Health Committee on March 26th, 2009

[Dr. David Butler-Jones]

I guess my concern is the urgency of it. I think we can accommodate the concerns in terms of which bugs are in and which bugs are out, and other things in terms of the levels of intrusiveness, activity, etc. My concern is that by leaving it out, and given the amount of time it takes....

We believe we can address the serious concerns through the development of the regulatory process; otherwise, you have to come back to a new act, a new regulatory process, and that will take time.

If we have an accident in Canada in the meantime, when we have no authority and the provinces have no authority, that is a huge risk.

It was suggested to me today that one of the analogies for this is the banking system. In other words, you can regulate the big six banks, but the Bank Act actually has regulations that affect trust companies and others. It's not as if you just look at the big ones, but you actually look across all of them and have a different regime that's appropriate and scalable relative to the needs.

I was just reminded that as of February there's been an executive order in the U.S. whereby they are looking to regulate or provide oversight of biosafety in all labs in the United States. It looks as if they're moving down this path, in any case.

But whatever happens in the U.S., we need to focus on what works for Canadians and the community here. We're not going to duplicate what the Americans have done. We're going to avoid the problems that have been created and focus on a scalable approach that I think will address the issues effectively.

[Colin Carrie, Conservative, Oshawa, ON]

Dr. Matlashewski mentioned the regulations included in the bill.

I think that's a question on which we could perhaps go back a little bit with him to see what the usual process is and how you intend to bring these regulations forward, so people understand them.

Would you be okay to go back and forth on that, Doctor?

[Prof. Greg Matlashewski]

One of the things that concern me is that there have been some amendments suggested here. Again, it boils down to the problem of the regulations with respect to level 2 pathogens. According to this, for a first offence—a first offence—there's a $50,000 fine with respect to level 2 pathogens. That's for a first offence.

We've never had a bill like this in Canada before. We will have a bill in Canada saying that for a first offence of not dealing with level 2 pathogens, according to the regulation, it will be a $50,000 fine. It's written here in your amendments for clause 53.

I can tell you this will have an incredible impact on the Canadian scientific community. It will not put us on a level playing field; it will put us at the bottom. We will not be able to compete with other countries in terms of scientific research, and it will not provide any additional security to Canadians.

So, to me, it is a real problem just to leave the bill as is without the regulations. The regulations have to be in the bill, so these kinds of mistakes are removed and we don't have to deal with them in the future.

[Colin Carrie, Conservative, Oshawa, ON]

Could we address that over here?

[Jane Allain]

The first thing I would say is that with regard to the example you have from Bill C-11, in terms of how we set out the prohibitions and the controlled activities, linking back to the powers of the inspectors, as well as the licensing regime that is envisioned, the model that's used is quite a common model. We have various other examples. Whether it's the Food and Drugs Act, the Controlled Drugs and Substances Act, or the Hazardous Products Act, these types of schemes, under the criminal law power, are set out that way.

You put into regulations the specificity that you need for the different components. For example, what will the standards be for the biological safety officers? What specific conditions will you have for licence-holders? What specific elements will you need for the biosafety aspects of the bill?

The reason you frame it this way is to allow flexibility and adaptability in order to reflect in the regulations the concerns you are expressing. If you fix it in the statute itself, it's frozen. It can never be changed. It can never be amended.

The regulatory process itself is quite an onerous process. There is a duty and an obligation on the part of the government, when they go out and develop the regulations, to consult. The consulting is open, meaningful, and balanced, as they are required to do. They are required to basically prepublish what they intend to do in the regulations, in the Gazette, before they actually make them. There will be a period in which you will see the actual regulations and be able to comment on them. They will be reflective of the changes that are needed, or based on the intended dialogue with the various communities.

That's the first thing I would say in terms of the regulatory process and why you design a law the way you do. The second thing I would say is about penalties.

