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)

[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?

[Hedy Fry, Liberal, Vancouver Centre, BC]

Yes, Mr. Speaker. The system was not as bogged down when the Liberals were in power as it is currently. The system now takes a long time to move. It takes a long time to get notice of compliance to approve drugs. It takes a long time to get out adverse reporting and that is because the government has severely cut back on the resources needed to move it forward. It has been shown that by voluntarily asking manufacturers to okay whether a drug can be recalled or whether various restrictions can be put on a drug, industry has to agree and that takes a long time.

We have learned certain things over the years. One can go back as far as the 1920s and ask why certain things were not done then. Body of knowledge information, what other countries are doing, best practices, allow us now to see where we should be going.

We should be making the strong changes that are in this legislation and we should be adding the ones that would make it stronger. We need to ensure resources are available to do so.

[Charlie Angus, NDP, Timmins—James Bay, ON]

Mr. Speaker, I remember when OxyContin was first prescribed in Ontario. At the time it was supposed to be a miracle drug because it was not supposed to be addictive. We found that it was heavily over-prescribed, leading to all manner of problems in the general community. In my region, people who would never become addicted to opiates or that were given OxyContin without explanation of the effects. It raises the question of optimal prescribing practices and the need to work with the medical community to ensure that when doctors are given new medicines on the market that the issue of side effects and the implications of those drugs are properly explained.

The Canadian Agency for Drugs and Technologies in Health currently operates the optimal use program. It produces clinical guidelines and disseminates them to physicians, but it seems that there is an insufficient relationship between the impact of drugs and how this is being explained to physicians.

Given my hon. colleague's experience in the medical community, what does she think we need to do to ensure that when drugs are brought onto the market the issue of side effects and implications of those drugs are properly given to physicians on the front line?

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, that is a very good question. It shows why this bill is important and why some of the measures have talked about to strengthen the bill would make this bill different.

For starters, when a drug goes through clinical trials before it gets to Health Canada and gets a notice of compliance, all of that information is kept absolutely secret. No one knows about it. Physicians are not warned. Pharmacists are not warned. Nobody knows how the clinical trials went, what the reasons were for accepting the drug, or what the problems were with the drug.

That is what we are asking for. They are doing it in Europe, and the FDA has now tabled its desire to do that and has put it forward.

At the same time, clinical trials are limited, in that they only go to a certain cohort of people. When the drug hits the general public, adverse reactions and risk factors, as in the case of OxyContin, do not come forward until it has been in the marketplace for some time. It is then that we suddenly find that people are finding very specific uses for it out there.

Every single opiate is addictive, and so was OxyContin. Everyone knew that, but the fact that people could take OxyContin and syringe it and add various things to it and inject it was not known in the clinical trials because they were not doing it in the clinical trials. That is another reason we want complete surveillance of drugs. It is to provide a warning, over the course of time, as to what the new adverse effects are.

It therefore blows my mind, knowing all of this, that the government would approve the generic production of OxyContin to six different generic companies within the last year, knowing what it now knows about OxyContin and having been asked not to do it.

[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.

[Alain Giguère, NDP, Marc-Aurèle-Fortin, QC]

Mr. Speaker, the text of this proposed legislation is important, but so is enforcement. Unfortunately, Canada has one great weakness: it passes bills but does nothing to enforce them. Just yesterday, we talked about rail safety issues with the distinguished member. In theory, there is a law that protects Canadians, but the Auditor General discovered that the law is not enforced. There is no real oversight, just a smokescreen.

The member indicated that the minister is open to amendments to improve what is a necessary and useful bill. My question for my distinguished colleague is this: will measures also be taken to enforce this law on the ground? Passing a bill without doing anything to enforce compliance is pointless. What guarantees can my distinguished colleague offer about the idea behind this excellent bill?

[Dan Albas, Conservative, Okanagan—Coquihalla, BC]

Mr. Speaker, I worked with the member opposite on the public accounts committee and always enjoy his joining in the debate.

First of all, this is at second reading. I believe we should swiftly send this piece of legislation to the committee so that we can have a thorough examination. Then if members have ideas about how to increase the efficiency and effectiveness of this legislation, I am sure the committee would be happy to hear them.

Specific to the member's concern about not being able to get the job done, as I said in my speech, it is important that Health Canada, through the Minister of Health, have the ability to compel recalls in a safe and effective manner. This legislation will do that.

I would hope that the member would recognize that and not only support the bill's referral to committee so that we can have it studied but also support it at third reading so that we can have this measure in place and give the tools to Health Canada to protect the health and safety of Canadians, as I am sure this member, and every single member of this place, wants to see happen.

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

Mr. Speaker, I am sure the member listened to what the Liberal Party's critic had to say on the legislation. We see the benefits of having the bill go to committee. The Liberal Party has suggested, in a very tangible way, a number of amendments that need to be made to the legislation to improve it.

