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.

Food and Drugs Act

[Megan Leslie, NDP, Halifax, NS]

Mr. Speaker, of course resources are needed that go hand in hand when it comes to drug safety. I will say, though, that I am really going to fight for changes in legislation here.

I was doing media commentary in 2012, about Alysena 28, the birth control pill. There were about two or three rows of sugar pills in this birth control package, so women were at risk of pregnancy. For some women, it is a very serious medical issue if they get pregnant. People make all kinds of decisions about why they are taking birth control.

I did media for the NDP when that was happening. I was so frustrated because it was actually a pharmacist who disclosed that this was happening; it was not even the government. I wondered where the government was and why it was not doing something about this. The government actually could not say to the company that it had to recall it.

There are some legislative places where we need to give powers to the minister. Of course, then, the next step is making sure there are resources, so the minister has the ability to enforce them. We do need to make those changes to legislation.

[Murray Rankin, NDP, Victoria, BC]

Mr. Speaker, I thank the member for Halifax for her very passionate response to an equally passionate and powerful presentation by the member for Oakville.

In the member for Oakville's speech, he referred to the fact that GlaxoSmithKline, as just one example, paid a fine of $3 billion, having made $26 billion in the period of time at issue. However, what I see in this bill before us, if I understand it properly, is that the maximum is $5 million and imprisonment, I am pleased to see. As the member for Oakville pointed out, no big pharma rep has ever been to jail.

As you talk about the amendments you would be seeking in this legislation, would you support a larger fine beyond the $5 million that is currently in the bill, in order to address the huge discrepancy that the member for Oakville brought to our attention?

[The Speaker, Andrew Scheer]

I would just remind the hon. member for Victoria to address his questions to the Chair, not directly to the member for Halifax.

The hon. member for Halifax.

[Megan Leslie, NDP, Halifax, NS]

Mr. Speaker, I would really look forward to a discussion at committee about just that, hearing from some experts like Joel Lexchin, for example, from York University. That is because the point of fines in this case would be to deter. Companies are making unfathomable amounts of money, so if the fine is not high enough, it is just the cost of doing business. It is much like the cost of doing business is sending their pharmaceutical reps for a cruise after they score a good contract, or down to the south with their families for a couple of weeks. This really happens. It is a gravy train, if one gets a job as a pharmaceutical rep.

Therefore, if a fine is just the cost of doing business and they are still going to make tonnes of money because they have changed one molecule in a drug, then it is not serving the purpose, is it? We will have to ask that at committee.

[Rosane Doré Lefebvre, NDP, Alfred-Pellan, QC]

Mr. Speaker, today I am honoured to be speaking to Bill C-17, An Act to amend the Food and Drugs Act.

Before I begin, I would like to thank the hon. member for Oakville for the courage and determination he has shown in having this bill introduced in the House and in supporting it, as it touches him personally.

It is very important that we debate such a sensitive and important bill. The federal government must shoulder its responsibilities regarding the Food and Drugs Act. It is good that we are debating this today. I would like to assure the hon. member opposite, the member for Oakville, that the official opposition will be supporting the bill.

I understand that the minister would be open to amendments. We would be more than pleased to participate in the debate and put forward amendments to Bill C-17 so that it can be improved and so that we create the best legislation possible. In that way, we can keep cases like Vanessa's and so many others from happening in Canada.

The NDP will be supporting Bill C-17, which makes several key improvements to drug safety laws.

First, it allows the government to recall drugs or order the distributor to take corrective action to remedy the problem with the drug. That is an extremely important element, one that I will come back to later on in my speech.

Second, it allows the health minister to order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. The minister can also order a review of the drug and require that a copy of the review be given to the department. In addition, the minister can require manufacturers to update Canadian information about the risks associated with their drug even if the safety risks were discovered in other countries

This bill is a good first step in establishing a comprehensive drug plan and in setting the course for our society on this issue. After calls from many health care professionals and advocates, this bill will finally grant the health minister the necessary power to pull unsafe drugs from the market and ensure better labelling of possible adverse effects of drugs.

We support this legislative measure and we hope that even more practical measures will follow. We support this bill, but there is still much to be done to improve drug safety measures. We will therefore propose amendments to improve this bill in committee.

We hope that our efforts will lead to a comprehensive piece of legislation that will include follow-up by Health Canada on adverse drug reactions, increased transparency with regard to the assessment of prescription drugs and a better system for communicating the risks associated with drugs to health care professionals and patients, in particular.

