Health Committee on March 5th, 2009

[Dr. Peter Singer]

Let me deal briefly with the coordination question, and then come back to the level 2 issue.

On coordination, I heard the question that I think you asked, and I heard Frank Plummer's response from Tuesday. It sounded to me like Frank Plummer presented a pretty good case for a lot of table-top exercises and coordination within the government.

My point is that coordination within the government is necessary, but it's not sufficient to achieve biosecurity. The governmental communities, the life science communities in the universities, and the private sector communities all need to be working together and on the same page.

When I was on this National Academy committee--and I'm not proposing this for Canada--it started with people talking about their conflicts of interest. These were all scientists like these guys, from Stanford, etc., and every single person went around and said, “I'm on the XYZ committee of the Defense Intelligence Agency.” There was real outside-of-government input into government. That's the sort of coordination or interaction I don't see in Canada. Maybe the Americans have taken that too far, but maybe there's a middle road.

So that's what I mean by how the pieces are working together, the web of protection. I think you need a detailed look at that, and I'm suggesting the Council of Canadian Academies can do that.

With respect to the issue of level 2, very briefly, I think what you're facing is this--and I don't want to do their job for them; they're doing such a great job themselves, the PHAC people, in their comments. But I'm sure they'll come and say, “Look, we've guaranteed to you that in our regulations, level 2 will be different. Most of the scenarios that Greg raised we'll deal with through regulations. They won't be a problem. We won't require security clearances for level 2.” And so on.

So I think the choices for this committee are.... On the one hand, do you say it's enough to leave it to regulations, the distinction between level 2 on the one hand and levels 3 and 4 on the other? At the other extreme is what these guys are saying, which is to take level 2 completely out of the bill. And I think you'll want to ask them what the harm of that would be.

In the middle, should you decide not to take either extreme, is exactly why I've proposed the advisory committee mechanism. Because that's a user committee that provides ongoing input at the level of the minister into implementation issues even beyond the regulatory period, where there are other mechanisms for input.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Singer.

Dr. Carrie.

[Colin Carrie, Conservative, Oshawa, ON]

Thank you very much, Madam Chair.

I want to thank the witnesses today, because you've certainly been thought provoking for the committee members, I can tell.

I do want to get you to elaborate a little bit more and also ask if you will be staying afterward, because we're having the officials come forward. As Dr. Singer mentioned, there may be some really good responses to the questions you brought up, and I'm looking forward to that.

But again, I want to look at the level 2 pathogens, how you suggested that perhaps we need to take them out entirely. I do see a little bit of a conflict here.

You were saying, Dr. Singer, that a good microbiologist, even with regular research, may be manipulating a pathogen that might start off as a level 2, but may become a level 3 or level 4, even. The lab that would be working on that may not be prepared to handle that type of scenario, and there are biosecurity issues.

I had a recent conversation with the nuclear people, and they were talking about the heavy water incident. With nuclear waste you can make dirty bombs, which are not as bad as a nuclear bomb, but there are different regulations for that.

Would you be able to comment on the balance part of it? I'll ask each of you to elaborate a little bit more, because this is a challenge we're facing here on committee.

Dr. Singer, could we start with you?

[Dr. Peter Singer]

It's really important for committee members not to be trapped in metaphors, which is why I said what I said about nuclear. Nuclear security—real nuclear bombs, not dirty bombs, which are a little easier—are at one end of the spectrum. You can get nuclear security by controlling highly enriched uranium and plutonium. At the other end of the spectrum is cyber-crime. Some 12-year-old in your basement can do a lot of damage with a virus—it's so disseminated.

Close to cyber-crime, but a little bit closer to nuclear, you have chemical, and just to the left of chemical is about where biological sits. What I was really saying is, don't get trapped into the nuclear metaphor and think that just because you have pathogen security you have biosecurity. It's necessary, but not sufficient.

I thought that was really important for the committee to understand, because then you're not going to go to the nth degree on every last little thing in pathogen security. It won't get you to where you need to be anyway. You need the support of the scientists, because of the “needle in the haystack” problem, and you need to deal with the other issues, such as the life sciences outside of this bill.

So that's the spectrum.

In fact, the first recommendation from our National Academy committee was a broader perspective on the threat spectrum. Scientists who had lived in the United States with the select agent rules—the analog of these rules—for five years said stop being so pathogen-centric; don't only think of pathogens.

You must think of pathogens, but the extreme version of those guys wouldn't have any select agent rules at all. I disagree with that, especially when it comes to level 3 or level 4. But very clearly what they're saying is, don't be pathogen-centric alone; think about these other things. I was exaggerating a little, but not too much, about going from level 0 to level 3.

