Debates of May 27th, 2014

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

[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 Prepulsic 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 Prepulsic. 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?

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

Mr. Speaker, I would like to thank my colleague from Algoma—Manitoulin—Kapuskasing.

I completely agree with her. There is no doubt that Bill C-17 is very important. This is a brave step forward in the interest of everyone's well-being.

However, we have to improve it, and I hope we can do that quickly. I believe everyone here agrees on that. The minister herself even said that she is ready to accept amendments.

We have to take decisive action against dangerous drugs. We have a once-in-a-generation chance to make sure this bill is as strong as possible.

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

Mr. Speaker, this is really an important piece of legislation. As we said, it has been a long time coming. The Liberals certainly did not act on this issue. Given that we see a government that is going in the right direction but that sometimes thinks that what it has put forward is the be-all and end-all, it is again important to indicate that there needs to be oversight with respect to the amendments that will be put forward. Certainly our party is willing to put amendments forward once it goes to committee, but we should not be rushing legislation in the House just so it can get to committee for discussion and have the government members not even look at those amendments. Those are extremely important.

I know that my colleague is well aware of the Auditor General's report in 2011 on this issue, but I am asking if she thinks the bill is comprehensive enough. I am sure her answer will be “Of course not, because we have talked about amendments”, but maybe she can elaborate a bit on some of the other safety aspects that we should be putting in place.

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

Mr. Speaker, in terms of the comprehensiveness of the bill, it certainly addresses a lot of the right areas, and a lot will remain to be done by regulation.

We want to see the transparency that I referred to around all trials. All drug trials should be registered and their results made public. We want to see transparency around Health Canada's decisions on whether it is going to allow a drug or not, around the area of fines, and around drug recalls. We need to have much better information on the side effects of prescription drugs. As well, the labelling should be as clear as possible so that anyone with a prescription drug is able to see, without having to search out secondary materials, whether there are significant side effect risks with this drug.

Those pieces are coming in subsequent regulations, but when we go to committee, we will study it more closely. We are in somewhat of a hurry, because the sooner we act, the more Canadians can be protected from drugs that they never would have used if they had known of their health risks.

[Libby Davies, NDP, Vancouver East, BC]

Mr. Speaker, I am pleased to be in the House today to debate Bill C-17 at second reading, which is an opportunity to talk about the bill in principle before it goes to committee.

Before I begin my remarks, I just want to note that although we give numbers to bills, this bill has been referred to as “Vanessa's law”. I want to pay tribute to our colleague on the other side of the House, the member for Oakville, for the incredible work he has done around drug safety, not only in his own constituency but also nationally, across the country. It is appropriate that the bill be named Vanessa's law and that it be a reminder to us all of what can happen when we do not have adequate legislation around drug safety in this country.

I am glad we are debating this bill. I have been told by some of my colleagues that a number of the government members are quizzing the opposition as to why this bill is not being rushed through. I want to begin with that point, because it is a familiar strain to hear.

The government introduced this bill back in December, I believe, but it did not come into the House for debate until March. When it came up for debate, it was a Friday afternoon, so it had maybe an hour of debate. This is the only opportunity that has come forward. Therefore, any suggestion that we have to rush this bill through or that somehow the opposition is holding this bill up is absurd and not based on reality, because it is the government itself that has dragged its feet on this bill.

We have said continually that we believe the bill should go to committee, but I am aware that some of my colleagues want to speak to this bill in principle at second reading, which is as it should be. I hope that it will go to committee soon so that the Standing Committee on Health can get into the bill, call witnesses, and examine it more closely.

I wanted to get that out of the way before we talk about the substance of the bill. It irks and irritates me that we so often hear this refrain that something has been slowed down or is not going fast enough when it is the government's own calendar and timetable that have pre-empted a bill being in the House.

We have had very minimal debate on this bill. Let us be clear about that. We do need to have debate at second reading. Second reading is here for a purpose. It is here for all members of Parliament to debate a bill in principle and get an overall understanding of it before it goes to committee and gets wedged into the clause-by-clause process.

Therefore, I am happy to be speaking today at second reading on Bill C-17, which would amend the Food and Drugs Act.

For the record, a number of my colleagues who have spoken to the bill and I as the health critic for the NDP, the official opposition, have said that we think this bill is a good first step in protecting the health of Canadians and improving the gaps in the current drug safety legislation. The bill is long overdue. When I say “long overdue”, I mean decades.