As I mentioned, this bill will make it possible for the government to compel manufacturers to recall drugs and order distributors to take corrective action to resolve problems with their products. In this regard, at the end of her speech, my colleague from Halifax gave the example of a mistake that was made in 2011 by the manufacturer of Alesse 28.

Alesse 28 is a type of birth control pill that generally works on a 28-day cycle. Women take the product for the first 21 days and then they take a placebo for the remaining seven days. The placebos are often just sugar pills. The problem that occurred had to do with the content of the pills. Rather than containing 21 birth control pills, a package of the product contained two weeks' worth of placebo pills.

Obviously, this can have a rather serious impact on a woman's menstrual cycle. I do not necessarily want to get into the details of how the menstrual cycle works, but having good birth control that works is really very important.

Since 1969, the year in which woman were given access to oral contraceptives, thousands of women in Canada and throughout the world have been using this method of birth control. I have used it myself, as many other female members of the House likely have, and many Canadian women use it.

It is an extremely important part of our family planning, for all sorts of reasons. There are various reasons why women use birth control. A drug that does not have the anticipated effect can have an extremely harmful impact on the health of women and on family planning.

These thousands of women trust in the system, in our health care system and in the drug manufacturers. The women affected by this problem experienced low hormone levels, which caused a number of problems. The main purpose of the product is to prevent ovulation. The placebos prevent that prevention, so to speak, and allow the woman to ovulate. That can have a serious impact on family planning.

Bill C-17 could do something about this. How did people find out about this mistake? Pharmaceutical companies were certainly not forthcoming about it. Pharmacists were the ones who sounded the alarm after noticing that there was a problem with the drugs they were selling. If the pharmacists had not spoken up and told people about the situation, the pharmaceutical companies surely would not have told anyone. There is no telling how far the situation might have gone.

It is good to know that with Bill C-17, new provisions will enable the federal government to do something. Currently, it cannot do anything about situations like that. The government has no power to act. It is very important to create legislation to address these situations. I am speaking on behalf of many women who believe that the federal government should have a say in the matter. We have to make sure that women have access to the best possible drugs, the best possible oral contraceptives.

Once again, I would like to thank the member for Oakville for introducing this measure in his bill.

As I said, we will support this bill at second reading, and we will probably put forward a number of amendments in committee just to make it better. That said, we do think that it is a step in the right direction.

We would like to see several more things in this bill. I know that I will not be able to go into detail because my time is almost up, but the bill ought to include a number of measures, such as optimal prescribing practices to ensure that Canadians are being prescribed the most appropriate drugs. Public disclosure of clinical trial results is also important because, in Canada, the results of numerous clinical trials are never published or made available to the public. We are also asking the government to strengthen the common drug review.

In closing, I would like to say that Bill C-17 is a step in the right direction and that the federal government has to step up to its responsibility with respect to the Food and Drugs Act. I am also pleased that the government is so open to amendments that might be put forward. I am very happy that we are talking about this bill in the House. I can assure the member for Oakville that we will vote in favour of the bill and that we will make sure it is the best it can be.

[Terence Young, Conservative, Oakville, ON]

Mr. Speaker, I want to thank all the members for their contributions to the debate and their kind words today.

The member for Victoria raised an issue, and I guess he did not hear what I said in my speech. I mentioned that for situations of criminal negligence, where a pharmaceutical company covers up the risk of one of their drugs and it leads to serious harm to patients, there is authority for unlimited fines.

If a judge saw fit, he or she could fine the drug company, for example, the total amount of sales for that drug for the period it was on the market. That would be the absolute best way, and I would suggest the only way, to stop these corrupt practices.

The key problem with the pharmaceutical industry and why Vanessa's law is so important is that CEOs of pharmaceutical companies, like all companies that sell shares on the market, have to by law increase shareholder value. On the other hand, there is no law against putting a risky drug on the market because all drugs cause adverse effects.

It is the level of the risk that has to be monitored. That is why Vanessa's law is necessary.

[The Speaker, Andrew Scheer]

We have time for a brief response before we move on to members' statements.

[Rosane Doré Lefebvre, NDP, Alfred-Pellan, QC]

Mr. Speaker, I thank the hon. member for Oakville for his comments. I must say, I am very happy that the bill contains provisions to change the current system.

As I already mentioned, the NDP will vote in favour of Bill C-17, and we look forward to discussing it in committee in order to make some changes that are even more significant. I appreciate the comments from the member for Oakville.

[The Speaker, Andrew Scheer]

There will be approximately three minutes left for questions and comments after question period.

Right now we will move on to statements by members.

The House resumed from March 28 consideration of the motion that Bill C-17, An Act to amend the Food and Drugs Act, be read the second time and referred to a committee.

