Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 4 - Evidence - June 10, 2009
OTTAWA, Wednesday, June 10, 2009
The Standing Senate Committee on Social Affairs, Science and Technology met today at 4:12 p.m. to examine Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins.
Senator Art Eggleton (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
Today we will continue with our consideration of Bill C-11, an act to promote safety and security with respect to human pathogens and toxins.
I want to welcome to the committee Senator Cochrane, who was on the committee at a previous time, but today she is a substitute. Senator Raine, you are not a regular member of the committee, either. Welcome to you, to Senator Peterson and to Senator Merchant. We have a lot of substitute members today. Welcome to all of you, and thank you for being here as we continue our second meeting on this subject.
We will hear from two witnesses in our first panel. Marc Ouellette is a professor at Laval University, a full professor at the Department of Medical Biology. He is the author and co-author of 149 peer-reviewed research papers and 16 book chapters, and he has given over 300 lectures at scientific meetings and international symposiums.
Dr. Peter Singer is the director of the McLaughlin-Rotman Centre for Global Health at the University Health Network and the University of Toronto. Dr. Singer is a professor of medicine and Sun Life Financial chair in bioethics. A recipient of many awards, Dr. Singer has published more than 240 articles and written more than 30 op- eds in national newspapers.
If you could give us five minutes each, then we will enter into a dialogue with members of the committee.
[Translation]
Marc Ouellette, Professor, Laval University: Mr. Chair, I am pleased to appear today before the Standing Senate Committee on Social Affairs, Science and Technology. My name is Marc Ouellette and I am full professor at the Infectiology Research Centre at Laval University and holder of a Canada research chair on resistance to antimicrobial agents. I am a member of two committees that are relevant to my appearance today.
First, I was the academic representative on a drafting committee for the 2004 third edition entitled Guidelines for biosecurity in Health Canada laboratories. That was the Bible for the import and export of pathogens and I was involved in the drafting of that document which is still governing our activities relating to importation and exportation of pathogens in Canada.
The second committee of which I am a member and which is relevant to this appearance is that I am a representative of the biosecurity committee at Laval University. Each institution has a biosecurity committee that examines the work that we are doing with pathogens. I also had the opportunity to appear twice before the House of Commons Standing Committee on Health regarding Bill C-11. So this is my third appearance together with Dr. Singer.
[English]
Today I am speaking for myself. I think it is fair to say that most individuals in Canada share to a great extent the views that I will express today.
First, I would like to emphasize that we are highly supportive of an act that will increase the biosafety of Canadians. There is no question about that.
Nonetheless, in its current form, one may question whether this act will not serve as a break to scientific processes in the formation of the next generation of students. I will try to describe that to you today.
I would like to convey three messages. The first is that the current guidelines that we have are working well. Level 2 pathogens, which have been extensively discussed before the House of Commons Standing Committee on Health, we believe, should not have been included in this act. However, now they are part of this act, so I will try to describe why level 2 pathogens are so different from the others.
Therefore, to recap, the first message is that the current guidelines work well, level 2 pathogens should not be included, and there is too much dependence on the regulations.
I will try to explain what we have to do to import or export a pathogen in Canada. I am a frequent importer. We must fill out a permit for the Public Health Agency of Canada, PHAC, which are these pages plus 23 other pages — I will leave it with the committee — informing them whether we are ready to work with it, whether we have the facilities to work with it and so on.
Most of the pathogens we work with not only infect humans but also infect animals. We must also fill out a permit to the Canadian Food Inspection Agency, CFIA. They have different ways of doing things. In this bill, there is nothing about how these different agencies will interact, and we are concerned about how complex it will become to import things through this new bill.
In addition, not only do we have to import things but we need to obtain funds to be able to do research with those micro-organisms and toxins. Funds are required for the Canadian Institutes of Health Research, CIHR; the Natural Sciences and Engineering Research Council of Canada, NSERC; or the Social Sciences and Humanities Research Council, SSHRC, although the microbes they deal with are mostly in the computers and not on the bench. Nonetheless, they may ask for funds there as well.
We need to find bio-confinement. Is it level 1, 2, 3 or 4? If we are lucky and we get the funds, there are committees within each university that will look at the grant, determine which level it is and whether you have the facilities for it. If you do not comply, you will not get funds.
Many controls are in place to be able to import pathogens already, and I think the system has been working fairly well.
[Translation]
My first message was that the present guidelines are working well. My second is that level 2 pathogens should not be part of this legislation. I must insist that there is a very large consensus on this in academic circles. The Public Health Agency has refused to budge on this, but I must admit that significant changes have been made and all of them deal with level 2 pathogens. The level 2 pathogens are not similar to level 3 or 4 pathogens.
It is mostly the legislation as written that defines organisms from risk group 2 as human pathogen agents presenting a moderate risk for individual health and a low risk for public health.
So it is mostly the person who will handle these agents that will be in danger, rather than the general public. You cannot have zero risk, that is clear. That is impossible. But there are ways to minimize that risk.
That is why our laboratories are licensed by Health Canada, by CFIA and other agencies that work with vegetal pathogens. All these persons who work with these organisms must follow a biosecurity training.
One must recall that this legislation deals with levels 2, 3 and 4. Ninety per cent of all activities in Canada and perhaps even more, but at least 90 per cent are level 2 pathogens. That was my second message, and my third message is the following one.
[English]
My third message is that there is too much emphasis on regulations, whereas it would be easier to fix it within the legislation itself. This has been a major source of discussion among the group of academics that presented at the House of Commons Standing Committee on Health and the Public Health Agency administrators. I acknowledge that PHAC has been responsive to some of our requests. The major change is that now people working with level 2 pathogens will not need a security check. This was a total disaster for universities, to have all the students requiring a security check. We could not imagine how this would be possible. I thank the Public Health Agency of Canada for including that in this bill. In fact, most changes that are included in the May 5 version were done for level 2 pathogens, another demonstration that they do not belong with level 3 and 4 pathogens.
[Translation]
In conclusion, I wanted to deliver three messages. The first is that the present system is already functioning well. Level 2 pathogens should not be part of this legislation and, as well, we will be too dependent on regulations that we have not seen yet.
I thank you for your attention and for your efforts in relation with this bill, which has an enormous importance for the science community. I will be pleased to answer your questions.
[English]
Dr. Peter Singer, Director, McLaughlin-Rotman Centre for Global Health: Thank you very much for the opportunity to appear before you. I am the director of the McLaughlin-Rotman Centre for Global Health at the University Health Network and the University of Toronto.
While my primary focus is on global health, I have worked on issues of biosecurity with the U.S. National Academy of Sciences, the U.S. Center for Strategic and International Studies, and with the United Nations Office of the Secretary-General. I appear today as an individual to comment on two issues: first, the implementation issues around Bill C-11; and, second, the broader context of the bill with respect to biosecurity.
I will make concrete recommendations in both areas. However, please understand up front that my fundamental position is that this is an important bill that plugs a hole in Canada's preparedness on biosafety and biosecurity, and its passage should not be unduly delayed.
The first issue I want to comment on is around the implementation of Bill C-11. There are intertwined implementation issues that do cause discomfort with this bill, especially the use of the criminal law and the inclusion, as you just heard from my colleague, of level 2 pathogens. This makes the bill broader than even the U.S. biosecurity regimes, such as the Select Agent Rules. The negative scenario includes sending scientists to jail for paperwork infractions, choking off needed medical education programs, stifling commercially important research and getting in the way of cooperation between public health agencies. Even perceptions that are negative are important because you actually need the scientific community onside in the quest to achieve biosafety and biosecurity, for reasons we can get into in the discussion period.
These scenarios should not transpire with a thoughtful implementation of this bill. However, as you know, life is 10 per cent planning and 90 per cent execution. Having said that, these issues also have been extensively discussed before the Health Committee, and the PHAC has made satisfactory amendments that help, such as the creation of an advisory committee to the minister; the clear distinction between level 2 and level 3 and 4 pathogens in the bill; and provisions in the bill to bring proposed regulations before the Health Committee.
To this mix, I would recommend that you consider two further steps that flow from the discussions that you had previously on this bill in your committee with Dr. Butler-Jones and with others.
Step one is that I would recommend that you broaden the ambit of the independent advisory committee to advise the minister not only on which pathogens should be on what list — level 2, 3 or 4 — but also to advise the minister on issues of implementation with respect to the bill. It is likely that advisory committee members who have expertise to say what list each pathogen or toxin should be on also have their ears relatively close to the ground in the university community and so on, and can provide ongoing feedback and advice about implementation.
Step two is that it would be good to state clearly in the bill what Dr. Butler-Jones said in his testimony before you last week, which is that he would use the criminal powers in the bill as a last resort. It would be good to state that in the bill.
Those are a couple of recommendations on implementation to ensure that a negative scenario does not develop.
The second issue I would like to address is the broader context of Bill C-11 with respect to biosecurity. In an editorial in The Globe and Mail in January, I asked the question of whether Canada is prepared for bioterrorism. My answer was that I am not sure. Addressing pathogen security through this bill helps answer that question in the affirmative.
