Health Committee on March 12th, 2009

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you.

Thank you, Madam Chair.

[The Chair, Conservative, Joy Smith]

I want to thank you. I want to thank our guests for coming.

I will ask the Public Health Agency of Canada to step up now, and we'll begin our questioning of them.

Mr. Conlan and Mr. Ghalami, you've done a fantastic presentation today, as have all our witnesses we've heard in this last of couple of days. Thank you.

[Ayoob Ghalami]

Thank you, honourable members.

I always watch Dr. Bennett. It is an honour to see you.

[The Chair, Conservative, Joy Smith]

We'll now begin our second round.

I understand that Dr. Butler-Jones, who is the Chief Public Health Officer, will be speaking first. I want to welcome back Dr. Tam, the director general for the Centre for Emergency Preparedness and Response, infectious diseases and emergency preparedness branch. You have a very long title. I think it's wonderful that you're back again. Thank you. Welcome also to Jane Allain, from legal services.

Dr. Butler-Jones, please.

[Dr. David Butler-Jones]

Thank you very much.

I want to begin by thanking the committee members. I'm going to be very brief in my comments and leave lots of time for questions.

I really want to thank you for the time and the work being put into reviewing the legislation. We take all of it very seriously. It is interesting to reflect that part of my pleasure is that five or six years ago, before SARS and before the agency, it was difficult to get anybody to pay attention to these issues. Now people are paying attention. That is only a good thing.

I think we can agree that the proposed Human Pathogens and Toxins Act is an important tool--

[Judy Wasylycia-Leis]

Be careful what you wish for.

[Dr. Butler-Jones]

No, I prefer this, I must say, for protecting the health and safety of Canadians.

Accordingly, we've taken its development very seriously.

The legislation has already benefited from a series of meetings with over 400 stakeholders since it was tabled, including some of the witnesses you've already heard from. Through these discussions several common themes have emerged. These themes will provide the basis for continued stakeholder dialogue on elements of the proposed regulations moving forward. Our objective in working with stakeholders is to make sure that the program and the regulatory framework strike a balance between the needs of biosafety and biosecurity and the interests of ongoing science and research.

We have heard this committee.

We at the Public Health Agency of Canada will do whatever is necessary to provide this committee with the assurances needed.

We will follow through with our stated intentions regarding the program and regulatory framework, and I think you've seen the regulatory framework. In light of recent dialogue around this bill we will redouble our efforts to engage the stakeholders and to listen and respond to their concerns in keeping with the commitments we have made before this committee and across the country. We have made available this program and regulatory framework document earlier this week. I think you'll find it a good discussion point to start from with respect to a number of concerns that people have raised.

Let me thank you again for your time and thought. We are here to try to address all the questions you might raise.

Madam.

[The Chair, Conservative, Joy Smith]

Thank you very much Dr. Butler-Jones.

We're going to go directly into the questions, and we'll be back to the first round, seven minutes per person.

We will begin with Dr. Bennett.

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

Dr. Butler-Jones, in terms of the statement: “We will follow through with our stated intentions regarding the program and the regulatory framework”, does that mean that in spite of the testimony to date, you are going to be recommending amendments to the minister?

[Dr. David Butler-Jones]

Well, at this point the committee is reviewing it. Under our original intent, the legislation itself was high-level, but often legislation is. At the point where the rubber hits the road, many of the concerns will be difficult to address in legislation, because it's a bit of a blunt instrument. For example, is it all level two pathogens that we are concerned about? No. Is it even all level three pathogens that we're concerned about? No. But it will require an extensive consultation with those who are experts in all of these fields to know which ones we're worried about and which we aren't. Questions about whether something is E. coli 157 or the E. coli that everybody has in their gut, et cetera, will require extensive consultation to make sure we have the right ones in the right categories from a regulatory standpoint.