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

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, I rise to support this bill, but to support sending it to committee. While this bill is a substantial improvement on the status quo, it has still taken the current government eight years, even though as Liberals we have pushed the government to change the way it regulates, the way it develops, and the way it looks at drug safety for Canadians.

However, the Conservatives have put the bill forward and there are some pieces of the bill that we like, but we think it falls short. There are other things we would like to see in this bill, and the minister herself has said in the House when she introduced the bill that she is open to amendments, so we are taking the minister at her word, and we are going to say we would like it to go to committee. We hope the minister will be true to her word and will look at our amendments then.

Here are some things we like about the bill.

We think that the minister getting the power to recall drugs is a very important piece that has been a long time coming. The minister has to be able to do so without first getting the manufacturer's approval. Before this, the minister had to get the manufacturer's approval to recall a drug or to say that a drug has severe side effects. The new language says that “If the Minister believes that a therapeutic product may present a serious risk of injury to human health...”. That is good language, and we support the minister getting those powers.

The minister used to have to overcome the reluctance of the companies to want to give that information. Now the minister would have the ability to compel industry to provide the information about the drugs that the minister wishes to either seek a notice of compliance on or that are actually out there in the public, and be able to recall them. This is all common sense, but it is crucial because nobody but the company itself knows the background of the clinical trials, of how the company formulated the drug and how that innovation occurred. Therefore it is important that the company is made to be forthcoming with some of that information.

What we also like about this bill is that the minister would compel health care providers and pharmacists to mandatorially report at-risk drug reactions. As a physician, I can say that was a difficult thing to do because it meant that physicians, after a whole busy day of seeing patients, at the end of the day then had to report all these things. It can take sometimes two hours out of their day. Now that the minister would provide an electronic means by which this could be easily done, it would make it much easier for physicians to comply with this.

The minister's ability to enforce conditions on market authorization and to compel changes to product labels is also very important, and the ability to move that forward would ensure patient safety. We think that is important, but we also want the minister not to do so in a hurry so that it would stop due diligence in terms of the ability to get the kind of information we need.

The fines of up to $5 million a day for the failure to remove a drug or the failure to obey the enforcement measures by the minister is also a very positive area.

Members will notice that we are saying that there are some very positive things about this bill. However, before this bill came about, I was writing a bill on this very same thing because we got a little tired of waiting for the government to do this after eight years; so I had some round-table meetings with experts on the issue. Here are some of the major elements that these experts feel are missing from the bill, which would make the bill stronger: better implementation of the ability to ensure patient safety, to ensure that there are appropriate regulations, and to ensure pre- and post-market surveillance of drugs.

This is about the precautionary principle, which should give the minister the power to ensure that the first and foremost thing she or he is concerned about, wherever possible, is being sure that on reasonable grounds, to prevent potential injury to a person or a citizen, the minister has that power to recall or remove a drug or not allow for notice of compliance. “Reasonable grounds” is sufficient. The minister should be protected for her ability to do this, using the term “reasonable grounds”. The minister's power should not just be limited to those who sell the drugs, because we know that in some areas the people who manufacture the drugs are not the people who sell the drugs.

They have different production arms and different distribution arms that distribute their drugs under different names. Therefore, it is important for the minister to look at the whole chain of distribution not merely at the manufacturer when recalling a drug.

Right now I think that the definitive issue of injury or harm is up for interpretation. For instance, let us look at the birth control drugs that did not work recently. No one felt that this was an important reason not to allow the drug a notice of compliance or to recall it, because they felt that if women became pregnant when using a contraceptive that did not work, it was not an adverse reaction and it did not cause severe injury or harm, because pregnancy is a lifestyle choice. I think that was a bending of the interpretation of what harm is. If women are taking a contraceptive, it is because they do not want to get pregnant. If they get pregnant, that is an adverse reaction. I think the ability to define what is injury or harm should be more clearly spelled out for two reasons: one, to protect the patient; and, two, to protect the minister from any kind of reaction from the company because it is clear what she means and what the legislation means by injury or harm. That should be clearly spelled out. It should be based not on subjective but on objective criteria that are in keeping with what we know about risks and harms pertaining to drugs. That would provide the minister protection and give her broader powers.