However, it is really important, senators, for you to realize that pathogen and toxin security, which is the focus of this bill, is not equivalent to biosecurity. In contrast to nuclear security, which is where much of the misconceptions come from, where the technologies are highly centralized, capital-intensive, require state action, the knowledge is classified and there is a single choke point — if you control the plutonium and the highly enriched uranium — biosecurity involves technologies that are widely decentralized, not capital-intensive, can be used by non-state actors — and this is really the fear — the knowledge is widely available and there is no single choke point. Controlling pathogens is not like controlling fissile materials.
To achieve biosecurity, because there is no single choke point, a suite of solutions is required. This includes some that have been addressed already in Canada such as a robust surveillance system and public health response — pretty well developed in Canada as a result of SARS and the recent excellent handling of H1N1 influenza — and pathogen biosafety and biosecurity, which is addressed in this bill. However, for biosecurity, some areas have not yet been addressed such as attention to next-generation threats and the application of knowledge to pathogens and toxins. To give you a few examples, with anthrax — and you know about the anthrax attacks in the United States — imagine that it has been genetically modified so that the organism is resistant to antibiotics. Other examples include better bioweapon delivery systems using nanotechnology; small molecules that wipe out your memory because you have a convergence of biology and chemistry in the threat; synthesis of poliovirus de novo using the publicly available genetic code of poliovirus that was published in a journal a few years ago.
Therefore, one piece that is needed in addition is to address some of the knowledge to pathogens and toxins.
The second piece is what I could call the web of protection. By this I mean how well the scientific, business, health care, public health, intelligence and law enforcement communities, both inside government and outside government, work together on biosecurity. If there is one thing I have learned about the key to the lock of biosecurity, it is that cooperation amongst a wide array of communities inside and outside government that is so important.
Recognizing these issues in its deliberations on this bill, the Health Committee passed the following motion:
. . . the Committee recommend to the Minister that Public Health Agency of Canada request the Council of Canadian Academies, working with the Canadian Academy of Health Sciences and the Canadian Academy of Engineering to conduct a study to evaluate whether Canada is prepared for bioterrorism, with special emphasis on next generation threats and the web of protection and that this study also evaluate the appropriate approach to level 2 pathogens.
That was the motion that was passed by the Health Committee, recognizing that this was a piece of the puzzle and needed to be seen in its context.
The Council of Canadian Academies and the other academies I mentioned, as well as the Royal Society, have been working together to be prepared to do such an assessment jointly. My recommendation on the second area to you, senators, is that you also endorse this motion. The risk here is that one thinks the job is done with the passage of this bill. It is a good step forward, but the job is not done, and this is a great next step toward being able to answer the overall question in the affirmative.
In summary, I have talked about implementation issues, made a recommendation about the mandate of the advisory committee and about stating in the bill that the criminal powers would be used as a last resort. I have talked about the context of pathogen security, that it is not equivalent to biosecurity and that there are four or five different elements, a couple of which we have handled well, a couple of which we do need to handle even to come up to the level of other countries; and I have suggested a mechanism to do that that has actually been passed as a recommendation by the Health Committee, and I would suggest that you consider also endorsing that recommendation in that direction.
Thank you very much for your attention and for your efforts to make Canada better prepared with respect to issues of biosafety and biosecurity. I would be pleased to answer your questions.
The Chair: Thank you very much to both of you for starting us off today.
I think we understand and appreciate the desire for biosafety and biosecurity to ensure that bioterrorism will not become a problem, as much as we can. However, at the same time, we hear about issues that leave us wondering about possible overreach, for example, use of the Criminal Code in this context; unintended consequences, perhaps some of this goes too broadly; level 2 pathogens being included; and maybe too much red tape. We already have some rules, as you say, Professor Ouellette, that work well.
Both of you have said that you think that level 2 pathogens should not be in here. Level 2 pathogens are not listed in the United States or in the United Kingdom. They have far smaller lists than the lists attached to this bill. Should we amend to remove those? What would replace them? There still is a concern. The Public Health Agency has indicated that they are concerned about some level 2 human pathogens — legionnaires' disease, Walkerton E. coli, salmonella and C. difficile — that have been regulated under the human pathogens importation regulations since 1994.
I know you have said, Professor Ouellette, the import rules are there, but again the Public Health Agency says that we need to deal with not only the imports but the domestic situation as well. Comment on that, if you will.
Dr. Singer, you mentioned that the use of the criminal law in the bill should be used only as a last resort and that we should actually put that into legislation. I do not know how we do that. I do not know how we put those words in a legal legislative context. In any event, who would make the decision as to when the Criminal Code would be invoked and charges laid, and would this not create a chill in the research community with respect to the concern of having an accident and being charged and sent to jail?
Dr. Singer: On the issue of level 2 pathogens, I am in equipoise. I felt much more strongly before there were mitigating issues, and I have suggested a couple more. I can see the positives and the negatives. I would not push you too strongly either way. On the positive side, you have the example Dr. Butler-Jones gave. He finds a freezer somewhere from some abandoned laboratory and needs some way to actually open the freezer to see what is in there and know what is in there in advance.
You saw with H1N1 influenza the important role for a coordinated federal-provincial response but with strong federal leadership. There are thousands of level 2 labs and far fewer level 3 and 4 labs. You are capturing much more of the laboratory activity. I see some advantages. I see some disadvantages, and I painted those in the negative scenario — the stifling of research, the education, et cetera. However, if this is implemented in a sensible way, those disadvantages can be mitigated. There have been a few amendments that help in that direction. I have made a couple of other suggestions that help in that direction, one of which you have asked me to comment on.
I am in equipoise. It is not a clear answer; it is a close call. I can see the benefits of a strong, coordinated federal response that stretches across thousands of laboratories if it has an extremely light touch and if it keeps the scientific communities onside. That is how I would respond on level 2.
Without the amendments, without the additional things I have suggested — and this is the position I took at the Health Committee — I thought it would make more sense to take level 2 out. Now it is balanced because of the response of PHAC and so on.
I am not a lawyer, but I do understand that the Criminal Code is the vehicle, the method actually used for federal reach in this jurisdiction. For instance, the federal government is not in the business of licensing laboratories. Those are provincial. The way the federal government can enter this area is through the criminal law. I have already said that it is a good idea to have federal leadership in this area. That is the vehicle available to the federal government.
Dr. Butler-Jones said that they have always used it sensibly; they would only use it sensibly. I do not know the constitutional issues. You would have to ask a constitutional lawyer.
One of the amendments was to make clear in the legislation that the use of the law is proportionate to the level of the risk. That is a principle stated in the legislation, in the amendments. They have made clear distinctions between level 2 labs and level 3 and 4 labs. If there was a way to legislate, or as a second-best in the regulations, that the criminal law here would be used in just the way Dr. Butler-Jones said that it would be used, that would build confidence on the part of the scientific community that you need to get onside. Whether that is a proposal that would pass constitutional scrutiny, whether it is an appropriate provision in a piece of legislation, as a non-lawyer, I cannot advise you, but as a scientist, I can tell you, if it said that, it would be much better in terms of perceptions around implementation.
Mr. Ouellette: With respect to level 2, this has been one of the dominating themes at all the hearings we had at the Health Committee. As I said, currently it is working very well. We were not consulted on the first drafting, and then we received that through the universities. The Public Health Agency went to different places throughout Canada to explain it. However, no real dialogue occurred between the Public Health Agency of Canada and the scientists doing the work with the level 2 pathogens.
The first discussion we had was through the MPs. We were at the same table but discussing with the members of Parliament. They showed an openness. They did modify a couple of aspects from the March and May versions, and they did indeed remove the security check for level 2 and include that an advisory committee will decide which pathogens will be on what list. You spoke about Walkerton E. coli, but strains of E. coli exist that are non-pathogens. Every undergraduate student will work with E. coli. There are differences between different E. coli. An advisory committee needs to be able to look at those issues.
In those aspects, they have been responsive. We were appalled that a first offence would be $250,000 for someone importing a pathogen. They have reduced that to $50,000. For a normal person, $50,000 is still a large amount of money. Therefore, yes, they responded to that, but I do not think it was reasonable to put an amount of money for importing level 2 pathogens if it is your first offence. You can say that you should not do this. It cannot happen because there is no way to import a pathogen.
You are saying that, internationally, it is well regulated. How is it regulated nationally? If I want a strain from Vancouver, Winnipeg or Toronto, I also need to get this import permit. It is less clear with my neighbour in the lab next to mine if I give him a strain. How do they want to know that? As I understand it, they want to have the university as the owner of the permit. Others will be licensees. However, this creates a problem. If one of the 1,000 is behaving badly, does that mean the 999 others will lose their permit and not have the ability to work?
There has been a very strong effort to remove level 2 pathogens. The Public Health Agency of Canada has insisted on keeping it. They are telling us that about half the labs are complying with those regulations. They give a number of 3,500; at the same time, they say 3,500 labs do not comply. We asked repeatedly where those labs are that do not comply. They say that they cannot discuss that, and I believe them. Nonetheless, I find it amazing that there would be labs outside of the Public Health Agency and universities that would have streptococcus pneumonia, staphylococcus aureus, C. difficile and other virus strains.
