the bill.

If the government were serious, it would have introduced this bill a long time ago. Members will recall that it finally introduced the bill in December as a result of pressure from the opposition. However, debate was very short, as the House spent less than one hour on it. Today, the government has finally brought it back. We understand that it wants to put it in place quickly. However, if it was in such a hurry, it could have introduced it a long time ago.

When people call on their government to provide a service, that government should listen instead of always passing harmful regulations and laws. For example, when the government amended the Navigable Waters Protection Act, the amendments were very detrimental for the fishing industry in my region. Instead of spending this time on bills that are detrimental to my constituents, we could have passed bills that everyone in the House could get behind, that warranted our attention, and that deserved being passed as quickly as possible.

For example, we could have addressed health issues. We absolutely must look after our constituents. They expect the House to do what it takes to ensure that they have all the services they deserve. We absolutely have to think of our constituents. When there is a possibility that some people will take medications that are diluted, improperly prescribed or that clearly do not comply with regulations, the best course of action is to inform people, pharmacists and doctors about the specific trials conducted, the reasons why the medications provided by pharmaceutical companies are on the market and their usefulness.

Canadians need to know that the drugs they are taking have been approved and that they are adapted to their needs. However, they do not have this information. Once this bill passes, someone would still have a hard time understanding why a drug is useful.

We want to have faith in our doctors, pharmacists, nurses and government. However, for that to happen, Canadians need to know that the government is giving them all the information available.

That is why it is so important for clinical trials to be transparent, and a number of witnesses called for that. They want more transparency.

Everyone would win if the government were more transparent, and being transparent in this bill would be a good start.

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

May 27th, 2014 / 12:05 p.m.
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NDP

Libby Davies NDP Vancouver East, BC

Mr. Speaker, I am pleased to be in the House today to debate Bill C-17 at second reading, which is an opportunity to talk about the bill in principle before it goes to committee.

Before I begin my remarks, I just want to note that although we give numbers to bills, this bill has been referred to as “Vanessa's law”. I want to pay tribute to our colleague on the other side of the House, the member for Oakville, for the incredible work he has done around drug safety, not only in his own constituency but also nationally, across the country. It is appropriate that the bill be named Vanessa's law and that it be a reminder to us all of what can happen when we do not have adequate legislation around drug safety in this country.

I am glad we are debating this bill. I have been told by some of my colleagues that a number of the government members are quizzing the opposition as to why this bill is not being rushed through. I want to begin with that point, because it is a familiar strain to hear.

The government introduced this bill back in December, I believe, but it did not come into the House for debate until March. When it came up for debate, it was a Friday afternoon, so it had maybe an hour of debate. This is the only opportunity that has come forward. Therefore, any suggestion that we have to rush this bill through or that somehow the opposition is holding this bill up is absurd and not based on reality, because it is the government itself that has dragged its feet on this bill.

We have said continually that we believe the bill should go to committee, but I am aware that some of my colleagues want to speak to this bill in principle at second reading, which is as it should be. I hope that it will go to committee soon so that the Standing Committee on Health can get into the bill, call witnesses, and examine it more closely.

I wanted to get that out of the way before we talk about the substance of the bill. It irks and irritates me that we so often hear this refrain that something has been slowed down or is not going fast enough when it is the government's own calendar and timetable that have pre-empted a bill being in the House.

We have had very minimal debate on this bill. Let us be clear about that. We do need to have debate at second reading. Second reading is here for a purpose. It is here for all members of Parliament to debate a bill in principle and get an overall understanding of it before it goes to committee and gets wedged into the clause-by-clause process.

Therefore, I am happy to be speaking today at second reading on Bill C-17, which would amend the Food and Drugs Act.

For the record, a number of my colleagues who have spoken to the bill and I as the health critic for the NDP, the official opposition, have said that we think this bill is a good first step in protecting the health of Canadians and improving the gaps in the current drug safety legislation. The bill is long overdue. When I say “long overdue”, I mean decades.

I read an article in the Canadian Medical Association Journal a couple of months ago presented by Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, and Barbara Mintzes, who happens to be a researcher who lives in my community in east Vancouver. It was a good analysis of this bill and it was interesting to read their analysis.

It begins by pointing out something that people have probably forgotten, because it is one of those historical stories that happened long ago, but it had a profound effect on the lives of children, families, and Canadians overall. In their analysis, they begin by pointing out that Canada was the last developed country in the world to remove thalidomide from the market. To do that required an act of Parliament. That was in 1962. There are those of us here who remember hearing about the devastating consequences and catastrophic effects of that drug and what it did to children and families. Therefore, it is incredible that it required a specific act of Parliament to withdraw that particular drug. In fact, the two manufacturers voluntarily withdrew the drug from the market in March 1962.

However, that legislation stopped short of granting legal authority to the director at the health branch to unilaterally recall drugs, even though officials recognized that the co-operation of the manufacturer to recall a drug from the market could not be solely relied on.

Here we are, more than 50 years later, and we still have this gaping hole in Canada's Food and Drugs Act. We still have a huge issue around drug safety. Certainly, Health Canada is a regulator. It is meant to analyze new drugs that come on the market and approve them. Astoundingly, however, the federal government has never had the power to actually recall a drug. It has to negotiate around that.

There are many examples over the years where we have seen consequences from minor to serious to catastrophic to death because of this lack of oversight and based on the principles of caution and safety of Canadians. We are very glad to see that the bill would allow the minister to recall drugs. It would give fairly extensive powers, which is very important.

I want to give some broader oversight. A number of issues related to the bill are also very important.

I just quoted from an article in the Canadian Medical Association Journal. While they support Bill C-17, they outline the need for at least six critical elements to be looked at and hopefully examined and added to the bill. All these people are experts. They are very involved in the issue of drug safety in Canada, and have done a lot of analysis not only on this bill, but on the reality of drug safety in Canada. I would like to spend a little time going over those elements.

By way of backdrop, we should be aware that even the Auditor General, in 2011, warned consumers, the government and all of us as legislators that consumers were not receiving proper safety warnings about pharmaceutical drugs fast enough because Health Canada was so slow to act on the potential issues that it identified. That was a pretty serious matter, and it took the Auditor General making a public report to flag the issue of drug safety. In that report, the time lag was characterized as very serious. It noted that it meant people sometimes had to wait more than two years before Health Canada completed a drug safety review of a product already on the market and provided updated information about the risks.

As the Interim auditor general noted at the time, “I think two years is too long”, and we certainly agree with that point.

That same 2011 audit also found there were gaps in the transparency about drug information. In fact, it is really keeping Canadians in the dark about Health Canada's drug safety work. There has been an issue about clinical trials and the lack of information that is being provided, which has been a long-standing issue.

We should note that in many other countries, information around clinical trials is provided so researchers, medical practitioners and consumers alike can make themselves aware, if they want to, about a product, particularly at the clinical trial level, and this is very important.

I know the minister recently made announcements about providing better information. Again, this is a good step, but it is very important to have this as part of a legislative package to ensure there is transparency in the work of Health Canada.

What do we have to hide? We should have nothing to hide. This information is critical to the health and safety of Canadians and to the medical community. It is also critical to health researchers who examine new products that are coming on to the market and the kind of testing and clinical trials that have been done.

We should always be on the side of transparency, of accountability and of advocating for much greater safety measures. If this means some of the procedures become more complicated for the manufacturers or they have to go through other steps, so be it. What is paramount and what is the first order of the day is patient and drug safety. Certainly the bill will help in this regard, but more needs to be done.

Here are some of the other issues that hopefully will be examined at committee. Although the bill calls for mandatory reporting measures for health care institutions, we really need to look at not so much the issue of adverse reactions, but the failure of Health Canada to follow up on them, which the bill does not do.

Again, there is a huge issue in safety, adverse reactions and what kind of process is in place to ensure this is properly followed up on by Health Canada so we have a continuum. There should be a seamless process that is clear and transparent for Canadians, for people who are interested in this issue to know they do not have to keep digging deeper and deeper to try to figure out a little information here and there, or if an adverse reaction is reported, will it be followed up. These things should be taking place as a matter of course. These things should be fundamentally inherent in the Health Canada process. Unfortunately, we have seen these gaps and so it becomes a bit of a patchwork approach that simply has failed. This system has not been a great model for drug safety for Canadians.

This is one element of the bill that needs to be looked at because it does not deal with the failure of Health Canada to follow up on adverse reactions. Nor does the bill deal with the issue regarding off-label prescriptions for drugs for adults and the risks this may pose.

The bill impacts prescribing off-label drugs to children, which is a step in the right direction. As we know, the practice of off-label prescriptions means a prescription is used for another use than originally intended, which is often totally legitimately. However, the need for oversight on the safety of off-label prescriptions is really important. This question requires some examination.

I have spoken about access to public information, about drug trials and the need for additional drug testing as to why medications are considered safe or not. These are some of the questions that need to be examined at committee. We have to go through the system step-by-step and really examine where there are gaps are holes. We will have to question the officials very closely on this. None of us are particularly expert on this, but we will have to try to navigate that process as best we can. Then we will have to look at the bill and layer it over that process and determine what holes still exist and what gaps, problems and issues have not been identified and dealt with in the bill. I have named a few.

Certainly another issue is the question of labelling. We are very concerned that there needs to be a much better communications system set up between doctors, pharmacists and patients for communicating and reporting on risks. If we have a good system in place, if an adverse report has been made and if we know there is a risk, how can we ensure there is a better communication of those risks, either through labelling or how the medical community addresses this?

In fact, this has been a big issue at the Standing Committee on Health in recent months. We looked at the whole question of prescription drugs and how they could be either misused, mis-prescribed or abused.

These drugs can save lives, help people heal and get better, but they can also kill if they are not used properly. We heard many stories and examples about prescription drugs and the lack of information, or a heavy-duty selling job by a pharmaceutical company or not enough transparency and information about safety concerns or adverse effects of it affecting people.

Unfortunately, there are too many tragedies. There are too many cases of people suffering from adverse effects of prescription drugs because of improper prescribing or, worst case, of a fatal overdose and death.

This is a very important. In fact, we need some sort of national database that effectively communicates between the different parts of the health system. We have a complex health system, but there is a federal role, which is to provide leadership and give overall oversight on patient and drug safety.

Health care is delivered at a provincial level, and many players involved. At the end of the day, there has to be some federal responsibility. While I am glad the Minister of Health has understood and been clear that this issue needs to be addressed, we have a long way to go, not only in drug safety but in oversight of our health care system and ensuring there is proper communication between different parts of our health care system.

Joel Lexchin of York University, a real expert on drug safety and someone who has been before the Standing Committee on Health since I have been there, said that Bill C-17 was a step forward for Canada's drug safety legislation. However, he also expressed concern that the legislation did not go far enough and that Canadians still needed to know about the evaluation process that determined whether medications were safe enough to be sold in Canada.

I look forward to this going to committee. We support the bill at second reading. It is an important first step, but more needs to be done. I hope that when the bill gets to committee, we can actually look at it in good faith and look at it on its merit to determine the elements of the bill that are in good order, approve them and sent them back to the House for approval. However, I hope we also look at the bill with a critical eye. Surely that is what we are here to do.

Unfortunately, over the last few years I have seen amendments shot down at committee just because they came from the opposition. I really hope that does not happen. I know there are colleagues who care deeply about the bill and I know that at the end of the day we want to see the best bill we can.

I appeal to the members that when we get to committee, we look at its merits and at what we can do to make the bill better, to answer some of the concerns. There is overall broad support, but there are issues and concerns. Let us address those. Let us look into that and work in good faith to ensure the bill is the best it can be. We will then have done a good job.

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

May 27th, 2014 / noon
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Green

Elizabeth May Green Saanich—Gulf Islands, BC

Mr. Speaker, I would like to thank my colleague from Algoma—Manitoulin—Kapuskasing.

I completely agree with her. There is no doubt that Bill C-17 is very important. This is a brave step forward in the interest of everyone's well-being.

However, we have to improve it, and I hope we can do that quickly. I believe everyone here agrees on that. The minister herself even said that she is ready to accept amendments.

We have to take decisive action against dangerous drugs. We have a once-in-a-generation chance to make sure this bill is as strong as possible.