To what degree does the member believe the government will listen to opposition members, in particular individuals like the Liberal Party's health critic, who is exceptionally knowledgeable about the issue and wants to improve the legislation?

We recognize there is benefit, and we want to see the legislation go to committee.

Does the member equally recognize the benefit of improving the legislation through amendments, even if they come through the opposition?

[Dan Albas, Conservative, Okanagan—Coquihalla, BC]

Mr. Speaker, first, I served on the justice committee, one of the committees I quite enjoyed working on, when it considered the not criminally responsible legislation. We actually took amendments from both the New Democrats and the Liberals where they made sense.

If we can all agree that this is good legislation, a good first step, as one member said, is to take it to committee and put forward common sense amendments that would improve the bill. I am sure they would be looked at and, hopefully, supported. We all want the health and safety of Canadians to be first and foremost.

On his other point about whether we will listen to the health critic, I am sure the health committee will say that it listens to the health critic all the time.

However, by the same token, many of the provisions she mentioned in her speech, I believe, exceed the actual bill's scope. Some of those ideas may be perfectly appropriate and some of them may be ruled out of order. We will let the committee process go forward and find out which amendments can be tabled and are in order. Then the committee can examine and articulate which suggestions should go forward and which ones should remain on the table.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

Mr. Speaker, it is an honour and a pleasure for me today to stand to support and talk to the House about Vanessa's law.

As my colleague from Okanagan—Coquihalla mentioned, this bill requires the reporting of serious adverse drug reactions to ensure that doctors and patients are aware of new risks, and introduces new tough fines for companies that put Canadians at risk. I encourage all members to support the bill's referral to committee so some progress can made on the important issue of drug safety and work toward better protections for Canadian patients.

I will focus my remarks on the importance of mandatory reporting of serious adverse drug reactions and also medical device incidents by health care institutions and how this would improve our ability to respond to safety issues that would help keep Canadians safe.

As members of the House can appreciate, drugs can not only have beneficial effects for patients, but can sometimes have unintended and unwanted side effects. These side effects, better known as adverse drug reactions, can sometimes represent very serious medical risks. What are termed serious adverse drug reactions in the bill are ones that require hospitalization and are often life threatening or result in permanent disability.

Adverse reactions to medications are estimated to amount up to 25% of emergency room visits and hospital admissions, an amazing number that would likely shock most of us. That is why I find it so appropriate that the bill has been entitled Vanessa's law, in memory of the member for Oakville's late daughter, who tragically died of a heart attack while on prescription drugs that were later deemed not safe and then removed from the market.

The bill would make it a requirement for certain health care institutions to provide Health Canada with serious adverse drug reactions or medical device incidents. This information would allow Health Canada to take steps to prevent further harm related to these products. As I mentioned, although a significant number of Canadians are admitted to hospitals each year for serious drug reactions, again 25%, this important information about drugs and medical devices does not always reach Health Canada. This is a serious concern and one that legislators can actually help address.

Our country has one of the most rigorous drug approval systems in the world. Before a drug reaches the marketplace, the department reviews it for safety, quality and effectiveness. This review is generally based on scientific data that is attained through previous studies and observed in clinical testing.

Clinical testing is an important part in the development of drugs and medical devices, and we have every reason to have the confidence in the science. However, studying drugs before they are put on the market cannot tell us everything about these products. When a drug or medical device is introduced to the real world, it may produce different results from those that were observed in a controlled clinical trial setting. In fact, some serious issues may only become known after a medical device or drug is actually on the market.

It is therefore critical that we continue to monitor the use of drugs and medical devices in the marketplace and that information on serious adverse reactions are reported to Health Canada in a timely manner. Under current law, and this is interesting, only manufacturers and sponsors of clinical trials must report serious adverse reactions. However, they do not receive reports on some of the serious adverse reactions and cannot report incidents to the department if they do not know about them.

I will give credit where credit is due. Adverse drug reactions reported to Health Canada have been on the rise over the past five years. Unfortunately, despite these improvements, it is estimated that less than 10% of adverse drug reactions are actually reported. This underreporting of important safety information is a serious concern as it limits Health Canada's ability to identify at an early stage the potential safety issues with a product and to take timely action to prevent additional patient harm.

Some positive steps have already been taken to address underreporting by educating health care professionals on the value of reporting and how to properly report to Health Canada. Pre-emptive steps have also been taken to introduce new simplified forms and electronic forms to report. Devoting health care resources needlessly to an overly complex system creates a problem in itself and nipping this in the bud is simply good policy. In addition, Health Canada has worked with standard-setting bodies such as Accreditation Canada to assist health care institutions to standardize their process for reporting. Although this has helped, it is still not enough. We need to do better.