The underlying theme of our efforts has been trying to remove level 2 pathogens. I understand that we are now at the stage where there will be fine tuning or maybe amendments. If level 2 pathogens are there, it has to be clearly stated that we have to be involved in this. We are the ones who will suffer, and the training of the next generation of students, if level 2 pathogens are treated the same as level 3 or level 4 pathogens.
Senator Eaton: Thank you for coming with your passion, interest and knowledge.
I have a different perception of the bill, Professor Ouellette. I have understood from the minister that on Royal Assent, it is a matter of who, where and what. You say that we do not know who does not comply. That is exactly why the federal government would like to know where the labs are and what they have.
A biological safety officer will be required. Both of you seem very concerned about criminal intent. My understanding is that once Royal Assent has been given, there will be extensive consultations. These will include what the consultations should look like and discussion of issues such as the criminalization. I was told that it is not about a student tripping and spilling something on the lab floor, it is more about intent. You will get warning and a ministerial letter if there is an inspection. Dr. Singer, the regulations will show that criminalization is the last resort. It is not to punish anyone.
Dr. Singer he has a position that he is not so sure about, or he sees both sides, but Professor Ouellette, you said that you follow current guidelines established in 1994 and that they work very well.
Mr. Ouellette: From 2004, the third edition.
Senator Eaton: The first ones that you said worked well. What about the labs that we do not know about, which are not university labs, that are not necessarily following any guidelines? Why should we not have safety guidelines that are part of the law for students coming into your lab in September? What is your objection to that?
Mr. Ouellette: Apparently the Public Health Agency of Canada also does not know about those labs. It is not only me.
[Translation]
Senator Eaton: We must know as well?
Mr. Ouellette: Absolutely, I fully understand. Are there 3,500 of them?
[English]
I am not sure about that. It sounds like a large number to me. You need "know how'' to be able to work with pathogens. It is not that everyone will start growing something under the absence of oxygen and so on.
Currently, the guidelines do not seem to have the teeth to be able to request that people provide information. I do not know what they are. Are they cheese producers?
Senator Eaton: It could be cosmetic firms.
The Chair: I am sorry, Senator Eaton; it is Professor Ouellette's turn to respond.
Mr. Ouellette: I am not sure that 3,500 labs exist in Canada that do not observe that, but the law will allow for this.
With respect to your point about students, the way the law is now written, there will not need to be a security check for people, which was not the case two or three weeks ago, but now it is. The changes made were to try to soften restrictions for people working with level 2 pathogens, which I acknowledge is great. We did not see that between the first and second versions from Bill C-54 to Bill C-11. If this bill passed as is, it will not complicate things for my students.
However, things are going well currently. Why change things that are going well?
Senator Eaton: I want to make one last point on students.
Thirty thousand people die in North America every year from influenza. I think influenza is a risk 2.
Mr. Ouellette: Yes. Can I respond?
The Chair: Go ahead. I thought you did.
Mr. Ouellette: Probably more people in the world are dying from E. coli. It is not the infectious risk that we are talking about. There are frequent infectious diseases, such as C. difficile; we have heard about that. It is not because a disease can cause a dangerous infection. We are not talking about people here. It is how you handle it in the lab. This is a very different business.
However, yes, influenza is one of the biggest killers, and we must worry about this.
Dr. Singer: I have two points to make in 10 seconds. First, I am very sure of my position; I am sure it is a close call. Second, make no mistake, this law does criminalize the handling of level 2 and level 3 and 4 pathogens. It is a piece of criminal law. However, we should be very careful to couch those criminal penalties in the most sensible, judicious way. A number of things have been done in my additional recommendations, which we discussed before. The reason for this is because even a criminal charge, let alone a criminal conviction — forget about a fine of up to $50,000 — has a devastating effect on the life of a scientist or a professional.
Senator Callbeck: Thank you both for coming. I want to ask about regulations. Professor Ouellette, you mentioned that there is too much emphasis on regulations. We have heard that before. I understand that the Health Committee in the other place is also hearing that.
There is a long list of regulatory powers here. Are there specific ones that you believe should be in legislation rather than regulation? If so, why?
Mr. Ouellette: Yes. It would be difficult for me to tell you exactly which. I am a modest scientist and am not aware of how laws are made, but we are appalled by what is written here. The people from the Public Health Agency of Canada constantly reassure us. They tell us not to worry, that they will take our comments into consideration in the regulations.
It is my understanding that regulations are quite flexible, that it depends on the day, that if there was a bioterrorist attack, the regulations may be very different than if there was not a bioterrorist attack. However, the law is the law, and to change the law is difficult.
People working with level 2 pathogens had to be security checked. Under this bill, only people working with level 3 and level 4 pathogens must be checked. Why keep so much for the regulations? The Public Health Agency of Canada tells us not to worry, that they know we do our homework. However, we do not know what will change.
One new concept is the inspector. Who will name the inspector? What will his powers be? Can he close a lab? These are concepts that we are not used to. Perhaps with discussion things will change, but we need to be reassured that there will be discussion and that the regulations will meet the needs of the people who work with pathogens.
Senator Callbeck: Dr. Singer, do you have a comment?
Dr. Singer: I think it strikes the right balance between legislation and regulation. The main change is that the risk rating between level 2 on the one hand and level 3 and 4 on the other hand is now in the legislation whereas before it was not.
Leaving many things to regulation has its benefit because science changes and the health scenario changes. Therefore, we must strike the right balance between the important distinctions that are in legislation and the flexibility of regulations, which is important in an area where science is changing and you want to be making mid-course corrections on implementation.
I believe it is probably about the right balance now with the amendments.
Senator Merchant: I understand that you are concerned that no consultations occurred on the drafting of this bill. Witnesses in the other place also indicated they were not consulted, and this is a concern.
What the U.K. and the U.S. have been doing was referenced. Can you tell us how they have handled the issue of the level 2 pathogens?
Mr. Ouellette: It is correct that we were not consulted in the drafting. We receive many emails, as you do. When I opened one and looked at the list of pathogens in the annex, I saw that my favourite bug was now a level 3 pathogen. Although I received a letter from the Minister of Health saying that that was a mistake, we were appalled. From Bill C- 54 to Bill C-11, the only change was to move our pathogen from level 3 to level 2.
They did not consult us in the drafting, but they did inform us afterwards, to be accurate. They have gone throughout Canada explaining both Bill C-54 and Bill C-11. They keep telling us — and I am sure they will do it — that they will consult us on the regulations and that we will be more involved. I am pleased with that.
I am less familiar with the U.K., so I will not be able to comment on their situation, but the U.S. has a list of selected pathogens with which there are strict rules associated. They have security checks, and they are now talking about conducting psychological testing.
They have some rules to follow for level 2 pathogens. I was talking to a committee from the U.S. yesterday. I told them that I would be here today and asked them about the situation there. They said that there are no specific guidelines except for exporting things. For exporting to Canada they need a permit, but domestically it is fairly simple.
Dr. Singer: Consultation is extremely important in a bill where you need to have the communities on side. At the same time, you do not want to keep consulting until an unintentional release or a bioterrorist strike happens. You must strike a balance, and by now many people have weighed in with many opinions.
On regulation in the United States, the level 3 and 4 type pathogens are part of the Select Agent Rules under the Patriot Act, which is a similar structure to this. I do not think the level 2 pathogens have the force of federal criminal law in the United States. I believe they are regulated through biosafety guidelines, which I think are endorsed by the Centers for Disease Control and Prevention, CDC.
Senator Merchant: Do you think that is what we should do? The U.S. has every reason to be very careful, and they are very careful.
Dr. Singer: That would be a very good way to go, except they do not have the federal-provincial division of powers, and, as I understand it, they are able to regulate certain matters of health through CDC at a federal level in a way that is more difficult in Canada given the division of powers. That is why I believe this legislation is set up as it is using the force of the criminal law.
If we could do it that way, I think that would be better. However, I do not believe we can do it that way, which is why they are not doing it that way.
The Chair: Colleagues, on the issue of consultation, we have before us notes and session reports prepared by the Public Health Agency of Canada. Some of these consultations go back to before the bill was drafted. Some go back to the original bill, Bill C-54, now replaced by Bill C-11, and some are more recent.
Questions still remain on whether people were consulted at appropriate stages and also whether everyone was consulted. We will hear, in the next panel, from people who do not think they were properly consulted. I wanted to point out that that documentation is before you.
Senator Dyck: Thank you for your presentations. They were very clear.
Are you happy with the way the regulations are set up with respect to the appointment of biological safety officers and the process for appointing inspectors, which is not specifically mentioned under regulations?
Mr. Ouellette: They discuss at length the role of the inspectors, although some aspects are not entirely clear. This is something new for us, something we will have to deal with. This is a new structure.
As to biological safety officers, you will hear about the University of Toronto biological safety officer from the next panel. We are used to working with safety officers as well as applications for import permits. Things have changed because of this. Now it has to go through the biological safety officer, which greatly increases the workload of that person. University officials worry that they will have to hire more staff to be able to accept the increase in workloads. That is the universities' problem more than our problem, but we have to deal with it.
