Health Committee on March 26th, 2009

[Theresa Tam]

There are only two laboratories at level 4, and they belong to the federal government and are situated in Winnipeg. There are approximately 130 level 3 laboratories. We believe the majority of those—almost all—are already importing pathogens. They essentially already have permits under the human pathogen importation regulations, so we know they're following laboratory safety procedures.

Again, with that in mind, we do not believe the regulatory and programmatic elements will have massive impacts on these laboratories, which are already following laboratory biosafety guidelines.

For select level 3 and 4 laboratories, we are going to be looking at security clearance applications. So that would certainly be one of the key elements that will impact them.

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

Dr. Descoteaux did quite a scenario around the research they are currently doing on AIDS and sample banks, so I'm just wondering if I could hear really clearly articulated how this bill might impact this important work, because I believe you were saying AIDS is 2.9. What will happen in terms of that particular example?

[Theresa Tam]

For all laboratories, what's currently envisaged is a phased approach. The initial phase upon royal assent is very simple. The impact on them is that they have to call us and make sure we know who they are and that they're only holding level 2 pathogens, or whether they're holding certain level 3 and 4 pathogens. They shouldn't have smallpox under this type of requirement. We certainly have bounced these kinds of impacts off our risk group 2 labs, and they don't believe there will be major impacts during this initial phase.

For risk group 3s, we are prepared to have discussions with the community, because we do not believe that all risk group 3s are created equal; hence, to only a certain number of them would the biosecurity elements apply. So if you are an HIV researcher, we do not believe that HIV is likely to be used as a bioterrorism weapon, so it will not be treated the same as something like anthrax.

So that will come under the regulatory design of the program at that point in time. That discussion still has to take place, but essentially the risk-based approach will take that into account.

They will obviously be looking at inventories, for example, and certainly making sure that with risk group 2s we don't have risk group 3s inadvertently mixed up with them, or those types of things. But we're not going to ask for detailed inventories for those labs.

As for risk groups 3 and 4, the 3s will be under further discussion—again, depending on which risk group 3 pathogens you have. For HIV, if it's feasible and effective just to say, well, we have handled HIV, that could be it, but we need to know which laboratories are handling HIV.

Again, what we want to do is to design something that has as little impact as possible. But if you are already filling out the forms for the human pathogen importation regulations, when our regulations come into force—which will probably be in many years' time—we will be looking at effective ways of incorporating them into one administrative procedure. So the scope of the licence will include the importation elements in it and you will not be trying to do two things; we'll be trying to deal with both the domestic and the importation piece together.

[The Chair, Conservative, Joy Smith]

You just have one more minute, Ms. McLeod.

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

Certainly, from my perspective, the development of regulations is quite a technical piece. Certainly, even with my medical background, which is much less than that of many of our guests here, I believe in setting a framework. I'm actually surprised it was suggested that we put a lot of the regulations right into the legislation, because I would have thought the scientific community would prefer a different process.

I just wanted to make that point in my last minute. Thank you.

[The Chair, Conservative, Joy Smith]

Thank you very much.

We'll now go to Monsieur Dufour.

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you.

From the outset, Dr. Butler-Jones told us that you had looked at legislation in other countries to get an idea of what aspects could be included in Bill C-11. However, the scientists have shown us that the list is much shorter in the United States and that we should perhaps move in that direction rather than the much more rigid structure of Bill C-11.

Just now, the scientists told us that, because of the proposed fines, they feel that they are under attack, even before the bill is passed. They are already being treated like criminals. As you know, people have to be found guilty before they can be fined. We must not forget that legislation exists to be used.

I am surprised by one thing. Fines can be imposed, but on whom? Is it the universities, the hospitals, the professors? We all know that this is provincial jurisdiction.

On the one hand, you tell me that the legislation will not be challenged, that it will move forward and that the provinces see no problem with it. On the other hand, who gets fined? If we start fining hospitals and universities, we are going right into provincial jurisdiction, it seems to me.

[The Chair, Conservative, Joy Smith]

Ms. Allain, do you want to address that?