With Vanessa's Law, we will strengthen serious adverse drug reaction and medical device incident reporting, as well as provide the tools needed to respond to unsafe drugs.

Let me give a few examples to illustrate how this safety information can benefit patients and how the bill would support these measures.

When Health Canada receives important information about a certain medical device or drug, it will take the necessary steps to prevent future harm. Health Canada could alert health care professionals to any new harms and how they could be mitigated, or require the manufacturer to change the labelling to add a warning.

We know that many serious adverse drug reactions are preventable. Taking action to prevent these harms will free up valuable hospital resources, through addressing threats to health and safety before hospitalization is required.

As alluded to earlier, we are well aware of how busy health care institutions have become and we do not intend to impose any unnecessary burden on an already strained health care system. That is why we are strongly committed to further consultations with health care institutions, as well as with provincial and territorial governments.

There is a clear commitment in the bill to developing regulations that will set out what information is required, how it is reported and which health care institutions will be required to report.

Only those health care institutions that are best positioned to improve the quantity and quality of reporting would be required to report. Only useful safety information about a drug or medical device will be gathered in ways that are efficient and within time frames that are meaningful. Again, all with a view to ensure the least burdensome way to get the safety information that is needed.

Further, it is an expressed commitment in the bill that reported requirements will take into account existing information management systems with the view to not imposing any unnecessary administrative burden. This will lead to the development of a meaningful reporting system that is not only focused on increasing the quantity of data, but also in gathering quality data.

It is important for Health Canada to continue to monitor drugs and medical devices once they are on the market. The information that health care institutions will provide on serious adverse drug reactions will allow Health Canada to assess the balance between the benefits and the risks of a drug while it is on the market. More important, it will support timely identification of safety issues and early action to prevent future harm.

Our government's priority is the health and safety of Canadians families. Strengthening the reporting requirements for drugs and medical devices will better protect Canadians and their families from preventable harm.

These important measures need to be taken, and I hope Vanessa's Law will receive support from all parties so that all of us as a country can take action for better protection of Canadians.

I am thankful for the time allotted for me to speak to such an important bill and I look forward to questions.

[Matthew Dubé, NDP, Chambly—Borduas, QC]

Mr. Speaker, I thank my colleague for his speech.

Although we support the bill, we are nevertheless disappointed that it was introduced such a long time after the problems were flagged.

I believe my colleague is aware of the 2011 Auditor General's report. After all, we were both members of the Standing Committee on Public Accounts, and he knows as well as I do that the Auditor General had deplored the time lag in disclosing information about the safety of drugs.

Does my colleague know what caused this time lag? In his opinion, why has it taken the government so long to take action in this important matter?

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

Mr. Speaker, I would like to thank my colleague from the other side for his question. We have spent time together on public accounts. When we receive the Auditor General's reports, we as a government and as a Parliament make our best efforts to improve what we may think is best for Canadians when we are going through a process or legislation.

In this particular case, we have now got an incredible bill in front of us, put forward by the member for Oakville. It is not only about his family. We all heard the speech he gave in support of this bill. What this bill would do is relate back to our communities and our families about the significance of making, in this case, some very significant changes for the protection of Canadians.

It would provide the monitoring and the ability to take products that may be harmful to us and get the labelling changed. It would introduce monitoring, so we could actually provide assurance that the medications we are taking are safe.

It is not only for adults. We know, in this particular case, that although the product may have been good for an adult, it had some very serious adverse effects for a young person.

To answer my colleague's question, we are moving ahead and we are moving ahead quickly. We want to get this bill into committee, so that if there are changes and, as the Minister of Health has said, if there are good amendments that make sense in moving this forward for the protection of Canadians, we will make them.

I look forward to the support of this bill as we move forward.

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

Mr. Speaker, I want to pick up on one of the comments that the member made when he talked about medications and drugs and the benefits versus the risks. It is critically important that we recognize that, when we have these prescription drugs, quite often there is this mindset that they are good for us and that, at the end of the day, no one is going to die from them or have negative side effects to the degree in which they prevail in society today.

That is why education is a very important aspect when it comes to medications. Along with that education, we have to have the information. We have to know the impact that these medications have, as a general rule. This is where there has been a great shortfall.

I wonder if the member would like to pick up on that particular point, which is the need not only that we have the information, but that the information be passed on through education in order to prevent people in the future from dying or falling quite ill as a result of getting prescription drugs that they should not have been taking.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

Mr. Speaker, I thank my colleague, because what he talked about is real life. One of the key issues of that question is that the education process is needed.

The other part of it is reporting when there are adverse effects. Right now, basically, the manufacturer and the sponsor are the only ones that are required to do the reporting. When we have medical professionals who acknowledge and see adverse effects that are happening to a patient, they would now have to do that reporting. That is going to be part of the education, at least at the professional level.