Dr. Singer: I think you are right that the next panel is probably in a better position to deal with that question.
Senator Dyck: Do you see a role for the advisory committee in determining the functions and qualifications and so on with respect to those two positions?
Dr. Singer: I do. As I indicated in my comments, it would be a good idea to have a broader role for the advisory committee focusing on broader issues of implementation and broader advice to the minister. All the consultation about regulations that happens in the Health Committee that is written into the legislation is all a priori. The real question is how it is working out in practice. It would be helpful, since implementation is so critical with respect to this bill, to have an independent channel of advice to the minister on the broad suite of issues around implementation. That is a reasonable proposal, and I think it would help. This will be about how this is executed. That is why I can say level 2 pathogens, in or out, is a close call. The issue is how it is executed. An additional channel to feedback on implementation to the minister would be in everyone's interest.
The Chair: What type of composition would you suggest on that advisory group?
Dr. Singer: That is a good question. At the core, you need some microbiologists, such as Dr. Ouellette, because one of the functions is what should be a level 2, 3 or 4. I would like to see some broader-minded people from the university and business communities, and then some people who have a big-picture sense of what is happening in biosecurity.
It is easy to get locked into metaphors, as I tried to imply in my comments. Many people misapply, for instance, the nuclear metaphor to biosecurity. Implementation here is critical. The way you find a rogue scientist is not through law enforcement and not through your controlling pathogens; it will be the peer scientists that see something unusual. You need to have the scientific community onside, and therefore you need to ensure that when you implement this, you keep that community onside and have their feedback. That is the sort of composition I would suggest.
These are serious matters. A U.S. congressional panel opined that, by the year 2013, it was more likely than not that a weapons-of-mass-destruction attack would occur somewhere in the world and that biological was more likely than nuclear. These are serious matters, and you need to keep the scientists onside. That means it needs to be implemented well. A good, broad suite of advice to the minister on how it is going in implementation seems to me a reasonable measure in everyone's interest.
Senator Cochrane: Professor Ouellette, you indicated that the current guidelines have been working well. Are you aware of any cases where they have not been working well?
Mr. Ouellette: Personally, no, but I am sure there must be some. As you know when you drive your car, not everyone follows the 100 kilometres an hour sign on the road. I presume there must be some people who have put things in their pocket, yes, but the way I do it and the way university people do it is that we observe the guidelines and ask for the import permit. They ask through the PHAC and CFIA if it also infects animals. If it also infects plants, you need a permit from Agriculture and Agri-Food Canada.
This is the way we do it, and the people from the universities are viewed that way by the PHAC. Yes, we do have to follow the rules because this is how we do things now. If I ask for biological materials from France, I write my permits, and, a month later, I will receive the biological materials that have been requested. If you want to buy biological materials, there are repositories where they have thousands of strains. One is the American Type Culture Collection, ATCC. I think I have the acronym correctly. Now there is a company in Canada where you fill out the forms for the Public Health Agency of Canada and get those strains. Otherwise there is no way to get them.
PHAC was a little worried about someone from Ottawa bringing his or her car to my lab where I give him or her a strain and then that person returns. This is not really a problem in the sense that if this person is habilitated to work with level 2 pathogens and I give that person a level 2 pathogen, this is included in his permit. This is the way I understand it. This is not the way it is right now. Right now, the person from Ottawa will make a request, I will ask for the import permit to be sent to me and then I will send it to him.
I am speaking for myself. I obey the rules, and I go through the import permits. If others do not, I do not know about that. It is difficult for me to say.
Senator Cochrane: Personally, I am concerned about other countries and what they have done in sharing information. At the same time, I think that we in Canada are leaders. We should be prepared in advance for what may come. We cannot just sit back and use what we have now. We always have to be prepared for other dangers. Other dangers are out there; trust me. We do not have them now, but others will come. People are becoming more sophisticated in the way they do things and in their thinking. We have to be prepared, regardless of what other countries do. That is my spiel.
Mr. Ouellette: I totally agree with you, but this is bioterrorism. We have criminal laws that look at these activities. This is not a scientist who was sending something. The law is not exactly looking at those evil minds that want to commit a bioterrorism act. This is a little different. Dr. Singer, in his first speech to the House of Commons, listed a number of items where we should worry even more than we do about these living organisms.
Dr. Singer: I mentioned the work we had done with the United Nations Office of the Secretary-General. That is all about the best approach to this problem internationally. We have an international regime for nuclear matters, the International Atomic Energy Agency inspectors. That will not work for biosecurity because of the decentralized nature of the threat. What will work is a different form of governance that is not purely intergovernmental but where scientists and business people come together. They balance the positive uses of bioscience for development, the crops that are draught-tolerant, the vitamin-enriched plants and the better vaccines, and they protect against the negative uses. There is an interesting international discussion, which we will not have here for purposes of time; however, if you watch what will be happening in some of those international communities I mentioned, this will move forward, but not in the form you might expect of a pure intergovernmental thing because it does not fit the problem.
I suggest you take a serious look at my second recommendation because the issues of the knowledge and web of protection are part of the international issues that need to be addressed, along with public health surveillance and response, and pathogen security. If I write an article in The Globe and Mail two years from now and ask the question of whether Canada is prepared for biosecurity, hopefully I can answer that I think so. However, I will not be able to say that if you just have the public health piece and the pathogens security piece. You need to have the knowledge and web of protection pieces and a vibrant suite of solutions. Many of the threats are international. You can get a on a plane somewhere else, come here in a day and cause a large problem with something that is terrible.
The Chair: I have to wrap up this panel in five minutes. I have three more people on the list. If each of the three of you could put your questions, then I will have Dr. Singer and Dr. Ouellette answer them all at once. That will be the end of it. Put your questions clearly and succinctly.
Senator Martin: My question has been addressed, but I wish to make a comment to our presenters today. I appreciate, Professor Ouellette, your passion and advocating for your profession, as well as the students, and how important that is. I also appreciate you, Dr. Singer, for your very balanced perspective on this issue. You began by saying that this bill fills a gap. From our conversation today, I know that, as a mother and as a citizen, we can fill a gap to ensure not only that we are protecting the citizens but also that the labs are doing what they should be doing. You are assuring us, but there may be labs that are not. I want to thank you for your presentations today.
Senator Cordy: When I read through the bill and look at clause 39, I get nervous about the broad powers that the minister has for disclosing information. She can disclose personal information obtained under the act to provinces, foreign governments, other government departments and so on. If there is an immediate danger to the public, that may be necessary. However, when I look at the broad, sweeping powers in the bill, I get a little nervous about the minister's ability to be able to disclose information picked up under the act and disclose it to whomever. Would you comment on that?
Mr. Ouellette: I will make one comment. This is an excellent point that was also raised during the other hearings that we had. A change was made from the former draft in this draft. Unfortunately, I have the French version here. It states that it will be communicated only if there is a legal obligation that is constraining the minister. It is a literal translation that I am doing because I cannot find it. The French and the English versions are sometimes not in the same place.
Yes, it has been discussed. They have tried to look at that by adding this sentence at the end — at least, in the French version.
Senator Cordy: Disclosure is necessary.
The Chair: They should be side by side, at least in my copy.
Mr. Ouellette: Yes, they are side by side.
The Chair: It is clause 39 of the bill.
Mr. Ouellette: It says, "unless they are required by law to disclose it.'' Yes, it is at the same place. You are right. This was not there before; this has been added.
Senator Cordy: Is that enough?
Mr. Ouellette: There is no security check now for level 2. Is that enough? We were hoping that level 2 would be out, and now they have made an effort. Is that enough? Dr. Singer, this is your field.
Dr. Singer: In addition to not being a constitutional lawyer, I am not a technical privacy expert. As a broader strategic issue, first, I can understand why you would be concerned, particularly in relation to disclosure of information to international groups. I know what you are thinking about.
At the same time, playing off your point, senator, the three points about disclosure in the bill are that it is necessary for the administration of the act; the minister has reasonable grounds to believe that it is necessary to address a serious and imminent danger; or to enable Canada to fulfill international obligations. By that, I think they are probably referring to international health regulations and being able to say what we have to the World Health Organization. There are three circumscribed areas at least. I understand the concern, but those three elements potentially seem reasonable.
I think it would be a good question. I know you talked about the Privacy Commissioner last time in your deliberations. I think that is a reasonable question. Without getting into the details of privacy law, let me say that I can understand why you would raise that concern, and I can understand why they would put each of these specific provisions there because there have been problems in the past, for instance, around reporting with respect to SARS, or what have you, to the international community, for example.
Senator Martin, your question is easy to answer. Thank you very much.
The Chair: Thank you very much; it goes both ways. We appreciate both of you coming in today and contributing to our knowledge base on this as we try to come to grips with Bill C-11.
We now have the second panel with us. We have Paul Gould, Chief Executive Officer, Ontario Association of Medical Laboratories. The association is the voice of the community laboratory industry in Ontario and represents the interests of its members to government, other health professions and to the public.
Dr. Nick Busing, I take it, has been replaced. This is with respect to the Association of Faculties of Medicine of Canada, AFMC. Could you introduce yourself, since I do not have any information about you?