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

May 27th, 2014 / 11:55 a.m.
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Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, I thank the member for Saanich—Gulf Islands from the bottom of my heart for a heartfelt and highly accurate speech. I certainly agree that the Therapeutics Initiative is one of the best institutes in Canada for identifying safety risks around prescription drugs, and has been for some time. Her call for amendments to be bill, from my viewpoint, are more than welcome, and the Minister of Health has said she is willing to consider amendments. In my view, this is democracy at its best. It is a non-partisan issue and the minister is taking a non-partisan approach, so I am very pleased about that.

The member talked about fines of $5 million a day. The bill also includes the provision that when there is criminal negligence and a court saw that it needed to be addressed with a major fine, there could be unlimited fines. A judge could conceivably fine a big pharma company that committed criminal negligence the full amount of their sales for the period of time the drug was on the market.

We need Bill C-17 now, as soon as possible. We need it approved now at second reading to get it to the health committee, if the House approves. We can talk about those issues and hopefully get the bill passed by the end of June. We need to get it approved now. I am hoping that today, at the end of the hour, the parties will agree to send it to committee so that we can reduce the damage and the adverse drug reactions that patients might otherwise experience if we drag out this process.

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

May 27th, 2014 / 11:45 a.m.
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Green

Elizabeth May Green Saanich—Gulf Islands, BC

Mr. Speaker, it is a pleasure to rise today to support Bill C-17, an act that would protect patients and indeed all Canadians from drugs that are approved and used as prescribed and yet can result in patient deaths.

It is rare in this place to have such unanimity around a bill put forward by the government. This important legislation would amend the Food and Drugs Act. The government has taken a courageous step. The Minister of Health should have the right to recall an unsafe drug. That has been obvious since 1962, when Canada's Parliament discovered that it needed a special act of Parliament to pull thalidomide off the shelves. For half a century we have continued in the same circumstance. The Minister of Health has no power to recall a drug when that drug is recognized as dangerous. It is quite astonishing. It is not because parliamentarians and various ministers of health have not frequently wondered why they lacked those powers but it is because of one thing and that is the unholy, somewhat criminal power, that pharmaceutical lobbies hold over governments around the world.

I will be supporting Bill C-17 but I will be suggesting some areas where it could be strengthened.

I would like to pay tribute to two people. The first is the Canadian Minister of Health. Even though this legislation could be much stronger, it took courage to bring it this far.

I have to pay tribute, as everyone has mentioned, to the member of Parliament for Oakville whose own personal story is now well known. This is Vanessa's law. This legislation is named for his daughter. There really are no words to express the depth of my admiration and gratitude to this individual member of Parliament.

The member's situation and that of many others brings to light a really significant threat. I have been looking for the statistics for Canada but I will use those for the United States. In the U.S., roughly 100,000 people a year die from using prescription drugs as prescribed. There are a lot of risks to using prescription drugs. Pain relief drugs can create an addiction problem. People are using prescription drugs in ways that were not prescribed. Canadians use roughly the same drugs. The number of Canadians who die every year from using a drug prescribed by a doctor they trust, without any warning about side effects or possible death, must be in the thousands.

In the case of the hon. member for Oakville, his daughter Vanessa Charlotte Young took the drug Prepulsic as prescribed for a fairly minor health condition. Her parents went with her to every medical appointment. No one said anything about a side effect that might cause death. No parent would ever have allowed their child to take that drug had they known.

The hon. member for Oakville wrote a wonderful book called Death By Prescription. In the book he tells of going on Johnson & Johnson's website after his daughter's death to find out information on Prepulsic. He found other stories online and found that investigations had been done on this drug and that 80 deaths had been associated with it. The doctor did not know that when he prescribed the drug. The parents did not know that. Young Vanessa certainly did not know that.

Bill C-17 shines a light on a very large problem but it only begins to deal with the problem. When we think about the drug-pushing criminal element, we do not tend to think of white-collar crime. That is what this is. When a pharmaceutical executive decides not to warn the health minister that there are problems with a drug, that some people might die, because the company's profit margins are high, then that kind of activity should be criminal. If that executive decides that any studies done on a drug are proprietary, are confidential, and should never be shared, that kind of activity should be criminal. This legislation proposes steps to criminalize it.

I think a lot of members will have read the book The Constant Gardener or saw the film. It always struck me that the most powerful part of that work of fiction by John le Carré was his comment in the legal disclaimer so that no drug company could sue him. He wrote:

...I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with reality, my story was as tame as a holiday postcard.

We are dealing with a seriously corrupt process. I am not talking about any individuals within it, but when the large pharmaceutical companies around the world have so much power over regulators that they can avoid having automatic recalls for drugs or having the drugs assessed properly before they are registered, we have a real problem.

One place we could look for solutions is a wonderful institution that operates out of the University of British Columbia called the Therapeutics Initiative. That institution does something that, unfortunately, is all too uncommon. It refuses to accept any favours, trips, or presents from drug companies. It operates on a very strict ethical code of conduct and reviews the data packages that it is allowed to see from the health department of British Columbia. It decides and advises the government whether pharmaceutical drugs being proposed for use in the B.C. health care system will do more benefit than harm. It has come to different conclusions than Health Canada on a number of occasions.

Where are the clauses of the bill that need to be beefed up? Some of my colleagues have mentioned this already. Briefly, we need to look at transparency. The Canadian Medical Association Journal, by the way, wrote an excellent review on this bill called, “Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?” It was released May 13 of this year and I commend it to members. It provides some very good areas where the bill could be strengthened.

One thing it points to, and others have as well, is that there should be the registration of all drug trials and the results of those drug trials should be made public. A recommendation from the Canadian Medical Association Journal article is that we should also make sure that when Health Canada decides not to register a drug and concludes it might be unsafe, that information should also be made public. Health regulators should no longer tremble with fear about what the pharmaceutical industry might do to them if they warn the citizens of their country that a drug may have very significant side effects that pose a threat to life and health. Therefore, more transparency is required, and I hope that will be seen at committee.

The second area is clause 31.2 of the bill, that would increase the level of fines up to $5 million. It sounds like a lot until we look at the recent drug company settlements around the world. This is a list just in the last few years, since 2008. GlaxoSmithKline, for fraud and illegal promotion of Paxil, Wellbutrin, and Avandia, was fined $3 billion since 2012. The $5-million penalty in this bill puts it into a bit of perspective. Merck, for kickbacks to health care providers, paid $1.6 billion in settlements and fines since 2008. Eli Lilly, for the illegal promotion of Zyprexa, has paid $1.3 billion since 2009.

There is a very long list here of significant fines. For off-label promotion of Topamax, an epilepsy drug, Johnson & Johnson was fined $81 million. There were $600 million in fines for the off-label promotion of botox to Allergan. Novartis was fined $422.5 million for the off-label promotion of Trileptal in 2010. The list is longer than I have time for in my short speech. I hope it makes it clear to parliamentarians that while $5 million is a big number to us, it is small change to big pharma. We need to boost the penalties.

In my remaining time, I want to suggest that at the end of the question and comment period following my speech, we put to the House that since all members in all parties that have so far spoken to this bill today support its passage and would like to see it go to committee, we ask for unanimous consent to approve this quite excellent bill and work to make it better.

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

May 27th, 2014 / 11:40 a.m.
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NDP

Niki Ashton NDP Churchill, MB

Mr. Speaker, absolutely, it is critical to take leadership on this front and to respond to the call of the global community when it comes to transparency and really supporting safety of clinical trials of drugs that Canadians would use. This is obviously very connected to the drug that I mentioned, RU486, where Health Canada has been notoriously cryptic. In fact, at first, it said it was not in trial and then it remembered it was and yet, there is no way for us to know at which stage it is and what these trials look like. All we do know is that 57 countries around the world see this drug as safe and beneficial to women in their country, particularly, women in remote areas. Yet, in our country, our own health department is keeping this information from us, not just in connection with this drug but, generally, it has not practised the kind of transparency we would need.

We hope that Bill C-17 would be just the first step of many that the government will take to ensure that we have a robust safety system when it comes to approving drugs and making it clear to Canadians what that process is, along the way.

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

May 27th, 2014 / 11:30 a.m.
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NDP

Niki Ashton NDP Churchill, MB

Mr. Speaker, I am very pleased to rise in the House to speak on Bill C-17, an act to amend the Food and Drugs Act.

As has been stated in the House, we in the NDP are supporting the bill at second reading. We believe that Bill C-17 would bring several key improvements to current drug safety laws.

The bill would allow the government to recall drugs or order a distributor to take corrective action to remedy a problem with a drug. The health minister could order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. The health minister could order a review of a drug and require a copy of the review. The bill would require manufacturers to update Canadian information on the risks associated with a drug, even if the safety risks were discovered in another country.

We believe that this bill is a good first step in protecting Canadians' health and in improving the gaps in current drug safety legislation. Most importantly, it would give the health minister the long-needed power to recall unsafe drugs and to require that drugs undergo further testing if they appear to pose a health risk.

However, we believe that this proposed legislation does not go far enough. We want to see more comprehensive drug safety planning that goes beyond the measures in the bill.

As I have acknowledged, Canada needs a comprehensive drug safety plan so that Canadians can be assured that their medications are safe for use. Canadians need to have access to plain-language information about why their medications are safe, including on testing processes and on medication labelling.

To give some background, we know that 150,000 Canadians annually experience serious reactions from prescription drugs. In 2013 alone we saw several major drug safety incidents, such as diluted chemotherapy drugs given to over 1,200 patients in Ontario and New Brunswick.

France banned the product Diane-35 in January 2013 after four French deaths were linked to the drug, but Health Canada has remained quiet and has refused any follow-up action to ensure that Canadians are aware of the risks. Off-label use of acne medication Diane-35 is linked to nine adverse reactions causing death in Canada.

Another example is drug-maker Apotex, which was sanctioned by the FDA due to concerns raised about quality control and repeated deficiencies at two of its Toronto area manufacturing facilities. Health Canada was apparently not concerned about the warnings, even though it had not inspected the facilities since 2011.

Finally, I and many of my colleagues have raised a drug incident with the minister, and I know that many Canadians have been concerned about this, particularly Canadian women.

For example, there have been voluntary recalls of high-profile drugs used to treat heart problems, high blood pressure, infections, and mental illness. However, I want to point to a particular concern, as I said, for Canadian women, which is the birth control pill Alysena-28 and five other popular birth control pills that were voluntarily recalled or had serious safety warnings issued about them: Diane-35, Yaz, Yazmin, Esme-28, and Freya-28.

Despite warning signs and the fact that many Canadian women were sharing on social media and with the mainstream media information about the deficiencies they were noticing and hearing about, the Conservative government was slow to act in terms of recalls.

We know that most risks associated with prescription drugs are identified after they are introduced to consumers. Almost one-fifth of new active substances approved by Health Canada between 1995 and 2010 were later given serious safety warnings. Despite this, Health Canada still does not require post-market drug studies.

We know that seniors are five times more likely to be hospitalized for adverse drug reactions. A recent study showed that one in 200 seniors are hospitalized for an adverse drug reaction versus one in 1,000 for other Canadians.

We know that seniors are often on more medications, and this demonstrates the need for a better evaluation and monitoring system to prevent adverse reactions.

We also heard from the Auditor General, who in 2011 reported on Health Canada's regulation of pharmaceutical drugs. The Auditor General at that time stated:

The Department does not take timely action in its regulatory activities, with the exception of its review of two types of drug submissions. In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information.

The Auditor General went on to raise various concerns when it comes to our regulation system.

When it comes to delays in terms of drugs that are necessary and have been proven to be very beneficial to people, I want to draw attention to the pill RU-486. Sadly, too many people have not familiarized themselves with the literature. It is an integral method in terms of reproductive choices, including medical abortion, that women have around the world in countries like the U.S. and 56 other countries. We know that Health Canada is taking too long in approving this pill. Despite the fact that it has been shown to be beneficial, we have yet to see an approval that would put Canada in the group of so many like-minded countries in making sure that women have access to medication they actually need.

We acknowledge that this is an important first step and a step in the right direction. However, we need the government to be far more proactive when it comes to drug safety and when it comes to recognizing the importance of making medication available to people.

