Health Committee on March 3rd, 2009

[The Chair, Conservative, Joy Smith]

Good afternoon. I want to welcome everybody here today.

My apologies for the late start of this committee. We had many votes to go through in the House today, and that is what delayed the committee's start. I dare say we were probably as impatient as you were as witnesses, with everybody around this table trying to get things done in a timely fashion.

We're going to go right into the testimony from the witnesses, and then following that, we did have committee business. Is it the will of the committee? I want to ask this. We were going to do committee business, but because of the late start in today's agenda and hearing the witnesses, what I would say is this. Could we use the last five minutes for committee business, just so I could hand out some things for you to look at for Thursday?

I have to say we did have cancellation of some people coming to committee today, so we could have the department people back in the second hour on Thursday.

Number one, is it the will of the committee to suspend the committee for the last five minutes just to quickly have some handouts? Can I have agreement to that?

[Some hon. members]

Agreed.

[The Chair, Conservative, Joy Smith]

Great. That is carried.

For the second hour on Thursday, could I have agreement that we would have our witnesses back, if they are able to come this week to continue? Is that agreeable to the committee?

[Some hon. members]

Agreed.

[The Chair, Conservative, Joy Smith]

That is carried. Thank you very much.

Pursuant to the order of reference of Monday, February 23, 2009, Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins, from the Public Health Agency of Canada we have Theresa Tam, who is the director general, centre for emergency preparedness and response, infectious disease and emergency preparedness branch. Welcome to our committee. We have James Gilbert, director general of the strategic policy directorate. Welcome also. We have Jane Allain, general counsel for legal services. Welcome. Of course, everyone is familiar with Dr. Frank Plummer, scientific director general of the National Microbiology Laboratory.

In front of us today we have some of the best minds in our country, and we're very happy and pleased that you could come to join us again.

We will have presentations of seven minutes, or do you want to go right into the questioning?

We will start with Theresa Tam. That's a 10-minute presentation, Ms. Tam. Then we'll go on to our next witness. Thank you.

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

Thank you.

Madam Chair and members of the committee, I am pleased to appear before the Standing Committee on Health today to discuss Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins..

My colleagues have been introduced.

We have an opportunity at this committee today to discuss the key elements of this bill, which seeks to provide protections to safeguard Canadians against the health and safety risks posed by the most dangerous human pathogens and toxins. Let me first discuss the current system.

Currently, approximately 3,500 laboratories that import human pathogens or toxins are regulated under the human pathogens importation regulations. These laboratories must also comply with the laboratory biosafety guidelines, which are widely accepted as Canada's national biosafety standard.

Even though these guidelines are in place, additional legislation and regulations are required to reinforce safe laboratory practices and establish consistency. The bill seeks to do this by ensuring that all laboratories in Canada, whether federal, provincial, or private, whether or not they import pathogens, are adhering to the laboratory biosafety guidelines.

The need to enhance biosafety in Canada's labs by preventing an accidental release of these agents is one of the two primary focuses of Bill C-11. The other is the desire to safeguard Canadians from the risk of an intentional release of a dangerous agent, such as anthrax, by someone who is trying to harm Canadians.

Ensuring that persons who have access to the most dangerous human pathogens or toxins are properly security screened can ultimately reduce the risk of an intentional release of a pathogen and enhance the biosecurity standard in Canada.

The intention of the bill is to try to balance biosafety and biosecurity requirements with the need to advance science, innovation, and research. The intention of this bill is not to restrict research and development but rather to introduce a risk-based approach to the management of human pathogens so they are handled safely and accounted for across Canada.

In this vein, the program and regulatory framework around this legislation is intended to be less stringent for those individuals who are handling less dangerous pathogens and toxins and more stringent on those handling the more dangerous pathogens and toxins. For example, there is no intention of security-screening individuals working with risk group 2 human pathogens, such as salmonella, under this act.

Because of the risk posed by dangerous human pathogens and toxins, Bill C-11 relies primarily on the criminal law jurisdiction of Parliament. In this regard, Bill C-11 includes a range of prohibitions, inspection powers, and security-screening requirements designed to address the health and safety of Canadians.