Marianna Newkirk, Associate Dean, Research, McGill University: I am Dr. Marianna Newkirk, Associate Dean of Research, McGill University. I am speaking on behalf of all the deans for the medical faculties from across Canada, the AFMC.
The Chair: We will also hear from Professor Andrew Bognar from the University of Toronto; and Dr. Wayne Conlan, from the National Research Council Canada.
We will begin with Paul Gould, from the Ontario Association of Medical Laboratories.
Paul Gould, Chief Executive Officer, Ontario Association of Medical Laboratories: I thank the committee for the opportunity to appear to hear our concerns about Bill C-11. As non-hospital-based laboratories, our members perform over 50 per cent of Ontario's diagnostic testing. The work we perform in Ontario represents a significant portion of community laboratory testing across the country. The vast majority of the diagnostic work is performed on risk 2 pathogens.
The Ontario Association of Medical Laboratories, OAML, supports the spirit and intent of Bill C-11; however, the bill has an unreasonably broad reach and unnecessarily combines biosafety and biosecurity issues. We wish to identify the following five concerns, which have been more fully explained in our written submission to the committee.
First, there has been inadequate consultation with the affected communities. Community and hospital laboratories perform the bulk of diagnostic testing in Ontario and have a clear understanding of the impact of what is being proposed, yet neither the OAML nor the Ontario Hospital Association were provided adequate opportunity to provide input.
Second, the bill duplicates the provincial licensing inspection services and regulations, which leads to inefficiency and red tape, and ultimately impacts negatively on patient safety. Biosafety level 3 and 4 laboratories are already licensed and inspected by the Public Health Agency of Canada and the Canadian Food Inspection Agency. Biosafety level 2 laboratories must meet these agencies' biosafety requirements if the laboratory is importing risk 2 pathogens. The bill duplicates Ontario workers safety requirements, which are regulated under Ontario's Occupational Health and Safety Act, the Health Promotion and Protection Act and through the Ontario Laboratory Accreditation safety requirements. The federal Transportation of Dangerous Goods Act is also duplicated since it already provides sufficient regulations to ensure the biosafety of pathogens when moved from one facility to another. Inadequate recognition is given to the Ontario Laboratory Accreditation program, regulatory requirements and licensing inspection programs, all of which contribute to ensuring the biosafety and biosecurity of laboratory operations. This causes further duplication. In Ontario, diagnostic laboratories are governed by the Laboratory and Specimen Collection Centre Licensing Act, which includes accreditation based on internationally accepted and approved ISO standards. In addition, medical laboratory technologists and physicians are accountable to their respective colleges, where they can be disciplined if found to be acting in a way not consistent with patient and public safety.
Third, unnecessary inclusion of risk group 2 in the proposed legislation will burden the laboratory system and ultimately reduce patient access. The greatest infectious disease dangers to which Canadians are exposed are likely to be from contaminated food and water. They do not originate as a result of the risk group 2 pathogens escaping from the laboratory and causing disease in the community. However, this bill will apply to thousands of community, hospital and academic laboratories across the country instead of the 130 biosafety level 3 laboratories and two biosafety level 4 laboratories in the country, where it would be applicable. This bill will require most community and hospital laboratories currently operating at biosafety level 2 standards to upgrade to biosafety level 3 to accommodate the very few risk group 3 pathogens that they see on an occasional basis.
Fourth, the 16 million patients who utilize our 330 specimen collection centres, SCC, would be affected by this bill because community laboratories would be challenged to upgrade SCC facilities to meet laboratory requirements for level 2 and level 3 pathogens. This additional financial and administrative burden will result in a reduction in patient access to collection centres.
Fifth, some sections of the bill may be ultra vires Parliament of Canada under the Constitution Act, 1867. We are concerned that sections pertaining to risk group 2 pathogens may be viewed by the courts as infringing on provincial areas of jurisdiction as recognized by this act.
In conclusion, the OAML supports the introduction of additional measures to ensure the biosafety and biosecurity for risk group 4 pathogens and for some risk group 3 pathogens. It is unreasonable to impose additional unnecessary regulatory burdens on Ontario's diagnostic testing laboratories for risk group 2 pathogens, unless there is a well- identified need with clear benefits to be gained. This is not the case. In fact, such inclusion would have negative implications in terms of patient safety and access.
Our written submission speaks to these concerns in more detail and provides the following recommendations: First, amend the bill to avoid unnecessary duplication of licensing, regulation and inspection services. Second, remove risk group 2 pathogens from the bill. If risk group 2 pathogens are not removed from the bill, then third, provide a specific exemption for Ontario community laboratories with respect to risk group 2 pathogens to avoid having to use limited health care resources on duplicate regulatory framework, licensing and inspection services. Fourth, provide exemptions for biosafety level 2 laboratories and collection centres that occasionally encounter risk group 3 pathogens. These laboratories should be provided with the opportunity to continue to operate at a biosafety level 2 and be permitted to apply for pathogen-specific exemptions for those risk group 3 pathogens that they routinely or occasionally encounter, such as HIV. Alternatively, a notification process for risk group 3 pathogens could be implemented that would require the community laboratories operating at biosafety level 2 to notify the Public Health Agency of Canada when they encounter risk group 3 pathogens in the course of their work. Fifth, establish a process to provide adequate consultation with the OAML, other stakeholders and affected parties who understand the practical implications of the bill, while addressing the biosafety and biosecurity concerns.
If the above recommendations are not accepted, we would then recommend that the bill be placed in abeyance until the Supreme Court of Canada releases its judgment on Quebec's constitutional challenge to the Assisted Human Reproduction Act.
The Chair: Dr. Newkirk, please proceed.
Ms. Newkirk: Thank you for giving us the opportunity to address the committee. The faculties of medicine from across Canada are research-intensive environments and have a jurisdiction to educate. As such, pathogens of level 2 are indispensable tools in the laboratory. For example, there are more than 275,000 publications in the medical literature on E. coli. The vast majority of them have nothing to do with people getting sick but are there as tools used in a biochemistry lab. However, in order to use these tools in a research lab, students have to be taught how to use them, and that must be done in a very safe manner. It is critical that such pathogens be accessible for both learning and research. It would be impossible to teach the next generation of microbiologists if access to these pathogens were so onerous that it impeded the education of our scientists and physicians.
Indeed, our brightest young scientists in the high school science fair circuit are even using these pathogens to discover new things. I have been a judge at science fairs and, indeed, level 2s are among the biological materials with which they are working. We do not want to shut down this pipeline to creativity and our future.
For the level 3 and 4 pathogens, since far fewer people work with them across Canada, or are trained to work with them, more restricted access is less problematic from our perspective and in reality already exists.
We have a number of specific recommendations for you to consider. First, for the requirement for special permits, the regulation will impose delays of perhaps several weeks to send most microbiology samples from laboratory to laboratory, even diagnostic samples from clinical laboratories where people have to know what it is in order to know how to treat the person; and if you cannot send it from one laboratory to another in an expeditious way, you are then halting the therapy of those individuals.
Some imports, as you have heard, can take several months — for example, such as cholera toxin.
We appreciate that, with the modifications to the bill that have been recently made, this is now somewhat easier for the level 2 pathogens. However, we would like to ensure that this acquisition of permits is speedy, ideally less than five to ten working days, if possible; as both for research and teaching purposes — the ladder of graduate students, for example — the lack of productivity because a critical resource is unavailable for their research due to a problem with paperwork can be extremely detrimental for continued funding from the major funding agencies.
Our second point is on the security checks on all individuals with any potential access to biosafety level 3, again, we would want there to be some obvious clearance. However, we want it to be done in an expeditious manner, especially since many of our trainees are foreign students. Canada attracts graduate students and post-doctoral fellows from across the world. We would want to ensure that the time needed for the security checks will be no more than 14 working days. Salaries for support for trainees have very precise start and end dates. Theoretically, we would have the money to start paying an individual, yet they would not actually have the clearance to be able to work. This is a waste of taxpayers' money because the salary would be coming in. We often do not have much lead time on some of these applications.
Also, with respect to visiting faculty members who enrich our university, they are brought in to educate faculty or trainees, and we would not like to see them impeded by an inefficient regulatory checkpoint.
Our third point is about the question of supervision of non-laboratory personnel in maintaining records of all visitors to the laboratories. This regulation appears to apply regardless of whether the people are actually working in the lab, and this is an issue that will be difficult to deal with in our undergraduate environment. It will also restrict access by the media, community outreach programs, et cetera. We appreciate that there should be regulation and protection of the population at large, and we agree that there should be supervision where possible of non-laboratory personnel in the ideal world against these pathogens. However, what happens when a major pipe bursts in the middle of the night? The crew that would be brought in to look after this flood — and this actually has happened in our aging infrastructure — would have to be supervised. Who would keep a list of all these people? Keeping a list of visitors also may have to include people such as the Fed-Ex person who brings in a supply or reagent. If the intent is to cover the people who are actually working in the laboratory, then that is how the bill should be worded so that these other people are exempt from this documentation.
