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)

[Libby Davies, NDP, Vancouver East, BC]

Mr. Speaker, I would like to thank my colleague for two excellent questions, and I certainly agree that we will examine the bill in depth and will try to improve it.

The member made a very good point on the resources. We have seen cuts in Health Canada; however, we need the tools and resources to provide the transparency, improve the timeline of reporting on adverse reactions, and acknowledge the concerns that the auditor general made in 2011. Those all require human resources.

I do not know how much we will get into that at committee, but it is certainly something we would like to raise to make sure that the bill, when it is finally approved and implemented, would actually work and that the resources would be there.

In terms of generic drugs and the transparency that is needed, particularly if they are coming from abroad, I think the member raises a very good question. We in the official opposition are steadfast in our belief that there needs to be full transparency, not just around trials, but on any drugs that are being used.

People should be able to get drug information, whether on brand name drugs, generic drugs, or drugs that have come from somewhere else. They should get the information they need whether they are patients, researchers, or medical practitioners. Again, we have to err on the side of caution. We have to err on the side of full transparency.

I appreciate the member's point, and I think it is going to be a very interesting debate at the committee as we get into these questions.

[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.

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

Mr. Speaker, I have had the opportunity to comment on the bill and pose a few questions. I recognize that there is a need for the legislation. The Liberal Party health critic has talked about what is positive about the bill. It is also important, from the Liberal Party's perspective, that the government be open to amendments to the legislation. Given the interventions from members of the Conservative Party, in the sense of goodwill moving forward and looking to the possibility of allowing amendments, one of the interventions made the suggestion that we consider passing this legislation before we break today.

My question to the member is this. To what degree is the NDP prepared to allow this bill to pass today or does it think that it is necessary to continue the debate into the days ahead?

[Philip Toone, NDP, Gaspésie—Îles-de-la-Madeleine, QC]

Mr. Speaker, I thank my colleague from the other opposition party for his question.

There was barely one hour of debate on this bill when it was introduced in the House in December. It deserves much more attention. I think the committee deserves to hear what the House thinks to get a better idea of what direction the House would like the committee to take.

We invite members to share their constituents' thoughts on this bill in today's debate, to ensure that the debate is complete. We need more debate. The amount of time spent on this debate depends on the members in the House, on both the opposition and government sides.

It is up to the Speaker and the members to decide how long this bill should be debated.

[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 would like to thank the member for his suggestion.

[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?

[Philip Toone, NDP, Gaspésie—Îles-de-la-Madeleine, QC]

Mr. Speaker, I thank my colleague for her question.

That actually brings us to the issue of transparency and the real trust people have in this government when it comes to consultation.

Previous bills have eroded this trust. It is very difficult to trust the government when consultations are often bogus or non-existent. We know that the government often tries to push bills through the various stages very quickly. Mammoth bills are a very good example, because we have very little time to debate them. However, we need to take the time to do so. I want the House to be able to express its point of view so that the committee understands the direction the House is taking.

I invite the members of the House who want to move forward more quickly to make their comments as soon as possible so that we can guide the committee in its work.

In addition, the government often—all too often—tends to limit debate on bills. We have seen this on many occasions. I hope the government will clearly understand that a bill must not be passed quickly; instead, it should be well thought out. Experts and stakeholders must be given an opportunity to testify.

We hope there will be a good debate in committee, as well as in the House.

[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.

[Terence Young, Conservative, Oakville, ON]

Mr. Speaker, I would like to thank the member for his speech and his remarks. He made comment about the difficulties in the pharmaceutical industry in bringing a drug to market and addressing the issues in the health care field.

It is worth noting, though, that one of the key problems in the industry is that most of what is produced is drugs that offer no significant new therapy. The source of that information is the marketed products prices review board of Canada. It reviews every new drug that it wants to get approved on the market, and it decides if it is a significant new therapy or not. If it is a significant new therapy, it will allow for more to be charged for the drug.

In the past, it has had years where, when the drug companies come to Canada to apply to put on the market and get a notice of compliance, as many as 97% of all new drugs are copycat drugs. The companies have taken a molecule of an existing drug, such as Viagra, and made a new drug out of it, such as Cialis or Levitra. It is a variation of an existing drug on the market. That is the industry's key problem. It is not coming up with new drugs that offer significant new therapies.

I would like to ask the member to go to your House leader. You have recognized the importance of the bill. Ask your House leader to help us send it to committee today.

[The Acting Speaker, Conservative, Barry Devolin]

I presume it is not my House leader.

The hon. member for Louis-Hébert.

[Denis Blanchette, NDP, Louis-Hébert, QC]

Mr. Speaker, I thank the member opposite for his comments.

I hear his suggestion, and we all agree with the bill in principle, but I would like to know why his House leader did not put this bill forward faster. Why did his leader not introduce it faster?

We are not here just to do trivial, unimportant things. What we do here has an impact, and this time, it will have a real impact on the health of Canadians. In the lead-up to his question, the member talked about new drug molecules and variations on molecules, demonstrating just how complicated the drug sector is.

That is why I think we need the best possible legislation. We do not want to have to revisit this issue with new legislation because the work was not done properly the first time around.

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

Mr. Speaker, when we think of medications, it is important that we recognize that there are benefits versus risks. I would think that one of the greatest challenges that we have within government is the education about those benefits and risks.

A part of education means that we have to understand where we have issues with certain drugs when the risks are too high. There is this lack of information flow that supports Health Canada and other organizations to be able to educate the user. This is something that is critically important. I say that, because when I look at this legislation, what the Liberal Party and I see is legislation that at least moves us in the right direction. The Liberal Party's health critic has spoken on this legislation and indicated that we would like to see the bill go to committee. We are even prepared to see the bill go today.

My question for the member is, if the NDP is not in a position to pass this today, does he believe that they would like to get the bill called again? If so, when would they like to see it called again?

[Denis Blanchette, NDP, Louis-Hébert, QC]

Mr. Speaker, I always find it strange that, when a piece of legislation deserves our attention, they tell us we have to act fast.

If a piece of legislation is important and vital, we have to take our time with it, pay attention and propose amendments. When members of the House rise to give speeches, what are they doing? Nothing less than enhancing the work of the committee when the time comes to study the bill. This is enhancing that work. That is why I think we have to carry on for as long as it takes.

[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.