[Jane Allain]

First, as I mentioned previously, this bill does not give the Public Health Agency of Canada the power to impose fines. It is wrong to believe that the fact that a fine is set at $50,000 gives us the power to impose it. On the contrary, it establishes a penalty, and, to determine the penalty, you first have to look at the activities that are regulated and what the people have to commit to as a result. So, essentially, a licence holder must, for example, contravene one of the conditions of his licence or fail to comply with the law. After an inspection, or some other investigation, the person could be prosecuted. In other words, a summary charge could be laid. With a summary charge, penalties and procedures are much less onerous. Essentially, that is the mechanism that Parliament provides for establishing criminal penalties.

So it does not mean that we can impose fines on anyone. It essentially provides the ability to prosecute people who contravene the law. As Dr. Butler-Jones said, it would be just in cases where people did not comply with instructions given by inspectors, and it would depend.

I would also like to emphasize that the bill as written provides for the due diligence defence. So if a person has taken legitimate and reasonable precautions established as his obligation and duty under the regulations or the legislation, it is a full defence to section 53. It would then be a question of the penalties intended for risk group 2.

This is a procedure that allows the government to bring prosecutions, but only if the act is contravened. Ultimately, it is up to the court to decide if the act has been contravened and if the accused should be found guilty. I should mention that the penalty indicated is the maximum. It is very rare for a court to impose the maximum penalty in anything but an extreme case. Penalties are determined completely within the scope of sentencing principles that a court must consider. For example, the person's behaviour is a factor. A court would impose a maximum penalty only in cases where there had been prior warning, where the accused had not followed the guidelines, or where he had flatly refused to observe the law.

[The Chair, Conservative, Joy Smith]

Dr. Butler-Jones, would you like to comment?

[Dr. David Butler-Jones]

We do not regulate laboratories or hospitals. This legislation deals with pathogens and is applied only in that context.

In the United Kingdom, the legislation on pathogens contains more than 15 pages and puts levels 2, 3 and 4 together. That is one example.

[Nicolas Dufour, Bloc, Repentigny, QC]

Did you do a ...

[The Chair, Conservative, Joy Smith]

I'd ask you to defer. It's now Dr. Bennett's turn.

You have my apologies. You had a little bit more time.

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

I would like to give my time to the witnesses who have been called so that they can ask the officials whatever questions they want in terms of whether they're satisfied. Mainly it is to ask the witnesses whether it would it make them feel better if the regulations came back to this committee and if the process for coming to the regulations were to be better articulated in the bill, in terms of “thou shalt consult”.

Who would like to have my time?

[The Chair, Conservative, Joy Smith]

Go ahead, Monsieur Ouellette.

[Prof. Marc Ouellette]

Thank you very much.

When Bill C-54 first came, and then Bill C-11 afterwards, it was like an atomic bomb in the research community. We were not prepared for it. The way we read the law--and I even read the document explaining the law--it was appalling to the people in the community who had been following the guidelines for those 15 years.

At level 4, there's one big lab in Winnipeg. At level 3, there are 120 labs, but most of those level 3 labs are not dealing with biothreats. Yes, there is HIV, and a couple of them deal with TB. The labs that have to work with anthrax are mostly military labs. I know Burkholderia pseudomallei is being worked with in Calgary, and possibly they have special arrangements there.

When I came the first time....

The regulations governing the import of pathogens are already very, very substantial. We do not know what the process of communication will be between the people on the ground and those who will be making the regulations. It is certain that level 2 will be different from levels 3 and 4, but that is not how the bill is written.

I understood very well when you said, “Well, gee, if I was in your place I would not like to have regulations within the law”. This is not our field of expertise, and for us, when we read that, it looks pretty dangerous for the research we are doing, in the sense that we will overburden already overburdened people. Now with the regulations, I'm not aware of how the process will work, or whether it will come back to this chamber, or whether there will be communication. It's a chèque en blanc that they're asking for. You want something more from the Public Health Agency of Canada than a chèque en blanc.

[Dr. David Butler-Jones]

There are two things.

One is that we will be consulting on the consultation process for the development of regulations with provinces and territories, stakeholders and others to make sure we have the consultation process right and we have all the issues right in terms of what people have raised. That will be transparent, that will be open, and there will be many opportunities, bilateral, multilateral, a whole range of things, and people will see it. It's up to this committee, and ultimately the House, what will come back where, and we're quite comfortable with however you wish to handle it.