I wanted to give you that context, so that you're looking at that balance: you realize you're getting some stuff, but you're not solving the problem; hence the parallel process and the need to engage scientists.

Does that help as an elaboration?

[Colin Carrie, Conservative, Oshawa, ON]

It does, indeed. But I would like the other doctors to—

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Singer. I'm sorry, but right now we've reached 4:30 and are going to ask the Public Health Agency members, Dr. Tam, Dr. Plummer, Mr. Gilbert, and Ms. Allain, to come forward. We would invite you folks to sit in the audience and listen and have dialogue.

I'm not going to suspend the meeting. I would like the exchange of witnesses to be as quick as possible, and then we can get right into it.

We've had some very interesting questions and dialogue today. I want to thank you so much, Dr. Ouellette, Dr. Matlashewski, and Dr. Singer.

[Prof. Marc Ouellette]

Thanks also to you.

[The Chair, Conservative, Joy Smith]

Could the Public Health Agency please move forward? You can sit in the seats that were formally occupied by the Global Health agency. Thank you.

We're going to start straightaway with a new round. You made your presentations yesterday, so we'll go straight into the questioning.

Ms. Murray, you're up first.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Thank you.

Ms. Tam, have you seen the letter to Dr. Butler-Jones from Craig Knight, the assistant deputy minister of the B.C. Ministry of Health Services?

[Theresa Tam, Director General, Centre for Emergency Preparedness and Response, Infectious Disease and Emergency Preparedness Branch, Public Health Agency of Canada]

Yes, we have received that.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

It's pretty strongly worded there that outstanding questions about this bill have not been satisfactorily addressed by previous information sessions. There are some very strong concerns, I would say, not just about the duplication that I brought up last time, but really about the process of consultation or the lack of consultation. We just heard that from some of the very eminent heads of labs at the universities, who essentially weren't consulted on this either.

The question I have is, what's the rush? Why do the process this way? Why not take the time to adequately bring in the provinces, especially when there is concern about stepping into provincial jurisdiction and when your bill may well be subject to a court challenge as to whether it's even constitutional, for this kind of jurisdictional overlap? Why not take the time to get this right? What's the cost of waiting? Has there been a major incidence of problems that you're rushing to address, or what's the reason?

[James Gilbert, Director General, Strategic Policy Directorate, Public Health Agency of Canada]

First of all, it is viewed as an important security and safety issue. It's a gap in the country, and we recommend that Parliament address that.

On the consultations, there's been dialogue and there were information sessions before the bill was introduced. But I would agree with the witnesses about the kind of in-depth consultations on the bill itself. At the Public Health Agency of Canada, we have discussed the issue. We went out before the bill was introduced with a paper on what a framework would look like, but it was a quick information session.

On the role of the department in this, we've provided good policy advice to the government of the day on the legislation to bring forward. The tradition is that the legislation is seen when first introduced by the government in Parliament. So it's not the usual case that you consult on the legislation itself before it's introduced in Parliament. But we do need to have the stakeholder input, and this is what we heard from the witnesses. As soon as the bill was tabled we were out there across the country to talk about what it meant. We talked about the difference in risk levels between level 3, level 4, and level 2, with our specific interest being the safety and security on the level 3 side, and using the level 2 in a mostly voluntary regime to be able to get good biosafety messages out there.

Once the bill was a public document, we knew right away that we had to get out there, and we were free to talk to researchers across the country on that. We've looked at the letter from B.C. and we want to continue that. That's where true consultation can start on the regulatory side of things.

As far as what's there, concerns were put forward about whether we were going to get the regulations right. You have a clear view from a province of what they're going to be saying to us in the regulation, and I think that's the start of a very good dialogue.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Thank you.

I would contend that's not the only way to do it. Having brought forward a number of bills myself in a past life, I know you can consult fully before you draft the bill so it actually reflects the input of the very important jurisdictions this will be affecting.

I'm not sure who this question goes to, but clearly the regulatory burden goes up with this bill. I know that years ago in British Columbia we did a count of every regulation and regulatory--

[The Chair, Conservative, Joy Smith]

You only have 30 seconds left, Ms. Murray.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Is there any assessment of exactly what regulatory burden this will apply on the labs and the client sites?

[Theresa Tam]

I think that is in the development of the regulations where we really need to consult. Our intent is to get that balance between science and innovation and biosafety and biosecurity, which means that the burden is going to be much less in terms of level 2 than for select 3s and 4s.

We think the level 3 and 4 laboratories already comply--almost all of the 150 laboratories--with the current human pathogens importation regulations. So for them this is essentially already in place.