The fourth point that we wanted to make is about the reclassification of the non-pathgenic bacteria, the level 2 agents that we have heard a great deal about from other people. We use them extensively, and they have been well managed using good microbiological practices. If you regulate them, it will have a major impact on the design of our undergraduate teaching that uses classical approaches.
We are appreciative of all the amendments that have been made recently to the bill because they will make life much easier, and we want to ensure that they are incorporated and ratified. If you did not do it, not only would our molecular biology research across Canada be extremely curtailed, but we would also be at a huge disadvantage globally. Our training of our next generation of educators or researchers depends on the access to these level 2 procedures in a safe manner. As an analogy, imagine what impact preventing all surveys of public opinion would have on politicians planning their next strategy or platform. Curtailing access to level 2 would have exactly the same impact on us.
The final point is about intellectual property, IP, and it was brought up as a question to the previous panel. We would like to re-emphasize that protection of intellectual property is a most important issue, not only for the institutions involved but also for the Canadian economy. Research and innovation will form the backbone of the Canadian economy going forward, and, therefore, our IP must be protected from access by outside individuals and governments. It is therefore most important to create a regulatory system in which such information is not required or remains protected. As part of this protection, the potential of excessive search-and-seizure practices in carrying out a valid inspection must be limited.
We are sure that you, as taxpayers and politicians, want to see value for your tax dollars that go to research. It is critical to ensure that the intellectual property generated by working with these pathogens is protected, that is, keeping it confidential until such a time that it is marketed is critical. There is a huge potential for financial reward in this area for the development of therapies against these pathogens or vaccines, and we, as Canadians, should realize this and not let others inadvertently take advantage of these developments due to a lapse of confidentiality. The multinational pharmaceutical companies would obviously prefer not to have to pay patent costs to our universities if they somehow inadvertently got wind of what was happening.
With respect to the $50,000 fine — and it says "per day'' — for an offence, we were wondering whether there would be a cap. For example, if a diligent person came in on a Friday and found that someone was in violation, does this add up over the weekend? Those type of details needs to be clarified. One wants compliance with the law, but that would be a huge expense to the university because that is who would end up paying for it. It would be a big expense to the taxpayer.
In addition, already the university will incur additional costs, of which the university is aware, with extra biosafety officers. Right now, in the McGill University system, we have 1.5 biosafety officers on campus and one at each of the affiliated hospitals, so we have a total of 4.5 biosafety officers now. However, we would probably have to double this to help process the paperwork, train the staff and lab visitors and monitor all the labs on an annual basis.
In addition, laboratory and classroom infrastructure and maintenance cost will increase as an outcome of this bill; we do not know at the university level how we will finance all this, but that is our problem.
In terms of scientific advisory oversight, we strongly recommend that there be representation on the advisory committee from academic educators, namely, people who are teaching as well as doing the research because we would love to be involved in helping to craft the regulations. We at AFMC would be most pleased to be involved in that. I have the contact information for the AFMC for interest down the line; we would be willing to work with people in the future on this.
The Chair: Thank you very much. Next is Mr. Bognar, Chair of the Biosafety Committee, Molecular Genetics at the University of Toronto.
Andrew Bognar, Associate Professor, Department of Molecular Genetics, University of Toronto: I am speaking as an individual, but at the University of Toronto we have had several sessions, internal consultations with our faculty and also with biosafety staff. In part, my views are coloured by the results of these consultation.
At the University of Toronto, we have a good working relationship between the environmental health and safety office and the biosafety committee, of which I am the chair. We have two biosafety officers, and we will soon hire a third. They do inspections for importation, and we also do spot checks now, as would be required if this law were implemented. We already do these things. We have biosafety coordinators in all our major buildings and all three campuses. We have biosafety certificates that every lab must obtain. If they do not obtain these certificates, then the administration will freeze their funding. We have enforcement of that. Within these certificates, we have a requirement for an inventory of all organisms that are being used, risk groups 1, 2, and 3.
In the House of Commons Health Committee, Dr. Butler-Jones mentioned that one of the main things they want in this bill is that they know where the level 2 organisms are. With our system, we do know where our level 2 organisms are. We have just purchased a database so that very soon we will be able to access that information quickly.
We also have training programs for biosafety for all faculty and staff, and we have medical surveillance for students and staff who work with pathogens or blood.
My proposal to the committee is that the Public Health Agency of Canada should use these resources that we have and let us administer compliance with Bill C-11, at least for risk group 2 organisms. Primarily, this would mean that the licensing should be on an institutional level rather than on an individual basis. A good model for this is the Canadian Nuclear Safety Act, in which our institution has a consolidated licence, and we administer compliance to radiation safety ourselves. They have inspectors who come by from time to time and do audits and inspections, but for day-to-day operations, the university handles compliance itself. I suggest the same should be done for this bill, at least for level 2 organisms.
I do not know if there is a mention of a biosafety committee at all in this bill, yet most universities have biosafety committees. These are also resources that can be used. On the schedules that you have, they mention the organisms, but nothing is said about materials such as recombinant DNA or retroviral vectors, to give two examples. We can use the biosafety committee to adjudicate over the use of not just the organisms but the recombinant DNA, and we match the risk group with the containment level. We do this on a daily basis. I suggest you allow us to continue doing this and not have everyone having to phone Health Canada every time there is a question of compliance.
Therefore, the obligation to inform the minister of situations such as every-day small spills or unintended non- compliance would only be for the level 3 facilities, and we can handle these things ourselves internally. Of course, the federal inspectors would still be able to audit our records. They would have access to our records of our inventories, for example, and they will have the ability to do site visits any time they wish. From day to day, we could administer the compliance to the bill ourselves.
I should add, with respect to these inspectors, that nothing is said in the bill as to what their qualifications should be. I would strongly suggest that they should have at least the qualifications that we have for our biosafety officers. I understand PHAC will have courses and exams for biosafety officers. I would suggest that the inspectors would have to pass these exams as well.
We were all encouraged by the amendment that excludes risk group 2 organisms from requiring security clearances. However, clause 31 in Bill C-11 still mentions that labs would need to have a list of authorized personnel and also of visitors. This does not exclude level 2 labs from this requirement.
I was talking to some hospital biosafety officers in preparation for this meeting. They mentioned this as a problem because they have their diagnostic labs, at least some of them, with full access to the public. If they were to regulate public access, they would have to hire security guards. It is almost like a backdoor mechanism for requiring security for level 2 labs. I think that should be removed from the bill.
At the University of Toronto, we have one level 3 facility, and we will soon open a second one. The level 3 facilities constitute a significant part of our research, particularly for research on the future health of Canadians.
Dr. Newkirk has already eloquently described how we cannot allow the personnel that we want to hire for these level 3 facilities to be held up by excessive timelines for getting security clearance. The mechanism for security clearances should be sped up as much as possible. I add my voice to hers in that regard.
Finally, we are also very concerned about intellectual property, although the amendments say that reasonable grounds are required for representatives of the minister to get information. It does worry us that under the Access to Information Act, other people, companies, even foreign governments, might be able to access proprietary information that people have worked hard to achieve. That should be safeguarded as much as possible.
The Chair: Thank you very much. Both you and Dr. Newkirk have talked about certain changes and amendments. If you have anything specific you would like us to look at, please put that in writing. Mr. Gould did put that in writing in his submission. If you have any specific recommendations, it would be helpful for us to look at those.
Dr. Wayne Conlan, Research Officer, National Research Council Canada: I would like to thank you for the opportunity to appear today and to give my opinions about Bill C-11. I am an employee of the National Research Council Canada, NRC, but I am appearing today as an interested individual. I am a microbiologist with 27 years' experience working in level 2 and 3 containment laboratories in the United Kingdom, the United States and Canada.
I guess the fact that I am able to appear before you today means that I have been doing things properly all that time.
I was a member of the committee that compiled the current Health Canada laboratory biosafety guidelines. Currently, I run a small animal level 3 biocontainment facility at the NRC, with a focus on highly virulent biodefence pathogens that cause life-threatening infections when inhaled. I have been the responsible official for the design and implementation of all of the biocontainment, biosafety and biosecurity policies associated with this facility, and for training of staff in all these areas. Annually, for the past 10 years, this facility has been certified for this purpose by both PHAC and the CFIA.
I also receive significant funding for this work from the U.S. National Institutes of Health. Therefore, my laboratory must also comply with the U.S. Select Agent Rules, on which Bill C-11 appears to be partially modelled. Consequently, our level 3 containment facility has being inspected by representatives from the U.S. Centers for Disease Control and Prevention, most recently in October of 2008, to ensure they are operating under the conditions equivalent to those required by the Select Agent Rules.
In complying with the Select Agent Rules, our laboratory is already fully operating within the limits being proposed by Bill C-11. I think the provisions set out by Bill C-11 for working with risk group 3 pathogens seem entirely appropriate. I do not anticipate that compliance with Bill C-11 will impose any undue additional hardship on the operations of current level 3 containment facilities in Canada.
In this regard, many thousands of U.S. researchers are complying with the Select Agent Rules, which do actually cover some level 2 pathogens. They comply for the simple reason that their federal funding depends on their compliance.