The program and regulatory framework to be developed under Bill C-11 will include requirements for licensing, inventories, biological safety officers, information gathering, and the transferring of human pathogens and toxins. The legislation has been drafted with care to ensure the bill fully respects the rights and freedoms of Canadians entrenched in the Canadian Charter of Rights and Freedoms.

The Public Health Agency of Canada has already conducted four rounds of information sessions with stakeholders.

In September 2007 a proposed legislative framework was discussed with the academic, research, and diagnostic communities as well as private industry across Canada. As well, discussions about the proposed legislation took place with the chief medical officers of health from the provinces and territories in October 2007.

Following the tabling last year of the previous version of this legislation, Bill C-54, the Public Health Agency held more information sessions with stakeholders, including the laboratory community across Canada, to gauge some reactions to the new legislation. Most sessions were open to all who wanted to attend and took place in Halifax, Quebec City, Montreal, Toronto, Saskatoon, Calgary, and Vancouver.

Stakeholders expressed agreement with the general need to enhance federal oversight of human pathogens and toxins, although they did raise some technical and operational issues regarding how the entire program would be implemented. Based on the feedback we have received from stakeholders, the Public Health Agency has developed an initial program and regulatory framework that outlines what the regulations under the bill could potentially look like.

With regards to the financial impacts of Bill C-11 on laboratories across Canada, although we cannot anticipate for certain what the costs will be until the full suite of regulations have been developed, we anticipate that there should be little impact on laboratories that are already in compliance with the laboratory biosafety guidelines.

In addition, avoiding unnecessary financial burdens on laboratories is a priority. For this reason, to help laboratories adjust to the new requirements, it's envisaged that the act will be implemented in three phases to allow time for stakeholders to adjust to new requirements without unduly interfering with research activities, with a view to minimizing any potential costs.

A concern was raised at second reading about potential privatization. The policy intent of this bill is not to privatize public laboratories. The Public Health Agency of Canada will conduct in-depth and meaningful consultations with stakeholders across the country to discuss the program and regulatory framework. These consultations will include the matters that stakeholders identified to us, such as inventories, licensing, and security screening. This will help balance the needs for biosafety and security on the one hand and the interests of ongoing and innovative science and research on the other.

Madam Chair, Bill C-11 is required to safeguard the health and well-being of Canadians. The bill will finally enable Canada to eliminate the biosafety and biosecurity gap that has been filled by most of its G8 partners. As we learned during consultations and information sessions, most stakeholders recognize the need to move ahead with expanded federal oversight of human pathogens and toxins. We look forward to the committee's inquiries regarding this important piece of legislation.

Thank you very much.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Tam. It's very helpful for us to hear your comments.

We're now going to go to the health committee, and we will start with round one. You have seven minutes in round one.

We will begin with Ms. Murray.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Thank you.

And thanks for your presentation. This is clearly an effort by the agency and the government to do some work for the public good with respect to protecting people from these products.

I do have some questions about jurisdiction. My first question would be this. Since provincial health care facilities, laboratories, and private labs that conduct tests for provincially covered health care are already provincially licensed and accredited, what's the rationale for licensing these facilities by the federal government as well? Why does there not appear to be a provision for equivalency agreements in the legislation?

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

I'll get my specific notes.

You're correct in the sense that the purpose of this bill is to create a comprehensive national regime to deal with the safety and security with respect to human pathogens and toxins. It will create a licensing scheme, essentially, that will require people to obtain a licence before undertaking certain activities with human pathogens and toxins.

Some provinces have specific legislation requiring the licensing and accreditation of their laboratories, including Alberta, Ontario, Quebec, Manitoba, and Saskatchewan, and that's specific legislation on licensing and accreditation. All provincial legislation deals primarily with workplace safety and laboratory operations, and they usually set things like standards for quality assurance and diagnostic testing as well as specific standards for laboratory equipment.

