Health Committee on March 5th, 2009

[Theresa Tam]

The way we've approached this is really to do it through the regulatory development process. We had some very extensive discussions about this concept of equivalency at the bill's drafting stage; there was much discussion. The issue was the interpretation of equivalency and the objective of certain schemes, and it was very difficult to arrive at that benchmarking piece. Really, we feel that the key step, moving forward, is, as we've now publicly stated, that we would look at ways of harmonization through the program implementation process.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Tam.

Ms. Wasylycia-Leis.

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

Thank you very much.

I'd like to hear a direct response to Professors Ouellette and Matlashewski. Maybe you, Dr. Plummer, as someone from the research/academic/scientific community, heard their concerns. They're very worried about the impact on their ability to encourage students and be able to teach them and provide opportunities for scientific innovation. Can you respond to their concerns?

[Dr. Frank Plummer, Scientific Director General, National Microbiology Laboratory, Public Health Agency of Canada]

Yes, I'd be happy to.

In my testimony on Tuesday before the committee I mentioned that when I initially looked at what was being proposed in the bill, I had many of the same concerns. I've been reassured and convinced by my colleagues in, I would say, rather vigorous discussions within the agency that this will be addressed through regulations, that there will not be onerous burdens placed on individuals working on level 2 agents, and that teaching and research will continue. There will be some burden, but I don't believe it's over-burdensome; it can be managed.

Many of the things that need to be put in place or would be required by the bill should be there anyway in a well-managed laboratory—inventories and those sorts of things. Although the risk to the public health of a laboratory-acquired infection by a level 2 agent is low overall, there is a risk. There's an influenza virus currently circulating, of H1N1 type, that probably originated from a laboratory accident or intentional release in Russia in the 1970s. It's been circulating ever since, causing a minor pandemic. So it's not zero-risk.

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

I hear what you're saying. I thank you for your assurances, but I'm a little concerned and wary about leaving everything to regulation. We've been down that path before. We lose control as parliamentarians. Unless we require and pass a motion that says all regulations must come before this committee, as we've done with reproductive technologies, and we're still waiting--I think about eight years after the fact--I'm not confident we have any assurances we're going to achieve the desired results. We're hearing some very significant concerns, and I think we need to be able to tell the academic community something more than to just wait for the regulations.

So I'd like to hear about that, and then of course the other suggestion around something more concrete than simply saying we deal with external advisory committees all the time, or it's part of the process...something. If it's not in the law and we're going to leave it to regulations, then we need something we have some relationship with, some way to hold accountability and transparency.

[James Gilbert]

For us there's always a choice in terms of recommending what would go into legislation and what would go into the regulation, but as I was saying the last time I was before the committee, it's very complex, and members and witnesses are rightly saying you need to work with stakeholders and get it figured out. A lot of this is working over a long period of time to make sure the governance systems mesh, to make sure the program is designed in a way that makes sense and the regulatory system fits the issues we're dealing with. To try to get that right in legislation, where it's locked in, is very difficult, and the regulation moving it in there allows us to have the consultative process we need at the Public Health Agency of Canada to be able to set up the best program.

Beyond that, though, we are here today saying, for instance, we're not going to have security clearance for level 2. We're in front of the House committee to say this is our intent in moving forward with that, that the inventories will be more simple, that the licensing for the regime for level 2 will be a web-based system where you'll put in your request to the Public Health Agency and analysts will have a look at it and make sure you've got an inventory, and there's your licence. So we're really trying to make this difference between the really deadly level 3 and level 4 pathogens and what that's going to look like and very clearly articulating that on level 2 the focus is going to be on good biosafety, just so we know who's got what and that what they actually have in their lab is a level 2 and not a level 3 or a level 4. So we need to find that out, and that's why we're going to the level 2 side.

But on the regulatory side, we want to get it right. We want the dialogue with stakeholders, and the regulatory process allows us to do that much better than the legislative process does.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Gilbert. I'm sorry. Our time is up.

Mrs. Davidson.

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

Thank you, Chair. I'll ask the question I didn't get enough time to ask the last time.

We were talking about pursuing biosecurity issues. Does the department have concrete plans to continue on biosecurity? Are there concrete plans to set up an advisory committee to continue with this further implementation? I think everybody has said this bill, although it gives pathogens security, hopefully, it does not give biosecurity. So are there further plans to go ahead with that?