When I originally appeared as an expert witness before the Health Committee in March 2009 to discuss Bill C-11 in its then current form, one of the major concerns was the provision that people working with risk group 2 pathogens should obtain a security clearance. It is clear that this proposal has now been removed from the current revision. It appears that has been dealt with in a manner that should be satisfactory for all concerned.
Overall, given the level of compliance being sought by Bill C-11 with respect to level 2 pathogens, it is really difficult to argue against their formal inclusion in the act. However, level 2 labs are far more numerous than level 3 and 4 labs, and the system could be overwhelmed if they all try to register at once with the new act. It is incumbent on PHAC to ensure that the process of online registration for level 2 labs is an essentially painless experience that does not delay research progress. Allowing organizations to register all of their level 2 labs in a single application could help in this matter.
I thank you all for your time, and I am happy to answer any questions that you might have.
The Chair: Mr. Gould, you are representing what you call community laboratories. You are talking about diagnostic analysis that you do for thousands upon thousands of patients, and you have a large quantity of these laboratories. You are just dealing with Ontario; I would imagine there are many more across the country.
You said that patient safety was at risk. I would like you to expand on that. I would also like you to comment on something that I thought I heard a week ago from Dr. Butler-Jones, but I am not absolutely sure. I believe he said that it was not their intention to have diagnostic laboratories, such as the type that you are operating, covered by this legislation or in any way penalized or put through an extra administrative burden.
I am not sure exactly how that comes into it, whether it is something that would be sorted out in the regulations. There is a clause in the bill that does exempt people who collect specimens — physicians and such. However, that does not appear to exempt your clients, the laboratories.
Could you comment on that generally — whether what Dr. Butler-Jones has suggested will not be an additional burden for you, and why you think patient safety is at risk?
Mr. Gould: On the notion that diagnostic collection is exempt, most of our 300-odd collection centres also handle specimens. They are aliquoting, separating out, centrifuging and taking the stopper out of the test tubes. That goes beyond the definition of collection. Therefore, we are captured into that, which would nullify the exemption with respect to the collection itself.
With respect to safety, the requirement to document when moving specimens from one facility to the next is really a delay factor to being able to move specimens in an expeditious and timely fashion to ensure that the testing does get done and results reported. It is the additional requirements that slow down the likelihood of that happening expeditiously.
The Chair: How does that compromise patient safety?
Mr. Gould: The testing does not get done in a timely fashion; the results are being slowed down.
Senator Eaton: Thank you all for the interesting points of view. Mr. Gould, I have to assume that your diagnostic laboratories have been following biosafety guidelines for a long time, have they not?
Mr. Gould: That is correct.
Senator Eaton: How would your costs be increased?
Mr. Gould: Due to the added administrative burden, the redundancy of having these new requirements that may be different from requirements in Ontario. The multiple requirements we have through the Occupational Health and Safety Act, the licensing regimen and the accreditation process all have components of safety requirements. We will be adding duplication that may include different administrative requirements.
Senator Eaton: Please enlighten me more. I thought the provincial acts were more to do with labour safety and standards. This bill deals more with the actual bugs; is that not right? This bill deals with the actual standards for pathogens and for ensuring that the pathogens are dealt with in a safe fashion; that they are not released inadvertently or thrown down a drain.
Mr. Gould: That is what laboratory workers are familiar with. The regulations and expertise cover that. These are specimens that are in the laboratory handled by expert technologists.
Senator Eaton: I do not see the duplication if you have been practising certain standards. We have a different point of view.
Mr. Gould: It is the different administrative requirements.
One example that has already been identified is the requirement to register people in our collection centres. The patients who are coming into our collection facilities would have to be registered.
Senator Eaton: You mean they would have to sign a book?
Mr. Gould: I am not sure what the actual implications would be in terms of the process of registration.
The previous version dealt with having to deal with the security clearance. That has been removed, but the requirement to register remains, as Mr. Bognar also mentioned.
Senator Eaton: Dr. Newkirk, you were talking about a major impact on your teaching in mostly risk group 2 labs. My understanding is that it would mean that students would have to register in the course and sign in and out of the lab. Is that not right?
Ms. Newkirk: You are right. In terms of level 2, with the modifications that have been made, there will not be as big a problem as there had been previously. We see a bigger problem with where we want expeditious processing for level 3. The graduate students, the people learning to work with those pathogens, those who are giving the knowledge base so the next generation is trained, those are the individuals who will be impacted by going through security clearances and so on.
Senator Eaton: It is my understanding that the safety advisory committee that will be put together will look. I understand that some university laboratories have tuberculosis, which is a risk group 3.
Ms. Newkirk: That is right.
Senator Eaton: However, that it will differentiate between those that need security clearance and those found more often in a university lab, such as TB.
Ms. Newkirk: However, it is level 3.
Senator Eaton: Yes, it is level 3. However, they will make a difference in the level 3s — those that a university can have without creating another whole containment area and those that would need security clearance. I think, right now in universities, you actively have risk group 3.
Ms. Newkirk: Right now, the level 3 system is very well contained. It is inspected, and the government comes to ensure that everything is fine. We are not allowed to open them unless that is the case.
We are talking more about the students who are working in there. They are the ones who will need to have the security clearance. We are worried that will hold up their ability to work in that environment, if there is excessive time taken for them to go through a security clearance.
Senator Eaton: I thought the bill specifies that, for a student or visiting professor, you do not need a security clearance if you have supervision by someone with security clearance.
Ms. Newkirk: We actually restrict these level 3 containment areas to only two people. In the one we have at the Montreal General Hospital, for example, only two people are allowed in there at one time. It will be problematic. You will need to have security clearance if you follow the law the way it is now written.
Senator Raine: In your presentations, it is obvious that level 2 is very broad in the range of toxins and pathogens. Most of them are not that hazardous.
If we are trying to apply something and the categories do not fit what our objectives are — which is to provide a safer situation — should we perhaps be looking at how the pathogens are classified? Is our system the same as other countries?
Ms. Newkirk: I have the CDC list here. I can leave it with you. It is the list in which they are considering bioterrorist agents.
The Chair: Is that for the United States?
Ms. Newkirk: Yes, the United States. Although they are mostly level 3 and 4, a couple of level 2 on the list are consider to be potential bioterrorist threats. However, the vast majority of level 2s are not on here.
Therefore, indeed, the U.S.A. has done exactly that. They have identified some level 2 that they have particular concerns about. That may be something that needs to be looked at in drawing up a list and determining which pathogens or toxins are highest risk and need the tighter security.
Senator Raine: I am uninformed here, but how is the level 2 determined? How is it determined whether a substance is level 2 or 3? I have heard that some of the students are working with level 3.
Ms. Newkirk: They are, but only after they have been trained and know how proceed properly. We would never allow them to work with biological materials without that training. Of course, we want to train our next generation, so we have to train them on level 2, 3, and 4.
Some level 2s that are absolutely safe we can work with on the bench top. That is the whole problem with this. We have a broad spectrum of pathogens here, some with very little pathogenic potential at all. However, some are of major concern, and we do need to protect our population from them.
Mr. Bognar: Level 2 pathogens are ones that are not that easily spread. They do cause disease, but they are not that easily spread. Whereas level 3 might be spread through aerosols, for example, and those are very easy to pass on.
Senator Champagne: They do spread in the hospital, for example. Looking at the list of level 2 pathogens, I had the pleasure of hosting three of them at the same time, and it does not make things easy.
Mr. Bognar: In a lab setting, they are not that easily spread.
Dr. Conlan: You have to understand that risk group categorization is based as much on what you are planning to do with the pathogen as what it is capable of doing. For example, if you are just culturing the bacteria that cause legionnaires' disease, it is considered to be a level 2 pathogen. However, if you want to make deliberate aerosols of this to infect some animals to test a vaccine, it has to be considered a level 3 pathogen. Some of these organisms straddle. Some go down; after a body of evidence has amassed, they are reduced to risk group 2. Others go up to risk group 3. For example, the Walkerton E. coli is currently considered a level 2 pathogen here, but it is considered a level 3 pathogen in the U.K.
Senator Raine: With respect to the concern about duplication of regulations and the difficulty in dealing with that, obviously this legislation has been proposed because it is perceived that holes exist in the current situation. Could you comment on that?
Do you think this legislation is required, or are you bluntly saying that it is not? Obviously, we would not be proposing this if we did not think there was a need for it.
Dr. Conlan: The federal government ought to want to know who has what and where and, to some extent, in what quantity. You might want to know that for a variety of reasons. There are clearly still concerns over the administrative burden for level 2 pathogens, but it seems that most of those can be addressed and still keep these organisms in the bill.
What would happen if tomorrow PHAC decides that E. coli is a risk group 3 pathogen? If it does not know who is working with them at level 2, how will it ever be able to inform them that it is no longer a level 2 pathogen? That would be one example of why you would want to know who has what and where.
Similarly, if a laboratorian goes on vacation and gets sick, who will tell them what they may have if they are no longer at their host institution when they fall ill?
Mr. Bognar: At present, the only regulation is for when you import pathogens. The gap this bill would fill is that it regulates labs at all times for what they are using.