It's the same with the issue of security clearance. We have no desire for or interest in security clearance for level two alone. That is an unnecessary burden and will not assist us. The whole intent of it, through the regulatory process and the program framework, is to have the least intrusive, most effective regime, with the fewest side effects—just as we have therapeutically. That will require a lot more detailed conversation and consultation than we can get by means of the development of the act itself. But the act will set the framework from which we can move. It will take us some time to get to the regulatory...but that's what I mean by our intent: to continue through with it.

We all want this to be right; we all want it to be a minimum burden; we all want to be effective. We have already had situations.... For example, some members of the committee will remember when we identified H2N2, being distributed all around the world.

H2N2 was the last pandemic virus, from the 1960s. No one born since then has any immunity. It was sent as a lab proficiency test labelled as pathogen level two to 8,000 labs, including doctors' offices, around the world. That could have been the next pandemic. It's only because we had the regulatory framework in place for imported pathogens that we were able not only to identify where it came from, but also to deal with all the facilities in Canada that had imported it, so that very quickly they could destroy it. That's just one instance.

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

In terms of what you're saying, a lot of the testimony has been that “high-level” is too broad and takes in too much stuff, particularly in the schedules. Will you be helping the minister with some amendments to this?

You know what our problem is. People were invited to an information session—today's testimony was a bit different—that they now perceive was a one-way communication. Every concern they then expressed they expressed again here at committee. They do not feel that their concerns were reflected in the new bill. Continuing to consult on the regs when people have serious concerns with the bill isn't going to do the trick for those of us who heard the witnesses and are worried that what may be “high-level” is too broad or has unintended consequences around security clearances and duplication.

Both B.C. and Ontario are upset. They're also upset with being treated like a stakeholder instead of a partner. Somehow the pre-work to bring a bill to the Parliament of Canada doesn't seem to have been done, in terms of the two-way communication needed to get a better bill.

Concerning my comments last week that the minister was let down, I believe that in any kind of stakeholder engagement people need to feel that they were heard. If you're not able to do what they said, then it is our requirement to go back to them to say: “you said this; we're not going to be able to do it because of Y”; or, “you said this, but harmonizing with the world means we have to do this”. The concern we had, that two big universities in the States have stopped dealing with certain pathogens because of this too-restrictive regime, is very worrying to us, as a deterrent to getting a safe Canada; certain people just think it's too expensive or complicated to do the research that is required.

I want to ask again. On quality assurance around citizen engagement, you heard a lot of stuff that a lot of witnesses say is not reflected in the new bill. Could you, even at your own agency, go back to find out what you heard and table for us what you heard and tell us why you can't do it? Why is it not reflected in the bill?

[The Chair, Conservative, Joy Smith]

We just have a minute left, but you can have more than that if you can answer some--

[Dr. David Butler-Jones]

I'll be very brief.

With both the previous bill and the current bill we have engaged with a whole range of people--partners and others--in the last while. We'll be quite happy to table it once we have it translated. This is basically on who was there, what they said, and what we heard. We will continue to do that.

The issue, which is partly a parliamentary and government decision, is what do you put in the act versus what do you put in the regulations. It's not that we won't address it, but what is absolutely necessary in the act versus the specificity you need in the regulations? So it is partly for the legislatures to pursue that conversation.

What we have heard through the discussions and what we have heard now resonates with us and our intent. If you look at our draft regulatory framework you see that most of what they're talking about is actually accommodated in our plan as we move forward. But we will need to consult quite extensively throughout this whole process over the next while in the development of the program architecture and the regulatory framework to make sure we have it right.

At the end of the day, to be a little bit realistic, until things are actually in force and they see how it's applied, people will be putting down markers: please don't do this, or we're worried about that. Until it's actually lived with.... I don't really know these guys, so it's interesting to hear them talk about their experience--because they're already regulated by us due to their importation--and their comfort level with the way we've been doing it. A lot of the others don't have that kind of requirement, so they're nervous about what might be, and just us saying it until they see it is difficult.

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

So you think the bill is perfect the way it is right now.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Butler-Jones.

I have to go on to Mr. Malo. We're over time.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Madam Chair.

Thank you for joining us once again.

