Health Committee on March 24th, 2009

[Dr. David Butler-Jones]

It's not common to have undated letters, but in terms of one of the things as we move forward, B.C. is an important partner for us through the B.C. Centre for Disease Control, as well as the Ministry of Health and its divisions. They have been very much engaged through this process, but not every single person in the departments has been engaged to the same degree.

We've had a number of conversations since then, including conversations with all the chief medical officers across the country, plus the provincial lab directors and others, sort of building on the previous conversations. I think all of them are looking forward to whatever happens. Obviously, as officials we're not going to preempt your legislative process. We are open to clarification and other things as you work through the next few days.

But at the same time, as we develop the regulations, they are really looking forward to the process of consultation that we've outlined, and their engagement in ensuring that the consultation and the process that follows will be comprehensive and effective, as we've described. All the conversations I've had with provincial officials and others is that they will do that. That, they see, is a way forward. We think we've addressed, and we will continue to address, the concerns in a way that is reasonable.

We have responded formally--I think the committee may have a copy of the letter in response--as we have responded to each of the others that have written to us.

[Colin Carrie, Conservative, Oshawa, ON]

That's what I was going to follow up with. In your opinion, in regard to when the original letter was written, do you feel there's a greater understanding of the intent now, as opposed to when the letter may have been written? Can you comment on that?

[Dr. David Butler-Jones]

I think so. Again, we all have large systems and multiple players, and some of us have multiple departments. Even though I had talked to the deputy with the broadest responsibility in this area and the chief medical officer and others, not everybody at that point was aware of it.

We received the letter, and since that time we have had conversations with the deputy on that side and others. We'll continue that dialogue as we move forward. I think there's a level of comfort in that process as we address these issues.

[Colin Carrie, Conservative, Oshawa, ON]

There was an issue about doing the regulations afterwards. I was wondering about that. Are there precedents? Have we done this the same way in the past? There seems to be a concern among some people who say they want to see the regulations now. Maybe it's the Quarantine Act. We talked about the Assisted Human Reproduction Act. Is there a precedent that says the government has done it this way in the past?

[Jane Allain]

The normal process is that you get Parliament's authority, essentially, to make the regulations. The normal process is for Parliament first to enact the statute. Then the secondary legislation, which is the regulations, has a process whereby it's been authorized by Parliament for us to do it. The normal process is for the act to be passed and then the regulatory framework is developed. Through the consultation process and through the gazetting process, that's done.

There are examples, such as the Assisted Human Reproduction Act, for example, where, as you have all noted at different points, the House of Commons and the Senate.... There is an explicit provision in this statute that requires the government to come back and table its regulations before they're made, before both Houses. It's not a very common amendment, but that type of provision does exist.

[Colin Carrie, Conservative, Oshawa, ON]

Subclause 3(2) of Bill C-11 states that for the purposes of this act, “a human pathogen or toxin includes (a) a substance that contains a human pathogen or toxin”. Clause 4 of the bill also provides that the act doesn't apply to “a human pathogen or toxin that is in an environment in which it naturally occurs if it has not been cultivated or intentionally collected or extracted”.

There was a comment that waste treatment facilities commonly collect and treat water that contains human pathogens or toxins. The waste water is in a natural environment for human pathogens and toxins, so according to clause 4 of Bill C-11, the act does not apply to these. Dr. Tellier also brought up a point about patients who perhaps have diseases that have these things as part of them. Is it possible to consider these facilities as substances under clause 3 of Bill C-11 so as to include them under the act?

[Dr. Theresa Tam]

This is actually a conversation that we've had with water treatment facilities, and we certainly consider waste water that is collected and contains pathogens to be a natural environment. To us this is clear in the bill as it exists.

So you do have to interpret the bill, and its different sections, in its entirety. We had no intention of considering a facility that is not cultivating and extracting these pathogens as falling under the scheme. I think that's clear.

We have exemptions, and those exemptions came after we heard the concerns expressed in the consultations stage of the initial draft of Bill C-54, but we also have a provision that we can make further exemptions in the regulations themselves.

