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)

[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.

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

Mr. Speaker, it is a pleasure to rise today to support Bill C-17, an act that would protect patients and indeed all Canadians from drugs that are approved and used as prescribed and yet can result in patient deaths.

It is rare in this place to have such unanimity around a bill put forward by the government. This important legislation would amend the Food and Drugs Act. The government has taken a courageous step. The Minister of Health should have the right to recall an unsafe drug. That has been obvious since 1962, when Canada's Parliament discovered that it needed a special act of Parliament to pull thalidomide off the shelves. For half a century we have continued in the same circumstance. The Minister of Health has no power to recall a drug when that drug is recognized as dangerous. It is quite astonishing. It is not because parliamentarians and various ministers of health have not frequently wondered why they lacked those powers but it is because of one thing and that is the unholy, somewhat criminal power, that pharmaceutical lobbies hold over governments around the world.

I will be supporting Bill C-17 but I will be suggesting some areas where it could be strengthened.

I would like to pay tribute to two people. The first is the Canadian Minister of Health. Even though this legislation could be much stronger, it took courage to bring it this far.

I have to pay tribute, as everyone has mentioned, to the member of Parliament for Oakville whose own personal story is now well known. This is Vanessa's law. This legislation is named for his daughter. There really are no words to express the depth of my admiration and gratitude to this individual member of Parliament.

The member's situation and that of many others brings to light a really significant threat. I have been looking for the statistics for Canada but I will use those for the United States. In the U.S., roughly 100,000 people a year die from using prescription drugs as prescribed. There are a lot of risks to using prescription drugs. Pain relief drugs can create an addiction problem. People are using prescription drugs in ways that were not prescribed. Canadians use roughly the same drugs. The number of Canadians who die every year from using a drug prescribed by a doctor they trust, without any warning about side effects or possible death, must be in the thousands.

In the case of the hon. member for Oakville, his daughter Vanessa Charlotte Young took the drug Prepulsid as prescribed for a fairly minor health condition. Her parents went with her to every medical appointment. No one said anything about a side effect that might cause death. No parent would ever have allowed their child to take that drug had they known.

The hon. member for Oakville wrote a wonderful book called Death By Prescription. In the book he tells of going on Johnson & Johnson's website after his daughter's death to find out information on Prepulsid. He found other stories online and found that investigations had been done on this drug and that 80 deaths had been associated with it. The doctor did not know that when he prescribed the drug. The parents did not know that. Young Vanessa certainly did not know that.

Bill C-17 shines a light on a very large problem but it only begins to deal with the problem. When we think about the drug-pushing criminal element, we do not tend to think of white-collar crime. That is what this is. When a pharmaceutical executive decides not to warn the health minister that there are problems with a drug, that some people might die, because the company's profit margins are high, then that kind of activity should be criminal. If that executive decides that any studies done on a drug are proprietary, are confidential, and should never be shared, that kind of activity should be criminal. This legislation proposes steps to criminalize it.

I think a lot of members will have read the book The Constant Gardener or saw the film. It always struck me that the most powerful part of that work of fiction by John le Carré was his comment in the legal disclaimer so that no drug company could sue him. He wrote:

...I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with reality, my story was as tame as a holiday postcard.

We are dealing with a seriously corrupt process. I am not talking about any individuals within it, but when the large pharmaceutical companies around the world have so much power over regulators that they can avoid having automatic recalls for drugs or having the drugs assessed properly before they are registered, we have a real problem.

One place we could look for solutions is a wonderful institution that operates out of the University of British Columbia called the Therapeutics Initiative. That institution does something that, unfortunately, is all too uncommon. It refuses to accept any favours, trips, or presents from drug companies. It operates on a very strict ethical code of conduct and reviews the data packages that it is allowed to see from the health department of British Columbia. It decides and advises the government whether pharmaceutical drugs being proposed for use in the B.C. health care system will do more benefit than harm. It has come to different conclusions than Health Canada on a number of occasions.

Where are the clauses of the bill that need to be beefed up? Some of my colleagues have mentioned this already. Briefly, we need to look at transparency. The Canadian Medical Association Journal, by the way, wrote an excellent review on this bill called, “Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?” It was released May 13 of this year and I commend it to members. It provides some very good areas where the bill could be strengthened.

One thing it points to, and others have as well, is that there should be the registration of all drug trials and the results of those drug trials should be made public. A recommendation from the Canadian Medical Association Journal article is that we should also make sure that when Health Canada decides not to register a drug and concludes it might be unsafe, that information should also be made public. Health regulators should no longer tremble with fear about what the pharmaceutical industry might do to them if they warn the citizens of their country that a drug may have very significant side effects that pose a threat to life and health. Therefore, more transparency is required, and I hope that will be seen at committee.

The second area is clause 31.2 of the bill, that would increase the level of fines up to $5 million. It sounds like a lot until we look at the recent drug company settlements around the world. This is a list just in the last few years, since 2008. GlaxoSmithKline, for fraud and illegal promotion of Paxil, Wellbutrin, and Avandia, was fined $3 billion since 2012. The $5-million penalty in this bill puts it into a bit of perspective. Merck, for kickbacks to health care providers, paid $1.6 billion in settlements and fines since 2008. Eli Lilly, for the illegal promotion of Zyprexa, has paid $1.3 billion since 2009.

