Speaking out for drug safety

Ms. Libby Davies (Vancouver East, NDP): 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 in not only 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 refrain 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, and this is the only opportunity that has come forward. Therefore, any suggestion that we have to rush this 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 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 itself, its calendar and its timetable that has pre-empted a bill being in the House.

    We have had 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 have said, and I as the health critic for the NDP, the official opposition, say that we do 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. It was interesting to read their analysis because it begins by pointing out something that people have probably forgotten because it is one of those historical stories that happened long ago but 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. In order to do that it 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 in this country. 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, based on the principle of caution and based on the principle of the safety of Canadians. We are very glad to see that this bill before us today would allow the minister to recall drugs. It would give fairly extensive powers, so that is something which will be very important.

    I do want to give some broader oversight and say that there are a number of issues related to this bill that are also very important. In fact, in the article that I just quoted from, from the Canadian Medical Association Journal, while they do support Bill C-17, they have outlined the need for at least six critical elements that need to be looked at and hopefully examined and added to in this particular bill. These are all people who are experts, who are very involved in this issue of drug safety in Canada, and who 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 bit of 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 and flagging this issue of drug safety. In that report, the time lag was characterized as something that was very serious, and noted that it meant that 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” . I would say that we certainly agree with that point.

    That same audit from 2011 also found that there are 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. This has been a long-standing issue.

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

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

    What do we have to hide? We should have nothing to hide. This is information that is critical to the health and safety of Canadians. It is information that is critical to the medical community.

    It is information that is critical to health researchers who are examining what new products are coming on and what kind of testing and what kind of clinical trials are being done.

    I would say we should always be on the side of transparency. We should always be on the side of accountability. We should always be on the side of advocating for much greater safety measures.

    If that means that some of the procedures become more complicated for the manufacturers or they have to go through other steps, I say, so be it. What is paramount and what is the first order of the day is patient safety. It is drug safety in this country. Certainly the bill will help in this regard, but we think that more needs to be done.

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

    Again, there is a huge issue here in terms of safety, adverse reactions and what kind of process is in place to ensure that this is properly followed up on by Health Canada so that 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 that they do not have to keep digging deeper and deeper and have to keep on trying to figure out a little bit of information here and a little bit of information there, or if an adverse reaction is reported, is it going to 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, but unfortunately, we have seen these gaps and so it becomes a bit of a patchwork approach that simply has failed. I think we could say that 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 the bill does not deal with this issue of the failure of Health Canada to follow up on adverse reactions. Another issue I would identify is the bill does not deal with the issue regarding off-label prescriptions for drugs for adults and the risks that this may pose.

    The bill does impact prescribing off-label drugs to children which again is a step in the right direction. As we know, the practice of off-label prescriptions, meaning that a prescription is used for another use, often totally legitimately other than what is intended for by its labelling, and this is a practice that does take place. But again, the need for oversight on the safety of off-label prescriptions is something that is really important. We think this is a question that 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 we think do need to be examined at committee. We have to go through the system step-by-step and really examine where there are gaps, where there are holes. We will have to question the officials very closely on this. None of us is particularly expert, but as best we can we will have to try and navigate that process and then look at the bill and layer it over that process and determine what holes still exist, what gaps, what problems, what issues have actually not been identified and dealt with in the bill.

    I have named a few. Certainly another one 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 and an adverse reporting has been made and we know that there is a risk, how can we ensure that there is a better communication of those risks, either through labelling or in terms of how the medical community addresses this?

     In fact, this has been a very big issue at the Standing Committee on Health in recent months, where we looked at the whole question of prescription drugs and how they can be either misused, mis-prescribed or abused. It is a huge issues.

    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 many examples of prescription drugs, because of a lack of information or maybe because there was a heavy-duty selling job by a pharmaceutical company or maybe there was not enough transparency and information about safety concerns or adverse effects, with the consequence of it actually affecting people in their real lives.

    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 something that we think is very important. In fact, what we need to see is 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. That federal role is to provide leadership. It is to give overall oversight on patient safety and drug safety.

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

    I would note that one of the policy experts, actually someone who has been before the Standing Committee on Health since I have been there, Joel Lexchin, York University, who is a real expert on drug safety, has said that Bill C-17 is a step forward for Canada’s drug safety legislation. He, too, has expressed concern that the legislation does not go far enough and that Canadians still need to know about the evaluation process that determines whether or not medications are safe enough to be sold in Canada.

    I do look forward to this going to committee. We are supporting this bill at second reading. It is an important bill. It is an important first step, but more needs to be done. I have a hope. I have a message to my colleagues on the other side of the House that when this bill gets to committee that we can actually look at the bill in good faith, we can look at the bill on its merit, and we can determine the elements of the bill that we think are in good order and need to be approved and sent back to the House for approval, but that we also look at the bill with a critical eye. Surely that is what we are here to do.

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

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