We truly believe that as more stakeholders come forth, different scenarios may come up in the future, because some of these labs are not known to us. So having that provision allowing further exemptions in the regulations, if needed, is built in.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Tam.

We're now going to go to our second round, a five-minute round of questions and answers, starting with Dr. Duncan.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you, Madam Chair.

Good afternoon, everyone.

I think we all agree that biosafety and biosecurity are of paramount importance and that we have to get them right. I think there is also a real concern, after the testimony of the last weeks, that we're perhaps rushing this. We've had real recommendations, which are in that document. We've heard similar testimony.

Is it possible to take this back and do more consultations and to incorporate the recommendations and testimony and make it stronger, because the issue is so important? Is that possible?

[The Chair, Conservative, Joy Smith]

Dr. Jones.

[Dr. David Butler-Jones]

I'll just start on that and maybe I'll get Theresa to speak to the importance of why we should do it now.

In this process in the committee, it sounds as if you will perhaps be considering some ways to make the legislation clearer in terms of our intent. Our intent is clear. I'm on the record, we're on the record, the government is on the record on how we plan to proceed. Quite honestly, my personal integrity is on the record in dealing with this. But no legislator should depend on that; I'm not suggesting it at all. If there are ways to make that intent clear and explicit in the legislation, obviously we would welcome that.

I would be concerned about further delay beyond that, taking it back and starting over. There's been work on this and the need for it has been recognized for at least a decade. There has been work around animal pathogens. We are better at controlling animal pathogens in this country than human ones, or have a better understanding of the things that kill sheep and cattle in this country than humans, when it comes to regulation. We do regulate imports and exports. We do regulate transport of these things. But at half the labs in this country, nobody really has a clear handle on this.

So in terms of the importance of this, I'll turn to Theresa and then will come back to you, Madam.

[Dr. Theresa Tam]

I think looking at further assurance, if you like, in the legislation is certainly something we would be prepared to look at. We haven't rushed into this. We have had human pathogen importation regulations for 15 years. The concept of the need to know who possessed what domestically and how we could safely handle these pathogens took place around 1999. Then came the anthrax scare, then came SARS. Nobody knew who possessed the SARS virus. Then the drafting of the legislation began in 2004.

I think the concerns we've heard are the ones we've heard before. We certainly feel that they can be taken care of in regulations. But if we can provide further assurance in some way, then that is good. The proposed program and regulatory framework are also posted publicly on our website.

I think every other day something else happens. The H2N2 distribution happened. Something could happen tomorrow. Someone talked about the polio virus and about the fact that we don't know where the polio virus is in Canada. It's important; I would like to know--by tomorrow, if possible--exactly who in Canada has the polio virus.

While it is not specifically in the schedule, it is captured under the risk group definitions. You can provide examples, but you will always leave out certain examples, or be more inclusive in the list than perhaps others wish. But you don't want something to happen tomorrow, and within the experience of our programs....

A few weeks ago--in “a” province--we came across a laboratory that was abandoned, with nine freezers full of pathogens. In another province, an “underground” laboratory was discovered, and we had no ability to necessarily regulate. There are very non-uniform practices.

I think the good academic labs that have biosafety programs in place are again the ones that we feel could comply with the legislation rapidly. But what you don't want to see is that these other laboratories have issues that will arise without our taking care of it, having thought about this for ten years.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I agree, and--

[The Chair, Conservative, Joy Smith]

I'm sorry to interrupt you, but your five minutes are up.

Dr. Tam, thank you.

We will now go to Ms. Davidson.

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

Thank you, Madam Chair.

Thanks very much to our presenters this afternoon.

We keep hearing some of the same things over and over again. Some are new things and some are different things, with maybe variations of some of the same concerns. But we are also hearing today answers to a lot of these concerns.