I want to share one particular area where the federal government, sadly, is not showing leadership. It is in the cutbacks to medical coverage, including drug coverage, for first nations people. In fact, just yesterday, I met with the leaders from a first nation in Manitoba, Fisher River, and spoke with other first nations leaders who are very concerned about the cuts to non-insured health benefits, including drug coverage. It is a situation that is sadly putting more and more first nations people, including elders, in vulnerable situations, given that they are not able to access the kind of medical service and coverage they need to be the healthiest they can be. I am particularly concerned that this is affecting a population that we know lives disproportionately in poverty. They often have less access to medical services, such as the care of a doctor, or nurses, for that matter. I find it particularly troubling that the government, despite its commitment to moving forward when it comes to safe drug coverage, at the same time is cutting drug coverage for first nations people who would be covered under non-insured health benefits.

While we acknowledge that this is an important step, we also ask for leadership from the government when it comes to drug safety, drug coverage, and understanding that the federal government has a critical role to play in ensuring safety for the citizens of our country. Certainly we in the official opposition, the NDP, stand on the side of so many Canadians who are asking the federal government to finally take action.

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

May 27th, 2014 / 11:25 a.m.
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Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, I want to thank the members opposite for supporting Vanessa's law, Bill C-17, the protecting Canadians from unsafe drugs act. I want to give my sincere thanks to all the members who are supporting it.

I am pleased to tell the House that we have had really tremendous cross-party support. This is a non-partisan issue, of course. This legislation has received that support since it was introduced. In fact, the NDP health critic, the member for Vancouver East, issued a press release the day it was tabled and called it a step in the right direction, as the member opposite just did.

I was also happy to hear that the Minister of Health has heard support from the Liberal member for Malpeque, who urged the minister to secure passage of Bill C-17, Vanessa's law, which will strengthen the federal government's ability to provide oversight and to take action to assure the safety of drugs after they have been approved.

I want to thank that member for that support as well.

The cross-party support this bill has received is very encouraging, and I look forward to working with these members and others in securing its swift passage. To that point, I want to request that we please get this bill out of the House today. I am hoping it will be approved to go forward to the Standing Committee on Health, of which I am member.

If we do that quickly, we can get it to committee next week. It is my wish and my hope that this bill will be passed before the end of June in the House of Commons and sent to the Senate. This is important, because Canadians are suffering adverse drug reactions daily. If we hold up Vanessa's law, that will continue and will be more likely to continue throughout the summer. The publicity from this bill is making Canadians more aware of the risks of adverse drug reactions when taking prescription drugs.

I ask members to help get this bill out of here by noon today, get it to the Standing Committee on Health, and get it approved and sent to the Senate, for the safety of Canadians.

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

May 27th, 2014 / 10:50 a.m.
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Okanagan—Coquihalla B.C.

Conservative

Dan Albas ConservativeParliamentary Secretary to the President of the Treasury Board

Mr. Speaker, I will be splitting my time with the member for Lambton—Kent—Middlesex.

I am pleased to speak today on Bill C-17, which proposes to amend the Food and Drugs Act to better protect Canadians from potentially dangerous and unsafe drugs.

Over the past three years I have served on the Standing Joint Committee for the Scrutiny of Regulations and have come to appreciate first-hand the importance of regularly reviewing and carefully scrutinizing regulations in our legislation. Often the results can be quite surprising when reviewing regulations, and that is certainly apparent in the Food and Drugs Act. In my view, that is why the amendments proposed in Bill C-17 are extremely important to Canadians.

I would like to highlight this with an example. Under the current act, if a drug or medical device poses an unacceptable risk to patient health, only the drug and medical device manufacturers can initiate a recall, and that is only after they become aware that a risk exists. In other words, under our existing laws, it is up to the manufacturers to determine whether or not there is a health risk serious enough to warrant a recall. Health Canada plays a secondary role. The current law only requires a manufacturer to notify Health Canada of the manufacturer's decision to issue a recall after the fact.

However, it does not end there. Under our current laws, government cannot step in and order a manufacturer to recall a drug or medical device that is unsafe. Where our existing law becomes more bizarre is that if something like a candy bar is deemed unsafe to the public, the Minister of Health can issue a recall. To summarize, the Minister of Health can issue recalls for dangerous and unsafe foods, but not for dangerous and unsafe drugs. In my view, this situation is completely unacceptable.

Bill C-17 proposes to remedy this situation by ensuring that the Minister of Health has mandatory recall power to compel a manufacturer to recall a drug or medical device if it is determined that it presents a serious or imminent risk of injury to health. This authority provides government with the power to initiate a recall instead of leaving the decision to the manufacturer or requiring Health Canada to negotiate with industry when the health and safety of Canadians is at stake.

I should also add that under this recall provision, once a recall is ordered, anyone who sells a drug or medical device and is aware that the product has been subject to recall may be convicted of an offence. There is also a provision for an exemption to this penalty, an exemption that allows for Health Canada to have the flexibility to authorize the sale of a recalled product with our without condition. Why does that make sense? It is because it is conceivable that in some circumstances a patient may have unique medical needs for which no alternative to a recalled drug is available.

I should also point out that under the new recall measures there would be no changes that would limit a manufacturer's ability to issue a voluntary recall. However, if a manufacturer fails to act quickly and decisively, the Minister of Health would have new powers to better protect the health and safety of Canadians.

Recently I met with a constituent who shared with me the importance of quality control in diabetes testing strips. How much insulin to take is determined by these strips, and serious failure in these test strips could result in death. The need for increased protection for Canadians in this area, and many others, is important, and that is why I will be supporting the bill. The health and safety of Canadian families must absolutely come first, and serious risks at the manufacturing level have to be treated seriously.

While researching the bill late last evening, I was struck deeply when I came across the number of Canadian families that have suffered the loss of a loved one as a result of a dangerous drug. Indeed, a colleague of ours in this place knows all too well the serious need for Bill C-17. In fact, the more I researched this area, the more apparent it became of the need for Bill C-17 to become law.

In my view, this bill is long overdue. It is simply not acceptable that drugs that could pose a risk to patients remain on the market at the arbitrary discretion of the manufacturer.

To give some further perspective on how out of date these current regulations are, fines under the act are $5,000, while under Bill C-17 these fines can be increased to up to $5 million a day. Even jail time can be imposed under very serious circumstances. These are protections, I would argue, that Canadians need.

Before I close, here is some brief history I also believe is relevant and that I am sure many members of this House would appreciate hearing. Canada's Food and Drugs Act was first passed in 1920. Significant changes were made in 1947. Further changes were made in the 1960s, after a dangerous drug that was legal at the time resulted in the death and deformation of thousands of infant children.

I believe that Bill C-17, which amends the Food and Drugs Act, is long overdue. Protecting Canadians from unsafe therapeutic products without delay or administrative red tape is a priority that I believe all members of this place should share.

I would also note that the Minister of Health has stated that she would be open to amendments to Bill C-17 if ideas are brought forward that would better protect Canadian patients.

From a regulatory perspective, the mandatory recall measures proposed in this bill are consistent with mandatory recall measures for therapeutic products in other countries, including the United States and the European Union.

I submit that it is time that Canada joined the list of countries with mandatory recall legislation, and I ask that all members of this House join me in supporting Bill C-17. I thank all members for taking the time to hear my thoughts on this piece of legislation.

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

May 27th, 2014 / 10:40 a.m.
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NDP

Lysane Blanchette-Lamothe NDP Pierrefonds—Dollard, QC

Mr. Speaker, I thank my colleague for her speech. I am sure she is very knowledgeable about many health-related issues.

As she probably knows, in his 2011 report, the Auditor General pointed to problems with Health Canada's timelines for informing people about problems with drugs. Up to two years can go by before Health Canada even finds out about problems.

The report was released in 2011, but it was not until December 2013 that the government introduced this bill, which is a step in the right direction. As my colleague said, Bill C-17 was a long time coming. However, I wonder why previous Liberal governments did not tackle this problem when they had the chance.

Were they not aware of the problem? Can my colleague enlighten me?

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

May 27th, 2014 / 10:20 a.m.
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Liberal

Hedy Fry Liberal Vancouver Centre, BC

Mr. Speaker, I rise to support this bill, but to support sending it to committee. While this bill is a substantial improvement on the status quo, it has still taken the current government eight years, even though as Liberals we have pushed the government to change the way it regulates, the way it develops, and the way it looks at drug safety for Canadians.

However, the Conservatives have put the bill forward and there are some pieces of the bill that we like, but we think it falls short. There are other things we would like to see in this bill, and the minister herself has said in the House when she introduced the bill that she is open to amendments. So we are taking the minister at her word, and we are going to say we would like it to go to committee, and we hope the minister will be true to her word and will look at our amendments then.

Here are some things we like about the bill.

We think that the minister getting the power to recall drugs is a very important piece that has been a long time coming. The minister has to be able to do so without first getting the manufacturer's approval. Before this, the minister had to get the manufacturer's approval to recall a drug or to say that a drug has severe side effects. The new language says that “If the Minister believes that a therapeutic product may present a serious risk of injury to human health...”. That is good language, and we support the minister getting those powers.

The minister used to have to overcome the reluctance of the companies to want to give that information. Now the minister would have the ability to compel industry to provide the information about the drugs that the minister wishes to either seek a notice of compliance on or that are actually out there in the public, and be able to recall them. This is all common sense, but it is crucial because nobody but the company itself knows the background of the clinical trials, of how the company formulated the drug and how that innovation occurred. Therefore it is important that the company is made to be forthcoming with some of that information.

What we also like about this bill is that the minister would compel health care providers and pharmacists to mandatorially report at-risk drug reactions. As a physician, I can say that was a difficult thing to do because it meant that physicians, after a whole busy day of seeing patients, at the end of the day then had to report all these things. It can take sometimes two hours out of their day. Now that the minister would provide an electronic means by which this could be easily done, it would make it much easier for physicians to comply with this.

The minister's ability to enforce conditions on market authorization and to compel changes to product labels is also very important, and the ability to move that forward would ensure patient safety. We think that is important, but we also want the minister not to do so in a hurry so that it would stop due diligence in terms of the ability to get the kind of information we need.

The fines of up to $5 million a day for the failure to remove a drug or the failure to obey the enforcement measures by the minister is also a very positive area.

Members will notice that we are saying that there are some very positive things about this bill. However, before this bill came about, I was writing a bill on this very same thing because we got a little tired of waiting for the government to do this after eight years; so I had some round-table meetings with experts on the issue. Here are some of the major elements that these experts feel are missing from the bill, which would make the bill stronger: better implementation of the ability to ensure patient safety, to ensure that there are appropriate regulations, and to ensure pre- and post-market surveillance of drugs.

This is about the precautionary principle, which should give the minister the power to ensure that the first and foremost thing she or he is concerned about, wherever possible, is being sure that on reasonable grounds, to prevent potential injury to a person or a citizen, the minister has that power to recall or remove a drug or not allow for notice of compliance. “Reasonable grounds” is sufficient. The minister should be protected for her ability to do this, using the term “reasonable grounds”. The minister's power should not just be limited to those who sell the drugs, because we know that in some areas the people who manufacture the drugs are not the people who sell the drugs.

They have different production arms and different distribution arms that distribute their drugs under different names. Therefore, it is important for the minister to look at the whole chain of distribution not merely at the manufacturer when recalling a drug.

Right now I think that the definitive issue of injury or harm is up for interpretation. For instance, let us look at the birth control drugs that did not work recently. No one felt that this was an important reason not to allow the drug a notice of compliance or to recall it, because they felt that if women became pregnant when using a contraceptive that did not work, it was not an adverse reaction and it did not cause severe injury or harm, because pregnancy is a lifestyle choice. I think that was a bending of the interpretation of what harm is. If women are taking a contraceptive, it is because they do not want to get pregnant. If they get pregnant, that is an adverse reaction. I think the ability to define what is injury or harm should be more clearly spelled out for two reasons: one, to protect the patient; and, two, to protect the minister from any kind of reaction from the company because it is clear what she means and what the legislation means by injury or harm. That should be clearly spelled out. It should be based not on subjective but on objective criteria that are in keeping with what we know about risks and harms pertaining to drugs. That would provide the minister protection and give her broader powers.