I read an article in the Canadian Medical Association Journal a couple of months ago presented by Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, and Barbara Mintzes, who happens to be a researcher who lives in my community in east Vancouver. It was a good analysis of this bill and it was interesting to read their analysis.

It begins by pointing out something that people have probably forgotten, because it is one of those historical stories that happened long ago, but it had a profound effect on the lives of children, families, and Canadians overall. In their analysis, they begin by pointing out that Canada was the last developed country in the world to remove thalidomide from the market. To do that required an act of Parliament. That was in 1962. There are those of us here who remember hearing about the devastating consequences and catastrophic effects of that drug and what it did to children and families. Therefore, it is incredible that it required a specific act of Parliament to withdraw that particular drug. In fact, the two manufacturers voluntarily withdrew the drug from the market in March 1962.

However, that legislation stopped short of granting legal authority to the director at the health branch to unilaterally recall drugs, even though officials recognized that the co-operation of the manufacturer to recall a drug from the market could not be solely relied on.

Here we are, more than 50 years later, and we still have this gaping hole in Canada's Food and Drugs Act. We still have a huge issue around drug safety. Certainly, Health Canada is a regulator. It is meant to analyze new drugs that come on the market and approve them. Astoundingly, however, the federal government has never had the power to actually recall a drug. It has to negotiate around that.

There are many examples over the years where we have seen consequences from minor to serious to catastrophic to death because of this lack of oversight and based on the principles of caution and safety of Canadians. We are very glad to see that the bill would allow the minister to recall drugs. It would give fairly extensive powers, which is very important.

I want to give some broader oversight. A number of issues related to the bill are also very important.

I just quoted from an article in the Canadian Medical Association Journal. While they support Bill C-17, they outline the need for at least six critical elements to be looked at and hopefully examined and added to the bill. All these people are experts. They are very involved in the issue of drug safety in Canada, and have done a lot of analysis not only on this bill, but on the reality of drug safety in Canada. I would like to spend a little time going over those elements.

By way of backdrop, we should be aware that even the Auditor General, in 2011, warned consumers, the government and all of us as legislators that consumers were not receiving proper safety warnings about pharmaceutical drugs fast enough because Health Canada was so slow to act on the potential issues that it identified. That was a pretty serious matter, and it took the Auditor General making a public report to flag the issue of drug safety. In that report, the time lag was characterized as very serious. It noted that it meant people sometimes had to wait more than two years before Health Canada completed a drug safety review of a product already on the market and provided updated information about the risks.

As the Interim auditor general noted at the time, “I think two years is too long”, and we certainly agree with that point.

That same 2011 audit also found there were gaps in the transparency about drug information. In fact, it is really keeping Canadians in the dark about Health Canada's drug safety work. There has been an issue about clinical trials and the lack of information that is being provided, which has been a long-standing issue.

We should note that in many other countries, information around clinical trials is provided so researchers, medical practitioners and consumers alike can make themselves aware, if they want to, about a product, particularly at the clinical trial level, and this is very important.

I know the minister recently made announcements about providing better information. Again, this is a good step, but it is very important to have this as part of a legislative package to ensure there is transparency in the work of Health Canada.

What do we have to hide? We should have nothing to hide. This information is critical to the health and safety of Canadians and to the medical community. It is also critical to health researchers who examine new products that are coming on to the market and the kind of testing and clinical trials that have been done.

We should always be on the side of transparency, of accountability and of advocating for much greater safety measures. If this means some of the procedures become more complicated for the manufacturers or they have to go through other steps, so be it. What is paramount and what is the first order of the day is patient and drug safety. Certainly the bill will help in this regard, but more needs to be done.

Here are some of the other issues that hopefully will be examined at committee. Although the bill calls for mandatory reporting measures for health care institutions, we really need to look at not so much the issue of adverse reactions, but the failure of Health Canada to follow up on them, which the bill does not do.

Again, there is a huge issue in safety, adverse reactions and what kind of process is in place to ensure this is properly followed up on by Health Canada so we have a continuum. There should be a seamless process that is clear and transparent for Canadians, for people who are interested in this issue to know they do not have to keep digging deeper and deeper to try to figure out a little information here and there, or if an adverse reaction is reported, will it be followed up. These things should be taking place as a matter of course. These things should be fundamentally inherent in the Health Canada process. Unfortunately, we have seen these gaps and so it becomes a bit of a patchwork approach that simply has failed. This system has not been a great model for drug safety for Canadians.