There is a very long list here of significant fines. For off-label promotion of Topamax, an epilepsy drug, Johnson & Johnson was fined $81 million. There were $600 million in fines for the off-label promotion of botox to Allergan. Novartis was fined $422.5 million for the off-label promotion of Trileptal in 2010. The list is longer than I have time for in my short speech. I hope it makes it clear to parliamentarians that while $5 million is a big number to us, it is small change to big pharma. We need to boost the penalties.

In my remaining time, I want to suggest that at the end of the question and comment period following my speech, we put to the House that since all members in all parties that have so far spoken to this bill today support its passage and would like to see it go to committee, we ask for unanimous consent to approve this quite excellent bill and work to make it better.

[Terence Young, Conservative, Oakville, ON]

Mr. Speaker, I thank the member for Saanich—Gulf Islands from the bottom of my heart for a heartfelt and highly accurate speech. I certainly agree that the Therapeutics Initiative is one of the best institutes in Canada for identifying safety risks around prescription drugs, and has been for some time. Her call for amendments to be bill, from my viewpoint, are more than welcome, and the Minister of Health has said she is willing to consider amendments. In my view, this is democracy at its best. It is a non-partisan issue and the minister is taking a non-partisan approach, so I am very pleased about that.

The member talked about fines of $5 million a day. The bill also includes the provision that when there is criminal negligence and a court saw that it needed to be addressed with a major fine, there could be unlimited fines. A judge could conceivably fine a big pharma company that committed criminal negligence the full amount of their sales for the period of time the drug was on the market.

We need Bill C-17 now, as soon as possible. We need it approved now at second reading to get it to the health committee, if the House approves. We can talk about those issues and hopefully get the bill passed by the end of June. We need to get it approved now. I am hoping that today, at the end of the hour, the parties will agree to send it to committee so that we can reduce the damage and the adverse drug reactions that patients might otherwise experience if we drag out this process.

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

Mr. Speaker, I am humbled by the very kind words of the member for Oakville. He knows this file better than anybody, at a personal cost that none of us should have to pay. We are in his debt.

I am certainly heartened that it is possible for the fines to be increased if the courts find criminal negligence causing death, but I think the minister should have the ability to raise the fines, rather than just having the ability for a judge down the road, at the judge's discretion, to apply the kinds of fines that will make big pharma recognize that Canada is not a country where they can play fast and loose with our health.

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

Mr. Speaker, I listened with great interest to my hon. colleague and I was very interested in the litany of fines that have been paid out by big pharma.

There was a real eye-opener for me one night when I was at a restaurant that a friend owned. The friend was putting on a dinner for doctors. It was a private function. Someone showed up at the door of the restaurant with an envelope containing $500 cash. The restaurant owner asked him what he was doing there, and he said he was paying for the booze. It was a salesman from a drug company.

The restaurant owner said, “I am sorry; this is not something I am supporting. You can leave if you are going to pay money to anybody to promote your drugs. If you want to promote your drugs, do it outside my premises”.

I was very shocked by that. I had no idea whether this was a common practice or not, but it certainly struck me.

I ask my hon. colleague if she could drill down a bit more for people listening to this debate about the kinds of fines that have been paid by these companies, because these fines really raise questions about basic standards of putting public interest ahead of the very large profit margins that may be at stake.

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

Mr. Speaker, I wish the story of the hon. member for Timmins—James Bay about someone showing up with an envelope full of cash was unusual in this business. I was shocked to hear from experts in the Therapeutics Initiative, and this is a stunning statistic, that for every doctor in Canada, there are three drug salesmen. There are conferences. A seminar on a new drug happens to be held in Hawaii.

In his book, the hon. member for Oakville tells a story that I found at page 253. In referring to his time as a member of the provincial legislature in Ontario, he writes:

The Big Pharma lobbyists are nice people. They have a job to do. And in most cases it includes spreading around a lot of money. They do it subtly. There is no quid pro quo. “Hey, if I buy you dinner...will you speak up to help get our drug approved...?” But before you finish the last bit of your beef tenderloin, you will have heard the marvellous story of how their drug keeps patients out of the hospital and saves the taxpayers hundreds of millions.

There is the pressure from the pharmaceutical lobby and the quite inappropriate distribution of gifts. As the hon. member for Timmins—James Bay said, the fact is that there is a litany. I did not mention Abbott, which blocked 23 states from obtaining a cheaper alternative to their cholesterol drug. They were fined $22.5 million in 2010 for blocking jurisdictions in the U.S. from accessing a cheaper version of the drug that works just as well.

Let us pull back the blinds on the pharmaceutical industry, which spends more money to find a cure for baldness than it does to deal with malaria. Let us look at the profit motive, which is insidious, and find more ways to get generics out there. Let us look very closely at trade agreements like CETA and the trans-Pacific trade partnership and see what that is doing to advance the profits of pharmaceutical companies at the expense of the people they are supposed to be curing.

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

Mr. Speaker, I really appreciate my colleague's comments. The member for Timmins—James Bay also emphasized prevention.

Every year, 150,000 Canadians experience serious reactions to prescription drugs. We have been waiting for this bill for a long time. The Liberals were in power for 13 years, and they did nothing to ensure that drugs in Canada are safe.

Given that 19.8% of the new active ingredients approved by Health Canada between 1995 and 2010 later became the subject of serious warnings, does my colleague think that this bill will address all of our concerns? Is there any way this bill can be improved?