As well, we know that we cannot tell the adverse effects of a drug purely from the clinical trials. When a drug is undergoing clinical trials, it is done with a cohort of people who have been chosen, and out of that cohort it can be decided what the negative and adverse reactions are to the drug. However, when the drug goes out into the main community, into the citizenry at large and the general public, individual reactions to drugs can differ. While people may not have had reactions during the clinical trial, others in the main community may show adverse reactions. Therefore, the minister must have the ability to say that, although the government gave the drug a notice of compliance, due to the new reporting requirements for physicians and pharmacists it has noticed that after a year or six months there are adverse reactions that were not intended and did not show up in the clinical trials and that the drug will be recalled temporarily while we check on these. Then, ensuring that the precautionary principle is in place, the government can look at the drug and either put it back on the market if changes have been made or permanently recall it before it does any further harm.

To clearly define what we are doing is in the best interests of the minister. It would protect her from any kind of legal suit and so forth. That is an important piece we would like to see included.

The Auditor General has spoken on many an occasion about the lack of transparency in Health Canada's decision-making process. For instance, Health Canada publishes only very limited information on drugs and high-risk medical devices for which a notice of compliance is applied for. However, it does not tell us why it did not allow a drug a notice of compliance. It does not tell us what its opinions are about the drug, even though it may give it a notice of compliance and say that it is generally safe. There may be other clinicians who have said there are some concerns about the drug. Health Canada should put that out there to the public, so that pharmacists, prescribers, and patients would know that there could be some conditions under which the drug was allowed to go out there. There may be some potential negative effects with which the minister and the department are concerned, but they are releasing the drug anyway. That was in the bill when it was put forward as Bill C-51. I noticed it has been removed. I wonder why, because it was a very good piece in that legislation that we agreed on and that the Auditor General wanted to happen. That enhances the transparency of Health Canada in terms of its regulations and looking at drug safety.

We cannot afford to use the fact that the manufacturer does not want us to give out trade secrets. We do not have to give out trade secrets when we are saying that we think there may or may not be a problem that we have in the back of our mind even though we have put the drug out there. It is an important thing to do. Europe is doing it. The European drug agency is putting out what the negative opinions are on a particular drug, even though it felt that the benefits outweighed the risks and that is why it put it forward.

There should be a legal requirement to register clinical trial data. This should be open to physicians, patients, and pharmacists so that they are able to know what clinical trial data shows. Now, I know that the government thinks that would let out trade secrets. However, the European drug agency is doing this.

The clinical data that is put out in terms of the clinical trial does not have to disclose proprietary issues regarding the drug itself or its trade secrets. It is about the ability to ensure patient safety, which is foremost in the mind of Health Canada, as it should be. Therefore, to release the full report of pre- and post-clinical trials and surveillance on an ongoing basis is an absolute necessity, but it is not in the bill. Not only is the European drug agency doing this, it is thinking of expanding it to bring in anonymous or non-nominal general patient responses to the drugs so that, again, there is full knowledge and full disclosure. Also, the FDA has just tabled its intention of doing the same thing.

Canada is way behind both Europe and the United States in terms of looking at patient safety, in terms of full disclosure, and in terms of acquiring full disclosure by the manufacturers, who do not seem to be worried about the proprietary issues of trade secrets because they know what to put in and what not to. Clinical information is not a proprietary trade secret. The formula of the drug and how the innovation occurred are proprietary trade secrets, but not clinical trials or data about them.

It is important for the minister to strengthen the bill by doing this and to do everything under the rubric of good independent research, and not just the companies' research. There should be an independent body that looks at those clinical trials, and not just Health Canada. Again, Europe is doing that, and the FDA has tabled its intention to do that. It has to be done in the name of public safety and good evidence-based information.

We would like to see more transparency from Health Canada on why it gives a drug a notice of compliance and why it does not. What are the reasons? Again, we need to know that about certain drugs. People read about drugs, and when they find out that other countries use certain drugs, they wonder why Canadians cannot get it. They want to know why they are not allowed access to drugs that could save their lives, et cetera.

Good information helps people understand why certain decisions are made. However, right now we do not know anything about why Health Canada approves a particular drug or not, why certain drugs are suspended, and why some drugs remain on the market in spite of adverse reactions in other countries. These are some things that we feel would strengthen the bill.

Disclosure in the name of public safety is always very good. We need to ensure that the first thing in the mind of Health Canada when it approves a drug, or not, is that people can trust Health Canada to make good decisions in their best interest, and be able to do so in an objective and clinical evidence-based response. I think that right now Health Canada faces a great deal of mistrust from the public and drug prescribers because it is not transparent in some of these things.

Why would the bill allow government and cabinet to impose stringent rules favouring data protection of manufacturers under the Food and Drugs Act? We do not think that should be able to stand alone.

