Evidence of meeting #7 for Health in the 40th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was stakeholders.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Theresa Tam  Director General, Centre for Emergency Preparedness and Response, Infectious Disease and Emergency Preparedness Branch, Public Health Agency of Canada
Jane Allain  General Counsel, Legal Services, Public Health Agency of Canada
James Gilbert  Director General, Strategic Policy Directorate, Public Health Agency of Canada
Frank Plummer  Scientific Director General, National Microbiology Laboratory, Public Health Agency of Canada

4:35 p.m.

Conservative

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?

4:35 p.m.

Some hon. members

Agreed.

4:35 p.m.

Conservative

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?

4:35 p.m.

Some hon. members

Agreed.

4:35 p.m.

Conservative

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.

March 3rd, 2009 / 4:35 p.m.

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.

4:45 p.m.

Conservative

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.

4:45 p.m.

Liberal

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?

4:45 p.m.

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.

4:45 p.m.

Liberal

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.

4:45 p.m.

General Counsel, Legal Services, Public Health Agency of Canada

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.

4:45 p.m.

Liberal

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?

4:50 p.m.

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.

4:50 p.m.

Liberal

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?

4:50 p.m.

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

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.

4:50 p.m.

Liberal

Joyce Murray Liberal Vancouver Quadra, BC

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

4:50 p.m.

Conservative

The Chair Conservative Joy Smith

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

Thank you, Ms. Tam.

Monsieur Malo, please.

4:50 p.m.

Bloc

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?

4:55 p.m.

Conservative

The Chair Conservative Joy Smith

Who would like to take the lead on that question?

Mr. Gilbert, would you like to start?

4:55 p.m.

Director General, Strategic Policy Directorate, Public Health Agency of Canada

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.

4:55 p.m.

Bloc

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.

5 p.m.

Director General, Strategic Policy Directorate, Public Health Agency of Canada

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.

5 p.m.

Bloc

Luc Malo Bloc Verchères—Les Patriotes, QC

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

5 p.m.

Conservative

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.

5 p.m.

NDP

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?

5 p.m.

Dr. Frank Plummer Scientific Director General, National Microbiology Laboratory, Public Health Agency of Canada

Thanks for the question.

I think Canada is one of the better-prepared countries in the world to deal with emerging infectious diseases. It's partly because of the laboratory in Winnipeg, but also because of the Public Health Agency in general and our international connections.

For instance, we have a mobile lab system that we make available to the World Health Organization to respond to outbreaks in any part of the world, but also to respond to bioterrorism threats domestically. This is a unique capability in the world. Nobody else has it. We work very closely with the WHO in supporting them in response to outbreaks anywhere in the world. We've been deployed to Angola, to the Democratic Republic of the Congo, to Iran, and to Bangladesh.

Canada is a leader in this field, and I believe that while we can always be better prepared, we do have a high level of preparedness.

5 p.m.

NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

Some have said that we have a hodge-podge of emergency preparedness systems in this country--there's a piece here in Health Canada; there's a piece in Public Safety. It's spread all over the place, and we really aren't coordinated enough to actually respond in the event of a bioterrorist attack.

I wonder if maybe you and Dr. Tam could respond to that in terms of what we can do to ensure that there is that kind of central coordination and so on that happens at all levels. We recently had here some paramedics from rural Ontario who said that they don't feel in the loop at all. I wonder what we're doing to coordinate and ensure that there is overall emergency preparedness.

5 p.m.

Scientific Director General, National Microbiology Laboratory, Public Health Agency of Canada

Dr. Frank Plummer

Maybe I'll start and just tell you about some of the things we're doing at the federal level to coordinate response capability across departments.

The Public Health Agency, through the National Microbiology Laboratory, provides biological support to the national nuclear, biological, and chemical defence response team. We exercise with the army and the RCMP on a regular basis so we can deploy, under their command, during terrorist events of many different kinds. We do that in exercises as practice. We also do it in fixed deployments for special events, such as the G8 summit, such as the 2010 Olympics, such as leaders summits. I think we have a very sophisticated capability that satisfies the requirements of the U.S. government, for instance. We have very, very high expectations of what kind of security, related to terrorist events, we can provide.

Maybe I'll ask Theresa to--

5:05 p.m.

NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

While you're doing that, Theresa, is there one minister who is responsible for it all coming together? What's the central focal point in the federal government for all of this?

