Evidence of meeting #33 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
9:40 a.m.
Prof. Elaine Gibson
It’s too complicated; that will bog it down. There's no reason they need to be twinned.
9:40 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
Thank you very much.
Thank you all for joining us today.
In the recent CMHA article that all of you co-authored, the subject of clinical trials was the main point that I took away, where you suggested that we really needed to improve this legislation regarding clinical trials.
Can you provide a comprehensive overview of what elements you feel are the most important aspects that we amend in this legislation to get that aspect right?
9:40 a.m.
Prof. Matthew Herder
I'm not sure if I quite understand the question. Are you asking with respect to clinical trials as a whole or the information around clinical trials that you thought, by virtue of a commitment to transparency, were asking to be made transparent?
9:40 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
Precisely. If we were to develop an amendment that best reflected that and captured that, what would you recommend that it absolutely include?
9:40 a.m.
Prof. Matthew Herder
I might defer to Joel and Janice for some of the particulars, but what I can say that I think is helpful is that there's been a lot of work to define the particular elements. The World Health Organization has sort of done some work that has led to a minimal set of information to be included: the number of patients, those who withdrew from the trial, the different kinds of outcomes they are looking for in the trial, the design of the trials. There are ready-made lists that talk about the key pieces of information to be included under any system of clinical trial registration.
Perhaps Joel and Janice can describe some of the more particular pieces of information.
9:40 a.m.
Professor, School of Health Policy and Management, York University, As an Individual
First of all, I would say that the clinical study reports would have to be made available. These are comprehensive documents. Sometimes they run into thousands of pages. Not everybody's going to read them, but people who do things like develop guidelines for practitioners, who do systematic reviews, will definitely read these and analyze them.
The other feature we need to make sure comes out, and this is not something that's particularly radical—GlaxoSmithKline has already made a commitment to do this—is that the full reports of all of the trials that have been undertaken will be released to qualified researchers. People will make applications to GlaxoSmithKline. The company is going to set up an independent committee to evaluate those requests to make sure they are legitimate, and if they are legitimate then GlaxoSmithKline will release all of the information. That's the raw data they collected in the conduct of the trials for their drugs.
I think we need two things. One is an unequivocal release of the clinical study reports without any formal requests. Secondly, the companies, on receipt of a valid request from researchers, will release all of the raw data for the clinical trials.
9:45 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
That actually speaks to another aspect. At Health Canada, I think there is a concern between balancing private business information and obviously ensuring that patients' safety is paramount. My perspective and I would imagine the perspective of everyone around this table is that consumer safety, patient safety, is just such an important priority that we really need to ensure that's where we put the focus and not as much on protecting private commercial information.
How would you strike the balance? Is this how you would suggest the best balance could be struck?
9:45 a.m.
Professor, School of Health Policy and Management, York University, As an Individual
Yes, I would. I think as a clinician, somebody who prescribes, patient safety is paramount, and I think that trumps anything else.
Manufacturers have legitimate concerns around things like how they make drugs that need to be protected. There are manufacturing secrets. We should obviously not disclose information where individual patients could be identified, but beyond that, safety trumps commercial secrecy.
9:45 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
I would fully concur.
Are there any other suggestions around the table on how we might strike that balance, or what else we ought to be making public?
9:45 a.m.
Prof. Matthew Herder
I guess I would simply echo that—I thought you were asking specifically about registration as a starter—other kinds of information are critical to get out as well. There's such a course of support for transparency right now that if we limit it to clinical trial registration, which has been happening for years and years in other countries, it's really at the risk of being a pyrrhic victory. We need results reporting backed by serious enforcement measures. We need clinical study reports. It's how we make them available, making sure we protect patients privacy, and excluding material or information such as Joel described around manufacturing processes.
But information derived from patients participating in studies about the safety and effectiveness of a drug has to be made available, and that's going to be most richly available in the clinical study reports.
Lastly we need the information about how Health Canada is interpreting that evidence. We're talking about probabilities and lots of uncertainty. Regulators come to different conclusions about the same drug for the same indication. There's a lot of complexity here, and regulators can learn from each other and learn in dialogue with independent entities like the Cochrane Collaboration, which can really improve the quality of their work.
All those three things—results reporting, clinical study reports, and the decisions and the reasons for them offered by the regulator—need to come in addition to clinical trial registration.
9:45 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
Thank you very much.
I'm actually sitting in for the Liberal health critic today, so you'll have to excuse me if my questions seem a bit rudimentary.
At the moment clinical trial registration is not required. Do I understand that to mean that if a company is going to do a clinical trial it has to somehow inform the government? I'm not sure exactly what it means.
9:45 a.m.