It does not require laboratories to report on which human pathogens and toxins they possess, nor does it require security clearances for access to the most dangerous human pathogens and toxins. The intent behind this legislation is to provide federal legislation to track which persons possess these human pathogens and toxins and to ensure, as Dr. Tam previously said, that all laboratories within Canada, whether they import or not, follow the same biosafety laboratory guidelines.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

So would it be a simple matter of addressing the fact that some provinces do have the regulations that you're wanting to put in place and some don't? An equivalency agreement would seem to address the concern of duplication, or a requirement that the province shows that its regime meets the standards that you're trying to make sure are in place on a national basis.

[Jane Allain]

We believe we can address those issues through the conditions of licensing as well as in the development of the regulations themselves. The regulations would take into consideration provincial legislation.

So it's not meant to be duplicative, it's meant to be complementary.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Well, I believe there's some concern about the level of consultation in that the provinces are not simply another stakeholder; they're actually the jurisdiction holder. In some ways, they're the big part of this.

I don't believe, at least in the province of British Columbia, there's been a sense of full consultation. Yes, there may have been some consultation, but I would suggest that far more engagement is needed, moving forward. It's being presented as a fait accompli, in fact. But this legislation does appear to have considerable cost implications for the provinces and territories.

Also, due to impacts on provincially run health care labs and private labs that do diagnostic tests that are paid for by provincial health care funds, will the federal government be assuming these additional costs?

[James Gilbert, Director General, Strategic Policy Directorate, Public Health Agency of Canada]

In terms of consultations with the provinces and territories, actually we would not look at provinces and territories as other stakeholders. However, we've done broad consultations where people...scientists who would work in provincial labs or university labs would be welcome to come. We've also used our Pan-Canadian Public Health Network, Public Health Network Council, and the Council of Chief Medical Officers of Health to discuss this issue. We'll continue to use that as our primary public health vehicle for consultations with provinces and territories. We would encourage people within those jurisdictions to be in touch with their chief medical officers of health. So we'll do more concerted efforts through the existing public health networks, under the Public Health Network, to ensure that provinces are involved.

In terms of costs, we need to look at that very carefully. As we've said before, the level 3 and level 4 laboratories that are already importing pathogens will be very much used to this scheme. There may be some extra costs around containment due to security clearances, that type of thing, that we'd have to take a look at. In terms of level 2s, we're looking at ways to very much minimize these costs and to work closely with stakeholders, moving them forward.

We wouldn't want to say that it's cost-neutral, but we don't necessarily think the cost will be a large amount. I think the stakeholders we've had dialogue with, once they realize what the intent is in terms of program design and regulation, have been less worried about the cost than just seeing the legislation move that forward.

We'd commit to having ongoing discussions with people--ranging anywhere from large universities to provincial governments to individual researchers--so that we can set up a system that will mitigate against increased costs but is still primarily looking at the health and safety of Canadians, first and foremost.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

It appears that the federal government in this bill is duplicating current worker safety requirements with regard to incident reporting. These are already covered by provincial worker health and safety legislation, at least in British Columbia. Is that the case? And if it is duplicating, why?

[Theresa Tam]

As Jane and I have said, provincial legislation is more focused on worker safety. We are focused on the handling of the pathogen and the security of the pathogen. Also, there is no requirement currently across the country for reporting. We're concerned not just with the individual health and safety of the laboratory worker but also with public health in terms of dissemination of the pathogen, or transmission from the workers to the community or the families.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Just to clarify, I had mentioned it being a--

[The Chair, Conservative, Joy Smith]

I have to interrupt you. We are out of time.

Thank you, Ms. Tam.

Monsieur Malo, please.

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

Thank you for joining us this afternoon.

In the responses that you gave Ms. Murray and in your opening remarks, you stated that you held some information sessions for many stakeholders in the community who will need to adapt the way they work to the new rules that will be in place once Bill C-11 is adopted. Basically, you're saying that they feel comfortable and that this bill does not cause any problems for them.

After meeting with the people that we contacted, it was clear that fundamentally they are not opposed to the bill and that they understand its merits. However, people still have some concerns. I'm pleased that these stakeholders will be appearing in the coming days and that they will be able to tell us clearly where, in their estimation, the problems lie. I'm wondering why, even after speaking with them, there are still a number of unknowns when it comes to identifying product users and the costs associated with modifying facilities.

