Health Committee on April 10th, 2008

[Jennifer Stoddart]

Yes, it could. Our Office is following very closely the issue of genome studies and genetic studies. In fact, this is one of the four research and action priorities that we have identified for the next few years, given the implications for privacy and other areas ranging from medicine to crime prevention legislation, national security considerations and so forth.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

In spite of everything, could the human genome be used in post-market studies to advance science, and at the same time, could people's privacy still be respected in the process?

[Jennifer Stoddart]

That is a very touchy question. In theory, I see no reason... There may be certain ethical, medical or scientific considerations of which I am not aware. In theory, if personal information protection laws are well crafted, they do not stand in the way of scientific advances.

It is important to distinguish between information that is truly personal, that is provided in a medical context, and other information that may be provided under other circumstances, for example, to Revenue Canada. Where privacy is concerned, it is important to look at the context.

Nevertheless, in theory, there is no reason why science could not benefit from human genome studies or why personal information could not still be protected at the same time.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you, Ms. Stoddart.

Thank you, Mr. Malo.

Go ahead, Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you, Mr. Chairperson.

Thanks to all of you for your presentations.

I want to start with the Auditor General.

Madam Fraser, you focus on some of the deficiencies in the system with respect to post-market surveillance. And you express hope that the new safety plan and the legislation that was just tabled this week will help in that regard. I want to get to that. But I first want to ask if you have evidence to suggest that we've actually done a proper job in terms of pre-market surveillance.

You say that without post-market surveillance there are consequences for the health and safety of Canadians because of exposure to unsafe drugs and products. If there are unsafe products getting to market, then maybe we haven't done a proper job in terms of actual pre-market surveillance.

You mentioned money. One indicator is that more of the money available has gone to pre-market than post-market. But has that produced any better results? Are we producing any safer products? Are there fewer incidents in terms of drugs on the market with respect to reactions and so on?

[Sheila Fraser]

Thank you, Chair.

The last time we actually looked at that question was in 2004, when we looked at the regulation of medical devices. We looked at the whole licensing activity there and at the pre-market evaluation process. We found that Health Canada was following their process rigorously. The issue there seemed more to be delays, but they did have a process.

That doesn't mean that because you have a good process to license a product problems won't surface after it's on the market. That's because of the limited trials and a number of reasons. So when we looked at medical devices, we found that the pre-market was fine. For post-market, though, there were a lot of issues--very few inspections of manufacturers, the whole question of reporting of adverse reactions, and the list goes on and on.

The more recent audit we did was on the department's ability to assure Parliament and Canadians that they were carrying out their regulatory activities appropriately. We expected, for a regulatory program, that the department would know what activities it should carry out, at what level--for example, the number of inspections it should do--what resources would be required, and what funding would be needed. We found, quite honestly, none of that. They would have inspections, but they would not be able to tell us how they had arrived at the number, what an appropriate number of inspections they should be doing was, or what resources would be required.

So there was the whole question of how the department itself knew that what it was doing was appropriate and sufficient.

On the whole question of funding, it started, actually, in our audit on medical devices. Some of the regulatory programs effectively have no base funding, and funds are being reallocated. Even funding that's been given for special initiatives--it could be for pre- or post-market activities--is being reallocated to other programs within the department.

So unless there's a clear baseline, a clear analysis of what activities should be carried out--what the baseline is, what the results of all that are, and what resources are required for the regulatory programs--it's difficult, I think, for Parliament to have assurance that these regulatory programs are being managed well.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

In other words, what you're saying is that we must get the department to come to this committee with information that was promised by March 31 of this year, in order to assess?

[Sheila Fraser]

That's right. There's a report that is to be tabled shortly. It is to be ready within this month, and I would certainly encourage the committee to ask the department to provide that report and perhaps to have a discussion with them on where they are in addressing those recommendations.

I think Mr. Maxwell would like to add a comment.

[Neil Maxwell, Assistant Auditor General, Office of the Auditor General of Canada]

Thank you, Chair.

I have just a short comment, which is to say again that it is worthwhile to follow up on that baseline report or, as they were calling it, comprehensive review. And it has been promised already to Parliament. The public accounts committee has been promised a copy of that, so I would think it would be available.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Is there an obligation on the department to table it in Parliament?

[Sheila Fraser]

They have committed to tabling it with the public accounts committee.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Okay. I'd love to spend more time on this, but I should get on to post-market surveillance and the question of adverse reactions, since that's our study.

I'd like to ask both of you, Madam Fraser and Mr. Alvarez, since both of you talked about the responsibility right now of manufacturers to report adverse reactions to government. I think you, Madam Fraser, have indicated that, at least in the past, that has not been done adequately. I haven't seen evidence to suggest that it's been done any more effectively recently. In fact, who should get the information and who's responsible are contentious points around these committee hearings. In the new legislation that just came down, there is an attempt to make mandatory reporting from health institutions, and lots of the witnesses here have big concerns about that.

What would be your advice on adverse reporting? Do you see that it's actually happening, that manufacturers are doing their job? Are we getting complete reports? How do we make it happen?

[Sheila Fraser]

Again, Chair, I'll refer to the audit we did in 2004 on the regulation of medical devices. I caution, again, that this is dated information.