Prof. Matthew Herder
Clinical trial sites have to receive approval from the government to have a trial conducted there, but they don't necessarily have to comply with any registration requirements. It depends on that site, where it's being conducted in Canada.
Publicly funded researchers have to comply with registration requirements pursuant to the tri-council policy statement, but that doesn't capture trials that are privately funded, conducted by private research organizations, which is fairly common in Canada.
9:45 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
I see.
Where do we stand comparatively with other nations? If we strengthen this bill, would we become leaders? I'm simply trying to get a sense of how Canada is situated.
I don't know who wants to take that question.
June 10th, 2014 / 9:50 a.m.
Professor, School of Health Policy and Management, York University, As an Individual
If you compare us with the United States and the EU, right now we're a distant third in terms of transparency. With the passage of Bill C-17, with the amendments that have been suggested, I think Canada would be leading both the U.S. and the EU. Right now, though, we're not doing very well in terms of transparency, disclosure of information.
9:50 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
If we passed Bill C-17 without the amendments, without strong amendments that have been suggested, would we be laggards? What I guess I'm getting at is whether this bill is simply a placebo, or is it going to make substantial progress anyway? Would we still be behind the United States and Europe, in terms of transparency, if we passed the bill without the amendments that you and others are suggesting?
9:50 a.m.
Professor, School of Health Policy and Management, York University, As an Individual
The bill is definitely a positive step, but right now the EU is willing to disclose clinical study reports. This bill does not mandate that, so I don't think—
9:50 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
Thank you, I appreciate that.
I find it odd as to why we don't have a stronger bill, because they're the same corporations that are in Canada. They benefit from the same trade law framework and they have the same concerns around intellectual property. I don't understand why we didn't level the playing field, since we're dealing with the same players. But anyway, that'll be a question for the government to answer.
In terms of your point about trade agreements, Professor Herder, do I understand that trade agreements are not an impediment to adopting the amendments that you and others have suggested, that it's only a question of getting the language right so that we protect your amendments and other amendments from trade challenges? Or is there an endemic problem here with trade agreements and ensuring the safety of patients?
9:50 a.m.
Prof. Matthew Herder
That's my view.
Under trade agreements, Canada is required to put into place measures to protect data, essentially, which might capture, or some would argue does capture, safety and effectiveness data around a drug. But there are two exceptions to that commitment. One is where it's necessary to protect the public, so a public interest exception, and I would make the argument that it is absolutely the case that we have to have this information. Some would contest that. So what I tried to do is to base it on the other exception, where a government has put into place measures to protect that data against unfair commercial uses.
What companies are most worried about when you talk about transparency is that you're going to give a free ride to their competitors, especially generic companies. Canada has put into place through regulations under the Food and Drugs Act periods of data exclusivity, quite apart from patents and other forms of market protection that might be available to first-mover companies. There's a period of eight years in which the Minister of Health cannot issue a notice of compliance to a competitor in respect of the same drug under the Food and Drugs Act, when you're talking about an innovative drug. Because we've done that, because we've protected data against unfair commercial uses, it's my position that it's open to the government, completely consistent with our trade obligations, to make this information more transparent.
9:50 a.m.
Vice President and Chief Operating Officer, Institute for Safe Medication Practices Canada
I have just a comment on one of your questions.
The Food and Drugs Act hasn't been amended in, I think, about 50 years. If you are asking, are we lagging behind? We are lagging behind a little in the authorities for Health Canada.
My understanding is that there were more complex bills proposed, Bill C-51, Bill C-52. They were comprehensive, complex, and they weren't enacted. This is a more simplified, to-the-point bill to take a step forward in safety in Canada.
Thirdly, Canada is leading in some ways already. There are only a handful of countries worldwide that post their adverse drug reaction reports online, available to the public and practitioners. Two other countries that I know of are the Netherlands and the U.K., and then there's Canada. We have taken some steps to show leadership worldwide. In the United States they do make the device incidents available online, but not the adverse reaction reports.
I just wanted to share with you a little bit about where Canada sits worldwide.
9:55 a.m.
Conservative
9:55 a.m.
Conservative
Terence Young Conservative Oakville, ON
Thank you, Chair.
I'd like to direct my first questions to Dr. Joel Lexchin with a brief introductory comment. We heard about 140 peer-reviewed papers that you authored or co-authored, and that you've been working on this issue for 30 years. I know that a significant part of your career has been against the current, especially in the early years when you were like a voice in the wilderness on drug safety. I wanted to thank you and congratulate you, on the record, for your work in leading this for so many years.
Could you please comment, Dr. Lexchin, on why transparency in clinical trials is important for patients? In other words, how will it net benefit patients and improve their health, and reduce adverse drug reactions?