I think what we're hearing today, and what we have heard in the information sessions and in a letter that British Columbia has crafted, are some of the details, and the devil really is in the detail of implementation. How would you structure your program so that cost is minimized? How would you structure a program for people who are working with the less dangerous pathogens, the risk group 2s? We're suggesting a less stringent requirement. So if you have no requirement for security clearance, if the inventories are very basic and you don't have risk groups 3 and 4, we're promoting a basic level of a national standard on laboratory biosafety.

I think the risk group 2 discussions are interesting, because we already require that people who import risk group 2 pathogens follow the laboratory biosafety guidelines under the human pathogen importation regulations. What we're suggesting is that for the 3,500 labs that we know are already doing this--including risk group 2 for importation purposes--we level the playing field in terms of all the other ones also requiring reasonable laboratory safety guidelines. If you remove risk group 2, you're going somewhat backwards on the human pathogen importation regulations and saying we're going to have a lower level than what we currently have for the 3,500 laboratories.

I think we will discuss all of the issues in terms of security clearance, costs, and not duplicating efforts already being made in the provinces in terms of how they're already looking, for example, at inspections of laboratories. We'll see where we can harmonize processes and increase efficiency in the development of the programmatic framework and the regulations development.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Tam.

Ms. McLeod.

[Cathy McLeod, Conservative, Kamloops—Thompson—Cariboo, BC]

Thank you, Madam Chair.

It's actually been very timely, at least to my thinking, that we had our previous panel and now we have an opportunity to discuss with you also. It really gives a much more robust understanding of the issue.

I'm sort of puzzling over one piece a little bit. We certainly heard very clearly from our university researchers that level 2.... They had a discomfort that the regulations would take care of that piece of the problem. But I also understand that we have laboratories across the country with level 2 that are not university laboratories. Are you suggesting that this is going to up their standard in terms of care? Can we just talk a little more about that piece?

[Theresa Tam]

Yes, it speaks a little bit about the different schemes currently existing in provinces as well. Provincial schemes and provincial guidelines and requirements tend to address certain laboratories--for example, the medical diagnostic labs, or there may be requirements for research grants for the research labs. There is not a single national standard that addresses all laboratories, and they may include people handling water treatment testing laboratories, environmental labs, as well as research, and Canadian academic and diagnostic communities. We believe it's very important for them all to have a national foundational piece of laboratory safety level. So we absolutely want to level the playing field.

We know that the research labs are probably the really good ones; the ones that the witnesses are from are already following laboratory biosafety guidelines. We do not believe the implementation of the bill, when you're already doing what we're expecting you to do, will result in a lot of extra effort in terms of duplication.

In terms of the processes and reducing administrative burden, we will do what we can in terms of program design to try to harmonize some of the different pieces. But you're correct, we're trying to level the playing field. There are lots of other labs out there that are not your absolutely brilliant research laboratories that are already following the guidelines.

[Cathy McLeod, Conservative, Kamloops—Thompson—Cariboo, BC]

That would add two quick things.

One, we saw a very extensive document for importing pathogens. I would presume this would be something that could be harmonized, so that it's not duplicated harmony.

[Theresa Tam]

Exactly.

The idea is that under the licensing scheme, for example, for a university or whatever, we will take into account the importation fees as well as addressing the licence to transfer pathogens of a particular risk group across Canada between institutions, etc. The requirements for permits and licence can actually simplify and harmonize some of those areas. We will not be requiring separate import permits and separate other licences for the domestic fees. That will be harmonized.

[Cathy McLeod, Conservative, Kamloops—Thompson—Cariboo, BC]

Thank you.

[The Chair, Conservative, Joy Smith]

You have another minute if you would like to use it, Mrs. McLeod, or if you'd like to share your time with one of your colleagues.

Mrs. Davidson.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you, Madam Chair.

I think Dr. Singer said pathogen security does not equal biosecurity. He had a concern that this bill couldn't cover everything, but that was a concern he raised.

Could somebody please comment further on that?

[Theresa Tam]

I think we welcome Dr. Singer's ideas. The two of us certainly have other dialogues. There is a much bigger piece to the whole picture, for sure. However, this bill and the ensuing regulations will address one step of the way. It is not the whole answer to biosecurity. He suggested other ideas, and I'm sure other researchers or other experts will have other ideas as well.

I think the witnesses preceding us also gave us some ideas as to what might be in an expert advisory committee to advise us on the development of the regulations and, over time, on what should be in the different risk groups, etc. We are envisaging the development of a committee. This is already under the Public Health Agency of Canada Act whereby the minister can strike expert committees to address the needs of the development of the regulations.