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)

[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.

[Terence Young, Conservative, Oakville, ON]

Mr. Speaker, I want to thank the members opposite for supporting Vanessa's law, Bill C-17, the protecting Canadians from unsafe drugs act. I want to give my sincere thanks to all the members who are supporting it.

I am pleased to tell the House that we have had really tremendous cross-party support. This is a non-partisan issue, of course. This legislation has received that support since it was introduced. In fact, the NDP health critic, the member for Vancouver East, issued a press release the day it was tabled and called it a step in the right direction, as the member opposite just did.

I was also happy to hear that the Minister of Health has heard support from the Liberal member for Malpeque, who urged the minister to secure passage of Bill C-17, Vanessa's law, which will strengthen the federal government's ability to provide oversight and to take action to assure the safety of drugs after they have been approved.

I want to thank that member for that support as well.

The cross-party support this bill has received is very encouraging, and I look forward to working with these members and others in securing its swift passage. To that point, I want to request that we please get this bill out of the House today. I am hoping it will be approved to go forward to the Standing Committee on Health, of which I am member.

If we do that quickly, we can get it to committee next week. It is my wish and my hope that this bill will be passed before the end of June in the House of Commons and sent to the Senate. This is important, because Canadians are suffering adverse drug reactions daily. If we hold up Vanessa's law, that will continue and will be more likely to continue throughout the summer. The publicity from this bill is making Canadians more aware of the risks of adverse drug reactions when taking prescription drugs.

I ask members to help get this bill out of here by noon today, get it to the Standing Committee on Health, and get it approved and sent to the Senate, for the safety of Canadians.

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

Mr. Speaker, we do indeed recognize the work of this member, but we also recognize the work of all the members and critics involved in this matter. Clearly, we recognize the urgency of the situation. We also recognize the importance of raising certain issues and making the necessary improvements in committee.

My colleague talked about the positive aspect of this bill receiving support from all parties. However, it is important to point out another positive aspect in that the government seems to be prepared to hear some amendments at committee stage.

Once again, let me congratulate the member for his courage to participate in this debate and to use his personal story. I agree with him that our health care system is one of the cornerstones of our identity and our society. We must ensure that the system works properly, especially when it comes to drugs. At the end of the day, those drugs intended to treat people must be safe.

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

Mr. Speaker, I am encouraged by the intervention by the Conservative member in regard to the bill. In essence, he has requested that we try to get this bill passed here this morning.

Given the assurances provided by government members, and particularly by this Conservative member, there is merit in concluding this bill before lunchtime. I would ask the member from the New Democratic Party if his party is prepared to allow it to pass before lunchtime. I suspect that we could get consensus to do that.

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

Mr. Speaker, I will not speak for my colleagues. Since I am sharing my time with my colleague from Churchill, perhaps others will want to comment on the issue and add their two cents' worth to the debate. It is not for me to stand in their way. That is their right as members of Parliament.

However, we do recognize the urgency of this matter, just like the members of the other parties. At the same time, I will leave it up to my colleagues who wish to speak to do so. We are also going to make every effort to work effectively in committee and ensure that the bill will be studied, in order to keep improving the situation.

[Niki Ashton, NDP, Churchill, MB]

Mr. Speaker, I am very pleased to rise in the House to speak on Bill C-17, an act to amend the Food and Drugs Act.

As has been stated in the House, we in the NDP are supporting the bill at second reading. We believe that Bill C-17 would bring several key improvements to current drug safety laws.

The bill would allow the government to recall drugs or order a distributor to take corrective action to remedy a problem with a drug. The health minister could order a manufacturer or importer to modify the label of a drug to update the side effects or health risks associated with it. The health minister could order a review of a drug and require a copy of the review. The bill would require manufacturers to update Canadian information on the risks associated with a drug, even if the safety risks were discovered in another country.

We believe that this bill is a good first step in protecting Canadians' health and in improving the gaps in current drug safety legislation. Most importantly, it would give the health minister the long-needed power to recall unsafe drugs and to require that drugs undergo further testing if they appear to pose a health risk.

However, we believe that this proposed legislation does not go far enough. We want to see more comprehensive drug safety planning that goes beyond the measures in the bill.

As I have acknowledged, Canada needs a comprehensive drug safety plan so that Canadians can be assured that their medications are safe for use. Canadians need to have access to plain-language information about why their medications are safe, including on testing processes and on medication labelling.

To give some background, we know that 150,000 Canadians annually experience serious reactions from prescription drugs. In 2013 alone we saw several major drug safety incidents, such as diluted chemotherapy drugs given to over 1,200 patients in Ontario and New Brunswick.

France banned the product Diane-35 in January 2013 after four French deaths were linked to the drug, but Health Canada has remained quiet and has refused any follow-up action to ensure that Canadians are aware of the risks. Off-label use of acne medication Diane-35 is linked to nine adverse reactions causing death in Canada.

Another example is drug-maker Apotex, which was sanctioned by the FDA due to concerns raised about quality control and repeated deficiencies at two of its Toronto area manufacturing facilities. Health Canada was apparently not concerned about the warnings, even though it had not inspected the facilities since 2011.

Finally, I and many of my colleagues have raised a drug incident with the minister, and I know that many Canadians have been concerned about this, particularly Canadian women.

