Health Committee on March 26th, 2009

[The Chair, Conservative, Joy Smith]

There was the constitutionality.

[Dr. David Butler-Jones]

I'll turn it to the expert.

[Jane Allain, General Counsel, Legal Services, Public Health Agency of Canada]

I don't know if I would use that term.

As a rule, a law can be considered as falling within Parliament's jurisdiction over criminal law. As I mentioned before, when there's a prohibition accompanied by a sanction, and the prohibition is targeted towards a legitimate public purpose or interest, the criminal law purposes can be to address the public peace and order, security, environmental protection, or health and safety. Those are just examples. They're not the exclusive areas of criminal law.

It's a broad area of jurisdiction, and it has a broad range of legislation that has been enacted under that head of power already. The criminal law is not frozen in time, nor is it confined to a fixed area of activity. The courts have told us over many years that Parliament can respond to new realities, and Parliament has the power to decide what is criminal and what is not, and what new crimes...what is needed to respond to changes in social situations.

The simple assessment that the courts ask Parliament to make is whether there's a reasoned apprehension of harm.

The criminal law part doesn't have to create total and direct prohibitions. It can actually use indirect goals to achieve the criminal law purpose. Again, it can pass purely preventive legislation criminalizing only secondary aspects of activities such as the regulation of tobacco.

We have many examples of criminal law legislation that have contained valid exemptions and the conduct and control of certain activities. The Supreme Court of Canada has told us over many times and in various legislation, whether it's the Food and Drugs Act, the Hazardous Products Act, the Controlled Drugs and Substances Act, or the Firearms Act, that these are legitimate regimes, and they can actually be accompanied by very detailed regulations. But that does not make it a non-criminal law. It's still a criminal law. These highly detailed requirements and standards can be set out in the regulations, and that is essentially the regime that you have currently under the Food and Drugs Act.

So this is the type of model legislation that is envisioned under Bill C-11, and it's to establish, as many witnesses have said, a safety and regulatory regime, a safety and security regime to protect the health and safety of Canadians against the risks and harms posed by the use, possession, transfer, disposition, or destruction of human pathogens and toxins. So we believe it's on very solid constitutional grounds.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Allain.

We'll now go to Mr. Dufour.

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you very much, Madam Chair.

Thank you for being here. Your statements were short, but you were able to point out some of your fears about the proposed amendments in the Public Health Agency of Canada's document. You say that you were advised 24 hours in advance. So I assume that you received their information 24 hours in advance.

Could you tell me if the government's proposed amendments change the bill significantly? Do they give you that impression?

[Prof. Marc Ouellette]

My statement was short because I was told that this was mostly a time for discussion. So I can give you a little longer answer now.

Yes, we did receive the Public Health Agency of Canada's amendments 24 hours in advance. I have to say that the amendments are significant in their way. But they are cosmetic given that the experts who have come to testify, from a legal, scientific or medical perspective, all agree: the bill would be perfect for levels 3 and 4.

However, when you start to try to bring in level 2, things get a little more complicated. Even at level 3, to some extent. Our colleague Dr. Descoteaux mentioned HIV, which is not presently classed at level 3, because it is not aerosol-transmitted, but at level 2.8 or 2.9. Without going into technical details, according to the guidelines, HIV is not the same thing as tuberculosis or anthrax, for example. Do not forget that the HIV lobby is very strong and, if ever HIV were made a level 3 pathogen, people would be up in arms.

That said, we do not think that the bill should exclude level 2 entirely. Health Canada can attest to the fact that we do apply for licences. I gave you a document...

of about 22 pages that we have to fill out in order to be able to import strains from all around the world. So now there's a new amendment, and under the amendment we will also now need something in order to export. We will have to do due diligence on the people to whom we're going to send the strains. This is something new for us. It was not in the bill itself, but it was in the amendment.

So how do we do the due diligence on the people to whom we will send the strains? Is it enough that they be a university professor of biosafety? Or do we have to do a criminal check? I don't think it will be that way, but this is new for us.

To export things now, we also have to ask permission. They need their import permit for what we're sending.

Since we were coming here today, we received a number of documents from Health Canada, which we very much appreciated. I didn't know which document it was, so I read the first one, and I thought it was pretty bad. It was actually Bill C-11, and how it was explained to people.

I said there are new things here, and some are good and some are not that good. Those were the regulations. So why not put the regulations into the bill and then everybody will understand what the goal is?

Level 2 pathogens constitute 95% of the activity. Level 3 is pretty much 5% because there is only one laboratory in Canada that handles level 4, in Winnipeg. We all agree, when we are working with diseases that are potentially very dangerous, there has to be an extreme level of security.