[Theresa Tam]

I think we heard some good ideas today. Dr. Singer has already discussed with us the concept of having the Canadian academies look at a study, at least to start off with. So we are certainly going to be looking at some of those approaches.

In terms of counterterrorism or bioterrorism, there are many other aspects to the approach the Public Health Agency does take. For example, we have a smallpox plan and we have vaccines stockpiled. We have anthrax countermeasures, etc. So there are many other components, but I think what Dr. Singer has spoken to in terms of the emerging pieces are probably the areas...the “state of the art, what might be coming next” approach. We haven't really looked at it in any concerted detail. There may be other aspects of government, such as in defence research, that do look at some of these aspects, and we will certainly be collaborating with those departments as well.

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

Thank you. I'm sorry I wasn't here Tuesday to hear your presentations, but I have a letter I received from the Ontario Agency for Health Protection and Promotion, and I'm assuming you have received that letter as well. They had expressed some concerns about several specific areas where they thought further scrutiny was warranted, and they talked about consultation before making regulations, avoiding multiple inspection regimes, and that may be what Ms. Duncan was referring to. They also talk about the scope and application of a legislation, the licensing, clarity on occupational risk versus public risk, and disclosure of information to the minister.

Would you like to comment on some of those things as far as Ontario is concerned, and could you tell me if they are similar to the concerns raised by British Columbia?

[Theresa Tam]

I think they are quite similar. Some of the implementation issues are also similar to what we heard in the initial information sessions. We are going to be meeting with Dr. Vivek Goel next week to go over things in detail.

We've talked a little about security clearance. We're going to have a concerted look at trying to harmonize and not duplicate efforts in the program design and regulations.

I think there's also some anxiety about not having bottlenecks in security clearance, for example. On the one hand, having the federal government shoulder the cost of security clearance is a plus point, but there is anxiety around whether they can process them fast enough. We need to look at the security clearance program itself, with the stakeholders as well, to see what is acceptable, feasible, and reasonable.

Regarding the issue of the power of the Minister of Health, while it's essentially on par with the usual legal language in a bill, we wanted to reassure the provinces and territories that there are limits. The minister can have information disclosed or exercise the powers in the bill only if it pertains to the act itself. On the two other conditions, certain information can be disclosed if there is imminent danger or a public safety incident, or if there are international reporting requirements, such as the international health regulations. So there are some very specific boundaries pertaining to those powers.

I don't know if Jane has anything to add on that.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Tam.

We'll now go to Dr. Carrie.

[Colin Carrie, Conservative, Oshawa, ON]

Thank you very much, Madam Chair.

I want to bring forward a couple of things. With any type of regulation or legislation you want to make sure it is balanced. I think you've put in a significant effort and done a good job of getting that right, but I do have concerns. I think Dr. Ouellette was saying that sometimes in these labs they do genetic manipulations, and pathogens are modified. Will each of these things, in day-to-day work, be put under onerous regulations? I don't want to do anything to impede the research and development we do here in Canada.

I wonder if you can think about what Dr. Matlashewski was saying and alleviate some of those concerns. We have this legislation in front of us. I've gone over it and it looks really good. Is there anything else you'd like to say that will help the research community know that you're going to be committed to consulting with them as things get phased in?

[Theresa Tam]

What is enlightening to me is that there is a gap in trying to increase awareness of what happens between the bill, which is all-encompassing, and regulations development. We need to do a better job of communicating that.

We're absolutely committed to consultation. On some of the current framework, we're thinking about a licence that will encompass the risk group as a whole. We're not asking for licences for individual pathogens. If you manipulate a pathogen, as long as you don't increase its impact on health or its pathogenicity, and it's within that scope, you're not required to have another licence just because you've manipulated an organism. If, however, the way you've manipulated the organism increases its pathogenicity and brings it to a level 3 or 4 risk, give us a call about any questions on that. We would like to discuss it, and this expert scientific committee can be brought to bear to discuss some of those situations.

In the licensing scheme itself we can certainly go a long way toward minimizing the actual burden on the research community.

[Colin Carrie, Conservative, Oshawa, ON]

Would anybody else like to comment? Did we learn something today, in listening to the researchers, on how to better set that out?

[Dr. Frank Plummer]

I think we were aware there would be concerns around some of those things. The scientists who work with me in the national microbiology lab have expressed those kinds of concerns. But if you have a very limited licence, as Theresa just described, I don't see that as being onerous. I'm going to have to implement this too, and I don't see this as being onerous at all.