For example, there have been voluntary recalls of high-profile drugs used to treat heart problems, high blood pressure, infections, and mental illness. However, I want to point to a particular concern, as I said, for Canadian women, which is the birth control pill Alysena-28 and five other popular birth control pills that were voluntarily recalled or had serious safety warnings issued about them: Diane-35, Yaz, Yazmin, Esme-28, and Freya-28.

Despite warning signs and the fact that many Canadian women were sharing on social media and with the mainstream media information about the deficiencies they were noticing and hearing about, the Conservative government was slow to act in terms of recalls.

We know that most risks associated with prescription drugs are identified after they are introduced to consumers. Almost one-fifth of new active substances approved by Health Canada between 1995 and 2010 were later given serious safety warnings. Despite this, Health Canada still does not require post-market drug studies.

We know that seniors are five times more likely to be hospitalized for adverse drug reactions. A recent study showed that one in 200 seniors are hospitalized for an adverse drug reaction versus one in 1,000 for other Canadians.

We know that seniors are often on more medications, and this demonstrates the need for a better evaluation and monitoring system to prevent adverse reactions.

We also heard from the Auditor General, who in 2011 reported on Health Canada's regulation of pharmaceutical drugs. The Auditor General at that time stated:

The Department does not take timely action in its regulatory activities, with the exception of its review of two types of drug submissions. In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information.

The Auditor General went on to raise various concerns when it comes to our regulation system.

When it comes to delays in terms of drugs that are necessary and have been proven to be very beneficial to people, I want to draw attention to the pill RU-486. Sadly, too many people have not familiarized themselves with the literature. It is an integral method in terms of reproductive choices, including medical abortion, that women have around the world in countries like the U.S. and 56 other countries. We know that Health Canada is taking too long in approving this pill. Despite the fact that it has been shown to be beneficial, we have yet to see an approval that would put Canada in the group of so many like-minded countries in making sure that women have access to medication they actually need.

We acknowledge that this is an important first step and a step in the right direction. However, we need the government to be far more proactive when it comes to drug safety and when it comes to recognizing the importance of making medication available to people.

I want to share one particular area where the federal government, sadly, is not showing leadership. It is in the cutbacks to medical coverage, including drug coverage, for first nations people. In fact, just yesterday, I met with the leaders from a first nation in Manitoba, Fisher River, and spoke with other first nations leaders who are very concerned about the cuts to non-insured health benefits, including drug coverage. It is a situation that is sadly putting more and more first nations people, including elders, in vulnerable situations, given that they are not able to access the kind of medical service and coverage they need to be the healthiest they can be. I am particularly concerned that this is affecting a population that we know lives disproportionately in poverty. They often have less access to medical services, such as the care of a doctor, or nurses, for that matter. I find it particularly troubling that the government, despite its commitment to moving forward when it comes to safe drug coverage, at the same time is cutting drug coverage for first nations people who would be covered under non-insured health benefits.

While we acknowledge that this is an important step, we also ask for leadership from the government when it comes to drug safety, drug coverage, and understanding that the federal government has a critical role to play in ensuring safety for the citizens of our country. Certainly we in the official opposition, the NDP, stand on the side of so many Canadians who are asking the federal government to finally take action.

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

Mr. Speaker, I listened with great interest to my hon. colleague and the points she raised in this important discussion on ensuring that we have the protocols in place to protect health in dealing with drugs that are being put on the market.

One of the questions that has been raised is the importance of public disclosure of clinical trial results. Currently the results of many clinical trials are never published or made publicly available in Canada. There has been a move to have these reports, good or bad, put out there so that patients, physicians, and researchers have all the information they need to deal with new drugs being put on the market.

In 2005, the World Health Organization stated its support for the requirement to register clinical trials, to develop worldwide standards for trial registration, and to encourage sponsors to make their data public. I would like to ask my hon. colleague what she thinks about the importance of making the clinical trial information on the drugs being prepared available to the public.

[Niki Ashton, NDP, Churchill, MB]

Mr. Speaker, absolutely, it is critical to take leadership on this front and to respond to the call of the global community when it comes to transparency and really supporting safety of clinical trials of drugs that Canadians would use. This is obviously very connected to the drug that I mentioned, RU486, where Health Canada has been notoriously cryptic. In fact, at first, it said it was not in trial and then it remembered it was and yet, there is no way for us to know at which stage it is and what these trials look like. All we do know is that 57 countries around the world see this drug as safe and beneficial to women in their country, particularly, women in remote areas. Yet, in our country, our own health department is keeping this information from us, not just in connection with this drug but, generally, it has not practised the kind of transparency we would need.

We hope that Bill C-17 would be just the first step of many that the government will take to ensure that we have a robust safety system when it comes to approving drugs and making it clear to Canadians what that process is, along the way.

[Elizabeth May, Green, Saanich—Gulf Islands, BC]

Mr. Speaker, I appreciate the member's remarks and the fact that the official opposition will be voting in support of the bill, as will I. I certainly hope it will pass before we rise this summer, as the hon. member for Oakville has indicated he would like to see.

Would the hon. member for Churchill agree that perhaps at the close of our second reading debate today, we might be able to move for unanimous consent that the bill go straight to committee?

[Niki Ashton, NDP, Churchill, MB]

Mr. Speaker, as we have indicated, we are very much in support of the bill and have been from the beginning. I think it is important for us to be able to share our position and, certainly, our hopes for further steps that need to be taken in this same vein. I think that is an absolutely critical role that we have as parliamentarians. Certainly, I expect that many of us will share our support and share further steps as this debate goes forward. We certainly hope that we can bring this bill into law sooner rather than later.