5:05 p.m.

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

Theresa Tam

Public Safety Canada has the key role in terms of coordination of emergencies. Health is only one type of emergency, and both Health Canada and the Public Health Agency of Canada together respond as a health portfolio to health-related emergencies.

Emergency response in Canada is from the local level up to the provinces and from the provinces to the federal government. Through the Pan-Canadian Public Health Network, one of the expert groups, we have been pulling together a pan-Canadian health emergency management system. To operate that and to interconnect, we've essentially been looking at protocols and at the operationalization of an incident management system.

What we've discovered is that emergency management in each of the provinces and territories has progressed in recent years. All of them have emergency management systems. Our role, actually, is to link with all of them and ensure interoperability and communication among them. The concept of a pan-Canadian health emergency management system is as interoperable, connected 13 jurisdictions connected with the federal level. They all sort of function together. It's a separate system, but connected together.

We have done quite a bit of work in recent years to make that happen. We're testing 24/7 contact points, for example, in the provinces and territories. That is a lot more systematic than what the previous state was, which was that we all knew each other, so we knew how to phone someone else, such as another chief medical officer, while he was skiing in Whistler or something. Now we have a 24/7...[Inaudible--Editor]...contact mechanism.

5:05 p.m.

NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

Let me go back to the coordination in terms of the health area and reference previous concerns of the Auditor General about a number of issues concerning surveillance of drugs and foods. She has commented a couple of times, at least, that Health Canada and the Public Health Agency don't seem to always be talking to each other, that there isn't some kind of overall coordination when it comes to surveillance in this area. In fact, the listeriosis crisis sort of brought some of that to the fore. The Canadian Medical Association actually said--

5:05 p.m.

Conservative

The Chair Conservative Joy Smith

Ms. Wasylycia-Leis, you're over time.

5:05 p.m.

NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

--that Canada is less prepared now for epidemics than it was in the past.

5:05 p.m.

Conservative

The Chair Conservative Joy Smith

Can someone quickly give an answer, as best you can, to Ms. Wasylycia-Leis's question?

5:05 p.m.

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

Theresa Tam

As a health portfolio at the Public Health Agency of Canada, we have one health portfolio emergency response plan, so we function together in that plan. There are also specific protocols, such as the food-borne infectious outbreak response protocol, which is actually going to be updated to incorporate lessons learned from listeriosis. We have to work with the CFIA and other agencies to get those things updated as well.

5:05 p.m.

Conservative

The Chair Conservative Joy Smith

Thank you very much.

We'll now go to Dr. Carrie. I understand you're sharing your time with Mr. Brown.

5:05 p.m.

Conservative

Colin Carrie Conservative Oshawa, ON

With Ms. McLeod.

5:05 p.m.

Conservative

The Chair Conservative Joy Smith

With Ms. McLeod. Okay, thank you.

Please would you start, Dr. Carrie.

5:05 p.m.

Conservative

Colin Carrie Conservative Oshawa, ON

Thank you very much, and thank you very much to the witnesses.

For a couple of years I spent some time at Industry Canada, and I recognize the need to encourage the research and innovation. I was wondering how you can assure the committee that the proposed legislation establishes an appropriate balance between the need for biosafety and the need for support for important research activities right here in Canada.

5:05 p.m.

Scientific Director General, National Microbiology Laboratory, Public Health Agency of Canada

Dr. Frank Plummer

I'll try that one first. The legislation concerning level 3 and level 4 pathogens is absolutely required. And if people are not meeting the standards there, they shouldn't be working on those organisms because of the risk to the laboratory workers and also because of the risk to the public.

For the level 2 organisms, they can also cause laboratory-acquired infections, so it's important that workers know how to safely handle them and have the appropriate equipment and training in order to do that, so they are less of a threat to public health overall.

I was initially concerned about the fact that the bill encompassed level 2 pathogens, but in discussions within the agency I've satisfied myself that this will have minimal impact on the ability for university research labs to do the work that we want to see them doing. And that can be accomplished through regulations, and the regulations around class 2 pathogens are going to be really quite minimal.

5:05 p.m.

Conservative

The Chair Conservative Joy Smith

Ms. McLeod is next.

5:10 p.m.

Conservative

Cathy McLeod Conservative Kamloops—Thompson—Cariboo, BC

Thank you, Madam Chair.