This is one element of the bill that needs to be looked at because it does not deal with the failure of Health Canada to follow up on adverse reactions. Nor does the bill deal with the issue regarding off-label prescriptions for drugs for adults and the risks this may pose.

The bill impacts prescribing off-label drugs to children, which is a step in the right direction. As we know, the practice of off-label prescriptions means a prescription is used for another use than originally intended, which is often totally legitimately. However, the need for oversight on the safety of off-label prescriptions is really important. This question requires some examination.

I have spoken about access to public information, about drug trials and the need for additional drug testing as to why medications are considered safe or not. These are some of the questions that need to be examined at committee. We have to go through the system step-by-step and really examine where there are gaps are holes. We will have to question the officials very closely on this. None of us are particularly expert on this, but we will have to try to navigate that process as best we can. Then we will have to look at the bill and layer it over that process and determine what holes still exist and what gaps, problems and issues have not been identified and dealt with in the bill. I have named a few.

Certainly another issue is the question of labelling. We are very concerned that there needs to be a much better communications system set up between doctors, pharmacists and patients for communicating and reporting on risks. If we have a good system in place, if an adverse report has been made and if we know there is a risk, how can we ensure there is a better communication of those risks, either through labelling or how the medical community addresses this?

In fact, this has been a big issue at the Standing Committee on Health in recent months. We looked at the whole question of prescription drugs and how they could be either misused, mis-prescribed or abused.

These drugs can save lives, help people heal and get better, but they can also kill if they are not used properly. We heard many stories and examples about prescription drugs and the lack of information, or a heavy-duty selling job by a pharmaceutical company or not enough transparency and information about safety concerns or adverse effects of it affecting people.

Unfortunately, there are too many tragedies. There are too many cases of people suffering from adverse effects of prescription drugs because of improper prescribing or, worst case, of a fatal overdose and death.

This is a very important. In fact, we need some sort of national database that effectively communicates between the different parts of the health system. We have a complex health system, but there is a federal role, which is to provide leadership and give overall oversight on patient and drug safety.

Health care is delivered at a provincial level, and many players involved. At the end of the day, there has to be some federal responsibility. While I am glad the Minister of Health has understood and been clear that this issue needs to be addressed, we have a long way to go, not only in drug safety but in oversight of our health care system and ensuring there is proper communication between different parts of our health care system.

Joel Lexchin of York University, a real expert on drug safety and someone who has been before the Standing Committee on Health since I have been there, said that Bill C-17 was a step forward for Canada's drug safety legislation. However, he also expressed concern that the legislation did not go far enough and that Canadians still needed to know about the evaluation process that determined whether medications were safe enough to be sold in Canada.

I look forward to this going to committee. We support the bill at second reading. It is an important first step, but more needs to be done. I hope that when the bill gets to committee, we can actually look at it in good faith and look at it on its merit to determine the elements of the bill that are in good order, approve them and sent them back to the House for approval. However, I hope we also look at the bill with a critical eye. Surely that is what we are here to do.

Unfortunately, over the last few years I have seen amendments shot down at committee just because they came from the opposition. I really hope that does not happen. I know there are colleagues who care deeply about the bill and I know that at the end of the day we want to see the best bill we can.

I appeal to the members that when we get to committee, we look at its merits and at what we can do to make the bill better, to answer some of the concerns. There is overall broad support, but there are issues and concerns. Let us address those. Let us look into that and work in good faith to ensure the bill is the best it can be. We will then have done a good job.

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

Mr. Speaker, I have listened with great interest to my colleague. She has such immense experience in the issues of the need for a national health care strategy in this country and the need for the federal government not to walk away from its long-standing role in the delivery of health care.

I would like to ask my colleague about the issue of prescribing practices.

I raised the issue earlier of when OxyContin was first put on the market. In Ontario, in particular, I noticed that it was being prescribed for all manner of reasons. People who would go in with a back problem or people who would go in for surgery were being prescribed sometimes large amounts of OxyContin. The impacts, the very addictive impacts of this drug, were not fully explained to the physicians who were prescribing, and it was certainly not explained to the people who received it. We saw spikes of addictions all across the spectrum of society. People ended up becoming addicted to this very addictive drug because there had not been the proper explanations. In the end, there was certainly a backlash on the whole use of OxyContin.

The Canadian Agency for Drugs and Technologies in Health has an optimal use program around the issue of prescribing and awareness amongst doctors.

There is an attempt to raise awareness, but there are concerns that there is not enough work being done to ensure that physicians are fully informed, independent of the drug companies' claims, of the potential impacts before they start to prescribe.