Level 2 pathogens are the bread and butter of people doing research. We already have regulations. I mentioned that, in order to get money, we have to get approval from regulatory bodies, university bodies, institutional bodies and the bodies that are going to give us the money. Then, we have to apply for licences from Health Canada.

When we're asking for a strain for importation, we need Health Canada, but we also need CFIA, the Canadian Food Inspection Agency. Do the governments talk to each other, or will there be another set of regulations for CFIA,because it's not possible for us to import something only from the Public Health Agency? We also ask, will there be two types of regulations, one for Health Canada and one for CFIA?

In conclusion,

...level 2 pathogens should be controlled as they are now, and I feel that it works very well. It is a system that has been institutionalized for a long time. For pathogens in levels 3 and 4, the dangerous ones like anthrax, the bill should go into effect. We will have to see about HIV. For level 2, we still have concerns.

[Nicolas Dufour, Bloc, Repentigny, QC]

Do you feel the same way, Dr. Descoteaux?

[Dr. Albert Descoteaux]

Yes; I received a copy of the proposed amendments after the witnesses were heard. It does not seem that the advice about excluding level 2 micro-organisms has been taken into consideration. You have reduced the fine from $250,000 to $50,000. Thank you very much, that is a great relief. It means that, the first time a student in my laboratory commits an offence, or I do, we have $200,000 less to pay.

Something else continues to bother me. As Marc mentioned, 95% of the people in Canada are working with level 2 micro-organisms that pose no danger to health. But the words that frequently come up are penalty, offence, contravention. Microbiology researchers and students are being treated like potential criminals. I have a problem with that. I do not think that we should be treated like criminals. We are working to understand infectious diseases better, so that we can diagnose and treat them. I see no reason why we should be treated like potential criminals. That is the problem.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Descoteaux.

Ms. Wasylycia-Leis.

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

I'm tempted to ask whether you've read Bill C-9, the bill that we just passed yesterday on the transportation of dangerous goods, and see whether there's also some conflict between Bill C-11 and Bill C-9. But I won't go there right now.

I sense a less than enthusiastic response from our scientific research community to these amendments.

I want to start by asking Mr. Singer what he thought of Mr. Butler-Jones' response to his suggestion of separating out all level 2s.

[Dr. Peter Singer]

I thought, as usual, there was a lot of cogency in what David Butler-Jones said. He gave an actual scenario that did establish some benefit in regulating level 2s. What I would like to go back to in the back and forth with him is that it was almost that an implicit assumption was that you're regulating them through Bill C-11, where they're completely unregulated. So even taking that scenario, for instance, thinking about the institutional regulatory frameworks, the provincial regulatory frameworks, all the various other regulatory frameworks, which are less intrusive than the criminal law, could not one have achieved, in that or similar cases, a similar result? That's one question I would ask back.

Secondly, for me, this U.S. comparison is very revealing. I'd really appreciate an answer to the question, if the United States, in the wake of an actual anthrax attack, passed legislation that criminalizes stuff that looks like level 3 and level 4, but level 2 pathogens, by and large, as I understand it, in the United States are dealt with through CDC guidelines, and so on, not criminal law, why does Canada need to criminalize more of the scope of pathogens than the United States does?

I also made a point about criminal law being important, even without penalties for scientists, and the day after the attack, which David may or may not want to respond to.

But really, these are the two things I'd love to hear in this back and forth.

One, wouldn't all the institutional regulation, provincial regulation, etc., cover scenarios like the one you described? Maybe not. That would be important to hear.

Secondly, in terms of the U.S. comparison, why should we criminalize more pathogens and more laboratories than the bioterrorism-stricken and more obsessed United States does, where we know that the Patriot Act and select agent rules have already had some unintended consequences, such as in the Butler case--not Butler-Jones, but Butler--that you mentioned last time?

[The Chair, Conservative, Joy Smith]

Go ahead.

[Dr. David Butler-Jones]

I guess there are a couple of things, and then I'll let Jane speak to the legal aspect more specifically.

But particularly as it relates to the ability or the limitations around the changing of the regulations and the development of the regulations--and it's not about criminalizing labs or scientists. In the 15 years that half the labs in the country have been importing and exporting under regulations, with penalties potentially including jail time, it has never been used. It's never needed to be used, because again, it's a collaborative, cooperative kind of process.

As far as the issue of whether the existing regimes can address it goes, I've just given you two examples of where they would not have addressed it, and could not address it, even in a province that has an extensive regulatory regime around laboratories. It's outside of their regime.