As well, we know that we cannot tell the adverse effects of a drug purely from the clinical trials. When a drug is undergoing clinical trials, it is done with a cohort of people who have been chosen, and out of that cohort it can be decided what the negative and adverse reactions are to the drug. However, when the drug goes out into the main community, into the citizenry at large and the general public, individual reactions to drugs can differ. While people may not have had reactions during the clinical trial, others in the main community may show adverse reactions. Therefore, the minister must have the ability to say that, although the government gave the drug a notice of compliance, due to the new reporting requirements for physicians and pharmacists it has noticed that after a year or six months there are adverse reactions that were not intended and did not show up in the clinical trials and that the drug will be recalled temporarily while we check on these. Then, ensuring that the precautionary principle is in place, the government can look at the drug and either put it back on the market if changes have been made or permanently recall it before it does any further harm.

To clearly define what we are doing is in the best interests of the minister. It would protect her from any kind of legal suit and so forth. That is an important piece we would like to see included.

The Auditor General has spoken on many an occasion about the lack of transparency in Health Canada's decision-making process. For instance, Health Canada publishes only very limited information on drugs and high-risk medical devices for which a notice of compliance is applied for. However, it does not tell us why it did not allow a drug a notice of compliance. It does not tell us what its opinions are about the drug, even though it may give it a notice of compliance and say that it is generally safe. There may be other clinicians who have said there are some concerns about the drug. Health Canada should put that out there to the public, so that pharmacists, prescribers, and patients would know that there could be some conditions under which the drug was allowed to go out there. There may be some potential negative effects with which the minister and the department are concerned, but they are releasing the drug anyway. That was in the bill when it was put forward as Bill C-51. I noticed it has been removed. I wonder why, because it was a very good piece in that legislation that we agreed on and that the Auditor General wanted to happen. That enhances the transparency of Health Canada in terms of its regulations and looking at drug safety.

We cannot afford to use the fact that the manufacturer does not want us to give out trade secrets. We do not have to give out trade secrets when we are saying that we think there may or may not be a problem that we have in the back of our mind even though we have put the drug out there. It is an important thing to do. Europe is doing it. The European drug agency is putting out what the negative opinions are on a particular drug, even though it felt that the benefits outweighed the risks and that is why it put it forward.

There should be a legal requirement to register clinical trial data. This should be open to physicians, patients, and pharmacists so that they are able to know what clinical trial data shows. Now, I know that the government thinks that would let out trade secrets. However, the European drug agency is doing this.

The clinical data that is put out in terms of the clinical trial does not have to disclose proprietary issues regarding the drug itself or its trade secrets. It is about the ability to ensure patient safety, which is foremost in the mind of Health Canada, as it should be. Therefore, to release the full report of pre- and post-clinical trials and surveillance on an ongoing basis is an absolute necessity, but it is not in the bill. Not only is the European drug agency doing this, it is thinking of expanding it to bring in anonymous or non-nominal general patient responses to the drugs so that, again, there is full knowledge and full disclosure. Also, the FDA has just tabled its intention of doing the same thing.

Canada is way behind both Europe and the United States in terms of looking at patient safety, in terms of full disclosure, and in terms of acquiring full disclosure by the manufacturers, who do not seem to be worried about the proprietary issues of trade secrets because they know what to put in and what not to. Clinical information is not a proprietary trade secret. The formula of the drug and how the innovation occurred are proprietary trade secrets, but not clinical trials or data about them.

It is important for the minister to strengthen the bill by doing this and to do everything under the rubric of good independent research, and not just the companies' research. There should be an independent body that looks at those clinical trials, and not just Health Canada. Again, Europe is doing that, and the FDA has tabled its intention to do that. It has to be done in the name of public safety and good evidence-based information.

We would like to see more transparency from Health Canada on why it gives a drug a notice of compliance and why it does not. What are the reasons? Again, we need to know that about certain drugs. People read about drugs, and when they find out that other countries use certain drugs, they wonder why Canadians cannot get it. They want to know why they are not allowed access to drugs that could save their lives, et cetera.

Good information helps people understand why certain decisions are made. However, right now we do not know anything about why Health Canada approves a particular drug or not, why certain drugs are suspended, and why some drugs remain on the market in spite of adverse reactions in other countries. These are some things that we feel would strengthen the bill.

Disclosure in the name of public safety is always very good. We need to ensure that the first thing in the mind of Health Canada when it approves a drug, or not, is that people can trust Health Canada to make good decisions in their best interest, and be able to do so in an objective and clinical evidence-based response. I think that right now Health Canada faces a great deal of mistrust from the public and drug prescribers because it is not transparent in some of these things.

Why would the bill allow government and cabinet to impose stringent rules favouring data protection of manufacturers under the Food and Drugs Act? We do not think that should be able to stand alone.

We have seen issues where people have asked for drugs, but the government has said that the Food and Drugs Act is the reason it is not doing certain things. However, the Supreme Court of Canada has ruled very clearly that the issues of right to life, liberty, and the security of the person trump any piece of legislation, which is under section 7 of the charter. Patient safety should be foremost in anything that the bill would bring forward.

We oppose the amendment to the Food and Drugs Act in the bill to protect manufacturers' data. It should only be for proprietary data protection and not for anything else. The government should be protecting the patient, and Canadians.

The Liberal Party thinks that the bill is long overdue. There are some good points in Bill C-17 that move forward, with some steps we approve of, to enhance patient safety and knowledge of drugs for therapeutic prescribers.

The minister said that the bill should be open to amendments. We have, as I said just now, about five amendments we would like to see that would strengthen the bill. We approve of big chunks of the bill, and we would like to see the bill go to committee. We hope that the minister will be true to her word and allow for amendments to come forward so that the bill can go to the House and be accepted by all of us unanimously, because it is in the best interest of patient safety.

The House resumed from March 28 consideration of the motion that Bill C-17, An Act to amend the Food and Drugs Act, be read the second time and referred to a committee.

Extension of Sitting HoursGovernment Orders

May 26th, 2014 / 12:15 p.m.
See context

York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader of the Government in the House of Commons

moved:

That, notwithstanding any Standing Order or usual practice of the House, commencing upon the adoption of this Order and concluding on Friday, June 20, 2014:

(a) on Mondays, Tuesdays, Wednesdays and Thursdays, the ordinary hour of daily adjournment shall be 12 midnight, except that it shall be 10 p.m. on a day when a debate, pursuant to Standing Order 52 or 53.1, is to take place;

(b) subject to paragraph (d), when a recorded division is demanded in respect of a debatable motion, including any division arising as a consequence of the application of Standing Order 61(2), but not including any division in relation to the Business of Supply or arising as a consequence of an order made pursuant to Standing Order 57, (i) before 2 p.m. on a Monday, Tuesday, Wednesday or Thursday, it shall stand deferred until the conclusion of oral questions at that day’s sitting, or (ii) after 2 p.m. on a Monday, Tuesday, Wednesday or Thursday, or at any time on a Friday, it shall stand deferred until the conclusion of oral questions at the next sitting day that is not a Friday;

(c) the time provided for Government Orders shall not be extended pursuant to Standing Order 45(7.1);

(d) when a recorded division, which would have ordinarily been deemed deferred to immediately before the time provided for Private Members’ Business on a Wednesday governed by this Order, is demanded, the said division is deemed to have been deferred until the conclusion of oral questions on the same Wednesday;

(e) any recorded division which, at the time of the adoption of this Order, stands deferred to immediately before the time provided for Private Members’ Business on the Wednesday immediately following the adoption of this Order shall be deemed to stand deferred to the conclusion of oral questions on the same Wednesday;

(f) a recorded division demanded in respect of a motion to concur in a government bill at the report stage pursuant to Standing Order 76.1(9), where the bill has neither been amended nor debated at the report stage, shall be deferred in the manner prescribed by paragraph (b);

(g) for greater certainty, this Order shall not limit the application of Standing Order 45(7);

(h) no dilatory motion may be proposed, except by a Minister of the Crown, after 6:30 p.m.; and

(i) when debate on a motion for the concurrence in a report from a standing, standing joint or special committee is adjourned or interrupted, the debate shall again be considered on a day designated by the government, after consultation with the House Leaders of the other parties, but in any case not later than the twentieth sitting day after the interruption.

Mr. Speaker, I am pleased to rise to speak to the government's motion proposing that we work a little bit of overtime over the next few weeks in the House.

I have the pleasure of serving in my fourth year as the government House leader during the 41st Parliament. That is, of course, on top of another 22 months during a previous Parliament, though some days it feels like I am just getting started since our government continues to implement an ambitious agenda that focuses on the priorities of Canadians. We still have much to do, and that is the basis for Motion No. 10, which we are debating today. Regardless of what other theories that folks might come up with, our objective is simple: to deliver results for Canadians, results on things Canadians want to see from their government.

As government House leader, I have worked to have the House operate in a productive, orderly, and hard-working fashion. Canadians expect their members of Parliament to work hard and get things done on their behalf. We agree, and that is exactly what has happened here in the House of Commons. However, do not take my word for it. Let us look at the facts.

In the previous session of the 41st Parliament, 61 government bills received royal assent and are now law. In 2013 alone, which was a shorter parliamentary year than normal, the government had a record-breaking year with 40 bills becoming law, more than any other calendar year since we took office, breaking our previous record of 37 new laws in 2007 when I also had the honour to be the leader of the House. That is the record of a hard-working, orderly, and productive Parliament. With more than a year left in this Parliament, the House has accomplished so much already, handing many bills over to the Senate for the final steps in the legislative process.

Just as we had a record year for legislative output, Canadian grain farmers experienced a bumper crop with a record yield in 2013. Understanding the real challenges faced by grain farmers, our government acted quickly on Bill C-30, the fair rail for grain farmers act, moving the bill through three readings and a committee study before handing it over to the Senate. This bill would support economic growth by ensuring that grain is able to get to market quickly and efficiently. The House also passed Bill C-23, the fair elections act, which would ensure that everyday citizens are in charge of democracy, ensuring the integrity of our electoral system and putting rule breakers out of business.

Two supply bills received royal assent, thereby ensuring that the government has the money it needs to continue providing services to the people.

When we passed Bill C-25, the Qalipu Mi'kmaq First Nation Act, we fulfilled our promise to protect the Qalipu Mi'kmaq First Nation's enrolment process, making it fair and equitable while ensuring that only eligible individuals will be granted membership.

Earlier this spring, royal assent was also given to Bill C-16, the Sioux Valley Dakota Nation Governance Act, making the Sioux Valley Dakota Nation the first self-governing nation on the prairies and the 34th aboriginal community in Canada to achieve self-governance.

Next on the agenda is Bill C-34, the Tla'amin Final Agreement Act, which will implement the agreement with the Tla'amin Nation. Bill C-34 will give the Tla'amin increased control over their own affairs. They will have ownership of their land and resources and will be able to create new investment opportunities and make decisions determining their economic future.

We considered and passed through all stages of Bill C-5, the Offshore Health and Safety Act, which will enhance safety standards for workers in Canada’s Atlantic offshore oil and gas industry to protect Canadians and the environment while supporting jobs and growth.

Bill C-14, the Not Criminally Responsible Reform Act, became law just a few weeks ago. This act will ensure that public safety should be the paramount consideration in the decision-making process involving high-risk accused found not criminally responsible on account of mental disorder.

Also, this spring, our government passed Bill C-15, the Northwest Territories Devolution Act, which honoured our government's commitment to giving northerners greater control over their resources and decision-making and completing devolution all before the agreed-upon implementation date of April 1, as well as Bill C-9, the First Nations Elections Act, which supports the Government of Canada's commitment to provide all Canadians with strong, accountable, and transparent government. Bill C-9 provides a robust election framework, improves the capacity of first nations to select leadership, build prosperous communities, and improve economic development in their communities.

However, despite these many accomplishments, there is more work to be done yet before we return to our constituencies for the summer, let alone before we seek the privilege of representing our constituents in the 42nd Parliament.

During this mandate, our government's top priority has been jobs, economic growth and long-term prosperity.

It is worth saying that again. During this mandate, our government's top priority has been jobs, economic growth, and long-term prosperity. That continues. Through three years and four budgets since the 2012 budget, we have passed initiatives that have helped create hundreds of thousands of jobs for Canadians, as part of the one million net new jobs since the global economic downturn. We have achieved this record while also ensuring that Canada's debt burden is the lowest in the G7 and we are on track to balance the budget in 2015.

As part of our efforts to build on this strong track record, our government has put forward this motion today. Motion No. 10 is simple. It is straightforward. It would extend the hours of the House to sit from Monday through Thursday. Instead of finishing the day around 6:30 p.m. or 7 p.m., the House would, instead, sit until midnight. This would give us an additional 20 hours each week to debate important bills. Of course, the hours on Friday would not change.