I would like to ask what my hon. colleague thinks of this.

[Libby Davies, NDP, Vancouver East, BC]

Mr. Speaker, that is a very important question. In fact, this is specifically one of the issues that the Standing Committee on Health looked at just a couple of months ago. I can tell members that we heard some pretty disturbing testimony. For example, we heard from researchers who told us that they went to so-called “educational sessions” that were paid for by pharmaceutical companies; that they were really about the promotion of a particular drug; and that then they would get, not a diploma, but some sort of certificate to say that they had gone to this educational session and that it was A-okay, green light ahead. Yet, of course, as the member points out, we have seen some really disturbing situations with OxyContin. It is a very powerful drug.

I have to say that pain management is a very important thing. It is a huge issue in this country. There are many people who are living with severe pain. In fact, there is a group called Canadian Pain Coalition that works on this every day. It is very concerned about ensuring that bona fide drugs are available for pain management.

However, there is a critical issue about prescribing practices and ensuring that drugs are being used for the appropriate setting with a patient and that the prescriptions are not just being ripped off the prescription pad; and of course in other circumstances people are actually selling the drug or abusing it themselves.

It is a huge issue, and I am very glad the member raised it, because I do not think we have really gotten to the bottom of it yet.

[Terence Young, Conservative, Oakville, ON]

Mr. Speaker, I thank the member opposite for her speech.

One of the reasons that Vanessa's law did not come to the House sooner is the wide consultations the government did. They have been very significant and wide ranging. The government consulted with numerous stakeholders, including patients, consumers, the industry, and health care professionals. It was a very exhaustive consultation.

Some of the key groups included the Canadian Treatment Action Council, PharmaWatch, which I believe the member is aware of, the Best Medicines Coalition, the Canadian Nurses Association, the Canadian Medical Association, and the provinces and territories.

The round tables with these patient groups and health care professionals yielded widely based support for a strengthened drug safety system.

They also enthusiastically supported increased recall powers and increased fines and penalties that would better reflect the very serious nature of the offences.

These consultations provided the opportunity for these groups to fine-tune the provisions in Vanessa's law before it was brought before the House.

Canada needs this law. We need it soon.

I would like to ask the member opposite this. Does her party, the official opposition, intend to allow the bill to go to committee today?

[Libby Davies, NDP, Vancouver East, BC]

Mr. Speaker, I do not think we disagree. I am glad the consultations were held. In fact, I am assuming that the member is saying that those consultations were held before the bill was tabled. I think he said it helped in the final drafting of the bill, which is very important. I wish that had been done with Bill C-23, that there had been some consultation with somebody—that is, the Chief Electoral Officer or other political parties—as it fundamentally changed the Canada Elections Act. I am glad it happened on this bill, but it is kind of a rare thing.

My comments at the beginning were more that, while the government introduced the bill in December, it did not come forward for debate until March, and then it was for a couple of hours, which is pretty minimal for second reading.

We are here debating the bill today, and I know some of my colleagues want to speak on it because they feel very strongly about it. They are not on the Standing Committee on Health, so I hope they will have an opportunity to do that.

I also hope that the bill will go to committee quickly and that we can get into it there. I am glad it has finally come back to the House to be debated today.

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

Mr. Speaker, I am pleased to rise in the House to speak to this bill. This is kind of a magical moment. Every now and then, a rare bill brings Parliament together to pass a law that is good for all Canadians. I believe that is what is happening now.

However, I have two concerns about this bill. The first is that we have to make sure the bill will be properly enforced. Passing a bill is all well and good, but it has to be enforced. Unfortunately, in many areas, the devil is in the enforcement details. The government has good intentions, but, unfortunately, it does not provide the tools to properly enforce the law. The unfortunate events that occurred in Walkerton are an example of that.

My second concern is about generic drugs. Most of them are not currently subject to clinical trials. Basically, the brand-name drugs go through clinical trials, and the generics just copy them. Unfortunately, too often, there are quality differences between the brand-name drugs and their generic equivalents. It has been found that imported generic drugs are often dangerous.

I would like the NDP health critic to tell me whether this bill will protect us from such situations.

[Libby Davies, NDP, Vancouver East, BC]

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

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

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

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

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

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

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

Mr. Speaker, I have the honour to rise today to speak to Bill C-17, An Act to amend the Food and Drugs Act, or Vanessa's law, as we call it in the House.

I will be sharing my time with the hon. member for Louis-Hébert.