My question relates to your phased-in approach. You mentioned that you'd give stakeholders some time to become compliant with any new requirements under the act and the subsequent program and regulatory framework. Obviously we're in very tough economic times right now, and I think it's important that we allow laboratories to have flexibility and that we really aim to minimize the costs.

You talked about your phases one, two, and three. I wonder if you could go into some more details about how you are planning to implement this legislation, and especially with regard to minimizing the burden on laboratories.

5:10 p.m.

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

Theresa Tam

I could go over this quickly, and then if there's any specific questions I can also address them.

In phase one, which is the first phase that would come into force on royal assent, it will cover essentially three prohibitions in the legislation. The first is banning activities with certain human pathogen toxins such as smallpox. Smallpox is the key one we want to ban. A second prohibition is intentionally releasing a human pathogen or toxin that's causing risk to the health or safety of the public—so, intentional harm. The third prohibition is failure to take reasonable precautions, which is a duty of care. So these come into force upon royal assent and will also bring into force offences related to those prohibitions.

Also in phase one, we are asking labs to give us some very basic information: the name of the lab, the address, someone we can contact to discuss the implementation of the rest of the different phases. Certainly having the contact point is very key, because we actually don't necessarily know all the labs out there. We know there are currently 3,500 labs under the human pathogens importation regulations, and we have already made some assumptions and calculated that there are probably another 4,000 labs out there that we haven't heard from. They need to contact us for us to be able to continue the dialogue, etc.

In that phase, we are needing to communicate very rapidly, so everybody knows about this particular act and so they can satisfy the phase one requirement.

In phase two, which we suspect will take a number of years, is the actual development of the program and regulatory framework. There will be a lot of consultations required, and this is where we will address some of the concerns and the details of implementation the labs are going to be discussing and have already voiced. So with the extensive consultations, we will be drafting the program and regulatory framework and addressing things like security screening for risk groups and for pathogens, etc.

The final phase is the bringing into force of the rest of the legislation and the associated regulatory framework. That will contain mandatory requirements, such as you now need to obtain a licence and report on inventories. We will still give stakeholders a period of time to comply from the date of the regulations coming into force.

The timeframe itself can also be discussed with stakeholders to see how much time is needed for them to adjust and then be able to comply. After that, the legislative and regulatory framework will be entirely in force.

We would think the second phase in particular is the longest one and it will take a number of years, a minimum of two years.

5:15 p.m.

Conservative

Cathy McLeod Conservative Kamloops—Thompson—Cariboo, BC

So in actual fact, the initial phase will not create much in terms of expense to the specific laboratories. Perhaps there will be some things incurred down the road, but through your consultation you are intending to try to minimize, to paraphrase the rule.

5:15 p.m.

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

Theresa Tam

Exactly. I think most concerns do come from the risk group 2 labs, the labs that work with the slightly less pathogenic organisms, and for that we're trying to be less stringent in terms of requirements. For example, we don't want to require security clearance for people working with risk group 2 pathogens. The inventorying of those labs will be less stringent. We just need to know they are not possessing risk group 3 and 4 pathogens, inadvertently or otherwise, and need a higher safety level for their work.

Mostly it is really to promote our safety guidance across the board in the whole country, so there is no two-tier system like we have now, where those who import are regulated and those who don't import but acquire the pathogens domestically are not regulated.

Really the biosafety piece is not addressed in the provincial legislation. Inspections will be required of laboratories in risk groups 3 and 4, and that is generally not part of provincial legislations either. As for level 2 risk groups, we are not asking for regular inspections of those labs either. If an incident occurs in a level 2 lab, we may need to then inspect them or do some spot checks every so often. But again, we focus on risk groups 3 and 4. All those risk group 3 and 4 labs already import pathogens, which means they should already be compliant.

5:15 p.m.

Conservative

The Chair Conservative Joy Smith

Thank you, Ms. Tam.

We are going to suspend the meeting right now just to finish off some business. We have some budgets to pass and a few things like that, which are very necessary, but it's my understanding that you could return for the second hour on Thursday. We really look forward to hearing you once again.

Again, my profound apologies to you for having to wait. We have no control over parliamentary votes.

We'll just suspend for one minute and get right back to business.

Thank you again. We look forward to seeing you on Thursday.

[Proceedings continue in camera]