Why were you not struck by these concerns when you consulted with these individuals, when in fact you had mentioned them in your briefing notes? This bill is not at all reassuring. The only positive thing you can offer them is that the process will be phased in and the regulatory framework will address their concerns.

Why doesn't the bill contain provisions to allow them to adapt to the new rules?

[The Chair, Conservative, Joy Smith]

Who would like to take the lead on that question?

Mr. Gilbert, would you like to start?

[James Gilbert]

Thank you for that question. This has been an ongoing dialogue we've had with stakeholders. I think the more we learn from stakeholders, the better and richer our regulatory and program regime will be.

It's highly complex in terms of dealing with and regulating a scientific environment like this, and we want to make sure we get it right and that we can be responsive to new emerging science, to stakeholder concerns.

Putting everything in legislation might work for the moment, but then if we need to revisit some of the detailed parts, going through legislative revision is not going to be the best way to be responsive. Putting more in the regulatory and program sides would give us that flexibility to continue the dialogue with stakeholders moving forward.

We found, through going across the country to talk to researchers, university administrators, and others working with human pathogens that the ongoing dialogue, whether it's on a licensing regime or on security, allows us to hear their concerns and to put that in the regulatory framework and the program design, which we think is a more fitting place.

When you look at just the legislation itself, there may be a lot of questions, a lot of concerns, but when we very clearly talked to stakeholders about our public health interests in meeting those concerns so that innovation and good public health research in the country can continue, and about having a regulatory regime and program design that respond to those stakeholders, people have--in my view--walked away satisfied.

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

Of course, that's what you intend to do right now, but how do we know that you follow through with your intentions in the years to come?

Your logic is as good as mine. The question of providing answers in the bill can be revisited later if the objective, first and foremost, is to reassure the people who do research in the field.

As you know, our research institutes—and I'm talking mainly here about our universities—do not have a great deal of money to do research. Some concerns have been expressed about the implementation costs.

You say in your notes that the bill's impact will be minimal. Nevertheless, it will have an impact of some kind. Often, having a minimal impact means that there will be no money available for completing the studies under way. I look forward to hearing in the days ahead from witnesses who are more knowledge about this field. If no provision is made in the bill for transitional measures to absorb these costs, people will continue to have some concerns, even long after the bill has been passed and the regulatory framework is in place.

[James Gilbert]

Thank you for that.

In moving forward, some of the guarantees you're looking at are that we're all working within public health, and we're all working in the areas of looking at protecting public health and public safety. Part of that is to ensure that pathogens are dealt with safely for the security of Canadians, and the other part is to ensure that the research by the Public Health Agency of Canada keeps going on.

We would have no interest in putting a regime in place—that's so onerous. It stops the very health research that we need to keep the country safe. And that's the balance between the safety and security measures in this bill, as well as the public health research that's so important for the health security of Canadians. We think this bill has it right in terms of looking at the regulatory and program design. It's entirely that back and forth with stakeholders that we need at that phase, given the complexity and the scientific nature of it, so that we can design a program that works well for all Canadians.

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

If that's the case, why then are people still concerned?

[The Chair, Conservative, Joy Smith]

Thank you very much, Mr. Gilbert.

Monsieur Malo, your time is up. Thank you.

We'll now go to Ms. Wasylycia-Leis.

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

Thank you, Madam Chairperson.

Thanks to all of you for your appearance today.

I would like to talk to Dr. Plummer a bit because he is an internationally known scientist, and science and research are really at the heart of what we're talking about today in terms of human pathogens and toxins. I think there's no doubt about the value of research being conducted in laboratories.

Dr. Plummer, you know more about this than anyone. You're known for your work on HIV and AIDS. You and your colleagues at the lab--which, by the way, is a world-class level 4 lab--are known for your work on Ebola and other outbreaks.

My question is, given the ever-changing nature of these human pathogens and toxins, and how they multiply and reconfigure and new things emerge, and given the fact that there were cutbacks in the budget for health research and for other research, are we able to keep on top of the ever-changing dynamic in this field? And notwithstanding this legislation, do you feel that we're well equipped to deal with these emerging new pathogens and toxins?