When we develop penalties for legislation, we don't do it in a vacuum. We always look at other pieces of legislation that are similar in aspects. We try to have some kind of uniformity and consistency between these different types of evidences. The rationale for this is to try for some consistency across Parliament so that when they're exercising these laws and enforcing these laws, they have a similar-type range of penalties.

I'd just like to indicate that these penalties are quite similar. Under the Food and Drugs Act, if you sell harmful food, or use misleading advertising, or prepare food in unsanitary conditions, that is a violation. A person would face three years in jail or a $250,000 fine--

[Prof. Greg Matlashewski]

I'm sorry, that's not the same thing at all. That is completely different.

[The Chair, Conservative, Joy Smith]

I'm sorry, we have to go on to round two. We can continue these questions.

We are going to the five-minute round now, beginning with Mr. Simms.

[Scott Simms, Liberal, Bonavista—Gander—Grand Falls—Windsor, NL]

Actually, I do have a question, but I'm going to let Dr. Matlashewski respond to what was brought up.

[Prof. Greg Matlashewski]

If you're looking at the sale of unsafe products, you're looking at something that's completely different. What we're talking about here is a first offence regarding a level 2 pathogen.

We have to teach more than 100 undergraduate students how to work with level 2 pathogens. If they do something wrong, they are criminally liable, because it will be the first time. It says in here, “first offence”. This is what's in the bill.

[Jane Allain]

No, but what that does is set out the maximum penalty a judge can impose if there was ever a prosecution and the prosecution ended up with a conviction. To get to that level, you have to actually go through the whole summary conviction procedure.

So it's not like a ticket is--

[Prof. Greg Matlashewski]

But this is the law.

[Jane Allain]

It is the law. And the law is setting the minimum threshold that the court would have to impose if it were going to look at it--

[Prof. Greg Matlashewski]

Universities will read this law and say, “We can no longer run an undergraduate teaching lab because we cannot be liable for a $50,000 fine per student if they don't follow the regulations.”

Any research laboratory or any research activity in the country would be liable for doing this.

[Jane Allain]

It's only if they're charged with an offence, first of all. They have to be charged with an offence and prosecuted. They have to be successfully prosecuted and convicted. After that, they would face a maximum of $50,000 in fines.

[Prof. Greg Matlashewski]

But if this bill were passed like this, I can assure you that universities would be in an uproar over it. They would view this as a severe impediment to teaching students. This would make our country even less educated in the area of microbiology, and therefore even more susceptible to problems in bioterrorism. With this bill, we will not be able to educate people properly in this area.

[The Chair, Conservative, Joy Smith]

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

[Dr. David Butler-Jones]

Yes, just very quickly.

I think virtually every university in this country currently comes under the regulations of import-export, with similar provisions in terms of the potential to be charged. Every single university in this country is in that position. Yet in 15 years of applying it, nobody has been charged. We work with the laboratories.

So unless the universities five years ago decided to do it, I can't imagine their deciding to change their whole regime today.

[Prof. Greg Matlashewski]

I can tell you that when Bill C-54 first came out, every single university department was afraid and up in arms over this. These amendments have not changed that; they will not make a difference in this.

[Dr. David Butler-Jones]

I think it's really important as we move through the regulations.... That's clear, but people should look at their current experience working with the existing regulations and they should be reassured in that process.

[The Chair, Conservative, Joy Smith]

Ms. Allain, did you have a comment you wanted to make? Your light is on.

[Jane Allain]

No, sorry.

[The Chair, Conservative, Joy Smith]

Mr. Simms.

[Scott Simms, Liberal, Bonavista—Gander—Grand Falls—Windsor, NL]

I don't know if I have much time, but let's find out.

[The Chair, Conservative, Joy Smith]

You have a minute.

[Scott Simms, Liberal, Bonavista—Gander—Grand Falls—Windsor, NL]

Okay.

Would you agree or concur with what Dr. Singer said about the fact that the level 2 aspect of it should be brought forward to certain groups, like the academic groups, before you enact it, so that it would be carved off into something different and consulted on before you get into the situation that you're talking about because of the concern raised by the community?