Ms. Gibson, you outlined some of your specific concerns--comprehensive consultation, risk 2 listings, jurisdictional issues that you felt were there, and maybe some Charter of Rights issues. In terms of the things you've heard today from departmental officials, what they've discussed and what they've given answers on, have they answered any of your questions or made you feel any differently from when you first came into the meeting?

[Elaine Gibson]

I am sorry to say, not at all.

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

Could you maybe say why?

[Elaine Gibson]

Well, I think I had a pretty clear indication of the position of the Public Health Agency of Canada based on the presentations they've made to this committee and based on what I've read in the minutes up to now. I am not hearing anything substantially different today.

I think the substance of my concern could be summarized as twofold, in the main. Setting aside the charter issues, it would be that holding over to regulation much of the “guts”, if I can use the word, of what is going to happen is problematic. It gives rise to issues of constitutional division of powers as well. If what's really going on here is primarily regulating laboratories in Canada, then that's going far down the road into property and civil rights within the provinces.

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

Okay.

Ms. Allain, I think you've answered these questions, but I would like to hear from you again, if I could.

[Jane Allain]

The intention is not to regulate labs for diagnostic purposes or for quality assurances or for how they conduct their business on a day-to-day basis. The purpose of this legislation is to create a scheme that would regulate the possession, use, and disposal of human pathogens and toxins so that they are done in a way that contains them and prevents them from being released in a greater environment to pose a risk to human safety essentially. So that's the basis of the criminal law power. It's not to see the practices on a day-to-day basis for their diagnostic testing. It's to see that their containment levels are appropriate—the steps they're taking to basically prohibit and stop the disposal and disclosure of these human pathogens, these dangerous goods essentially, to a greater audience and to the public at large. And that's the way the scheme is designed. It's not designed for that purpose.

So the reason a lot of things will happen in the regulations is that a lot of them are technical, in terms of the biological safety guidelines and how those will be incorporated into the regulations themselves. That aspect has to be done in technical standards and elements that have to be built up through that process. That's why they have to be done.

I didn't address the other issues Ms. Gibson has raised on the inspection powers, on the charter. The main thing I would say is that on clause 41 there is a reasonableness test there. The inspector has to have reasonable grounds to believe that one of the activities that is prohibited, if you don't have a licence, is going on in that institution before they can actually appear before it. So to us, he has to have reasonable grounds to believe that this is actually going on before he can proceed to that. As well, any kind of inspection power that he or she will exercise would have to comply with the charter, would have to be done in an appropriate manner, because they could be subject to a challenge subsequently. So the standard itself is a reasonable standard and the exercise would have to be done to a reasonable standard.

With regard to the disclosure of information as well, there are both, at different times in clauses 38 and 39, standards that basically refer to it being necessary, the disclosure, in certain limited circumstances that the minister may disclose. It says the minister would, without the consent, only disclose if necessary for the administration and enforcement of the act, and as well if it's necessary to fulfill its international obligations. The minister could also disclose if she has reasonable grounds to believe that the disclosure is necessary to address a serious and imminent danger to the health and safety of the public.

Those provisions are similar to provisions that exist elsewhere that have not been challenged and that we believe are constitutional. From our perspective, a reasonable standard exists for the serious and imminent danger, but a necessary standard is, from our perspective, a higher threshold than a reasonable standard. If something is necessary it's reasonable, but something could be reasonable but not necessary.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Allain.

[Elaine Gibson]

Could I respond on just one of the matters?

[The Chair, Conservative, Joy Smith]

Oh, yes, absolutely.

[Elaine Gibson]

Thank you. It's clause 41, “Entry by inspectors”. I read it in not quite the same way as Ms. Allain was presenting. The reasonableness in there is that the inspector believes on reasonable grounds that an activity, to which this act or the regulations apply, is conducted, not that there be.... I would be pleased if it were that there's reasonable grounds that an offence under this act might be being committed. I would be much more comfortable if that was what it was saying, but I read this as saying that one of the activities covered under this act is happening—i.e., that human pathogens are being used.

[The Chair, Conservative, Joy Smith]

Thank you.

Monsieur Dufour.