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.

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

[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.

[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.

[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.

[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?

[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.

[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.

[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.

[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.

[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.

[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 Prepulsid 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 Prepulsid. 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.

[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.

[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.

[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.

[Dan Albas, Conservative, Parliamentary 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.

[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?