Extended sitting hours is something that happens practically every June. Our government just wants to roll up its sleeves and work a little harder a bit earlier this year.

Productivity is not just a function of time invested, but also of efficiency. To that end, our motion would allow most votes to be deferred, automatically, until the end of question period to allow for all hon. members' schedules to be a bit more orderly.

Last year, we saw the New Democrats profess to be willing to work hard. Then, mere hours later, after the sun would go down and people were not watching, what would the NDP do? It would suggest we pack it in early and move adjournment, without any accomplishment to show for it.

In order to keep our focus on delivering results and not gamesmanship, we are suggesting that we use our extra evening hours to get something done, not to play idle, unproductive games. We are interested in working hard and being productive, and doing so in an orderly fashion. That is the extent of what Motion No. 10 would do. Members on this side of the House are willing to work a few extra hours to deliver real results for Canadians. What results are we seeking? Bills on which we want to see progress, that are of great significance to Canadians, are worth spending a little extra time to see them considered and, ideally, passed.

Of course, we have the important matter of passing Bill C-31, Economic Action Plan 2014, No. 1. This bill implements our government’s budget—a low tax plan for jobs, growth and a stronger Canadian economy. It is also an essential tool in placing the government on track to balanced budgets, starting in 2015.

We have a number of bills that continue to build on the work we have done in support of victims of crime. Bill C-13, the Protecting Canadians from Online Crime Act, is another essential piece of legislation that will crack down on cyberbullies and online threats by giving law enforcement officials the tools necessary to investigate and tackle these crimes. We are taking clear action to combat cyberbullying and I ask the opposition to join us in this pursuit.

Every day in Canada, our most vulnerable—our children—are the victims of sexual abuse. This is truly unacceptable and as a society we must do our part to better protect our youth. With Bill C-26, the Tougher Penalties for Child Predators Act, we are doing our part.

Our government's comprehensive legislation will better protect children from a range of sexual offences, including child pornography, while making our streets and communities safer by cracking down on the predators who hurt, abuse, and exploit our children.

Therefore, I ask the opposition to work with us, support this important piece of legislation by supporting this motion.

It is also important that we move forward with one of the most recent additions to our roster of other tackling crime legislation. Last month, we introduced Bill C-32, the victims bill of rights act, which will give victims of crime a more efficient and more effective voice in the criminal justice system. It seeks to create clear statutory rights at the federal level for victims of crime, for the first time in Canada's history. The legislation would establish rights to information, protection, participation, and restitution, and ensure a complaint process is in place for breaches of those rights on the part of victims. It would protect victims, and help to rebalance the justice system to give victims their rightful place. I hope we can debate this bill tomorrow night. By passing Motion No. 10, we will make that possible.

Our efforts to protect families and communities also extend to keeping contraband tobacco off our streets, so that the cheap baggies of illegal cigarettes do not lure children into the dangers of smoking. Bill C-10, the tackling contraband tobacco act, would combat this by establishing mandatory jail time for repeat offenders trafficking in contraband. Aside from protecting Canadian children from the health hazards of smoking, it will also address the more general problems with trafficking and contraband tobacco propelled by organized crime roots. With luck, I hope we can pass this bill on Friday.

Just before the constituency week, the Prime Minister announced Quanto's law. Bill C-35, the justice for animals in service act, would pose stiffer penalties on anyone who kills or injures a law enforcement, military, or service animal. I know that the hon. member for Richmond Hill, having previously introduced a private member's bill on the subject, will be keen to see the extra time used to debate and pass this bill at second reading before we head back to our constituencies.

Bill C-12, the drug-free prisons act, could also have a chance for some debate time if we pass Motion No. 10. This particular bill will tackle drug use and trade in the federal penitentiaries to make the correctional system a safer place, particularly for staff, but also for inmates, while also increasing the potential for success and rehabilitation of those inmates. As a former public safety minister, I can say that this is indeed an important initiative.

Delivering these results for Canadians is worth working a few extra hours each week. Our clear and steady focus on the strength of our Canadian economy does not simply apply to our budgets. We will also work hard next week to bring the Canada-Honduras free trade agreement into law. Bill C-20, the Canada-Honduras economic growth and prosperity act, would enhance provisions on cross-border trading services, investment, and government procurement between our two countries. It would also immediately benefit key sectors in the Canadian economy, by providing enhanced market access for beef, pork, potato products, vegetable oils, and grain products.

As a former trade minister, I can say first-hand that this government understands that trade and investment are the twin engines of the global economy that lead to more growth, the creation of good jobs, and greater prosperity. Trade is particularly important for a country like Canada, one that is relatively small yet stands tall in terms of its relationship and ability to export and trade with the rest of the world. If we are to enjoy that prosperity in the future, it is only through expanding free trade and seizing those opportunities that we can look forward to that kind of long-term prosperity.

Through Bill C-18, the agricultural growth act, we are providing further support to Canada's agriculture producers. This bill would modernize nine statues that regulate Canada's agriculture sector to bring them in line with modern science and technology, innovation, and international practices within the agriculture industry. The act will strengthen and safeguard Canada's agriculture sector by providing farmers with greater access to new crop varieties, enhancing both trade opportunities and the safety of agriculture products, and contributing to Canada's overall economic growth.

As the House knows, our government has made the interests of farmers a very important priority. We recognize that since Canada was born, our farmers in our agriculture sector have been key to Canada's economic success. As a result, Bill C-18 will be debated this afternoon. It would be nice to have the bill passed at second reading before the summer, so that the agriculture committee can harvest stakeholder opinion this autumn.

Over the next few weeks, with the co-operation and support of the opposition parties, we will hopefully work to make progress on other important initiatives.

My good friend, the President of the Treasury Board, will be happy to know that these extra hours would mean that I can find some time to debate Bill C-21, the red tape reduction act. This important bill should not be underestimated. It would enshrine into law our government's one-for-one rule, a successful system-wide control on regulatory red tape that affects Canadian employers. Treasury Board already takes seriously the practice of opining that rule, but we want to heighten its importance and ensure that it is binding on governments in the future. We want to ensure that Canadians do not face unreasonable red tape when they are simply trying to make a better living for themselves, and creating jobs and economic growth in their communities.

Another important government initiative sets out to strengthen the value of Canadian citizenship. For the first time in more than 35 years, our government is taking action to update the Citizenship Act. Through Bill C-24, the strengthening Canadian Citizenship Act, we are proposing stronger rules around access to Canadian citizenship to underline its true value and ensure that new Canadians are better prepared for full participation in Canadian life. This legislation will be called for debate on Wednesday.

The health and safety of Canadians is something that our government believes is worthy of some extra time and further hard work in the House of Commons.

Tomorrow evening, we will debate Bill C-17, the protecting Canadians from unsafe drugs act. Under Vanessa's law, as we have called it, we are proposing steps to protect Canadian families and children from unsafe medicines. Among other actions, the bill would enable the government to recall unsafe drugs, require stronger surveillance, provide the courts with discretion to impose stronger fines if violations were intentionally caused, and compel drug companies to do further testing on a product. In general, the bill would make sure that the interests of individual Canadians are looked out for and become a major priority when it comes to dealing with new medications and drugs.

Bill C-22, the energy safety and security act, would modernize safety and security for Canada's offshore and nuclear energy industries, thereby ensuring a world-class regulatory system, and strengthening safety and environmental protections. This legislation, at second reading, will be debated on Thursday.

Bill C-3, the safeguarding Canada's seas and skies act, could pass at third reading under the extended hours, so that we can secure these important updates and improvements to transportation law in Canada.

We could also pass the prohibiting cluster munitions act. As the Minister of Foreign Affairs explained at committee, the Government of Canada is committed to ridding the world of cluster munitions. Bill C-6 is an important step in that direction, but it is just the beginning of our work. Extending the relevant elements of the Oslo Convention into domestic law would allow Canada to join the growing list of countries that share that same goal. I hope members of all parties will support us in this worthy objective.

By supporting today's motion, the opposition would also be showing support for Canada's veterans. The extra hours would allow us to make progress on Bill C-27, the veterans hiring act. The measures included in this legislation would create new opportunities for men and women who have served their country to continue working for Canadians through the federal public service. As a nation, we have a responsibility to ensure that veterans have access to a broad range of programs and services to help them achieve new success after their time in uniform is complete. This initiative would do exactly that.

Of course, a quick reading of today's order paper would show that there are still more bills before the House of Commons for consideration and passage. I could go on and on, literally, since I have unlimited time to speak this afternoon, but I will not. Suffice it to say that we have a bold, ambitious, and important legislative agenda to implement. All of these measures are important, and they will improve the lives of Canadians. Each merits consideration and hard work on our part. Canadians expect each one of us to come to Ottawa to work hard, to vote on bills, to make decisions, and to get things done on their behalf.

I hope that opposition parties will be willing to support this reasonable plan and let it come to a vote. I am sure that members opposite would not be interested in going back to their constituents to say that they voted against working a little overtime before the House rises for the summer.

I commend this motion to the House and encourage all hon. members to vote for adding a few hours to our day to continue the work of our productive, orderly, and hard-working Parliament, and deliver real results for Canadians.

Business of the HouseOral Questions

May 15th, 2014 / 3:10 p.m.
See context

York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader of the Government in the House of Commons

Mr. Speaker, let me start by sharing a couple of sentiments with my friend.

First, on this side of the House—speaking for myself at least, and many others, including the Prime Minister—we congratulate the Montreal Canadiens on their success and wish them all the best in the next round, where I am optimistic Canadians will have much to look forward to.

Second, I have to agree with the member about the fact that what we saw today was a preview of what we would see if the NDP were ever to win government. We saw a grilling where the highlight was the question of NDP corruption and abuse of taxpayers' dollars. That is what we could expect to see if the NDP were ever to become government, and because Canadians know that, we will never have to fear it happening.

That abuse of taxpayers' funds goes beyond the question of breaking rules and not following rules. It goes to the whole NDP philosophy that taxpayers' money is there for them, they should get more of it, and they should spend it in every way possible. That is what the NDP is all about.

We in the Conservative Party, on the other hand, have an approach that is focused on a productive, hard-working, and orderly Parliament that respects taxpayers' dollars. As a result, we will continue with our agenda.

I will note the highlight today from the NDP. The NDP was defending itself on charges of improper spending and improperly using taxpayers' dollars for partisan activity. The member did not point out that the NDP's positive agenda was what they were proposing today in the House of Commons on one of the rare days when NDP members actually get to put forward their own policy proposals. It is funny how he says, “That is not the highlight”. I agree with him, because when they do get in power, they will have very little to advocate for.

That said, we on this side do follow the rules, and the rules require that we continue with the NDP opposition day motion for the balance of the day.

Tomorrow we will start the second reading debate of Bill C-27, the veterans hiring act, before we return to our constituencies for a week.

Upon our return we will roll up our sleeves and work hard for Canadians in the final sittings until the summer.

On Monday, May 26, we will consider Bill C-18, which is the agricultural growth act.

On Tuesday, May 27, we will resume the second reading debate on Vanessa's law, Bill C-17, the protecting Canadians from unsafe drugs act.

That will be followed by Bill C-32, the victims bill of rights act at second reading.

The next day will see us continue our productive, hard-working, and orderly agenda by returning to the second reading debate on Bill C-24, the strengthening Canadian Citizenship act. As hon. members might recall, the New Democrats proposed a second reading amendment to block the passage of this important bill.

On Thursday, May 29, we will continue the second reading debate on Bill C-22, the Energy Safety and Security Act. After that debate concludes, we will consider Bill C-6, the Prohibiting Cluster Munitions Act, at report stage. Finally, we will consider Bill C-10, the Tackling Contraband Tobacco Act, at report stage and third reading on Friday, May 30.

As you can see, Mr. Speaker, we still have a lot of work ahead of us this spring.

Food and Drugs ActGovernment Orders

March 28th, 2014 / 10:55 a.m.
See context

NDP

Rosane Doré Lefebvre NDP Alfred-Pellan, QC

Mr. Speaker, I thank the hon. member for Oakville for his comments. I must say, I am very happy that the bill contains provisions to change the current system.

