Bill C-17 (Historical)

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

An Act to amend the Food and Drugs Act

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

Opposition Motion—Survivors of thalidomide

[Costas Menegakis, Conservative, Parliamentary 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.

[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.

[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.

[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.

[Colin Carrie, Conservative, Parliamentary 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.

[Eve Adams, Conservative, Parliamentary 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.

[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.

Health

[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?

[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—

[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.

[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.

[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?

[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.

[Libby Davies, NDP, Vancouver East, BC]

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

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

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

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

[Terence Young, Conservative, Oakville, ON]

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

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