The labelling is going to help. We need to make sure that the labelling is also in an educational format, so that families can understand it.

[Matthew Dubé, NDP, Chambly—Borduas, QC]

Mr. Speaker, first of all, I would like to mention that I will be sharing my time with my colleague from Churchill.

I would also like to take the time to acknowledge the courage of my colleague from Oakville, with whom I had the opportunity to work in committee. To my mind, the fact that he took the time to share his experience is not only very moving, but also very important. Personal experience plays an important role in our efforts to make progress on such a file. It goes beyond politics.

As my colleagues said, the NDP will support the bill at second reading. We recognize that it is a step in the right direction. In fact, a number of my colleagues said so this morning. We also recognize that it is important to send this bill to committee in order to hear from certain witnesses who may not have been adequately consulted. I am thinking of the Canadian Nurses Association, among others, which says that the front-line workers who face medical challenges in communities were not sufficiently consulted. It will be a good opportunity for us to hear what these people have to say and perhaps to propose amendments.

It must be said, unfortunately, that we have been waiting for this for a very long time. The introduction of this bill has been delayed a bit. As I was saying earlier, when I asked my colleague a question in 2011, I was on the Standing Committee on Public Accounts. We were studying the Auditor General's report, which raised the problem of drug safety and the fact that the time between Health Canada receiving the information and sharing it with the public takes too long. In some cases it took two years, which is far too long.

I remember some of the testimony we heard. There did not seem to be a very clear commitment from the government at that time. Nonetheless, we have to look on the bright side. It is better late than never. The bill has been introduced and we believe it is a step in the right direction. We have to acknowledge that.

In this matter, we have to address a number of aspects having to do with drug safety. We will talk about it further. This is an extremely important issue. In the case of food safety, there were some explosive issues, such as the XL Foods recall, for example. This issue has a direct impact on the daily safety of thousands of people in Canada.

When it comes to food and drugs, we want to make sure that people can look after their health safely. People take drugs to feel better, not to end up with more problems. It is very important to ensure that companies can be required to recall their ineffective drugs. We must also ensure that information is shared. That is very important. What we noticed, and continue to notice, is that there is an issue with transparency and the sharing of information.

For example, one suggestion that the NDP made with regard to this issue and this bill relates to the public disclosure of the results of clinical trials. We know that information is not always being made public or shared with Canadians. I think that is a major problem, given that people often do not know anything about the drugs they are taking. They just go to the doctor and get a prescription. They rely on the doctor's expertise and the often very basic information they may have.

This is even more important today because, with all the information that is available on the Internet, many people may try to find the information themselves. If the government gave them information from reliable sources such as the department, it could be very reassuring for them. Canadians would know that the information provided by the government was reliable, accurate and complete. There is still a lot of work to be done in this regard.

Speaking of information and transparency, this also relates to food safety. I do not really like to make this comparison, since we are talking about two different issues, but they are similar in that the government and the minister need to take some responsibility. For example, with respect to the XL Foods recall, the Americans were the ones who discovered the problem. This bill contains an extremely important element in this regard: it ensures that the minister can issue a recall even when the negative effects of the drug are discovered outside Canada.

The information sent to the United States or Europe, for example, shows that many drugs are used throughout the world. We must not limit ourselves to our own experience. We must benefit from the knowledge of others.

Once again, this bill is a step in the right direction. It is becoming a recurring theme for the government to use information that was discovered, seen and recognized in other places to make important decisions regarding the safety of drugs in Canada.

The work of my colleague from Saint-Bruno—Saint-Hubert also ties into this since she introduced Bill C-523, which deals with drug shortages. At first glance, drug shortages do not seem to have a direct impact on drug safety, but I would venture to say that they do.

It has to do with transparency and the dissemination of information. It is problematic when the public—and not just patients, but doctors as well—does not have full information about drug shortages, a problem that my colleague's bill aimed to fix, because other drugs are used, including some lesser-known ones that could pose certain risks. These drugs are used in emergencies but the individuals involved do not necessarily understand all of the side effects that can sometimes be negative.

We need to understand why it is important to make this improvement. I know that a government member could tell me that the Minister of Health showed some openness on this issue last week when she claimed she was prepared to look into drug shortages. However, our team and one of our NDP colleagues made a meaningful suggestion, and this suggestion could significantly improve Canada's entire pharmaceutical system.

The provincial governments are obviously responsible for ensuring that the health care system runs smoothly. People have a lot of concerns about drugs. They need to have good information and we need to ensure that our prescription system helps take care of Canadians and does not cause harmful side effects. The public is very concerned about this, and we must take measures such as the ones in this bill to protect the public.

Although we have some concerns and this bill has some flaws, all parties can agree that it is still a step in the right direction to improve our health care system. After all, our public health care system is one of the cornerstones of our society. Any step in the right direction to improve this system must be supported.