We have seen issues where people have asked for drugs, but the government has said that the Food and Drugs Act is the reason it is not doing certain things. However, the Supreme Court of Canada has ruled very clearly that the issues of right to life, liberty, and the security of the person trump any piece of legislation, which is under section 7 of the charter. Patient safety should be foremost in anything that the bill would bring forward.

We oppose the amendment to the Food and Drugs Act in the bill to protect manufacturers' data. It should only be for proprietary data protection and not for anything else. The government should be protecting the patient, and Canadians.

The Liberal Party thinks that the bill is long overdue. There are some good points in Bill C-17 that move forward, with some steps we approve of, to enhance patient safety and knowledge of drugs for therapeutic prescribers.

The minister said that the bill should be open to amendments. We have, as I said just now, about five amendments we would like to see that would strengthen the bill. We approve of big chunks of the bill, and we would like to see the bill go to committee. We hope that the minister will be true to her word and allow for amendments to come forward so that the bill can go to the House and be accepted by all of us unanimously, because it is in the best interest of patient safety.

[Carol Hughes, NDP, Algoma—Manitoulin—Kapuskasing, ON]

Mr. Speaker, I agree with my colleague that this legislation is actually a good first step towards a comprehensive plan. There have been many calls from health professionals and advocates. The bill will finally grant the Minister of Health the necessary power to pull unsafe drugs from the market and ensure better labelling and possible adverse effects of drugs.

We have to remember that in 2011 the Auditor General warned that consumers are not receiving safety warnings about pharmaceutical drugs fast enough because Health Canada is slow to act on potential issues that it identifies.

New Democrats feel we need optimal prescribing practices. We want to make sure that Canadians are prescribed the most appropriate medication, that they know the medication they are taking is safe, that it is necessary, that it is prescribed the right way for the problem, and that negative side effects and drug interactions are avoided where possible. Every Canadians wants to make sure of that, but there have been situations where that has not been the case.

The Liberals had 13 years to do something on this when they were in power, and they failed to act. Does my colleague believe that Health Canada should increase the resources of the Common Drug Review, so that it can expand its work in evaluating the cost and effectiveness of prescription drugs? I think that would be a move in the right direction. Can she let me know whether or not she agrees with that?

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, the member's question is a good one.

One of the reasons we see such a delay, as the Auditor General pointed out, in telling adverse effects is because there are insufficient resources, but also because there was not any mandatory adverse drug reporting by physicians and pharmacists. The bill will go a long way to do that.

However, as the member heard, it is really important that the government be able to implement the elements of the bill when it is put forward and it has the resources to do so, and that it has some sort of independent advisory group that can look with a very clinical and objective eye at the drugs coming out, look at the clinical trials and say whether that drug is appropriate, whether it is needed, and whether its benefits outweigh the risks. There is no drug without a risk, not a single drug I know of that does not have a risk. It has to be benefit versus risk, but resources would go a long way to ensuring that all of this is done.

If we do not have resources, we see the same delays the Auditor General talked about. It is almost a year sometimes in getting some of that information out to the patient and the prescriber.

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

Mr. Speaker, my colleague is very knowledgeable about health care in general and recognizes the importance of pharmaceuticals that are affordable and safe. We try to ensure that patients receive the type of pharmaceuticals, prescription medications they need, but cost is becoming more and more of an issue.

Could the member comment on the ever-increasing cost of prescription drugs in Canada?

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, having a drug is one thing but the ability for people to access the drug is another.

Recent studies have shown that one in five patients with a chronic illness is not able to afford prescriptions so the medication is taken sporadically, which means that the medication is not doing the good it should do. People are getting sicker. When they go into a hospital this increases hospital costs and acute care for the patient. The ability to afford prescriptions is an important factor.

Canada is the only country in the industrialized world with a universal health care system that does not have a universal pharmaceutical strategy. One of the core objectives in the 2004 accord was to look at a national pharmaceutical strategy. The government, in its wisdom or lack thereof, completely ignored that in 2006. What we now have is one of the most costly and non-accessible pharmaceutical systems in the world.

We should be looking at what other countries are doing. New Zealand, for example, has a system whereby when the government buys a drug for a formulary, the cost is so much lower than the cost in Canada. We are paying the second-highest cost for drugs in the world. This is really ridiculous.

We need to look at a good pharmaceutical strategy. If we had the United Kingdom's national pharmaceutical strategy, we could save $14 billion a year. If we had the New Zealand pharmaceutical strategy, we could save more than that. That money could be put into the health care system in terms of health promotion and disease prevention, palliative care, mental health, all of the pieces that are missing right now.

It is like being penny-wise and pound foolish. I do not understand why the government has not let that happen and has let it lag.