At that time, we noted that there were several weaknesses in the analysis and the interpretation of data. While the manufacturers and importers were required to report adverse events, Health Canada had done very little work to increase the number and the quality of reports that were received from health care professionals, who are, of course, the first ones to see this. We compared in that report the rates of reporting among Canada, the U.S. and the U.K. In 2002—I'll just provide the information—the rate of reporting of adverse events per million of population was 510 in the U.S., 148 in the U.K., and 33 in Canada, which obviously would lead one to believe that the reporting of adverse events is not complete and is not adequate in this country.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Alvarez, do you have any reason to believe that's changed? How would you address the legislation on adverse mandatory reporting?

[Richard Alvarez]

Mr. Chair, I'm not in a position to address the legislation, but I am in a position to tell the committee that for the first time in Canada, we are now setting up databases on drugs and on other products that will have all people and all drugs. So even if you wanted to do true post-market surveillance prior, you didn't have the information to do that type of work. You had to rely on the pre-marketing through clinical trials.

We're now in a position to move in that direction, obviously depending upon privacy considerations, etc., which I know can in fact be incorporated, and these studies can in fact be done. I think, as we're moving into the system--and it's basically there in British Columbia and Alberta, and it's moving very quickly in Saskatchewan and in P.E.I--over the next 18 months to two years we will see these systems in place. It's going to take some will to increase our post-marketing surveillance, because the data will in fact be there.

[The Vice-Chair, Liberal, Lui Temelkovski]

Just wrap up.

[Richard Alvarez]

In terms of reporting, there are many pilot studies that we invest in to look at the feasibility of things that have never occurred before, and one of them is adverse events reporting. We are investing in a study with British Columbia right now in a neonatal unit.

Since the process started, the adverse reporting has tripled in terms of the reports that they were filing earlier on, and the follow-up has been substantial as well. Obviously if there's a will, there is a way of doing this.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Mr. Alvarez and Madam Wasylycia-Leis.

We'll move on to Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Mr. Chair, and thank you, witnesses.

I would also like to welcome Rob Clarke, the new member from Saskatchewan. I think Rob would be pleased to see that this committee is well behaved and is doing important work.

I won't comment on who's here and who's not here at present, but just on the Auditor General's report. Health Canada did respond to that report by tabling an action plan in February 2007. The action plan included commitments, I understand, by the department to put in place measures to improve resource allocation and operational planning, processes, performance measurement, and costing programs.

I believe the department also committed to conducting comprehensive reviews of its regulatory programs, and there are progress reports being provided every six months to the public accounts committee dealing with your report. I understand that report will be tabled here at health committee as well.

Madame Fraser, I wonder if you could comment on the impact of these follow-ups. I believe Health Canada accepted all of your recommendations.

I am just going to get all my questions out off the top.

In regard to Infoway, it seems that Infoway is going to be key in any post-market surveillance program. I wonder if you could explain to us the challenges of dealing with 14 different jurisdictions, private sector physicians, and all the other stakeholders, and what your approach is in dealing with those challenges? What is your vision regarding the health records of the surveillance tool?

If there's time, I'd ask the privacy people to comment on the previous two witnesses' comments.

[Sheila Fraser]

Thank you, Chair.

I would just respond that, yes, the department agreed with all the recommendations in that audit on the allocation of funds for the regulatory program. It did provide an action plan. In fact, it did begin even to take action on some issues we could see toward the end of our audit and even during the course of the audit. So we are cautiously optimistic that the issues will be addressed, but we will only make a final judgment when we go back to actually re-audit the issue and see if the department has put in place the actions it has committed to do.

[Richard Alvarez]

Mr. Chair, let me speak first to the approach. I've been in health care for nearly 25 to 30 years, both at the provincial and at the national level, and I've never seen as high a level of cooperation between the federal government, the provinces, and the territories as around this initiative.

The example I gave is that at one point in time, and not so long ago, with the exception of PharmaNet in B.C., where they were collecting information on all drugs and all people and giving it to the pharmacists to do the kind of work we're talking about on adverse drug events.... That was a 10-year-old project, and it never ever took off anywhere else in Canada. Today, it's now going to be right across Canada, adopting very much the same designs. And it's the same for the labs and the diagnostic imaging. It's the same for the architecture. All of the provinces and territories are coming together. And we've been using federal dollars to leverage their dollars, as well.

So in this arena, we don't have a program that goes into health surveillance. So there could well be a program started around post-surveillance that will have a common design, because you're going to need to be able to get a critical mass of as much data as you can; you're going to be looking at trends across the country. So there is a way, from a leadership perspective, to build this on a national basis, where the jurisdictions do collaborate with the federal government and others.

In terms of the EHR as a surveillance tool, as I said in my remarks, there is enormous potential, as long as it's done right from a privacy perspective.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

By the way, the federal government did invest an additional $400 million into Infoway, in addition to the $1.2 billion that was in the fund originally.

[The Vice-Chair, Liberal, Lui Temelkovski]

Go ahead, Madam Stoddart

[Jennifer Stoddart]

Thank you, Mr. Chair.

In response to the honourable member's question, I'm going to comment on the Auditor General's report. We too audit, but we audit for the protection of personal information. We think it's a very useful way to encourage compliance.

Last month, I tabled my reports on plans and priorities for the coming exercise before this House. In that you will find that we plan to audit electronic health information in its relation to personal information management, both in Infoway Canada and in Health Canada. But to do that we are going to wait until the fiscal exercise in 2009-10, after the Auditor General's report and then the follow-up has been tabled, from not only the reports that she just talked about, but her coming Infoway report, so we don't duplicate anything her office has done.

Mr. Chair, may I ask our general counsel to talk about the challenges of coordinating privacy among 14 jurisdictions?

[The Vice-Chair, Liberal, Lui Temelkovski]

Absolutely, please.