By all accounts, this bill deserves our support, at least for further debate in committee. Even though the fundamental and necessary steps have been taken, there are some gaps. My colleague was clear about that.

Let us talk about the bill. Why would we need this bill? Something that happened recently in New Brunswick effectively illustrates the need for this bill. It happened in Ontario as well. Diluted chemotherapy drugs had been administered. If I recall correctly, more than 1,000 patients received these substandard diluted drugs. The patients involved deserved a lot more information than was available at the time.

There needs to be transparency. The more information that patients, citizens, pharmacists, and doctors have, the better. We need to have reliable information. I do not want Canada to become like the United States where drugs are marketed to be sold at a profit for the pharmaceutical company.

The goal is to put Canadians' health first. To have good health, there is nothing better than self-defence. The individual should have the choice. I think my colleagues on the government side might very well understand that, fundamentally, it is an individual choice to know what drugs might best protect us. That choice is made in co-operation with pharmacists, doctors, and the government, who have the information and should ensure transparency.

We are talking about co-operation between experts in the field and the individual who must choose what is best. There needs to be information. The problem now is a lack of transparency. The bill before us today raises a lot of questions, namely whether the transparency that will be there once this bill is passed will be adequate. People want to make informed decisions. Canadians have less and less confidence in their government. They are wondering whether the government is providing them with the necessary information.

There is talk of letting 28,000 federal public servants go. We know full well that this will have an impact on services. Many scientists have been fired, as have front-line employees who took phone calls from people looking for information. The government needs to be there to provide services to the public. Taxpayers have paid for this piece of legislation before us and they should benefit from it. When bills are introduced by the government without sufficient funding, and there are not enough people to study and enforce them, then there is not enough information to share with Canadians.

The fundamental problem I have with this government is that it does not understand the correlation between government resources and sharing information with Canadians or being transparent with them.

That is exactly why I feel this must go to committee. We need to look at the lack of resources. Federal resources are constantly being cut. Tax credits are constantly being increased for companies that do not need them, such as banks. Those companies are benefiting tremendously. I think that they are capable of paying their own experts.

When it comes to fundamental issues such as health, medication options, and choosing medical services they rely on, Canadians often lack the necessary information and have to do their own research.

We want to see better collaboration with pharmacists. They are open; they want to talk about products. Unfortunately, even after this bill is passed, pharmacists will not have enough information to properly explain the merits of each medication to their clients.

Clinical trials will be no more transparent than they were before. Pharmacists will not know the results of clinical trials conducted by the companies, which are often private. Pharmacists try to have confidence, but open and public transparency is the best way for companies to gain their trust.

Unfortunately, this bill does not do enough to ensure this transparency and collaboration that in a democracy are vital to making informed decisions. Should the bill be defeated for that reason? I believe it deserves to be sent to committee for further debate. That way, the people working in the field and patients who need services and who have something to say will be able to provide input that will improve the bill.

If the government were serious, it would have introduced this bill a long time ago. Members will recall that it finally introduced the bill in December as a result of pressure from the opposition. However, debate was very short, as the House spent less than one hour on it. Today, the government has finally brought it back. We understand that it wants to put it in place quickly. However, if it was in such a hurry, it could have introduced it a long time ago.

When people call on their government to provide a service, that government should listen instead of always passing harmful regulations and laws. For example, when the government amended the Navigable Waters Protection Act, the amendments were very detrimental for the fishing industry in my region. Instead of spending this time on bills that are detrimental to my constituents, we could have passed bills that everyone in the House could get behind, that warranted our attention, and that deserved being passed as quickly as possible.

For example, we could have addressed health issues. We absolutely must look after our constituents. They expect the House to do what it takes to ensure that they have all the services they deserve. We absolutely have to think of our constituents. When there is a possibility that some people will take medications that are diluted, improperly prescribed or that clearly do not comply with regulations, the best course of action is to inform people, pharmacists and doctors about the specific trials conducted, the reasons why the medications provided by pharmaceutical companies are on the market and their usefulness.

Canadians need to know that the drugs they are taking have been approved and that they are adapted to their needs. However, they do not have this information. Once this bill passes, someone would still have a hard time understanding why a drug is useful.

We want to have faith in our doctors, pharmacists, nurses and government. However, for that to happen, Canadians need to know that the government is giving them all the information available.

That is why it is so important for clinical trials to be transparent, and a number of witnesses called for that. They want more transparency.

Everyone would win if the government were more transparent, and being transparent in this bill would be a good start.

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

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

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