There is an irony to it all. This is now several iterations of trying to get a bill on this to pass. The previous one was much more specific, and what we heard in all the consultations from across the country, from our colleagues in research and others, was to make it less specific, because they don't want all level 3 pathogens in. They want some time to think about what should be in and what should be out, and with level 2 and how to manage that. Make it less specific and then deal with it in the regulations, which are more amendable if there are new pathogens or new issues, etc. We changed it in that way, but now the concern is that it's too general and too complex. It was done based on our colleagues in science and elsewhere saying not to make it so specific, but make sure they're consulted well on what's in, what's out, the regulatory regimes, and all of that kind of stuff, which is our intent and our plan. That's how we will proceed, depending, again obviously, on how the House pursues this legislation.

[The Chair, Conservative, Joy Smith]

Thank you.

Ms. Wasylycia-Leis.

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

I'm a little leery about the suggestion that the proposed reduced penalties for people handling level 2s will never be used except in extreme cases, and of course it has to go through the courts and a judgment has to be made, blah, blah, blah.

It seems to me that just the threat of it being there is the problem, that this has the impact on the scientific and research community. Even if one argues it will never be used, it is, as was just said, like giving a blank cheque.

Again, the more we talk about this, the more I'm wondering about why we would even go this route. Maybe we should actually look at getting rid of level 2s for now, as Mr. Singer said, and get on with 3s and 4s. Leave it the way it is; have your regulations that deal with 3 and 4. They'll come to this committee and we'll have some oversight, but keep in mind that we don't get a chance to change the regulations. It is a blank cheque. We can review them with the amendment I proposed, we can comment on them, we can consult on them, but if the government insists, we can't change them. It's only a little bit of a check and balance in place.

Given all of that, can we revisit this once more, everybody together, and say, what's wrong with just deleting level 2s for now?

In fact, I originally had an amendment to do just that, to change clause 7, amend it after line 22 on page 5, saying that the subsection does not apply to any activity involving a micro-organism, nucleic acid or protein that is listed in schedule 2. What's wrong with that?

[The Chair, Conservative, Joy Smith]

Dr. Butler-Jones, would you like to answer that?

[Dr. David Butler-Jones]

The first thing is that in terms of the issue of potential penalties and prosecution, 3,500 current labs are currently under a regime that has that option. It has not changed their practice. In the U.K., it did not change or stifle or put a chill on research.

It's a hypothetical about whether this will make.... I think it will make some people feel more comfortable if it's removed. It will make me somewhat more nervous. Given the things that we're aware of in terms of things being abandoned and left behind, the mix-ups, people saying they're only level 2 but working with level 3, quite honestly we don't know what's out there. It's not like we want to create a great imposition, etc.

But I am worried about, the outliers, as Peter mentioned. If there's a mistake, if there's a problem, if there's a release, if there's a lab playing with anthrax and it gets released--not intentionally but because they don't have good biosafety--that is a concern.

There was an anthrax outbreak in the U.K. There was the H2N2 incident. That is my concern. Ultimately, it's up to legislators. I've said my piece. That is my concern--if there is a mistake.

We think we can accommodate the concerns through the regulations, but if in the meantime something happens, I would be concerned about that and it would be difficult to justify.

[The Chair, Conservative, Joy Smith]

I think Mr. Descoteaux wanted to make a comment. All of these comments are on the record and it makes us very responsible. Take your time.

[Dr. Albert Descoteaux]

The problem I have is that you always use fear. When you were talking about level 2 pathogens and anthrax releases, accidents, you were saying you're nervous about accidents happening. Even with this law in place, it will not prevent any accident, any spill, any release. I'm sorry, but prove to me that Bill C-11 would protect us from an accident, from a release, from a spill in the environment.

You're always talking about somebody who could work with smallpox or somebody who had anthrax....

[Dr. David Butler-Jones]

I did not say that.

[Dr. Albert Descoteaux]

That's what Mrs. Tam said earlier. We're talking about level 2 pathogens.