[Colin Carrie, Conservative, Oshawa, ON]

I think my colleague Mr. Uppal wants to say something.

[The Chair, Conservative, Joy Smith]

Mr. Uppal, would you like to finish off the time? You have two minutes.

[Tim Uppal, Conservative, Edmonton—Sherwood Park, AB]

Thank you, Madam Chair.

Just to touch a little bit on what you mentioned about the committee of scientists who would be dealing with some of these issues, in a practical sense, how easy would it be to get hold of them, how often are they going to meet, and how quick would the turnaround be on a question a laboratory may have?

[Theresa Tam]

I think this is where, again, we have to develop the advisory committee. There is in existence a reference group already for the current scheme and for the consultations, potentially, on the development of the regulations.

What we will see is that when this bill and the regulations development come into force, as it were, we will hear from a lot of different people. There are many scientists and many experts, both in Canada and internationally, whom we can leverage.

Some of the concept includes that we will have an expert advisory committee, but we also have rosters of experts on very specific pathogens, people who are already on a roster and have agreed to provide us with expert advice as, if, and when needed, in a fairly nimble fashion.

We actually need rosters of experts not only for this particular bill or regulations; we will need them for a nimble response to emerging pathogens in any case. As you can imagine, we already have two Leishmania experts, and they will probably want to sign up to help us, because they'll be ready to provide input. So I think there are incentives on both sides to create a committee that is viable, up-to-date, and effective.

What we would like to do is, potentially, to draft a concept we can consult on—“What do you think of this concept of the structure of a committee?”—to see what the reactions are from our stakeholders.

[The Chair, Conservative, Joy Smith]

Thank you very much, Dr. Tam.

We have just a few more minutes. We have gone through our rounds. Is there anybody here who would like to ask some additional questions? We have a few more minutes, if you would like to do that.

I have Dr. Bennett, Monsieur Malo, and Ms. Wasylycia-Leis. We won't get through everybody.

Dr. Bennett, you were first.

[Carolyn Bennett, Liberal, St. Paul's, ON]

I have two things. First, is there anything you want to answer respecting the previous panel's concerns? I'm sure you picked them up: the clearance piece, around colleagues sharing samples, and those kinds of things. Do you feel you would like to offer either a “what a great idea” or “yes, but” kind of answer to what the previous panel said?

My second question is this. We know that sometimes with advisory committees on science-based topics, governments are criticized on the grounds that as soon as the panel is announced, people know what the answer is going to be. Do you have any thoughts about how you'd put it in place and whether the Science Advisory Board of Health Canada could be involved in picking a panel of the best possible people to give advice on something as important as this?

The last question comes from Derek Lee. It seems that the back-end check on regulations is missing in this bill, in terms of their coming back to committee or back to Parliament. In all of these, on every single bill that has to do with regulations and science, we will be putting in an amendment from Derek Lee asking us to.... You can't take the front end and the back end out of parliamentary oversight.

[Theresa Tam]

There were a number of questions that some of the other panellists may be able to address better, but I want to pick up on a couple of other points that the previous witnesses mentioned.

The issue with risk group 2 is I think of greatest concern. What we have in the bill is a balance between a list that provides a level of clarity and some definitions, which will help us catch things that are not listed, for example. We've heard, from the E. coli issue, that you want to make sure we only talk about pathogenic types. We believe that the bill as a whole is only talking about human pathogens and does not address things that are non-pathogenic to humans.

But we are thinking of potentially putting in brackets—after “E. coli”, for instance—the pathogenic strains, which is reasonable. It's clear to us, but it seems to have generated a lot of angst among the community. While we can clarify that as an overarching piece, there are fairly easy ways in which we can probably deal with the risk of group 2 pathogens. But we are only interested in the ones that are pathogenic, not in the non-pathogenic ones.

In terms of the advisory committee, we'll certainly welcome any ideas people may have. We want it to be open and transparent. It has to be science-based; I think that is the fundamental principle. It cannot—

[Carolyn Bennett, Liberal, St. Paul's, ON]

The advisory committee must give transparent advice to the minister. The minister can do what she wants with it, but I think Canadians need to know what the scientists said. Then, if the minister has to make a political decision, that's different; that's fine. At least Canadians would know what the science says.

[Theresa Tam]

Yes, and I agree with that too.