Evidence of meeting #12 for Health in the 40th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was regulations.
A recording is available from Parliament.
Conservative
Professor, Institut Armand-Frappier, Institut national de la recherche scientifique
I want to know how this bill will protect us from an accident.
Chief Public Health Officer, Public Health Agency of Canada
Sorry, I don't mean to interrupt, but I did want to say that you're right, accidents will happen. There will be surprises. The advantage is in actually knowing who has what and that there are some basic standards in terms of biosafety.
Again, as I've said, I'm not worried about the university labs, and I'm not worried about places that have these things in place, but there are the outliers, and currently there are no authorities to deal with them. There is a limited ability to compel a lab that is an outlier. There is a limited ability to say, “What do you have and where have you sent it?” There is a limited ability to track it down, as we were able to do with the H2N2. We were able to very rapidly track it down and tell the labs they had it so that they could destroy it.
In the absence of the ability to do this, then we could not do that, and I'm not sure what would happen. Again, it's a relative risk issue and an issue of the level of tolerance of risk. At this point in the environment, I'm giving you my opinion from a public health perspective because we think we can minimize the impact of this. We think we can do it in a way that will not put a chill on or create problems for researchers and that will minimize the paperwork.
But at the same time, it will give us some assurance that, should there be a problem, we have some authority to do something that provinces currently do not have. There's a very varied regulatory regime across the country and this would be complementary to provincial activities. It would not duplicate or interfere with what they're doing.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Thank you, Madam Chair.
Again, thanks very much to our presenters.
There's some interesting discussion here again today.
Dr. Butler-Jones, I think you may have just answered the first question that I was going to ask. We've talked about the two level 4 labs and we've talked about the 120 level 3 labs. We've also talked a lot about those where we don't know what they have. Are they included in that 120 or are they over and above that?
Chief Public Health Officer, Public Health Agency of Canada
We think it's unlikely that there are level 3 labs that we're not aware of because of imports and exports and academic labs, etc.
You don't know what you don't know. We're estimating that there are 4,000 labs that do not come under import-export. Some of them, as have been identified, are university labs and come under their regime, but we don't know what we don't know.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Okay. So are those the ones you just indicated in your last comments that you're concerned about because there's no regulation? You can't—
Chief Public Health Officer, Public Health Agency of Canada
It's the ones that we don't know about that I'm worried about. I'm not worried about the ones that are based in universities and have their own regimes already in place.
Conservative
Chief Public Health Officer, Public Health Agency of Canada
Correct.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
If we don't pass this legislation, there's nothing, where we are today, that will protect the public from the ones that are not reporting now.
Chief Public Health Officer, Public Health Agency of Canada
As members and others have identified, I think there are levels. If we remove level 2, it will give us this at least for level 3 and level 4, but by and large, if we know about them, they're already under the regulatory regime.
My concern for the potential risk to public health is in the level 2 labs that we don't know about and that aren't under some kind of regulatory regime. If we don't include them, that will leave a big gap, in my view.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Okay.
Could you or one of your colleagues also please go over the regulatory process again? As opposed to the legislative process of passing the bill and then doing the regulations afterwards, which is normally the way that government bills are done, is there a reason why it can't be the other way? Does it make the regulations more difficult to change, as I think I have heard? Or does it make them impossible to change? What's the problem with doing that?
Chief Public Health Officer, Public Health Agency of Canada
Certainly, acts are more difficult to change than regulations. They all require processes. We cannot actually start on the development of and consultation on regulations until we actually have an act of Parliament that gives us authority to do that.
Conservative
Chief Public Health Officer, Public Health Agency of Canada
In the way it's normally structured, yes, but as has been described, you can ask for the regulations to come back, or you have any number of options.
Conservative
General Counsel, Legal Services, Public Health Agency of Canada
The only thing I would add is that the regulations have to comply with what Parliament has given the Governor in Council the authority to do. The Governor in Council can't do anything beyond the scope of what you've set out as their limits in the statute itself. The only kind of regulations they can bring are the ones that are enumerated in the statute itself. They couldn't create new offences, for example. They couldn't create a new category of schedules. That would have to be determined by Parliament, not by the Governor in Council.
I would describe the process for developing regulations as being much more flexible. It's a much more inclusive and transparent process in the sense that the government must go out and consult. The directive on how you consult is very clear. The consultations have to be open, they have to be meaningful, and they have to be balanced. As well, they have to actually include that in a document when they do their analysis. It's called a regulatory impact assessment, and they basically have to describe how they've done it before they actually make the regulations. They have to prepublish the regulations. There has to be a period during which these regulations are in the Gazette. They're open to comments by the public as well as the stakeholders they've engaged with. They take these back and then finalize the regulations before they actually table them and gazette them.
So it's quite a process. It does take a long time. This will take about two years.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Is it possible to exempt level 2s from any type of criminal charge? That seems to be a big concern.
General Counsel, Legal Services, Public Health Agency of Canada
No, there wouldn't be that ability to exempt them. You've created the architecture under the criminal law power that sets out the range of penalties you have. We could not exempt them from the criminal law.
Prof. Greg Matlashewski
I'll be very brief.
We're not saying that level 2 pathogens shouldn't be regulated, or that there shouldn't be a list of every lab working with level 2 pathogens. We're not saying that. What we're saying is that level 2 pathogens should not be under the same bill as level 3 and level 4 pathogens. They don't belong there.
So level 2 pathogens should be dealt with, but not under the same bill as level 3 and level 4 pathogens. They are very different organisms. It would be a mistake to have them within the same bill. They still have to be dealt with, but in another forum.
Conservative
Chief Public Health Officer, Public Health Agency of Canada
Yes, just very briefly.
There are two mechanisms to do that. You can have two bills and two different sets of regulations, or you can have one bill and different regulatory regimes to address it, which is what we've proposed. It would address, actually, the concerns. There would be a clear difference in terms of how they're handled.