I'm really not worried about academic labs and university labs. But there are a number of other labs, and nobody's really sure that they're out there and what they're doing, or what they have in their fridges and how they're doing it.

When provinces do regulate, by and large it's on occupational health and safety and on laboratory standards, not on public safety.

So any regime that we begin, both for what bugs are in and out and for the level of regulation, is really for consultation with scientists and others regarding what makes sense. It doesn't make sense to have tuberculosis at the same standard as others like anthrax, for instance. That will be addressed in the development of the regulations.

I think I'll leave it at that and turn it over to Jane, to talk in terms of the regulatory powers, and so on.

[Jane Allain]

Do you mean in terms of how you establish regulations?

[Dr. David Butler-Jones]

I mean once the regulations are established and the process of notification and so on that we would be following.... That would not, in terms of your scenario, Peter, about the day after...and suddenly we're going to do something.

[Jane Allain]

Right.

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

Could you also address, though, the issue of the difference between the U.S. system and this one, and whether or not level 2 is part of the Patriot Act, in terms of criminalization?

[Dr. David Butler-Jones]

I'll ask Theresa.

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

I could try to answer this.

The made-in-Canada solution, this Bill C-11 and the program thereafter, is to establish biosafety and biosecurity and to protect Canadians from pathogens. It's important for us to know who holds pathogens, whether they are in risk group 2 or not. All we want to do is to know that when institutions, organizations, and laboratories hold pathogens, we actually know who these people are and that they are handling things in a safe manner, according to laboratory biosafety guidelines.

Now, for risk group 2, for the most part, we are not asking for security clearance, because we do not believe they are a bioterrorism risk.

The type of risk group 3 pathogens and all the risk group 4 pathogens, or specific toxins, we would like to discuss in the regulatory development are probably similar to those on the U.S. list--I'm not saying the list would match, but they would probably have a similar kind of approach, so that the select agent rule is about biosecurity, bioterrorism.

This bill is establishing a single, uniform standard for safety in Canada, and that's important to Canadians. Every Canadian will want to know that we actually know where laboratories are and who holds pathogens, and that whoever is holding the pathogens is handling them in a safe manner.

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

Well, why doesn't the United States put their level 2s under a criminal code framework?

[Theresa Tam]

I can't comment on why the United States did what they did, but they certainly have a bioterrorism focus. We are promoting a biosafety regime that's uniform across Canada.

As Dr. Butler-Jones said, our human pathogen importation regulation actually has a maximum of up to three months of jail time as well. Again, that has never been utilized. If it's a repeat offence, if we've done a lot of work with the lab and they still didn't do anything and they were not diligent and abandoned their pathogens, etc.... Those extreme circumstances, I imagine, are exceedingly rare and we wouldn't really be going towards them. But that is still in the existing human pathogen importation regulations.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Tam.

Dr. Carrie.

[Colin Carrie, Conservative, Oshawa, ON]

Thank you very much, Madam Chair.

I, too, would like to get into a little bit of back and forth.

But first I want to ask, Dr. Singer--because you did have reasonable concerns about criminal penalties with these level 2 pathogens--if the bill was amended to clarify that risk group 2 pathogens would not be subject to the same degree of regulation, including security screening and penalties, whether that would help alleviate your concerns.

[Dr. Peter Singer]

Dr. Carrie, it would certainly help to alleviate my concerns. I would say that if there were clarity in the amendments, that level 2 versus level 3 and 4 pathogens were different, that level 2 pathogens didn't need security screening, and that the criminal penalties for level 2 were less, it would give you a better bill than what you have now.

The question I'm asking is whether that would be the best bill. What I'm really proposing to the committee is a very simple solution.

This bill is perfect for levels 3 and 4, and it needs to be urgently passed. I really support it, because there's a big gap here internationally. You don't want to have no federal power in level 3 and level 4 labs; that's not a very good situation to be in.

So the solution I would propose is to pass the bill with respect to levels 3 and 4, but with respect to level 2 pathogens, refer the question of what is the best mechanism to promote biosecurity in level 2 labs to an independent group, such as the Council of Canadian Academies. They can compare criminal sanctions, provincial laws, institutional regulations, and other types of approaches.

They may come back and say legislation is best. They would do so within two years or 18 months, and then you could amend the legislation. It would be about the same time as you'd be passing regulations for level 2 pathogens anyway, but you'd have some more confidence in the right way to go for level 2 pathogens.

That's really my position. I hope that's helpful.

[Colin Carrie, Conservative, Oshawa, ON]

Could I ask Dr. Butler-Jones to comment on that, so we can get a bit of back and forth going here?