I'd like to start with a general comment. We have heard today from two individuals who genuinely feel that they have been consulted and who are both supportive of the bill. Earlier, we heard from other witnesses have truly believe they were not consulted and who are opposed to the bill, with some qualifications. While they agree with the substance of the bill, they object to some of its provisions. That should be a lesson to us. When consultations are held, there is a greater likelihood of garnering widespread support. That is what has been lacking thus far. Feel free to comment if you like.

Now then, I'd like to discuss a letter that we received from the Privacy Commissioner. I felt it was important to seek out her opinion because certain aspects of the bill pertain directly to the disclosure of information. Here is the Commissioner's response:

We had hoped to see a privacy impact assessment (PIA) to understand how any privacy risks in this Bill had been mitigated, but we have not yet received one. [...] Our Office should be seeing PIAs well before the decisions have been implemented so we can provide feedback early in the process.

Why have you not provided these PIAs to the Commissioner? Have they been done?

[Dr. David Butler-Jones]

We welcome suggestions from most partners in Canada, but it is impossible to retain every single one. Occasionally, we do have discussions with them and subsequently, the problems are resolved. However, a week or two later, another problematic issue may arise.

We have promised to consult and to verify that the regulations are appropriate. As for the situation in the private sector, I will let Jane answer that question. As a rule the assessment is done within the framework of the program. We still do not have a program, but we will have one later. The three provisions in the bill are identical to the ones contained in the other piece of legislation.

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

The privacy impact assessment will be carried out as part of the process of developing the program and the regulations. The department is required to conduct this assessment.

The Privacy Act and the Charter will continue to apply when authority is exercised pursuant to the new act. We always do a PIA when we tackle such issues.

We have read the Commissioner's letter. Certain principles will continue to apply, particularly the ones having to do with the application of section 4 of the Privacy Act. Two principles are entrenched in the act. When the government is authorized to collect and disclose personal information, it must comply with certain regulations. We refer to this as

the minimum collection rule and the minimal disclosure principle.

These two principles will continue to apply in the case of all powers exercised pursuant to the new act.

I know the Commissioner has commented on similar provisions that appear in different acts, whether it be the Quarantine Act or the Food and Drug Act. These two acts contain similar restrictions. We strongly believe that our assessment has enabled us to draft these provisions properly and mitigate their limitations. We will continue to apply these principles.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you.

Earlier, Mr. Ghalami testified that the application of Bill C-11 could result in a brain drain. Can you give us any solid numbers as to the potential impact of the bill, given that witnesses have told us about lab closures in the United States? Mr. Ghalami even said that Canada had benefited from an influx of eminent researchers. Have you truly weighed the impact of the bill, to avoid having to contend with a similar situation here?

[Dr. David Butler-Jones]

Mr. Ghalami was speaking in connection with a risk group 2 security clearance. However, most labs that analyze viruses and other risk group 3 and 4 substances have certain expectations. They have told us that because of import laws, we really don't need to regulate risk group 2 pathogens for safety reasons.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Do you agree with some of our witnesses who contend that certain E.coli strains are pathogenic while others are not?

[Dr. David Butler-Jones]

Absolutely.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

A “human pathogen ” is defined in clause 3(1) to mean:

A micro-organism, nucleic acid or protein that: a. is listed in any of Schedules 2 to 4 or in Part 2 of Schedule 5; or

Someone argued that this definition does not specify whether certain strains are pathogenic or not.

Are you mindful that some provisions of the bill need to be amended?

[Dr. David Butler-Jones]

I will answer that question in English, for clarity's sake.

It gets back to this question, which is a legislator's question: what amount of detail do you need in the act versus follow-through in the regulations?

We felt that the general provisions in the act, and we would deal with all of these...and specificity in terms of what bugs are in or out. Even at level three, not all level threes are we as concerned about. Tuberculosis we're not as concerned about as we are with some other level threes.

So that will be the process of the development of the regulations. As the witnesses said earlier about the need to be flexible in what's in and what's out, I can--

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Can you understand that—