As I already mentioned, the NDP will vote in favour of Bill C-17, and we look forward to discussing it in committee in order to make some changes that are even more significant. I appreciate the comments from the member for Oakville.

Food and Drugs ActGovernment Orders

March 28th, 2014 / 10:45 a.m.
See context

NDP

Rosane Doré Lefebvre NDP Alfred-Pellan, QC

Mr. Speaker, today I am honoured to be speaking to Bill C-17, An Act to amend the Food and Drugs Act.

Before I begin, I would like to thank the hon. member for Oakville for the courage and determination he has shown in having this bill introduced in the House and in supporting it, as it touches him personally.

It is very important that we debate such a sensitive and important bill. The federal government must shoulder its responsibilities regarding the Food and Drugs Act. It is good that we are debating this today. I would like to assure the hon. member opposite, the member for Oakville, that the official opposition will be supporting the bill.

I understand that the minister would be open to amendments. We would be more than pleased to participate in the debate and put forward amendments to Bill C-17 so that it can be improved and so that we create the best legislation possible. In that way, we can keep cases like Vanessa's and so many others from happening in Canada.

The NDP will be supporting Bill C-17, which makes several key improvements to drug safety laws.

First, it allows the government to recall drugs or order the distributor to take corrective action to remedy the problem with the drug. That is an extremely important element, one that I will come back to later on in my speech.

Second, it allows the health minister to order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. The minister can also order a review of the drug and require that a copy of the review be given to the department. In addition, the minister can require manufacturers to update Canadian information about the risks associated with their drug even if the safety risks were discovered in other countries

This bill is a good first step in establishing a comprehensive drug plan and in setting the course for our society on this issue. After calls from many health care professionals and advocates, this bill will finally grant the health minister the necessary power to pull unsafe drugs from the market and ensure better labelling of possible adverse effects of drugs.

We support this legislative measure and we hope that even more practical measures will follow. We support this bill, but there is still much to be done to improve drug safety measures. We will therefore propose amendments to improve this bill in committee.

We hope that our efforts will lead to a comprehensive piece of legislation that will include follow-up by Health Canada on adverse drug reactions, increased transparency with regard to the assessment of prescription drugs and a better system for communicating the risks associated with drugs to health care professionals and patients, in particular.

As I mentioned, this bill will make it possible for the government to compel manufacturers to recall drugs and order distributors to take corrective action to resolve problems with their products. In this regard, at the end of her speech, my colleague from Halifax gave the example of a mistake that was made in 2011 by the manufacturer of Alesse 28.

Alesse 28 is a type of birth control pill that generally works on a 28-day cycle. Women take the product for the first 21 days and then they take a placebo for the remaining seven days. The placebos are often just sugar pills. The problem that occurred had to do with the content of the pills. Rather than containing 21 birth control pills, a package of the product contained two weeks' worth of placebo pills.

Obviously, this can have a rather serious impact on a woman's menstrual cycle. I do not necessarily want to get into the details of how the menstrual cycle works, but having good birth control that works is really very important.

Since 1969, the year in which woman were given access to oral contraceptives, thousands of women in Canada and throughout the world have been using this method of birth control. I have used it myself, as many other female members of the House likely have, and many Canadian women use it.

It is an extremely important part of our family planning, for all sorts of reasons. There are various reasons why women use birth control. A drug that does not have the anticipated effect can have an extremely harmful impact on the health of women and on family planning.

These thousands of women trust in the system, in our health care system and in the drug manufacturers. The women affected by this problem experienced low hormone levels, which caused a number of problems. The main purpose of the product is to prevent ovulation. The placebos prevent that prevention, so to speak, and allow the woman to ovulate. That can have a serious impact on family planning.

Bill C-17 could do something about this. How did people find out about this mistake? Pharmaceutical companies were certainly not forthcoming about it. Pharmacists were the ones who sounded the alarm after noticing that there was a problem with the drugs they were selling. If the pharmacists had not spoken up and told people about the situation, the pharmaceutical companies surely would not have told anyone. There is no telling how far the situation might have gone.

It is good to know that with Bill C-17, new provisions will enable the federal government to do something. Currently, it cannot do anything about situations like that. The government has no power to act. It is very important to create legislation to address these situations. I am speaking on behalf of many women who believe that the federal government should have a say in the matter. We have to make sure that women have access to the best possible drugs, the best possible oral contraceptives.

Once again, I would like to thank the member for Oakville for introducing this measure in his bill.

As I said, we will support this bill at second reading, and we will probably put forward a number of amendments in committee just to make it better. That said, we do think that it is a step in the right direction.

We would like to see several more things in this bill. I know that I will not be able to go into detail because my time is almost up, but the bill ought to include a number of measures, such as optimal prescribing practices to ensure that Canadians are being prescribed the most appropriate drugs. Public disclosure of clinical trial results is also important because, in Canada, the results of numerous clinical trials are never published or made available to the public. We are also asking the government to strengthen the common drug review.

In closing, I would like to say that Bill C-17 is a step in the right direction and that the federal government has to step up to its responsibility with respect to the Food and Drugs Act. I am also pleased that the government is so open to amendments that might be put forward. I am very happy that we are talking about this bill in the House. I can assure the member for Oakville that we will vote in favour of the bill and that we will make sure it is the best it can be.

Food and Drugs ActGovernment Orders

March 28th, 2014 / 10:05 a.m.
See context

Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, I am very pleased to stand in the Parliament of Canada today to endorse Vanessa's law, the protecting Canadians from unsafe drugs act.

I am honoured to be a member of the first Canadian government ever to tackle the insidious and largely hidden problem of the injuries and deaths routinely caused by prescription and over-the-counter drugs. I thank two consecutive ministers of health and the Prime Minister, who acted boldly to make Canadians safer, directly taking on the most influential industry in the world, big pharma, and the status quo in the practice of medicine, which has been corrupted by that industry.

Today is a milestone for me and the Young family as well as for the Government of Canada. I stand here today due to a tragedy in my family that took place exactly 14 years ago last week, on Saturday, March 18, 2000. Without warning, our 15-year-old daughter Vanessa, for whom this act is named, fell down dead in front of me, her heart stopped by the Johnson & Johnson blockbuster prescription drug Prepulsid, a drug we later discovered she should have never been given. Despite emergency ambulance services and the valiant efforts of doctors at two hospitals, Vanessa never regained consciousness and died the next day. We never had a chance to say goodbye.

On March 20, 2000, I began the journey that led me to the House of Commons this morning. The facts of this tragedy shock every layperson who hears them, yet I was to quickly discover that the insiders, the doctors, researchers, and people of big pharma, were never shocked. They knew all along that potentially life-threatening drugs were being pushed on patients with non-life-threatening conditions, as the drug business had become all about Wall Street, and they were benefiting financially big time.

Our doctors are groomed through highly sophisticated big pharma relationship marketing programs. They get their first free lunch the first week of medical school. They then go on to naively accept up to $4 billion a year in North America in gifts, lunches, dinners, event tickets, and free trips from drug companies, imagining that those debts of gratitude do not change their prescribing behaviour. Sometimes I would ask them, “Do you think a drug company takes a bunch of doctors to Bahamas out of kindness?” They also accept and hand out, without any prescription, $3 billion a year worth of free samples of new prescription drugs, creating debts of gratitude in their own patients. It is a dangerous practice, because patients get no safety warnings.

In November 2010, 18-year-old Brennan McCartney, of Bolton, Ontario, took a free sample of the anti-depressant Cipralex, with no safety warning about suicide, which is written right on its label. He went out and hanged himself from a tree in a public park.

Four doctors knew that Vanessa was taking Prepulsid for bloating and a mild form of bulimia, yet neither Vanessa nor we, her parents, were given any warning that the drug was already responsible for 80 deaths. Why? How could this happen to the beautiful, innocent child her doctor described as the picture of perfect health? How could four doctors, people we totally trusted, allow Vanessa to continue to take a drug that could stop her heart?

I began the next day to find out how Vanessa died and why, and I have uncovered many dark secrets. Prescription drugs, taken as prescribed, the right way, are the fourth leading cause of death in North America. There are over 106,000 deaths a year just in hospitals and another 100,000 outside hospitals. That is about 20,000 deaths a year in Canada and 200,000 serious drug injuries.

The drug industry representatives who infest Parliament Hill love to talk about when doctors make errors or when patients use the wrong drug or take too much of a drug. What they never talk about is when a drug used the right way kills or injures a patient, causing 10,000 deaths a year in Canada. In fact, one in nine patients in Canada who goes into hospital will suffer a serious adverse drug reaction in hospital.

All drugs are poisons. Any drug can be toxic; it is just a matter of dose. All drugs cause adverse effects. Some people think over-the-counter drugs are totally safe, yet ordinary Tylenol, acetaminophen, causes hundreds of deaths every year and more cases of acute liver failure than all other medications combined. Too much taken with alcohol can destroy one's liver. Has anyone's doctor ever mentioned that?

Ordinary aspirin and ibuprofen cause thousands of deaths every year across North America, mostly from internal bleeding, yet most patients have never heard this. Why not? There is only one reason. It is because the people who market the drugs, big pharma, do not want patients to know the truth. That would reduce sales.

What happened to Vanessa and Brennan McCartney could happen to anyone who takes drugs without proper safety warnings. Nothing significant has changed since 2000 except the current introduction of plain language labelling for drugs and this bill.

Vanessa's law will empower the Minister of Health to compel drug companies to change their labels to clearly reflect the true risk to patients from their drugs. Patients would be empowered to make informed decisions to take the drugs or not. Patients could then take drugs only when they are relatively safe.

Twenty-seven drugs have been pulled from the Canadian market since 1997 for injuring and killing patients. Prepulsid is one. Another, the painkiller Vioxx, killed 55,000 to 65,000 people worldwide in four years on the market. Why do most Canadians not know that? It is because the drug companies never admit that their drugs have harmed anyone. They spend months and months investigating serious reactions, and then they attempt to blame the patient. They conclude that patients must have taken too much, that they must have had a previously undiagnosed and unknown conditions, or that it must have been a combination of the company's great drug with the patients' other drugs. They then contraindicate their drug with the other drug and change the print on a 50-page label, which most doctors and few patients ever read. Then they carry on promoting it, including for off-label use, meaning for conditions for which it was never proven safe or effective.

Doctors can prescribe any drug at any time for any condition for any patient, even if it is never proven safe for such use. In fact, 70% of doctors prescribe off-label at least some of the time. Modern medicine can be the wild west.

That is what the Johnson and Johnson detail reps did to Vanessa's doctors. They whispered to them that Prepulsid was effective for teens who threw up after meals, yet it was contraindicated and dangerous for anyone throwing up. That was the official warning, but they did not whisper that in her doctors' ears, because Prepulsid was heading for blockbuster status. It was a golden calf, with $1 billion a year in sales.

Just before Health Canada is about to take action to expose risks, the drug companies will pull drugs off the market voluntarily. That way they can keep selling them in over 100 other countries in the world, because they have never admitted that the drug could cause anyone harm. That is the drug business.

Vanessa's law will give the Minister of Health the power to order drugs that present as serious or imminent risk of injury or death off the market without delay. Had this been done with Prepulsid, instead of negotiating over weeks with Janssen-Ortho, Prepulsid would have been recalled. Vanessa would be alive today, along with many others.

Drug companies refuse to provide the true number of serious adverse drug reactions to Health Canada. They report what they hear about, but what does not appear on their label is this crucial fact: only 1% of serious adverse drug reactions are ever reported by doctors. Whatever the number is on the label can usually be multiplied by 100 to get the true number, which the drug companies never do.

Most doctors never report adverse drug reactions. Outside of the doctors I have worked with in prescription drug safety, I have never met a doctor who has reported one.

Despite my advocacy for over 14 years that reporting adverse drug reactions saves lives by providing a widely based early warning system for dangerous drugs, the Canadian Medical Association and the Ontario Medical Association, to this day, do not support making adverse drug reaction reporting a standard practice or mandatory. Doctors are fooled by their own negligence in not reporting life-saving information. Patients die as a result.

On October 9, 2011, 18-year-old Allison Borges of Oakville was found in a stairwell of her residence at Queen's University, dead, having suffered a pulmonary embolism caused by Apri 28, a birth control pill that her doctor told her was safe. She received no warning that the newer birth control pills are more likely to cause deadly blood clots than the older ones.