Mr. Gould: The other issue is that this bill seems to be combining and not distinguishing sufficiently well the biosafety concerns with the biosecurity concerns. The biosafety issues are more adequately handled through other regulatory requirements in the provinces that have licensed diagnostic laboratories.
The Chair: Do you have something to add, Ms. Newkirk?
Ms. Newkirk: No, they have pretty adequately covered it.
The Chair: Let me ask a question about the use of the Criminal Code in this. If we are dealing with hospital bioterrorism, I do not think anyone would disagree with using the Criminal Code. The concern is that when it comes to legitimate research and the work of the diagnostic laboratories in the communities, a mistake should not be something prosecuted under the Criminal Code.
Dr. Butler-Jones said that is not the intention, but it is not very clear just where that decision is made, when it is made and who will make it as to whether any prosecution will take place or not. As we have heard earlier today, it was intended as a last resort.
How much of a chill does that create for people working in the diagnostic or research laboratories at our universities, or wherever, a chill about if you make a mistake, then, who knows, you might be subject to some criminal prosecution? How much of a concern do you have about that?
Ms. Newkirk: I can address this from my hat as the associate dean. We are very concerned about integrity. We are always working to ensure that our scientists are honest, careful and make as few errors as possible, but errors do happen. As long as people admit to them and never try to hide them, then that person is still considered to be someone who has integrity. However, if someone made an error and then tries to cover up on it because there may be a threat of severe penalty, then I would worry.
You have to consider that that could be a consequence of prosecution, where someone would actually try to cover up a mistake that they made because they feared the consequences. That is something else you need to think about in terms of what could happen with this legislation.
Dr. Conlan: The wording of the proposed act, however, is that it is only in cases of people flagrantly flouting the rules that it would be considered a criminal prosecution. It says somewhere that if something occurs whilst a person was acting in good faith, they would not be prosecuted, or words to that effect. It is only for people who are deliberately and flagrantly unsafe with what they are working with who would be prosecuted.
Maybe that needs to be spelled out more clearly. It seemed to me that it was the case where if you had a legitimate laboratory accident and you were following all the rules, that would not make you a criminal.
Ms. Newkirk: As long as you did not hide it.
Mr. Gould: I would reinforce that. There needs to be clarity because this criminalization does cause major concern with respect to diagnostic laboratories having regulated medical lab technologists and professional employees, who are experts in this technology, for making an inconsequential error that one would expect. Over a long period of time, errors will occur, and for this to be criminalized would not be acceptable.
Mr. Bognar: I think the fines are still very high. They reduced it to $50,000, but the next day they can hit you with a second offence at $250,000. It is still a chilling thought.
Senator Cordy: One of you mentioned access to information. Will this bill allow information on research to be accessed? I think it was you, Mr. Bognar, with respect to risking disclosure of research being done, proprietary information.
Mr. Bognar: I admit that I am not a lawyer and could not adequately answer that question, but I do know that we have had reporters come and ask us to divulge information. I think it was about everyone who was using recombinant organisms; they use the Access to Information Act to try to get information on that. It is a worry that I have, but I would have to consult with someone who really knows about it whether it is a specific problem.
Senator Cordy: If you find any information, would you let us know?
Mr. Bognar: Certainly.
Senator Cordy: With respect to my second question, I think it was you, Mr. Gould, who was talking about a lack of consultation or minimal consultation.
This is framework legislation, and so we hear that consultation will take place after we pass the bill, which is scary. We have also heard that regulations could be five years in the making, so in fact, even if the bill passes, it will take five years before the regulations are ready. We also know that the minister can hear the recommendations by the Senate and the House of Commons committees but does not have to accept the recommendations.
If it will take five years for the regulations to be developed and put in place, should we slow down the passage or hold back the passage of the bill until we have more meat on the bones of the legislation?
Mr. Gould: A lack of consultation really reflects that there have been opportunities to hear. There have been more information sessions than consultation sessions. Some of the concerns that have been raised today could perhaps have been addressed had it been a true consultation process or a more meaningful one with adequate opportunity.
That causes a certain amount of skepticism going forward of the assurance that a process will be in place to allow for adequate consultation through the development of regulations. Because it may take five years, there needs to be some assurance that adequate consultation will take place in the development of the regulations. Ideally, it would be best to have a better bill.
Senator Cordy: Also consultation before the bill passes?
Mr. Gould: Correct.
The Chair: I am sorry it took such a long time to do this. We are almost an hour over our usual time schedule, but thank you very much for your participation in this and all of the information that you have given us to absorb.
Members of the committee, we have a couple of things to discuss. A motion was passed by the Senate in my name yesterday that involves the Subcommittee on Cities meeting up until June 30, if necessary, if the Senate should adjourn. It is a straight procedural thing, but it requires the main committee to also deal with it. Is it agreed, honourable senators, that the committee delegate to its Subcommittee on Cities the power to sit up to and including June 30, 2009, for the purpose of its study on current social issues pertaining to Canada's largest cities, even though the Senate may then be adjourned for a period exceeding one week, as authorized by the Senate on June 9?
Hon. Senators: Agreed.
The Chair: That is carried.
I also want to spend a minute on where we go next on Bill C-11. You recall we had Elaine Gibson here last time from Dalhousie University who raised several issues, but she talked about, among other things, the Privacy Commissioner and also the constitutional aspects of this vis-à-vis the provinces and their systems. I think four provinces have laws relevant to this. She also raised the question of an almost parallel act that is in the Supreme Court of Canada relevant to an appeal by the Province of Quebec on this.
I would suggest two things. One, I have asked the Privacy Commissioner for a letter. She could not be here today.
Senator Eaton: We got a letter?
The Chair: I have asked for an update in view of where we are at this point following the amendments in the House of Commons. The office said that she would get something here on Monday.
I think we should put Bill C-11 on for next Wednesday. We can also have the Privacy Commissioner here.
I would also like to get some comments from the four provinces, if we can, with some procedures in this regard.
Then, depending on what information we have and if you have anything else you want to add in terms of additional people, we could deal with it at that meeting, or we could then go into discussion about the bill, any observations we may want to have, or we can do clause-by-clause consideration on the bill, if we are ready to do so.
Senator Eaton: I feel very frustrated as a new senator, having done a great deal of work on this, that we are getting so many agendas. In many cases, they have not read the bill; they are not getting expert opinion; there is so much emotion.
From what Professor Ouellette said today, one can see that there is so much misinformation being passed through here. I cannot rebut or argue with him, and I understand that is the way committees work. I hope the chair will consider asking the minister here. At least then you are getting it straight from the horse's mouth and not through various agendas and prisms.
I am sorry; I found them all so hostile and many of them had not really thought it through. For example, $50,000 is a last resort. If you read the bill, you know full well you have to prove criminal intent; it has to be someone who murderously sets out to hurt another, not someone spilling something or making a mistake in the lab.
The Chair: I am just asking about procedure at this point in time. We are not debating.
Senator Eaton: I am just saying it would be good if we —
The Chair: You are getting into a debate on the issues, and we are not at that point. We are still talking about how to process this next. We can ask the minister to come, if that is what you want.
Senator Eaton: I would love that. It would give all senators a really fair view.
The Chair: Let us ask the minister to come.
Senator Cordy: I feel very strongly that the Privacy Commissioner has to be at our committee meeting because I have some concerns. I have read the bill and have concerns that the minister has very broad powers to disclose information, and a letter from the Privacy Commissioner is not enough. Any commissioner's job is to appear before a committee if we need his or her input.
The Chair: Okay. I have the minister and the Privacy Commissioner. I do not know that we need the provinces to appear, but I would like to try to get the opinion of the provinces in writing.
Senator Cordy: Is there a constitutional expert who could talk to us? We have heard from a number of witnesses that there are two distinct things being put together in this bill: biosafety and biosecurity.
The Chair: That is what Elaine Gibson was about. She was here to advise us and is a constitutional authority in this regard.
Senator Cordy: If we overlap and pass a bill with provincial jurisdiction, then all our work is for nought because it will go to the court and all the work will be gone.
The Chair: We can look at that to see if there is anyone else in that category, but I think we should ask for the thoughts from the provinces with some regulatory system respecting these matters — pathogens, human pathogens and toxins.
Senator Martin: I was under the understanding that the consultation process to this point has been almost two years and that provinces have been consulted, so I wonder if we have a record of those consultations. I understand the importance of broad consultation, but we will always have individuals who, if they do not hear what they want, feel they have not been consulted. I do not know about all of the witnesses who have been here, but I thought Dr. Singer had the most balanced presentation where he critiqued what his concerns were but also said that, yes, this fills a gap. He was very helpful.
The Chair: Let me see what we can do for the next meeting in terms of more information that might begin to get us in a direction where we can deal with this matter.
Senator Martin: Rather than repeating the process, perhaps we can look at those records.
The Chair: I do not want to repeat processes; I want to look at where we have gaps, where we have not addressed questions.
Senator Martin: The past records of consultations.
The Chair: We can talk to the Privacy Commissioner, provinces, Minister of Health, if you like. Yes, where we will get new information that will help us answer some questions and concerns that we have heard.
Senator Martin: I agree. Thank you.
The Chair: Okay. With that, we now stand adjourned.
(The committee adjourned.)