No woman should be given a birth control pill without a clear warning about deadly blood clots, yet it happens all the time. Sadly, 18 year old Marit McKenzie of Calgary suffered the same fate in January 2013. Had Vanessa's law been in place and implemented, both deaths would have been prevented.

Vanessa's law will impose, for the first time, a duty on health care institutions to report all serious adverse drug reactions, which will capture any adverse drug reaction that causes patients to end up in a hospital or clinic. That will hopefully capture the majority of serious adverse drug reactions so that officials can be alerted to dangerous drugs faster. This will help get them off the market faster and save lives. We must rely on the provinces to persuade doctors themselves to stop covering up adverse drug reactions caused by their prescriptions.

Over half the serious side effects of new drugs will not be revealed during testing. In fact, in the first two years on the U.S. market, one in five, or 20% of new drugs, will be pulled off the market for injuring or killing patients or will be assigned the highest level of warning, a black box warning, to be handed to each patient with the prescription. It is a more effective warning than Canada has ever had and that, under Vanessa's law, it will have.

In May 2007, 18-year-old Sara Carlin of Oakville stopped taking her prescription anti-depressant Paxil abruptly. Then she doubled up, to catch up, two days later. She had no warning that Paxil could cause suicidal ideation and akathesia in those circumstances. Her father found her the next day, hanging by her own hand, in the basement of their home. Neither Sara nor her family had heard about the five “Dear Doctor” letter warnings Health Canada had sent out about Paxil.

Vanessa's law will for the first time allow the minister to order assessments of a drug, including conducting tests or studies and reporting them to Health Canada, and to change the drug labels to better reflect the newly identified risks. Proposed regulations for drug labelling will empower Health Canada to order drug companies to issue labels and patient information leaflets that are written in plain language, with the rare but dangerous potential side effects listed up front, on page one, where patients need to see them. Patient can then decide if they want to accept those dangers or not.

In 2003, Dr. Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline, the world's second largest pharmaceutical company, made this statement at a scientific meeting, thinking there were no journalists present: “The vast majority of drugs—more than 90 per cent—only work in 30 or 50 per cent of the people”.

What this means is that with a worldwide market of about $800 billion for prescription drugs, as much as $400 billion a year is not only wasted but millions of patients are exposed to dangers with no chance of benefiting.

According to the Canadian Pharmacists Association, between $2 billion and $9 billion a year is wasted in our drug system. This means that as patients increasingly reject the drug industry's pill for every ill, our health care system would save billions of dollars, hopefully to be invested in preventive care.

Seventy percent of adverse drug reactions are preventable. They are caused by the aggressive over-marketing of drugs, misleading sales pitches, and the covering up of harms that victimize patients.

How could any moral corporate executive push a drug that could stop a child's heart to treat bloating? That is exactly what the executives at Johnson and Johnson's drug arm Janssen-Ortho did, and they broke the law in doing it. It is quite normal in the drug business.

Drug safety is about one thing: does the potential risk of this drug outweigh the potential benefits for me? Yet the big pharma companies do everything they can to make sure that patients have no way to answer that question. They exaggerate the benefits and they hide the risks.

I know that this sounds outrageous. It sounds like a father who lost his daughter and then lost his objectivity, so let me give a few factual examples of where big pharma companies have openly admitted to crimes to increase sales of their drugs.

In 2012, GlaxoSmithKline, the people who made our H1N1 vaccine, paid a fine of $3 billion, the highest in history, to U.S. governments for illegally marketing three drugs: Paxil, an anti-depressant, which causes suicides; Avandia, a diabetes drug that causes heart attacks and strokes; and Wellbutrin, another anti-depressant with similar adverse effects. Yet GlaxoSmithKline had grossed $26 billion in sales for these three drugs in the previous six years. With markups on drugs at more than 100% and 1000%, a $3 billion fine is really just the cost of doing business for GlaxoSmithKline. It is kind of like a speeding ticket.

Shortly after Vanessa died, I asked adverse drug reaction expert Dr. Neil Shear, in Toronto, why drug companies do not take dangerous drugs like Prepulsid off the market. Here is what he replied: “In the drug industry, killing people is not bad for business. As long as it's not too many”. Nothing has changed since that time. Big pharma companies put the legal costs for injuries and deaths right in their business plans.

Here are some more examples of big pharma corporate criminals. I will read a short list from a list that could be pages long.

Merck has paid $1.6 billion in settlements since 2008, in part for paying illegal kickbacks to health care providers. Ely Lilly paid $1.3 billion in 2009 for illegally promoting Zyprexa, leading to the deaths of many seniors. Novartis paid $422 million in 2010 for off-label promotion of Trileptal. Forest Labs paid $313 million in 2010 for off-label promotion of Celexa and Levothroid. Allergan paid $825 million in 2010 for off-label promotion of Botox. AstraZeneca paid $520 million in 2010 for misleading doctors and patients about the safety of Seroquel. The list goes on, and these are just since 2008.

The question is, how do the big pharma companies get away with this?

They have power and influence. They are some of the wealthiest companies in the world and have no loyalty to any country, but, above all else, despite the thousands of deaths, no big pharma executive has ever gone to jail.

Imagine if murderers, rapists, or extortionists could simply negotiate payments with some government official to keep out of jail and to keep on doing what they are doing. The only way these companies will ever stop their corrupt practices is: one, if the practices become unprofitable; and, two, if those responsible face real jail time. Vanessa's law, for the first time, would impose tough new penalties for unsafe products, increasing fines from $5,000 a day to $5 million a day and including jail time for up to two years. That is the only way to actually get their attention and change their ways. And if these serious violations are caused intentionally, court-imposed fines could be unlimited.

My hope is that when life-threatening dangers are intentionally covered up, judges will fine offenders the entire amount of their sales of their blockbuster drug, or more, because nothing else will change their practices.

Vanessa's law would be the beginning of the end for the unscrupulous and corrupt marketing practices in big pharma companies in Canada. It would no doubt reduce drug injuries and deaths in Canada by thousands. It is much needed and it is long overdue. We can never have Vanessa back, in this life, or Sara Carlin, or Allison Borges, or Brennan McCartney, or Marit McKenzie, but we can change things moving forward. We can do what governments are supposed to do: protect vulnerable people.

Vanessa's law represents the highest calling of a government, in my view. When the death of an innocent child can lead to definitive action by the Government of Canada to help prevent others from the same fate, our democracy is at its best.

Every school day, across Canada, millions of children sing:

From far and wide,
O Canada, we stand on guard for thee.

However, that promise has to be a two-way street.

Vanessa Young would be proud to see that with Bill C-17, Canada is standing on guard for its school children, its seniors, and its other vulnerable patients.

Food and Drugs ActGovernment Orders

March 28th, 2014 / 10:05 a.m.
See context

Edmonton—Spruce Grove Alberta

Conservative

Rona Ambrose ConservativeMinister of Health

moved that Bill C-17, An Act to amend the Food and Drugs Act, be read the second time and referred to a committee.

Business of the HouseOral Questions

March 27th, 2014 / 3:10 p.m.
See context

York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader of the Government in the House of Commons

Mr. Speaker, I first want to say here what I said on Twitter last week; that is, I would like to thank the hon. member for Skeena—Bulkley Valley for the working relationship that we have enjoyed over the last couple of years. I wish him well with his new critic responsibilities.

Now let me thank the hon. member for Burnaby—New Westminster for his first Thursday question. I welcome the hon. member to his new role as the House leader of the official opposition. I have been told by my staff that he is the tenth House leader from across the aisle with whom I have had the pleasure of working.

While I am confident that his predecessor has briefed him on our government's approach toward facilitating a hard-working, productive, and orderly House of Commons, I see that he has already fallen into one of the grievous errors of his predecessor. For a whole bunch of reasons, I would encourage him to look in some detail at the House of Commons rules and procedures.

For example, he was concerned with time allocation and referred to it again as limiting debate, yet when he reviews the rules, as I know he is going to, and I know he will do that with some enthusiasm in the near term, he will notice citation 533 of Beauchesne's Parliamentary Rules and Forms of the House of Commons of Canada , sixth edition, which reminds us that:

Time allocation is a device for planning the use of time during the various stages of consideration of a bill rather than bringing the debate to an immediate conclusion.

That is what we have always tried to do here: schedule debates so that we can make decisions, have fair and adequate debate, and give members of Parliament an opportunity to decide questions. It is not to curtail debate; it is to schedule and facilitate decisions being made. I hope that the member will have regard for those rules, something that had escaped his predecessor.

However, I should say that I do look forward to working with him on our business in the future. That said—and I hope that he will not take personal offence to this—in our scheduling of these matters, we will continue to work off of the Gregorian calendar, not the Julian calendar.

Today, we will continue the third reading debate on Bill C-5, the Offshore Health and Safety Act. Tomorrow, we will start the second reading debate on Vanessa’s law, Bill C-17, the protecting Canadians from unsafe drugs act. Monday will see the third day of second reading debate on Bill C-20, the Canada-Honduras Economic Growth and Prosperity Act.

That is one that I know he is a great supporter of.

Tuesday, April 1, shall be the first allotted day. It being April 1 after all, I assume that the NDP will ask us to debate one of its economic policies.

Finally, starting on Wednesday, we will debate our spring budget implementation bill to enact many of the important measures contained in economic action plan 2014, our low-tax plan for Canadians, as we make further progress on balancing the budget in 2015.

I might also add that with regard to the grain situation, Bill C-30 is now before the House. There have been very positive discussions among the parties to date. I hope that they will lead further to being able to have that bill passed through at least second reading on a fairly constructive basis. I hope those discussions will yield fruit, in which case there might be some change to the schedule I have presented to the House today.

Business of the HouseOral Questions

March 6th, 2014 / 3:10 p.m.
See context

York—Simcoe Ontario

Conservative

Peter Van Loan ConservativeLeader of the Government in the House of Commons

Mr. Speaker, I thank the hon. whip for the opposition for her very kind comments about the abilities on this side of the House with regard to procedure. Of course, I am only as good as the team that I have.

However, I will say that one thing I have tried to outline and to make clear over some period of time is that the use of time allocation is very distinct from the use of closure. We have chosen an approach in this government to use time allocation as a scheduling device to set an amount of time that we believe is appropriate for debate on any particular issue, which, as the hon. member in her own comments confirmed, in some cases results in even more time being allocated than is necessary for debate.

One of the benefits, though, is that the time does not have to be used. If all speakers complete their discussion of the subject, the debate can collapse and we can move on to other matters. So, really, no time is to be lost from that approach. It is a very positive thing, one that allows certainty for the benefit of all members about how much debate we will have, when votes will happen, and when decisions will be made. That is the most important thing for us in our work up here: making decisions and getting the job done.

As for this morning, I know that the NDP keeps seeing conspiracies and ghosts behind curtains, particularly the House leader for the NDP, who has that concern.

I think everyone knows that the only time one can move these time allocation motions—and we do not need to have a great command of the Standing Orders to know this—is at the start of government orders, at the start of the day. So I really had no choice.

However, the committee had considerable flexibility, which it did exercise. There was no conspiracy. There was no obstruction.

I hope that the opposition House leader will take the benefit of the two weeks to calm down, hopefully look around, see that there are no people waiting behind every curtain and every tree, out to get him, and that some of the conspiracies he imagines are simply not there. It will lower his blood pressure. It will make his life much more comfortable, in total.

I know that the opposition whip will share that advice from me, with him.

This afternoon we will continue debating Bill C-20, Canada-Honduras Economic Growth and Prosperity Act, at second reading.

Tomorrow, we will conclude the second reading debate on Bill C-25, Qalipu Mi'kmaq First Nation Act.

Then, we will return to our constituencies, where we will have a chance to reconnect with our real bosses.

When we return on Monday, March 24, the House will have the seventh and final allotted day. At the end of that day, we will consider the supplementary estimates, as well as interim supply, so that these bills will be able to pass through the other place before the end of our fiscal year.

The government's legislative agenda for the balance of that week will focus on protecting Canadians. Tuesday, March 25 will see us start the second reading debate on Bill C-22, the energy safety and security act, a bill that will implement world-class safety standards in the offshore and nuclear sectors. That evening we will finish the debate on the motion to concur in the first report of the foreign affairs committee respecting the situation of Jewish refugees.

On Wednesday, March 26, we will consider Bill C-5, the offshore health and safety act, at report stage and third reading. This bill will complement legislation already passed by the provincial legislatures in Nova Scotia, and Newfoundland and Labrador, given the shared jurisdiction that exists in the offshore sector.

On Thursday, March 27, we will have the fourth day of second reading debate on Bill C-13, the protecting Canadians from online crime act. Through this bill, our government is demonstrating its commitment to ensuring that our children are safe from online predators and online exploitation.

Finally, on Friday, March 28, I hope that we will be able to start the second reading debate on Bill C-17, the protecting Canadians from unsafe drugs act, also known as Vanessa's law.

National Lyme Disease Strategy ActPrivate Members' Business

March 3rd, 2014 / 11:05 a.m.
See context

Green

Elizabeth May Green Saanich—Gulf Islands, BC

, seconded by the hon. member for Oakville, moved that Bill C-442, An Act respecting a National Lyme Disease Strategy, be read the second time and referred to a committee.

She said: Mr. Speaker, today I am very honoured to introduce this bill for a national strategy on Lyme disease at second reading. When we are able to work together as members of Parliament, anything is possible.

Today I stand here with the great honour of presenting a bill in my name. If I could, I would remove my name and put the names of all of us on it. This is a truly non-partisan effort, and this is reflected in the process of this legislation in the House so far.

At first reading, in June 2012, the seconder of my bill was my friend the hon. Liberal member for Etobicoke North, who has been very active on many health issues. Today I have the enormous honour of having my bill seconded by the hon. member for Oakville, himself a champion on a number of health issues. I commend him and the Minister of Health, in fact all of the Conservative members, for bringing forward Bill C-17, An Act to amend the Food and Drugs Act, Vanessa's law. I look forward to seeing that legislation made into law. These are important steps, which prove that individuals can change public policy, as I hope we will here.

By coincidence, the hon. member for Oakville has also taken a stand on the Lyme disease issue, having written a foreword to a Canadian book called Ending Denial: The Lyme Disease Epidemic.

In this non-partisan spirit, the official opposition, the New Democratic Party, was the first party to signal full support for my bill. The New Democratic Party health critic, the hon. member for Vancouver East, signalled some time ago that I could count on her party's support. It means a tremendous amount to me personally to have this support. It acknowledges the importance of this legislation.

The hon. member for Edmonton—Spruce Grove, the Minister of Health, has herself been very willing to work with me, which means the bill has the potential for success. We have sat down and worked over this bill, and there are some amendments that I would expect to see in committee. I do not regard them in any way as other than helpful. This bodes well for our ability to work together to make a difference on this issue.

What is this issue? Everyone in the Chamber is now familiar with the fact that Lyme disease is spreading. It is spread through a very specific bacteria that is carried by ticks, often blacklegged ticks or deer ticks, and it is now spreading to other species of ticks. The bacteria Borrelia burgdorferi is a bacteria that brings with it both a potential personal tragedy and a very troubling set of symptoms for diagnosis.

As I have said, this disease is spread through ticks. As we have seen, this disease can be delivered to other areas through the agency of birds. The range in which these ticks occurs across Canada has been spreading, and it is part of the increase in vector-borne diseases that are anticipated in relation to global warming and the climate crisis.

We know there are more cases of the disease. It was shocking to many, when in the summer of 2013, the Centers for Disease Control and Prevention, in Atlanta, Georgia, issued a revised estimate of Lyme disease in the United States. Its new estimate increased the prevalence of Lyme disease ten-fold, reporting that the previous year's 30,000 cases were probably 300,000. This is a timely reminder to us in Canada that the incidence of Lyme disease is spreading.

To the credit of Health Canada, since 2009 Lyme disease has been a reportable illness in Canada. There is no question that we know it exists in Canada, and health professionals have a mandatory duty to report a diagnosis of Lyme disease. We are also aware that it is under-reported. Currently any medical practitioner who diagnosis Lyme disease has a responsibility to inform the provincial health authorities, who in turn report this to the Public Health Agency of Canada. At this point, only 310 cases have been reported across Canada.

I am sure my colleagues on all sides of the House know that the number of cases is somewhat low, just in terms of our own anecdotal experience of constituents who have Lyme disease, and from the number of petitions we have received in this place from people urging us to find a solution and urging better treatment and a cure. We cannot estimate exactly how low that is, but as in the United States, I think we will find that as we increase awareness we will have a clearer understanding of the incidence of the disease.

Let me review quickly what the bill would do. This is a bill to deal with the threat of Lyme disease, but it does it in a couple of different ways. The bill's goals are to create a national surveillance system dealing with the problem that I just mentioned; we do not always have good information on exactly where the ticks are spreading and how prevalent they are.

The other area that is important is to get a handle on better awareness, perhaps national standards, or at least a sharing of best practices, to understand the challenges of diagnosis and treatment.

The bill calls for:

3.(b) the establishment of guidelines regarding the prevention, identification, treatment and management of Lyme disease, including a recommended national standard of care that reflects current best practices for the treatment of Lyme disease;

It also calls on the Minister of Health, working with others, to create a national program of educational materials to increase public awareness, but also to assist medical professionals. The process by which this would take place is that once the bill has come into force, there would be a mandatory obligation on the minister of health to convene, within six months, a national conference of provincial and territorial ministers of health, as well as the stakeholders, who are described in the bill as representatives of the medical community and patient groups, for the purpose of developing this national framework.

I am very heartened that at this relatively early stage in the consideration of Bill C-442, it has already received the support of important elements within the medical community. I want to cite particularly, and to thank, Eric Mang, director, health policy and government relations for the College of Family Physicians of Canada, who wrote in the fall of 2013 that they support the bill. He stated:

[The College of Family Physicians of Canada] supports further studying the economic and health impacts of Lyme Disease to ensure that Canadian physicians have the necessary tools and knowledge at their disposal. Guidelines produced as part of the strategy should include the input of family physicians and be available to all primary health care providers.

Even more recently, on February 27, 2014, I was thrilled to receive a letter from the Canadian Medical Association and its president, Dr. Louis Hugo Francescutti. Coming from the medical community, it is important that I read some of this letter into the record at second reading debate. He wrote the following:

Diagnosis of Lyme disease can be difficult because signs and symptoms can be non-specific and found in other conditions. If Lyme disease is not recognized during the early stages, patients may suffer seriously debilitating disease that may be more difficult to treat. Given the increasing incidence of Lyme disease in Canada, continuing education for health care and public health professionals and a national standard of care can improve identification, treatment and management of this disease. Greater awareness of where ticks are endemic in Canada, as well as information on the disease and prevention measures, can help Canadians protect themselves from infection. A national Lyme disease strategy that includes representation from the federal, provincial and territorial governments, the medical and patient communities can address concerns around research, surveillance, diagnosis, treatment and management of the disease. In addition, public health prevention measures will advance our current knowledge base, and improve the care and treatment of those suffering from Lyme disease.

With the support of those two important associations of medical professionals, the Canadian Medical Association and the College of Family Physicians of Canada, I am encouraged to know that we can work together as members of Parliament from all parties in this place. The approach set out in the bill for a national conference urges federal and provincial jurisdictional responsibility in the health community; the medical community, the doctors, health care professionals, nurses, people who deal with trying to sort out a diagnosis for Lyme disease when it is not always easy; and the patient communities, people who have advocated, who have cried out for help, people for whom this bill represents the first ray of light in what, for many, has been years of suffering. I am enormously encouraged by the support from the medical community.

I want to now turn to the support from the patient community. I would never have thought to put forward a private member's bill on Lyme disease had I not encountered so many Canadians who are suffering from the disease. My first friend who told me she had Lyme disease was Brenda Sterling, of Pictou County, Nova Scotia. From her wheelchair, she told me that she had been bitten by a tick and now she was virtually disabled. I was shocked. I did not know Lyme disease could be so serious when I first met Brenda, but she educated me about it.

Then when I moved to Saanich—Gulf Islands and was living in Sidney, I kept meeting people who were experiencing Lyme disease, some of them kids. It is heartbreaking to know a brilliant, beautiful young woman, Nicole Bottles, who is in a wheelchair and not able to go school. It is not because the wheelchair is a difficulty, but because the Lyme disease, as she says, muddles her brain from time to time. She has trouble concentrating and she has not been able to keep up with her schooling. However, she and her mother, Chris Powell, whom I think have met many of the people in this chamber today, have come to Ottawa and advocated for Bill C-442. They see it as a way to get to better levels of awareness.

I am so grateful to James, Michael, and other young constituents, like Eric, and his family. When I think about why I chose this bill, it had a lot to do with Eric and his family. His father-in-law was a strong supporter of mine, and I wondered how I could ever thank him. I am thankful to Fraser, among many people, for my bringing forward a bill that could try to make a difference in thousands of lives.

As we work toward this bill, let us keep a couple of hopeful things in mind. One is that we should never fear the outdoors. Some people have come to me since this bill was tabled saying, “For Heaven's sake, be careful that we don't create fear of going outside”. I want to emphasize that is not my intention.

I subscribe to the view of some who have described nature deficit disorder as a real threat to our kids. They need to get out and engage with wilderness. They need to be in nature. It increases learning abilities, capabilities, and emotional maturity. It is great for kids to spend time outdoors.

We have become used to the education challenge of a thinning ozone layer, which due to the Montreal protocol is reversing the thinning process. Over the years we have become used to asking what the UV rating is, wearing long-sleeved shirts, remembering to use sunscreen, and wearing a broad-rimmed hat, something that did not occur when I was a kid. These are common-sense prevention measures.

We need common sense to be a part of our daily routine. When our kids go out to play, we need to say, “Tuck your pant legs into your socks”, and when they come in from playing outdoors, to say, “Let me give you a quick check to make sure you haven't picked up a tick”. Those kinds of things are common-sense prevention measures.

The good news when facing Lyme disease is that it is preventable. That is why a federal framework makes so much sense. If we are aware of the disease, and watchful, we will not get it in the first place. However, if we do get it and diagnosis is speedy and correct, the treatment works. The treatment need not take long, and one can recover to a complete state of health and well-being.

Lastly, let us shine a light of hope for those dealing with the challenge of continuing debilitating symptoms. With a real focus and continued research, we can find treatment measures that will work for the entire Lyme patient community.

I am indebted to all of the members who have come here this morning for second reading, and thankful for their support. With their help, this bill will become law.

February 6th, 2014 / 9:35 a.m.
See context

Director, Government Affairs and Health Policy, Reckitt Benckiser Pharmaceuticals Canada

Cameron Bishop

One of the things we do lack is an accountability mechanism for some of the regulators for the companies. I have to say I'm pleased with, for example, Bill C-17, but in that context there's a lot of stuff that could be done to tighten it up, based on the recommendations here, that could make Bill C-17 stronger and could go a little bit of the way to addressing some of the things we've talked about here today.

Vanessa's LawStatements By Members

December 9th, 2013 / 2:15 p.m.
See context

Conservative

Terence Young Conservative Oakville, ON

Mr. Speaker, last Friday, I was proud to join Canada's Minister of Health to announce new patient safety legislation, Bill C-17, the protecting Canadians from unsafe drugs act, subtitled “Vanessa's Law”, named after my daughter, Vanessa Young. In 2000, at age 15, Vanessa's life was sacrificed to maintain the sales of a Wall Street blockbuster drug, Propulsid.

It is difficult to overstate the impact the bill will have for Canadians who take prescription and over the counter drugs. It represents a quantum leap forward in protecting vulnerable patients and reducing serious adverse drug reactions.

Combined with the plain language labelling initiative announced last June, Vanessa's law would: put an end to inadequate safety warnings; empower Health Canada to order unsafe drugs off the market when dangers first become clear; require mandatory adverse drug reaction reporting, creating an early and robust warning system for patients; and, undoubtedly, reduce preventable harm from drugs and save thousands of lives.

Vanessa would be pleased that her loss of life has led to this powerful legislation to prevent similar tragedies in other families.

Food and Drugs ActRoutine Proceedings

December 6th, 2013 / 12:10 p.m.
See context

Conservative

Leona Aglukkaq Conservative Nunavut, NU

moved for leave to introduce Bill C-17, An Act to amend the Food and Drugs Act.

(Motions deemed adopted, bill read the first time and printed)